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Title II — Administration of food safety program

S. 1995 · 116th Congress · Jun 26, 2019 · Lineage

II Administration of food safety program

Sec. 201 Administration of national program

(a)
In general— The Administrator shall—
(1)
administer a national food safety program (referred to in this section as the “program”) to protect public health; and
(2)
ensure that persons who produce or process food meet their responsibility to prevent or minimize food safety hazards related to their products.
(b)
Comprehensive analysis— The program shall be based on a comprehensive analysis of the hazards associated with different food and with the processing of different food, including the identification and evaluation of—
(1)
the severity of the health risks;
(2)
the sources and specific points of potential contamination extending from the farm or ranch to the consumer that may render food unsafe;
(3)
the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in food;
(4)
opportunities across the food production, processing, distribution, and retail system to manage and reduce potential health risks; and
(5)
opportunities for intentional contamination.
(c)
Program elements— In carrying out the program, the Administrator shall—
(1)
adopt and implement a national system for the registration of food facilities and regular unannounced inspection of food facilities;
(2)
verify and enforce the adoption of preventive process controls in food facilities, based on the best available scientific and public health considerations and best available technologies;
(3)
establish and enforce science-based standards for—
(A)
substances that may contaminate food; and
(B)
safety and sanitation in the processing and handling of food;
(4)
implement a statistically valid sampling program to ensure that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the performance standards established under this Act;
(5)
implement procedures and requirements to ensure the safety and security of imported food;
(6)
coordinate with other agencies and State or local governments in carrying out inspection, enforcement, research, and monitoring;
(7)
access the surveillance data of the Centers for Disease Control and Prevention, and other Federal Government agencies, in order to develop and implement a national surveillance system to assess the health risks associated with the human consumption of food or to create surveillance data and studies to mitigate food threats (such as antibiotic resistance) or to identify the ways that food contamination spreads through environments;
(8)
partner with relevant agencies to identify and prevent terrorist threats to food;
(9)
establish a process for providing a single point of contact to assist impacted consumers in navigating Federal, State, and local agencies involved in responding to or monitoring a foodborne outbreak;
(10)
develop public education risk communication and advisory programs;
(11)
implement a basic and applied research program to further the purposes of this Act; and
(12)
coordinate and prioritize food safety research and educational programs with other agencies, including State or local agencies.

Sec. 202 Registration of food facilities

(a)
In general— The Administrator shall require that all food and feed facilities register before the facility can operate in the United States or import food, feed, or ingredients into the United States.
(b)
Registration requirements—
(1)
In general— To be registered under subsection (a)—
(A)
all food facilities covered under this Act shall comply with registration requirements in section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d);
(B)
for food facilities that have not registered under such section 415 prior to the date of enactment of this Act, the requirement in subparagraph (A) applies beginning on the day that is 180 days after the date of enactment of this Act; and
(C)
for food facilities that have registered under such section 415 prior to the date of enactment of this Act, such facilities shall file an amended registration within 180 days of such date of enactment to deliver the information required by paragraph (2).
(2)
Categories— In addition to the information required under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to be included in registration, a food facility shall—
(A)
list the facility’s primary purpose and business activity, including the dates of operation if the food facility is operating seasonally; and
(B)
list the types of food handled at the facility and identify the activities conducted in the facility, that are relevant to determining whether the facility is a category 1, 2, 3, 4, or 5 facility.
(3)
Procedure— Upon receipt of a completed or amended registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, review the activities identified in the registration, designate the facility as a category 1, 2, 3, 4, or 5 food facility for the purposes of inspection, and assign a registration number to each food facility.
(4)
List— The Administrator—
(A)
shall compile and maintain an up-to-date list of food facilities that are registered under this section, in accordance with section 415(a)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d(a)(5)); and
(B)
may establish regulations on how the list may be shared with other governmental authorities.

