Regulatory Developments

Lautenberg Reintroduces TSCA Reform Legislation

April 18, 2011 PRINT

On April 14, 2011, Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011, which is intended to modernize the Toxic Substances Control Act (TSCA) to require chemical companies to demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency (EPA) to evaluate safety based on the best available science. The bill is co-sponsored by Senators Amy Klobuchar (D-MN), Charles Schumer (D-NY), and Barbara Boxer (D-CA). Lautenberg previously introduced TSCA reform legislation in the 111th Congress, the Safe Chemicals Act of 2010 (S. 3209). In response to feedback from chemical industry leaders, public officials, scientists, doctors, academics, and non-profit organizations, Lautenberg states that he has made several changes to improve the bill. For example, according to Lautenberg, the updated bill establishes risk-based prioritization categories so that EPA can focus its resources on the highest-risk chemicals. The bill also requires chemical companies to submit initially basic hazard and exposure data to determine quickly any risk, and to assess the need for further testing or restrictions. Below is a summary of key differences between Lautenberg's current bill and S. 3209, as well as significant provisions that have been retained. Detailed analysis of S. 3209 is available in our April 27, 2010 (online) and July 28, 2010 (online) memoranda. The current Lautenberg bill is 182 pages long (S. 3209 was 169 pages).

  • Section 3. Findings, Policy, and Goal -- While the changes to Section 2 of TSCA largely track with S. 3209, key changes from that bill 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 new Section 26(c)(3) 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 give 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:
      (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.
      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.
  • Section 4: Definitions -- Section 3 of TSCA has been revised as follows (numbers in parentheses identify the placement of the definitions discussed):
    • The definition for "adverse effect" which appeared in S. 3209 has been dropped although the term is still used, 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 S. 3209 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 S. 3209 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 same or similar adverse effect" (the italicized text is an addition to the S. 3209 definition and has the effect of broadening the meaning, especially as "similar" adverse effects are not explicitly defined).
    • Consistent with S. 3209, 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 S. 3209, "environment" (10) would be defined to include "ambient and indoor air."
    • Consistent with S. 3209, 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 S. 3209 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 S. 3209 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 S. 3209 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).
    • While generally consistent with S. 3209, the definition of "vulnerable human population" is clarified to make clear that only "human populations" are included. The term includes explicit subcategories similar to S. 3209 such as "workers that work with chemical substances and mixtures" and "members of any other appropriate population identified by the Administrator."
  • Section 5: Minimum Data Sets and Testing of Chemical Substances -- Section 4 of TSCA would be revised as follows:
    • The Minimum Data Set requirements at Section 4(a)(1) have been substantially revised compared to the approach in S. 3209 and the bill would require a rule to be promulgated by EPA that would:
      • Require Minimum Data Sets (changed from "set") to include the minimum amount of information necessary for the Administrator to conduct a "screening-level risk assessment of the chemical substance or category of chemical substances, including information on the characteristics, toxicological properties, exposure, and use of a chemical substance" (S. 3209 had tied the Minimum Data Sets requirement to a data set that "will be useful in conducting safety standard determinations" under Section 6 -- thus the revised bill would significantly reduce the purpose that must be met by the Minimum Data Sets). 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 set that applies" to a chemical substance or category of chemical substances. The net result is to provide substantially greater flexibility to EPA in developing the Minimum Data Set requirements; and
      • "[E]ncourage and facilitate the use of alternative testing methods and testing strategies to generate information quickly, at low cost, and without the use of animal-based testing, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening."
    • In an important change, Section 4(a)(2) would require "each manufacturer and processor" to submit the Minimum Data Set for the chemical -- S. 3209 had required "the manufacturers and processors" to submit the Minimum Data Set. The effect of the change is seemingly to impose an individual requirement for submitting the Minimum Data Set on each manufacturer and processor, whereas S. 3209 could be read to impose a collective requirement on all manufacturers and processors. The change is likely to increase the implementation complexity of meeting the Minimum Data 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 Data 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 a significant change and seems to have an effect of substantially increasing the scope and effect of the requirement to submit a Minimum Data Set and could be viewed as counter-balancing the flexibility otherwise seen in the Section 4(a)(1) changes. It is also likely to increase significantly the burdens on EPA in dealing with requests for exemptions from the Minimum Data Set as well as reimbursements for Minimum Data Set testing.
    • Consistent with S. 3209, the Minimum Data Set on existing chemicals would be due 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, whereas the Minimum Data 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 S. 3209).
    • The text in the remaining parts of this Section largely tracks the approach found in S. 3209, including giving EPA authority to require, by rule or order: testing "as necessary 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 S. 3209 had extended the new chemical notification requirements to mixtures, the revised bill has deleted mixtures from the requirements under Section 5. At the same time, as noted above, new 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.
