Regulatory Developments

TSCA Reform: Detailed Analysis of the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act

March 24, 2015

As noted in our recent memorandum on the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697, Lautenberg), Senators Barbara Boxer (D-CA) and Ed Markey (D-MA) recently introduced the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act (S. 725, Boxer-Markey), which presents their approach to revising the Toxic Substances Control Act (TSCA). We had committed to preparing a review comparing Lautenberg with the new Boxer-Markey bill, and that review is presented below.

Background

The Senate over the past several years has considered a number of legislative texts to amend TSCA. These include the Safe 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 Boxer, 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 release their draft officially, 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 those efforts are found in Lautenberg. This memorandum summarizes and analyzes Boxer-Markey as such and in comparison to Lautenberg and S. 1009.

Commentary

S. 725 is designed to address what Senators Boxer and Markey cite as fatal flaws in S. 697 and the "overwhelming" correspondence they received in opposition to the bill by environmental and citizen groups, Attorneys General, and other organizations that wish to strengthen the bill. The main cause of concern is rooted in the preemption provisions of the compromise Udall-Vitter proposal, as they believe the authority and intuition of State governments will far better protect the public from chemical risks. To a lesser degree, another major linchpin of the differences between the two bills is the safety standard of S. 725 -- "reasonable certainty... [of] no harm..." from chemical exposures -- also claimed to be far superior in requiring the U.S. Environmental Protection Agency (EPA) to prevent and mitigate harmful chemical exposures.

During the hearing held by the Senate EPW Committee, the rhetoric of Senators Boxer and Markey concerned chiefly these two issues, and the derision and disagreement over differences with S. 697 made any substantive discussion of the differences, or potential for finding any middle ground, difficult. Notwithstanding the hearing's contribution to political theater, there are a number of important issues that appear ripe for further development, such as the need to consider when any preemption effect of EPA action should begin (for example, at the time when any Federal restrictions are imposed, or simply during the time when Federal consideration of a "high-priority" chemical is occurring). The inherent possibility for long delays in completing reviews of sometimes difficult, scientifically complex assessments, as well as not wanting to create new incentives for delays, seemed to suggest among the panel members that more tinkering will be done in this space. From our perspective, making any preemptive effect begin at the conclusion of an EPA assessment and regulation will create incentives for chemical producers to assist with completion of the task. This type of approach seemed to interest Committee members who spoke of trying to find further improvements.

The functional differences between the dueling safety standards may also be less intense than the rhetoric at the hearing depending on the provisions that articulate how EPA would apply either standard. Differences over the pace of EPA work or deadlines for completed actions are real differences, but might be subject to negotiated compromise if the opposing sides are willing to attempt to find a middle ground on these and a number of important differences between the two bills.

And that may be the key to the future of TSCA reform -- do the sponsors want to find any compromise, or continue to criticize others' ideas and approaches as misguided and dangerous to either public health or future economic vitality. Reality is likely somewhere in-between regardless of the specific provisions, but at the moment, the rhetoric is seemingly too intense and to some degree too personal to predict that compromise is likely to be found. Our review indicates that on most apparent differences, compromise language could be achieved. Without some version of preemption, however, it is not clear whether Congressional allies of the chemical industry will see sufficient benefit in allowing EPA greatly enhanced authority to evaluate and control chemical risks at the Federal level. So stalemate is a real possibility -- and from our perspective a great concern -- given the current Congressional tendency to dysfunction.

If that happens, and if Safe Chemicals Act amendments are not successfully enacted, EPA will become ever more of a bystander both domestically and internationally. Future prospects for controlling public health or environmental risks from chemical exposures will center on States' ability to identify and control problem chemicals, which apparently, and despite the hearing statistic that only 12 chemicals have been regulated by States so far, is the currently preferred outcome for those who support S. 725.

Summary

While Boxer-Markey includes provisions that track with those as proposed in Lautenberg, it proposes an approach that substantially differs from Lautenberg in many and important respects. This is first seen in Section 3. Definitions where Boxer-Markey proposes to apply the concept of "reasonable certainty... [of] no harm..." to the safety standard, a change that colors and fundamentally shifts the regulatory standard and how it is to be applied in the two bills. Whereas Lautenberg had worked hard to clarify that cost-benefit considerations do not come into play in the prioritization, safety assessment, and safety determination processes, but do apply when determining and applying restriction actions, Boxer-Markey, by proposing a $100 million threshold requirement for the application of cost-benefit considerations, would largely remove cost-benefit considerations from essentially all of the control actions that might be taken under the bill. Boxer-Markey also proposes several new provisions in Section 6 (relating to actions on Persistent Bioaccumulative Toxic (PBT) chemicals and asbestos) and new TSCA titles regarding "disease clusters." The statement noted in our memorandum analyzing Lautenberg that "old issues remain and new ones are introduced by the changes made" also applies to Boxer-Markey.

