Regulatory Developments

Safe Chemicals Act of 2013: Lautenberg Reintroduces TSCA Reform Legislation

April 29, 2013 PRINT

As reported in our April 11, 2013, memorandum, on April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act of 2013 (S. 696) (SCA 2013), which would reform the Toxic Substances Control Act (TSCA). Senator Lautenberg's press release noted that the bill is identical to the Safe Chemicals Act of 2011 (S. 847) (SCA 2011), which was reported favorably out of the Senate Environment and Public Works (EPW) Committee on a party-line vote in the 112th Congress on July 25, 2012. Despite the Committee's passage of SCA 2011, Republicans criticized the scheduled markup, particularly in light of Lautenberg's earlier agreement to enter into bipartisan negotiations to create a "fresh legislation proposal" to reform TSCA. A summary of SCA 2013 is available online, and the full text of SCA 2013 is available online. Our April 11, 2013, memorandum is available online. Below is a summary of SCA 2013, noting key differences between Lautenberg's current bill and predecessor versions. The current Lautenberg bill is 256 pages long (SCA 2011, as introduced, was 182 pages).

Section 3. Findings, Policy, and Goal -- SCA 2013 did not revise Section 3 from that which existed at the time of the July 2012 hearing and Committee vote. The key changes in SCA 2013 from the Safe Chemicals Act of 2010 (S. 3209) (SCA 2010) (including changes made in SCA 2011) are as follows:

  • All references to "mixtures" have been deleted from this Section of the bill. Although this appears to be an important change, it is largely undone by Section 26(c)(3) in SCA 2011, which states that "any action authorized or required to be taken by the Administrator or any other person under any provision of this Act... is likewise also authorized or required with respect to a mixture, if the Administrator determines that such extension is reasonable and efficient" (emphasis added). The net effect of the new language at Section 26(c)(3) is to provide the U.S. Environmental Protection Agency (EPA) authority to extend all authorities and requirements under the Act to mixtures (this would include, for example, the following statutory requirements and EPA authorities: Section 4 Minimum Data Set; Section 5 new chemical notifications; Section 6 prioritization and safety standard determinations; Section 8 declarations; etc.) after making a determination that such an extension is "reasonable and efficient" -- terms not clearly defined in the bill.
     
  • In Section 2(c) on "Goal," the new bill retains S. 3209 language with an important change as shown:
     
    The effect is to specify that while the goal includes reviewing all chemical substances, it does not include determining whether all chemicals meet the safety standard.
     
    1. reviewing all chemical substances for safety and identifying the highest priority chemical substances for expedited review;
       
    2. determining whether all chemical substances in commerce meet the safety standard under this title.
       

Section 4: Definitions -- Section 3 of SCA 2013 is essentially identical to SCA 2010 and 2011. Key definitions in SCA 2013 in comparison to TSCA are as follows (numbers in parentheses identify the placement of the definitions discussed; note also that this section has retained discussion on important changes arising in earlier versions of the SCA):

  • The definition for "adverse effect" that appeared in SCA 2010 has been dropped, although the term is still used in SCA 2013, including in several definitions.
     
  • "Aggregate exposure" (2) is defined to include all sources of exposure, including exposures derivative of non-TSCA uses (uses subject to the Federal Food, Drug, and Cosmetic Act (FFDCA), for example), notwithstanding that regulating cosmetic chemical exposures using TSCA has not been discussed over the years.
     
  • The term "bioaccumulative" (3) would be defined as "the chemical substance or mixture, as determined by the Administrator, can significantly accumulate in biota, as indicated through monitoring data, or is highly likely to accumulate in biota, as indicated by other evidence." This is a change from SCA 2010, which cross-referenced EPA's policy statement on "Persistent, Bioaccumulative and Toxic" (PBT) chemicals, and the new requirement that the term includes a chemical-specific determination (as opposed to meeting specific criteria as appeared in EPA's Policy Statement) seems to both expand the possible meaning and to be tied to the way that PBTs are treated under Section 6 in the draft bill.
     
  • The definition for "chemical identity" (4) no longer includes provisions concerning mixtures, but see below where new Section 26(c)(3) grants EPA authority to extend authorities and requirements to mixtures if the Administrator determines that "such extension is reasonable and efficient."
     
  • The definition for "chemical substance" (5) deletes the reference to "articles" that appeared in SCA 2010 but retains the provision allowing the Administrator to determine, notwithstanding molecular identity, that a variant of a chemical substance is a new chemical substance (of key significance to the nano community).
     
  • The term "cumulative exposure" (7) is defined to refer to aggregate exposures from multiple chemicals that "are known or suspected to contribute appreciably to the risk of the same or similar adverse effect" (the italicized text is an addition to the SCA 2010 definition and has the effect of broadening the meaning, especially as "similar" adverse effects are not explicitly defined).
     
  • Consistent with SCA 2010, the definitions for terms "distribute in commerce" (8) and "distribution in commerce" would be expanded to include the export or offer for export of the substance, mixture, or article.
     
  • Consistent with SCA 2010, "environment" (10) would be defined to include "ambient and indoor air."
     
  • Consistent with SCA 2010, a "new chemical substance" (15) would be defined as one "for which the manufacturer or processor of the chemical substance has not submitted a declaration" (the use of "the" has the effect of extending this requirement to each manufacturer or processor of the new chemical).
     