    • Consistent with S. 3209, under Section 5(a)(1) a new chemical notification would be required of any person manufacturing or processing a new chemical. Also under this Section and consistent with S. 3209, EPA can approve a new chemical if it finds that the substance meets the Section 6 safety standard or that the substance does not meet a series of terms regarding production volume, release, toxicity, etc.
    • The text in the remaining parts of this Section largely tracks with that appearing in S. 3209, including deletion of the Section 5(h)(4) exemption authority that was found in TSCA.
  • Section 7: Prioritization Safety Standard Determination, and Risk Management -- Section 6 of TSCA would be revised as follows:
    • While Lautenberg's previous bill would have required EPA to develop and publish a priority list of not less than 300 chemical substances for which safety determinations would first be made, the current bill would amend TSCA Section 6 to require EPA to develop and publish a list that: (1) contains the names of the chemical substances or categories of chemical substances that the Administrator determines warrant placement within one of three "priority classes"; and (2) identifies the priority class to which each listed chemical substance or category of chemical substances has been assigned by the Administrator. Under S. 3209, prioritization for safety determinations was based on production volume, use, hazard, exposure information, etc. The chart below provides more information on the different priority classes that would be created under the bill (emphasis added):
  Priority Class 1 Priority Class 2 Priority Class 3
Definition Chemical substances that the Administrator determines require immediate risk management Chemical substances that the Administrator determines require safety standard determinations Chemical substances that the Administrator determines require no immediate action
Assignment The Administrator must determine that the chemical substance is, or is degraded and metabolized into, a persistent, bioaccumulative, and toxic substance with the potential for widespread exposure to humans or other organisms (1)In General -- If the Administrator determines, based on any more-than-theoretical concern, that there is uncertainty as to whether a chemical substance would satisfy the safety standard in a determination, the Administrator shall assign that chemical substance priority class 2. (2)Condition -- The Administrator shall assign chemical substances to priority class 2 subject to the conditions that: (I)The rate at which chemical substances are added to priority class 2 shall be expeditious, but shall not exceed the rate at which the Administrator reasonably anticipates completing safety standard determinations; and (II)The Administrator shall first assign to priority class 2 those chemical substances that present the greater risks to human health or the environment, as determined by the Administrator. The Administrator shall assign a chemical substance to priority class 3 if the chemical substance has intrinsic properties such that the chemical substance, as determined by the Administrator, does not and would not, at any stage of the lifecycle, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance
Initial Assignment Not later than one year after the date of enactment, the Administrator shall assign not less than 20, but not more than 30, chemical substances to the initial priority class 1    
Risk Management  
Expedited Exposure Reduction As soon as practicable, but not later than 18 months after the date on which a chemical substance is assigned to priority class 1, the Administrator shall impose conditions on the manufacturing, processing, use, distribution in commerce, and disposal of a chemical substance assigned to priority class 1 that the Administrator determines necessary to achieve the greatest practicable reductions in human or environmental exposure to the chemical substance    
Residual Risk Assessment Not later than one year after the effective date of any conditions established above, the Administrator shall -- 1. Determine whether the chemical substance meets the applicable safety standard for the chemical substance, taking into account the residual risk posed by continued exposure to the chemical substance; and 2. Impose any further conditions that the Administrator determines necessary to ensure that the chemical substance meets the applicable safety standard    
Updates  
Revisions The Administrator shall promptly revise the list whenever the Administrator determines that the addition or removal of a chemical substance from priority class 1 is warranted   The Administrator shall promptly revise the list whenever the Administrator determines that the addition or removal of a chemical substance from priority class 3 is warranted
Removal Procedure A chemical substance may be removed from the list only if the Administrator finds that such substance meets the safety standard The Administrator shall not remove a chemical substance from priority class 2 until the Administrator has made a safety standard determination
    • Consistent with S. 3209, the bill would prohibit judicial review of the assignment of a particular chemical substance; a determination by the Administrator of whether a particular assignment is warranted; a response to a petition to include a particular chemical substance on the list; and the issuance of a recommendation to list a chemical substance.
    • Under the Act (emphasis added), the Administrator "shall base the determination of whether the safety standard has been met solely on considerations of human health and the environment, including the health of vulnerable human populations." In making a safety standard determination, the Administrator shall: (1) to the extent practicable, review and incorporate any available scientific information relating to the effect of cumulative exposure to that chemical substance on human health and the environment; and (2) find that a chemical substance meets the safety standard only if there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance. The proposed standard is similar to the one contained in the House bill (H.R. 5820) from the last Congress. Relative to that bill, the proposal 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 noted above in the Definitions section, the current bill does not include a definition for this term, whereas S. 3209 had defined "reasonable certainty of no harm").
