TSCA Reform: Detailed Analysis of Frank R. Lautenberg Chemical Safety for the 21st Century Act: Significant Changes Made to Udall-Vitter Bill
The Senate over the past several years has considered a number of legislative texts to amend the Toxic Substances Control Act (TSCA). These include the Safer Chemicals Act, several versions of which were introduced by Senator Frank Lautenberg (D-NJ), with the most recent in 2013, and the Chemical Safety Improvement Act (S. 1009, CSIA) introduced by Senators Lautenberg and David Vitter (R-LA) in 2013. Senator Lautenberg died shortly after CSIA’s introduction and over time his mantle was picked up by Senator Tom Udall (D-NM), who continued to work with Senator Vitter on revisions to the CSIA. Their original plan had been to introduce a revised text as a discussion draft in September 2014, however, this did not occur because Senator Barbara Boxer (D-CA), then the Chair of the Senate Environment and Public Works (EPW) Committee, released her informal version of the text. In response, Senators Udall and Vitter decided not to officially release their draft, although copies surfaced or were prepared from existing texts. We discussed each of these texts in our memoranda prepared at the time. Senators Udall and Vitter continued their efforts to collaborate in developing amendments to TSCA and the results of that effort are found in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which was dropped recently in the Senate. This memorandum summarizes and analyzes Lautenberg as such and in comparison to S. 1009.
In a very recent development, Senators Boxer and Ed Markey (D-MA) have introduced the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act, which presents their approach to revising TSCA. We plan to do a future review comparing Lautenberg with the new bill from Senators Boxer and Markey.
On the whole, the bill offers a significant number of changes that will both please detractors of TSCA and challenge supporters of prior versions of TSCA reform that were less generous in key respects, including preemption, deference to the U.S. Environmental Protection Agency (EPA), testing for prioritization, review of new chemicals, and related issues. The bill is the most thorough attempt to date to capture what stakeholders have stated are the most important issues to “fix” or otherwise more fully articulate when compared to past legislative proposals. Most notably, for example, requirements concerning the very difficult issues of confidential business information (CBI) and preemption of state actions on chemicals are laid out in detail. Similarly, there is a proposed user fee requirement for partial funding with specified limits to help financially support any enhanced EPA chemical assessment program. These and other changes may not be the most perfect solutions to problematic or otherwise difficult issues, but they are the most specific — therefore offering the potential to further the debate as interested parties can evaluate specific legislative text and get beyond generalities that have characterized most of the debate over the past few years.
We provide both a summary and a detailed analysis of Lautenberg below. While the latter is long, the bill itself is 175 pages and chuck full of significant changes, the full import of which will need time to outline fully. We will expand upon this first-impression analysis as events unfold, and the description that follows incorporates some commentary on how the current bill seeks to address some of the most critical comments of past legislative proposals, especially in comparison to the 2013 attempt at bipartisan compromise (S. 1009).
While this Congress, with Republican majorities on both sides of Capitol Hill, might be considered as unlikely to support any expansion of EPA’s authorities or programmatic initiatives, the current bill might ironically have the best chance of enactment of any TSCA amendments since discussion of “TSCA reform principles” started in 2009. The bill as introduced has eight original co-sponsors who are Democrats (along with nine Republicans) as a show of bipartisan support, and includes the Chair of the Senate EPW Committee, Senator Jim Inhofe (R-OK). This is a substantial beginning providing some momentum for a bill to move through the Senate, something not characteristic of any earlier version of TSCA proposals.
Of course, the House has not seen any legislative action to date, and with the 2016 Presidential election already in full swing (the New Hampshire primary is less than a year away), the window of opportunity for successful legislation is even more truncated. If there is not floor action on any proposal by Labor Day of this year, if not floor action in both the Senate and House, then the functional window of opportunity may close and come crashing down on this effort notwithstanding any momentous beginning.
Lautenberg has substantially modified the structure and approach in CSIA by, among others, consolidating the policy, procedure, and guidance provisions in a new Section 3A and the provisions relating to prioritization screening in a new Section 4A. It also introduces new provisions relating to fees on industry to assist in defraying some of EPA’s costs associated with actions under the bill (Section 26(b)), as well as the creation of a new Sustainable Chemistry Program (Section 27(c)). Lautenberg also includes numerous deadlines for EPA action in, among others, developing policies and guidance, completing prioritization decisions, safety assessments, and determinations, and in taking needed control actions when the safety determination concludes that the safety standard cannot be met. The bill also proposes important changes and additions to CSIA’s approach, many of which strengthen the approach and may help to resolve issues identified regarding CSIA. At the same time, old issues remain and new ones are introduced by the changes made.
- Section 3 Definitions clarifies that a safety standard determination by EPA, while it does not take cost or other non-risk factors into consideration, includes consideration of exposures to vulnerable populations. These changes may be helpful in resolving issues identified for CSIA.
