TSCA Reform: Detailed Analysis of Substitute Version of Frank R. Lautenberg Chemical Safety for the 21st Century Act
A new version of the Frank R. Lautenberg Chemical Safety for the 21st Century Act was considered for markup by the Senate Environment and Public Works (EPW) Committee on April 28, 2015. The revised version, which we identify here as Lautenberg2, includes changes that appear to be intended to address issues and concerns identified by Senators with the previous version of the bill (Lautenberg1). Our review of Lautenberg1 is available online.
We reviewed the key changes that are proposed in Lautenberg2 in our recent memorandum, which also discussed the outcomes from the Senate EPW Committee markup on April 28, 2015. Below, we provide a detailed analysis of the current bill that integrates the new changes into the discussion, which we had provided previously as part of an effort to provide a detailed and consolidated “one stop shopping” for reviewers.
As many members of the EPW Committee pointed out, the new draft includes substantial changes that are intended to accommodate most if not all of the criticism of S. 697 as introduced. That this goal was essentially achieved is evidenced by the fact that three liberal Senators (Jeff Merkley (D-OR), Sheldon Whitehouse (D-RI), and Cory Booker (D-NJ)), who are Senate EPW Committee members, have now agreed to co-sponsor the legislation. Their support helped lead to a healthy bipartisan margin of support for the bill to move out of Committee (supported by a 15-5 vote). This is not to say the legislation will now smoothly sail through the Senate. As Senator Barbara Boxer (D-CA) apparently has serious objections to certain provisions, especially regarding the state preemption issue, it is unclear how the bill will fare. Importantly also, Boxer was not alone in expressing serious reservations at the Committee markup as described in our analysis of that event.
While preemption and various other issues have been extensively discussed in the recent Congressional hearings on the legislation, there are other provisions that, while clearly designed to fulfill many of the Toxic Substances Control Act’s (TSCA) original goals (testing of chemicals, assessment of chemicals, and control of identified risks), remain unclear as to how the legislation intends the program to be implemented to achieve those goals. Specifically, there are provisions with new or non-defined terms that could bedevil implementation attempts (for example: “significant hazard,” “as soon as practicable,” “more complex or targeted additional testing is necessary,” “make every effort,” and “in a timely manner”). Many of these vague terms are political fluffery designed to accommodate concerns in a conciliatory manner, but to a judge someday faced with litigation over the U.S. Environmental Protection Agency’s (EPA) decisions or compliance with deadlines, the “plain reading” of the law will be no such thing. Deadlines for completion of the many rules and guidance that will be crucial for underpinning the new program will simply not be met within the time mandated in the proposed legislation. It is easy to predict that EPA will face litigation over its pace of implementation. For example, EPA will not be able to issue all of the rules and guidance required within the first two-year period, so EPA will have to determine selectively which actions are most crucial to the program’s early implementation and need to be given priority over other mandates.
One example that is among the most discussed issues is how EPA can sort through the universe of 86,000 existing chemicals to implement an efficient and effective chemical testing program. Testimony has been given that this large number should eventually focus on approximately 800-1,000 chemicals that may need some significant amount of safety data and scrutiny through an EPA risk assessment process. Estimates have hinted that an Inventory reset might reduce the universe by 50 percent, along with another 50 percent reduction with a broad exclusion of “clearly safe” products (such as high molecular weight polymers, although even here there are complexities since a given TSCA polymer can be made and sold at multiple molecular weights) that could get the 86,000 number down to approximately 20,000 candidates. The eventual high-priority universe, those chemicals that over time will likely need some kind of detailed risk assessment, has been estimated at 1,000 or less — so what will become of that universe between 1,000 and 20,000?
The current text outlines a process for EPA to identify as low-priority those chemicals that EPA “concludes has sufficient information to establish that the chemical substance is likely to meet the safety standard.” It is unclear on what basis will EPA be able to make such a decision. Using the rough sorting estimates as described, there appears to be something like 19,000 or more chemicals in the “limbo” category — not clearly subject to an “out,” and not clearly needing extensive data generation and safety review. Some of these chemicals or classes of chemicals will have had some significant review as part of EPA’s current programs (especially the Premanufacture Notification (PMN) program and policies), past testing and assessment sojourns (e.g., the High Production Volume (HPV) Chemicals Program and the Chemical Assessment and Management Program (CHAMP)), and many chemicals may have Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)-driven data to offer. In addition, the new legislation will likely cause a general call-in based on the requirement to promulgate, within two years, Section 8 rules for reporting by manufacturers and processors of “the information necessary to carry out sections 4 and 6.” This could uncover literally thousands of new test data elements, as well as use and exposure information on potentially tens of thousands of chemicals. In developing the reporting rule, EPA will have to determine how much and what exposure data are sufficient to identify a low-priority chemical. All the while, this part of the legislation requires EPA to “make every effort to complete the designation of all active substances as high-priority or low-priority substances in a timely manner.”
Typically, much guidance will be given in the report language that will accompany the legislation. At this time, there has been no discussion of what any report language will contain, or how the drafters expect to craft language to help with interpreting the text. The bills currently in play are long and complicated (S. 697 as reported is 179 pages), and the public discussion has focused on a relatively few very important issues, which have dominated the debate (e.g., preemption of States, the safety standard, and regulatory requirements for Section 6 actions). And with no legislative text ever offered by the Obama Administration, there is even less clarity about EPA’s vision and thinking regarding how the many pivotal issues (e.g., reporting requirements, priority designations, testing requirements, exposure modeling, and fees, to name a few) can come together to “make it work.”
These comments are not intended to criticize current attempts at compromise or first-rate sausage-making. Rather, we note this to pose questions that if answered or further defined before legislation is enacted, or more clearly articulated in legislative report language, will enhance the chances of implementation success.
Lautenberg2 proposes a fundamentally new and different approach to chemical risk assessment and management compared to TSCA. The bill includes numerous deadlines for EPA action in, among others, developing policies and guidance, completing prioritization decisions, completing safety assessments, and making determinations, and in taking control actions on chemicals as appropriate when EPA determines the safety standard is not met under current conditions of use. It proposes provisions relating to fees on industry to assist in defraying some of EPA’s costs associated with actions under the bill, as well as the creation of a new Sustainable Chemistry Program.
- Section 3 Definitions proposes definitions for “conditions of use,” “safety assessment,” “safety determination,” “safety standard,” and “potentially exposed or susceptible population.” The definition of “safety standard” clarifies that it does not take cost or other non-risk factors into consideration, but that it includes consideration of exposures to “potentially” exposed or susceptible populations.
- Section 3A requires that EPA develop policies, procedures, and guidance regarding specified matters according to specified deadlines and also establishes a Science Advisory Committee on Chemicals. In our view, the concept behind creating the Committee is sound and important. The scope and complexity of the issues to be addressed suggest the deadlines are ambitious.
- Section 4 makes clear that EPA can require needed testing for prioritization, to assess new chemicals, or to support a safety assessment or determination under Section 6, while giving EPA authority to require testing by rule, consent agreement, and order. It also includes provisions relating to promoting alternatives to vertebrate testing.