Sec. 203 Preventive process controls to reduce adulteration of food

(a)
In general— The Administrator shall review existing regulations on hazard analysis and process controls and amend existing regulations as appropriate, upon the basis of best available public health, scientific, and technological information, to ensure that those regulations are working effectively to—
(1)
ensure food facilities operate in a sanitary manner so that food is not adulterated;
(2)
limit the presence of contaminants in food;
(3)
meet the performance standards established under section 204;
(4)
ensure fully processed or ready-to-eat foods are processed using reasonably available techniques and technologies to eliminate contaminants;
(5)
label food intended for final processing outside commercial food facilities with instructions for handling and preparation for consumption that will destroy contaminants;
(6)
require sampling and testing at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that performance standards are being met; and
(7)
provide for agency access to records kept by food facilities and submission of copies of the records to the Administrator, as the Administrator determines appropriate.
(b)
Processing controls— The Administrator may require any person with responsibility for or control over food or food ingredients to adopt process controls, if the process controls are needed to ensure the protection of the public health.

Sec. 204 Performance standards for contaminants in food

(a)
Performance standards— Whenever the Administrator determines that a foodborne contaminant presents the risk of serious adverse health consequences or death to consumers, causes food to be adulterated, or could promote the spread of communicable disease described in section 361 of the Public Health Service Act (42 U.S.C. 264), the Administrator shall issue a performance standard (in the form of guidance, action levels, or regulations) to prevent or control the contaminant.
(b)
Enforcement—
(1)
In general— Not later than 1 year after the promulgation of a performance standard under this section, the Administrator shall implement a statistically significant sampling program to determine whether food facilities are complying with the standards promulgated under this section.
(2)
Actions— If the Administrator determines that a food facility fails to meet a standard promulgated under this section, and such facility fails to take appropriate corrective action as determined by the Administrator, the Administrator shall, as appropriate—
(A)
detain, seize, or condemn food from the food facility under section 209(i);
(B)
order a recall of food from the food facility under section 402;
(C)
increase the inspection frequency for the food facility;
(D)
withdraw the mark of inspection from the food facility, if in use; or
(E)
take other appropriate enforcement action concerning the food facility, including suspension of registration.
(c)
Newly identified contaminants— Notwithstanding any other provision of this section, the Administrator shall promulgate interim performance standards for newly identified contaminants as necessary to protect the public health.
(d)
Revocation by Administrator— All performance standards, tolerances, action levels, or other similar standards with respect to food in effect on the date of enactment of this Act shall remain in effect until revised or revoked by the Administrator.

