On April 7, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a Discussion Draft of the "TSCA Modernization Act of 2015" (TMA DD). In the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a revised discussion draft of the bill, CICA2. In addition, Shimkus held "countless" hearings concerning reform of the Toxic Substances Control Act (TSCA). Memoranda summarizing these earlier bills and hearings are available on our website. According to the Subcommittee's April 7, 2015, press release, the TMA DD "builds off the subcommittee's work to reform chemical management last Congress and further bipartisan negotiations this year." The Subcommittee will hold a hearing on the TMA DD on April 14, 2015, at 10:15 a.m.
It is not clear from the changes made compared to last year's CICA2 or the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) what exactly the drafters intend with this draft. It would not be surprising that the House and Senate have different perspectives on the same issue, or that proposals representing a compromise in the Senate will not mirror compromise in the House. This draft, however, contains an uneven approach to changes in comparison to last year's legislation also introduced by Mr. Shimkus. In some provisions, changes made appear to be based on concerns that neither environmental advocacy nor chemical industry groups have raised up to now or during the many years of debate on TSCA reform.
While perhaps this could represent new and fresh thinking, some of these changes seem to move the debate backwards or suggest a more opaque approach regarding key issues. One glaring example in this regard is the lack of a prioritization scheme for how to triage or sort the existing universe of over 80,000 chemicals. The various recent proposals have differed over how many or how fast or how preemptive any sorting requirements should be, but this draft does not mention prioritization at all. Other changes seem not to be based on an attempt to respond to a concern raised by the various constituencies involved but rather propose a new approach or remain silent on changes to current law without incorporation of elements from last year's CICA2 that were not identified as a contentious point of debate. In our review, we identify concerns with various proposals made in TMA DD and we find ourselves struggling to understand both what the drafters are attempting to do and why. As optimists, we hope that the sponsors intend the bill as a gateway to compromise notwithstanding the clear differences between the House and Senate, as well as differences with some provisions between this and last year's bill.
The specific problem with the somewhat spotty approach in the new legislative draft is that the time left on the Congressional calendar is, in effect, short -- perhaps by the end of this summer or early fall before Presidential campaign politics make any legislation less likely. The number of significant issues still needing resolution is not small (preemption, deadlines, the regulatory standard and associated rulemaking requirements, resources and fees, and confidential business information (CBI), among others). The vagueness on some of these outstanding issues may be part of a strategy by the House sponsors to "get the debate rolling" to work towards a final consensus, but we would suggest the time is very short and this draft would move some issues out of the "settled" column and put back to the "no consensus" category. A new session of Congress certainly does mean that all drafts are drawn of new cloth, but the time allowed currently for sweater-knitting or sausage-making is deceptively short.
This review summarizes and analyzes the approach proposed in TMA DD as such and in comparison to CICA2 released in April 2014. The review also brings in comparisons to the recently tabled bill -- S. 697 -- to help the reader keep the various drafts in perspective.
Whereas CICA2 had proposed an elaborated series of changes to many TSCA sections, TMA DD takes an approach that is much narrower, in some cases almost surgical, and limited to the following TSCA sections only: Section 3 on definitions, Section 4 on testing, Section 6 on existing chemicals, Section 8 on information gathering, Section 9 concerning the relationship to other Federal laws, Section 14 concerning CBI, Section 18 on preemption, and Section 26 concerning administration of the Act. CICA2, by way of comparison, had proposed changes in additional sections, including the following: Section 2 on findings and policy, Section 5 on new chemicals, Section 12 concerning exports, Section 13 on imports, and Section 19 on judicial review.
Section 3. TMA DD retains all of TSCA's definitions and proposes three definitions as follows:
"Intended conditions of use" has been slightly modified from that in CICA2;
"Potentially exposed subpopulation" has been substantially revised from that in CICA2, including removing references to "intended conditions of use" and to a U.S. Environmental Protection Agency (EPA) determination; and
"Weight of the scientific evidence" is a new definition, although the term had been used in CICA2.
Section 4 has been substantially revised from the approach in CICA2 by returning to the TSCA approach of requiring EPA "findings" to impose testing requirements. The current TSCA findings have been retained and a new finding has been proposed to enable EPA to require testing if it is necessary to conduct a Section 6(b) risk evaluation. TMA DD would give EPA rule, order, and consent agreement authority for testing, although the findings requirement would need to be met in using any of these approaches (note that EPA does not currently make findings in using the Enforceable Consent Agreement (ECA) procedure to obtain testing). TMA DD no longer includes the concept of a role for prioritization of existing chemicals, and, given this silence, there is no discernible Congressional push in TMA DD for EPA to obtain testing needed to inform its understanding and tee up existing chemicals for a possible Section 6 risk evaluation. The changes proposed in Section 4 strike us as steps in the wrong direction at several levels and seem unlikely to help in turning around a testing program that has failed to meet EPA's needs for such information.