  • The term "persistent" (16) would be defined as "the chemical substance or mixture, as determined by the Administrator, significantly persists in 1 or more environmental media, as indicated by monitoring data or other evidence." This is a change from SCA 2010 which cross-referenced EPA's policy statement on PBT chemicals, and the new requirement that the term includes a chemical-specific determination (as opposed to meeting specific criteria as appeared in EPA's policy statement) seems to both expand the possible meaning and to be tied to the way that PBTs are treated under Section 6 in the draft bill.
     
  • The definition of "reasonable certainty of no harm" from SCA 2010 is no longer included, although the term (slightly modified to "reasonable certainty that no harm will result") is still used in the Section 6 safety standard. The SCA 2010 definition had included the concept of "negligible risk of any adverse effect" in the definition, which seemingly clarified the meaning of "no harm."
     
  • The definition for "special substance characteristic" has been retained, including considerations for size or size distribution; shape and surface structure; reactivity; and any other properties that may significantly affect the risks posed (again, of key significance to the nano community). For more information, see our blog.
     
  • While generally consistent with SCA 2010, the definition of "vulnerable human population" is clarified to make clear that only "human populations" are included. The term includes explicit subcategories similar to SCA 2010 such as "workers that work with chemical substances and mixtures" and "members of any other appropriate population identified by the Administrator."
     

Section 5: Minimum Information Sets and Testing of Chemical Substances -- SCA 2013 discusses "information" while SCA 2010 and SCA 2011 used the term "data." Section 4 of TSCA would be revised as follows:

  • By rule, EPA is to establish Minimum Information Sets, which involve "varied or tiered information," identify the "particular minimum information set that applies to a chemical substance," and specify that each Minimum Information Set includes "sufficient information" to categorize and conduct screening-level risk assessments for both new and existing chemicals.
     
    • SCA 2013 requires Minimum Information Sets (changed from "set" in SCA 2010 and SCA 2011) to include the minimum amount of information necessary for the Administrator to conduct a "screening-level risk assessment of the chemical substance, including information on the characteristics, toxicological properties, environmental and biological fate and behavior, exposure, and use of a chemical substance" (SCA 2010 had tied the Minimum Data Sets requirement to a data set that "will be useful in conducting safety standard determinations" under Section 6 -- thus SCA 2013 would significantly reduce the purpose that must be met by the Minimum Information Sets in comparison to SCA 2010). In addition, the revised bill makes clear that "varied or tiered data" requirements can be used and that EPA shall "identify the particular minimum data information that applies" to a chemical substance. The net result is to provide substantially greater flexibility to EPA in developing the Minimum Information Set requirements.
       
    • SCA 2013 revised Section 4(a)(1)(B) on the information types to be required in the Minimum Information Sets to also include:
       
      • "[E]nvironmental and biological fate and behavior (subsection (iii));
         
      • It also required EPA to "specify information quality and reliability requirements" (subsection (iv)); and
         
      • It also softened the animal welfare language at subsection (v) to "encourage and facilitate accommodate the use of alternative testing methods and testing strategies to generate information quickly, at low cost, and without the with reduced use of animal-based testing, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening."
         
  • Section 4(a)(2) of SCA 2013 would require "each manufacturer and processor" to submit the Minimum Information Set for the chemical. The effect of the language is seemingly to impose an individual requirement for submitting the Minimum Information Set on each manufacturer and processor. The requirement is likely to increase the implementation complexity of meeting the Minimum Information Set requirement and the need for "each manufacturer" and "each processor" to meet the requirement has an effect similar to a registration requirement (until a person has submitted the Minimum Information Set for a particular chemical substance, any manufacture or processing of the chemical substance by that person would be in violation of this requirement). This is significant and seems to increase significantly the scope and effect of the requirement to submit a Minimum Information Set and could be viewed as counter-balancing the flexibility otherwise seen in the Section 4(a)(1) changes in comparison to SCA 2010. It is also likely to increase significantly the burdens on EPA in addressing requests for exemptions from the Minimum Information Set, as well as reimbursements for Minimum Information Set testing.
     
  • Whereas SCA 2010 had required the Minimum Data Set on existing chemicals be submitted within the earlier of 18 months after the date on which the substance is assigned to a Section 6 priority class, or five years after the date of enactment, under SCA 2013, the Minimum Information Set would be required at the time of filing notifications for new chemicals (which continues the bias that was identified against new chemicals seen in SCA 2010 and SCA 2011) and, for an existing chemical, as required under Section 6 or by the Section 4(a)((1)(A) rule.
     
  • The text in the remaining parts of this section largely tracks the approach found in SCA 2010, including giving EPA authority to require, by rule or order: testing "as appropriate for making any determination or carrying out any provision of this Act"; and submission of samples. In determining these testing requirements and the period for submission, EPA is required to consider relative costs and the availability of facilities and personnel to do the required testing.
     

Section 6: Manufacturing and Processing Notices -- Section 5 of TSCA would be revised as follows:

  • Whereas SCA 2010 had extended the new chemical notification requirements to mixtures, this had been deleted in the original version of SCA 2011 and the change was retained in SCA 2013 (thus mixtures would not be subject to requirements under Section 5). At the same time, as noted above, Section 26(c)(3) gives EPA authority to extend such requirements to mixtures, a change that largely undermines the significance of the change made regarding mixtures under this section of the bill.
     