- Section 4A would establish numerical requirements for completing prioritization reviews for identifying high- and low-priority chemicals. It also requires a relatively strong conclusion from EPA in establishing that a low-priority chemical is likely to meet the safety standard; low-priority decisions are judicially reviewable per Section 18(f)(10). Lautenberg2 includes a provision regarding how State actions to restrict a chemical are to be brought to EPA’s attention and requires EPA to conduct a prioritization screening review for such chemicals. Lautenberg2 also includes a new provision giving a preference to identifying as high-priority certain chemicals that rank high for relating to persistence and bioaccumulation.
- Section 5 requires that EPA conduct an initial review of all Section 5 notices, make safety determinations, and if a chemical is determined unlikely to meet the safety standard, EPA is required to take regulatory actions needed to ensure that the safety standard is likely to be met. In the case of new chemicals that rank “high” for persistence and bioaccumulation, EPA is required to take control actions that reduce potential exposure to “the maximum extent possible.”
- Section 6 has been considerably revised relative to TSCA to require explicitly that EPA conduct and complete a safety assessment and determination on each high-priority chemical and to promulgate regulatory controls as appropriate on chemicals determined not to meet the safety standard, all within prescribed deadlines. Cost-benefit considerations come into play in considering the control measures to be applied and in determining eligibility for certain exemptions to such control measures. The approach taken would resolve many of the key criticisms with TSCA Section 6, including “least burdensome.” Section 6 includes a provision similar to that in Section 5 concerning reducing exposures to “high” persistent/bioaccumulative chemicals to “the maximum extent possible.” Lautenberg2 specifies that safety assessments and determinations, as well as Section 6 control rules, are considered final agency action.
- Section 8 includes provisions regarding industry reporting and EPA identification of Inventory chemicals as “active” versus “inactive.” The status of inactive chemicals can be changed to active via a notice to EPA. Lautenberg2 includes specific requirements for substantiation of confidential business information (CBI) claims by industry and their review by EPA; it explicitly disallows CBI claims for the chemical identity of any chemical on the non-confidential portion of the list of active and inactive chemicals.
- Section 14 on Confidential Information has been substantially rewritten and restructured relative to TSCA and includes sections concerning information generally protected from disclosure and information not protected from disclosure, as well as imposing requirements that CBI claims be asserted and substantiated at the time of submission and for EPA review of the claims. A new provision outlines a procedure for removing CBI claims from chemicals that are the subject of ban or phase-out actions under Section 6(d).
- In Section 18, Lautenberg2 includes important changes from Lautenberg1 related to the provisions concerning State-Federal relationships or preemption. Of particular significance, Lautenberg2 revises the effective dates for when preemption takes place, extending the timeframe within which States can regulate chemicals from the time the safety assessment is commenced to the time when the scope of the safety assessment is defined. Other important changes include revisions to the criteria that EPA must determine are met for it to approve a State waiver application and exempt a statute or administrative action from preemption and the process under which EPA will review and either grant or deny a waiver application.
- Section 19 on judicial review, while it retains the TSCA “substantial evidence” standard for review, reduces the requirements for the rulemaking record and eliminates certain procedural provisions that had been included in TSCA.
- Section 26, in a major development representing a clear break from TSCA, proposes a series of fees that, when collected from manufacturers and processors, will be used to defray costs associated with actions under the Act. It requires EPA to establish “reasonable fees” by rule on manufacturers and processors for new chemical notices, reporting under Section 8, and for chemicals subject to Section 6 on safety assessments and determinations. In setting fees, EPA is to consider a number of aspects and set fees that will provide funds to defray approximately 25 percent of the costs, not to exceed $18 million.
- Section 27 includes requirements for development and implementation of an interagency Sustainable Chemistry Program to promote and encourage use of sustainable chemistry approaches.
Detailed Analysis of Lautenberg2
Section 2. Findings, Policy, and Intent
Lautenberg2 retains TSCA Sections 2(a) Findings and (b) Policy without change and proposes to add a new subsection (2) to Section 2(c) Intent of Congress. The new subsection, entitled Reform, includes provisions regarding protection of vulnerable populations, public availability of chemical information to public health officials and first responders, and protection of common law rights of action.
Section 3. Definitions
Lautenberg2 retains most of TSCA’s definitions, including “chemical substance” and “health and safety study,” among others. Lautenberg2 proposes definitions for “conditions of use,” “safety assessment,” “safety determination,” “safety standard,” and “potentially exposed or susceptible population.”
- “Conditions of use” is defined to involve an EPA determination of the “intended, known, or reasonably foreseeable circumstances” of a chemical’s manufacture, processing, etc.
- “Potentially exposed or susceptible population” is proposed to be defined as follows:(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE POPULATION. — The term ‘potentially exposed or susceptible population’ means 1 or more groups — (A) of individuals within the general population who may be (i) differentially exposed to chemical substances under the conditions of use; or (ii) susceptible to greater adverse health consequences from chemical exposures than the general population; and (B) that when identified by the Administrator may include such groups as infants, children, pregnant women, workers, and the elderly.
- “Safety assessment” means a risk assessment that integrates hazard, use, and exposure information.
- “Safety determination” means a “determination by the Administrator as to whether a chemical substance meets the safety standard under the conditions of use.”
- “Safety standard” has been defined so as to make clear that it does not involve consideration of cost or other non-risk factors, while explicitly including a reference to vulnerable populations. The proposed definition for this key term is as follows:(16) SAFETY STANDARD. — The term ‘safety standard’ means a standard that ensures, without taking into consideration cost or other nonrisk factors, that no unreasonable risk of injury to health or the environment will result from exposure to a chemical substance under the conditions of use, including no unreasonable risk of injury to — (A) the general population; or (B) any potentially exposed or susceptible population that the Administrator has identified as relevant to the safety assessment and safety determination for a chemical substance.
Section 3A. Policies, Procedures, and Guidance
Section 3A does not have a counterpart in TSCA. It consolidates “policies, procedures, and guidance” provisions and includes a requirement for formation of and consultation with a Science Advisory Committee on Chemicals. The section identifies policies and procedures that are proposed to be developed by EPA, including in some cases by rule. The section also includes a number of deadlines, although one can debate the reasonableness of the timelines offered. From our perspective, the deadlines are exceedingly tight given the scope and complexity of the issues, as well as the time needed for review by the Office of Management and Budget (OMB). Key deadline requirements are discussed below.
- Lautenberg2 Section 3A(b) imposes a two-year deadline on EPA for developing via notice and comment “any policies, procedures, and guidance” determined to be necessary to carry out responsibilities for testing, prioritization, new chemicals, and existing chemicals, as well as to meet guidance requirements established by Section 3A.
- EPA is required under Section 3A(e) to review these policies, procedures, and guidance every five years thereafter, and to revise them as necessary to reflect new scientific developments or understandings. While useful, this imposes a heavy burden on EPA and may be more frequent than necessary and the process may benefit from greater flexibility as far as timing is concerned.
- Other deadlines include a requirement for an annual plan identifying the chemical safety assessments and safety determinations to be completed that year, one year to develop guidance for use by outside parties in developing draft safety assessments (these may be used at EPA’s discretion), and one year to establish the Advisory Committee.
Lautenberg2 Section 3A(c) Use of Science requires EPA to establish policies, procedures, and guidance for its use of science, the goal of which “shall be” to make the basis of decisions clear to the public. These are to be developed “consistent with the best available science,” taking into account, among others, the variability and uncertainty in the underlying information and the extent to which the information has been subject to independent verification and peer review. Lautenberg2 also requires EPA in taking decisions to provide a clear description of the entities that funded testing or assessment efforts used by EPA and that, if appropriate, EPA consider the recommendations from the National Academy of Sciences’ chemical assessment reports.