- Section 3A requires that EPA develop a number of policies, procedures, and guidance regarding various matters according to specified deadlines and also establishes a Science Advisory Committee on Chemicals. In our view, the scope and complexity of the issues to be dealt with seem to call into question the reasonableness of the deadlines; on the other hand, we very much like the concept of establishing the Committee.
- Section 4 makes clear that EPA can require needed testing for prioritization and assess new chemicals (thus potentially resolving these concerns with CSIA) while continuing the approach in CSIA of giving EPA authority to require testing by rule, consent agreement, and order.
- Section 4A would establish numerical requirements for completing prioritization reviews for identifying high- and low-priority chemicals. It also strengthens the nature of the conclusion that is required of EPA in establishing that a low-priority chemical is likely to meet the safety standard; this change should help to resolve issues identified with the approach in CSIA. Lautenberg includes a revised 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. In an important change, Lautenberg has deleted the notation in CSIA that prioritization decisions are not final agency actions.
- Section 6 has been considerably revised 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. Lautenberg retains the CSIA approach whereby safety assessments and determinations, as well as Section 6 control rules, are considered final agency action. The changes strike us as being helpful in resolving some of the issues identified, although undoubtedly old concerns remain and new ones have been created.
- Section 8 has retained the CSIA approach involving listing of Inventory chemicals as active and inactive, although specific aspects in the approach have been changed. The status of inactive chemicals can be changed to active via a notice to EPA. Lautenberg adds specific requirements for substantiation of 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 13 Imports proposes important new provisions, including a description of what constitutes “reasonable inquiry” in preparing an import certification and the steps EPA must take in requiring import certifications for articles. The latter include identifying the types of articles and the concentrations therein that would be subject to certification. The issue of articles also comes up in other sections of Lautenberg, including Section 3A (where EPA in restricting an article on the basis of chemicals contained in the article “shall have evidence of significant exposure” to the chemical from the article) and Section 6 (which gives EPA authority to exempt replacement parts manufactured before a compliance deadline). It seems to us that Lautenberg has introduced a number of important but difficult issues regarding the treatment of articles under the legislation and that this may be yet another area that will be difficult to sort out.
- Section 14 on Confidential Business Information (CBI) has been substantially rewritten and restructured 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 seems to have the effect of removing CBI claims from chemicals that are the subject of ban or phase-out actions under Section 6(d).
- Section 18 is retitled State-Federal Relationship and, while it contains substantive differences from S. 1009, remains one of the most controversial sections in the bill. Lautenberg has removed a provision in S. 1009 that would have prohibited State action on a chemical designated by EPA as a low-priority, although it retains the prohibition for State action on a high-priority chemical. Lautenberg revises and expands the provision regarding Preservation of Certain State Law, although it may need to be reconciled with other provisions. Lautenberg also revises the provision whereby States can apply to EPA for waivers.
- Lautenberg, in a major development representing a clear break from TSCA and S. 1009, 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 2. Findings, Policy, and Intent
Lautenberg retains TSCA Sections 2(a) Findings and (b) Policy without change and proposes to add a new subsection (2) Reform to Section2(c) Intent of Congress. The new provisions include protection of vulnerable populations, public availability of chemical information to public health officials and first responders, and protection of common law right of action. In proposing this change, Lautenberg has deleted a number of the concepts that had appeared in S. 1009 Section 2, including innovation, building public confidence, and the use of robust scientific evidence.
Section 3. Definitions
Lautenberg retains most of TSCA’s definitions, including “chemical substance” and “health and safety study,” among others. Whereas S. 1009 had proposed to define “best available science,” this definition has been deleted in Lautenberg. Lautenberg proposes, and in some cases revises, previous definitions for “conditions of use,” “safety assessment,” “safety determination,” and “safety standard,” and proposes a new definition, “potentially exposed or susceptible population,” thus responding to a gap identified by some in S. 1009:
- “Conditions of use” is defined to involve an EPA determination of the “intended, known, or reasonably foreseeable circumstances” of a chemicals manufacture, processing, etc.
- “Safety assessment” continues to mean a risk assessment that integrates hazard, use, and exposure information but no longer includes the concept of “reference parameters” (such as margin of exposure).
- “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 changed from that in S. 1009 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 harm to health or the environment will result from exposure to a chemical substance under the conditions of use, including no unreasonable risk of harm 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.
In making these changes and additions, Lautenberg has responded to a number of the issues identified regarding S. 1009 by explicitly including the concept of “potentially exposed or susceptible population” and making clear that a safety determination does not consider cost factors, while deleting the definition of “best available science” that had appeared in S. 1009.