  • SCA 2011, as originally introduced, would, under Section 5(b)(1), require a new chemical notification of any person manufacturing or processing a new chemical. SCA 2013 (and the version of SCA 2011 that passed the Committee) revised this to require notification prior to manufacture of a new chemical and, for processing, limits this to processing a chemical for a use that is proposed to meet the Section 6(h)(2)(B) criteria for a critical use exemption.
     
  • In an important change that was seen in the Committee-approved version of SCA 2011, EPA's new chemical review determination is to be made "not later than 90 days" after receipt of the notification and the determination has been broadened and softened somewhat to involve a finding that the new chemical is "likely to meet the safety standard under Section 6(d); in SCA 2011, the new chemical had to "meet" the standard. In the case of critical use exemption requests, approval is contingent on the notifier establishing "by clear and convincing evidence" that the chemical meets the critical use exemption criteria. The Committee-approved version and SCA 2013 also deleted several "expectations" regarding production volume, release, toxicity, and related factors that EPA would otherwise have had to consider.
     
  • SCA 2013, and the Committee-approved version of SCA 2011, would amend TSCA Section 5(b)(2) to create several categories of substances and require EPA to promulgate within one year a rule that "specifies the process and criteria the Administrator will use to categorize new chemical substances." In categorizing a new chemical, EPA is to consider a variety of information, including that in the notification or that is otherwise accessible to EPA (including from "another jurisdiction," perhaps intended as a reference to the European Union (EU)), the results of "validated" structure-activity relationship or other models, and other related information.
     
  • SCA 2013 creates the following categories and outcomes for new chemicals:
     
    • Very high concern (VHC) -- PBT or highly hazardous (note "hazardous," NOT "risky") -- these can be made only in accord with the critical use exemption;
       
    • Likely to meet the safety standard -- Can be made/used subject to any EPA conditions;
       
    • Very low concern (VLC) -- To qualify, EPA must determine that the chemical possesses "intrinsic low-hazard properties";
       
    • Substances to undergo safety standard review -- Those that are not VHC or VLC, during which time manufacture/use is in accord with EPA requirements intended to ensure the new chemical meets the safety standard;
       
    • Insufficient information chemicals -- Need to submit more information and are out of commerce until requirements have been satisfied and the chemical has been recategorized; and
       
    • Unlikely to meet safety standard -- Cannot be manufactured.
       
  • SCA 2013 Section 5(c) addresses new uses of existing chemicals and, in so doing, considers whether a safety standard determination has been made on the existing chemical.
     
    • For existing chemicals prior to a safety standard determination, no person can manufacture or process the chemical for a use that was not ongoing or a volume that is "significantly increased" from that on the date of enactment unless a notice has been submitted to EPA by "the person" and EPA has determined that the use/volume is likely to meet the safety standard.
       
    • For existing chemicals that have been the subject of a safety standard determination, new uses, increased volumes, or changes in practices from those specified by EPA require notification by "the person" to EPA for a use that was not ongoing or a volume that is "significantly increased" from that on the date of enactment. The purpose of the notice is to establish that the chemical will continue to meet the safety standard. Following its review (and within 180 days of receipt), EPA is to determine whether the new use/volume is likely to meet the safety standard (this timeline can be extended for a period not to exceed one year).
       
  • SCA 2013 Section 5(d) establishes requirements for submission of a notice of commencement (which is considered equivalent to a declaration under Section 8(b)(2)). It also explicitly allows withdrawal of a notice prior to commencement.
     
  • SCA 2013 Section 5(e) considers chemicals exhibiting "special substance characteristics" and such chemicals are required to meet EPA's conditions per rule or order, or, if found to be a "distinct chemical substance," must meet new chemical notice requirements.
     
  • SCA 2013 Section 5(h) introduces several exemptions that did not appear in prior versions of the SCA, including:
     
    • "Intrinsically safe substances" -- Requires a determination by EPA that the chemical "does not and would not pose any risk of injury to human health or the environment under any intended or reasonably anticipated levels of production, patterns of use, or exposures arising at any stage across the lifecycle of the chemical substance" (emphasis added). Consideration of exposure is explicitly excluded from the determination. While it would seem virtually impossible to meet the multiple "any" criteria, if EPA is satisfied, it may grant the exemption (or a subset of the request) by order.
       
    • Prior exemptions granted by EPA under TSCA Section 5(h)(4) (including polymer exemptions) need to be reviewed by EPA within 180 days of enactment to determine if an exemption is "appropriate under this section" and subject to any additional EPA requirements. Former polymer exemptions must submit a notice of commencement and EPA determines if an exemption is "appropriate." While SCA 2013 addresses the issue of existing exemptions, the approach seems excessive and, considering the number of such exemptions in existence (likely thousands), seems to set an impossible timeline.
       

Section 7: Batching, Categorization, Prioritization, Safety Standard Determination, and Risk Management -- Section 6 of TSCA would be revised as follows:

  • Under SCA 2011, prioritization for safety determinations was based on production volume, use, hazard, exposure information, and related considerations, and a series of priority classes was created. SCA 2013 takes a different approach and would establish a complex sequential process involving batching of chemicals to create an "efficient and orderly process," categorization to separate chemicals into categories similar to those under the new Section 5, and a prioritization process to tee up chemicals for review, development of the safety determination, and subsequent risk management.
     