Lautenberg2 Section 3A(f) Sources of Information requires that EPA, in taking “any” decision regarding testing, prioritization, and new and existing chemicals, consider a wide range of sources of information available to it, including information provided by a State or information that is “submitted to a governmental entity in any jurisdiction pursuant to a governmental requirement relating to the protection of health or the environment.” The listing is generous. While it is limited to information that is “reasonably available” to EPA, it is easy to anticipate possible consequences in future situations where EPA is alleged to fail to “take into consideration” such information.
Lautenberg2 Section 3A(g) Testing of Chemical Substances and Mixtures includes a role for tiered testing involving screening-level and higher-tier testing (the latter is termed “additional testing”). Lautenberg2 explicitly states that in developing testing policies and procedures, EPA “shall not interpret the lack of exposure information as a lack of exposure or exposure potential.” Lautenberg2 essentially retains the concept from TSCA that EPA must determine that required testing “is necessary,” although this is not in the form of an EPA finding as required under TSCA. A provision that had appeared in Lautenberg1, Section 3A(g)(4)(D) concerning tiered-testing, has been moved, without text changes, to Section 4(d)(4).
Lautenberg2 Section 3A(h) Safety Assessments and Safety Determinations outlines requirements for EPA to announce a schedule for completion of safety assessments and determinations and to develop by rule the associated policies and procedures to be applied, including defining the scope of the safety assessments and safety determinations. The concept of “aggregate exposures” is included in Lautenberg2 Section 3A(h)(2)(C)(iii) where EPA is required to “describe the manner in which aggregate exposures, or significant subsets of exposures, to a chemical substance under the conditions of use will be considered, and explain the basis for that consideration in the final safety assessment.” Lautenberg2 also includes a requirement that EPA, in conducting safety assessments and determinations, consider available information on the extent of Federal regulation under other Federal statutes (Section 3A(h)(2)(C)(vi)). Lautenberg2 has deleted a provision that had appeared in Lautenberg1 Section 3A(h)(3) concerning restricting an article on the basis of chemicals contained in the article, although considerations regarding regulation of articles have been picked up elsewhere in Lautenberg2, including in Sections 5(b)(3) and 6(d)(2)(A)(iv).
Lautenberg2 Section 3A(j) requires EPA to establish and consult with the “Science Advisory Committee on Chemicals,” subject to the Federal Advisory Committee Act (FACA). The Committee’s purpose is to provide independent advice regarding scientific and technical aspects relating to implementation of the Act. This addition strikes us as a good idea, as it reflects diverse interests (including labor, public health, public interest, animal protection, and industry groups), and should also prove helpful in assisting and strengthening EPA’s efforts, much as the Federal Insecticide, Fungicide, and Rodenticide Act’s (FIFRA) Scientific Advisory Panel (SAP) has done for that program.
Section 4. Testing of Chemical Substances and Mixtures
Lautenberg2 has deleted all of TSCA Section 4 except for the provisions relating to the Interagency Testing Committee (redesignated as Section 4(f)) and TSCA Section 4(f) Required Actions, redesignated as Section 4(g). In redesignating these sections, Lautenberg2 has clarified that the term “unreasonable risk” where it appeared in these sections, does not include consideration of cost or other non-risk factors. Lautenberg2 has also modified redesignated Section 4(g) to delete the limitation to “cancer, gene mutations, or birth defects,” thus making it applicable to any “significant risk of serious or widespread harm” to humans.
The title of Lautenberg2 Section 4(a) Development of New Information on Chemical Substances and Mixtures reflects a shift from TSCA with the use of the considerably broader term “information.” As revised, this section would allow EPA to require development of information that is “necessary” for any of several purposes, including to review a new chemical, to support a safety assessment or determination under Section 6, to implement a control action on a new or existing chemical, or to meet the regulatory testing needs of another Federal authority. EPA can also require limited testing for prioritization purposes if EPA determines that additional information is necessary to establish a chemical’s priority. Lautenberg2 allows EPA to use rule, testing consent agreement, or order authority to require development of new information.
Lautenberg2 Section 4(b) Statement of Need requires that EPA develop and release a “statement of need” when requiring development of new information, including the need for additional explanation when EPA relies on order authority.
Lautenberg2 Section 4(c) Reduction of Testing on Vertebrates requires that EPA “shall minimize, to the extent practicable, the use of vertebrate animals in testing.” EPA would be required to fund research and validation studies, to promote the development and timely incorporation of new testing methods, and to develop a strategic plan, among others. Lautenberg2 makes clear that the elements of the strategic plan need to be reflected in EPA’s testing requirements and that the animal welfare provisions apply to testing under any section of the Act. Subsection (2) discusses efforts by EPA to “promote the development and timely incorporation” of alternative testing not based on vertebrates. Included among these is a requirement that EPA develop within two years a strategic plan to promote the development and implementation of alternative test methods and strategies. EPA is also required in the strategic plan, among other provisions, to identify “particular alternative test methods or testing strategies” that are scientifically reliable and relevant, and capable of providing information of equivalent scientific reliability and quality compared to animal testing.
Lautenberg2 includes a new Section 4(c)(4) Voluntary Testing that states that any person in conducting voluntary testing for submission under the Act “shall first attempt” to develop the information by means of an alternative identified by EPA under Section 4(c)(2).
The provisions in Lautenberg2 Section 4(d) Testing Requirements give EPA authority to require development of information by manufacturers and processors (this is consistent with TSCA) and also discuss the role of tiered testing, including screening-level tests and additional testing. EPA may require more advanced testing without conducting screening-level tests when information available to EPA “justifies the advanced testing.”
The net effect of Lautenberg2 has been to broaden and strengthen EPA authority to require information development, most notably on new chemicals and for prioritization purposes, while also clarifying and strengthening the animal welfare provisions.
Section 4A. Prioritization Screening
Lautenberg2 Section 4A(a) Establishment and List of Substances imposes a one-year deadline for establishing a risk-based screening process and specifies that this be done by rule and that EPA develop “explicit criteria” for identifying high- and low-priority chemicals for development of safety assessments and determinations under Section 6. Lautenberg2 requires that EPA develop an initial list of high- and low-priority substances within 180 days. The initial list is required to contain at least ten high-priority chemicals (including five chemicals on the TSCA Work Plan) and ten low-priority chemicals; subsequent lists are to include additional Work Plan chemicals until all have been designated as either high- or low-priority. Lautenberg2 adds a new Subsection 4A(a)(2)(B)(iii), which states that in identifying initial and additional high-priority substances, EPA shall give preference to chemicals scored as “high” for persistence and bioaccumulation in the October 2014 TSCA Work Plan (the basis for EPA’s “high” score is discussed under Section 5).
Section 4A(a)(2)(C) includes goals and deadlines for undertaking or completing the Section 6(a) safety assessment process for high-priority chemicals and for designating low-priority chemicals: three years after the date of enactment, ensure that at least 20 high-priority chemicals have undergone or are undergoing the safety assessment process and that 20 low-priority chemicals have been designated; within five years, the goals are increased to 25 for each of high- and low-priority chemicals.
