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Assessing and Managing Chemicals under TSCA

Frequent Questions on the Frank R. Lautenberg Chemical Safety for the 21st Century Act

General

Preemption

Learn more about the law, summary information, and frequently asked questions.


General

Q1. What are the key changes in the law?

The law includes a number of important improvements, including:

  • For the first time, requiring EPA to evaluate the safety of existing chemicals in commerce, starting with those most likely to cause risks;
  • Requiring risk-based chemical assessments;
  • Empowering EPA to require the development of chemical information necessary to support these evaluations;
  • Establishing clear and enforceable deadlines that ensure both timely review of prioritized chemicals and timely action on identified risks;
  • Increasing the public transparency of chemical information by limiting unwarranted claims of confidentiality and allowing for the appropriate sharing of confidential information with states and health and environmental professionals; and
  • Providing a consistent source of funding for EPA to carry out these significant new responsibilities.

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Q2. How does the law help ensure that the chemicals manufactured and used in this country are safe for them, their families, and the environment?

As described above, the law addresses fundamental flaws in TSCA that have, for nearly 40 years, limited EPA’s ability to protect the public from dangerous chemicals. EPA views the law as a major victory for chemical safety, public health and the environment - particularly the mandatory duty to evaluate chemicals and risk-based chemical assessments. Learn more about how EPA has implemented the Lautenberg Act.

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Q3. When did the law take effect?

The law took effect immediately upon signature by the President, which occurred on June 22, 2016.

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Q4. Does EPA seek stakeholder input on its implementation activities?

Yes. EPA believes that input from interested stakeholders and the public is critical to successful implementation of the law. EPA has been and is continuing to seek input from all stakeholders on critical implementation elements of amended TSCA. EPA has held a number of public meetings (on issues related to new chemicals, pre-prioritization, uses and scopes for the first ten chemicals selected for risk evaluation, and alternative test methods and strategies to reduce animal testing) and will continue to do so. Please visit this link to sign-up for updates on EPA’s stakeholder engagement efforts.

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Q5. What were the immediate effects of the law?

The most immediate effects have been on the new chemicals review process. EPA is now required to make an affirmative determination on a new chemical or significant new use of an existing chemical before manufacturing can commence.

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Q6. How has the law impacted state laws and regulations?

States can continue to act on any chemical, or particular uses or risks from a chemical that EPA has not yet addressed. States also retain authority to address local environmental concerns related to air, water, waste treatment and disposal. For state and federal requirements that are identical, states retain the ability to partner with the federal government on enforcement. Finally, the law preserves state laws already on the books (as of April 22, 2016).

Generally, state action on a chemical is preempted only when EPA has acted – either by finding a chemical to be safe or by regulating a chemical to address identified risks. State action is also temporarily “paused” when EPA is evaluating a chemical, although states can avail themselves of a mandatory waiver from the “pause” if they still seek to pursue their own regulation.

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Q7. When will EPA decide how to collect fees to support implementation of the law?

On September 27, 2018, EPA finalized a fees rule to collect fees from certain chemical manufacturers (including importers) and processors to defray a portion of TSCA implementation costs. The final rule became effective on October 18, 2018. Learn more.

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Q8. What are the requirements that affect EPA’s review of new chemicals?

The law now requires EPA to make an affirmative finding on new chemicals or significant new uses of existing chemicals before they can proceed to the marketplace. Learn more.

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Q9. What has changed regarding the revised TSCA § 14 concerning confidential business information (CBI) claims for information submitted to EPA?

For information on CBI under amended TSCA, visit our TSCA CBI page.

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Q10. What does section 6(h) of TSCA require?

Section 6(h) of TSCA, as amended by the Lautenberg Chemical Safety Act, requires EPA to take expedited regulatory action to address risks from certain persistent, bioaccumulative and toxic (PBT) chemicals. Learn more.

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Preemption

NOTE: These responses convey the EPA's general and preliminary interpretation of TSCA section 18. They are intended to address the extent to which TSCA may preempt state law under a variety of general circumstances, including how EPA's own actions may affect the potential scope of preemption. These responses also convey the EPA's preliminary interpretation of its own authorities and obligations to grant waivers from any such federal preemption. The Agency does not adjudicate disputes as to whether particular state laws are subject to federal preemption and these responses are not intended to resolve such disputes, or to otherwise establish the preemption status of a particular state law.

Q11. Are the first 10 Work Plan chemicals exempt from TSCA 18(b) pause preemption?