Section 3A. Policies, Procedures, and Guidance
The new Section 3A does not have a counterpart in TSCA and consolidates “policies, procedures, and guidance” provisions that had been scattered in S. 1009 and also includes a number of new concepts, including requiring formation of and consultation with a Science Advisory Committee on Chemicals. The approach taken in Lautenberg to consolidate and clarify these provisions provides a much clearer understanding to the reader of what is at play. At the same time, the consolidation makes clearer the number that is proposed to be developed by EPA, including in some cases by rule. These include those needed to carry out Sections 4, 4A, 5, and 6, as well as specific policy, procedure, and/or guidance regarding the use of science, for testing under Section 4, and in the preparation of safety assessments and determinations under Section 6, including guidance for use by outside entities in preparing draft safety assessments. These are discussed in more detail below.
One of the criticisms of S. 1009 had been the lack of deadlines and Lautenberg responds to this by including a number of deadlines in this section, 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).
- Lautenberg 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 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, and one year to establish the Advisory Committee.
Lautenberg 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. Lautenberg 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.
Lautenberg 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 protection of health or the environment.” The listing strikes us as generous. While it is limited to information that is “reasonably available” to EPA, one can foresee unclear but possible consequences in future situations where EPA fails to “take into consideration” such information.
Lautenberg Section 3A(g) Testing of Chemical Substances and Mixtures picks up a number of the concepts that had appeared in S. 1009, including roles for tiered testing involving screening-level and higher-tier testing (the latter is termed “additional testing” in Lautenberg). Whereas S. 1009 had discussed the role of limited availability of information as a factor in identifying high-priority chemicals, Lautenberg 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.” Lautenberg 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 by TSCA. Regarding screening-level and additional testing, whereas S. 1009 had required that higher-tier testing be preceded by screening-level testing, a limitation that had drawn criticism, Lautenberg Section 3A(g)(4)(D) explicitly allows EPA to go directly to more advanced testing when EPA “justifies” its decision.
Lautenberg 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. Whereas S. 1009 did not include the concept of “aggregate exposures,” it has been included in Lautenberg 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.” Other notable changes from S. 1009 include 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)) and that EPA in restricting an article on the basis of chemicals contained in the article “shall have evidence of significant exposure” to the chemical from the article (Section 3A(h)(3)).
Lautenberg 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
S. 1009 Section 4 had proposed to delete all of TSCA Section 4 except for Section 4(e) relating to the Interagency Testing Committee and introduced numerous new provisions outlining a fundamentally new approach to TSCA prioritization, chemical assessment, and testing. Lautenberg consolidates and shifts the S. 1009 provisions relating to prioritization and assessment to Sections 4A and 3A, respectively, and largely limits Section 4 to considerations relating to testing and development of new information. Whereas S. 1009 had proposed to delete TSCA Section 4(f) Required Actions (under which EPA had been required to make certain determinations and as appropriate take actions when new information concerning adverse health effects was obtained), Lautenberg retains, redesignates (as Section 4(g)), and modifies the provision 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.
While Lautenberg generally follows the approach taken in S. 1009 Sections 4(f)-(k), the provisions, which now appear in Sections 4(a)-(e) of Lautenberg, also include a number of significant changes as discussed below.
The title of Lautenberg 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. This change represents a clarification relative to S. 1009 in EPA’s authority to require testing on new chemicals or to implement control actions. Lautenberg Section 4(a)(2) addresses one of the criticisms of S. 1009 by making clear that EPA can require limited testing for prioritization purposes if EPA determines that additional information is necessary to establish a chemical’s priority. Lautenberg retains the S. 1009 approach of allowing EPA to use rule, testing consent agreement, or order authority to require development of new information.
Lautenberg Section 4(b) Statement of Need retains the requirement in S. 1009 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.
Lautenberg Section 4(c) Reduction of Testing on Vertebrates maintains but clarifies the approach found in S. 1009 Section 4(i). Whereas S. 1009 had required that EPA “shall minimize the use of animals in testing,” Lautenberg adds nuance by applying this “to the extent practicable” and limits it to vertebrate animals. As in S. 1009, 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. Lautenberg 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.
The provisions in Lautenberg Sections 4(d) Testing Requirements and 4(e) Transparency have been retained from the corresponding sections in S. 1009 without change.
The net effect of the Lautenberg modifications has been to broaden and strengthen EPA authority to require information development, most notably on new chemicals and for prioritization purposes, while also clarifying the animal welfare provisions.
Section 4A. Prioritization Screening
Lautenberg Section 4A is based on S. 1009 Section 4(e) and includes the addition of several new prioritization goals and deadlines and some important wording modifications and deletions. It also includes new provisions regarding State notification to EPA concerning planned or completed State statutory or regulatory actions on chemicals not designated as high-priority by EPA, and requirements on EPA following such notifications, as well as a provision allowing industry to request, subject to payment of a fee, that EPA designate an “active” chemical for a safety assessment and determination if certain conditions can be met. Importantly, Lautenberg would remove the provision in S. 1009 that had specified that actions under this section “shall” not be considered final agency actions or subject to judicial review, thus making both high- and low-priority decisions potentially subject to review.