Section 6 has been revised to remove the reference to "least burdensome requirement" in TSCA Section 6(a). TMA DD also states that a risk evaluation does not include cost or other factors "not directly related" to health or the environment, although the full effect of this language is not immediately clear to us. TMA DD, as noted above, does not include the concept of prioritization and EPA is instructed to conduct a risk evaluation on a chemical if it "finds a reasonable basis" for concluding that the "combination" of hazard and exposure under the intended conditions of use "has the potential to be high enough" to present an unreasonable risk, or if a manufacturer requests (and pays for) such an evaluation. While we appreciate the EPA discretion afforded by this formulation, it is not clear why an EPA "finding" is required; the "high enough" language strikes us as unclear, and we would prefer to see more of a statutory push on EPA to get about its work on existing chemicals. TMA DD imposes deadlines for completion of risk evaluations, although it is not clear to us why company-requested evaluations have a shorter deadline than evaluations initiated by EPA.
If EPA determines, based on its risk evaluation, that the chemical presents an unreasonable risk, it has 90 days to propose a Section 6(a) regulation with finalization to occur within 180 days, although extensions are possible if additional information is needed. These deadlines strike us as unduly tight given the likely complexity of such rules and standing requirements for the Office of Management and Budget (OMB) review. TMA DD has deleted a number of the procedural requirements at TSCA Section 6(c) while also expanding the points to be considered and published in promulgating a Section 6(a) rule, including determining that the controls are "cost-effective" and that technically and economically feasible alternatives "will be" reasonably available.
If EPA determines that the chemical will not present an unreasonable risk, it is required to publish a preliminary determination and provide an opportunity for notice and comment. After finalization, such determinations would be considered a final agency action.
TSCA Section 8 has been retained unchanged in TMA DD with the addition of a provision requiring what strikes us as a "hard" reset of the Inventory, in that the Inventory would be revised to remove chemicals that are no longer manufactured or processed. This represents a significant change from that in CICA2, which had included the concept of creating an "active" versus an "inactive" Inventory with an EPA notification being required to change from inactive to active status (and thus providing a "soft" reset).
TMA DD largely retains TSCA Section 14 on Confidential Business Information (CBI) with a few important changes: CBI could be shared with State, local, and tribal government officials and be provided to treating physicians to assist in diagnosis or treatment; CBI claims would require substantiation and expire after ten years unless the requester asks for renewal; and Section 14(b) would be amended to make clear that the subsection does not authorize disclosure of information on formulas (in addition to processes, as specified in TSCA).
TMA DD largely retains the TSCA approach to preemption with important changes, including essentially preempting State action on chemicals where EPA has made a final Section 6(b) determination that a chemical will not present an unreasonable risk.
TMA DD Section 26 revises the approach to fees in TSCA by including a provision authorizing fees for manufacturers who request that EPA conduct a Section 6(b) risk evaluation and by deleting the TSCA $2,500 limitation on fees. TMA DD retains provisions appearing in CICA2 concerning Scientific Standards and Weight of Scientific Evidence. The former lists the factors to be considered in scientifically evaluating information from studies and tests, and in carrying out Sections 4, 5, and 6, while the latter states that EPA shall make decisions under these sections based on the weight of the scientific evidence. TMA DD largely retains the provision in CICA2 concerning requirements on EPA to develop policies, procedures, and guidance, although it relaxes the deadline from CICA2's one year to two years and no longer specifies that notice and comment procedures be used in issuing the policies, procedures, and guidance. Finally, TMA DD Section 26(l) proposes a savings clause to ensure that interpretation of State tort and contract law is not affected by the Act.
Section 3: Definitions
TMA DD retains all of TSCA's definitions and would add the following new definitions:
"Intended conditions of use" -- The circumstances under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, and disposed of.
The definition is similar to that proposed in CICA2, differing as indicated by redlining below:
[T]he circumstances under which a chemical substance is intended, known, or reasonably foreseen
anticipated to be manufactured, processed, distributed in commerce, used, and disposed of.
