SEC. 101. Definition.
In this division, the term “Secretary” means the Secretary of Agriculture.
Division HH — Agriculture
DIVISION HH Agriculture
TITLE I Conservation
SEC. 201. Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program.
Definitions.— In this section:
Advisory council.— The term “Advisory Council” means the Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program Advisory Council established under subsection (f)(1).
Agriculture or forestry credit.— The term “agriculture or forestry credit” means a credit representing an amount of greenhouse gas emissions from an agricultural or forestry activity that are prevented, reduced, or mitigated (including through the sequestration of carbon) as a result of an agricultural or forestry activity.
Beginning, socially disadvantaged, limited resource, or veteran farmer, rancher, or private forest landowner.— The term “beginning, socially disadvantaged, limited resource, or veteran farmer, rancher, or private forest landowner” means a farmer, rancher, or private forest landowner who is—
a beginning farmer or rancher (as defined in section 2501(a) of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 2279(a)));
a socially disadvantaged farmer or rancher (as defined in section 355(e) of the Consolidated Farm and Rural Development Act (7 U.S.C. 2003(e)));
a limited resource farmer or rancher (as defined in section 1470.3 of title 7, Code of Federal Regulations (or successor regulations)); or
a veteran farmer (as defined in section 2501 of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 2279)).
Covered entity.— The term “covered entity” means a person or entity, including a private business, non-profit organization, or public agency, that either—
is a provider of technical assistance to farmers, ranchers, or private forest landowners in carrying out sustainable land use management practices that prevent, reduce, or mitigate greenhouse gas emissions (including through the sequestration of carbon); or
is a third-party verifier entity that conducts the verification of the processes described in protocols for voluntary environmental credit markets.
Greenhouse gas.— The term “greenhouse gas” means—
carbon dioxide;
methane;
nitrous oxide; and
any other gas that the Secretary, in consultation with the Advisory Council, determines has been identified to have heat trapping qualities.
Program.— The term “Program” means the Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program established under subsection (b).
Protocol.— The term “protocol” means a systematic approach for generating an agriculture or forestry credit, which follows a transparent and thorough science-based methodology (including 1 or more baseline scenarios)—
for the development of projects to prevent, reduce, or mitigate greenhouse gas emissions (including projects to sequester carbon); and
for demonstrating how to quantify, monitor, report, and verify the prevention, reduction, or mitigation of greenhouse gas emissions by projects described in subparagraph (A).
Socially disadvantaged group.— The term “socially disadvantaged group” has the meaning given that term in section 355(e) of the Consolidated Farm and Rural Development Act (7 U.S.C. 2003(e)).
Technical assistance.— The term “technical assistance” means technical expertise, information, and tools to assist a farmer, rancher, or private forest landowner, who is engaged in or wants to engage in a project to prevent, reduce, or mitigate greenhouse gas emissions (including a project to sequester carbon), as necessary to meet a protocol.
Voluntary environmental credit market.— The term “voluntary environmental credit market” means a voluntary market through which agriculture or forestry credits may be bought or sold.
Establishment of Program.—
Determination.—
In general.— Not later than 270 days after the date of enactment of this Act, the Secretary shall make a determination of whether establishing a voluntary program to register covered entities that carry out activities described in subsection (c)(2) will further each of the following purposes:
Facilitating the participation of farmers, ranchers, and private forest landowners in voluntary environmental credit markets.
Facilitating the provision of technical assistance, through covered entities, to farmers, ranchers, and private forest landowners to help overcome barriers to entry into voluntary environmental credit markets.
Ensuring that participating farmers, ranchers, and private forest landowners receive fair distribution of revenues derived from the sale of an agriculture or forestry credit.
Increasing access for farmers, ranchers, and private forest landowners to resources relating to existing voluntary environmental credit markets, including information relating to the basic market structure and the various roles and qualifications of different parties.
Considerations.— In making the determination under this paragraph, the Secretary shall consider the results of the assessment conducted under subsection (g)(2)(A) and any other relevant information.
Establishment.— If the Secretary determines under paragraph (1) that establishing such a program will further such purposes, the Secretary shall establish a voluntary program, to be known as the “Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program”, to register covered entities that carry out activities described in subsection (c).
Report.— Not later than 90 days after making the determination under paragraph (1), the Secretary shall publish a report describing the reasons for such determination, including how establishing a program under this subsection would or would not further each of the purposes described in paragraph (1)(A).
Protocols, Qualifications, and Activities.—
Widely accepted protocols and qualifications.— After providing public notice and at least a 60-day period for public comment, but not later than 90 days after the date on which the Program is established, the Secretary shall publish—
a list of, and documents relating to, widely accepted protocols that are designed to ensure consistency, reliability, effectiveness, efficiency, and transparency of voluntary environmental credit markets, including protocol documents and details relating to—
calculations;
sampling methodologies;
voluntary environmental credit accounting principles;
systems for verification, monitoring, measurement, and reporting; and
methods to account for additionality, permanence, leakage, and, where appropriate, avoidance of double counting; and
descriptions of widely accepted qualifications possessed by covered entities that provide technical assistance to farmers, ranchers, and private forest landowners.
Activities.— A covered entity may register under the Program with respect to technical assistance or process verification the covered entity carries out for activities that prevent, reduce, or mitigate greenhouse gas emissions, including—
land or soil carbon sequestration;
emissions reductions derived from fuel choice or reduced fuel use;
livestock emissions reductions, including emissions reductions achieved through—
feeds, feed additives, and the use of byproducts as feed sources; or
manure management practices;
on-farm energy generation;
energy feedstock production;
fertilizer or nutrient use emissions reductions;
reforestation;
forest management, including improving harvesting practices and thinning diseased trees;
prevention of the conversion of forests, grasslands, and wetlands;
restoration of wetlands or grasslands;
grassland management, including prescribed grazing;
current practices associated with private land conservation programs administered by the Secretary; and
such other activities, or combinations of activities, that the Secretary, in consultation with the Advisory Council, determines to be appropriate.
Inclusions.— In publishing the list of widely accepted protocols and the descriptions of widely accepted qualifications under paragraph (1), the Secretary, in consultation with the Advisory Council, shall include all relevant information relating to market-based protocols, as appropriate, with regard to—
quantification;
verification;
additionality;
permanence;
reporting; and
other expertise, as determined by the Secretary.
Periodic review.— As appropriate, the Secretary shall periodically review and revise the list and descriptions published under paragraph (1) to include any additional protocols or qualifications described in paragraph (3).
Registration, Website, and Publication of Lists.—
Registration list.—
In general.— Not later than 1 year after establishing the Program, the Secretary shall publish, through a website maintained by the Secretary, a registration list consisting of a list of covered entities that have submitted information to the Secretary, which list the Secretary shall regularly update.
Registration.— A covered entity may register under the Program to be included on the registration list by submitting to the Secretary, through a website maintained by the Secretary, information that—
shall include—
the region in which the covered entity provides its services;
whether the covered entity is a technical assistance provider or a verifier; and
the protocols in which the covered entity has proficiency; and
may include additional information that—
has been identified by the Advisory Council in its initial assessment under subsection (g)(1) to ensure certainty for producers in the marketplace for agriculture or forestry credits; and
the Secretary determines is appropriate for inclusion.
Website and solicitation.— During the 180-day period beginning on the date on which the Program is established, the Secretary shall publish, through an existing website maintained by the Secretary—
information describing how covered entities may register under the Program in accordance with paragraph (1);
a list of the widely accepted protocols and qualifications published by the Secretary under subsection (c)(1); and
instructions and suggestions to assist farmers, ranchers, and private forest landowners in facilitating the development of agriculture or forestry credits and accessing voluntary environmental credit markets, including—
through working with covered entities registered under the Program; and
by providing information relating to programs, registries, and protocols of programs and registries that provide market-based participation opportunities for working and conservation agricultural and forestry lands.
Programmatic integrity.— The Secretary shall ensure, to the maximum extent practicable, that covered entities registered under the Program—
act in good faith to provide realistic estimates of costs and revenues relating to activities and verification of processes described in subsection (c)(2), as applicable to the covered entity; and
demonstrate expertise in, and are able to perform in accordance with, best management practices for agricultural and forestry activities that prevent, reduce, or mitigate greenhouse gas emissions (including through the sequestration of carbon).
Removal from registration list.—
In general.—
Removal.— The Secretary shall remove a covered entity from the registration list under the Program if the Secretary determines that the covered entity has not acted in accordance with—
the information provided by the entity under paragraph (1)(B); or
best management practices for agricultural and forestry activities that prevent, reduce, or mitigate greenhouse gas emissions (including through the sequestration of carbon).
Determination.— The Secretary may make a determination under clause (i)—
based on a periodic review of a representative sample of covered entities, which shall occur not less frequently than once each year; or
as necessary.
Appeal of removal.—
In general.— A covered entity that has been removed from the registration list pursuant to subparagraph (A) may appeal the determination to the Secretary.
Re-registration.— A covered entity that appeals a determination under clause (i) may re-register under the Program if the covered entity successfully proves, as determined by the Secretary, that the covered entity has acted in accordance with, as applicable—
the information provided by the entity under paragraph (1)(B); and
best management practices for agricultural and forestry activities that prevent, reduce, or mitigate greenhouse gas emissions (including through the sequestration of carbon).
Notification.— If the Secretary removes a covered entity from the registration list pursuant to subparagraph (A), to the extent practicable, the Secretary shall—
request from that covered entity contact information for all farmers, ranchers, and private forest landowners to which the covered entity provided technical assistance or the verification of the processes described in protocols of voluntary environmental credit markets; and
notify those farmers, ranchers, and private forest landowners of the removal.
Savings clause.— Nothing in this section authorizes the Secretary to compel a farmer, rancher, or private forest landowner to participate in a transaction or project facilitated by a covered entity certified under paragraph (1).
Submission of Fraudulent Information or Claims.—
In general.— A person or entity, regardless of whether the person or entity is registered under the Program, shall not make a fraudulent submission under subsection (d) or make a fraudulent claim regarding the presence of that person or entity on the registration list published under such subsection.
Penalty.— Any person or entity that violates paragraph (1) shall be—
subject to a civil penalty equal to such amount as the Secretary determines to be appropriate, not to exceed $1,000 per violation; and
ineligible to register under the Program for the 5-year period beginning on the date of the violation.
Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program Advisory Council.—
In general.— During the 90-day period beginning on the date on which the Program is established, the Secretary shall establish an advisory council, to be known as the “Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program Advisory Council”.
Membership.—
In general.— The Advisory Council shall be composed of members appointed by the Secretary in accordance with this paragraph.
General representation.— The Advisory Council shall—
be broadly representative of the agriculture and private forest sectors;
include beginning, socially disadvantaged, limited resource, and veteran farmers, ranchers, and private forest landowners; and
be composed of not less than 51 percent farmers, ranchers, or private forest landowners.
Members.— Members appointed under subparagraph (A) shall include—
not more than 2 representatives of the Department of Agriculture, as determined by the Secretary;
not more than 1 representative of the Environmental Protection Agency, as determined by the Administrator of the Environmental Protection Agency;
not more than 1 representative of the National Institute of Standards and Technology;
not fewer than 12 representatives of the agriculture industry, appointed in a manner that is broadly representative of the agriculture sector, including not fewer than 6 active farmers and ranchers;
not fewer than 4 representatives of private forest landowners or the forestry and forest products industry appointed in a manner that is broadly representative of the private forest sector;
not more than 4 representatives of the relevant scientific research community, including not fewer than 2 representatives from land-grant colleges and universities (as defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3103)), of which 1 shall be a representative of a college or university eligible to receive funds under the Act of August 30, 1890 (commonly known as the “Second Morrill Act”) (26 Stat. 417, chapter 841; 7 U.S.C. 321 et seq.), including Tuskegee University;
not more than 2 experts or professionals familiar with voluntary environmental credit markets and the verification requirements in those markets;
not more than 3 members of nongovernmental or civil society organizations with relevant expertise, of which not fewer than 1 shall represent the interests of socially disadvantaged groups;
not more than 3 members of private sector entities or organizations that participate in voluntary environmental credit markets; and
any other individual whom the Secretary determines to be necessary to ensure that the Advisory Council is composed of a diverse group of representatives of industry, academia, independent researchers, and public and private entities.
Chair.— The Secretary shall designate a member of the Advisory Council to serve as the Chair.
Terms.—
In general.— The term of a member of the Advisory Council shall be 2 years, except that, of the members first appointed—
not fewer than 8 members shall serve for a term of 1 year;
not fewer than 12 members shall serve for a term of 2 years; and
not fewer than 12 members shall serve for a term of 3 years.
Additional terms.— After the initial term of a member of the Advisory Council, including the members first appointed, the member may serve not more than 4 additional 2-year terms.
Meetings.—
Frequency.— The Advisory Council shall meet not less frequently than annually, at the call of the Chair.
Initial meeting.— During the 90-day period beginning on the date on which the members are appointed under paragraph (2)(A), the Advisory Council shall hold an initial meeting.
General duties.— The Advisory Council shall—
periodically review and recommend any appropriate changes to—
the list of protocols and description of qualifications published by the Secretary under subsection (c)(1); and
the activities described in subsection (c)(1)(B);
make recommendations to the Secretary regarding the best practices that should be included in the protocols, description of qualifications, and activities described in subparagraph (A); and
advise the Secretary regarding—
the current methods used by voluntary environmental credit markets to quantify and verify the prevention, reduction, or mitigation of greenhouse gas emissions (including the sequestration of carbon);
means to reduce barriers to entry in the business of providing technical assistance or the verification of the processes described in protocols of voluntary environmental credit markets for covered entities, including by improving technical assistance provided by the Secretary;
means to reduce compliance and verification costs for farmers, ranchers, and private forest landowners in entering voluntary environmental credit markets, including through mechanisms and processes to aggregate the value of activities across land ownership;
issues relating to land and asset ownership in light of evolving voluntary environmental credit markets; and
additional means to reduce barriers to entry in voluntary environmental credit markets for farmers, ranchers, and private forest landowners, particularly for beginning, socially disadvantaged, limited resource, and veteran farmers, ranchers, and private forest landowners.
Compensation.— The members of the Advisory Council shall serve without compensation.
Conflict of interest.— The Secretary shall prohibit any member of the Advisory Council from—
engaging in any determinations or activities of the Advisory Council that may result in the favoring of, or a direct and predictable effect on—
the member or a family member, as determined by the Secretary;
stock owned by the member or a family member, as determined by the Secretary; or
the employer of, or a business owned in whole or in part by, the member or a family member, as determined by the Secretary; or
providing advice or recommendations regarding, or otherwise participating in, matters of the Advisory Council that—
constitute a conflict of interest under section 208 of title 18, United States Code; or
may call into question the integrity of the Advisory Council, the Program, or the technical assistance or verification activities described under subsection (c)(2).
FACA applicability.— The Advisory Council shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.), except that section 14(a)(2) of that Act shall not apply.
Assessment.—
Initial assessment.— Not later than 90 days after the Advisory Council holds an initial meeting, the Advisory Council shall submit to the Secretary, the Committee on Agriculture of the House of Representatives, and the Committee on Agriculture, Nutrition, and Forestry of the Senate an initial assessment that examines ways to ensure certainty for farmers, ranchers, or private forest landowners in the marketplace for agriculture or forestry credits, including identification of any information that may be appropriate for entities to provide when registering under subsection (d)(1)(B).