Lautenberg Section 4A(a) Establishment and List of Substances retains the one-year deadline for establishing a risk-based screening process but 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. Lautenberg retains the requirement that EPA develop an initial list of high- and low-priority substances but adds additional specificity in the form of a 180-day deadline for release of the initial list, which 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.
Section 4A(a)(2)(C) is a new provision that 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.
The requirements in S. 1009 regarding implementation and consideration of active and inactive chemicals are found in Lautenberg 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. Lautenberg applies certain requirements for repopulating the list of high-priority chemicals until a safety assessment and determination is completed for all such chemicals, 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.
Lautenberg Section 4A(a)(4) Criteria has been modified from the corresponding section in S. 1009 to strengthen certain requirements. These include: in the chapeau to the subsection that “[t]he criteria described in paragraph (1) shall
consider account for” (redlining added) a series of aspects, including State recommendations, and hazard and exposure potential, among others; at subsection (G) concerning the ability of limited availability of information to provide a sufficient basis for designating a chemical as a high-priority chemical “ provided that subject to the condition that limited availability shall not require a designation as a high-priority substance” (redlining added).
Lautenberg Section 4A(b) Prioritization Screening Process and Decisions generally follows the approach in S. 1009, including an ability for EPA to defer decisions pending development of needed information, with a number of significant changes. Among the changes, subsections (3)(A) and (3)(B) concerning identification of high-priority substances uses the term “high hazard and/or widespread exposure” (depending on the subsection; emphasis added), whereas S. 1009 had spoken to “high exposure” in the corresponding provisions.
In an important change likely intended to respond to criticisms of the approach in S. 1009, Lautenberg has considerably strengthened the EPA determination that is required in identifying low-priority substances in subsection (4) by requiring that EPA “concludes [it] has information sufficient to establish that the chemical substance is likely to meet the applicable safety standard” (emphasis added; the corresponding provision in S. 1009 had merely required an EPA determination based on available information that the chemical is likely to meet the standard).
Lautenberg deletes and replaces S. 1009 Section 4A(e)(4) Expedited Prioritization Screening with a new provision at Section 4A(b)(9) Other Information Relevant to Prioritization. The original provision had allowed a State to recommend a chemical to EPA for designation as a high- or low-priority and described the process and requirements to be applied. The provision in Lautenberg has been considerably changed and 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 Business Information (CBI) 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.” Lautenberg proposes a new provision at Section 4A(c) Additional Priorities for Safety Assessments and Determinations. This provision 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. This relatively complex provision 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.”
- “[S]hall ensure” that not more than 15 percent of the total chemicals designated for safety assessments and determinations come from this procedure and that the resources used “are proportionate to the number” of such chemicals relative to the total number designated to undergo safety assessments and determinations.
- Provides 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 4A(c)(5) states that requests granted under this provision “shall not be subject to” Section 18(b) regarding preemption of State statutes enacted following enactment of Lautenberg that restrict chemicals designated as high-priorities under Section 4A as of the date EPA commences the safety assessment or Section 4A(a)(3)(iii) on repopulation. Finally, as noted above, another important change in Lautenberg is the deletion of the provision in S. 1009 that had stated that prioritization screening actions shall not be considered a final agency action or subject to judicial review.
Section 5. New Chemicals and Significant New Uses
Lautenberg takes a somewhat different approach in the structuring of Section 5 relative to TSCA and to the approach in S. 1009. Specifically, Lautenberg’s structure for Section 5 involves:
- Section 5(a) Definition. Lautenberg 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. Lautenberg redesignates and retitles TSCA Section 5(a) In General but, consistent with the approach taken in S. 1009, otherwise retains the original TSCA text with changes conforming to the new structure and terms used.
- Section 5(c) Content of Notice. Lautenberg, consistent with S. 1009, deletes TSCA Section 5(c) Extension of Notice Period. Lautenberg has redesignated TSCA Section 5(d) as Section 5(c) and otherwise makes conforming changes and applies the approach taken in the corresponding subsection in S. 1009.
- Section 5(d) Review of Notice. Lautenberg redesignates S. 1009 Section 5(c) Review of Notice as Section 5(d). Notable changes are discussed below.
- Section 5(e) Notice of Commencement. Lautenberg redesignates S. 1009 Section 5(d) as 5(e) but otherwise largely retains the same text, including allowing notifiers to withdraw notices.