  • Section 3 Definitions, as noted above, proposes to apply the concept of "reasonable certainty... [of] no harm...," which harkens back to the approach in the Safe Chemicals Act, rather than the "no unreasonable risk of harm" standard proposed in Lautenberg.
     
  • Section 3A accepts the deadlines proposed in Lautenberg for this section but Boxer-Markey makes a number of important procedural and substantive wording changes relative to Lautenberg. These include not requiring rulemaking in developing the policies and procedures for this section, and requiring that in each safety assessment and determination that EPA "identify all potentially exposed or susceptible populations" (emphasis added), and determine the "nature and extent of exposures to the chemical substance by the general population and each potentially exposed or susceptible population" (emphasis added).
     
  • Section 4 generally takes the same approach as in Lautenberg.
     
  • Section 4A on prioritization screening proposes many wording changes to this section, including some that are significant. Boxer-Markey does not include a number of the provisions that had been proposed in Lautenberg, including a role for State notification to EPA concerning planned or completed State statutory or regulatory actions in prompting EPA consideration of such cases for prioritization and in allowing companies to request and pay for safety assessments and determinations for chemicals meeting certain criteria. Boxer-Markey generally accepts the deadlines proposed in Lautenberg but requires somewhat higher numeric targets for chemical prioritization and review. Regarding criteria for determining priority, Boxer-Markey proposes use of "hazard" rather than hazard and exposure criteria as in Lautenberg and additional criteria regarding the threat presented to drinking water supplies. One of the important provisions concerns the nature of the conclusion that would be required of EPA in identifying low-priority substances; Boxer-Markey would strengthen the requirements to be met and the analysis to be provided by EPA. Boxer-Markey, importantly, proposes to make low-priority designations final agency actions and subject to judicial review, a proposal that is not found in Lautenberg.
     
  • Section 6 has been considerably revised by the addition of new provisions relating to PBTs and asbestos and others that fundamentally change the nature of the requirement for cost-benefit analysis compared to the approach in Lautenberg. Boxer-Markey also adds requirements for State and essentially local notification by entities when a required disposal may occur and proposes other important changes as discussed below.
     
  • In Section 8, although structured somewhat differently from Lautenberg, Boxer-Markey applies the same approaches, deadlines, and requirements with a few exceptions, such as not including the chemical nomenclature provisions that had appeared in S. 1009 and Lautenberg.
     
  • Section 12. Exports. Boxer-Markey proposes a somewhat different structure in certain section designations, although the approach proposed seems similar to that in Lautenberg. More importantly, Boxer-Markey proposes changes in several provisions regarding mixtures and articles relative to the approach in Lautenberg, which was more generally worded.
     
  • Section 13. Imports. While the two bills appear to take the same approach in other subsections, they differ in Section 13(b) Certifications. Boxer-Markey in this section does not include several provisions in Lautenberg relating to the role of "reasonable inquiry" in determining compliance with this section, nor language proposed in Lautenberg that required EPA to "identify, with reasonable specificity, the types of articles, including parts or components of articles, that will be subject to the certification requirement."
     
  • Section 14 on Confidential Business Information (CBI). Boxer-Markey, like Lautenberg, proposes substantially to rewrite and restructure CBI provisions, including additional procedures to substantiate CBI claims and to limit the duration of CBI protection. Boxer-Markey includes some important distinctions from Lautenberg, particularly in not creating a "presumption" that certain types of information are protected from disclosure and by not specifying that identities of the components in a mixture will be protected from disclosure.
     
  • Section 18. Preemption. Boxer-Markey proposes that EPA actions have no preemption effect on State actions. This represents a fundamental difference between the two bills.
     
  • Section 19. Judicial Review. Boxer-Markey proposes no substantive changes to the "substantial evidence" standard in the current TSCA.
     
  • Section 26. Administration. Boxer-Markey proposes a fees provision that differs significantly from that proposed in Lautenberg. In general, the provisions in this section of Boxer-Markey are fewer and less detailed and nuanced than those presented in Lautenberg. In an important difference, Boxer-Markey proposes to apply fees exclusively to manufacturers whereas Lautenberg had applied fees to both manufacturers and processors. Boxer-Markey also gives EPA discretion to adjust fees for small businesses, whereas Lautenberg had required that EPA apply lower fees to such entities.

