H.R. 2576 — what changed

“(b) Risk evaluations

“(1) In general—The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not a chemical substance presents or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment.

changed “(2) Applying requirements—The Administrator shall apply requirements with respect to a chemical substance through a rule under subsection (a) only if the Administrator determines through a risk evaluation under this subsection subsection, without consideration of costs or other non-risk factors, that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment.

“(3) Conducting risk evaluation

“(A) Required risk evaluations—The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if—

“(i) the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or

changed “(ii) a manufacturer of the chemical substance requests such a risk evaluation.evaluation in a form and manner prescribed by the Administrator.

“(B) TSCA Work Plan chemicals—The Administrator may, without making a determination under subparagraph (A)(i), conduct and publish the results of a risk evaluation under this subsection for a chemical substance that, on the date of enactment of the TSCA Modernization Act of 2015, is listed in the TSCA Work Plan for Chemical Assessments published by the Administrator.

“(4) Requirements—In conducting a risk evaluation under this subsection, the Administrator shall—

“(A) integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations;

“(B) not consider information on cost and other factors not directly related to health or the environment;

“(C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance;

“(D) describe the weight of the scientific evidence for identified hazard and exposure;

“(E) consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur; and

“(F) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection Agency, including contractor costs, of conducting the risk evaluation are paid for by the manufacturer.

“(5) Deadlines

changed “(A) Risk evaluations—The Administrator shall conduct and publish a risk evaluation under this subsection for a chemical substance as soon as reasonably possible, subject to the availability of resources, but not later than 3 years after the date on which—than—

changed “(i) 3 years after the date on which the Administrator—

“(I) makes a determination under paragraph (3)(A)(i); or

“(II) begins the risk evaluation under paragraph (3)(B); or

changed “(ii) a manufacturer requests in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii).(3)(A)(ii), 2 years after the later of the date on which—

changed “(B) Subsection (a) rules—If, based on a risk evaluation conducted under this subsection, “(I) the Administrator determines that a chemical substance presents or will present, in manufacturer requests the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall—evaluation; or

changed “(i) propose a rule under subsection (a) for the chemical substance not later than 90 days after the date on which “(II) if applicable, the risk evaluation regarding such chemical substance is published under initiated pursuant to subparagraph (A); and(B).

changed “(ii) publish in “(B) Deadline adjustment—If the Federal Register a final rule not later Administrator receives more requests for risk evaluations under paragraph (3)(A)(ii) than 180 days after the date on which Administrator has resources to conduct by the risk evaluation regarding such chemical substance is published deadline under subparagraph (A).(A)(ii)(I) (taking into account the requirement in paragraph (4)(F)), the Administrator shall—

changed “(C) Extension—If the Administrator determines that additional information is necessary to make a “(i) initiate risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph (A) accordingly, except evaluations that exceed the deadline may not be extended to a date that is later than—Administrator’s allotted resources as soon as resources for such risk evaluations are available; and

added “(ii) not collect a fee under section 26 from the manufacturer for a risk evaluation until the Administrator initiates the risk evaluation.

added “(C) Subsection (a) rules—If, based on a risk evaluation conducted under this subsection, the Administrator determines, without consideration of costs or other non-risk factors, that a chemical substance presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall—

added “(i) propose a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and

added “(ii) publish in the Federal Register a final rule not later than 2 years after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A).

added “(D) Extension—If the Administrator determines that additional information is necessary to make a risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph (A) accordingly, except that the deadline may not be extended to a date that is later than—

“(i) 90 days after receipt of such additional information; or

added “(ii) 2 years after the deadline being extended under this subparagraph.

removed “(ii) 2 years after the original deadline.

“(6) Determinations of no unreasonable risk

“(A) Notice and comment—Not later than 30 days before publishing a final determination under this subsection that a chemical substance does not and will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination.

added “(B) Potentially exposed subpopulations—The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of injury to one or more potentially exposed subpopulations.

removed “(B) Potentially exposed subpopulations—The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of injury to 1 or more potentially exposed subpopulations.

“(C) Final action—A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall be considered a final agency action.

“(7) Minimum number—Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment of the TSCA Modernization Act of 2015.”