Implementation considerations and requirements for active and inactive chemicals (see Section 8 for discussion of requirements to identify active and inactive chemicals) are found in Lautenberg2 Section 4A(a)(3) and, while they emphasize active chemicals, they allow EPA to identify inactive chemicals as a high-priority if certain requirements can be met. Lautenberg2 applies certain requirements for repopulating the list of high-priority chemicals until a safety assessment and determination is completed for all such chemicals (Section 4A(a)(3)(A)(iii)), requires that the prioritization process begin 180 days after promulgation of the Section 4A(a) rule, requires that EPA attempt to complete the prioritization designation process for all active chemicals in a timely manner, and requires development of an annual goal for the prioritization process, among others.
The chapeau to Section 4A(a)(4) Criteria states that “[t]he criteria described in paragraph (I) shall account for” a series of aspects, including State recommendations and hazard and exposure potential, among others. Subsection (G) makes clear that limited availability of information can provide a sufficient basis for designating a chemical as a high-priority chemical “subject to the condition that limited availability shall not require designation as a high-priority substance.”
Section 4A(b) Prioritization Screening Process and Decisions gives EPA authority to defer decisions pending development of needed information. Lautenberg2 Section 4A(b)(3) amends the considerations to be applied by EPA in identifying high-priority chemicals relative to those in Lautenberg1: active chemicals which have the potential for “
high significant hazard” and/or “ high significant exposure” (redlining added to show the changes). The intended meaning of “significant hazard” is not further elaborated in the text and there is no prior TSCA experience with the concept. “Significant exposure” appears in TSCA provisions relating to the exposure-based findings in Section 4 test rules and to Section 5(e) control actions and thus there is possibly relevant experience as outlined below:
- Regarding the former, EPA offered its interpretation of the term “significant human exposure” in the “TSCA Section 4(a)(1)(B) Final Statement of Policy” (58 Fed. Reg. 24736 (May 14, 1993)) as follows:”[S]ignificant exposure” refers to the nature of the exposure. A finding of “significant exposure” would generally be made when the numerical threshold for numbers of persons exposed for “substantial exposure” is not met, but the nature of the exposure is sufficiently direct, large, or prolonged (page 28741).
- EPA has also developed criteria for its TSCA Section 5(e) exposure-based policy and the following points from that policy document are relevant to the concept of “significant exposure” in the context of new chemicals:Exposure Parameter – TSCA 5(e) Exposure-Based Policy Criterion
2. Significant or Substantial Human Exposure: High Number of Workers Exposed – 1,000 workers or more exposed
3. Significant or Substantial Human Exposure: Acute Worker Exposure – 100 or more workers exposed to 10 mg/day or more
4. Significant or Substantial Human Exposure: Chronic Worker Exposure, Inhalation – 100 or more workers exposed to 1-10 mg/day for 100 days/yr or more
5. Significant or Substantial Human Exposure: Chronic Worker Exposure, Dermal – 250 or more workers exposed by routine dermal contact for 100 days/yr or more
6. Significant or Substantial Human Exposure: Consumer – Presence in consumer product where exposures are likely
7. Significant Human Exposure: Ambient General Population – 70 mg/yr exposure or more via drinking water, air, or groundwater
Lautenberg2 Section 4A(b)(4) Identification of Low-Priority Substances requires in identifying low-priority chemicals that EPA “concludes [it] has information sufficient to establish that the chemical substance is likely to meet the safety standard” (emphasis added). In an important addition to the bill, EPA’s decisions to “designate” a low-priority chemical is judicially reviewable by “any person” per a provision at Section 18(f)(10) (Preemption). The combination of requiring a strengthened conclusion by EPA in identifying low-priority chemicals and the availability of judicial review considerably strengthen the bill’s treatment of low-priority identifications, an area that had been identified as a concern by some Democratic Senators and environmental groups.
Section 4A(b)(9) Other Information Relevant to Prioritization requires that if a State proposes an action or enacts a statute, or takes an action, to restrict a chemical that has not been designated by EPA as a high-priority, the State “shall notify” EPA about such measures. EPA can then request available information from the State concerning the measure and, per subsection (C) Prioritization Screening, “shall conduct” a prioritization screening on chemicals that have been so notified to EPA and for which EPA determines are likely to have significant health or environmental impacts, are likely to have significant impact on interstate commerce, or have been subject to a restriction action in two or more States. The provision goes on to require public release of the information received from a State subject to Section 14 on Confidential Information and any applicable State law regarding protection of confidential information.
Finally, subsection (E) Effect of Paragraph states: “Nothing in this paragraph shall preempt a State statute or administrative action, require approval of a State statute or administrative action, or apply section 15 [regarding prohibited acts and enforcement] to a State.”
Section 4A(c) Additional Priorities for Safety Assessments and Determinations is a relatively complex section that establishes a requirement that the Section 4A(a) prioritization screening process “shall” include a process whereby a manufacturer or processor of an active chemical that has not been designated a high-priority chemical or has not been subject to or is not in the process of an EPA prioritization screening may request that EPA designate the chemical for a safety assessment and determination under Section 6, subject to the payment of fees pursuant to Section 26(b)(3)(E). The fee is required to be “at a level sufficient to defray the full costs” to EPA of conducting the safety assessment and determination. Section 4A(c)(1)(C) states that requests granted under this subsection “shall not be subject to” the repopulation provision at Section 4A(a)(3)(A)(iii) or Section 18(b) regarding preemption. A new Section 4A(c)(3) discusses the application of this procedure with regard to Work Plan chemicals previously identified by EPA. Regarding fees, Section 26(b)(3)(E) has been revised wherein companies must pay only 50 percent of the costs when requesting that EPA review a Work Plan chemical.
Section 4A(c) goes on to require that EPA:
- Develop guidance for submitters on the information to be provided and specify the criteria that EPA “shall use” in determining whether or not to grant such a request.
- In deciding whether to grant requests, “shall give a preference” to requests concerning chemicals where EPA determines that restrictions imposed by one or more States “have the potential to have a significant impact on interstate commerce or health or the environment.”
- Meet percentage caps that limit the number of chemicals that can be acted on under this provision.
- Provide public notice and an opportunity for comment, “shall decide” whether or not to grant a request within 180 days, and if EPA grants a request, the safety assessment and determinations “shall” be conducted as required for other chemicals and without any “special treatment.”
Section 5. New Chemicals and Significant New Uses
The structure of Lautenberg2 Section 5 involves a number of changes relative to TSCA:
- Section 5(a) Definition. Lautenberg2 retains and redesignates TSCA Section 5(i) as Section 5(a) and thus at the outset of the section defines “manufacture” and “processing” in Section 5 to mean undertaking such activities for “commercial purposes.”
- Section 5(b) Notices. Lautenberg2 redesignates and retitles TSCA Section 5(a) In General but otherwise retains the original TSCA text with changes conforming to the new structure and terms used. A new Section 5(b)(3) is proposed and is discussed below.
- Section 5(c) Content of Notice. Lautenberg2 deletes TSCA Section 5(c) Extension of Notice Period and redesignates TSCA Section 5(d) as Section 5(c) and otherwise makes conforming changes.
- Section 5(d) Review of Notice. Notable provisions are discussed below.
- Section 5(e) Notice of Commencement.
- Section 5(f) Further Evaluation.