Detailed Analysis

Section 2. Findings, Policy, and Intent

Relative to Lautenberg, Boxer-Markey seemingly accepts the Lautenberg proposed language but reorders the provisions and inserts them into the Findings subsection rather than the Intent of Congress subsection.

Section 3. Definitions

Boxer-Markey proposes to define a new term -- "information," largely accepts certain definitions in Lautenberg, and proposes important changes in the other definitions. The important changes include:

  • Proposing to define the term "Intended or reasonably foreseeable conditions of use" (redlining to show differences from Lautenberg), which, relative to Lautenberg, adds the concept of environmental releases, "including reasonably foreseeable but unintended exposure conditions from unplanned releases"; and
     
  • To define "safety standard" as involving the concept of "reasonable certainty... [of] no harm...," which harkens back to the approach in the Safe Chemicals Act, rather than the "no unreasonable risk of harm" standard proposed in Lautenberg.

Section 3A. Policies, Procedures, and Guidance

Boxer-Markey accepts the deadlines proposed in Lautenberg for this section, but does not propose to define the term "guidance" as was done in Lautenberg, and otherwise proposes a number of wording changes throughout the section, including:

  • Section 3A(b) regarding use of science by EPA does not include references to "weight of the scientific evidence" and to "independent verification" that had appeared in Lautenberg, and whereas Lautenberg had referred generally to National Academy of Sciences chemical assessment reports, Boxer-Markey specifically references a series of such reports.
     
  • Section 3A(f) Testing of Chemical Substances and Mixtures, while it generally accepts the concept of tiered testing, adds the concept that "lack of information on exposure or exposure potential shall not, by itself, be a reason not to require testing," adds a reference to "accumulation of chemical substances in the human body" in discussing additional testing, and, regarding animal welfare aspects, references "mammals" whereas Lautenberg had referred to "vertebrates."
     
  • Regarding safety assessments and determinations (Section 3A(g)), Boxer-Markey makes a number of changes relative to the approach in Lautenberg, including the following:
     
    • Does not specify use of rulemaking in developing policies and procedures for this section nor does it include a requirement for development of an annual plan.
       
    • Requires that EPA in each safety assessment and determination "identify all potentially exposed or susceptible populations" (emphasis added), identify the hazards of the substance and its metabolites and breakdown products, and determine the "nature and extent of exposures to the chemical substance by the general population and by each potentially exposed or susceptible population" (emphasis added).
       
    • Boxer-Markey does not include the provision in Lautenberg regarding restrictions in articles wherein EPA in taking such action was required to have evidence of significant exposure to the chemical from the article.
       
    • Finally, Boxer-Markey requires development of conflict of interest policies in establishing the Advisory Committee.

In Section 3A, Boxer-Markey also first proposes to use the concept of "determined by EPA to be needed" whereas Lautenberg had applied the concept of "determined by EPA to be necessary" in the relevant provisions. This change is carried throughout Boxer-Markey.

Section 4. Testing of Chemical Substances and Mixtures

Boxer-Markey generally takes the same approach as Lautenberg in deleting certain subsections and in proposing to retain but revise 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) by deleting the limitation to "cancer, gene mutations, or birth defects," thus making it applicable to any "significant risk of serious or widespread harm" to humans.

Boxer-Markey Section 4(a) Development of New Information on Chemical Substances and Mixtures is similar to that proposed in Lautenberg, however, Boxer-Markey does not include the Lautenberg provisions relating to testing of new chemicals or for a rule promulgated under Section 6(d)(3). Whereas Lautenberg had limited the provision relating to testing requested by another Federal agency to that needed to meet its "regulatory testing needs," Boxer-Markey does not include this limitation. Boxer-Markey retains the provision in Lautenberg giving EPA authority to require testing for prioritization purposes but, in what may be a significant change, has revised the title of the subsection as follows: "(2) Limited Testing for Prioritization Purposes" (redlining to show change).

Boxer-Markey Section 4(b) Statement of Need appears to track with the approach in Lautenberg and, in Section 4(c), proposes to revise the title as follows (redlining shows change relative to Lautenberg): Reduction of Testing on Vertebrates Mammals." Other provisions in Section 4(c) appear to follow the approach in Lautenberg except that Boxer-Markey does not include the provision that had ensured that the strategic plan was actually applied and, regarding funding of research for animal alternative testing, applies this provision "to the extent practicable."