Sec. 205 Inspections of food facilities

(a)
In general— The Administrator shall establish an inspection program, which shall include sampling and testing of food and food facilities, to determine if each food facility—
(1)
is operating in a sanitary manner;
(2)
has continuous systems, interventions, and processes in place to minimize or eliminate contaminants in food;
(3)
uses validated process controls and ongoing verification;
(4)
is in compliance with applicable performance standards established under section 204, process control regulations, and other requirements;
(5)
is processing food that is safe and not adulterated or misbranded;
(6)
maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and
(7)
is in compliance with the requirements of the applicable food safety law.
(b)
Facility categories and inspection frequencies— Inspections of food facilities under this Act shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e):
(1)
Category 1 food facilities— A category 1 food facility shall be subject to antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that—
(A)
diseased animals are not offered for slaughter;
(B)
the food facility has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and has destroyed or reprocessed contaminated carcasses in a manner acceptable to the Administrator; and
(C)
applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.
(2)
Category 2 food facilities— A category 2 food facility shall be randomly inspected at least daily.
(3)
Category 3 food facilities— A category 3 food facility shall—
(A)
provide documentation to the Administrator on request that ongoing verification shows that its processes are controlled; and
(B)
be randomly inspected at least monthly.
(4)
Category 4 food facilities— A category 4 food facility shall be randomly inspected at least quarterly.
(5)
Category 5 food facilities— A category 5 food facility shall be randomly inspected at least annually.
(c)
Establishment of inspection procedures— The Administrator shall establish procedures under which inspectors or safety officers inspect food facilities, which shall allow the taking of random samples, photographs, and copies of records in food facilities.
(d)
Alternative inspection frequencies—
(1)
In general— With respect to a category 2, 3, 4, or 5 food facility, to foster a risk-based allocation of resources, the Administrator may establish, in accordance with this subsection, alternative increased or decreased inspection frequencies for—
(A)
1 or more subcategories of food facilities under paragraph (2); and
(B)
1 or more specific food facilities under paragraph (3).
(2)
Determination of subcategories and frequencies—
(A)
In general— The Administrator shall define, by regulation, each subcategory of food facilities established under paragraph (1)(A) and the alternative inspection frequency of that subcategory.
(B)
Considerations— In defining a subcategory of food facilities and the alternative inspection frequency of that subcategory under subparagraph (A), the Administrator shall consider—
(i)
the nature of the foods being processed, stored, or transported;
(ii)
the manner in which foods are processed, stored, or transported;
(iii)
the inherent likelihood that the foods will contribute to the risk of foodborne illness;
(iv)
the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of facilities; and
(v)
the overall record of compliance with the food safety law among facilities in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.
(3)
Specific facilities—
(A)
In general— The Administrator—
(i)
may establish an alternative inspection frequency for increased or decreased inspection for a specific food facility; and
(ii)
shall annually publish a list of food facilities subject to alternative inspection frequencies under clause (i).
(B)
Considerations— In establishing an alternative inspection frequency for a specific food facility, the Administrator shall consider—
(i)
the supporting evidence that the specific food facility shall submit to the Administrator relating to whether an alternative inspection frequency should be established for that facility by the Administrator;
(ii)
whether products from the specific food facility have been associated with a case or an outbreak of foodborne illness;
(iii)
the record of the facility of compliance with the food safety law, including compliance with applicable performance standards and the frequency of recalls; and
(iv)
the considerations described in clauses (i) through (iii) of paragraph (2)(B).
(4)
Frequency requirements for categories 2, 3, and 4— An alternative inspection frequency for a subcategory of food facilities or a specific food facility under this subsection shall be—
(A)
in the case of a category 2 food facility, not less frequently than monthly; and
(B)
in the case of a category 3 or 4 food facility, not less frequently than annually.
(5)
Requirements for decreased frequencies— Before issuing a regulation or order establishing a decreased alternative inspection frequency for a subcategory of food facilities or an individual food facility under this subsection, the Administrator shall—
(A)
describe, in general terms, the alternative uses of resources of the Administration that would have been required to carry out the inspection activity; and
(B)
determine, based on the best available evidence, that the alternative uses of the resources would make a greater contribution to protecting the public health and reducing the risk of foodborne illness.
(e)
Inspection transition— The Administrator shall manage the transition to the inspection system described in this Act as follows:
(1)
Regulations— The Administrator shall promulgate regulations to implement this section no later than 24 months after the date of enactment of this Act.
(2)
Limit on reduction in inspection frequency— For any food facility, the Administrator shall not reduce the inspection frequency from the frequency required pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) until the food facility has demonstrated that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved.
(f)
Official mark—
(1)
In general—
(A)
Establishment— Before the completion of the transition process under subsection (e), the Administrator shall by regulation establish an official mark that can be affixed to a food produced in a category 1, 2, or 3 food facility if—
(i)
the facility is in compliance with the food safety law; and
(ii)
has been inspected in accordance with the inspection frequencies under this section.
(B)
Removal of official mark— The Administrator shall promulgate regulations that provide for the removal of the official mark under this subsection if—
(i)
the Administrator makes a finding that the facility is not in compliance with the food safety law; or
(ii)
the Administrator suspends the registration of the facility.
(2)
Category 1, 2, or 3 food facilities— In the case of products manufactured, slaughtered, processed, or held in a category 1, 2, or 3 food facility—
(A)
products subject to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as of the date of enactment of this Act shall remain subject to the requirement under those Acts that they bear the mark of inspection pending completion of the transition process under subsection (e);
(B)
the Administrator shall publicly certify on a monthly basis that the inspection frequencies required under this section have been achieved; and
(C)
a product from a facility that has not been inspected in accordance with the required frequencies under this section shall not bear the official mark and shall not be shipped in interstate commerce.
(3)
Category 4 and 5 food facilities— In the case of a product manufactured, slaughtered, processed, or held in a category 4 or 5 food facility, the Administrator shall provide by regulation for the voluntary use of the official mark established under paragraph (1), subject to—
(A)
such minimum inspection frequencies as determined appropriate by the Administrator;
(B)
compliance with applicable performance standards and other provisions of the food safety law; and
(C)
such other requirements as the Administrator considers appropriate.
(g)
Maintenance and inspection of records—
(1)
In general—
(A)
Records— A food facility shall—
(i)
maintain such records as the Administrator requires by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and
(ii)
permit the Administrator, in addition to any authority of the food safety agencies in effect on the day before the date of enactment of this Act, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food facility representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator to determine whether the food is contaminated or not in compliance with the food safety law.
(B)
Required disclosure— A food facility shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food that is positive for any contaminant.
(2)
Maintenance of records— The records required by paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.
(3)
Requirements— The records required by paragraph (1) shall include records describing—
(A)
the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients;
(B)
the identity and quantity of ingredients used in the food;
(C)
the processing of the food;
(D)
the results of laboratory, sanitation, or other tests performed on the food or in the food facility;
(E)
consumer complaints concerning the food or packaging of the food;
(F)
the production codes, open date codes, and locations of food production; and
(G)
other matters reasonably related to whether food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.
(h)
Protection of sensitive information—
(1)
In general— The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or confidential information obtained by the Administrator.
(2)
Limitation— The requirement under this subsection does not—
(A)
limit the authority of the Administrator to inspect or copy records or to require the facility or maintenance of records under this Act;
(B)
have any legal effect on section 1905 of title 18, United States Code;
(C)
extend to any food recipe, financial data, pricing data, personnel data, or sales data (other than shipment dates relating to sales);
(D)
limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 402; or
(E)
limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities.
(i)
Bribery of or gifts to inspector or other officers and acceptance of gifts— Section 22 of the Federal Meat Inspection Act (21 U.S.C. 622) shall apply under this Act.