General assessment.— Not later than 240 days after the date of enactment of this Act, the Secretary, in consultation with the Administrator of the Environmental Protection Agency, shall—
conduct an assessment, which incorporates information from existing publications and reports of the Department of Agriculture and other entities with relevant expertise, regarding—
the number and categories of non-Federal actors in the nonprofit and for-profit sectors involved in development, generation, or sale of agriculture or forestry credits in voluntary environmental credit markets;
the estimated overall domestic market demand for agriculture or forestry credits at the end of the preceding 4-calendar year period, and historically, in voluntary environmental credit markets;
the total number of agriculture or forestry credits (measured in metric tons of carbon dioxide equivalent) that were estimated to be in development, generated, or sold in market transactions during the preceding 4-calendar year period, and historically, in voluntary environmental credit markets;
the estimated supply and demand of metric tons of carbon dioxide equivalent of offsets in the global marketplace for the next 4 years;
the barriers to entry due to compliance and verification costs described in subsection (f)(4)(C)(iii);
the state of monitoring and measurement technologies needed to quantify long-term carbon sequestration in soils and from other activities to prevent, reduce, or mitigate greenhouse gas emissions in the agriculture and forestry sectors;
means to reduce barriers to entry into voluntary environmental credit markets for beginning, socially disadvantaged, limited resource, and veteran farmers, ranchers, and private forest landowners, and the extent to which existing protocols of voluntary environmental credit markets allow for aggregation of projects among farmers, ranchers, and private forest landowners;
the extent to which the existing regimes for generating and selling agriculture or forestry credits (as the regimes exist at the end of the preceding 4-calendar year period, and historically), and existing voluntary environmental credit markets, may be impeded or constricted, or achieve greater scale and reach, if the Department of Agriculture were involved, including involvement in education described in clause (ix);
the extent to which Department of Agriculture education of stakeholders about voluntary environmental credit markets would benefit those stakeholders, including whether that education would reduce barriers to entry identified under clause (v);
the extent to which existing protocols of voluntary environmental credit markets, including verification, additionality, permanence, and reporting, adequately take into consideration and account for factors encountered by the agriculture and private forest sectors in preventing, reducing, or mitigating greenhouse gas emissions (including by sequestering carbon) through agriculture and forestry practices, considering variances across regions, topography, soil types, crop or species varieties, and business models;
the extent to which existing protocols of voluntary environmental credit markets consider options to ensure the continued valuation, through discounting or other means, of agriculture and forestry credits in the case of the practices underlying those credits being disrupted due to unavoidable events, including production challenges and natural disasters; and
opportunities for other voluntary markets outside of voluntary environmental credit markets to foster the trading, buying, or selling of credits that are derived from activities that provide other ecosystem service benefits, including activities that improve water quality, water quantity, wildlife habitat enhancement, and other ecosystem services, as the Secretary determines appropriate;
publish the assessment; and
submit the assessment to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives.
Quadriennial assessment.— The Secretary, in consultation with the Administrator of the Environmental Protection Agency and the Advisory Council, shall conduct the assessment described in paragraph (2)(A) and publish and submit such assessment in accordance with subparagraphs (B) and (C) of paragraph (2) every 4 years after the publication and submission of the first assessment under subparagraphs (B) and (C) of paragraph (2).
Confidentiality.—
Prohibition.—
In general.— Except as provided in paragraph (2), the Secretary, any other officer or employee of the Department of Agriculture or any agency of the Department of Agriculture, or any other person may not disclose to the public the information held by the Secretary described in subparagraph (B).
Information.—
In general.— Except as provided in clause (ii), the information prohibited from disclosure under subparagraph (A) is—
personally identifiable information, including in a contract or service agreement, of a farmer, rancher, or private forest landowner, obtained by the Secretary under subsection (d)(4)(C)(i); and
confidential business information in a contract or service agreement of a farmer, rancher, or private forest landowner obtained by the Secretary under subsection (d)(4)(C)(i).
Aggregated release.— Information described in clause (i) may be released to the public if the information has been transformed into a statistical or aggregate form that does not allow the identification of the person who supplied or is the subject of the particular information.
Exception.— Paragraph (1) shall not prohibit the disclosure by an officer or employee of the Federal Government of information described in paragraph (1)(B) as otherwise directed by the Secretary or the Attorney General for enforcement purposes.
Funding.—
Authorization of appropriations.— In addition to the amount made available under paragraph (2), there is authorized to be appropriated to carry out this section $1,000,000 for each of fiscal years 2023 through 2027.
Direct funding.—
Rescission.— There is rescinded $4,100,000 of the unobligated balance of amounts made available by section 1003 of the American Rescue Plan Act of 2021 (Public Law 117–2).
Appropriation.— If such unobligated amounts are available to execute the rescission under subparagraph (A), on the day after the execution of the rescission, there is appropriated to the Secretary, out of amounts in the Treasury not otherwise appropriated, $4,100,000 to carry out this section to remain available for fiscal years 2023 through 2027.
Prohibition.— None of the funds of the Commodity Credit Corporation shall be used to carry out this section.
Rule of Construction.— Nothing in this section shall be construed to provide authority to the Secretary for the establishment or operation of a Federal market through which agriculture or forestry credits may be bought or sold.
SEC. 202. Acceptance and Use of Private Funds for Public-Private Partnerships.
Section 1241(f) of the Food Security Act of 1985 (16 U.S.C. 3841(f)) is amended—
in the subsection heading, by inserting “ for Public-Private Partnerships” after “ Contributions”;
by amending paragraph (1) to read as follows:
“(1) Establishment of public-private partnership contributions accounts.—The Secretary shall establish the necessary accounts and process to accept contributions of private funds for the purposes of addressing the changing climate, sequestering carbon, improving wildlife habitat, protecting sources of drinking water, and addressing other natural resource priorities identified by the Secretary.”
in paragraph (2), by striking “ a conservation program administered by the Secretary under subtitle D shall be deposited into the sub-account” and inserting “ a covered program shall be deposited into the account”; and
by adding at the end the following:
“(3) Secretarial authority.—
“(A) In general.—The Secretary may accept under this subsection contributions of such funds as the Secretary determines appropriate, taking into consideration—
“(i) the source of the funds to be contributed;
“(ii) the natural resource concerns to be addressed through the use of the funds;
“(iii) the amount of funds to be contributed;
“(iv) whether the activities proposed to be carried out using the funds are consistent with the priorities of the Secretary; and
“(v) any other factors the Secretary determines to be relevant.
“(B) Determination.—A determination of whether to accept private funds under this subsection shall be at the sole discretion of the Secretary.
“(4) Match of contributed funds.—
“(A) In general.—Subject to subparagraph (B), the Secretary may provide matching Federal funds, and determine the level of such match, which shall not exceed 75 percent, for the private funds contributed under this subsection, subject to the availability of funding for the applicable covered program.
“(B) Distribution of federal funding for states.—The Secretary may not provide any matching Federal funds pursuant to subparagraph (A) in a manner that would result in a substantial reduction in the historical distribution of Federal funding to any State for any covered program.
“(C) Limitation.—No funds made available pursuant to Public Law 117–169 may be used to provide matching Federal funds pursuant to subparagraph (A).
“(5) Role of contributing entity.—An entity contributing funds under this subsection may—
“(A) designate the covered program for which the contributed funds are intended to be used;
“(B) specify the geographic area in which the contributed funds are intended to be used;
“(C) identify a natural resource concern the contributed funds are intended to be used to address;
“(D) with respect to an activity funded pursuant to this subsection that may result in environmental services benefits to be sold through an environmental services market, subject to the approval of the Secretary, prescribe the terms for ownership of the entity’s share of such environmental services benefits resulting from such activity; and
“(E) work with the Secretary to promote the activities funded pursuant to this subsection.
“(6) Producer participation.—
“(A) Notification.—The Secretary shall establish a process to provide notice to producers—
“(i) of activities that may be carried out, through a covered program, pursuant to this section; and
“(ii) any terms prescribed by the contributing entity under paragraph (5)(D) with respect to such activities.
“(B) Retention of environmental services benefits.—The Secretary shall not claim or impede any action of a producer with respect to the environmental services benefits they accrue through activities funded pursuant to this subsection.
“(7) Consistency with program requirements.—
“(A) In general.—Except as provided in subparagraph (B), the Secretary shall ensure that the terms and conditions of activities carried out using funds contributed under this subsection are consistent with the requirements of the applicable covered program.
“(B) Adjustments.—
“(i) In general.—The Secretary may, if the Secretary determines necessary, adjust a regulatory requirement of a covered program, or related guidance, as it applies to an activity carried out using funds contributed under this subsection—
“(I) to provide a simplified process; or
“(II) to better reflect unique local circumstances and to address a specific priority of the contributing entity.
“(ii) Limitation.—The Secretary shall not adjust the application of statutory requirements for a covered program, including requirements governing appeals, payment limits, and conservation compliance.
“(8) Report.—Not later than December 31, 2024, and each year thereafter through December 31, 2031, the Secretary shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that contains—
“(A) the name and a description of each entity contributing private funds under this subsection that took an action under paragraph (5), and a description of each such action;
“(B) the name and a description of each entity contributing private funds under this subsection for which the Secretary has provided matching Federal funds, and the level of that match, including the amount of such matching Federal funds; and
“(C) the total amounts of—
“(i) private funds contributed under this subsection; and
“(ii) matching Federal funds provided by the Secretary under paragraph (4).
“(9) Covered program defined.—In this subsection, the term ‘covered program’ means a program carried out by the Secretary under—
“(A) subtitle D (except for subchapter B of such subtitle), subtitle H, or subtitle I;
“(B) section 403 of the Agricultural Credit Act of 1978 (16 U.S.C. 2203);
“(C) title V of the Healthy Forests Restoration Act of 2003 (16 U.S.C. 6571 et seq.); or
“(D) the Watershed Protection and Flood Prevention Act (16 U.S.C. 1001 et seq.), except for any program established by the Secretary to carry out section 14 of such Act (16 U.S.C. 1012).
“(10) Duration of authority.—The authority of the Secretary under this subsection shall expire, with respect to each covered program, on the date on which the authority of the covered program expires.”
TITLE II Commodity Futures Trading Commission Whistleblower Program
SEC. 301. In General.
Section 1(b) of Public Law 117–25 (135 Stat. 297; 136 Stat. 2133) is amended—
by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;
by inserting after paragraph (1) the following:
“(2) Additional transfers.—In addition to amounts transferred under paragraph (1), the Commission may transfer up to $10,000,000 from the Fund into the account.”
in paragraph (3) (as so redesignated)—
by striking “ paragraph (1)” and inserting “ paragraphs (1) and (2)”; and
by striking “ until” and all that follows through the period at the end and inserting “ until October 1, 2024.”; and
in paragraph (4) (as so redesignated), by striking “ on” and all that follows through “ shall” and inserting “ on October 1, 2024, shall”.
TITLE III Forestry
SEC. 401. Modification or Termination of Easements under the Healthy Forests Reserve Program.
Section 502 of the Healthy Forests Restoration Act of 2003 (16 U.S.C. 6572) is amended by adding at the end the following:
“(g) Easement Modification or Termination.—
“(1) In general.—The Secretary may modify or terminate an easement or other interest in land administered by the Secretary under this title if—
“(A) the owner of the land agrees to the modification or termination; and
“(B) the Secretary determines that the modification or termination—
“(i) will address a compelling public need for which there is no practicable alternative; and
“(ii) is in the public interest.
“(2) Consideration; conditions.—
“(A) Termination.—As consideration for termination of an easement or other interest in land under this subsection, the Secretary shall enter into a compensatory arrangement, as the Secretary determines to be appropriate.
“(B) Modification.—In the case of a modification of an easement or other interest in land under this subsection—
“(i) as a condition of the modification, the owner of the land shall enter into a compensatory arrangement, as the Secretary determines to be appropriate, to incur the costs of modification; and
“(ii) the Secretary shall ensure that—
“(I) the modification will not adversely affect the forest ecosystem functions and values for which the easement or other interest in land was acquired;
“(II) any adverse impacts will be mitigated by enrollment and restoration of other land that provides greater forest ecosystem functions and values at no additional cost to the Federal Government; and
“(III) the modification will result in equal or greater environmental and economic values to the United States.”
TITLE IV Nutrition
SEC. 501. Ebt Benefit Fraud Prevention.
Guidance; Rulemaking.— The Secretary shall—
issue guidance to State agencies, on an ongoing basis, as informed by the process outlined in paragraph (4), that describes security measures that—
are effective, as determined by the Secretary, in detecting and preventing theft of benefits, including through card skimming, card cloning, and other similar fraudulent methods;
are consistent with industry standards for detecting, identifying, and preventing debit and credit card skimming, card cloning, and other similar fraudulent methods; and
consider the feasibility of cost, availability, and implementation for States;
promulgate regulations through notice-and-comment rulemaking to require State agencies to take the security measures described in the guidance issued under paragraph (1);
not later than December 1, 2023, promulgate regulations (including an interim final rule) to require State agencies to implement procedures for the replacement of benefits consistent with subsection (b);
coordinate with the Administrator of the Administration for Children and Families of the Department of Health and Human Services, the Attorney General of the United States, State agencies, retail food stores, and EBT contractors—
to determine—
how benefits are being stolen through card skimming, card cloning, and other similar fraudulent methods;
how those stolen benefits are used; and
to the maximum extent practicable, the locations where card skimming, card cloning, and other similar fraudulent methods are taking place;
to establish measures, including equipment enhancements for retail food stores, to prevent benefits from being stolen through card skimming, card cloning, and other similar fraudulent methods; and
to establish standard reporting methods for States to collect and share data with the Secretary on the scope of benefits being stolen through card skimming, card cloning, and other similar fraudulent methods; and
not later than October 1, 2024, submit to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives a report that includes—
to the maximum extent practicable, information on the frequency of theft of benefits and the location of those thefts, including benefits stolen through card skimming, card cloning, and other similar fraudulent methods;
a description of the determinations made under paragraph (4)(A), the measures established under paragraph (4)(B), and methods established in paragraph (4)(C);
a description of the industry standards described in paragraph (1)(B); and
recommendations on how to consistently detect, track, report, and prevent theft of benefits, including benefits stolen through card skimming, card cloning, and other similar fraudulent methods.
Replacement of Benefits.— The Secretary shall use funds appropriated under section 18 of the Food and Nutrition Act of 2008 (7 U.S.C. 2027) to require States to replace benefits that are determined by the State agency to have been stolen through card skimming, card cloning, or similar fraudulent methods, subject to the conditions that—
the State agency shall submit to the Secretary not later than 60 days after the date of the enactment of this Act for prior approval a plan for the replacement of stolen benefits that—
includes appropriate procedures, as determined by the Secretary, for the timely submission of claims to, timely validation of claims by, and replacement issuance by the State agency that includes—
a signed statement by the affected household on the benefit theft, consistent with the signature requirements and options provided by section 11(e)(2)(C) of the Food and Nutrition Act of 2008, as amended (7 U.S.C. 2020(e)(2)(C));
criteria to determine if a submitted claim is valid;
procedures for the documentation of replacement issuances, including the submitted claims and findings from the validation;
the submission of data reports on benefit theft and replacement activity to the Secretary;
procedures to inform households of their right to a fair hearing, consistent with those already established by section 11(e) of the Food and Nutrition Act of 2008 (7 U.S.C. 2020(e)) and corresponding regulations concerning replacement issuances; and
the State agency’s use and planned use of benefit theft prevention measures, including any additional guidance that may be issued under subsection (a)(1);
includes appropriate procedures, as determined by the Secretary, for reporting the scope and frequency of card skimming affecting households within the State to the Secretary;
upon approval shall be incorporated into the State plan of operation required under section 11(e) of the Food and Nutrition Act of 2008 (7 U.S.C. 2020(e)); and
the Secretary may approve after the date on which guidance is issued under subsection (a)(1);
the replacement of stolen benefits for a household—
shall not exceed the lesser of—
the amount of benefits stolen from the household; or
the amount equal to 2 months of the monthly allotment of the household immediately prior to the date on which the benefits were stolen;
shall not occur more than 2 times per Federal fiscal year per household by a single State agency; and
shall only apply to benefits stolen during the period beginning on October 1, 2022, and ending on September 30, 2024;
plans approved under paragraph (1) will remain in effect until the effective date of the rule promulgated pursuant to subsection (a)(3); and
replacements of benefits under this section shall not be regarded as losses for the purpose of section 7(e) of the Food and Nutrition Act of 2008 (7 U.S.C. 2016(e)) to the extent such replacements are made in accordance with an approved plan that complies with this subsection.