The remaining provisions in Section 4 appear to track with those in Lautenberg.

Section 4A. Prioritization Screening

Boxer-Markey proposes many wording changes to this section, including some that are significant. It does not include a number of the provisions that had been proposed in Lautenberg, including a role for State notification to EPA concerning planned or completed State statutory or regulatory actions in prompting EPA consideration of such cases for prioritization and in allowing companies to request and pay for safety assessments and determinations for chemicals meeting certain criteria. Boxer-Markey generally accepts the deadlines proposed in Lautenberg but requires somewhat different numeric targets for chemical prioritization and review as discussed below. Whereas Lautenberg had removed 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, Boxer-Markey, importantly, proposes to make low-priority designations final agency actions and subject to judicial review. High-priority designations would not be considered final agency actions or subject to judicial review. Some of these proposed changes and additions are discussed below.

Whereas Lautenberg Section 4A(a) Establishment and List of Substances had proposed that an initial list of priority chemicals contain at least ten each of high- and low-priority chemicals, Boxer-Markey would require 15 high-priority entries and is silent on low-priority entries on the list. Boxer-Markey would require that EPA initiate safety assessment and determination within six months of enactment while Lautenberg had conditioned this as a "may" requirement. Regarding additions to the priority list, Boxer-Markey would require 15 high-priority substances be added for each of the next four years, yielding a total of 60 high-priority chemicals for which safety assessments and determinations have been initiated or continued. Lautenberg would take a somewhat different approach and require that within five years a total of 25 high-priority chemicals have undergone or are undergoing the safety assessment and determination process while 25 low-priority designations have been completed. Regarding repopulation, whereas Lautenberg had required that one new high-priority chemical be added for each chemical removed due to completion of a safety assessment and determination, Boxer-Markey would require that three high-priority chemicals be added "subject to section 21, when fees are in place."

Regarding Section 4A(a)(5)(B) Timely Completion of Prioritization Screening Process, while Lautenberg gives EPA 90 days to designate a substance after receipt of new Section 4 information, Boxer-Markey would give EPA 120 days. Boxer-Markey requires EPA to screen chemicals taking into consideration the "requirement to meet the deadlines under section 6 of this Act," whereas Lautenberg had conditioned this on EPA's ability to "schedule and complete" safety assessments and determinations.

Boxer-Markey proposes some important revisions to Section 4A(a)(6) Criteria, including that:

  • The criteria developed by EPA "shall include" various components, whereas Lautenberg had required that EPA "shall account for" (emphasis added) the various components;
     
  • Boxer-Markey requires at Subsection (6)(B) that the criteria include "the hazard" of a chemical versus Lautenberg, which had required hazard and exposure potential;
     
  • Boxer-Markey adds new criteria relating to the potential threat to drinking water supplies, the extent of human accumulation of a chemical, and "other relevant criteria identified" by EPA; and
     
  • Boxer-Markey does not include the criterion in Lautenberg concerning the extent of Federal or State regulation.

Section 4A(b) Prioritization Screening Process and Decisions differs significantly in some aspects between the two bills:

  • Boxer-Markey does not include the provision at Lautenberg Section 4A(b)(2) that had explicitly required that screening decisions "shall integrate any hazard and exposure information";
     
  • Boxer-Markey revises the subsection on Identification of High-Priority Substances in important ways, including (note that redlining below shows additions to and deletions from version in Lautenberg):
     
    • Subsection (A) states that EPA shall identify as high-priority a chemical that the "Administrator determines has, or has the potential for, high significant hazard and widespread significant or substantial exposure";
       
    • Subsection (B) states that EPA may identify as high-priority a chemical that "relative to other chemical substances, the Administrator determines has, or has the potential for, high significant hazard or widespread significant or substantial exposure"; and
       
    • Subsection (D) is a new provision that states EPA may identify a chemical "that accumulates in the body" as a high-priority.

The subsection titled Identification of Low-Priority Substances (designated as Section 4A(b)(4) in Lautenberg and (3) in Boxer-Markey) is an important provision that differs between the two bills, as shown below:

Lautenberg:

The Administrator shall identify as a low-priority substance a chemical substance that the Administrator concludes has information sufficient to establish that the chemical substance is likely to meet the applicable safety standard.