- Section 5(f) Further Evaluation. Lautenberg redesignates S. 1009 Section 5(e) as Section 5(f) but otherwise retains the same text.
- Section 5(g) Transparency. Lautenberg redesignates S. 1009 Section 5(f) as Section 5(g) but otherwise retains the same text.
- Section 5(h) Exemptions. Lautenberg retains TSCA’s structure regarding Section 5(h) Exemptions and keeps most of S. 1009’s edits, although there are important changes to this section as discussed below. Regarding Section 5(d) Review of Notice, Lautenberg retains much of the text without change from the corresponding section in S. 1009, however, there are also several important changes.
- Lautenberg Section 5(d)(3) and (4) concerning restrictions and determinations by EPA that a new chemical is “not likely to meet the safety standard” or that additional information is needed clarifies and strengthens the S. 1009 requirements by stating that, per subsection 4(A)(i)(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.” In cases where EPA determines that a new chemical or a significant new use “is likely to meet the standard,” the submitter may commence manufacture at the end of the review period.
- Lautenberg Section 5(d)(4)(B) includes a new requirement that EPA, within 90 days of implementing a consent agreement or order, must proceed to either implement a Significant New Use Rule (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 Significant New Use Notifications (SNUN), 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.
- A new provision at Lautenberg Section 5(d)(4)(D) requires EPA to “consult” with the Occupational Safety and Health Administration (OSHA) prior to “adopting any prohibition or other restrictions” 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.
- Lautenberg adds “subject to Section 18(g)” (Preemption) cross references to Sections 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. Lautenberg otherwise clarifies but generally retains the S. 1009 language regarding the provisions in this subsection. Section 5(d)(4)(C)(i) relates to restrictions involving requirements for markings or warnings and specifically applies the “subject to Section 18(g)” provision to such actions. Lautenberg Sections 5(d)(4)(C)(iii) and (v) broaden EPA’s authority beyond that in the corresponding section of S. 1009 by allowing 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.” The authority in S. 1009 was limited to particular uses.
- Lautenberg Section 5(d)(4)(E) Definition of Requirement is a new provision stating that “[f]or purposes of this Act, the term ‘requirement’ as used in this section does not displace common law.” Lautenberg Section 5(h)(3) on exemptions has retained the S. 1009 approach to TSCA Section 5(h)(4) (which was used to develop the polymer and low volume exemptions, among others) by replacing the regulatory standard used in TSCA (“will not present an unreasonable risk”) with the “will meet the safety standard” regulatory standard applied in S. 1009 and Lautenberg. Lautenberg goes beyond S. 1009 by deleting 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).”
Section 6. Safety Assessments and Safety Determinations
Lautenberg substantially revises the approach in and restructures Section 6 relative to both TSCA and S. 1009. 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 S. 1009. 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.
Concerning TSCA, as was done in S. 1009, Lautenberg deletes TSCA Sections 6(a) through (d) and redesignates Section 6(e) (concerning polychlorinated biphenyls (PCB)) as Section 6(g). Provisions in S. 1009 relating to the development of safety assessments and determinations have been moved elsewhere in the text, including to Section 3A. The structure of Section 6 in Lautenberg is as follows:
- Section 6(a) In General outlines requirements and deadlines for conducting safety assessments and determinations and for establishing restrictions and promulgating control measures.
- Section 6(b) Prior Actions is a new section that 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.
- Section 6(c) Safety Determinations has been revised from that in S. 1009 as discussed below.
- Section 6(d) Rule derives in part from S. 1009 Section 6(c)(9) Additional Restrictions and 6(d)(10) Exemptions, although the approach has been considerably revised and is discussed below.
- Section 6(e) Immediate Effect is a new section relative to S. 1009 that gives EPA authority to declare a proposed Section 6(d) rule to be effective on publication if certain EPA determinations can be satisfied. Note that this provision is similar to that found in TSCA Section 6(d)(2).
- Section 6(f) Final Agency Action derives from Section 6(d)(11) of S. 1009, although there are important changes as discussed below.
- Section 6(g) Polychlorinated Biphenyls was, as noted above, redesignated from TSCA Section 6(e).
Lautenberg Section 6(a) explicitly requires that EPA shall:
- Conduct a safety assessment and make a safety determination on each high-priority chemical;
- Define the scope of the safety assessment and determination 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.
Lautenberg Section 6(c) continues but somewhat modifies the approach in S. 1009 regarding safety determinations.
- Per Section 6(c)(1), EPA continues to be required to determine whether the chemical “meets” or “does not meet” the safety standard, or that additional information is required. But whereas S. 1009 had merely required that EPA “shall impose additional restrictions” (emphasis added) when it determines that a chemical does not meet the safety standard, Lautenberg expands and clarifies this point by requiring that EPA “shall, by rule under subsection (d)” impose restrictions necessary to assure that the substance meets the safety standard, or, where the safety standard cannot be met with the application of restrictions, to ban or phase out the substance.