S. 697 takes an approach similar to that in TMA DD, except that S. 697 also includes a determination by EPA.
"Potentially exposed subpopulation" -- A group of individuals within the general population who, due to either greater susceptibility or greater potential exposure, are at greater risk than the general population of adverse health effects from exposure to a chemical substance.
The proposed definition differs in several ways from that in CICA2, which had keyed the term to "intended conditions of use" (the reference has been deleted), provided examples of subpopulations, and also included an EPA determination. The new definition also includes the concept of "greater risk." The changes are shown by redlining:
or groups of individuals within the general population who the Administrator has reason to believe may be differentially exposed to a chemical substance under the intended conditions of use or who may be susceptible to more serious adverse health consequences from chemical substance exposures than the general population, which where appropriate may include infants, children, pregnant women, workers, and the elderly, due to either greater susceptibility or greater potential exposure, are at greater risk than the general population of adverse health effects from exposure to a chemical substance.
The approach in S. 697 was generally similar to that in CICA2 in keying the concept to "intended conditions of use" and including examples of relevant populations.
"Weight of the scientific evidence" -- The results of an approach that gives appropriate weight to all relevant information in an integrative and objective manner that takes into account the strengths and limitations associated with each type of information.
This is a new term that does not seem to have been defined as such in earlier texts, although the term was used.
Section 4: Testing of Chemical Substances and Mixtures
TMA DD largely retains TSCA Section 4 with surgical changes. TMA DD would amend TSCA Section 4(a) to give EPA the authority to require testing of a chemical substance if necessary to conduct a risk evaluation under Section 6(b). EPA would be able to do so by order or consent agreement, as well as by rule.
The requirement in TSCA Section 4(a) that EPA make findings in requiring testing is retained in TMA DD. These include the current TSCA findings for "may present an unreasonable risk" and/or "substantial production/exposure," plus "insufficiency of data" and "testing is necessary," and, as noted above, an additional "or" finding is proposed to allow EPA to require testing if it is necessary to conduct a Section 6(b) risk evaluation. The net effect of the change seems to be that in requiring testing beyond that "necessary to conduct" a Section 6 risk evaluation, EPA would be required to satisfy the current TSCA findings requirements despite the fact that these have proven difficult for EPA to meet and apply over the law's history. Because TMA DD is silent on concepts such as prioritization (which had been included in CICA2, as well as in S. 697), there is no discernible push from Congress for EPA to obtain testing needed to inform its understanding on and to tee-up promptly existing chemicals for a possible Section 6 risk evaluation. In addition, the requirement for EPA findings under TMA DD would apply to testing obtained by rule, order, and consent agreement (we note in this regard that EPA does not currently make findings in using the ECA procedure to obtain testing). The changes discussed in this paragraph strike us as steps in the wrong direction at several levels and seem unlikely to help in ensuring that EPA will implement a robust program to develop the testing needed to inform adequately its screening and prioritization judgments in selecting chemicals for risk evaluation.
TMA DD does not include other provisions in CICA2 concerning, for example, animal welfare aspects and the need to develop and issue a "statement of need" in requiring testing (perhaps in recognition that the TSCA "findings" requirements have been retained).
Section 6: Regulation of Hazardous Chemical Substances and Mixtures
The TMA DD would amend TSCA Section 6(a) by striking the "least burdensome requirement" in TSCA Section 6(a), a provision that many believe had been a key contributor to EPA's inability to regulate asbestos and other existing chemicals.
Whereas CICA2 Section 6 had required EPA to conduct prioritization reviews and to conduct risk evaluations on "high priority" designations, TMA DD, as noted above, does not include the concept of prioritization and Section 6(b)(3) requires EPA to conduct a risk evaluation if:
It "finds a reasonable basis" for concluding that the "combination" of hazard and exposure under the intended conditions of use "has the potential to be high enough" to present an unreasonable risk; or
The manufacturer requests (and pays for) such an evaluation.
While it is not clear to us why the first of these requires an EPA "finding" rather than a "determination," the approach may be workable in the discretion afforded EPA, although the term "high enough" strikes us as lacking clarity. At the same time, we regret that TMA DD has lost the concept of prioritization. In our view, EPA needs Congressional guidance and a statutory "push" to get about its work on existing chemicals and TMA DD continues the "silent treatment" in this regard found in TSCA.