Boxer-Markey (italicized text attempts to give emphasis to key differences relative to Lautenberg):

The Administrator shall identify as a low-priority substance a chemical substance if the Administrator--
(A) concludes that sufficient hazard and exposure information is available for an informed evaluation of the substance's risks to human health and the environment;
 
(B) determines, based on a review of the information available, that the substance is likely to meet the safety standard under the intended or reasonably foreseeable conditions of use, and
 
(C) identifies the information on which the determination is based and describes the Administrator's analysis of this information.

Section 5. New Chemicals and Significant New Uses

Boxer-Markey applies an approach that is similar to that in Lautenberg although using a somewhat differing subsection structure and adding/removing/changing provisions relative to the proposals made in Lautenberg. Examples of the latter include:

  • Removing Section 18 references that appeared in this section of Lautenberg and adding a new Section 5(c)(4)(D) Rule of Construction, which states that any Subsection (C) restriction involving a requirement, warning, or instruction "does not establish a uniform national standard for the purpose of supplanting, displacing, or preempting State law."
     
  • Adding additional Subsection (C) restriction provisions that specifically reference mixtures or articles.
     
  • Adding a new provision at Section 5(c)(6) that explicitly allows manufacture to commence pending development of information if EPA determines the restrictions are otherwise likely to ensure the chemical meets the safety standard.
     
  • At Section 5(c)(7) Commencement of Manufacture, applying the provision to manufacture for a significant new use.

Regarding the determinations required of EPA in reviewing a Section 5 notice (Section 5(c)(3)) or in granting an exemption request corresponding to TSCA Section 5(h)(4), Boxer-Markey uses the same formulations proposed in Lautenberg (i.e., "is/is not likely to meet the safety standard" and "will meet the safety standard," respectively), although, as noted above, different safety standards are applied by the two bills.

Section 6. Safety Assessments and Safety Determinations

Boxer-Markey takes a somewhat different approach to the structure of this section relative to Lautenberg, including retaining TSCA Section 6(b) Quality Control (redesignated as Section 6(m), and proposing several new sections that had appeared in earlier legislative proposals. These include Section 6(f) Expedited Action on PBTs (which seems similar in part to that proposed in Section 32 of the Toxic Chemicals Safety Action of 2010 dropped in the House), and Section 6(l) Asbestos (which would add provisions that appear similar to those in Section 6(k) of the Safe Chemicals Act of 2013 dropped in the Senate). Interestingly, in retaining and redesignating the Quality Control section, Boxer-Markey replaces the term "unreasonable risk" with a new term "significant risks," a change that introduces a new and different regulatory standard unique to this provision (that is, it does not apply the safety standard proposed in Boxer-Markey).

Boxer-Markey does not include references to Section 18 that had appeared in this section in Lautenberg, although Boxer-Markey Section 6(d)(5) does include the Rule of Construction provision noted above in Section 5. In a provision at Section 6(d)(4)(G) concerning regulation of disposal, Boxer-Markey specifies that such a requirement may not require an action in violation of any State law or requirement and also states that each person subject to the requirement must "notify each State and political subdivision in which a required disposal may occur." Boxer-Markey proposes a number of important changes to other provisions in Section 6, including some that fundamentally change the nature of the requirement for cost-benefit analysis, compared to the approach in Lautenberg. The changes include:

  • Boxer-Markey does not include at Section 6(a) the provision at Section 6(a)(2) in Lautenberg that had required EPA within six months of designating a chemical as high-priority to define the scope of the safety assessment and determination to be conducted. Boxer-Markey also would require EPA to complete a safety assessment and determination within two years of designation as high-priority; Lautenberg had allowed three years.
     
  • Boxer-Markey Section 6(b)(1) requires EPA to conduct a "risk-based safety assessment and make a risk-based safety determination" (redlining to show additions relative to Lautenberg). This formulation had been used in S. 1009.
     
  • Boxer-Markey at Section 6(d)(2), which concerns the scope of restrictions rules,
     
    • Adds specific references to "mixture or article" to provisions that in Lautenberg had been limited to "chemical substances," thus explicitly broadening their potential scope.
       
    • Retains the provision in Lautenberg concerning exempting replacement parts manufactured prior to a compliance deadline.
       
    • At Subsection (B), requires compliance dates that are "as soon as feasible practicable...but which shall be no later than 2 years after the date on which the rule is promulgated" (redlining to show change relative to Lautenberg).
       
  • Section 6(d)(4)(H) concerns restriction actions requiring companies to notify downstream customers. In Lautenberg, the required notice concerned EPA's determination that a chemical did not meet the safety standard and it could be required to be given to distributors and to others in the chain of commerce. Boxer-Markey changes the nature of the notice required and also expands the scope of notification, as follows: companies can be required to give "notice of significant risks of harm (without taking into consideration cost or other non-risk factors) to distributors... other persons in the chain of commerce... and to give public notice of such significant risks of harm" (emphasis added).
     