    • Not later than five years after the date of enactment, and not less frequently than once every five years thereafter, the Administrator shall review the methodology and may revise it to reflect new scientific developments or understandings. A determination by the Administrator that a manufacturer or processor has not established that the chemical substance meets the applicable safety standard would not be subject to judicial review.
    • The revised bill provides considerable latitude in determining that a chemical falls into priority class 2 -- this comes from the "any more-than- theoretical concern that there is uncertainty" as to whether the chemical would satisfy the safety standard. Within 30 months after a chemical substance is assigned to priority class 2, manufacturers and processors must update the Minimum Data Set, if the data set was submitted prior to the assignment of the chemical substance to priority class 2; submit any additional information the Administrator may require to make a safety standard determination, including any information the Administrator determines is necessary to be developed by testing; and indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified uses, meets the safety standard.
    • The Administrator would have one year after the earlier of the date of receipt of a complete submission or the applicable submission deadline, or after initiating a redetermination, to determine, or redetermine, as appropriate, whether the manufacturers and processors have established that the chemical substance meets the safety standard.
    • As for the burden of proof, and consistent with S. 3209, it "shall be the duty of... the manufacturers and processors of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the applicable safety standard." In what seems to be a subtle but important change compared to S. 3209, the current bill would not require that EPA assess whether industry has met its burden of proof; rather it would require that EPA determine whether the applicable safety standard has been met.
    • Interestingly, the safety determination shall be "supported by an assessment of risk conducted by an employee of the Environmental Protection Agency" and the "determination of whether the safety standard has been met... [shall be based] solely on considerations of human health and the environment, including the health of vulnerable human populations."
    • EPA is to base safety determinations on the "best available science" and the Administrator "shall base the determination on the recommendation of the National Academy of Sciences in the report 'Science and Decisions.'" It is not clear how any conflict over this language would be resolved if the Academy or other authoritative body were to change its recommended approach over time.
    • The exemption provisions at Section 6(e) are essentially the same as those in S. 3209.
  • Section 9: Reporting and Retention of Information -- Section 8 of TSCA would be revised as follows:
    • The bill no longer includes a requirement that the Administrator publish in the Federal Register a list of all chemical substances distributed in commerce that categorizes the chemical substances "into categories based on known health or environmental effects, exposure, insufficient data, or other category that the Administrator considers appropriate."
    • The other provisions largely track those found in S. 3209.
  • Section 12: Exports
    • Whereas S. 3209 had deleted TSCA's export notification requirements for actions taken under Section 4 of TSCA, the current bill 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 seemingly would require export notifications on all chemicals (this seems to be the case because all chemicals, both new and existing, would seemingly be subject to the Section 4 Minimum Data Set, e.g., it is not clear that chemicals can be exempted from this requirement, although perhaps some flexibility can be found).
  • Section 13: Entry into Customs Territory of the United States
    • TSCA Section 13 would be amended to include an important new provision regarding import as part of an article: "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 Minimum Data Set, new chemical notification, Section 8 declaration, etc.) unless and to the extent such requirements have been excluded by rule.
  • Section 14: Disclosure of Data
    • 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 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 the previous bill included a preemption provision, the provision has been completely rewritten and seemingly narrowed compared to S. 3209:
      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 23: Administration of the Toxic Substances Control 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: Expedited Action on Chemicals of Highest Concern
    • The current bill does not include this provision.
  • The other Sections in the revised bill largely track with the provisions that appeared in S. 3209.

Observations and Comments

The newly circulated language makes clear attempts to respond to industry's criticism of last year's proposal, and which was 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 Data 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 explicit Section 6 "hit list" is removed and left to a process where EPA will evaluate the data and is to take action. The proposed bill also attempts to strike a more workable balance in its approach to preemption. 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 Data Set; that seemingly all chemicals would be subject to export notification; and that substances in imported articles must meet all statutory requirements unless the requirements have been excluded by rule.

As is often noted, "the devil is in the details," and even with a 182-page proposal, there are unclear elements about the proposal 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 earlier criticisms, which should put more pressure on those in the chemical industry to respond with specific counter-proposals or an altogether alternative set of amendments.


 
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