“(1) Requirements for rule—In promulgating any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall—

“(A) consider and publish a statement with respect to—

“(i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture;

“(ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to the chemical substance or mixture;

“(iii) the benefits of the chemical substance or mixture for various uses; and

“(iv) the reasonably ascertainable economic consequences of the rule, including consideration of the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health;

“(B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except where the Administrator determines that additional or different requirements described in subsection (a) are necessary to protect against the identified risk;

“(C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an appropriate transition period for such action, determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect;

“(D) exempt replacement parts designed prior to the date of publication in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to identified potentially exposed subpopulations; and

“(E) in selecting among prohibitions and other restrictions to address an identified risk, apply prohibitions or other restrictions to articles on the basis of a chemical substance or mixture contained in the article only to the extent necessary to protect against the identified risk.”

changed “(g) Non-risk Non-Risk factors—The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a).

“(h) Critical use exemptions

“(1) Criteria for exemption—The Administrator may grant an exemption from a requirement of a subsection (a) rule for a specific use of a chemical substance or mixture, if—

“(A) the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and

“(B) the Administrator finds that—

“(i) the specific use is a critical or essential use; or

“(ii) the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure.

“(2) Procedure—An exemption granted under paragraph (1) shall be—

“(A) supported by clear and convincing evidence;

“(B) preceded by public notice of the proposed exemption and an opportunity for comment; and

“(C) followed by notice of the granted exemption—

“(i) to the public, by the Administrator; and

“(ii) to known commercial purchasers of the chemical substance or mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture.

“(3) Period of exemption—An exemption granted under paragraph (1) shall expire after a period not to exceed 5 years, but may be renewed for one or more additional 5-year periods if the Administrator finds that the requirements of paragraph (1) continue to be met.

“(4) Conditions—The Administrator shall impose conditions on any use for which an exemption is granted under paragraph (1) to reduce risk from the chemical substance or mixture to the greatest extent feasible.

“(i) Chemicals that are persistent, bioaccumulative, and toxic

“(1) Identification—Not later than 9 months after the date of enactment of the TSCA Modernization Act of 2015, the Administrator shall publish a list of those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to subsection (e).

“(2) Confirmation of concern—Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015, the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)—

“(A) that, with respect to persistence and bioaccumulation, scores high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and

“(B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator.

“(3) Expedited action—Notwithstanding subsection (b)(2), subject to the availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule under subsection (a) with respect to the chemical substance to reduce likely exposure to the extent practicable.

“(4) Relationship to subsection (b)—If, at any time prior to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with respect to a chemical substance, such chemical substance shall not be subject to this subsection.”

Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is amended—

“(5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and

“(6) shall be disclosed upon request—

“(A) to a health or environmental professional employed by a Federal or State agency in response to an environmental release; or

changed “(B) to a treating physician or other health care professional to assist in the diagnosis or treatment of 1 one or more individuals.”

“(1)

“(A) In submitting information under this Act after date of enactment of the TSCA Modernization Act of 2015, a manufacturer, processor, or distributor in commerce shall designate the information which such person believes is entitled to protection under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include—

“(i) justification for each designation of confidentiality;

“(ii) a certification that the information is not otherwise publicly available; and

changed “(iii) separate copies of all submitted information, with 1 one copy containing and 1 one copy excluding the information to which the request applies.

“(B) Designations made under subparagraph (A) after the date of enactment of the TSCA Modernization Act of 2015 shall expire after 10 years, at which time the information shall be made public unless the manufacturer, processor, or distributor in commerce has reasserted the claim for protection, in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission.

“(C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B).”

“(f) Prohibition—No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such information.

“(g) Savings—Nothing in this section shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding.”