Definitions.— In this section, the terms “allotment”, “benefit”, “household”, “retail food store”, and “State agency” have the meaning given those terms in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012).
Rescission.— Of the unobligated balances made available for the Supplemental Nutrition Assistance Program as authorized by section 1101(b)(1) of the American Rescue Plan Act of 2021 (Public Law 117–2), $8,000,000 is hereby rescinded.
SEC. 502. Increasing Access to Summer Meals for Children Through Ebt and Alternative Delivery Options.
Agreements.— Section 12(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1760(b)) is amended—
by inserting “ and Indian Tribal organizations” after “ State agencies” each place it appears; and
in paragraph (2)(B), in the matter preceding clause (i), by inserting “ and Indian Tribal organization” before “ budget”.
Noncongregate Meals.— Section 13 of the Richard B. Russell National School Lunch Act (42 U.S.C. 1761) is amended—
in subsection (a), by adding at the end the following:
“(13) Noncongregate meals.—
“(A) In general.—Beginning not later than summer 2023, the Secretary shall make available an option to States to provide program meals under this section for noncongregate consumption in a rural area with no congregate meal service, as determined by the Secretary.
“(B) Summer 2023.—Notwithstanding any other provision in this paragraph, for summer 2023, the Secretary may allow States to use implementation models developed by the Secretary for demonstration projects carried out under section 749(g) of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat. 2132), to carry out subparagraph (A).
“(C) Eligibility determination.—In administering this paragraph, the Secretary shall ensure that noncongregate meals are only available for a child—
“(i) in an area in which poor economic conditions exist; and
“(ii) in an area that is not an area in which poor economic conditions exist, if the child is determined to be eligible for a free or reduced price lunch under this Act or a free or reduced price breakfast under section 4 of the Child Nutrition Act of 1966 (42 U.S.C. 1773).
“(D) Priorities.—
“(i) In general.—States shall—
“(I) identify areas with no congregate meal service that could benefit the most from the provision of noncongregate meals; and
“(II) encourage participating service institutions in those areas to provide noncongregate meals as appropriate.
“(ii) Areas.—Areas identified under clause (i) may include areas that are not areas in which poor economic conditions exist but that have children who are determined to be eligible for free or reduced price lunch under this Act or free or reduced price breakfast under section 4 of the Child Nutrition Act of 1966 (42 U.S.C. 1773).
“(E) Administration.—In administering this paragraph, the Secretary shall ensure that—
“(i) any meal served for noncongregate consumption—
“(I) meets all applicable State and local health, safety, and sanitation standards; and
“(II) meets the requirements under subsection (f)(1);
“(ii) over a 10-day calendar period, the number of reimbursable meals provided to a child does not exceed the number of meals that could be provided over a 10-day calendar period, as established under subsection (b)(2); and
“(iii) States establish a process for identifying gaps in service and barriers in reaching needy children for congregate and noncongregate models.
“(F) Regulations.—Not later than 1 year after the date of enactment of this paragraph, the Secretary shall promulgate regulations (which shall include interim final regulations) to carry out this section, including provisions—
“(i) to ensure the integrity of the alternative option for program delivery described in subparagraph (A); and
“(ii) to incorporate best practices and lessons learned from noncongregate demonstration projects under section 749(g) of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat. 2132).”
; and
in subsection (n)—
by striking “ by January 1 of each year of its intent to administer the program and shall submit for approval by February 15” and inserting “ of its intent to administer the program and shall submit for approval by April 1, 2023,”;
by striking “ (1)” and inserting “ (A)”;
by striking “ (2)” and inserting “ (B)”;
by striking “ (3)” and inserting “ (C)”;
by striking “ (4)” and inserting “ (D)”;
by striking “ (5)” and inserting “ (E)”;
by striking “ and (6)” and inserting “ (F)”;
by striking the period at the end and inserting “ ; and (G) the State’s plan for using the alternative option for program delivery described in subsection (a)(13), if applicable, including plans to provide a reasonable opportunity to access meals across all areas of the State.”;
by striking the subsection designation and all that follows through “ Each State” and inserting the following:
“(n) Management and Administration State Plans.—
“(1) Summer 2023.—Each State”
; and
by adding at the end the following:
“(2) Summer 2024 and beyond.—Beginning in 2024, each State desiring to participate in the program under this section or in the summer EBT program under section 13A shall notify the Secretary by January 1 of each year of its intent to administer the applicable program and shall submit for approval by February 15 a management and administration plan for the applicable program for the fiscal year, which shall include, as applicable—
“(A) the requirements listed in subparagraphs (A) through (G) of paragraph (1);
“(B) the administrative budget of the State for administering the summer EBT program under section 13A;
“(C) the State’s plan to comply with the State requirements in section 13A(c) and any other standards prescribed by the Secretary under section 13A;
“(D) the State’s plan to identify areas with no congregate meal service;
“(E) the State’s plan to target priority areas identified under subsection (a)(13)(D)(i)(I); and
“(F) the State’s plan to ensure that summer EBT benefits (as described in section 13A(a)) are issued to children based on their school attendance at the end of the instructional year immediately preceding such summer.”
Summer EBT.— The Richard B. Russell National School Lunch Act is amended by inserting after section 13 (42 U.S.C. 1761) the following:
“SEC. 13A. SUMMER ELECTRONIC BENEFITS TRANSFER FOR CHILDREN PROGRAM.
“(a) Program Established.—The Secretary shall establish a program under which States and covered Indian Tribal organizations electing to participate in such program shall, beginning with summer 2024 and annually for each summer thereafter, issue to each eligible household summer electronic benefit transfer benefits (referred to in this section as ‘summer EBT benefits’)—
“(1) in accordance with this section; and
“(2) for the purpose of providing nutrition assistance through electronic benefit transfer or methods described in clauses (ii) and (iii) of subsection (b)(2)(B) during the summer months for each eligible child, to ensure continued access to food when school is not in session for the summer.
“(b) Summer EBT Benefits Requirements.—
“(1) Purchase options.—
“(A) Benefits issued by states.—Summer EBT benefits issued pursuant to subsection (a) by a State may only be used by the eligible household that receives such summer EBT benefits to purchase food (as defined in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C. 2012)) from retail food stores that have been approved for participation in the supplemental nutrition assistance program established under such Act and in accordance with section 7(b) of such Act (7 U.S.C. 2016(b)) or in the nutrition assistance program in American Samoa, the Commonwealth of Puerto Rico, and the Commonwealth of the Northern Mariana Islands.
“(B) Benefits issued by covered indian tribal organizations.—Summer EBT benefits issued pursuant to subsection (a) by a covered Indian Tribal organization may only be used by the eligible household that receives such summer EBT benefits to purchase supplemental foods from vendors that have been approved for participation in the special supplemental nutrition program for women, infants, and children under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786).
“(2) Amount.—Summer EBT benefits issued pursuant to subsection (a)—
“(A) shall be—
“(i) for calendar year 2024, in an amount equal to $40, which may be proportionately higher consistent with the adjustments established under section 12(f) for each eligible child in the eligible household per month during the summer operational period; and
“(ii) for calendar year 2025 and each year thereafter, in an amount equal to the unrounded benefit amount from the prior year, adjusted to the nearest lower dollar increment to reflect changes to the cost of the diet described in section 3(u) of the Food and Nutrition Act of 2008 (7 U.S.C. 2012(u)) for the 12-month period ending on November 30 of the preceding calendar year and rounded to the nearest lower dollar increment; and
“(B) may be issued—
“(i) in the form of an EBT card;
“(ii) through other electronic methods, as determined by the Secretary; or
“(iii) in the case of a State that does not issue nutrition assistance program benefits electronically, using the same methods by which that State issues benefits under the nutrition assistance program of that State.
“(3) Enforcement.—Summer EBT benefits issued pursuant to subsection (a) shall—
“(A) be subject to sections 12, 14, and 15 of the Food and Nutrition Act of 2008 (7 U.S.C. 2021, 2023, 2024) and subsections (n), (o), and (p) of section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786), as applicable; and
“(B) to the maximum extent practicable, incorporate technology tools consistent with industry standards that track or prevent theft of benefits, cloning, or other fraudulent activities.
“(4) Timing.—
“(A) In general.—Except as provided in subparagraph (B), summer EBT benefits issued pursuant to subsection (a) may only be issued for the purpose of purchasing food during the summer months, with appropriate issuance and expungement timelines as determined by the Secretary (but with an expungement timeline not to exceed 4 months).
“(B) Continuous school calendar.—In the case of children who are under a continuous school calendar, the Secretary shall establish alternative plans for the period during which summer EBT benefits may be issued pursuant to subsection (a) and used.
“(c) Enrollment in Program.—
“(1) State requirements.—States that elect to participate in the program under this section shall—
“(A) with respect to summer, automatically enroll each eligible child who is directly certified, is an identified student (as defined in section 11(a)(1)(F)(i)), or is otherwise determined by a school food authority to be eligible to receive free or reduced price meals in the instructional year immediately preceding the summer or during the summer operational period in the program under this section, without further application from households;
“(B) make an application available for children who do not meet the criteria described in subparagraph (A) and make eligibility determinations using the eligibility criteria for free or reduced price lunches under this Act;
“(C) establish procedures to carry out the enrollment described in subparagraph (A);
“(D) establish procedures for expunging summer EBT benefits from the account of a household, consistent with the requirements under subsection (b)(4); and
“(E) allow eligible households to opt out of participation in the program under this section and establish procedures for opting out of such participation.
“(2) Covered indian tribal organization requirements.—Covered Indian Tribal organizations participating in the program under this section shall, to the maximum extent practicable, meet the requirements under paragraph (1).
“(d) Administrative Expenses.—The Secretary shall pay to each State agency and covered Indian Tribal organization an amount equal to 50 percent of the administrative expenses incurred by the State agency or covered Indian Tribal organization in operating the program under this section, including the administrative expenses of local educational agencies and other agencies in each State or covered Indian Tribal organization relating to the operation of the program under this section.
“(e) Summer EBT Authority.—Beginning in summer 2024, the Secretary shall not allow States to use the authority in section 749(g) of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat. 2132), to provide access to food through electronic benefit transfer benefits to children during the summer months when schools are not in regular session.
“(f) Issuance of Interim Final Regulations.—Not later than 1 year after the date of enactment of this section, the Secretary shall promulgate regulations (which shall include interim final regulations) to carry out this section, including provisions that—
“(1) incorporate best practices and lessons learned from demonstration projects under—
“(A) section 749(g) of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat. 2132); and
“(B) the pandemic EBT program under section 1101 of the Families First Coronavirus Response Act (7 U.S.C. 2011 note; Public Law 116–127);
“(2) ensure timely and fair service to applicants for and recipients of benefits under this section;
“(3) establish quality assurance and program integrity procedures to ensure that States and local educational agencies have adequate processes—
“(A) to correctly determine the eligibility of children for benefits under this section; and
“(B) to reliably enroll and issue benefits to eligible children; and
“(4) allow States and covered Indian Tribal organizations to streamline program administration, including by—
“(A) automatically enrolling each eligible child who is able to be directly certified; and
“(B) establishing a single summer operational period.
“(g) Administrative and Management Plan.—Beginning in 2024, each State desiring to participate in the program under this section shall comply with the requirements under section 13(n).
“(h) Definitions.—In this section:
“(1) Covered indian tribal organization.—The term ‘covered Indian Tribal organization’ means an Indian Tribal organization that participates in the special supplemental nutrition program for women, infants, and children established under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786).
“(2) Eligible child.—The term ‘eligible child’ means, with respect to a summer, a child who—
“(A) was, at the end of the instructional year immediately preceding such summer or during the summer operational period—
“(i) certified to receive free or reduced price lunch under the school lunch program under this Act;
“(ii) certified to receive free or reduced price breakfast under the school breakfast program under section 4 of the Child Nutrition Act of 1966 (42 U.S.C. 1773); or
“(iii) able to be directly certified;
“(B) was, at the end of the instructional year immediately preceding such summer—
“(i) enrolled in a school described in subparagraph (B), (C), (D), (E), or (F) of section 11(a)(1); and
“(ii)
(I) an identified student (as defined in section 11(a)(1)(F)(i)); or
“(II) a child who otherwise met the requirements to receive free or reduced price meals, as determined through an application process using the eligibility criteria for free or reduced price meals under this Act; or
“(C) has been determined to be eligible for the program under this section in accordance with subsection (c)(1)(B).
“(3) Eligible household.—The term ‘eligible household’ means a household that includes at least 1 eligible child.
“(4) Supplemental foods.—The term ‘supplemental foods’—
“(A) means foods—
“(i) containing nutrients determined by nutritional research to be lacking in the diets of children; and
“(ii) that promote the health of the population served by the program under this section, as indicated by relevant nutrition science, public health concerns, and cultural eating patterns, as determined by the Secretary; and
“(B) includes foods not described in subparagraph (A) substituted by State agencies, with the approval of the Secretary, that—
“(i) provide the nutritional equivalent of foods described in such subparagraph; and
“(ii) allow for different cultural eating patterns than foods described in such subparagraph.”
Amendments to P-EBT for Summer 2023.— Section 1101(i) of the Families First Coronavirus Response Act (7 U.S.C. 2011 note; Public Law 116–127) is amended—
by striking “ The Secretary” and inserting the following:
“(1) In general.—The Secretary”
in paragraph (1) (as so designated), by inserting “ approve or” after “ may”; and
by adding at the end the following:
“(2) Limitation.—A State shall not provide benefits during a covered summer period pursuant to paragraph (1) to children who, at the end of the school year immediately preceding the covered summer period, attended a school that did not participate in the school lunch program or school breakfast program described in that paragraph.
“(3) Other assistance not required.—A State shall not be required to provide assistance under subsection (a) or (h) in order to provide assistance under this subsection.”
No Duplication of Summer Benefits.— A State may not provide to a household summer EBT benefits (as described in section 13A(a) of the Richard B. Russell National School Lunch Act) under that section and benefits under section 1101(i) of the Families First Coronavirus Response Act (7 U.S.C. 2011 note; Public Law 116–127) for the same period.
SEC. 503. Offsets.
Summer 2023.— Section 1101(i) of the Families First Coronavirus Response Act (7 U.S.C. 2011 note; Public Law 116–127) (as amended by section 502(d)) is amended by adding at the end the following:
“(4) Summer 2023.—Any benefits issued to households during a covered summer period pursuant to paragraph (1) in summer 2023 shall not exceed $120 per child for the covered summer period, except that benefits may be proportionately higher consistent with any adjustments established under section 12(f) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1760(f)).”
Allotments.— Section 2302 of the Families First Coronavirus Response Act (7 U.S.C. 2011 note; Public Law 116–127) is amended by adding at the end the following:
“(d) Sunset.—The authority under subsection (a)(1) shall expire after the issuance of February 2023 benefits under that subsection.”
TITLE V Other Matters
SEC. 601. Support for Cotton Merchandisers.
Cotton Merchandiser Pandemic Assistance.—
Pandemic assistance payments to cotton merchandisers.— The Secretary shall make pandemic assistance payments, under terms and conditions as determined by the Secretary, to cotton merchandisers that purchased cotton from a United States cotton producer or marketed cotton on behalf of a United States cotton producer during the period that begins on March 1, 2020, and ends on the date of enactment of this Act.
Payment determinations.— The Secretary shall take into consideration economic impacts of COVID–19 and other supply chain disruptions in determining payment rates under this subsection, such that the amounts made available under paragraph (4)(A) are fully expended no later than 1 year after the date of enactment of this section.
Cotton merchandiser defined.— In this subsection, the term “cotton merchandiser” means an entity that markets, sells, or trades cotton to end users.
Funding limitations.—
In general.— Of the funds made available under subsection (b), the Secretary shall make available $100,000,000 to carry out this subsection.