- Section 5(g) Transparency.
- Section 5(h) Exemptions. Lautenberg2 proposes important changes relative to TSCA as discussed below.
Lautenberg2 adds a new Section 5(b)(3) Article Consideration that states that EPA may require Significant New Use Notification (SNUN) for import or processing of a chemical as part of an article or a category of articles if EPA “makes an affirmative finding” in the Significant New Use Rule (SNUR) that the “reasonable potential for exposure” to the chemical through the article “warrants notification.”
Section 5(d) Review of Notice requires that EPA conduct an initial review of the Section 5 notice within 90 days and make any needed determinations under subsection (3). These determinations include that the new chemical or significant new use is: “(A) … not likely to meet the safety standard” in which case EPA is required to take appropriate action under Section 5(d)(4); “(B) … likely to meet the safety standard” in which case the review period is to be allowed to expire without additional restrictions; or “(C) additional information is necessary.”
Lautenberg2 Section 5(d)(4)(A)(i) concerning restrictions on new chemicals determined by EPA as “not likely to meet the safety standard” or that additional information is needed, states that, per subsection (I), the restrictions applied must be determined by EPA to be “sufficient to ensure that the chemical substance or significant new use is likely to meet the safety standard” and that, per subsection (II), “no person may commence manufacture…or processing…except in compliance with the restrictions specified in the consent agreement or order.”
Section 5(d)(4)(B) Requirements states that EPA, within 90 days of implementing a consent agreement or order, must proceed to either implement a SNUR or publish a statement of reasons why such action is not needed. Whereas TSCA Section 5(g) had applied this concept to EPA’s review of SNUNs, the effect of this provision seems likely to increase the number of regulated new chemicals that are made subject to a SNUR, as it may be easier to take a SNUR action than it would be to explain why the action is not needed.
Lautenberg2 adds “subject to Section 18(g)” (Preemption) cross references to Section 5(d)(3) and Section 5(d)(4)(C)(i). The former discusses the determinations that EPA is required to make before the end of the review period for Section 5 notices. The available determinations, all of which would be “subject to Section 18(g),” include whether the chemical “is not likely to meet the safety standard,” “is likely” to meet the standard, or additional information is needed to make the determination. Section 5(d)(4)(C)(i) relates to restrictions involving requirements for markings or warnings and specifically applies Section 18(g) to such actions.
Sections 5(d)(4)(C)(iii) and (v) allow EPA to restrict the quantity of a chemical that may be commercialized and to restrict manufacture, processing, or distribution in commerce, respectively, “in general” or “for a particular use.”
“for a particular use.”
Lautenberg2 proposes a new Section 5(d)(4)(D) Persistent and Bioaccumulative Substances, which states that:
For a chemical substance the Administrator determines ranks high for persistence and bioaccumulation, the Administrator shall, in selecting among prohibitions and other restrictions that the Administrator determines are sufficient to ensure that the chemical substance is likely to meet the safety standard, reduce potential exposure to the substance to the maximum extent practicable.
The inclusion of the modifier “potential” exposure would appear to expand significantly the scope of this provision. Assuming that EPA applies the criteria developed in its “TSCA Work Plan Chemicals: Methods Document“, the document notes that the criteria are also used in the New Chemicals Program to identify new chemicals having high persistence/bioaccumulation, this provision would apply to chemicals having a combined persistence/bioaccumulation rank score of 5-6 that involves the following:
|Persistence||Rank score||Bioaccumulation||Rank score|
|Half-life > 6 months||3||BCF or BAF > 5000||3|
|Half-life > 2 months||2||BCF or BAF > 1000||2|
Thus, any new chemical having a persistence/bioaccumulation score of 5-6 could be captured by this provision and be required to reduce potential exposure to the “maximum extent practicable.” It is not clear to us what “maximum extent practicable” translates to when applied by EPA in control actions concerning “potential exposure,” but it could result in bans for chemicals not made and used in fully enclosed systems.
Section 5(d)(4)(E) requires EPA to “consult” with the Occupational Safety and Health Administration (OSHA) prior to “adopting any prohibition or other restriction” affecting workplace exposures. This type of provision also appears in several other places (including Section 6(d)) and, while it is difficult to argue against the concept of consultation with the Federal agency having general responsibility for workplace issues, the provision could have the effect of somewhat limiting EPA action in this area.
Section 5(d)(4)(F) Definition of Requirement states that “[f]or purposes of this Act, the term ‘requirement’ as used in this section does not displace common law.”
Lautenberg2 Section 5(h)(3) corresponds to TSCA Section 5(h)(4), which was used to develop the polymer and low volume exemptions, among others. Lautenberg2 replaces the regulatory standard used in TSCA (“will not present an unreasonable risk”) with the “will meet the safety standard” regulatory standard applied in Lautenberg2. Lautenberg2 also proposes to delete the requirement in TSCA Section 5(h)(4) that rules promulgated under the subsection “shall be promulgated in accordance with paragraphs (2) and (3) of section 6(c),” a change that somewhat reduces the procedural requirements for such rulemaking.
Section 6. Safety Assessments and Safety Determinations
Lautenberg2 substantially revises the approach in and structure of Section 6 relative to TSCA. In many ways, the scope and the specifics of the changes are surprising in how far they lean in the direction of responding to environmental group criticisms of the original approach to Section 6 in earlier versions of the bill. There are also changes that seem to improve the process and procedural aspects. Among the important shifts are the following: specification in the text of ambitious deadlines for decisions and actions; an explicit ability for EPA to utilize already existing assessments and determinations; a requirement that EPA merely “take into consideration” the costs and benefits of the proposed action; and a more workable and useful exemptions process and procedure.
Lautenberg2 deletes TSCA Sections 6(a) through (d) and redesignates Section 6(e) (concerning polychlorinated biphenyls (PCBs)) as Section 6(g). The revised structure of Section 6 is as follows:
- Section 6(a) In General.
- Section 6(b) Prior Actions and Notice of Existing Information.
- Section 6(c) Safety Determinations.
- Section 6(d) Rule.
- Section 6(e) Immediate Effect gives EPA authority to declare a proposed Section 6(d) rule to be effective on publication if certain EPA determinations can be satisfied. This provision is similar to that found in TSCA Section 6(d)(2).
- Section 6(f) Final Agency Action.
- Section 6(g) Polychlorinated Biphenyls was, as noted above, redesignated from TSCA Section 6(e).
Lautenberg2 Section 6(a) outlines requirements and deadlines for conducting safety assessments and determinations and for establishing restrictions and promulgating control measures. It explicitly requires that EPA shall:
- Conduct a safety assessment and make a safety determination on each high-priority chemical;
- Define and publish the scope of the safety assessment and determination as soon as practicable and within six months after a chemical is designated a high-priority;
- Complete both the safety assessment and determination within three years after making the high-priority designation; and
- Promulgate a final rule pursuant to Section 6(d) within two years after completing the safety determination.
EPA can extend these deadline timeframes for up to two years in the aggregate.
Section 6(b) Prior Actions and Notice of Existing Information makes clear that EPA can initiate, continue, and/or complete assessments and determinations prior to the effective date of the policies and procedures established under Sections 3A or 4A. It also includes a “savings clause”-type provision regarding safety assessments, determinations, or rules completed before the Section 3A or 4A policies and procedures are finalized.
