TSCA Reform: Detailed Review of Representative Shimkus’ Second Discussion Draft of TSCA Reform Legislation
On May 12, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a new (second) draft of the TSCA Modernization Act of 2015 (TMA2 DD). In April, Shimkus released an initial discussion draft of the TSCA Modernization Act of 2015 (TMA1); our memorandum on TMA1 is available online. 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 May 2015 press release, “the House Energy and Commerce Committee today unveiled a new draft of the TSCA Modernization Act” that is “backed by Environment and the Economy Subcommittee Chairman John Shimkus (R-IL), Subcommittee Ranking Member Paul Tonko (D-NY), full committee Chairman Fred Upton (R-MI), and Ranking Member Frank Pallone, Jr. (D-NJ).” The Subcommittee held a markup on Thursday, May 14, 2015. Our memorandum summarizing the hearing is available online.
As we have noted in past analyses of the 2015 House legislative drafts, there remain significant questions in the legislation regarding how effectively it seeks to prioritize, evaluate, and regulate chemicals in a timely manner. Important elements of a more complete design are given in the current Senate bill (S. 697) as reported by the Senate Environment and Public Works (EPW) Committee. Many of these elements are discussed below, especially concerning likely hurdles regarding testing, deadlines for actions, ill-defined or unclear terms, and resources, among others, and the absence of provisions regarding important matters such as prioritization and Section 8 information gathering.
Also unclear is whether the drafters of the legislation have received input from the U.S. Environmental Protection Agency (EPA) program staff or others experienced in the design and operation of a serious risk management statute. EPA’s role in drafting any specific text is obliquely referred to regularly as offers of “technical assistance,” which differs from a more granular level of involvement that appears to be missing. Politically, there may be compromises made that are intentionally vague or even contradictory in order to achieve political consensus — but both the Senate and House legislation appear to lack a clear outline of how the ambitious goals of the proposals can readily or timely be achieved.
As the proposals continue to make their way to becoming law, there is ample opportunity to address such shortcomings. And the fact that on both sides of Capitol Hill there is strong bipartisan support for further discussion and refinement means there may be progress made on significant implementation issues. We note with caution, however, that the most time, focus, and rhetoric remains centered on a few issues, which, while important for legislative triumph (such as compromise on any state preemption provision), will not necessarily address many of the issues we identify here as crucial for future programmatic success.
This review summarizes and analyzes the approach proposed in TMA2 DD. To help the reader keep the various drafts in perspective, our memorandum also brings in comparisons to TMA1 and the new version of the Senate bill — S. 697 — that was recently passed by the Senate EPW Committee and favorably reported to the Senate Floor.
Relative to S. 697, TMA2 DD takes an approach that is much narrower, in some cases almost surgical, and limited to substantive changes in the following TSCA sections only: Section 3 on definitions, Section 4 on testing, Section 6 on existing chemicals, Section 9 concerning the relationship to other Federal laws, Section 14 concerning confidential business information (CBI), Section 18 on preemption, and Section 26 concerning administration of the Act. Whereas TMA1 also proposed changes to TSCA Section 8 on information gathering, TMA2 DD deleted the proposed changes. S. 697, by way of comparison, proposed changes in additional sections, including the following: Section 2 on findings and policy, Section 5 on new chemicals, Section 8 on information gathering, Section 12 concerning exports, Section 19 on judicial review, and Section 27 concerning a new Sustainable Chemistry Program.
Section 3. TMA2 DD retains all of TSCA’s definitions and proposes two definitions as follows:
- “Intended conditions of use” has been slightly modified from that in TMA1; and
- “Potentially exposed subpopulation” has been revised and broadened from that in TMA1 in that it now involves “a group of individuals…who,…are likely to be at greater risk…” (redlining shows the added text).
TMA2 DD also deleted the definition proposed in TMA1 of “weight of the scientific evidence,” although the term is used in Sections 6 and 26.
TMA2 DD Section 4, consistent with the approach proposed in TMA1, proposes to return to the TSCA approach of requiring EPA “findings” to impose testing requirements. TMA2 DD retains the current TSCA findings 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. While the flexibility provided by the new finding is helpful, it is only available once EPA is at the point of conducting a risk evaluation. TMA2 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 procedure to obtain testing).
Unlike S. 697, TMA2 DD does not include the concept of a role for prioritization of existing chemicals, and, given this silence, there is no discernible Congressional push in TMA2 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, particularly, but not limited to, the retention of the TSCA findings, strike us as steps that are unhelpful 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). TMA2 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.
TMA2 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 “determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use” (emphasis added), or if a manufacturer requests (and pays for) such an evaluation. In addition, EPA can directly initiate a risk evaluation on a Work Plan chemical. While we appreciate the flexibility afforded by requiring a “determination” rather than a “finding” (as in TMA1), it is not clear to us that the other changes provide the clarity needed in this critical provision. While we see merit in the general concept of applying a “may present” determination, we would prefer that it be unadorned by the additional hazard and exposure phrase. We believe that after almost 40 years, both EPA and stakeholders have a pretty good idea of what a “may present” determination involves. We also find little comfort in the term “potential route of exposure,” as it seems that most if not all chemicals satisfy the requirement for having a potential route of exposure (dermal or inhalation). If our reading is correct, then the provision devolves to a hazard-based trigger, which does not seem to be the intent. We question, however, what the effect would be if EPA made a “may present” finding under Section 4. Would this mean that EPA has essentially also satisfied this Section 6 provision and started the risk evaluation clock?