Administrative expenses.— The Secretary may use not more than 1 percent of the funds under subparagraph (A) for administrative costs necessary to carry out this subsection.
Funding.— The Secretary shall make available $100,000,000 to be derived from the unobligated balances of amounts made available under section 751 of division N of the Consolidated Appropriations Act, 2021 (Public Law 116–260) to carry out subsection (a).
SEC. 602. Assistance for Rice Producers.
In General.— The Secretary shall make a 1-time payment to each producer of rice on a farm in the United States with respect to the 2022 crop year.
Payment Amount.— In accordance with the amount made available under subsection (e), the amount of a payment to a rice producer on a farm under subsection (a) shall be equal to the product obtained by multiplying—
the payment rate per pound, as determined by the Secretary, but which shall be—
the same for all varieties of rice;
not less than 2 cents per pound; and
notwithstanding subparagraph (B), adjusted by the Secretary such that the amount made available under subsection (e) is fully expended;
in the case of a producer with an average actual production history per planted acre of rice determined in accordance with subparagraphs (A), (B), and (E) of section 508(g)(2) of the Federal Crop Insurance Act (7 U.S.C. 1508(g)(2)), that average actual production history; or
in the case of a producer without an average actual production history described in subparagraph (A)—
if an area yield for the 2022 crop year determined in accordance with subparagraphs (C) and (E) of that section is available, that area yield; or
if an area yield described in clause (i) is not available, the yield determined by the Secretary; and
the sum obtained by adding, as applicable—
the number of certified planted acres of rice on the farm for the 2022 crop year, as reported to the Secretary; and
the number of certified acres of rice prevented from being planted on the farm for the 2022 crop year, as reported to the Secretary, multiplied by the prevented planting coverage factor applicable to those acres.
Limitations.—
In general.— In carrying out this section, the Secretary shall impose payment limitations consistent with section 760.1507(b) of title 7, Code of Federal Regulations (as in effect on September 30, 2021).
Separate limitations.— The payment limitations imposed under paragraph (1) shall be separate from annual payment limitations under any other program.
Deadline.— The Secretary shall make payments under this section not later than 120 days after the date of enactment of this Act.
Funding.—
Rescission.— Of the unobligated balance of the amounts made available by section 751 of division N of the Consolidated Appropriations Act, 2021 (Public Law 116–260; 134 Stat. 2105), $250,000,000 is rescinded.
Appropriation.— There is appropriated to the Secretary, out of any amounts in the Treasury not otherwise appropriated, $250,000,000 to carry out this section.
SEC. 603. Enactment of Chronic Wasting Disease Research and Management Act.
The provisions of H.R. 5608 of the 117th Congress, as engrossed in the House of Representatives on December 8, 2021, are hereby enacted into law.
TITLE VI Pesticides
Subtitle A Pesticide Registration Improvement Act of 2022
SEC. 701. Short Title.
This title may be cited as the “Pesticide Registration Improvement Act of 2022”.
SEC. 702. Bilingual Labeling.
Section 3(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(f)) is amended by adding at the end the following:
“(5) Bilingual labeling.—
“(A) Requirement.—
“(i) In general.—Subject to clause (ii), not later than the applicable deadline described in subparagraph (B), each registered pesticide product released for shipment shall include—
“(I) the translation of the parts of the labeling contained in the Spanish Translation Guide described in subparagraph (G) on the product container; or
“(II) a link to such translation via scannable technology or other electronic methods readily accessible on the product label.
“(ii) Exceptions.—Notwithstanding clause (i)—
“(I) an antimicrobial pesticide product may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product label; or
“(II) a non-agricultural pesticide product that is not classified by the Administrator as restricted use under subsection (d)(1)(A) may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product label.
“(B) Deadlines for bilingual labeling.—
“(i) Pesticide products classified as restricted use.—In the case of pesticide products classified by the Administrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph is the date that is 3 years following the date of enactment of this paragraph.
“(ii) Pesticide products not classified as restricted use.—In the case of pesticide products not classified by the Administrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph shall be as follows:
“(I) Agricultural.—
“(aa) Acute toxicity category i.—For agricultural pesticides classified as Acute Toxicity Category I, the date that is 3 years after the date of enactment of this paragraph.
“(bb) Acute toxicity category ii.—For agricultural pesticides classified as Acute Toxicity Category II, the date that is 5 years after the date of enactment of this paragraph.
“(II) Antimicrobial and non-agricultural.—
“(aa) Acute toxicity category i.—For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category I, the date that is 4 years after the date of enactment of this paragraph.
“(bb) Acute toxicity category ii.—For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category II, the date that is 6 years after the date of enactment of this paragraph.
“(III) Other pesticide products.—With respect to pesticide products not described in subclause (I) or (II), the date that is 8 years after the date of enactment of this paragraph.
“(C) Implementation.—
“(i) Non-notification.—
“(I) In general.—In carrying out this paragraph, the Administrator shall allow translations of the parts of the label of a pesticide contained in the Spanish Translation Guide described in subparagraph (G) and scannable technology or other electronic methods to be added using non-notification procedures.
“(II) Non-notification procedure defined.—In this clause, the term ‘non-notification procedure’ refers to a procedure under which a change may be made to a pesticide label without notifying the Administrator.
“(ii) Cooperation and consultation.—In carrying out this paragraph, the Administrator shall cooperate and consult with State lead agencies for pesticide regulation for the purpose of implementing bilingual labeling as provided in this paragraph as expeditiously as possible.
“(iii) End use labeling.—The labeling requirements of this paragraph shall apply to end use product labels.
“(iv) Incorporation timeframe.—After initial translation deadlines provided in subparagraph (B), updates to the Spanish Translation Guide described in subparagraph (G) shall be incorporated into labeling on the earlier of—
“(I) in the case of agricultural use pesticide labels, as determined by the Administrator—
“(aa) 1 year after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or
“(bb) the released for shipment date specified on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); and
“(II) in the case of antimicrobial and non-agricultural use pesticide labels, as determined by the Administrator—
“(aa) 2 years after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or
“(bb) the released for shipment date specified on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G).
“(v) Notification of updates to the spanish translation guide for pesticide labeling.—Not later than 10 days after updating the Spanish Translation Guide described in subparagraph (G), the Administrator shall notify registrants of the update to such guide.
“(D) Accessibility of bilingual labeling for farm workers.—Not later than 180 days after the date of enactment of this paragraph, to the maximum extent practicable, the Administrator shall seek stakeholder input on ways to make bilingual labeling required under this paragraph accessible to farm workers.
“(E) Plan.—Not later than 3 years after the date of enactment of this paragraph, the Administrator shall implement a plan to ensure that farm workers have access to the bilingual labeling required under this paragraph.
“(F) Reporting.—Not later than 2 years after the date of enactment of this paragraph, the Administrator shall develop and implement, and make publicly available, a plan for tracking the adoption of the bilingual labeling required under this paragraph.
“(G) Spanish translation guide described.—The Spanish Translation Guide described in this subparagraph is the Spanish Translation Guide for Pesticide Labeling issued in October 2019, as in effect on the date of enactment of the Pesticide Registration Improvement Act of 2022, and any successor guides or amendments to such guide.”
SEC. 703. Extension and Modification of Maintenance Fee Authority.
Extension and Modification of Maintenance Fee Authority.— Section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)) is amended—
in paragraph (1)—
in subparagraph (C), by striking “ 2023” and inserting “ 2022, and $42,000,000 for each of fiscal years 2023 through 2027”;
in subparagraph (D)—
in clause (i), by striking “ 2023” and inserting “ 2022, and $172,000 for each of fiscal years 2023 through 2027”; and
in clause (ii), by striking “ 2023” and inserting “ 2022, and $277,200 for each of fiscal years 2023 through 2027”;
in subparagraph (E)(i)—
in subclause (I), by striking “ 2023” and inserting “ 2022, and $105,000 for each of fiscal years 2023 through 2027”; and
in subclause (II), by striking “ 2023” and inserting “ 2022, and $184,800 for each of fiscal years 2023 through 2027”;
by redesignating subparagraphs (G), (H), and (I) as subparagraphs (L), (M), and (N);
by inserting after subparagraph (F) the following:
“(G) Farm worker training and education grants.—
“(i) Set-aside.—In addition to amounts otherwise available, for fiscal years 2023 through 2027, the Administrator shall use not more than $7,500,000 of the amounts collected under this paragraph to provide grants to organizations described in clause (ii) for purposes of facilitating—
“(I) training of farm workers;
“(II) education of farm workers with respect to—
“(aa) rights of farm workers relating to pesticide safety; and
“(bb) the worker protection standard under part 170 of title 40, Code of Federal Regulations (or successor regulations);
“(III) the development of new informational materials;
“(IV) the development of training modules; and
“(V) the development of innovative methods of delivery of such informational materials and training modules.
“(ii) Eligibility.—To be eligible to receive a grant under this subparagraph, an organization shall have demonstrated experience in—
“(I) providing training and education services for farm workers or handlers of pesticides; or
“(II) developing informational materials for farm workers or handlers of pesticides.
“(iii) Community-based organizations.—
“(I) Community-based non-profit farm worker organization grants.—The Administrator shall use funds available under clause (i) to provide grants to community-based non-profit farm worker organizations.
“(II) Application of funds.—The Administrator shall apply the unspent balance of funds available (up to $1,800,000) under clause (i) in fiscal years 2025 through 2027 to carry out subclause (I).
“(iv) Interim funding.—In addition to amounts otherwise available, the Administrator may use not more than $1,200,000 in fiscal years 2023 and 2024 to fund existing cooperative agreements that were authorized under section 33(c)(3)(B), as such section was in effect as of March 8, 2019.
“(v) Partnerships.—Organizations described in clause (ii) may apply for a grant under this subparagraph as a partnership with another organization, provided such organizations, at the time of application, have entered into an agreement designating—
“(I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expenditure of Federal funds;
“(II) performance of the assistance agreement;
“(III) liability for claims for recovery of unallowable costs incurred under the agreement; and
“(IV) specifying roles in performing the proposed scope of work for the assistance agreement.
“(H) Health care provider training.—
“(i) Set-aside.—In addition to other amounts available, for the period of fiscal years 2023 through 2027, the Administrator shall use not more than $2,500,000 of the amounts collected under this paragraph to provide grants to nonprofit organizations described in clause (ii) for purposes of facilitating—
“(I) technical assistance and training of health care providers relating to the recognition, treatment, and management of pesticide-related injuries and illnesses;
“(II) the development of informational materials for technical assistance and training described in subclause (I); and
“(III) the development of outreach and delivery methods relating to the recognition, treatment, and management of pesticide-related illnesses.
“(ii) Eligibility.—To be eligible to receive a grant under this subparagraph, a nonprofit organization shall have demonstrated experience in providing technical assistance and training to health care providers who serve farm worker populations.
“(iii) Partnerships.—Organizations described in clause (ii) may apply for a grant under this subparagraph as a partnership with another organization, provided such organizations, at the time of application, have entered into an agreement designating—
“(I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expenditure of Federal funds;
“(II) performance of the assistance agreement;
“(III) liability for claims for recovery of unallowable costs incurred under the agreement; and
“(IV) roles in performing the proposed scope of work for the assistance agreement.
“(I) Partnership grants.—In addition to funds otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts collected under this paragraph for partnership grants.
“(J) Pesticide safety education program.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts collected under this paragraph to carry out the pesticide safety education program.
“(K) Technical assistance to grantees.—
“(i) Set-aside.—In addition to other amounts available, for fiscal years 2023 through 2027, the Administrator shall use not more than $1,750,000 of the amounts collected under this paragraph to provide grants to nonprofit organizations, subject to such conditions as the Administrator establishes to prevent conflicts of interest, to provide easily accessible technical assistance to grantees receiving, and potential grantees applying for, grants under subparagraphs (G) and (H).
“(ii) Considerations.—In evaluating requests for grants under this subparagraph, the Administrator shall consider, at a minimum, the extent to which—
“(I) the organization applying for the grant has experience providing technical assistance to farm worker or clinician-training organizations; and
“(II) the proposed project would make specific technical assistance available to organizations seeking information and assistance concerning—
“(aa) the grant application process;
“(bb) the drafting of grant applications; and
“(cc) compliance with grant management and reporting requirements.
“(iii) No suitable organization.—If no suitable organization requests a grant under this subparagraph, the Administrator shall provide technical assistance described in clause (i) using the amounts made available by that clause.
“(iv) Stakeholder input.—In formulating requests for proposals for grants under subparagraphs (G) and (H) for a fiscal year, the Administrator shall solicit and consider, in an open and transparent manner that does not provide a competitive advantage to any person or persons, input from persons who conduct farm worker education and training, or technical assistance and training of clinicians, regarding the request for proposals.”
; and
in subparagraph (N) (as so redesignated), by striking “ 2023” and inserting “ 2027”; and
in paragraph (2)—
by striking “ section 33(b)(3)” and inserting “ section 33(b)(3)(B)”; and
by striking “ the Pesticide Registration Improvement Extension Act of 2018 and ending on September 30, 2025” and inserting “ the Pesticide Registration Improvement Act of 2022 and ending on September 30, 2029”.
Extension of Prohibition on Tolerance Fees.— Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking “ the Pesticide Registration Improvement Renewal Act and ending on September 30, 2023” and inserting “ the Pesticide Registration Improvement Act of 2022 and ending on September 30, 2027”.
SEC. 704. Reregistration and Expedited Processing Fund.
Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is amended—
in paragraph (2)(A), in the first sentence, by inserting “ including, to the maximum extent practicable, during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations,” after “ limitation,”;
by striking paragraphs (3) and (4) and inserting the following:
“(3) Review of registrant submissions not covered by section 33(b)(3)(b).—
“(A) Definition of submission not covered by section 33(b)(3)(b).—In this paragraph, the term ‘submission not covered by section 33(b)(3)(B)’ means any submission filed by a registrant with the Administrator relating to a registration that is not covered by a fee table under section 33(b)(3)(B).
“(B) Set-aside.—
“(i) In general.—In addition to amounts otherwise available for each of fiscal years 2023 through 2027, the Administrator shall use approximately ⅛ of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in clause (ii).
“(ii) Activities.—In addition to amounts otherwise available, the Administrator shall use amounts made available under clause (i) to obtain sufficient personnel and resources to process submissions not covered by section 33(b)(3)(B) to meet the applicable deadlines described in—
“(I) the notice of the Administrator entitled ‘Pesticide Registration Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formulation Amendments’ and dated October 22, 1998 (and any successor amendments to such notice); and
“(II) subsections (c)(3)(B) and (h) of section 3.
“(4) Development of public health performance standards for antimicrobial pesticide devices.—
“(A) Set-aside.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).
“(B) Antimicrobial pesticide devices.—The Administrator shall use amounts made available under subparagraph (A) to develop efficacy test methods for antimicrobial pesticide devices making public health claims.”
in paragraph (5)(A), by striking “ 2018 through 2023” and inserting “ 2023 through 2027”;
by redesignating paragraphs (6) and (7) as paragraphs (9) and (10), respectively;
by inserting after paragraph (5) the following:
“(6) Agency training and staff.—
“(A) Set-aside.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).
“(B) Activities.—The Administrator shall use amounts made available under subparagraph (A) to carry out the following activities:
“(i) Training for agency employees.—The Administrator shall administer training and education programs for employees of the Environmental Protection Agency, relating to the regulatory responsibilities and policies established by this Act, including programs—
“(I) for improving the scientific, technical, and administrative skills of officers and employees authorized to administer programs under this Act;
“(II) to align competencies identified by the Administrator for mission accomplishment;
“(III) for addressing best practices for operational performance and improvement;
“(IV) for improving administrative processes and procedures and addressing efficiency issues;
“(V) to promote consistent regulatory decision-making; and
“(VI) for educating registrants and regulated stakeholders on regulatory procedures.