  • The first batch would be created by EPA within 270 days after enactment and every five years thereafter until all chemicals on the "active inventory" (see SCA 2013 Section 8(h)) have been batched.
     
  • Not later than one year after enactment, EPA shall promulgate regulations establishing categories and the process and criteria used to create them, as well as the process and criteria that will be used to prioritize chemicals for safety determination. In making categorization and prioritization decisions, EPA is required to use the information available to it and manufacturers and processors, among others, can submit information not available to EPA. The first set of categorizations is to be published 180 days after the regulation establishing categories and the prioritization process, with subsequent sets every 180 days thereafter. The first prioritization class assignments are to be published 270 days after the date of the first categorization and 270 days after the subsequent categorization decisions.
     
  • SCA 2013 would create the following categories (which are similar to those for new chemicals) and process:
     
    • VHC -- VHCs are substances having widespread exposure and which are PBTs, highly hazardous (not risk), or regulated under Section 6. The Section 4 Minimum Information Set is not required to be submitted for these chemicals. VHC chemicals have a shorter timeframe for EPA's risk management decision (following identification as VHC, EPA within one year is to complete its assessment of the known uses and exposures and, "as soon as practicable, but not later than 18 months" after VHC identification must issue an order to achieve "maximum practicable reduction" in exposure (Section 6(e)(A)). The order takes effect 18 months after its issuance, although EPA can grant a one-time extension of not longer than five years if the company can make certain showings concerning "compelling technological need" or "factors wholly beyond the control" of the company. EPA is then required to complete a safety standard determination of the "residual risk" not later than one year after the deadline specified per the above process and impose any additional conditions needed to ensure the chemical meets the safety standard.
       
    • VLC -- VLCs are substances that have intrinsic low hazard. A Section 4 Minimum Information Set is required unless EPA determines it is not needed based on "high degree of confidence" in the otherwise available information. EPA can require additional information to be developed if there is conflicting information or ambiguity.
       
    • Chemicals to undergo safety standard determination -- Chemicals that do not meet the criteria for VHC or VLC will undergo a safety standard determination if and when sufficient information is available to inform prioritization.
       
      • The criteria for prioritization of such non-VHC/VLC chemicals include "potential" hazard and exposure:
         
        • Priority Class (PC) 1 -- Chemicals that have "relatively greater hazard potential" and "evidence of more significant or widespread exposure," and which are determined by EPA to warrant a safety standard determination in the short term. Section 6(d)(4) specifies that the safety standard determinations for the first set of PC1 chemicals are to be completed within five years of enactment; safety standard determinations on subsequent batches of PC1 chemicals are also to be completed within five years of designation.
           
        • PC2 -- Determined by EPA to be of lower priority than PC1. The Section 4 Minimum Information Set is due within five years followed by reprioritization, after which the chemical may be designated PC1 and the schedule described therein applied.
           
        • PC3 chemicals are to be completed after PC1 and PC2 safety standard determinations have been completed or if priority changes. The Section 4 Minimum Information Set is not required until the chemical is elevated to PC1/PC2; after the Section 4 Minimum Information Set is received, the chemical will be reprioritized.
           
      • Chemicals with insufficient information -- Development of a Section 4 Minimum Information Set will be required within five years for chemicals that lack sufficient quality information, after which the chemical will be recategorized.
         
  • Consistent with SCA 2010 and SCA 2011, SCA 2013 Section 6(c)(1) states that EPA decisions on batches, categories, and prioritizations are not final agency actions and are not subject to judicial review.
     
  • SCA 2013 Section 6(d) discusses the safety standard determination process for PC1 chemicals under which:
     
    • Industry "shall at all times bear the burden of proof in any legal proceeding" regarding whether a chemical meets the safety standard. In what seems to be a subtle but important change compared to SCA 2010, Section 6(d)(5) of SCA 2013 (as did SCA 2011) would not require that EPA assess whether industry has met its burden of proof; rather it would require that EPA determine whether the manufacturers and processors have established that the chemical meets the safety standard;
       
    • It shall be a "duty" of the manufacturer or processor to provide sufficient information to EPA to determine if the safety standard is met; and
       
    • A chemical can be manufactured, processed, or distributed in commerce if EPA determines that the chemical or specific uses of the chemical, considering any conditions or controls imposed, meet the safety standard.
       
  • In making a safety standard determination, EPA under SCA 2013 Section 6(d)(B):
     
    • Shall base the determination solely on consideration of human health and the environment, including the health of vulnerable populations;
       
    • Shall to the extent practicable consider the effect of cumulative exposure; and
       
    • Can find that a chemical meets the safety standard "only if the Administrator finds that there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance."
       
  • SCA 2013's proposed standard is similar to the one contained in the House bill for the Toxic Chemicals Safety Act from the 111th Congress. Relative to that bill, SCA 2013 would delete the need to consider the life-cycle of the chemical but is otherwise generally similar. The revised bill makes explicit that the standard is based "solely" on health and the environment and that the standard is met "only" if there is a reasonable certainty that no harm will result from aggregate exposure (as defined in Section 3(2)).
     