While we would prefer to see more of a statutory push on EPA to get about its work on existing chemicals, TMA2 DD imposes deadlines for completion of risk evaluations that can be extended if more information is needed. In a new provision, TMA2 DD proposes to require that EPA, “[s]ubject to the availability of appropriations,” initiate ten or more risk evaluations each fiscal year.
If EPA determines, based on the risk evaluation, that the chemical “presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury,” EPA has 90 days, after publishing its risk evaluation, to propose a Section 6(a) risk management rule with the final rule due within 180 days. These regulatory deadlines are inflexible and strike us as unduly tight given the likely complexity of such rules and standing requirements for review by the Office of Management and Budget (OMB). TMA2 DD has deleted a number of the procedural requirements in 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. TMA2 DD includes new and relatively complicated provisions regarding control actions in cases where EPA “determines that it is not practicable to protect against the identified risk using cost-effective requirements.” Relevant to this is new Section 6(h) Critical Use Exemptions, which, if certain requirements can be met, can be applied in cases where EPA determines that the required protections are not cost-effective.
If EPA determines that a 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.
Finally, new Section 6(i) concerns persistent, bioaccumulative, and toxic (PBT) chemicals. It involves a relatively complicated process wherein EPA publishes the list of PBT chemicals within nine months of enactment and then within two years confirms and designates as PBT “chemicals of concern” those that satisfy the criteria specified. In such cases, EPA then has two years to promulgate a Section 6(a) rule to “reduce likely exposure to the extent practicable” (emphasis added). While an off-ramp is available if certain steps are taken within 90 days after EPA publishes the list of PBT chemicals, the deadlines for confirming the PBTs and finalizing the Section 6(a) control actions are otherwise inflexible, although the latter deadline is “[s]ubject to the availability of appropriations.” Regardless, since all PBT “chemicals of concern” would need to complete both the designation and regulation steps within a maximum of four years, the regulatory deadline in particular seems daunting to us.
Whereas TMA1 had retained TSCA Section 8 and added a new provision requiring what seemed to us to involve a “hard” reset of the Inventory (in that the Inventory would be revised to remove chemicals that are no longer manufactured or processed), this provision has not been retained in TMA2 DD and the draft proposes to retain TSCA Section 8 unchanged.
TMA2 DD largely retains TSCA Section 14 on CBI but, in an important change from TMA1, would explicitly protect from disclosure information on “molecular structures.” In addition, consistent with TMA1, 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.
TMA2 DD largely retains the TSCA approach to preemption with important changes, including essentially preempting future State action on chemicals once EPA has made a final Section 6(b) determination that a chemical will not present an unreasonable risk. TMA2 DD also adds additional provisions to the approach in TMA1 by adding exemptions from preemption (e.g., certain cases when the State requirement “is adopted to protect air or water quality or is related to waste treatment or waste disposal”) and including a “Savings” provision to set forth those existing State laws that will not be preempted by TMA2 DD.
TMA2 DD Section 26 clarifies and adds additional provisions to the approach in TMA1 concerning fees. Consistent with TMA1, it would allow fees for manufacturers who request that EPA conduct a Section 6(b) risk evaluation and would also delete the $2,500 cap on fees in TSCA. TMA2 DD would allow EPA, by rule, to require fees that are “sufficient and not more than reasonably necessary” to be collected from anyone submitting data under Sections 4 or 5 and thus to allow for fees to cover the costs of reviewing Section 4 data submissions and notices under Section 5 (which, as worded, seems to include the costs to review and regulate new chemicals by EPA). TMA2 DD does not provide for fees to be used to support EPA-initiated risk evaluations and regulatory actions under Section 6 (these would be covered by appropriations). TMA2 DD also establishes a Treasury fund to receive fees from and disburse funds to EPA to cover its costs and imposes requirements for accounting and auditing by EPA.
TMA2 DD clarifies several of the provisions found in TMA1 Section 26(h) Scientific Standards. TMA2 DD Sections 26(i), (j), and (k) retain unchanged the provisions in TMA1 concerning the weight of scientific evidence and the availability of information, as well as requirements and deadlines on EPA to develop policies, procedures, and guidance.
Section 3: Definitions
TMA2 DD proposes to revise slightly the definitions for “intended conditions of use” and “potentially exposed subpopulation” compared to those in TMA1 and to delete the definition for “weight of the scientific evidence.” It otherwise retains all of TSCA’s definitions. The proposed revisions are as follows:
- “Intended conditions of use” – “[T]he circumstances under which a chemical substance is intended, known, or reasonably
foreseenforeseeable to be manufactured, processed, distributed in commerce, used, and disposed of” (redlining added to show the changes).
The approach in S. 697 is similar to that in TMA2 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 likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance” (redlining added to show the changes).