“(ii) Agreements with institutions of higher education.—Not later than 1 year, to the maximum extent practicable, after the date of enactment of the Pesticide Registration Improvement Act of 2022, the Administrator shall establish a competitive grant program to develop training curricula and programs in accordance with clause (i) through financial assistance agreements with 1 or more of the following institutions of higher education:
“(I) Non-land-grant colleges of agriculture (as defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3103)).
“(II) Land-grant colleges and universities (as defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3103)).
“(III) 1994 Institutions (as defined in section 532 of the Equity in Educational Land-Grant Status Act of 1994 (7 U.S.C. 301 note; Public Law 103–382)).
“(7) Vector expedited review vouchers.—
“(A) Set-aside.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund to establish and carry out the Vector Expedited Review Voucher program in accordance with subparagraph (B).
“(B) Vector expedited review voucher program.—
“(i) Definitions.—In this subparagraph:
“(I) Program.—The term ‘program’ means the Vector Expedited Review Voucher program established under clause (ii).
“(II) Voucher.—The term ‘voucher’ means a voucher—
“(aa) issued under the program by the Administrator to a pesticide registration applicant that entitles the holder to an expedited review described under clause (vi) of a single different pesticide registration action; and
“(bb) the entitlement to which may be transferred (including by sale) by the holder of the voucher, without limitation on the number of times the voucher may be transferred, before the voucher is redeemed.
“(ii) Establishment.—Not later than one year after the date of enactment of the Pesticide Registration Improvement Act of 2022, the Administrator, acting though the Office of Pesticide Programs, shall establish a program to be known as the Vector Expedited Review Voucher program.
“(iii) Purpose.—The purpose of the program is to incentivize the development of new insecticides to control and prevent the spread of vector borne disease by expediting reviews by decreasing decision review times provided in section 33(b)(3)(B).
“(iv) Issuance of vouchers.—
“(I) In general.—For each of fiscal years 2023 through 2027, the Administrator shall issue a voucher to a pesticide registration applicant for a new active ingredient if the applicant submits and has successfully registered a mosquito-control product that—
“(aa) demonstrates a proven efficacy against pyrethroid or other insecticide-resistant mosquitoes;
“(bb) prevents, mitigates, destroys, or repels pyrethroid or other insecticide-resistant mosquitoes, with a novel or unique mechanism or mode of action, different from other insecticides already registered by the Administrator for mosquito control;
“(cc) targets mosquitoes capable of spreading such diseases as Malaria, Dengue, Zika, Chikungunya, St. Louis encephalitis, Eastern encephalitis, Western encephalitis, West Nile encephalitis, Cache Valley encephalitis, LaCrosse encephalitis, and Yellow Fever;
“(dd) the registrant has submitted a global access plan that will be made publicly available for the active ingredient and that includes—
“(AA) manufacturing locations, including any licensed third-party manufacturers;
“(BB) distribution and procurement processes for malaria vector control programs in selected countries; and
“(CC) the prices for common quantities of the product;
“(ee) meets the appropriate guidelines as being effective in the primary vector control intervention areas, including insecticide-treated nets and indoor residual spray;
“(ff) is made accessible for use in—
“(AA) the United States, including territories or possessions of the United States; and
“(BB) countries where mosquito-borne diseases, such as malaria, are prevalent;
“(gg) meets registration requirements for human health and environmental effects, labeling, and presents no unreasonable adverse effects to the environment;
“(hh) broadens the adoption of integrated pest management strategies, such as insecticide resistance management, or makes those strategies more effective;
“(ii) is not contained in any pesticide product registered by the Administrator as of the date of the enactment of the Pesticide Registration Improvement Act of 2022; or
“(jj) does not contain as attested to by the registrant, an active ingredient approved in the 2-year period preceding the date of registration by any global stringent regulatory authority for the same uses, vectors, and applications.
“(II) Mosquito vector priority.—For each of fiscal years 2023 through 2027, the focus of the program shall be to incentivize the development of insecticides to control and prevent the spread of mosquitoes bearing diseases described in subclause (I)(cc).
“(III) Exception.—If the Administrator determines that there is a significant public health benefit, an active ingredient that is registered for agricultural use that is repurposed and submitted for control of mosquitoes and that otherwise meets the requirements of subclause (I) (excluding items (bb) and (jj)) as determined necessary by the Administrator, shall be considered a mosquito control product meeting the criteria specified in such subclause.
“(IV) Eligibility criteria modifications.—
“(aa) In general.—Beginning in fiscal year 2028, the Administrator shall review the program and recommend—
“(AA) modifications to the requirements described in subclause (I); and
“(BB) additional vectors to be included in the program, prioritizing vectors that pose the most significant population health risks.
“(bb) Public involvement.—In carrying out item (aa), the Administrator shall solicit the involvement of registrants, nongovernmental organizations, and governmental agencies engaged in vector-borne disease mitigation and treatment.
“(v) Redemption of vouchers.—To redeem a voucher, the holder shall—
“(I) notify the Administrator of the intent of the holder to submit a pesticide application with a voucher for expedited review not less than 90 days before the submission of the application; and
“(II) pay the applicable registration service fee under section 33(b).
“(vi) Expedited review.—On redemption of a voucher, in furtherance of the purpose described in clause (iii), the Administrator shall expedite decision review times as follows:
“(I) 6 months less than the decision review time for Category R010, New Active Ingredient, Food use.
“(II) 6 months less than the decision review time for Category R020, New Active Ingredient, Food use; reduced risk.
“(III) 6 months less than the decision review time for Category R060, New Active Ingredient, Non-food use; outdoor.
“(IV) 6 months less than the decision review time for Category R110, New Active Ingredient, Non-food use; indoor.
“(V) 4 months less than the decision review time for Category R070, New Active Ingredient, Non-food use; outdoor; reduced risk.
“(VI) 2 months less than the decision review time for Category R120, New Active Ingredient, Non-food use; indoor; reduced risk.
“(vii) Reports.—Not later than September 30, 2025, and not later than September 30 of each year thereafter, the Administrator shall issue a report on the program, including—
“(I) the number of submissions seeking a voucher;
“(II) the total time in review for each such submission;
“(III) the number of such vouchers awarded;
“(IV) the number of such vouchers redeemed; and
“(V) with respect to each such redeemed voucher—
“(aa) the decision review time for the pesticide application for which the voucher was redeemed; and
“(bb) the average standard decision review time for the applicable pesticide category.
“(C) Unused amounts.—Any unused amounts made available under this paragraph at the end of each fiscal year shall be made available to the Administrator to carry out other activities for which amounts in the Reregistration and Expedited Processing Fund are authorized to be used.
“(8) Pesticide surveillance program.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund to support the interagency agreement with the National Institute for Occupational Safety and Health to support the Sentinel Event Notification System for Occupational Risk pesticides program—
“(A) with a goal of increasing the number of participating States, prioritizing expansion in States with the highest numbers of agricultural workers; and
“(B) to improve reporting by participating States.”
; and
in paragraph (10) (as so redesignated), in the first sentence, by striking “ (2), (3), (4), and (5)” and inserting “ (2) through (8)”.
SEC. 705. Pesticide Registration Service Fees.
Extension and Modification of Fee Authority.—
In general.— Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—
in paragraph (2)(E)(iii), by striking “ after review” and inserting “ on completion of, where appropriate, the initial screening of the contents of the application or the preliminary technical screening”;
by striking “ paragraph (3)” each place it appears and inserting “ paragraph (3)(B)”;
in paragraph (3), by striking “ Subject to paragraph (6),” and inserting the following:
“(A) Data evaluation records.—At the decision review time under a fee table specified in subparagraph (B) or as agreed upon under subsection (f)(5), for each covered application under a fee table specified in such subparagraph (B), the Administrator shall—
“(i) complete data evaluation records for studies submitted by the applicant in support of the application; and
“(ii) release those data evaluation records to the applicant, using appropriate protections for confidential business information.
“(B) Schedule, actions, and fees.—Subject to paragraph (6),”
in paragraph (6)—
by amending subparagraph (A) to read as follows: “ Subject to the following sentence, effective for a covered application received during the period beginning on October 1, 2024, and ending on September 30, 2026, the Administrator may increase by 5 percent the registration service fee payable for the application under paragraph (3). No adjustment may be made under the preceding sentence until the date on which the Administrator begins to implement clauses (i) and (ii) of subsection (k)(2)(A).”; and
by amending subparagraph (B) to read as follows: “ Subject to the following sentence, effective for a covered application received on or after October 1, 2026, the Administrator may increase by an additional 5 percent the registration service fee in effect as of September 30, 2026. No adjustment may be made under the preceding sentence until the date on which the Administrator begins to implement any recommendations for process improvements contained in the report under subsection (c)(4), as appropriate.”; and
in paragraph (7)(A), by striking “ (commonly referred to as a Gold Seal letter)” and inserting “ (including a Gold Seal letter and a Certificate of Establishment)”.
Conforming amendment.— Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8) is amended by striking “ subsection (b)(3)” each place it appears and inserting “ subsection (b)(3)(B)”.
Pesticide Registration Fund.— Section 33(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c)) is amended—
in paragraph (3), by striking subparagraph (B) and inserting the following:
“(B) Endangered species review of outdoor use of pesticide products.—
“(i) In general.—The Administrator shall use the amounts made available in the Fund to develop, receive comments with respect to, and finalize, guidance to registrants regarding analysis necessary to support the review of outdoor uses of pesticide products under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.).
“(ii) Deadlines for guidance.—The Administrator shall issue final guidance required by clause (i) in accordance with the following:
“(I) With respect to new active ingredients or any registration review decision proposed for 1 or more outdoor uses, not later than 9 months after the date of enactment of the Pesticide Registration Improvement Act of 2022.
“(II) With respect to new outdoor uses of a registered pesticide, not later than 1 year after the date of enactment of the Pesticide Registration Improvement Act of 2022.
“(III) With respect to antimicrobial pesticide products, not later than 3 years after the date of enactment of the Pesticide Registration Improvement Act of 2022.
“(C) Independent third party assessments.—
“(i) In general.—The Administrator shall use the amounts made available in the Fund to carry out the activities described in clauses (ii) and (iii).
“(ii) Workforce assessment.—
“(I) In general.—The Administrator shall procure a competitive contract with a qualified, independent contractor with expertise in assessing public sector workforce data analysis and reporting to conduct an assessment of current methodologies and data or metrics available to represent the workforce implementing the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act, including an assessment of filled and vacant positions and full-time equivalent employees relating to that implementation.
“(II) Report.—Not later than 2 years after the date of enactment of the Pesticide Registration Improvement Act of 2022—
“(aa) the contractor selected under subclause (I) shall submit to the Administrator a report describing—
“(AA) the findings from the assessment under that subclause; and
“(BB) recommendations for improved methodologies to represent full-time equivalent resources described in that subclause; and
“(bb) the Administrator shall publish the report submitted under item (aa) on the website of the Environmental Protection Agency.
“(iii) Process assessment.—
“(I) In general.—
“(aa) Contracts.—Within 1 year of the date of enactment of the Pesticide Registration Improvement Act of 2022, to the extent practicable, the Administrator shall issue a competitive contract to a private, independent consulting firm—
“(AA) to conduct the assessment described in subclause (II); and
“(BB) to submit to the Administrator a report describing the findings of the assessment and the processes and performance of the Environmental Protection Agency relating to the implementation of the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act.
“(bb) Eligibility.—The firm described in item (aa) shall be capable of performing the technical analysis, management assessment, and program evaluation tasks required to address the scope of the assessment under subclause (II).
“(II) Assessment.—
“(aa) In general.—The Administrator, applicants, and registrants shall participate in a targeted assessment of the process for the review of applications submitted under this Act.
“(bb) Consultation.—The firm selected under subclause (I) shall consult with the Administrator and applicants at the start of the assessment under item (aa) and prior to submission of the report under subclause (I)(aa)(BB).
“(cc) Requirements.—The assessment under item (aa) shall evaluate and make recommendations regarding—
“(AA) the initial content screen;
“(BB) the preliminary technical screen;
“(CC) performance, processes, and progress toward reducing renegotiation rates and the average length of renegotiations;
“(DD) performance, processes, and progress toward eliminating the backlog of registrant submissions not covered by subsection (b)(3);
“(EE) performance, processes, and progress toward ensuring that all registrant submissions not covered by subsection (b)(3) are completed by the applicable deadlines described in the notice of the Administrator entitled ‘Pesticide Registration Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formulation Amendments’ and dated October 22, 1998 (and any successor amendments to that notice) and described in subsections (c)(3)(B) and (h) of section 3;
“(FF) compliance with the provisions of this Act relating to renegotiations and registrant submissions not covered by subsection (b)(3);
“(GG) information technology systems;
“(HH) recommended improvements to employee training;
“(II) performance, progress, and processes in completing registration review; and
“(JJ) other appropriate issues, such as submissions by inert suppliers and fast-track amendments under subsections (c)(3)(B) and (h) of section 3.
“(III) Report to congress.—Not later than 1 year after the receipt of an assessment required under this section, the Administrator shall submit to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives—
“(aa) a copy of each such assessment; and
“(bb) the Administrator’s evaluation of the findings and recommendations contained in each such assessment.
“(IV) Recommendations.—The Administrator shall include with the report submitted under subclause (III) a classification of each recommendation described in the report as—
“(aa) can be implemented through administrative action of the Administrator; or
“(bb) requires a statutory change.”
; and
in paragraph (4)—
in subparagraph (A), by striking “ and” at the end;
by redesignating subparagraph (B) as subparagraph (C); and
by inserting after subparagraph (A) the following:
“(B) shall be available during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations; and”
Assessment of Fees.— Section 33(d)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(d)(2)) is amended—
by striking “ (as in existence in fiscal year 2012)”; and
by striking “ the amount of appropriations for covered functions for fiscal year 2012 (excluding the amount of any fees appropriated for the fiscal year).” and inserting “ $166,000,000.”.
Reforms to Reduce Decision Time Review Periods and Prevent Double Payment of Registration Fees.— Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is amended—
by striking the subsection designation and heading and all that follows through “ To the maximum” and inserting the following:
“(e) Reforms to Reduce Decision Time Review Periods and Prevent Double Payment of Registration Fees.—
“(1) Reduction of decision time review periods.—To the maximum”
; and
by adding at the end the following:
“(2) Prevention of double payment of registration service fees.—The Administrator shall develop and implement a process to determine the appropriate fee category or categories for an application that qualifies for more than one fee category in order to assist applicants and prevent unnecessary payment of fees for multiple categories for a single application.”
Decision Time Review Periods.— Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)) is amended—
in paragraph (1), by striking “ Pesticide Registration Improvement Extension Act of 2018” and inserting “ Pesticide Registration Improvement Act of 2022”;
in paragraph (4)—
in subparagraph (B)—
in clause (i), by adding at the end the following:
“(III) Final fee category.—The fee category of a covered application or other actions may not be changed, without providing the information to the applicant, after completion of the preliminary technical screening described in clause (iv).”
in clause (iii), in the matter preceding subclause (I), by inserting “ automate the process, to the maximum extent practicable, and” before “ determine”; and
in clause (iv)—
in the matter preceding subclause (I), by striking “ shall determine if—” and inserting “ shall—”;
in subclause (I)—
by inserting “ determine if” before “ the application and”; and
by striking “ and” at the end;
in subclause (II)—
by inserting “ determine if” before “ the application, data,”; and
by striking the period at the end and inserting a semicolon; and
by adding at the end the following:
“(III) determine, if applicable, whether an application qualifies for a reduced risk determination under subsection (c)(10) or (h) of section 3;
“(IV) grant or deny any data waiver requests submitted by the applicant with the application;
“(V) verify and validate the accuracy of the fee category selected by the applicant; and
“(VI) notify the applicant, in writing, if a new or different fee category is required and calculate the new decision review time based on the original submission date.”