    It is not clear to us who (EPA or each company) judges the significant risks of harm requiring notice nor how the concept of significant risks of harm relates to the safety standard determinations otherwise required under Section 6.
     
  • Section 6(d)(6) Analysis for Rulemaking in Boxer-Markey differs in important ways from the approach proposed in the corresponding section of Lautenberg, including, in particular, the following: whereas Lautenberg had required the analysis to be prepared for any restriction action, Boxer-Markey would limit the requirement to rules that have an annual effect on the economy of more than $100 million.
     
    It is our view that, while some restriction rules that might be taken on chemicals could rise to this level, the effect of this provision is essentially to eliminate the need to consider costs and benefits, regulatory alternatives, and the availability of technically and economically feasible alternatives for almost all restriction actions that might be taken under the Act.
     
  • The approach to Section 6(d)(7) Exemptions in Boxer-Markey differs from that in Lautenberg in important ways, including at Subsection (A)(i)(II), which is reworded and seemingly narrowed as follows: "(II) causing significant disruption in the national economy due to the lack of availability of a chemical substance for the exempted use" (redlining to show proposed addition).
     
  • Boxer-Markey does not include the provision found at Section 6(d)(4)(D) in Lautenberg that had required an additional analysis in the case of a ban or phase-out.

Boxer-Markey Section 6(h) Final Agency Action makes clear that safety assessments, safety determinations, and any associated final rules are considered to be final agency actions. The same approach was proposed in Lautenberg.

Section 8. Information Collecting and Reporting

Although structured somewhat differently from Lautenberg, Boxer-Markey applies the same approaches, deadlines, and requirements in the revised Section 8, except for the following:

  • Boxer-Markey does not propose to revise the scope of the TSCA Section 8(a)(3)(A)(ii)(I) small business exemption for reporting. Lautenberg proposes to modify and broaden this provision to allow EPA to require reporting by small businesses on chemicals that are subject to regulations under Section 5; the TSCA provision had limited this to actions taken under Section 5(b)(4), the so-called "chemicals of concern" list.
     
  • Boxer-Markey does not include the nomenclature provision regarding certain Class 2 chemicals and statutory mixtures that had appeared in both S. 1009 and Lautenberg.

Section 9. Relationship to Other Federal Laws

Boxer-Markey proposes conforming changes to this section that track with those in Lautenberg. Boxer-Markey does not include the new provision proposed in Lautenberg at Section 9(e) Exposure Information, which would require 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 the [EPA]," to make such information available to the relevant Federal authority.

Section 12. Exports

Boxer-Markey proposes a somewhat different structure in certain section designations, although in these provisions the approach seems similar. More importantly, it proposes changes in several provisions regarding mixtures and articles relative to the approach in Lautenberg. Boxer-Markey Section 12(a)(3) Waivers proposes to return to an approach which is similar in some respects to that in TSCA. This provision, which relates to waivers from the Section 12(a)(1) exclusion for any chemical substance, mixture, or article manufactured for export only, as proposed in Boxer-Markey would require EPA in granting a waiver to make specific findings that the "chemical substance as contained in the mixture or article will meet the safety standard" (underlining added to show additions relative to Lautenberg; TSCA also required a finding, although its approach involved a more general unreasonable risk finding). The approach in Lautenberg was more generally worded and had required EPA "determinations."

Boxer-Markey retains the Lautenberg provision at Section 12(a)(4) Testing, which also appears in TSCA Section 12(a), that applies Section 4 testing authority to all chemicals.

Section 13. Imports

While the two bills appear to take the same approach in Sections 13(a), (c), and (d), they differ in Section 13(b) Certifications. Boxer-Markey does not include several provisions in Lautenberg relating to the role of "reasonable inquiry" in determining compliance with this section. For example, Boxer-Markey does not include text found in Lautenberg Section 13(b)(1), as follows (redlining to show Boxer-Markey proposed changes relative to Lautenberg):

...shall certify to the Secretary of Homeland Security that (A) after reasonably inquiry and to the best knowledge and belief of the person, the chemical substance or mixture is in compliance...