TMA DD Section 6(b)(4) describes requirements on EPA in conducting a risk evaluation and states that such an evaluation does not include information on costs or other factors "not directly related" to health or the environment. In our view, the full effect of the "not directly related" language is not immediately clear. EPA is required to take exposures into account under the intended conditions of use, to describe the weight of the scientific evidence for hazard and exposure, and to consider whether the weight of the scientific evidence supports the identification of threshold doses below which no adverse effect can be expected to occur (this last concept was also included in CICA2).
TMA DD would require risk evaluations on chemicals selected by EPA to be completed within three years, while risk evaluations initiated at the request of manufacturers would be completed within 180 days. If EPA determines, based on a risk evaluation, that a chemical "presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury," EPA, after publishing its risk evaluation, has 90 days to propose a Section 6(a) risk management rule with the final rule due within 180 days. TMA DD would allow EPA to extend the 90-day deadline if EPA determines that additional information is necessary. It is not clear to us why EPA is given a tighter deadline for completing company-requested evaluations and we also question the practical workability of the Section 6(a) rule completion deadlines given the likely complexity of such rules and existing requirements for OMB review. We note that the tight regulatory deadlines imposed on EPA could have an effect of delaying EPA's release of its risk evaluation to give it the time needed to sort through and prepare its regulatory approach if the deadlines are to be met.
In the case of a determination of no unreasonable risk, EPA would publish a preliminary determination and provide at least a 30-day period for notice and comment. The TMA DD would prohibit EPA from making such a determination if it determines that the chemical, under the intended conditions of use, poses an unreasonable risk to one or more potentially exposed subpopulations. A final determination that a chemical will not present an unreasonable risk would be considered a final agency action. Recognizing that EPA, like other bureaucracies, tends to be risk averse and cautious, we question whether EPA might feel compelled to use its Section 5(a)(2) Significant New Use Rule (SNUR) authority to "lock-in" the current use and exposure profile that enabled it to conclude that a chemical "will not present an unreasonable risk," and thereby ensure that the risk standard will be met while potentially helping to deflect legal challenges to such a final agency action.
TMA DD makes several important changes to TSCA Section 6(c) Promulgation of Subsection (a) Rules, including deleting a number of procedural requirements that otherwise allowed informal hearings and cross-examination, while also expanding (beyond those in TSCA) the points to be considered and published in promulgating a Section 6(a) rule. These additional points include:
Imposing controls that EPA determines are "cost-effective";
Determining whether technically and economically feasible alternatives "will be" reasonably available when the action takes effect;
Exempting replacement parts for articles that are manufactured prior to the effective date unless EPA makes significant risk determinations concerning such replacement parts; and
In restricting chemicals in articles, limiting such actions to the extent necessary to mitigate the identified risk.
Finally, Section 6(d) requires that Section 6(a) rules provide for a "reasonable transition period."
Many of the Section 6(c) and (d) elements discussed above had also appeared in CICA2. The approach in S. 697 is markedly different from that in TMA DD.
Section 8: Reporting and Retention of Information
TSCA Section 8 would be retained unchanged in TMA DD albeit with the addition of a new requirement for EPA to implement periodically an Inventory "reset" procedure by collecting information as necessary to remove from the TSCA Inventory any chemical that is no longer manufactured or processed, and to revise the Inventory accordingly. The procedure seems to us to have the effect of a "hard" reset in that chemicals following their removal from the Inventory would need to go through the Section 5 new chemicals process to reenter commerce. This approach represents a substantial difference from that in CICA2 and S. 697, which had included the concept of creating an "active" versus an "inactive" Inventory with an EPA notification being required to change from inactive to active status (and thus providing a "soft" reset).
CICA2 and S. 697 had also included other Section 8 provisions, such as recognizing certain chemical nomenclatures and the Inventory status of "statutory mixtures"; these provisions, among others, do not appear in TMA DD.
Section 9: Relationship to Other Federal Laws
TMA DD would amend Section 9(b) by adding a requirement that EPA, in making a determination that it is in the public interest for EPA to take an action under TSCA rather than under another EPA administered law, shall compare the relative risks, estimated costs, and efficiencies of the action to be taken under TSCA and an action to be taken under such other law to protect against such risk. This provision, which had appeared in CICA2, does not have a counterpart in S. 697.
Section 14: Disclosure of Data
TMA DD largely retains the approach in TSCA Section 14. It would amend TSCA Section 14(a) to allow the disclosure of CBI to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law. In addition, CBI would be disclosed, upon request, to a health or environmental professional employed by a Federal or State agency in response to an environmental release, or to a treating physician or other health care professional to assist in the diagnosis or treatment of one or more individuals.