Lautenberg2 proposes a new provision at Section 6(b)(3) Notice of Existing Information that requires that EPA “take notice of” existing hazard and exposure information “published” by other agencies and the National Academies and “incorporate” the information in its safety assessments and determinations, to the extent practicable and where relevant and scientifically reliable, to increase the efficiency of the safety assessments and determinations. This provision seemingly is intended to help avoid duplication of effort by EPA in reviewing chemicals.
Section 6(c) Safety Determinations requires EPA, per subsection (1), to determine whether the chemical “meets” or “does not meet” the safety standard, or that additional information is required. When EPA determines that a chemical does not meet the safety standard, EPA “shall, by rule under subsection (d)” impose restrictions necessary to assure that the substance meets the safety standard under the conditions of use, or, where the safety standard cannot be met with the application of restrictions, to ban or phase out the substance.
Lautenberg2 Section 6(c)(2) expands and clarifies the steps taken when additional information is determined to be needed. Specifically, the text reinforces the Section 6(a) deadlines and restarts the clock once EPA “finds” that the new information “supports” the assessment and determination, although how this finding is to be made or be communicated is not discussed. It also requires that EPA “shall establish a deadline” for submission of the needed information by industry.
Section 6(d)(1) requires that for chemicals determined not to meet the safety standard that EPA “shall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard.” In taking such actions, EPA is required per Section 6(d)(2)(A) to include mandatory compliance dates that “shall be as soon as practicable” and may vary for different affected persons based on EPA’s determination. In the case of a ban or phase-out of the chemical, EPA is required to “implement the ban or phase-out in as short a period as practicable.” In important provisions for article manufacturers, EPA, per subsection (iii), “shall exempt replacement parts” manufactured prior to the effective date of the rule unless EPA finds that the replacement parts “contribute significantly to the identified risk,” and, per subsection (iv), “shall in selecting among prohibitions and other restrictions, apply such prohibitions or other restrictions to articles containing the chemical substance only to the extent necessary to address the identified risks in order to determine that the chemical substance meets the safety standard.”
Lautenberg2 proposes a new Subsection 6(d)(2)(B) Persistent and Bioaccumulative Substances, which generally tracks with the corresponding provision under Section 5. The provision reads:
(B) Persistent and Bioaccumulative Substances. For a chemical substance the Administrator determines ranks high for persistence and bioaccumulation, the Administrator shall, in selecting among prohibitions and other restrictions that the Administrator determines are sufficient to ensure that the chemical substance meets the safety standard, reduce exposure to the substance to the maximum extent practicable.
Assuming that EPA applies the Work Plan criteria for persistence and bioaccumulation as discussed above in Section 5, this provision would apply to existing chemicals having a combined persistence/bioaccumulation score of 5-6. As was the case in the new chemicals provision, it is not clear to us what “maximum extent practicable” translates to when applied by EPA in control actions on such chemicals.
EPA is also required to consult with OSHA prior to adopting any actions to address workplace exposures.
Lautenberg2 Section 6(d)(3) Restrictions outlines the wide array of restriction actions that the rule “may include, as appropriate.” Section 6(d)(3)(A) restrictions requiring markings or warnings have been made subject to Section 18 (Preemption).
Section 6(d)(4) Analysis for Rulemaking is a critical provision that requires EPA “in deciding which restrictions to impose…shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by” EPA (emphasis added). Further, “[a]s part of the analysis,” EPA is required to “review any 1 or more technically and economically feasible alternatives” that EPA “determines are relevant to the rulemaking” (emphasis added). The analysis is to be made publicly available as part of the rule proposal and, in issuing the rule in final, EPA “shall include a statement describing how the analysis … was taken into account.” With these changes, Lautenberg2 has considerably softened the cost-benefit requirements that would apply to regulatory actions compared to those that had appeared in TSCA Section 6 (including “least burdensome”).
Section 6(d)(5) Exemptions is another critical provision in the text. EPA “may exempt 1 or more uses of a chemical” from “any restriction” if EPA “determines” that the rule cannot be complied with without “harming national security;… causing significant disruption in the national economy due to the lack of availability of a chemical substance;… or interfering with a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure” (emphasis added). Alternatively, EPA can base the exemption on a determination that “the use of the chemical substance, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety” (emphasis added).
EPA is further required to make available as part of the proposed rule any exemption analysis conducted under Section 6(d)(5) and to include a statement in the final rule describing how the exemption analysis was taken into account.
In determining whether an exemption should be granted for ban or phase-out actions, EPA is required in the proposed rule to “take into consideration … the quantifiable and nonquantifable costs and benefits of the 1 or more technically and economically feasible alternatives” most likely to be used in place of the chemical under the conditions of use if the rule is promulgated.
Regarding the time limit for exemptions, per Section 6(d)(5)(F), EPA is required to determine and establish a reasonable “case-by case” time limit for the exemption. EPA can also by rule extend, modify, or eliminate an exemption when warranted. Issuance of and establishment of time periods for exemptions are to be based on consideration of factors determined by EPA to be “relevant to the goals of fostering innovation and the development of alternatives that meet the safety standard.” This subsection states that any renewal of an exemption for a ban/phase-out chemical “shall not exceed 5 years.”
Finally, per Section 6(f) and subject to Section 18 (Preemption), all safety determinations and associated safety assessments, as well as rules promulgated under Section 6(d), are considered final agency actions.
Section 8. Information Collecting and Reporting
Lautenberg2 Section 8 includes reporting requirements for information needed to inform EPA’s identification of TSCA Inventory chemicals as “active” or “inactive,” provisions ensuring the continued application of certain chemical nomenclatures, and proposes to establish several deadlines and provisions regarding CBI.
Lautenberg2 proposes a small but potentially significant change to TSCA Section 8(a)(3)(A)(ii)(I). This provision concerns EPA’s ability to require Section 8 reporting by small businesses on chemicals that are subject to certain TSCA rules. For purposes of Section 5, TSCA had limited this to chemicals subject to a rule proposed or promulgated under TSCA Section 5(b)(4), the so-called “chemicals of concern” list, or an order in effect under Section 5(e). The changes would allow EPA to require reporting by small businesses on any chemicals subject to proposed or promulgated rules under Section 5, which would expand the provision to include SNURs, as well as orders in effect under Section 5(d)(4) (which corresponds to TSCA Section 5(e)).
Lautenberg2 Section 8(a)(4) specifies a two-year deadline for promulgating reporting rules to obtain the information “necessary to carry out sections 4 and 6.” Reporting by processors is required to be included in the rule. EPA is required to limit the potential for duplicative reporting, minimize the impact on small manufacturers and processors, and apply the reporting obligation to the persons likely to have relevant information. One question is whether the Section 8(a)(4) rule requirement should reference “4, 4A, and 6” to make clear and ensure that the information needed to support Section 4A prioritizations is available to EPA.
Lautenberg2 retains the nomenclature provision regarding certain Class 2 chemicals and statutory mixtures that had been proposed in earlier versions of the bill.
Lautenberg2 also retains an “Inventory reset” component at Section 8(a)(4) with a one-year deadline for EPA to promulgate a reporting rule for identifying “active” chemicals; the rule would be applicable to chemicals manufactured or processed over the past ten years. Lautenberg2 specifies a 180-day reporting period. The information received would be used by EPA to designate and list chemicals as “active.” As part of this reporting on active chemicals, “any existing” CBI claims for chemical identity would need to be reaffirmed and be substantiated; EPA is also instructed to maintain both a confidential and a non-confidential portion of the Inventory.