Sec. 206 Food production establishments

In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production establishments, to—
(1)
visit and inspect food production establishments in the United States and in foreign countries for food safety purposes;
(2)
review food safety records as needed to carry out traceback and for other food safety purposes;
(3)
set good practice standards to protect the public and promote food safety;
(4)
partner with appropriate agencies to monitor animals, plants, products, or the environment, as appropriate; and
(5)
collect and maintain information relevant to public health and farm practices.

Sec. 207 Federal and State cooperation

(a)
In general— The Administrator shall work with the States to carry out activities and programs that create a national food safety program so that Federal and State programs function in a coordinated and cost-effective manner.
(b)
State action— The Administrator shall work with States to—
(1)
continue, strengthen, or establish State food safety programs, especially with respect to the regulation of retail commercial food establishments, transportation, harvesting, and fresh markets;
(2)
continue, strengthen, or establish inspection programs and requirements to ensure that food under the jurisdiction of the State is safe; and
(3)
support recall authorities at the State and local levels.
(c)
Assistance— To assist in planning, developing, and implementing a food safety program, the Administrator may provide to a State—
(1)
advisory assistance;
(2)
technical and laboratory assistance and training (including necessary materials and equipment); and
(3)
financial assistance, in kind assistance, and other aid.
(d)
Service agreements—
(1)
In general— The Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise the personnel and services of those agencies in carrying out this Act.
(2)
Training— Agreements with a State under this subsection may provide for training of State employees.
(3)
Maintenance of agreements— The Administrator shall maintain any agreement that is in effect on the day before the date of enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement.
(e)
Audits—
(1)
In general— The Administrator shall annually conduct a comprehensive review of each State program that provides services to the Administrator in carrying out the responsibilities under this Act, including mandated inspections under section 205.
(2)
Requirements— The review shall—
(A)
include a determination of the effectiveness of the State program; and
(B)
identify any changes necessary to ensure enforcement of Federal requirements under this Act.
(f)
No Federal preemption— Nothing in this Act shall be construed to preempt the enforcement of State food safety laws and standards that are at least as stringent as those under this Act.