Among the other differences, Boxer-Markey does not include:

  • Language proposed in Lautenberg that required EPA to "identify, with reasonable specificity, the types of articles, including parts or components of articles, that will be subject to the certification requirement";
     
  • Several "factors for consideration" proposed in Lautenberg Section 13(b)(2)(C), including those relating to the need to consider the contribution to potential risk and the potential for certification to "impede or disrupt import of articles"; and
     
  • A description of "reasonable inquiry" that was proposed at Lautenberg Section 13(b)(3).

Section 14. Confidential Information

Boxer-Markey devotes 26 pages of text, approximately 15 percent of the entire bill, to the provision related to confidential information (Lautenberg devotes a similarly large percentage of text to this provision). There thus are several new provisions and requirements that would apply to confidential information for companies to understand.

Many of these additions are similar to Lautenberg, including but not limited to the proposed new requirements to:

  • Define more specifically than the current TSCA Section 14 the types of confidential information (e.g., information describing the processes used in manufacture or processing of a chemical substance, mixture, or article; information identifying suppliers or customers; specific production or import volumes);
     
  • Define information not protected from disclosure (e.g., safety assessments developed or safety determinations made under Section 6; general information describing manufacturing volumes);
     
  • Substantiate claims of CBI at the time confidential information is submitted;
     
  • Require EPA to develop guidance on the determination of structurally descriptive generic names, in case of claims for the protection against disclosure of specific chemical identity;
     
  • Require, when claiming chemical identity information, that claims include a structurally descriptive generic name that conforms to EPA guidance;
     
  • Remove CBI protection for information related to substances that are the subject of ban or phase-out actions pursuant to Section 6(d);
     
  • Expand the exceptions to data protected from disclosure to include certain disclosures to States; health and environmental professionals employed by a Federal or State agency, or a treating physician or nurse in a nonemergency situation when certain conditions are satisfied; and a treating physician, nurse, agent of a poison control center, public health or environmental official of a State, or first responder in emergency situations when certain conditions are satisfied;
     
  • Limit the duration of protection from disclosure to ten years, with criteria when that time period can be shortened and criteria when the person asserting the claim can seek to extend that protection for a period not to exceed ten years;
     
  • Require EPA to develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure, including an annually published list of substances for which claims to protect specific chemical identity from disclosure have been approved; and
     
  • Establish a detailed procedure for when EPA denies or modifies a claim for confidential protection.

There also are notable differences between Boxer-Markey and Lautenberg, including but not limited to the following:

  • Boxer-Markey contains a provision not in Lautenberg that describes the "information generally protected from disclosure." In this section, Boxer-Markey provides that information meeting requirements for confidentiality shall be protected, except that: (1) information may still be disclosed in accordance with exemptions from disclosure; (2) information is subject to review and substantiation requirements; and (3) nothing shall operate to prohibit the disclosure of such information through discovery, subpoena, other court orders, or any other judicial process otherwise allowed under applicable state or Federal laws.
     
  • Lautenberg Section 14(b) describes the types of information that are "presumed" to be protected from disclosure. Boxer-Markey Section 14(b) describes similar types of information that are protected from disclosure, but Boxer-Markey does not state that such information is "presumed" to be protected. This distinction may impact the burden companies are faced with for an issue as to how confidential information will be treated.
     
  • One distinction between the types of information that are protected (or assumed to be protected under Lautenberg) relates to the components of a mixture. While Lautenberg would presume to protect "details of the full composition of a mixture and the respective percentages of constituents," Boxer-Markey would protect only "the percentages of the components of a mixture." Thus, under Boxer-Markey, the confidentiality status of information regarding the identities of the components is unclear.
     
  • Another distinction between the types of information that are protected is that under Boxer-Markey, specific identity of a chemical substance can be protected provided, in part, that the substance is not an active substance under Section 8(b)(4). This criterion is not included in Lautenberg.
     
  • Boxer-Markey contains a provision not in Lautenberg stating that, except in certain circumstances, "the specific identity of any chemical that is not on the confidential portion of the list published under section (8)(b)(1) or subsequently added to the confidential portion of the list pursuant to this section shall not be eligible for protection from disclosure."
     
  • Boxer-Markey contains additional circumstances when EPA can review a claim for confidentiality and require the company to withdraw or re-substantiate the claim, notably when EPA received substantial risk information under Section 8(e).
     
  • Boxer-Markey defines "first responder" as "a person duly authorized by a State or political subdivision of a State or Federal agency, trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician."
     
  • Boxer-Markey contains a provision not in Lautenberg that provides that nothing in the bill, or any amendment, regulation, or related action, shall affect the right of a State or a political subdivision of a State to "adopt or enforce any regulation, requirement, standard of performance, safety determination, scientific assessment, or any protection for public health or the environment that is different from, or in addition to, any regulation, requirement, standard of performance, safety determination, or scientific assessment implemented pursuant to this Act."