One year after compiling the list of active chemicals, EPA would be required to establish by rule a plan to, within five years (with a two-year extension being possible), review all CBI claims for chemical identity, including any CBI substantiation claims for chemical identity made by companies over the past five years, and to “approve, modify, or deny each claim.” Any such approvals are limited to ten years. Lautenberg2 also states that the plan shall “encourage” manufacturers and processors that made CBI claims on chemical identity of inactive chemicals to review and either withdraw or substantiate such claims.
Section 8(b)(5) Active and Inactive Substances requires that EPA “shall maintain and keep current” (a requirement that applies language from TSCA Section 8(b) regarding the Inventory) designations on active and inactive chemicals and that it update the list as soon as practicable after new reporting under the Chemical Data Reporting Rule (CDR; 40 C.F.R. Part 711). EPA is also instructed to use the CDR data from the reporting period that most closely preceded the date of enactment to create an interim list of active chemicals for purposes of Section 4A (Prioritization Screening). This subsection goes on to require that anyone intending to manufacture or process an inactive chemical shall notify EPA before that occurs. If the chemical is on the confidential portion of the list, the notifier can seek to maintain an existing CBI claim for chemical identity if the claim is substantiated. EPA would then add the chemical to the active list and consider the CBI claim as outlined in the preceding paragraph.
Section 8(b)(8) explicitly disallows new CBI claims for chemical identity of any chemical on the non-confidential portion of the list of active and inactive chemicals.
Lautenberg2 Section 8(e)(2) allows any person to submit information “reasonably supporting the conclusion that a chemical substance or mixture presents, will present, or does not present a substantial risk.”
Section 9. Relationship to Other Federal Laws
Lautenberg2 makes conforming changes to this section and also proposes Section 9(e) Exposure Information. This section requires that EPA, when it obtains information related to exposures or releases of chemicals that “may be prevented or reduced under another Federal law, including laws not administered by [EPA],” shall make such information available to the relevant Federal authority.
Section 12. Exports
Lautenberg2 Section 12(a)(4), consistent with TSCA, gives EPA authority to require Section 4 testing on chemicals intended for export only for the purpose of determining whether the chemical meets the safety standard within the U.S.
Section 12(b)(1) requires export notices for chemicals for which actions have been proposed or finalized under Section 5 or 6, or to meet U.S. treaty obligations (for example under the Stockholm Convention on Persistent Organic Pollutants (POPs)). Consistent with TSCA, Section 12(b)(1)(E) would require export notification on chemicals “for which the submission of information is required under section 4.” There is also a savings clause-type provision at Lautenberg2 Section 12(b)(1)(D) for existing restrictions under TSCA.
Section 13. Imports
Whereas Lautenberg1 had proposed changes to TSCA Section 13 concerning imports, Lautenberg2 has dropped the changes and proposes to retain the TSCA text in this section.
Section 14. Confidential Information
The proposed structure of this section is as follows:
- Section 14(a) In General.
- Section 14(b) Information Generally Protected from Disclosure.
- Section 14(c) Information Not Protected from Disclosure.
- Section 14(d) Requirements for Confidentiality Claims.
- Section 14(e) Exceptions to Protection from Disclosure.
- Section 14(f) Duration of Protection from Disclosure.
- Section 14(g) Duties of the Administrator.
- Section 14(h) Criminal Penalty for Wrongful Disclosure.
Relative to the earlier bills, Lautenberg2 clarifies the language at several points and also proposes a new “rebuttable presumption” procedure at Section 14(g)(3) for removing CBI claims from chemicals subject to a Section 6(d) ban or phase-out action.
The chapeau to Section 14(a) In General states: “Except as otherwise provided in this section” (emphasis added), EPA shall not disclose information that is exempt from disclosure under the Freedom of Information Act.
Section 14(b) Information Generally Protected from Disclosure also has a new chapeau, which states that certain information as enumerated in the section “shall be presumed to be protected from disclosure” except through discovery, subpoena, and other legal actions under Federal or State law. Lautenberg2 also adds a cross reference to the Section 14(g)(3) rebuttable presumption procedure. Examples (emphasis added) of protected information include:
- “Specific information describing the processes used in manufacture or processing”;
- “Details of the full composition of a mixture” (although this strikes us as not very clear while limiting the protection afforded); and
- “Except as otherwise provided in this section, the specific identity of a chemical substance prior to the date on which the chemical substance is first offered for commercial distribution… if — (A) the specific identity was claimed as confidential information at the time it was submitted in a notice under section 5” and it otherwise meets CBI requirements, including substantiation and review by EPA.
Section 14(c) Information Not Protected from Disclosure is a dense and complex section, which states that Section 14(a) “does not prohibit the disclosure of” health and safety studies on chemicals offered in commerce, or that are subject to Section 4 testing or been notified under Section 5. There are specific subprovisions regarding chemical identity and other requirements that will need careful analysis to understand the full effect. Section 14(c)(5) Ban or Phase-Out specifically states that for chemicals regulated via a Section 6(d) ban or phase-out, subject to Section 14(g)(2), (3), and (4), “any protection from disclosure provided under this section with respect to the specific identity of the chemical substance and other information relating to the chemical substance shall no longer apply” (redlining shows changes relative to Lautenberg1).
Section 14(d) Requirements for Confidentiality Claims requires that such claims be asserted and substantiated at the time of submission. The text clarifies in several instances that these statements should provide a “reasonable basis” to believe or to conclude, which seems a helpful clarification of what is expected to be provided. Finally, if the chemical identity is claimed as CBI, the submitter must provide a structurally descriptive generic name and EPA is to provide guidance on how to do this.
Lautenberg2 revises Section 14(e) Exceptions to Protection from Disclosure relative to that in Lautenberg1 to add a bit of nuance. As worded in Lautenberg1, this provision had required that information “shall be disclosed” if any of provisions (1) through (9) was met. As revised, subsection (7), concerning disclosure by EPA if it determines that disclosure is relevant in a proceeding under this Act, has been changed to “may be disclosed.”
Section 14(f) Duration of Protection from Disclosure applies a ten-year limitation for CBI claims. Before expiration of the time limit, EPA is required to notify and the party must reply with a reassertion within 30 days, and EPA has 30 days to make a determination, which can be to grant an extension for another ten years (with no limit on the number of extensions) or to deny the request (EPA can also modify the request per Section 14(g)(1)(A), although this is not expressly stated). Subsection (2) Review and Resubstantiation includes a number of specific provisions that, among others, allow EPA to review a CBI claim at any time and request that the claim be withdrawn or be resubstantiated, including, “in limited circumstances,” when EPA determines that disclosure of certain information would assist EPA in conducting safety assessments and determinations.
Section 14(f)(3) includes a requirement for EPA to develop a “unique identifier” for each CBI chemical identity and the information on the chemical is organized under that identifier (the purpose is to allow EPA to consolidate and release non-CBI on the chemical (e.g., such as that received under the CDR rule)). Related to this is a provision at Section 14(f)(3)(B) that requires EPA to publish a list of the chemicals claimed as CBI — with the unique identifier — and expiration dates for CBI claims.