  • EPA is to use the "best available science" and apply the National Academy of Sciences' recommendations from "Science and Decisions." The methodology is to be reviewed and be revised to reflect new scientific developments every five years. The assessment is to consider "potential or demonstrated cancer and noncancer endpoints," and the risks in the United States involving long range environmental transport of the chemical or the import of articles or mixtures containing the chemical.
     
  • EPA is to consider all available information and can require, by rule or order, that manufacturers or processors develop any additional information needed to conduct the safety determination. EPA is to take into consideration "but not rely on" assessments of safety or of the effectiveness of existing control measures.
     
  • A determination by EPA that the manufacturer or processor has not shown that the chemical meets the safety standard shall not be subject to judicial review.
     
  • In cases where EPA fails to meet the timelines specified for completion of the safety standard determination, "each manufacturer and processor" of a chemical is required to provide the public, employees, and their recognized bargaining agents, and each known customer with a written notice that the determination is pending.
     
  • Per proposed Section 6(d)(5) of SCA 2013, the outcomes following completion of the safety standard determination include:
     
    • A "positive safety standard determination," with or without conditions, shall be issued by order and include the allowed uses (which are limited to those evaluated in the determination), and any conditions on the specified uses (Section 6(d)(5)(B) and (C)).
       
      • The effective date of the determination order is 90 days if no new conditions are imposed and 18 months if new conditions are required (this can be extended one time for a period not to exceed five years if the company can meet specified showings involving "compelling technological need[s]" or "factor[s] wholly beyond the control" of the company).
         
    • EPA is required to initiate a redetermination if information or changes "raise a credible question as to whether the chemical" continues to meet the safety standard; and may initiate a redetermination if there are significant changes in methodologies or in response to a petition.
       
  • A "negative safety standard determination" (Section 6(d)(5)(F)) shall take effect 18 months after the determination is made after which no person shall manufacture, process, or distribute the chemical. EPA can grant a manufacturer or processor a one-time extension for a period not longer than five years if the company meets the showings discussed in regard to Section 6(d)(5)(B) and (C), above.
     
  • Section 6(f) of SCA 2013 concerns the Risk Management actions that EPA can impose by order. The available actions are very broad and encompassing.
     
  • Section 6(g) of SCA 2013 discusses Quality Control Orders and applies a scheme very close to that in TSCA Section 6(b)(2).
     
  • Section 6(h) of SCA 2013 considers Exemption to Restrictions and Section 6(h)(2) describes the process by which a person may request an exemption from a restriction for a "specified use" of the chemical. EPA may grant the exemption for "the use" of the chemical if it meets the following criteria:EPA may grant the exemption for one or more additional five-year periods if the chemical continues to meet the criteria.
     
    • The exemption is "in the paramount interest of national security";
       
    • The lack of availability of the chemical "would cause significant disruption in the national economy"; or
       
    • The use for which the exemption is sought is "critical or essential" and there is "no feasible safer alternative" or the use provides "substantial net benefit."
       
  • Section 6(h)(4) provides some additional timing flexibility if the restrictions would otherwise affect articles sold to consumers.
     
  • Section 6(j) concerns restrictions on mercury.
     
  • Section 6(k) requires EPA to designate asbestos as a VHC substance within 90 days of enactment and requires that actions be promptly completed to regulate the substance.
     

Section 9: Reporting and Retention of Information -- Section 8 of TSCA would be revised as follows:

  • Section 8 of SCA 2013 largely tracks the provisions found in SCA 2011.
     
  • Section 8(b)(2) requires declarations be submitted within 180 days of enactment by the manufacturer or processor of chemicals in commerce at enactment or chemicals of "potential commercial interest" (must be a substitute for a chemical of current interest). Companies can also submit declarations of cessation of manufacture or processing under Section 8(b)(4) (these will go on the inactive inventory as discussed below).
     
  • Section 8(c) of SCA 2013 requires periodic reporting by manufacturers. The requirements are to be implemented by rulemaking not later than 180 days after enactment and allows for certain exemptions.
     
  • Section 8(d) of SCA 2013 requires recordkeeping to support declarations and periodic reports.
     
  • Section 8(e) of SCA 2013 describes substance identification and information requirements for processors and also allows for exemptions.
     
  • Section 8(g)(1)(A) of SCA 2013 provides rule and order authority to EPA to require any person who "manufactures, processes, distributes in commerce, uses, or disposes of" a chemical substance, or a mixture or article containing the substance, to maintain records and submit information that would assist EPA in any of a variety of activities, including making a safety standard determination, determining testing or information needs, assigning a chemical to a batch, category, or priority class, implementing risk management conditions, assessing hazards, exposures, and risks, and related considerations.
     
  • Section 8(g)(1)(B) of SCA 2013 gives EPA authority to require by rule or order reporting regarding chemical identity and special substance characteristics.
     
  • Section 8(g)(2) provides for a small quantity exemption (as under current TSCA) and an exemption for small businesses. The latter is more narrowly drawn than in current TSCA as it "may exempt certain small businesses" if EPA determines that their participation would not assist in administration of the Act.
     
  • Section 8(h) establishes an "active" inventory and an "inactive" inventory. The former includes chemicals that were the subject of declarations or a notice of commencement of manufacture under Section 5. The inactive inventory concerns chemicals for which a declaration of cessation of manufacture was the only submission(s) received. Companies can notify EPA of their intention to commence manufacture or processing of an inactive chemical by providing certain information, after which EPA must move the chemical to the active inventory and add the chemical to the current batch of chemicals pursuant to Section 6(a) and prioritize the chemical pursuant to Section 6(b).
     