- Lautenberg Section 6(c), subsections (2) and (3) also 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.
- A new provision under Lautenberg Section 6(c)(1) picks up the concept introduced at Section 3A(h)(2)(C)(i)(II) concerning development of “draft safety assessments” by interested outside parties, which, per Section 3A(h)(2)(D), “may be considered” at EPA’s discretion in completing safety determinations.
Lautenberg 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) 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 an important provision for article manufacturers, EPA may “exempt replacement parts for articles manufactured prior to the applicable compliance deadline.” EPA is also required to consult with the Occupational Safety and Health Administration (OSHA) prior to adopting any actions to address workplace exposures. The provisions under Section 6(d)(2)(A) strike us as confusing because they seem to state that risk management may (1) apply to mixtures and (2) exempt replacement parts for articles manufactured before commencement of the applicable compliance deadline.
Lautenberg Section 6(d)(3) outlines the wide array of restrictions that the rule “may include, as appropriate.” As was the case for the corresponding provision regarding new chemicals, the Section 6(d)(3)(A) restrictions requiring markings or warnings have been made subject to Section 18 (Preemption).
Lautenberg Section 6(d)(4) Analysis for Rulemaking is a critical provision in the text that requires EPA “n deciding which restrictions to impose…shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and non-quantifiable 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, Lautenberg 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”) and in S. 1009.
Lautenberg substantially revises and expands Section 6(d)(5) Exemptions, another critical provision in the text, by somewhat rewording the exemption provisions and including a number of new process and procedural provisions. 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 [“net” in S. 1009] 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 Lautenberg 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.” Finally this subsection states that any renewal of an exemption for a ban/phase-out chemical “shall not exceed 5 years.”
Finally, per Lautenberg 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 (S. 1009 had limited this provision to safety determinations, although it also included the notation that these determinations (including the associated safety assessment) were subject to judicial review).
Section 8. Information Collecting and Reporting
Lautenberg, while it generally follows the approach taken in S. 1009, including requiring reporting to inform designation of TSCA chemicals as “active” or “inactive” and the continued application of certain chemical nomenclatures, proposes a number of important modifications, including the establishment of several deadlines and new provisions regarding CBI.
Lautenberg proposes a small but potentially significant change to TSCA Section 8(a)(3)(A)(ii)(I). This subsection concerns EPA’s ability to require reporting by small businesses on chemicals that are subject to certain TSCA rules. Lautenberg would allow EPA by rule to require such reporting on chemicals subject to regulations under Section 5 (the original TSCA provision had been limited to TSCA Section 5(b)(4), the so-called “chemicals of concern” list). This change would allow EPA to require reporting by small businesses on any chemicals subject to Section 5 SNURs.
Lautenberg adds a two-year deadline to the requirement at Section 8(a)(4) that EPA promulgate reporting rules to obtain the information “necessary to carry out Sections 4 and 6.” As proposed in S. 1009, reporting by processors is required to be included in the rule. Whereas S. 1009 had limited reporting to active substances and that it “shall apply only to the extent…necessary,” these provisions no longer appear. 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.
Lautenberg retains the nomenclature provision regarding certain Class 2 chemicals and statutory mixtures that appeared in S. 1009.
Lautenberg also retains an “Inventory reset” component at Section 8(a)(4) with a new 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 (up from five years in S. 1009). Lautenberg specifies a 180-day reporting period. The information received would be used by EPA to designate and list chemicals as “active.” S. 1009 had also required that EPA “designate” inactive chemicals in the corresponding provision but this provision has been deleted (although Section 8(b)(5)(A) refers to “designations of active and inactive substances”). As part of this reporting on active chemicals, “any existing” CBI claims for chemical identity would need to be reaffirmed and be substantiated (the latter seems to be a new requirement). 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 such claims, including any CBI substantiation claims for chemical identity made by companies over the past five years, and to “approve, modify, or deny such claim.” Any such approvals are limited to ten years. Lautenberg 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.
Lautenberg Section 8(b)(5) Active and Inactive Substances requires that EPA “shall maintain and keep current” (a new 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 identify 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.
Lautenberg Section 8(b)(8) is a new provision that explicitly disallows CBI claims for chemical identity of any chemical on the non-confidential portion of the list of active and inactive chemicals.
Lautenberg also revises S. 1009 Section 8(e)(2) by allowing 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” (redlining to show additions).
Section 9. Relationship to Other Federal Laws
Lautenberg makes conforming changes to this section and also proposes a new 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
Lautenberg continues to apply the conforming changes made in S. 1009 to this section and proposes some important changes and additions relative to TSCA and S. 1009 as discussed below.