Section 14(g) Duties of the Administrator outlines specific requirements imposed on EPA, including time deadlines for CBI determinations, and requires EPA to review all CBI claims for chemical identity (except for claims prior to the date on which a chemical is first offered for commercial distribution if certain other requirements at Section 14(b)(7) are met) and a “representative subset” of at least 25 percent of the CBI claims for other information. Lautenberg2 includes a new provision at Section 14(g)(2)(A) under which EPA is specifically required, after it has established a ban or phase-out of a chemical, to notify persons having CBI claims on that chemical. Section 14(g)(3) then outlines a new rebuttable presumption procedure for CBI claims on ban and phase-out chemicals.
Section 16. Penalties
Lautenberg2 would increase penalty amounts to $37,500 for each civil violation and to $50,000 for each criminal violation. It also includes a new penalty for a party that knowingly puts parties in imminent danger — $250,000, imprisonment, or both for a person and $1,000,000 for an organization.
Section 18. State-Federal Relationship
Lautenberg2 includes some important changes from Lautenberg1 related to the provisions concerning State-Federal relationships or preemption.
Of particular significance, Lautenberg2 Section 18(b) revises the effective dates for when preemption takes place. The language in Lautenberg1 had been criticized by the California Office of the Attorney General (AG) by providing a broad prohibition on State regulation of substances designated by EPA as “high-priority” substances once EPA commences its safety assessment. As revised, Lautenberg2 provides that preemption does not restrict the authority of a State to enforce any statute enacted or administrative action taken prior to the date that EPA defines the scope of a Section 6(a)(2) safety assessment. This extends the timeframe within which States can regulate chemicals, from the time the safety assessment is commenced to the time when the scope of the safety assessment is defined. States would still be preempted from enacting new law after EPA defines the scope of a safety assessment but before the safety assessment is complete, however.
Another change can be seen in Section 18(e), which addresses the Preservation of Certain State Law. Lautenberg1 preserved any State action taken before January 1, 2015, that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use or disposal of a chemical substance, as well as any action taken pursuant to a State law that was in effect on August 31, 2003. In Lautenberg2, the date has been expanded from January 1, 2015, to August 1, 2015.
Lautenberg2 also makes changes in Section 18(f) to the criteria that EPA must determine are met for it to approve a State waiver application and exempt a statute or administrative action from preemption and the process under which EPA will review and either grant or deny a waiver application. First, Lautenberg2 now distinguishes waiver exemptions between discretionary exemptions and required exemptions. The discretionary exemption criteria are the same in Lautenberg2 as Lautenberg1, which mimic what exists currently under TSCA plus two additional criteria: (1) that there be “compelling” conditions warranting EPA to grant a waiver; and (2) that there be some EPA judgment that the proposed requirement is consistent with sound objective scientific practices, the weight of the evidence, and the best available science. The conditions with regard to required exemptions have changed under Lautenberg2. In particular, two conditions that previously had to be satisfied have been removed: (1) that the State has a compelling local interest that warrants granting the waiver to protect health or the environment; and (2) the proposed requirement is grounded in reasonable scientific concern. There remains three conditions to be satisfied, two that were in Lautenberg1 — that compliance with the proposed requirement of the State will not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; and compliance with the proposed requirement will not cause a violation of any applicable Federal law, rule, or order — as well as a new condition not previously listed, namely, that the State or political subdivision of a State has a concern about the chemical substance or use of the chemical substance based in peer-reviewed science.
Lautenberg2 also contains a new provision providing that if EPA fails to make a determination within the 90 days provided for EPA to review a required exemption waiver application, the statute or administrative action at issue “shall not be considered to be an existing statute or administrative action,” meaning that the state would automatically receive the waiver and that statute or administrative action would not be preempted. This establishes a tight deadline for EPA to make a determination and significant consequences for not meeting that deadline.
Finally, Section 18(f)(7) regarding the duration of a waiver granted has been revised to recognize that a waiver granted or approved shall remain in effect or may be affected by judicial review.
Section 19. Judicial Review
Lautenberg2 alters the prescriptive definition in the current TSCA of the administrative record upon which judicial review of rules will be based, but retains the same unusual standard of review for such rules. The current TSCA establishes a hybrid form of judicial review in which the reviewing court utilizes the “substantial evidence” standard, which is normally employed only for formal rulemaking and adjudication, to review informal rulemaking. In general, the substantial evidence standard is considered to be more demanding than the conventional “arbitrary, capricious, or abuse of discretion” standard of review.
In the existing TSCA, the substantial evidence standard is applied to a rulemaking record that is defined with great specificity in Section 19(a)(3). Lautenberg2 eliminates this prescriptive definition, and applies the “substantial evidence” standard to any material that may be included in the rulemaking record compiled by EPA. The Act further eliminates current judicial review provisions pertaining to rights to cross-examination, but retains an innocuous provision stating that “the court may not review the contents and adequacy of any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule, except as part of the rulemaking record, taken as a whole.”
Section 26. Administration
Lautenberg2, in a clear break from TSCA, proposes a series of fees that when collected from manufacturers and processors will be used to defray costs associated with actions under the Act.
EPA is required per Section 26(b) to establish by rule within one year “1 or more reasonable fees” on manufacturers or processors submitting notifications under Section 5 or certain reporting under Section 8(a) and (b), and if they manufacture or process a chemical subject to a safety assessment and determination under Section 6. Per Section 26(b)(2)(A), fees collected can be used only to defray costs associated with EPA action to: collect, process, and protect information from disclosure, among others; review Section 5 notices and take actions; make prioritization decisions under Section 4A; and conduct and complete safety assessments and determinations and conduct any necessary rulemaking under Section 6(d).
In setting fees under this section, EPA is required to:
- Take into account the costs to EPA of conducting these activities.
- Prescribe lower fees for small businesses.
- Set fees at levels such that fees will “in aggregate, provide a sustainable source of funds to defray approximately 25 percent of the costs…not to exceed $18,000,000,” not including fees for “additional priority” assessments requested under Section 4A(c).
- Reflect an appropriate balance in fees between manufacturers and processors.
EPA is also required, prior to establishing or amending fees, to consult and meet with parties potentially subject to the fees. Obligations under FACA do not apply to these meetings. EPA is also required to meet every three years thereafter regarding fees for Section 26(b)(2)(A) activities (see above), “additional priority” assessments, and to account for inflation.
The section goes on to discuss a number of additional provisions regarding availability and oversight of the funds, including a ten-year sunset on the section unless reauthorized by Congress.
Section 27. Development and Evaluation of Test Methods
Lautenberg2 Section 27(c) Sustainable Chemistry Program (SCP) requires the President to establish an interagency SCP to:
- Promote and coordinate Federal sustainable chemistry research, development, and education, among other activities.
- Encourage consideration of sustainable chemistry in Federal and State research and development.
- Examine methods by which the Federal government can create incentives for consideration of sustainable chemistry approaches.
- Expand education and training, and other programs.
Lautenberg2 also requires creation by the President of an Interagency Working Group within 180 days that is responsible for overseeing the planning, management, and coordination of the SCP, including to establish goals and priorities, provide for interagency coordination, and establish and consult with an Advisory Council comprised of non-Federal representatives. The Workgroup is co-chaired by certain officials from the National Science Foundation and EPA.