Sec. 208 Foreign supplier verification program

(a)
In general— The Administrator shall require that each importer of products from a feed facility, food facility, or food producer establishment be in compliance with the foreign supplier verification program requirements under section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a).
(b)
Rule of construction— In applying subsection (a) with respect to products subject to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), references in section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) to sections 402, 403(w), 418, and 419 of such Act (21 U.S.C. 342, 343(w), 350g, and 350h) shall be construed to be references to the corresponding provisions of the food safety law, if any, that apply to such products, as determined by the Administrator.
(c)
Repeal of exemptions— Section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) is amended—
(1)
in subsection (a)(1), by striking “subsections (e) and (f)” and inserting “subsection (e)”;
(2)
by striking subsection (e); and
(3)
by redesignating subsections (f) and (g) as subsections (e) and (f), respectively.

Sec. 209 Imports

(a)
In general— Not later than 2 years after the date of enactment of this Act, the Administrator shall establish a system under which a foreign government seeking to certify food for importation into the United States shall submit a request for accreditation to the Administrator.
(b)
Accreditation standard— A foreign government requesting to be accredited to certify food for importation into the United States shall demonstrate, in a manner determined appropriate by the Administrator, that the foreign government (or an agency thereof) is capable of adequately ensuring that eligible entities or foods certified by such government (or agency) meet the requirements of the food safety law.
(c)
Request by foreign government— Prior to granting accreditation to a foreign government under this section, the Administrator shall review and audit the food safety program of the requesting foreign government and certify that such program (including all statutes, regulations, and inspection authority) meets the standard specified in subsection (b).
(d)
Limitations— Any accreditation of a foreign government under this section shall—
(1)
specify the foods covered by the accreditation; and
(2)
be limited to a period not to exceed 5 years.
(e)
Withdrawal of accreditation— The Administrator may withdraw accreditation fully or partially from a foreign government if the Administrator finds that—
(1)
food covered by the accreditation is linked to an outbreak of human illness;
(2)
the programs or procedures of the foreign government no longer meet the standards of the food safety programs and procedures of the United States; or
(3)
the foreign government refuses to allow United States officials to conduct such audits and investigations as may be necessary to fulfill the requirements under this section.
(f)
Renewal of accreditation— The Administrator shall audit foreign governments accredited under this section at least every 5 years to ensure the continued compliance by such governments with the standard set forth in subsection (b).
(g)
Required routine inspection— The Administrator shall routinely inspect food or food animals by physical examination before the food or food animals enter the United States to ensure that the food or food animals—
(1)
are safe;
(2)
are labeled as required for food produced in the United States; and
(3)
otherwise meet the requirements of the food safety law.
(h)
Enforcement— The Administrator may—
(1)
deny importation of food from any country if the country’s government does not permit United States officials to enter the country to conduct such audits and inspections as may be necessary to fulfill the requirements under this section;
(2)
deny importation of food from any country or foreign facility that does not consent to an investigation by the Administrator when food from that country or foreign facility is linked to a foodborne illness outbreak or is otherwise found to be adulterated or mislabeled; and
(3)
promulgate regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the standards of the food safety law.
(i)
Detention and seizure— Any food imported for consumption in the United States that fails to meet the standards of the food safety law may be detained, seized, or condemned.

Sec. 210 Traceback

(a)
In general— The Administrator, in order to protect the public health, shall establish requirements for a national system for tracing food, animals, or ingredients from point of origin to retail sale, subject to subsection (b).
(b)
Applicability— Traceability requirements shall—
(1)
be established in accordance with regulations and guidelines issued by the Administrator; and
(2)
apply to food production establishments and food facilities.

Sec. 211 Food safety technology

(a)
In general— The Administrator shall establish and implement a program, to be known as the Food Safety Technology Program, to foster innovation in food technologies and foods that have the potential to improve food safety at the point of production, processing, transport, storage, or final preparation.
(b)
Program described— The program under this section shall consist of technical guidance to and consultation with technology developers to assist them in meeting requirements for approval of technologies and products described in subsection (a).