Lautenberg proposes a new Section 12(a)(4), which 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.
Consistent with S. 1009, Lautenberg 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 to provide export notices (for example under the Stockholm Convention on Persistent Organic Pollutants (POPs)). In an important change relative to the approach in S. 1009, Lautenberg Section 12(b)(1)(E) would require export notification on chemicals “for which the submission of information is required under Section 4.” Although consistent with TSCA Section 12(b) (in that Section 4 actions triggered export notification requirements), this new requirement greatly increases the universe of chemicals for which such notices would have been required compared to S. 1009. There is also a new savings clause-type provision at Section 12(b)(1)(D) for existing restrictions under TSCA.
Section 13. Imports
Lautenberg retains and updates what can be considered conforming changes proposed in S. 1009, deletes certain provisions in S. 1009, and proposes some important new provisions, including ones regarding articles and a description of what constitutes “reasonable inquiry” in preparing an import certification.
Lautenberg deletes S. 1009 Section 13(a) Definition of Chemical Substance or Mixture and relies on the otherwise existing definitions for these terms. Lautenberg revises redesignated Section 13(a) Refusal of Entry by making conforming changes and also adds a provision explicitly allowing refusal of entry for chemicals not on the Inventory while also recognizing and allowing entry of new chemicals subject to exemptions granted under TSCA Section 5(h)(4).
Lautenberg Section 13(b)(3) Reasonable Inquiry is a helpful new provision describing requirements for a “reasonable inquiry” for import certification. Regarding certifications for chemicals contained in articles, subsection (B) states that reasonable inquiry shall include “good faith reliance by an importer on a certification by the supplier that the imported article satisfies the applicable certification requirements.”
Lautenberg otherwise revises and adds a lot of specificity as well as nuance to the approach to articles under this section. Section 13(a)(C) allows refusal of entry for “any article containing” the chemical or mixture in violation of an action in effect under the Act (which seems to limit the effect to actions that are specific to articles). New Section 13(b)(2) concerns certifications for articles, which states that EPA may by rule require certification for an article containing a chemical subject to a rule under Section 5 or 6 if the Section 13(b)(2)(A) rule identifies “with reasonable specificity, the types of articles, including parts or components of articles, that will be subject to the certification requirement.” In determining the need for and content of this rule, EPA shall take into consideration factors such as:
- The utility of the certification to enforcement of the action under Section 5 or 6;
- The contribution of imported articles to the potential risk of exposure to the chemical;
- The impact on commerce and potential for the certification to impede or disrupt import of articles;
- The frequency or duration of the certification requirement; and
- Specification of the concentration in an article that would subject the article to certification.
Finally, new Section 13(b)(4) in Lautenberg requires EPA, for purposes of the subsection, to provide “publicly accessible information” regarding chemical identity that would be “readily understood in import transactions.”
Section 14. Confidential Information
Lautenberg proposes major changes to this section and substantially rewrites it from the version in S. 1009. The proposed structure is:
- 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
- Section 14(g) Duties of the Administrator
- Section 14(h) Criminal Penalty for Wrongful Disclosure
The chapeau to Section 14(a) In General states “[e]xcept 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. Relative to S. 1009, the descriptions of the protected information have been sharpened, for example:
- “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” (emphasis added) 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, subject to Section 4 testing, or notified under Section 5, although there are specific subprovisions regarding chemical identity and other requirements that will need careful analysis to understand the full effect. A new Section 14(c)(5) Ban or Phase-Out seems to have the effect of removing CBI claims from chemicals that are the subject of such actions under Section 6(d).
Lautenberg substantially revises Section 14(d) Requirements for Confidentiality Claims, including:
- Requiring that such claims be asserted and substantiated at the time of submission.
- The text has been clarified 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.
- 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.
Section 14(e) Exceptions to Protection from Disclosure generally follows the approach in S. 1009, although the exceptions are somewhat expanded, including to parties responding to environmental emergencies.
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 new and 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 new 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 Lautenberg 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.
Under Section 14(g) Duties of the Administrator, Lautenberg adds specificity to the EPA obligations, 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.
Lautenberg Section 14(h) Criminal Penalty for Wrongful Disclosure would delete the requirement in S. 1009 for removal from office of an EPA employee for wrongful disclosure of CBI.
Section 16. Penalties
Lautenberg 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
The issue of preemption has been one of the major controversies throughout all iterations of TSCA reform bills. Lautenberg is similar to, but contains some substantive differences from, S. 1009. For starters, Lautenberg has changed the title of this section from “Preemption” to “State-Federal Relationship,” but a title change will not resolve the differing positions regarding the scope of preemption.