    • This latter aspect is an improvement over earlier versions that would have required a notice under Section 5 and EPA review before commencing manufacture or processing of an inactive chemical.
       
  • SCA 2013 also includes sections based on TSCA Section 8(c) ("allegations"; new Section 8(j)) and 8(e) ("substantial risk"; new section 8(l)), and various other requirements relating to other federal agencies, administration of the Act, and related requirements. Section 8(m) requires that certifications accompany each submission under Section 8.
     

Section 10: Relationship to Other Federal Laws

  • Section 9 of TSCA is retained with some conforming changes in SCA 2013.
     

Section 11: Inspections and Subpoenas

  • Under TSCA Section 11, the following are specifically excluded from inspection: financial data; sales data (other than shipment data); pricing data; personnel data; or research data. Section 11 of SCA 2013 does not include similar exclusions, however. Instead, the scope of an inspection "shall extend to all things within the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) regarding whether the owner or operator of the premises, conveyance, or records has complied with provisions of this Act applicable to the chemical substances, mixtures, articles, or records."
     

Section 12: Exports

  • Whereas SCA 2010 had deleted TSCA's export notification requirements for actions taken under Section 4 of TSCA, SCA 2013 (as did SCA 2011) would add back the requirement for export notifications if a chemical is subject to data submission requirements. This seems to be a significant change that would appear to require export notifications on all chemicals subject to the Section 4 Minimum Information Set (recall, however, that SCA 2013 modified the Minimum Information Set requirements such that they apply to chemicals when certain conditions have been met (new chemicals, certain chemicals identified for batching and prioritization, and related conditions)). Section 12 of SCA 2013 otherwise seems to follow the TSCA provisions.
     

Section 13: Entry into Customs Territory of the United States

  • TSCA Section 13 of SCA 2013 would be amended to include an important new provision regarding import as part of an article (Section 13(a)(3)): "Chemical substances and mixtures imported as part of an article shall be subject to the same requirements under this Act as if the substances and mixtures had been imported in bulk, except as the Administrator may provide by rule under this Act, or as the Secretary of Homeland Security may provide by rule." This requirement for substances and mixtures imported as part of an article would thus apply all statutory obligations to such substances in imported articles (including, e.g., submission of a Section 4 Minimum Information Set, new chemical notification, Section 8 declaration, and related obligations) unless and to the extent such requirements have been excluded by rule.
     

Section 14: Disclosure of Data

  • SCA 2011, as approved by the Committee, would create certain categories of information, and SCA 2013 includes these same categories:
     
    • Information that is always eligible for protection: This category would include precise information describing the manufacture, processing, or distribution of a chemical substance or mixture; marketing and sales information; information identifying the customers of a manufacturer, processor, or distributor; details of the full composition of a mixture of a particular manufacturer or processor; precise information about the use, function, or application of a chemical substance or mixture in a process, mixture, or product of a particular manufacturer or processor; and precise production or import volumes of a particular manufacturer, processor, or distributor;
       
    • Information that may be eligible for protection -- Identities of certain chemical substances claimed as confidential and impurities. Confidentiality claims would not be allowed for the identities of substances that are known or probable reproductive, developmental, neurological, or immunological toxicants, carcinogens, or mutagens, or PBTs; and
       
    • Information that is never eligible for protection: Except as provided above, the Administrator shall disclose the following information:
       
      • The identity of a chemical substance;
         
      • Any safety standard determination developed under Section 6, including supporting analysis developed by the Administrator;
         
      • Any health and safety study data that is submitted with respect to: (1) any chemical substance or mixture that has been offered for commercial distribution as of the date on which the study is to be disclosed, or for which testing is required under Section 4 or for which notification is required under Section 5; and (2) any data reported to, or otherwise obtained by, the Administrator from a health and safety study that relates to a chemical substance or mixture described in (1);
         
      • Health and safety data in notices of substantial risk submitted pursuant to Section 8(l) and in the underlying studies;
         
      • General information describing the manufacturing volumes, expressed in ranges, and industrial, commercial, or consumer functions and uses of a chemical substance or mixture;
         
      • Any information indicating the presence of a chemical substance in consumer products intended for use, or reasonably expected to be used, by children aged 14 years or younger, if:
         
        • The Administrator, or another authoritative body, has determined that the chemical substance is a known or probable reproductive, developmental, neurological, or immunological toxicant, carcinogen, or mutagen; or is PBT; or
           
        • For a chemical substance for which a safety standard determination has been made, the Administrator has not found that the chemical substance meets the safety standard.
           
  • Under the bill, no later than one year after the date of enactment, the EPA Administrator would identify by rule those types of information for which the Administrator shall not prospectively specify the term of confidentiality.
     
  • The provision allowing manufacturers, processors, or distributors to designate data believed to be entitled to confidential treatment does not limit the authority of the Administrator to determine that particular information, previously considered entitled to confidential treatment, is no longer entitled to such treatment.
     