TMA DD would also amend Section 14(b) to make clear that this subsection "does not authorize the release of any data which discloses formulas or processes" (redlining to show change from TSCA).
Under TMA DD Section 14(c), in submitting information after the date of enactment, CBI designations would require substantiation, including a "justification" for each CBI claim, and claims would expire after ten years. The CBI would be made public unless the manufacturer, processor, or distributor submits a request for renewal.
TMA DD includes a new Section 14(f) Prohibition, which states that no person receiving CBI may use or disclose the information except as specified or authorized, respectively. This provision does not have a counterpart in CICA2 or S. 697.
CICA2 had included an explicit provision at Section 14(d)(5) which stated that the term "health and safety data" does not include the specific identity of a chemical; this provision does not appear in TMA DD. S. 697 Section 14 is much more elaborated than that in TMA DD and includes a number of concepts not appearing in TMA DD (such as a requirement to develop a "unique identifier" and a subsection detailing EPA's responsibilities to review CBI claims).
Section 18: Effect on State Law
TMA DD largely retains the TSCA approach to preemption with important changes, including a new Section 18(a)(2)(B) concerning cases where EPA has made a final Section 6(b) determination that a chemical will not present an unreasonable risk under the intended conditions of use. In such cases, TMA DD would prohibit any State or political subdivision from establishing or continuing in effect any requirement that applies to such chemical under the intended conditions of use and that is designed to protect against exposure to such chemical under the intended conditions of use. TMA DD Section 18(a)(2)(C) corresponds to and revises the approach in TSCA Section 18(a)(2)(B) by:
Deleting some of the nuance (for example, TSCA had limited the effect to State actions "designed to protect against a risk of injury to health or the environment," whereas TMA DD would change this to "designed to protect against exposure to the chemical");
Clarifying that the preemption effect extends to State actions that apply to an article containing the EPA-regulated chemical; and
Deleting the provision in TSCA that had excluded preemption of State actions prohibiting "the use of such substance or mixture in such State ... (other than its use in the manufacture or processing of other substances or mixtures)."
Consistent with TSCA, TMA DD would exclude preemption of State actions that are identical to the requirement imposed by EPA or are adopted under the authority of a Federal law.
TMA DD retains without change the approach at TSCA Section 18(b) whereby States could request and obtain EPA exemptions from preemption, which would allow State actions to continue in effect if certain conditions can be met.
CICA2 had taken a generally different approach to preemption and had included provisions concerning the preemption effect of "low priority" designations. The approach in S. 697 also differs substantially from that in TMA DD.
Section 26: Administration of the Act
TMA DD revises the approach to fees in TSCA by including a provision authorizing fees for manufacturers who request that EPA conduct a Section 6(b) risk evaluation and by deleting the TSCA $2,500 limitation on fees. TMA DD does not otherwise include new provisions regarding fees for administering the Act.
Consistent with CICA2, TMA DD includes provisions concerning Scientific Standards (Section 26(h)) and Weight of Scientific Evidence (Section 26(i)). The former lists the factors to be considered in evaluating information from studies and tests, and in carrying out Sections 4, 5, and 6 to the extent that EPA makes a decision based on science, including: the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the intended use of the information; the information is relevant for EPA's intended use; the degree of clarity and completeness by which the data, assumptions, methods, quality assurance, sponsoring organizations, and analyses employed to generate the information are documented; the variability and uncertainty in the information; and the extent of independent verification, validation, and peer review of the information or the procedures, measures, methods, or models.
TMA DD Section 26(i) states that EPA shall make decisions under Sections 4, 5, and 6 based on the weight of the scientific evidence.
TMA DD includes a provision at Section 26(k) Policies, Procedures, and Guidance that is generally consistent with the approach taken in CICA2 as follows: EPA would have two years after enactment of the bill (versus one year in CICA2) to develop any policies, procedures, and guidance EPA determines are necessary to carry out the amendments made by the bill. Not later than five years after the date of enactment, and not less frequently than once every five years thereafter, EPA would be required to review the adequacy of the policies, procedures, and guidance developed, including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk; and to revise the policies, procedures, and guidance as EPA determines necessary to reflect new scientific developments or understandings. CICA2 had required that notice and comment procedures be used in developing and finalizing all policies, procedures, and guidance; this specification has been deleted in TMA DD.
Finally, TMA DD Section 26(l) Savings states: "Nothing in this title shall be construed to affect either the tort law or the law governing the interpretation of contracts of any State."