TSCA does not provide for “pause” preemption to occur while EPA is preparing risk evaluations for the initial batch of 10 Work Plan chemical substances (i.e., those that must be identified under TSCA section 6(b)(2)(A)). See TSCA section 18(b)(1), which specifies that pause preemption is only applicable with respect to a chemical substance “that is a high-priority substance designated under [TSCA section 6(b)(1)(B)(i)].” The designation of a chemical substance under TSCA section 6(b)(1)(B)(i) is distinct from the identification of a chemical substance under TSCA section 6(b)(2)(A). See TSCA section 6(b)(4)(C)(i). EPA’s interpretation is reflected in the legislative history of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (“FRL21”): “The first 10 chemicals EPA evaluates under the bill are . . . exempted from preemption until the final rule is issued. 162 Cong. Rec. S3511 (June 7, 2016). Similarly, “[Pause preemption] does not apply to the first 10 TSCA Work Plan chemicals the EPA reviews, and it does not apply to manufacturer-requested risk evaluations.” 162 Cong. Rec. S3521 (June 7, 2016).

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Q12. TSCA 18(e)(1)(B) exempts from preemption “any action taken pursuant to a State law that was in effect on August 31, 2003. Does “any action” include a state regulation (to be promulgated in the future) adopted pursuant to a state law in effect before August 31, 2003?

A state action “taken pursuant to a State law that was in effect on August 31, 2003,” is not preempted by TSCA. See section 18(e)(1)(B). In contrast to section 18(e)(1)(A), which is limited in scope to state actions taken prior to April 22, 2016, TSCA section 18(e)(1)(B) specifies no cutoff for when the state action in question must have been taken. Thus, EPA understands that TSCA section 18(e)(1)(B) applies irrespective of when the state action was taken, if it is “pursuant to a State law that was in effect on August 31, 2003.”  EPA’s interpretation is reflected in the legislative history of the Lautenberg Chemical Safety Act: “Section 18(e) . . . grandfathers . . . requirements imposed now or in the future under the authority of state laws that were in effect on August 31, 2003.” 162 Cong. Rec. S3518 (June 7, 2016).

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Q13. TSCA 18(d)(1)(A)(iii) exempts from preemption state regulations adopted pursuant to state law “related to water quality, air quality, or waste treatment or disposal,” except to the extent that a regulation meets certain narrow criteria. If a state regulation was adopted pursuant to a state law promulgated before 2003 (and so would otherwise be grandfathered under TSCA 18(e)(1)(B)), but falls within the exception to exemption from preemption under 18(d)(1)(A)(iii), is the state regulation preempted or not?

The grandfathering provision of section 18(e)(1)(B) applies even when other exceptions from preemption under section 18(d)(1)(A) are unavailable. Section 18(e)(1)(B) states that “[n]othing in this chapter . . . shall be construed to preempt or otherwise affect,” state actions that qualify for the grandfathering. TSCA indicates that grandfathering should be construed as “subject to subsection (g),” but is silent as to any interdependency with section 18(d)(1)(A). EPA therefore infers that sections 18(d)(1)(A) and 18(e)(1)(B) operate independently. A state action otherwise qualifying under section 18(e)(1)(B) should not be considered to have lost its grandfathering simply because it does not doubly qualify as exempt from preemption under one of the further grounds listed at section 18(d)(1)(A).

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Q14. EPA published risk assessments on a number of chemicals prior to enactment of amended TSCA. Section 26(l)(4) gives EPA authority to proceed to risk management on these “completed risk assessment” chemicals. Would state actions or regulations involving these chemicals be subject to permanent preemption or pause preemption as a result of these rules?

EPA believes there is a reasonable argument that a state statute, criminal penalty, or administrative action to prohibit or otherwise restrict the manufacture, processing, distribution in commerce, or use of a “completed risk assessment” chemical will not be preempted under either section 18(a)(1)(B) or 18(b). The extent of preemption under section 18(a)(1)(B) is “consistent with the scope of the risk evaluation under section (6)(b)(4)(D).” The extent of preemption under 18(b) is similarly tied to the “scope of the risk evaluation pursuant to section 6(b)(4)(D).” EPA’s rulemaking authority for the “completed risk assessment” chemicals is in section 26(l)(4), which provides EPA authority to publish section 6(a) rules for chemical substances for which completed risk assessments were published prior to the date of recent amendments to TSCA, “consistent with the scope of the completed risk assessment.” In EPA’s view, the risk assessments that have been completed prior to the recent amendments to TSCA that can form the basis of these rulemakings are not the equivalent of risk evaluations under 6(b)(4)(D). Therefore, it is reasonable to argue that a section 6(a) rule promulgated under the authority of section 26(l)(4) will not preempt a state law or action on that chemical under either section 18(a)(1)(B) or section 18(b).

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