; and
by striking subparagraph (E) and inserting the following:
“(E) Applications for reduced risk.—
“(i) Fee.—If an application for a reduced risk new active ingredient or a reduced risk new use is determined not to qualify as reduced risk, the applicant shall pay the difference in fee for the corresponding non-reduced risk application.
“(ii) Decision review time period.—After receipt by the Administrator of the original covered reduced risk application and fee, the decision time review period for the corresponding non-reduced risk application shall begin within the time periods described in subparagraph (A), based on the submission date of the original covered reduced risk application.”
; and
by striking paragraph (5) and inserting the following:
“(5) Extension of decision time review period.—
“(A) Notification.—If the Administrator cannot meet a decision time review period under this subsection, the Administrator shall notify the applicant, in writing, of—
“(i) the reasons why additional time is needed; and
“(ii) the number of days needed that would allow the Administrator to make a regulatory decision.
“(B) Extension by negotiation or mutual agreement.—The Administrator, acting solely through the Director of the Office of Pesticide Programs, and the applicant may mutually agree, in writing, to extend a decision time review period under this subsection if—
“(i) there is new or additional data or information from the applicant that is necessary for the Administrator to make a decision on the application that cannot be made available within the original decision time review period; or
“(ii) a public comment period associated with the application generates significant comments that cannot be addressed within the original decision time review period.
“(C) Priority.—Once a decision time review period for a covered action described in subsection (b)(3)(B) is missed or extended, the Administrator shall make any action on the application a priority.”
Reports and Information Technology.— Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8) is amended by striking subsection (k) and inserting the following:
“(k) Reports and Information Technology.—
“(1) Reports.—
“(A) In general.—Not later than 120 days after the last day of each of fiscal years 2023 through 2027, the Administrator shall publish an annual report describing—
“(i) actions taken under this section;
“(ii) registrant submissions not covered by subsection (b)(3)(B);
“(iii) the initial content and preliminary technical screenings required in subsection (f)(4)(B); and
“(iv) staffing relating to implementing the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act.
“(B) Contents.—Each report published under subparagraph (A) shall include a summary of the following information:
“(i) Actions under this section.—To the extent practicable, data for each action taken under this section that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—
“(I) the Action Code;
“(II) the application receipt date;
“(III) the electronic portal tracking number assigned to the application at the time of submission to the electronic submission portal or the Environmental Protection Agency tracking number;
“(IV) the original decision due date based on the Action Code;
“(V) the dates of any renegotiations and the renegotiated due dates, if applicable;
“(VI) the reasons for each renegotiation, if applicable;
“(VII) if the submission had to be recoded, reassigned codes, if applicable;
“(VIII) the date that the submission was recoded, if applicable;
“(IX) the decision completion date, if the action has been completed;
“(X) the status of the action, which may be—
“(aa) failed initial content screen;
“(bb) failed preliminary technical screen;
“(cc) approved;
“(dd) withdrawn;
“(ee) denied;
“(ff) do not grant; or
“(gg) pending;
“(XI) the reason for any denial or do not grant decision, if applicable;
“(XII) a review of the progress made in carrying out each requirement of subsections (e) and (f), including, to the extent determined appropriate by the Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for the allowance and use of summaries of acute toxicity studies;
“(XIII) a review of the progress in carrying out section 3(g), including—
“(aa) the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—
“(AA) the number of cases cancelled;
“(BB) the number of cases requiring risk mitigation measures;
“(CC) the number of cases removing risk mitigation measures;
“(DD) the number of cases with no risk mitigation needed; and
“(EE) the number of cases in which risk mitigation has been fully implemented;
“(XIV) a review of the progress made toward implementing enhancements to—
“(aa) the electronic tracking of conditional registrations; and
“(bb) the endangered species database;
“(XV) a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate);
“(XVI) an assessment of the public availability of summary pesticide usage data;
“(XVII) the number of the active ingredients approved, new uses, and pesticide end use products granted in connection with the Design for the Environment program (or any successor program) of the Environmental Protection Agency;
“(XVIII) with respect to funds in the Reregistration and Expedited Processing Fund described under section 4(k), a review that includes—
“(aa) a description of the amount and use of such funds—
“(AA) to carry out activities relating to worker protection under subparagraphs (G) and (H) of section 4(i)(1);
“(BB) to award partnership grants under subparagraph (I) of such section; and
“(CC) to carry out the pesticide safety education program under subparagraph (J) of such section;
“(bb) an evaluation of the appropriateness and effectiveness of the activities, grants, and program under subparagraphs (G), (H), (I), and (J) of such section;
“(cc) a description of how stakeholders are engaged in the decision to fund such activities, grants, and program in accordance with the stakeholder input provided under such subparagraphs; and
“(dd) with respect to activities relating to worker protection carried out under subparagraphs (G) and (H) of section 4(i)(1), a summary of the analyses from stakeholders, including from worker community-based organizations, on the appropriateness and effectiveness of such activities.
“(XIX) beginning two years after enactment, report on the progress of meeting the deadlines listed in paragraph (5) of section 3(f); and
“(XX) a review of progress made in implementing the pesticide surveillance program referred to in paragraph (8) of section 4(k).
“(ii) Registrant submissions not covered by section 33(b)(3)(b).—Each registrant submission not covered by subsection (b)(3)(B), that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—
“(I) the submission date;
“(II) the electronic portal tracking number assigned to the application at the time of the submission of the application to the electronic submission portal;
“(III) the type of regulatory action, as defined by statute or guidance document, and the specific label action;
“(IV) the status of the action;
“(V) the due date;
“(VI) the reason for the outcome; and
“(VII) the completion date, if applicable.
“(iii) Screening process.—Data for the initial content screens and preliminary technical screens that are completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—
“(I) the number of applications successfully passing each type of screen;
“(II) the number of applications that failed the screening process for each type of screen;
“(III) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(II);
“(IV) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(I) and the number of applications resulting in a rejection; and
“(V) the number of notifications issued under section 152.105 of title 40, Code of Federal Regulations (or successor regulations), and to the extent practicable, the reasons for that issuance.
“(iv) Staffing.—Data on the staffing relating to work covered under the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act, organized by registering division, including—
“(I) the number of new hires and personnel departures;
“(II) the number of full-time equivalents at the end of each fiscal year;
“(III) the number of full-time equivalents working on registration review activities; and
“(IV) the number of full-time equivalents working on registrant submissions not covered by subsection (b)(3)(B).
“(C) Publication.—The Administrator shall publish each report under subparagraph (A)—
“(i) on the website of the Environmental Protection Agency; and
“(ii) by such other methods as the Administrator determines to be the most effective for efficiently disseminating the report.
“(2) Information technology.—
“(A) System.—Not later than 1 year after the date of enactment of the Pesticide Registration Improvement Act of 2022, the Administrator shall establish an information technology system that—
“(i) includes all registering divisions in the Office of Pesticide Programs;
“(ii) provides a real-time, accurate, tracking system for all regulatory submissions to the Office of Pesticide Programs;
“(iii) provides a real-time, accessible information that provides each applicant confidential, online access to the status and progress of the regulatory submissions of the applicant; and
“(iv) updates the electronic submission portal—
“(I) to ensure that label reviews are limited to current label changes, to the maximum extent practicable;
“(II) to automate, to the extent practicable, minor, low risk regulatory actions; and
“(III) to allow self-certification of certain regulatory actions, as determined by the Administrator.
“(B) Access to registration data and decisions.—The Administrator shall implement efforts to expand existing, and develop new, information technology tools and databases to improve access by Environmental Protection Agency employees to data used to fulfill registrations, and public access to information about regulatory decisionmaking tools, including opportunities for—
“(i) analysis of the impact of submitted studies on Environmental Protection Agency assessments and decisions;
“(ii) facilitation of read-across or computational model development to help fill information gaps;
“(iii) tracking and reporting submission and decision metrics relating to the use and acceptance of test methods; and
“(iv) drafting and publication of policies communicating Environmental Protection Agency acceptance of novel technologies or approaches.”
Termination of Effectiveness.— Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)) is amended—
by striking “ 2023” each place it appears and inserting “ 2027”; and
in paragraph (2)—
in subparagraph (A)—
in the subparagraph heading, by striking “ 2024” and inserting “ 2028” ; and
by striking “ 2024” and inserting “ 2028”; and
in each of subparagraphs (B) and (C)—
in the subparagraph heading, by striking “ 2025” each place it appears and inserting “ 2029”; and
by striking “ 2025” each place it appears and inserting “ 2029”.
SEC. 706. Revision of Tables Regarding Covered Pesticide Registration Applications and Other Covered Actions and Their Corresponding Registration Service Fees.
Section 33(b)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(3)) (as amended by section 705(a)(1)(C)) is amended by striking subparagraph (B) and inserting the following:
“(B) Schedule, actions, and fees.—Subject to paragraph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows:
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |
|---|---|---|---|---|---|
| R010 | 1 | New Active Ingredient, Food use. (2) (3) | 36 | 1,079,356 | |
| R020 | 2 | New Active Ingredient, Food use; reduced risk. (2) (3) | 27 | 899,464 | |
| R040 | 3 | New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3) (4) | 18 | 662,883 | |
| R060 | 4 | New Active Ingredient, Non-food use; outdoor. (2) (3) | 30 | 749,886 | |
| R070 | 5 | New Active Ingredient, Non-food use; outdoor; reduced risk. (2) (3) | 24 | 624,905 | |
| R090 | 6 | New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3) (4) | 16 | 463,930 | |
| R110 | 7 | New Active Ingredient, Non-food use; indoor. (2) (3) (4) | 20 | 417,069 | |
| R120 | 8 | New Active Ingredient, Non-food use; indoor; reduced risk. (2) (3) (4) | 14 | 347,556 | |
| R121 | 9 | New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3) (4) | 18 | 261,322 | |
| R122 | 10 | Enriched isomer(s) of registered mixed-isomer active ingredient. (2) (3) | 27 | 454,526 | |
| R123 | 11 | New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; non-food use, not requiring a tolerance. (2) (3) | 27 | 676,296 | |
| R126 | 12 | (new) | New Active Ingredient, Seed treatment only; limited uptake into raw agricultural commodities; use requiring a tolerance. (2) (3) | 31 | 743,925 |
| R125 | 13 | New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3) (4) | 16 | 463,930 | |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | |||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | |||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |
|---|---|---|---|---|---|
| R130 | 14 | First food use; indoor; food/food handling. (2) (3) (5) | 23 | 274,388 | |
| R140 | 15 | Additional food use; Indoor; food/food handling. (3) (4) (5) | 17 | 64,028 | |
| R150 | 16 | First food use. (2) (3) (5) | 23 | 454,490 | |
| R155 | 17 | First food use, Experimental Use Permit application; active ingredient registered for non-food use. (3) (4) (5) | 21 | 378,742 | |
| R160 | 18 | First food use; reduced risk. (2) (3) (5) | 18 | 378,742 | |
| R170 | 19 | Additional food use. (3) (4) (5) | 17 | 113,728 | |
| R175 | 20 | Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. (3) (4) (5) | 14 | 94,774 | |
| R180 | 21 | Additional food use; reduced risk. (3) (4) (5) | 12 | 94,774 | |
| R190 | 22 | Additional food uses; 6 or more submitted in one application. (3) (4) (5) | 17 | 682,357 | |
| R200 | 23 | Additional Food Use; 6 or more submitted in one application; Reduced Risk. (3) (4) (5) | 12 | 568,632 | |
| R210 | 24 | Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration. (3) (4) (5) | 12 | 70,210 | |
| R220 | 25 | Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration. (3) (4) (5) | 6 | 28,434 | |
| R230 | 26 | Additional use; non-food; outdoor. (3) (4) (5) | 16 | 45,453 | |
| R240 | 27 | Additional use; non-food; outdoor; reduced risk. (3) (4) (5) | 10 | 37,878 | |
| R250 | 28 | Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration. (3) (4) (5) | 6 | 28,434 | |
| R251 | 29 | Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis. (3) (5) | 8 | 28,434 | |
| R260 | 30 | New use; non-food; indoor. (3) (4) (5) | 12 | 21,954 | |
| R270 | 31 | New use; non-food; indoor; reduced risk. (3) (4) (5) | 9 | 18,296 | |
| R271 | 32 | New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration. (3) (4) (5) | 6 | 13,940 | |
| R273 | 33 | Additional use; seed treatment only; use not requiring a new tolerance; includes crops with established tolerances (e.g., for soil or foliar application). (3) (4) (5) | 12 | 72,302 | |
| R274 | 34 | Additional use; seed treatment only; 6 or more submitted in one application; uses not requiring new tolerances; includes crops with established tolerances (e.g., for soil or foliar application). (3) (4) (5) | 12 | 433,793 | |
| R276 | 35 | (new) | Additional use, seed treatment only; limited uptake into raw agricultural commodities; use requiring a tolerance. (3) (4) (5) | 14 | 79,560 |
| R277 | 36 | (new) | Additional use, seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; use requiring a tolerance. (3) (4) (5) | 14 | 477,360 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | |||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||
| Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application. | |||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | |||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |
|---|---|---|---|---|---|
| R280 | 37 | Establish tolerances for residues in imported commodities; new active ingredient or first food use. (2) | 22 | 457,311 | |
| R290 | 38 | Establish tolerances for residues in imported commodities; Additional new food use. | 16 | 91,465 | |
| R291 | 39 | Establish tolerances for residues in imported commodities; additional food uses; 6 or more crops submitted in one petition. | 16 | 548,773 | |
| R292 | 40 | Amend an established tolerance (e.g., decrease or increase) and/or harmonize established tolerances with Codex Maximum Residue Limits; domestic or import; applicant-initiated. | 12 | 64,987 | |
| R293 | 41 | Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated. | 13 | 76,656 | |
| R294 | 42 | Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated. | 13 | 459,922 | |
| R295 | 43 | Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated. (3) (4) | 16 | 94,774 | |
| R296 | 44 | Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated. (3) (4) | 16 | 568,632 | |
| R297 | 45 | Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated. | 12 | 389,897 | |
| R298 | 46 | Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review). (3) (4) | 14 | 83,940 | |
| R299 | 47 | Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review). (3) (4) | 14 | 408,853 | |
| R281 | 48 | (new) | Establish tolerances for residues in imported commodities; additional new food use; submission of residue chemistry data review conducted by Codex or other competent national regulatory authority. | 12 | 68,599 |
| R282 | 49 | (new) | Establish tolerances for residues in imported commodities; additional new food uses; 6 or more crops submitted in one petition; submission of residue chemistry data review conducted by Codex or other competent national regulatory authority. | 12 | 411,580 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | |||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||
| Amendment applications to add the revised use pattern(s) to registered product labels are covered by the base fee for the category. All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the amendment application package is subject to the registration service fee for a new product or a new inert approval. However, if an amendment application only proposes to register the amendment for a new product and there are no amendments in the application, then review of one new product application is covered by the base fee. All such associated applications that are submitted together will be subject to the category decision review time. | |||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |||||
|---|---|---|---|---|---|---|---|---|---|
| R300 | 50 | New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or child-resistant packaging — only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re- package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) | 4 | 2,270 | |||||
| R301 | 51 | New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy (identical data citation and claims to cited product(s)), where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) | 4 | 2,720 | |||||
| R310 | 52 | New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 4. Child-resistant packaging and/or | 4. pest(s) requiring efficacy – for up to 3 target pests. (2) (3) (4) | 7 | 10,466 | |
| R314 | 53 | New end-use product containing up to three registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. child resistant packaging and/or | 4. pest(s) requiring efficacy (4) for up to 3 target pests. (2) (3) | 8 | 12,364 | |
| R319 | 54 | New end-use product containing up to three registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. child resistant packaging and/or | 4. pest(s) requiring efficacy (4) - for 4 to 7 target pests. (2) (3) | 10 | 18,097 | |