  • The bill would amend TSCA to allow that, if the EPA Administrator determines that the release of confidential data is necessary to protect against an "imminent and substantial endangerment to health or the environment," then no notice is required. TSCA Section 14(c)(2)(B)(i) currently allows EPA to release confidential data if the Administrator determines that the release is necessary to protect against an "imminent, unreasonable risk of injury to health or the environment," using such means as the Administrator determines will provide at least 24 hours notice before such release.
     
  • The bill would clarify that confidential business information (CBI) may be shared with state governments if "1 or more applicable agreements ensure that the recipient government will take appropriate steps, and has adequate authority, to maintain the confidentiality of the information."
     
  • The bill contains a catch-all provision that clarifies the Administrator retains the authority to determine that certain information previously determined as eligible for CBI treatment is no longer subject to such protection.
     

Section 18: Preemption

  • While SCA 2010 included a preemption provision, the provision had been completely rewritten and seemingly narrowed in SCA 2011 and this version has been retained without change in SCA 2013:
    Nothing in this Act affects the right of a State or a political subdivision of a State to adopt or enforce any regulation, requirement, or standard of performance that is different from, or in addition to, a regulation, requirement, liability, or standard of performance established pursuant to this Act unless compliance with both this Act and the State or political subdivision of a State regulation, requirement, or standard of performance is impossible, in which case the applicable provisions of this Act shall control.

Section 19: Judicial Review

  • SCA 2011, as approved by the Committee, and SCA 2013 would change the standard of review. Currently, for TSCA rulemakings under Sections 4(a), 5(b)(4), 6(a), or 6(e), the court must find that the rule is not supported by substantial evidence in the rulemaking record taken as a whole. SCA 2013 would revise TSCA so that courts would review challenges in accordance with the Administrative Procedure Act, under which courts would set aside rulemakings found to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."
     

Section 21: Citizens Petitions

  • TSCA Section 21 has been retained with conforming changes in SCA 2013.
     

Section 23: Administration of TSCA

  • Section 26(b) of SCA 2013 includes new fee language whereby EPA can by rule require fees to defray the cost of administering the Act.
     
  • As noted above, the bill would amend TSCA Section 26(c) to add the following provision, which would greatly expand the scope of the bill and EPA's jurisdiction:
    MIXTURES. -- Any action authorized or required to be taken by the Administrator or any other person under any provision of this Act with respect to a chemical substance is likewise also authorized or required with respect to a mixture, if the Administrator determines that such extension is reasonable and efficient.

Section 29: Children's Environmental Health Research Program

  • Section 29 would establish within 90 days of enactment, a Children's Environmental Health Research Program to provide independent advice, expert consultation, and peer review regarding scientific and technical aspects relating to implementation of the Act regarding research on protecting children's health. The Act creates an Interagency Science Advisory Board on Children's Health Research. Section 29(c)(1) states that biomonitoring studies can be conducted by EPA on chemicals that may be present in humans and that may have an effect on human development. If a chemical is "determined to be present" in such a study, information on uses and presence in articles must be reported by manufacturers and processors of the chemical.
     

Section 30: Reduction of Animal-Based Testing

  • SCA 2013 Section 30 would require EPA to minimize the use of animals in testing of chemical substances or mixtures by encouraging the use of existing data, grouping of chemical substances for testing, formation of industry consortia to reduce redundancy, use of existing methods that eliminate or reduce the use of animals, and the development and validation of emerging methods and models. SCA 2013 also proposes to establish an Interagency Science Advisory Board on Alternative Testing Methods and develop a strategic plan to provide independent advice and peer review on scientific and technical aspects of the issue and to develop a strategic plan to promote alternative methods.
     

Section 31: Safer Alternatives and Green Chemistry and Engineering

  • This section would require EPA, within one year of enactment of SCA 2013, to create market incentives for development of safer alternatives to existing chemicals that reduce or avoid the use and generation of hazardous substances. New chemical substances that a manufacturer or processor claims are safer alternatives would receive expedited review. The program also would require recognition efforts and the development of other incentives to encourage development, marketing, and use of chemicals or products that EPA determines are safer alternatives for the particular use. The examples of incentives given are job training and worker assistance. SCA 2013 would require the establishment of a Green Chemistry Research Network, consisting of not less than four regional green chemistry and engineering centers, to support the development and adoption of safer alternatives to existing chemicals, particularly those listed under SCA 2013 Section 6(a).
     
  • This section would authorize EPA to promote safer alternatives and would create a Green Chemistry Workforce Education and Training Program. The goals of the Program would be to provide workforce training on skills that would: (1) facilitate the expansion of green chemistry; (2) develop scientific and technical leadership in green chemistry; (3) facilitate the successful and safe integration of green chemistry into infrastructure projects; (4) inform and engage communities about green chemistry; and (5) promote innovation and strong public health and environmental protections. EPA would implement the Program by helping to develop a broad range of skills relevant to the production and use of such safer alternatives, including their design, manufacturing, and use and disposal; develop partnerships with educational institutions, training organizations, private sector companies, and community organizations; and provide grants to state and local governments and to the partnerships established to promote and support activities consistent with achieving the goals of the Program.
     

Section 32: Cooperation with International Efforts

  • This section would require EPA to cooperate with international efforts to develop a common protocol or electronic database for chemical substances and mixtures or to develop safer alternatives for chemical substances.
     

Section 33: Reliable Information and Advice

  • This section requires EPA to establish and implement by order procedures to ensure data reliability, including random inspections of laboratories, annual comprehensive data audits on a subset of the submissions received, and similar requirements.
     