“(B) if the Administrator makes a final determination under section 6(b) that a chemical substance will not present an unreasonable risk of injury to health or the environment under the intended condition of use, no State or political subdivision may, after the date of publication of such determination, establish or continue in effect any requirement that applies to such chemical substance under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b), and is designed to protect against exposure to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision—

“(i) is adopted under the authority of a Federal law; or

“(ii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement; and

“(C) if the Administrator imposes a requirement, through a rule or order under section 5 or 6, that applies to a chemical substance or mixture (other than a requirement described in section 6(a)(6)) and is designed to protect against a risk of injury to health or the environment associated with such chemical substance or mixture, no State or political subdivision may, after the effective date of such requirement, establish or continue in effect any requirement that applies to such chemical substance or mixture (including a requirement that applies to an article because the article contains the chemical substance or mixture) and is designed to protect against exposure to the chemical substance or mixture either under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b) or from a use identified in a notice received by the Administrator under section 5(a), or, in the case of a requirement imposed pursuant to section 6(i), is designed to protect against a risk of injury considered by the Administrator in imposing such requirement, unless the requirement of the State or political subdivision—

“(i) is identical to the requirement imposed by the Administrator;

“(ii) is adopted under the authority of a Federal law; or

“(iii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement.”

“(3) In the case of an identical requirement described in paragraph (2)(C)(i)—

“(A) a State may not assess a penalty for a specific violation for which the Administrator has assessed a penalty under section 16; and

“(B) if a State has assessed a penalty for a specific violation, the Administrator may not assess a penalty for that violation in an amount that would cause the total of the penalties assessed for the violation by the State and the Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16.”

“(c) Savings

changed “(1) Prior State actions—Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance, or any action taken pursuant to a State law requirement that was in effect on August 31, 2003, unless an action or determination made by the Administrator under this title actually conflicts with the action has taken pursuant to such a State law.effect—

added “(A) before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or

added “(B) pursuant to a State law that was in effect on August 31, 2003,

“(2) Tort and contract law—Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect either Federal or State tort law or the law governing the interpretation of contracts of any State, including any remedy for civil relief, whether under statutory or common law, including a remedy for civil damages, and any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory relating to tort law.

“(3) Intent of Congress—It is not the intent of Congress that this title, or rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title actually conflicts with the State court action.

“(4) Application—For purposes of this title, the term requirements does not include civil tort actions for damages under State law.”

Section 26 of the Toxic Substances Control Act (15 U.S.C. 2625) is amended—

“(3) Fund

“(A) Establishment—There is established in the Treasury of the United States a revolving fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the “Fund”), consisting of such amounts as are deposited in the Fund under this paragraph.

“(B) Collection and deposit of fees—The Administrator shall collect the fees described in paragraph (1) and deposit those fees in the Fund.

“(C) Crediting and availability of fees—On request by the Administrator, the Secretary of the Treasury shall transfer from the Fund to the Administrator amounts appropriated to pay or recover the full costs incurred by the Environmental Protection Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1).

changed “(D) Use of funds by Administrator—Amounts equivalent to fees Administrator—Fees authorized under this section shall be collected by and available for obligation only to the Administrator extent and deposited in the Fund under this section amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation to the Administrator, subject to the availability of appropriations, for use only in administering the provisions of this title for which the fees are collected.

“(E) Accounting and auditing

“(i) Accounting—The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code.

“(ii) Auditing

“(I) In general—For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency.

“(II) Components of audit—The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of—

“(aa) the fees collected and amounts disbursed under this subsection;

“(bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the title for which the fees are collected; and

“(cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(3)(A)(ii).

“(III) Federal responsibility—The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit.”

“(h) Scientific standards—In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall consider, as applicable—

“(1) the extent to which the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the use of the information;

“(2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture;

“(3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;

“(4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized; and

“(5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, or models.

“(i) Weight of scientific evidence—The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence.

“(j) Availability of information—Subject to section 14, the Administrator shall make available to the public all notices, determinations, findings, rules, and orders of the Administrator under this title.

“(k) Policies, procedures, and guidance

“(1) Development—Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015, the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the TSCA Modernization Act of 2015.

“(2) Review—Not later than 5 years after the date of enactment of the TSCA Modernization Act of 2015, and not less frequently than once every 5 years thereafter, the Administrator shall—

“(A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and

“(B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings.

“(l) Report to Congress

“(1) Initial report—Not later than 6 months after the date of enactment of the TSCA Modernization Act of 2015, the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of—

“(A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under subparagraphs (A)(i) and (B) of section 6(b)(3), and the resources necessary to initiate the minimum number of risk evaluations required under section 6(b)(7);

“(B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(3)(A)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand;

“(C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and

“(D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b).

“(2) Subsequent reports—The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years.”