| R318 | 55 | New end-use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. child resistant packaging and/or | 4. pest(s) requiring efficacy – for up to 3 target pests. (2) (3) (4) | 9 | 18,994 | |
| R321 | 56 | New end-use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. child resistant packaging and/or | 4. pest(s) requiring efficacy (4) - for 4 to 7 target pests. (2) (3) | 11 | 24,727 | |
| R315 | 57 | New end-use on-animal product, registered source of active ingredient(s) with submission of data and/or waivers for only: | 1. animal safety and | 2. pest(s) requiring efficacy and/or | 3. product chemistry and/or | 4. acute toxicity and/or | 5. child resistant packaging. (2) (3) (4) | 9 | 14,075 |
| R316 | 58 | New end-use or manufacturing-use product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. child resistant packaging and/or | 4. pest(s) requiring efficacy - for 4 to 7 target pests. (2) (3) (4) | 9 | 16,199 | |
| R317 | 59 | New end-use or manufacturing-use product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. child resistant packaging and/or | 4. Pest(s) requiring efficacy - for greater than 7 target pests, (2) (3) (4) | 10 | 21,932 | |
| R320 | 60 | New product; new physical form; requires data review in science divisions. (2) (3) (5) | 12 | 18,958 | |||||
| R331 | 61 | New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only. (2) (3) | 3 | 3,627 | |||||
| R332 | 62 | New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions. (2) (3) | 24 | 405,919 | |||||
| R333 | 63 | New product; manufacturing-use product or end-use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2) (3) | 11 | 28,434 | |||||
| R334 | 64 | New product; manufacturing-use product or end-use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2) (3) | 12 | 33,108 | |||||
| R361 | 65 | (new) | New end-use product containing up to three registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. Child resistant packaging and/or | 4. pest(s) requiring efficacy – for more than 7 target pests. (2) (3) (4) | 12 | 23,400 |
| R362 | 66 | (new) | New end-use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. Child resistant packaging and/or | 4. pest(s) requiring efficacy – for more than 7 target pests. (2) (3) (4) | 13 | 25,350 |
| R363 | 67 | (new) | New product; repack of identical registered manufacturing-use product as an end-use product; same registered uses only, with no additional data. (2) (3) | 6 | 7,800 | ||||
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||||||
| An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. | |||||||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||||||
| For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” are both invertebrate and vertebrate pests. Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are listed in the product performance rule, subpart R of part 158 of title 40, Code of Federal Regulations. This list may be updated/refined as invasive pest needs arise. All other pests (e.g., vertebrates) are listed in the Pesticide Registration Notice 2002-1. To determine the number of pests for the PRIA categories, pest groups, subgroups, and pest specific claims as listed in part 158 of title 40, Code of Federal Regulations, should be counted as follows. If seeking a label claim against a general pest group (e.g., cockroaches, mosquitoes, termites, etc.), each group will count as 1. If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.) or specific pests (e.g., smokybrown cockroach, house fly, etc.) without a general claim, then each subgroup or specific pest will count as 1. | |||||||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | |||||||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |||||
|---|---|---|---|---|---|---|---|---|---|
| R340 | 68 | Amendment requiring data review within RD (e.g., changes to precautionary label statements); includes adding/modifying pest(s) claims for up to 2 target pests; excludes products requiring or citing an animal safety study. (2) (3) | 4 | 7,150 | |||||
| R341 | 69 | Amendment requiring data review within RD (e.g., changes to precautionary label statements), includes adding/modifying pest(s) claims for greater than 2 target pests; excludes products requiring or citing an animal safety study. (2) (3) | 6 | 8,584 | |||||
| R345 | 70 | Amending on-animal products previously registered, with the submission of data and/or waivers for only: | 1. animal safety and | 2. pest(s) requiring efficacy and/or | 3. product chemistry and/or | 4. acute toxicity and/or | 5. child resistant packaging. (2) (3) (4) | 7 | 12,643 |
| R350 | 71 | Amendment requiring data review in science divisions (e.g., changes to Restricted Entry Interval, or Personal Protective Equipment, or Preharvest Interval, or use rate, or number of applications; or add aerial application; or modify Ground Water/Surface Water advisory statement). (2) (3) (5) | 9 | 18,958 | |||||
| R351 | 72 | Amendment adding a new unregistered source of active ingredient. (2) (3) | 8 | 18,958 | |||||
| R352 | 73 | Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data. (2) (3) | 8 | 18,958 | |||||
| R371 | 74 | Amendment to Experimental Use Permit; (does not include extending a permit’s time period). (3) | 6 | 14,463 | |||||
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||||||
| (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. | |||||||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||||||
| For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” are both invertebrate and vertebrate pests. Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are listed in the product performance rule, subpart R of part 158 of title 40, Code of Federal Regulations. This list may be updated/refined as invasive pest needs arise. All other pests (e.g., vertebrates) are listed in the Pesticide Registration Notice 2002-1. To determine the number of pests for the PRIA categories, pest groups, subgroups, and pest specific claims as listed in part 158 of title 40, Code of Federal Regulations, should be counted as follows. If seeking a label claim against a general pest group (e.g., cockroaches, mosquitoes, termites, etc.), each group will count as 1. If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.) or specific pests (e.g., smokybrown cockroach, house fly, etc.) without a general claim, then each subgroup or specific pest will count as 1. | |||||||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | |||||||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |
|---|---|---|---|---|---|
| R124 | 75 | Conditional Ruling on Pre-application Study Waivers; applicant-initiated. | 6 | 3,627 | |
| R272 | 76 | Review of Study Protocol applicant- initiated; excludes Data Analysis Reporting Tool, pre- registration conference, Rapid Response review, developmental neurotoxicity protocol review, protocol needing Human Studies Review Board review, companion animal safety protocol. | 3 | 3,627 | |
| R275 | 77 | Rebuttal of Agency reviewed protocol, applicant initiated. | 3 | 3,627 | |
| R278 | 78 | (new) | Review of Protocol for companion animal safety study. | 5 | 4,927 |
| R279 | 79 | (new) | Comparative product determination for reduced risk submission, applicant initiated; submitted before application for reduced risk new active ingredient or reduced risk new use. | 3 | 5,200 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| A380 | 80 | New Active Ingredient; Indirect Food use; establish tolerance or tolerance exemption if required. (2) (3) (4) | 26 | 227,957 |
| A390 | 81 | New Active Ingredient; Direct Food use; establish tolerance or tolerance exemption if required. (2) (3) (4) | 26 | 329,265 |
| A410 | 82 | New Active Ingredient Non-food use. (2) (3) (4) | 23 | 278,659 |
| A431 | 83 | New Active Ingredient, Non-food use; low-risk. (2) (3) (4) | 14 | 114,984 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | ||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | ||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | ||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| A440 | 84 | New Use, Indirect Food Use, establish tolerance or tolerance exemption. (2) (3) (4) (6) | 23 | 45,737 |
| A441 | 85 | Additional Indirect food uses; establish tolerances or tolerance exemptions if required; 6 or more submitted in one application. (3) (4) (5) (6) | 23 | 164,639 |
| A450 | 86 | New use, Direct food use, establish tolerance or tolerance exemption. (2) (3) (4) (6) | 23 | 137,198 |
| A451 | 87 | Additional Direct food uses; establish tolerances or tolerance exemptions if required; 6 or more submitted in one application. (3) (4) (5) (6) | 22 | 261,333 |
| A500 | 88 | New use, non-food. (4) (5) (6) | 15 | 45,737 |
| A501 | 89 | New use, non-food; 6 or more submitted in one application. (4) (5) (6) | 17 | 109,764 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | ||||
| If EPA data rules are amended to newly require clearance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule. | ||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | ||||
| Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application. | ||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | ||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |
|---|---|---|---|---|---|
| A530 | 90 | New product, identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite all data citation or selective data citation where applicant owns all required data; or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) | 4 | 1,833 | |
| A531 | 91 | New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) | 4 | 2,616 | |
| A532 | 92 | New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted. (2) (3) | 5 | 7,322 | |
| A550 | 93 | New end-use product; uses other than FIFRA §2(mm); non-FQPA product. (2) (3) (5) | 9 | 18,958 | |
| A560 | 94 | New manufacturing-use product; registered active ingredient; selective data citation. (2) (3) | 6 | 18,054 | |
| A565 | 95 | New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of new generic data package; registered uses only; requires science review. (2) (3) | 18 | 26,135 | |
| A572 | 96 | New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to Restricted Entry Interval, or Personal Protective Equipment, or use rate). (2) (3) (4) (7) | 9 | 18,958 | |
| A460 | 97 | (new) | New end-use product; FIFRA §2(mm) uses only; 0 to 10 public health organisms. (2) (3) (5) (6) | 5 | 7,322 |
| A461 | 98 | (new) | New end-use product; FIFRA §2(mm) uses only; 11 to 20 public health organisms. (2) (3) (5) (6) | 6 | 10,158 |
| A462 | 99 | (new) | New end-use product; FIFRA §2(mm) uses only; 21 to 30 public health organisms. (2) (3) (5) (6) | 7 | 12,995 |
| A463 | 100 | (new) | New end-use product; FIFRA §2(mm) uses only; 31 to 40 public health organisms. (2) (3) (5) (6) | 9 | 15,831 |
| A464 | 101 | (new) | New end-use product; FIFRA §2(mm) uses only; 41 to 50 public health organisms. (2) (3) (5) (6) | 10 | 18,668 |
| A465 | 102 | (new) | New end-use product; FIFRA §2(mm) uses only; 51 or more public health organisms. (2) (3) (5) (6) | 11 | 21,505 |
| A470 | 103 | (new) | Label amendment requiring data review; 0 to 10 public health organisms. (3) (4) (5) (6) | 4 | 5,493 |
| A471 | 104 | (new) | Label amendment requiring data review; 11 to 20 public health organisms. (3) (4) (5) (6) | 5 | 8,506 |
| A472 | 105 | (new) | Label amendment requiring data review; 21 to 30 public health organisms. (3) (4) (5) (6) | 6 | 10,219 |
| A473 | 106 | (new) | Label amendment requiring data review; 31 to 40 public health organisms. (3) (4) (5) (6) | 7 | 11,933 |
| A474 | 107 | (new) | Label amendment requiring data review; 41 to 50 public health organisms. (3) (4) (5) (6) | 8 | 13,646 |
| A475 | 108 | (new) | Label amendment requiring data review; 51 or more public health organisms. (3) (4) (5) (6) | 9 | 15,766 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||
| An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. | |||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||
| (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. | |||||
| The applicant must identify the substantially similar product if opting to use cite-all or the selective method to support acute toxicity data requirements. | |||||
| Once an application for an amendment or a new product with public health organisms has been submitted and classified into any of categories A460 through A465 or A470 through A475, additional organisms submitted for the same product before the first application is granted will result in combination and reclassification of both the original and subsequent submissions into the appropriate new category based on the sum of the number of organisms in both submissions. Submission of additional organisms would result in a new PRIA start date and may require additional fees to meet the fee of a new category. | |||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | |||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |
|---|---|---|---|---|---|
| A520 | 109 | Experimental Use Permit application, non-food use. (2) (3) | 9 | 9,151 | |
| A521 | 110 | Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol; applicant-initiated; Tier 1. | 6 | 6,776 | |
| A522 | 111 | Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol; applicant-initiated; Tier 2. | 12 | 17,424 | |
| A537 | 112 | New Active Ingredient/New Use, Experimental Use Permit application; Direct food use; Establish tolerance or tolerance exemption if required. Credit 45% of fee toward new active ingredient/new use application that follows. (3) | 18 | 219,512 | |
| A538 | 113 | New Active Ingredient/New Use, Experimental Use Permit application; Indirect food use; Establish tolerance or tolerance exemption if required Credit 45% of fee toward new active ingredient/new use application that follows. (3) | 18 | 137,198 | |
| A539 | 114 | New Active Ingredient/New Use, Experimental Use Permit application; Nonfood use. Credit 45% of fee toward new active ingredient/new use application that follows. (3) | 15 | 132,094 | |
| A529 | 115 | Amendment to Experimental Use Permit; requires data review or risk assessment. (2) (3) | 9 | 16,383 | |
| A523 | 116 | Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols). | 9 | 17,424 | |
| A571 | 117 | Science reassessment: refined ecological risk, and/or endangered species; applicant-initiated. (3) | 18 | 137,198 | |
| A533 | 118 | Exemption from the requirement of an Experimental Use Permit. (2) | 4 | 3,559 | |
| A534 | 119 | Rebuttal of Agency reviewed protocol, applicant initiated. | 4 | 6,776 | |
| A535 | 120 | Conditional ruling on pre-application study waiver or data bridging argument; applicant-initiated. | 6 | 3,454 | |
| A536 | 121 | Conditional ruling on pre-application direct food, indirect food, nonfood use determination; applicant-initiated. | 4 | 3,559 | |
| A575 | 122 | (new) | Efficacy similarity determination; if two products can be bridged or if confirmatory efficacy data are needed. | 4 | 3,389 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||
| 3) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | |||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| B580 | 123 | New active ingredient; petition to establish a tolerance. (2) (3) (4) | 22 | 73,173 |
| B590 | 124 | New active ingredient; petition to establish a tolerance exemption. (2) (3) (4) | 20 | 45,737 |
| B600 | 125 | New active ingredient; no change to a permanent tolerance or tolerance exemption (includes non-food uses). (2) (3) (4) | 15 | 27,443 |
| B610 | 126 | New active ingredient; Experimental Use Permit application; petition to establish a permanent or temporary tolerance or temporary tolerance exemption. (3) (4) | 12 | 18,296 |
| B620 | 127 | New active ingredient; Experimental Use Permit application; non-food use (includes crop destruct). (3) (4) | 9 | 9,151 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | ||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | ||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | ||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| B630 | 128 | First food use; petition to establish/amend a tolerance exemption. (2) (4) (5) | 13 | 18,296 |
| B640 | 129 | First food use; petition to establish/amend a tolerance. (2) (4) (5) | 19 | 27,443 |
| B644 | 130 | New use, no change to an established tolerance or tolerance exemption (includes non-food uses). (3) (4) (5) | 8 | 18,296 |
| B645 | 131 | New use; Experimental Use Permit; petition to establish a permanent or temporary tolerance or tolerance exemption. (4) (5) | 12 | 18,296 |
| B646 | 132 | New use; Experimental Use Permit; non-food use (includes crop destruct). (4) (5) | 7 | 9,151 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | ||||
| Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application. | ||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | ||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | ||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |||||
|---|---|---|---|---|---|---|---|---|---|
| B660 | 133 | New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption; no data submission or data matrix (or submission of product chemistry data only). (2) (3) | 6 | 1,833 | |||||
| B670 | 134 | New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; (including non-food); Must address Product-Specific Data Requirements. (2) (3) | 9 | 7,322 | |||||
| B672 | 135 | New product; unregistered source of at least one active ingredient (or registered source with new generic data package); no change in an established tolerance or tolerance exemption (including non-food); must address Product-Specific and Generic Data Requirements. (2) (3) | 15 | 13,069 | |||||
| B673 | 136 | New product; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency; requires an Agency determination that the cited data support the new product. (2) (3) | 12 | 7,322 | |||||
| B674 | 137 | New product; repack of identical registered end-use product or repack of an end-use product as a manufacturing-use product; same registered uses only. (2) (3) | 4 | 1,833 | |||||
| B677 | 138 | New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: | 1. product chemistry and/or | 2. acute toxicity and/or | 3. public health pest efficacy and/or | 4. animal safety studies and/or | 5. child resistant packaging. (2) (3) | 12 | 12,643 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||||||
| An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. | |||||||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| B621 | 139 | Amendment; Experimental Use Permit; no change to an established temporary or permanent tolerance or tolerance exemption. (3) (4) | 7 | 7,322 |
| B622 | 140 | Amendment; Experimental Use Permit; petition to amend a permanent or temporary tolerance or tolerance exemption. (3) (4) | 11 | 18,296 |
| B641 | 141 | Amendment; changes to an established tolerance or tolerance exemption. (4) | 13 | 18,296 |
| B680 | 142 | Amendment; registered sources of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption; requires data submission. (2) (3) | 5 | 7,322 |
| B681 | 143 | Amendment; unregistered source of active ingredient(s); no change to an established tolerance or tolerance exemption; requires data submission. (2) (3) | 7 | 8,714 |
| B683 | 144 | Amendment; no change to an established tolerance or tolerance exemption; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to Restricted Entry Interval, Personal Protective Equipment, Preharvest Interval). (2) (3) | 6 | 7,322 |
| B684 | 145 | Amending non-food animal product that includes submission of target animal safety data; previously registered. (2) (3) | 8 | 12,643 |