Section 34: Hot Spots

  • Section 34 would require EPA to identify, assess, and develop action plans to address any "disproportionate exposures" of residential populations in localities to chemical substances or mixtures. "Disproportionate exposure" is defined as "residential population exposure to 1 or more toxic chemical substances or mixtures at levels that are significantly greater than the average exposure in the United States." The term "locality" is broadly defined. EPA would be required within 180 days of enactment of SCA 2013 to promulgate a rule to establish criteria to define disproportionate exposure and identify any locality that is disproportionately exposed. Section 34(c) requires EPA, 120 days after promulgation of the rule, to identify, using available information and public nominations, "localities in the United States that are subject to disproportionate exposure." EPA, after notice and consultation with state and local officials, would then be required to publish a list of the localities subject to disproportionate exposure. Within one year of publishing or updating that list (such updating is required at least every five years), EPA would be required to develop and publish an action plan for each identified locality that identifies the chemical substances and mixtures contributing to the disproportional exposure. The goal of each action plan "shall be" to reduce disproportionate exposures by establishing percentage exposure reduction goals for each chemical and mixture and a timeline to reach the percentage exposure reduction goal. EPA also would be required to provide to Congress an annual report identifying the localities, providing the action plans, and describing the progress on each action plan to date.
     
    Pursuant to Section 34(e), many of the steps described above shall not be subject to judicial review, including: a decision to identify a locality to be included on the list; a decision in response to nominations submitted; and a decision to list localities or update the list. Under SCA 2013, the failure of EPA to publish the list of localities or update the list shall be considered to be a failure to perform a nondiscretionary duty, and thus subject to judicial review.
     

Section 35: Application of This Act to Federal Agencies

  • This section would apply "all applicable requirements" under the Act to federal agencies and their employees, in the same manner and to the same extent as for any person subject to the requirement. The section includes an exemption where the President may grant an exception to any federal agency if it is in the paramount interest of the U.S. The exemption is for one year and can be extended for additional one-year periods if the President makes a subsequent determination as described above.
     

Section 36: Implementation of Stockholm Convention, the LRTAP POPs Protocol, and the Rotterdam Convention

  • This section would provide authority to implement U.S. requirements under the conventions if the U.S. is a party to the convention and a party to certain actions under the conventions. The Act provides definitions of "PIC [Prior Informed Consent under the Rotterdam Convention] chemical," "POPs [Persistent Organic Pollutant under the Stockholm Convention] Chemical," and LRTAP POPS [Convention on Long-Range Transboundary Air Pollution Persistent Organic Pollutant] chemical." Section 36(b) concerns U.S. implementation of the international agreements and Subsection 36(b)(2) states that: "Notwithstanding any other provision of law, no person may manufacture, process, distribute in commerce, use, dispose of, or take any other action with respect to a POPs chemical, LRTAP POPs chemical, or PIC chemical in a manner inconsistent with applicable obligations for that chemical" under the convention.
     
  • EPA is required to provide timely public notice and an opportunity to comment on any chemical proposed for action under a convention, and may require reporting of relevant information determined to be necessary to assist the U.S. in its review of chemicals proposed for action under a convention. Following a recommendation to the meeting of the parties to a convention to consider listing a chemical, EPA is required to provide notice and request comment and may require reporting of relevant information. Following a decision by the meeting of the parties to list a chemical on the Stockholm Convention, EPA is required to provide notice and an opportunity to comment. The notice is required to include a description of the amendment and identify changes to domestic activities that EPA believes would be necessary if the U.S. chose to be bound by the Stockholm listing decision. EPA may promulgate regulations necessary to carry out a convention or to ensure compliance with any convention obligations. In the case of chemicals subject to multiple conventions, EPA shall apply the most stringent of the obligations to ensure U.S. compliance with each of the conventions.

Observations and Comments

The newly circulated language makes clear attempts to respond to industry's criticism of last year's proposal, criticism similarly levied against the companion House legislation. Examples include making clear in Section 2 on "Goal" that a safety determination is not required on all chemicals, clarifying and limiting the purposes of the Section 4 Minimum Information Set to "screening level information," and separating out categories of Section 6 priorities and actions in lieu of blanket and encompassing data generation, assessment, and safety standard determination requirements that S. 3209 applied to all chemicals. The treatment of mixtures is greatly facilitated conceptually, but as noted, it remains potentially open-ended depending on the EPA definition of "reasonable and efficient" (and any decisions by EPA in this regard would likely involve litigation over its scope by parties who believe it is either too broad or too narrow).

At the same time, it is also clear that the proposal introduces a number of significant new requirements and expansions in other requirements. One example is the treatment of "mixtures" as discussed above. Other examples include the requirements that: each manufacturer or processor of a chemical must submit a Minimum Information Set; seemingly all chemicals would be subject to export notification; and substances in imported articles must meet all statutory requirements unless the requirements have been excluded by rule.

Even with a proposal as lengthy as this one, there are unclear elements that will determine exactly what the scope, reach, and impact of these amendments would be. At the same time, it is another set of specific amendments, re-drafted to respond to criticisms that should put pressure on stakeholders to respond with specific counter-proposals or an alternative set of amendments. Senator Vitter's much anticipated approach will likely provide such an alternative, and will really get the party started.


 
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