Section 16. Penalties

Boxer-Markey makes the same changes to this section as proposed in Lautenberg.

Section 18. Preemption

As noted in our discussion of Lautenberg, the issue of preemption has been one of the major controversies throughout all iterations of TSCA reform bills. The controversy continues with the approach proposed in Boxer-Markey, starting with the retention of the TSCA section title "Preemption" rather than Lautenberg's title of "State-Federal Relationship." Boxer-Markey proposes that actions under the Act have no preemption effect on State actions and does this by removing TSCA Section 18(b) Exemption and stating in Section 18(a) that "Nothing in this Chapter shall affect the authority of any State..." Boxer-Markey does include the savings provision that had appeared in Lautenberg but adds a new subsection entitled "No Preemption of State Laws" at Section 18(b)(4).

Section 19. Judicial 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). Boxer-Markey does not propose any substantive changes to the judicial review standard, which is different from Lautenberg that would eliminate this prescriptive definition, and instead apply the "substantial evidence" standard to any material that may be included in the rulemaking record compiled by EPA.

Section 21. Citizens' Petitions

Boxer-Markey proposes a change to the conclusion that a court would need to make in the de novo proceeding concerning a petition to issue a rule under Section 8. Boxer-Markey proposes to require a conclusion that the petitioned reporting or recordkeeping rule is necessary to obtain information relevant to determining whether a chemical may fail to meet the safety standard. In TSCA, this provision had required a conclusion that the action was necessary to protect against an unreasonable risk while Lautenberg had required a conclusion that the action was necessary to protect health or the environment or ensure that the chemical meets the safety standard.

Section 26. Administration

Boxer-Markey proposes a fees provision that differs significantly from that proposed in Lautenberg. In general, the provisions in Boxer-Markey are fewer and much less detailed and nuanced than those presented in Lautenberg. Among the important differences are the following:

  • Whereas Lautenberg Section 26(b)(1):
     
    • Included a one-year deadline for establishing the fee rule, Boxer-Markey has no deadline.
       
    • Used careful language in describing the activities for which a fee could be required from manufacturers and processors, Boxer-Markey would require fees from manufacturers alone.
       
    • Generally referenced the activities for which fees would be intended to defray costs, Boxer-Markey broadens the provision and applies fees to the costs of "administering this title, including but not limited to costs resulting from" an enumerated series of activities.
       
  • Regarding Subsection (2) Apportionment ("Amount and Adjustment of Fees; Refunds" in the corresponding Lautenberg Section 26(b)(3)), Boxer-Markey:
     
    • Apportions fees according to "each manufacturer's production or importation" of chemicals.
       
    • Gives EPA discretion that it "may set separate fees" for small businesses; Lautenberg, on the other hand, requires that EPA must prescribe lower fees for small businesses.
       
    • Instructs EPA to set fees at a level sufficient to enable EPA to perform all the responsibilities in Section 26(b)(1), meet responsibilities required under Section 6, and "add not less than 3 chemical substances" to the high-priority list for each chemical removed.
       
      Lautenberg does not include the "3 for 1" language but does include careful language that provides additional guidance to and requirements of EPA in setting fees. Examples include:
       
      • Setting fees at a level that provides a "sustainable source of funds" to defray approximately "25 percent of the costs... not to exceed $18,000,000";
         
      • Requiring that fees shall reflect an "appropriate balance" between manufacturers and processors; and
         
      • Requiring that EPA, prior to establishing fees, shall consult and meet with parties potentially subject to fees, and others.
         
  • Lautenberg also includes a ten-year sunset on the section unless reauthorized by Congress. This provision is not found in Boxer-Markey.

Section 27. Development and Evaluation of Test Methods

Boxer-Markey does not include the new Section 27(c) Sustainable Chemistry Program (SCP) proposed in Lautenberg.

Title II -- Strengthening Protections for Children and Communities from Disease Clusters

Boxer-Markey proposes a new Title II that does not appear in TSCA or in Lautenberg. The proposal seems similar in part to a provision proposed in the Safe Chemicals Act of 2013 Section 29. Children's Environmental Health Research Program, although the focus in Boxer-Markey is on disease clusters per se rather than children's health.

Title III -- Community Disease Cluster Technical Assistance Grants

Boxer-Markey proposes a new grant-making authority for EPA concerning activities described in the title.


 
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