Some of the changes include:
- In Section 18(b) regarding a State’s inability to establish a new statute or administrative action prohibiting or restricting the manufacture, processing, distribution in commerce, or use of a chemical substance, Lautenberg removes a provision that would have prohibited such a statute or administrative action for a chemical identified under Section 4A as a low-priority chemical. The Act thus expands the types of laws that can be promulgated by States, a notable concession to those seeking to limit the scope of preemption, although the Act still retains the prohibition for a State to enact a statute or administrative action prohibiting or restricting the manufacture, processing, distribution in commerce, or use of a chemical substance that is designated under Section 4A as a high-priority substance.
- A concern that has been identified as “insurmountable” by the California Office of the Attorney General (AG) is the inconsistent effective dates set forth for when preemption takes effect. Section 18(a) provides for Federal preemption of new or existing State statutes and administrative actions that require testing of a chemical substance where EPA has established testing requirements by rule, consent agreement, or order, or that prohibit or restrict manufacture, processing, distribution, or use of a substance that EPA has found meets the safety standard or which EPA has regulated after a finding that the safety standard is not met. In each case, preemption would “not occur until the effective date of the applicable action.” In contrast, Section 18(b) provides that Federal preemption of any new State statute or administrative action prohibiting or restricting manufacture, processing, or distribution of a chemical substance designated by EPA as a high-priority substance would occur “as of the date on which the Administrator commences a safety assessment under section 6.” Thus, although the Lautenberg bill relaxes restrictions on State regulation of chemical substances designated by EPA as “low priority” chemicals, it retains a broad prohibition on State regulation of substances designated by EPA as “high priority” substances once EPA commences its safety assessment. The California AG Office states that considering the time between commencement of a safety assessment under Section 6 and final regulatory action can take up to seven years, to not allow States to enact new laws once the safety assessment is commenced “constitutes poor public policy that undermines the fundamental health and environmental protection purposes of TSCA reform.” On the other hand, it arguably makes no sense to allow restrictive new State laws for substances that are under intensive EPA review and that will eventually be subject to preemption under Section 18(a).
- A significant change is a new Section 18(c) entitled “Scope of Preemption.” This section provides that any Federal preemption of State statutes and administrative actions applicable to specific substances shall apply only to: (1) if the chemical substance (or category of substances) is subject to a Section 4 rule, order, or consent agreement; (2) when the uses or conditions of use identified are subject to review in a safety assessment and included in the scope of the safety determination, or of any rule EPA promulgates pursuant to Section 6(d); and (3) the use of such substances that EPA has specified as significant new uses and for which EPA has required notification.
- Lautenberg Section 18(d) contains an “exemption” section, like most prior bills, that specifies those State statutes or administrative actions that cannot be restricted. Unlike S. 1009, however, Lautenberg provides additional criteria to exempt a statute or administrative action applicable to a specific chemical substance and related to water quality, air quality, or waste treatment or disposal. This limitation both clarifies and narrows the type of statute or administrative action that would be exempt from preemption.
- Section 18(e) addresses the “Preservation of Certain State Law” and expands such preservation to any 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. S. 1009 contained a similar provision, except that S. 1009 was more specific in preserving only “any warning requirement relating to consumer products or substances” and eliminating such preservation under certain circumstances if EPA later promulgates a rule under Section 6 that includes a warning requirement. The preservation set forth may need to be reconciled with Section 18(a)(1)(B), which sets forth a restrictive set of existing laws that States could not enforce as of the effective date of any applicable action taken by EPA.
- Section 18(f) sets forth a “States Waivers” procedure under which States can, upon application to EPA, seek to have EPA exempt a statute or administrative action relating to the effects of, or exposure to, a chemical substance under the conditions of use. TSCA currently has such a procedure, but the criteria under which EPA can grant such a waiver is different between TSCA, S. 1009, and Lautenberg. Under current law, EPA must find that compliance with the State law would not cause a violation under TSCA, that the State requirement provides a “significantly higher degree of protection,” and “does not, through difficulties in marketing, distribution, or other factors, unduly burden interstate commerce.” S. 1009 and Lautenberg add two additional criteria: (1) that there be “compelling” conditions warranting EPA to grant a waiver; and (2) that there be some judgment or decision that the requirement has some sound or reasonable scientific basis. Other changes in Lautenberg include: (1) the removal of language that would have required EPA to determine that a safety assessment or determination “has been unreasonably delayed”; and (2) a revision to the duration of any waiver granted to the later of “such time as the safety assessment and safety determination is completed” and “the date on which compliance with an applicable rule issued under section 6(d) is required.”
Section19. Judicial Review
The Lautenberg bill 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). The Lautenberg bill 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
Lautenberg, in a major development representing a clear break from TSCA and S. 1009, 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, protect from disclosure, among other actions, information; 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
Lautenberg adds a new Section 27(c) Sustainable Chemistry Program (SCP), which 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.
Lautenberg 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.