| B685 | 146 | Amendment; add a new biochemical unregistered source of active ingredient or a new microbial production site; requires submission of analysis of samples data and source/production site-specific manufacturing process description. (3) | 5 | 7,322 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. | ||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | ||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | ||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| B690 | 147 | SCLP; new active ingredient; food or non-food use. (2) (6) (7) | 7 | 3,662 |
| B700 | 148 | SCLP; Experimental Use Permit application; new active ingredient or new use. (6) (7) | 7 | 1,833 |
| B701 | 149 | SCLP; Extend or amend Experimental Use Permit. (6) (7) | 4 | 1,833 |
| B710 | 150 | SCLP; new product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption; no data submission or data matrix (or only product chemistry data); (Includes 100% re-pack; repack of registered end-use product as a manufacturing-use product). (3) (6) | 4 | 1,833 |
| B720 | 151 | SCLP; new product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption (including non-food); Must address Product-Specific Data Requirements. (3) (6) | 5 | 1,833 |
| B721 | 152 | SCLP: new product; unregistered source of active ingredient; no change in an established tolerance or tolerance exemption (including non-food); must address Product-Specific and Generic Data Requirements. (3) (6) | 7 | 3,836 |
| B722 | 153 | SCLP; new use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5) (6) (7) | 7 | 3,552 |
| B730 | 154 | SCLP; amendment requiring data submission. (4) (6) | 5 | 1,833 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the Agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. | ||||
| An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. | ||||
| (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. | ||||
| Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application. | ||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | ||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | ||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |
|---|---|---|---|---|---|
| B614 | 155 | Pre-application; Conditional Ruling on rationales for addressing a data requirement in lieu of data; applicant-initiated; applies to one (1) rationale at a time. | 3 | 3,627 | |
| B682 | 156 | Protocol review; applicant initiated; excludes time for Human Studies Review Board review (Includes rebuttal of protocol review). | 3 | 3,487 | |
| B616 | 157 | (new) | Pre-application; Conditional Ruling on a non-food use determination. | 5 | 4,715 |
| B617 | 158 | (new) | Pre-application; biochemical classification determination. | 5 | 4,715 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) | |||
|---|---|---|---|---|---|---|---|
| B740 | 159 | Experimental Use Permit application; no petition for tolerance/tolerance exemption; includes: | 1. non-food/feed use(s) for a new (2) or registered (3) PIP (12); | 2. food/feed use(s) for a new or registered PIP with crop destruct; | 3. food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4) (5) (12) | 9 | 137,198 |
| B750 | 160 | Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4) (12) | 12 | 182,927 | |||
| B771 | 161 | Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows. (5) (12) | 13 | 182,927 | |||
| B772 | 162 | Application to amend or extend a PIP Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. (12) | 3 | 18,296 | |||
| B773 | 163 | Application to amend or extend a PIP Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. (12) | 9 | 45,737 | |||
| B780 | 164 | Registration application; new (2) PIP; non-food/feed or food/feed without tolerance petition based on an existing permanent tolerance exemption. (5) (12) (14) | 16 | 228,657 | |||
| B800 | 165 | Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (5) (12) (14) | 17 | 246,949 | |||
| B820 | 166 | Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. (5) (12) (14) | 19 | 292,682 | |||
| B851 | 167 | Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). (12) | 9 | 182,927 | |||
| B870 | 168 | Registration application; registered (3) PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4) (12) (14) | 9 | 54,881 | |||
| B880 | 169 | Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (5) (6) (7) (12) (14) | 9 | 45,737 | |||
| B883 | 170 | Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (5) (8) (12) (14) | 13 | 182,927 | |||
| B884 | 171 | Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (5) (8) (12) (14) | 19 | 228,657 | |||
| B885 | 172 | Registration application; registered (2) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9) (12) | 6 | 45,737 | |||
| B890 | 173 | Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). (5) (12) (14) | 9 | 91,465 | |||
| B900 | 174 | Application to amend a registration, including actions such as modifying an IRM plan, or adding an insect to be controlled. (5) (10) (11) (12) | 6 | 18,296 | |||
| B902 | 175 | PIP Protocol review. | 3 | 9,151 | |||
| B903 | 176 | Inert ingredient permanent tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD. | 12 | 91,465 | |||
| B904 | 177 | Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient). | 12 | 182,927 | |||
| B905 | 178 | FIFRA Scientific Advisory Panel Review. | 6 | 91,465 | |||
| B906 | 179 | Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients. | 9 | 45,733 | |||
| B907 | 180 | Petition to establish a permanent tolerance/tolerance exemption for one or more active ingredients based on an existing temporary tolerance/tolerance exemption. | 9 | 18,296 | |||
| B909 | 181 | (new) | PIP tolerance exemption determination; applicant-initiated; request to determine if an existing tolerance exemption applies to a PIP. | 6 | 18,296 | ||
| B910 | 182 | (new) | Biotechnology Notification for small-scale field testing of genetically engineered microbes. | 3 | 9,151 | ||
| B921 | 183 | (new) | Experimental Use Permit application; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); non-food/feed. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. Credit 75% of B921 fee toward registration application for the new active ingredient that follows (B922). (5) (12) (13) | 12 | 182,927 | ||
| B922 | 184 | (new) | Registration application; new active ingredient; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); non-food/feed. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. (5) (12) (13) (14) | 16 | 228,657 | ||
| B923 | 185 | (new) | Experimental Use Permit application; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); with petition to establish a temporary or permanent tolerance/tolerance exemption of an active ingredient. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. Credit 75% of B923 fee toward registration application for the new active ingredient that follows (B924). (5) (12) (13) (14) | 15 | 228,658 | ||
| B924 | 186 | (new) | Registration application; new active ingredient; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); with petition to establish a permanent tolerance/tolerance exemption of an active ingredient. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. (5) (12) (13) (14) | 19 | 292,682 | ||
| B925 | 187 | (new) | Experimental Use Permit application; exogenous applications of RNA to elicit the RNA interference pathway in pests; non-food/feed; credit 75% of B925 fee toward registration application for the new active ingredient that follows (B926). (5) (12) | 11 | 27,452 | ||
| B926 | 188 | (new) | Registration application; new active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; non-food/feed. (5) (12) (14) | 17 | 82,329 | ||
| B927 | 189 | (new) | Experimental Use Permit application; exogenous applications of RNA to elicit the RNA interference pathway in pests; with petition to establish a temporary or permanent tolerance/tolerance exemption of an active ingredient; credit 75% of B927 fee toward registration application for the new active ingredient that follows (B928). (5) (12) | 14 | 54,889 | ||
| B928 | 190 | (new) | Registration application; new active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; with petition to establish a permanent tolerance/tolerance exemption of an active ingredient. (5) (12) (14) | 22 | 137,210 | ||
| B929 | 191 | (new) | Registration application; new product, registered active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (5) (12) | 10 | 7,322 | ||
| B930 | 192 | (new) | Application to amend or extend a non-PIP Emerging Technologies Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. (12) | 3 | 18,296 | ||
| B931 | 193 | (new) | Application to amend or extend a non-PIP Emerging Technologies Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. (12) | 9 | 45,737 | ||
| B932 | 194 | (new) | Amendment; application to amend a non-PIP Emerging Technologies registration. (4) (5) (12) | 6 | 18,296 | ||
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | |||||||
| ‘New PIP’ means a PIP with an active ingredient that has not been registered. | |||||||
| ‘Registered PIP’ means a PIP with an active ingredient that is currently registered. | |||||||
| Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn. | |||||||
| If, during review of the application, it is determined that review by the FIFRA Scientific Advisory Panel (SAP) is needed, the applicant will submit an application for category B905, which will be processed concurrently, and the decision review time for both applications will be the longer of the two associated applications. The scientific data involved in this category are complex. EPA often seeks technical advice from the SAP on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed. | |||||||
| Registered PIPs stacked through conventional breeding. | |||||||
| Deployment of a registered PIP with a different Insecticide Resistance Management (IRM) plan (e.g., seed blend). | |||||||
| The negotiated acreage cap will depend upon EPA’s determination of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category. | |||||||
| Application can be submitted prior to or concurrently with an application for commercial registration. | |||||||
| For example, IRM plan modifications that are applicant-initiated. | |||||||
| (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. | |||||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | |||||||
| This category does not include genetic modifications in animals not intended for use as a pesticide, e.g., genetic modifications in animals intended for food use or animals intended for use as companion animals. | |||||||
| If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension. | |||||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| I001 | 195 | Approval of new food use inert ingredient. (2) (3) | 15 | 38,698 |
| I002 | 196 | Amend currently approved inert ingredient tolerance or exemption from tolerance; new data. (2) | 13 | 10,750 |
| I003 | 197 | Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data. (2) | 11 | 4,742 |
| I004 | 198 | Approval of new non-food use inert ingredient. (2) | 6 | 15,803 |
| I005 | 199 | Amend currently approved non-food use inert ingredient with new use pattern; new data. (2) | 6 | 7,903 |
| I006 | 200 | Amend currently approved non-food use inert ingredient with new use pattern; no new data. (2) | 4 | 4,742 |
| I007 | 201 | Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern. (2) | 5 | 2,371 |
| I008 | 202 | Approval of new or amended polymer inert ingredient, food use. (2) | 7 | 5,374 |
| I009 | 203 | Approval of new or amended polymer inert ingredient, non-food use. (2) | 4 | 4,427 |
| I010 | 204 | Petition to amend a single tolerance exemption descriptor, or single non-food use descriptor, to add ≤ 10 CASRNs; no new data. (2) | 7 | 2,371 |
| I011 | 205 | Approval of new food use safener with tolerance or exemption from tolerance. (2) | 26 | 856,631 |
| I012 | 206 | Approval of new non-food use safener. (2) | 21 | 595,147 |
| I013 | 207 | Approval of additional food use for previously approved safener with tolerance or exemption from tolerance. (2) | 17 | 90,260 |
| I014 | 208 | Approval of additional non-food use for previously approved safener. (2) | 15 | 36,074 |
| I015 | 209 | Approval of new generic data for previously approved food use safener. (2) | 26 | 386,589 |
| I016 | 210 | Approval of amendment(s) to tolerance and label for previously approved safener. (2) | 15 | 79,942 |
| I017 | 211 (new) | Add new source of previously approved safener. | 8 | 18,958 |
| I018 | 212 (new) | Petition to add one approved inert ingredient (CASRN) to the Commodity Inert Ingredient List; no data. (4) | 3 | 2,371 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to its respective registration service fee. The decision review time for both submissions will be the longest of the associated applications. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients. | ||||
| If EPA data rules are amended to newly require clearance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule. | ||||
| Due to low fee and short time frame this category is not eligible for small business waivers. | ||||
| EPANo. | New CRNo. | Action | DecisionReview Time (Months)(1) | Registration Service Fee($) |
|---|---|---|---|---|
| M001 | 213 | Study protocol requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of a currently registered active ingredient. | 14 | 11,378 |
| M002 | 214 | Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient. (2) | 14 | 11,378 |
| M003 | 215 | External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active .ingredients. (3) | 12 | 91,651 |
| M004 | 216 | External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (3) | 18 | 91,651 |
| M005 | 217 | New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (4) (5) (6) | 9 | 31,604 |
| M006 | 218 | Request for up to 5 letters of certification (Gold Seal) for one actively registered product (excludes distributor products). (7) | 1 | 398 |
| M007 | 219 | Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii). | 12 | 7,903 |
| M008 | 220 | Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required. | 15 | 2,371 |
| M009 | 221 | Non-FIFRA Regulated Determination; applicant-initiated, per product. | 6 | 3,389 |
| M010 | 222 | Conditional ruling on pre-application, product substantial similarity. | 4 | 3,389 |
| M011 | 223 | Label amendment to add the DfE logo; requires data review; no other label changes. (8) | 4 | 5,230 |
| M012 | 224 (new) | Request for up to 5 letters of certification (Certificate of Establishment) for one actively registered product or one product produced for export (excludes distributor products). (7) | 1 | 398 |
| M013 | 225 (new) | Cancer reassessment; applicant-initiated. | 18 | 284,144 |
| M014 | 227 (new) | Pre-application nano-particle determination. | 8 | 17,424 |
| A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day. | ||||
| Any other covered application that is associated with and dependent on the review by the Human Studies Review Board will be subject to its separate registration service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest review time. | ||||
| Any other covered application that is associated with and dependent on the FIFRA Scientific Advisory Panel review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review. | ||||
| If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to its respective registration service fee. The decision review time for both submissions will be the longest of the associated applications. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients. | ||||
| An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. | ||||
| Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. | ||||
| Due to low fee and short time frame this category is not eligible for small business waivers. | ||||
| This category includes amendments the sole purpose of which is to add ‘Design for the Environment’ (DfE) (or equivalent terms that do not use ‘safe’ or derivatives of ‘safe’) logos to a label. DfE is a voluntary program. A label bearing a DfE logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet objective, scientific criteria established and widely publicized by EPA.”. | ||||
SEC. 707. Information.
Not later than 180 days after the date of enactment of this title, the Administrator of the Environmental Protection Agency shall post on a single webpage of the website of the Environmental Protection Agency aggregated information on pesticide regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), including—
all guidance relating to risk assessment, risk mitigation, benefits assessments, and cost-benefit balancing;
hyperlinks to resources, including the Department of Agriculture’s “national list of allowed and prohibited substances” for organic crop and livestock production;
biopesticides and pesticides exempt pursuant to section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w(b)); and
integrated pest management principles developed under section 28(c) of such Act (7 U.S.C. 136w–3(c)), including technical assistance for implementation of those principles.
SEC. 708. Implementation Dates with Respect to Fees.
Fee Increases.—
Registration service fees.— With respect to amendments made by this title to increase registration service fees specified in section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8), such increases shall not be effective until the date that is 60 days after the date of the enactment of this title, regardless of whether such section 33 specifies (as so amended) that such increases are effective for fiscal year 2023.
Maintenance fees.— With respect to amendments made by this title to increase the amount of maintenance fees to be collected under section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)), such increases shall be effective beginning on October 1, 2022.
Set-asides.— With respect to any set-asides specified in subsection (i) or (k) of section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1), such set-asides shall be effective beginning on October 1, 2022.
Subtitle B Other Matters Relating to Pesticides
SEC. 711. Registration Review Deadline Extension.
In General.— Notwithstanding section 3(g)(1)(A)(iii)(I) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(g)(1)(A)(iii)(I)), the Administrator of the Environmental Protection Agency (referred to in this section as the “Administrator”) shall complete the initial registration review of each pesticide or pesticide case covered by that section not later than October 1, 2026.
Interim Registration Review Decision Requirements.—
Definition of covered interim registration review decision.— In this subsection, the term “covered interim registration review decision” means an interim registration review decision—
that is associated with an initial registration review described in subsection (a);
that is noticed in the Federal Register during the period beginning on the date of enactment of this Act and ending on October 1, 2026; and
for which the Administrator has not, as of the date on which the decision is noticed in the Federal Register, made effects determinations or completed any necessary consultation under section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1536(a)(2)).
Requirements.— Any covered interim registration review decision shall include, where applicable, measures to reduce the effects of the applicable pesticide on—
species listed under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); or
any designated critical habitat.
Consultation.— In developing measures described in paragraph (2), the Administrator shall take into account the input received from the Secretary of Agriculture and other members of the interagency working group established under section 3(c)(11) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(11)).