The proposed addition of “likely” broadens the definition. The change causes us to wonder, considering that workers have greater potential exposure to many if not virtually all chemicals, what if anything is being excluded (i.e., given the exposure situation with regard to workers, based on the definition do not virtually all chemicals have potentially exposed subpopulations and, if so, is this what the drafters’ intend)? As was the case in TMA1, the definition does not involve an EPA determination nor does it use the term “intended conditions of use.” The corresponding definition in S. 697, in comparison, includes an EPA determination and seems to be narrower and more nuanced.
TMA2 DD has also deleted and thus proposes not to define the term “weight of the scientific evidence,” although the term is used in Sections 6(b)(4) and 26(i).
Section 4: Testing of Chemical Substances and Mixtures
As was done in TMA1, TMA2 DD largely retains TSCA Section 4 with surgical changes. TMA2 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 thus retained in TMA2 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. In addition, the requirement that EPA make findings under TMA2 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 Enforceable Consent Agreement procedure to obtain testing). Because TMA2 DD is silent on concepts such as prioritization (which is included 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 existing chemicals for a possible Section 6 risk evaluation. 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 testing program to develop the data needed to inform adequately its screening and prioritization judgments in selecting chemicals for risk evaluation.
TMA2 DD does not include other provisions found in S. 697 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
TMA2 DD, consistent with TMA1, would amend TSCA Section 6(a) by keying action under Section 6(a) to a determination under Section 6(b) or under Section 6(i)(2) (these are discussed more below) and by striking the “least burdensome requirement” in TSCA Section 6(a). Many believe the latter provision had been a key contributor to EPA’s inability to regulate asbestos and other existing chemicals. TMA2 DD proposes to add a reference to “potentially exposed subpopulation” in Section 6(a), as follows:
…[EPA] shall by rule apply one or more of the following requirements to such substance or mixture to the extent necessary to protect adequately against such risk
using the least burdensome requirements, including an identified risk to a potentially exposed subpopulation (redlining to show the changes).
Consistent with TMA1, TMA2 DD proposes to delete TSCA Section 6(b) Quality Control and to replace it with Section 6(b) Risk Evaluations. Section 6(b)(3)(A) has been revised from TMA1 in important ways, including no longer requiring EPA to make a finding in order to conduct a risk evaluation. The reworded provision also includes the concept of “may present an unreasonable risk.” The changes are shown by redlining:
The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if –
- the Administrator determines
finds a reasonable basis for concludingthat the combination of hazard and exposure tothe chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use has the potential to be high enough to present an unreasonable risk; or
- a manufacturer of the chemical substance requests (and per Section 26, pays for) such a risk evaluation.
In addition, EPA can directly initiate a risk evaluation on a Work Plan chemical. While we appreciate the flexibility afforded to EPA by requiring a “determination” rather than a “finding,” it is not clear to us that the other changes provide the clarity needed in this critical provision. While we see merit in the general concept of applying a “may present” determination, we would prefer that it be unadorned by the additional hazard and exposure phrase. We believe that after almost 40 years, both EPA and stakeholders have a pretty good idea of what a “may present” determination involves. In particular, we find little comfort in the term “potential route of exposure.” Do not most if not all chemicals satisfy the requirement for having a potential route of exposure (dermal or inhalation exposure potential, e.g., during transfer from a reactor after manufacture or during use)? If our reading is correct, then the provision devolves to a hazard-based trigger, which does not seem to be the intent. We do wonder, however, what the effect would be if EPA made a “may present” finding under Section 4 — would this mean that any time EPA makes a “may present” finding under Section 4, EPA has essentially also satisfied this Section 6 provision?
TMA2 DD Section 6(b)(4) describes requirements on EPA in conducting a risk evaluation and states that, consistent with TMA1, 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 “integrate and assess information on hazards and exposures for all of the intended conditions of use” (redlining to show changes from TMA1). While we appreciate the desire for EPA to prepare a reasonably comprehensive exposure assessment, we wonder about the effect of a “shall” requirement to evaluate exposures from “all of” the intended conditions of use (in some ways it reminds us of the all-encompassing effect of “least burdensome”). Additional provisions in this subsection track with those in TMA1, including 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 of the chemical substance below which no adverse effects can be expected to occur” (redlining shows change from TMA1).
Whereas TMA1 Section 6(b)(5) Deadlines had required that risk evaluations initiated at the request of manufacturers be completed within 180 days, TMA2 DD changes this to the same three-year deadline, which otherwise applies to EPA-initiated reviews. TMA2 DD would allow EPA to extend the risk evaluation deadline if EPA determines that additional information is necessary. In this regard, we wonder about the practicality of giving EPA only 90 days after receipt of additional information to complete the risk evaluation, recognizing that the new hazard and/or exposure information could be complex and/or voluminous and would need to be integrated into the risk evaluation.
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. These inflexible deadline periods are unchanged from those in TMA1. We 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.
In the case of a determination of no unreasonable risk, consistent with TMA1, EPA would publish a preliminary determination and provide at least a 30-day period for notice and comment. TMA2 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.
TMA2 DD proposes a new Section 6(b)(7) Minimum Number, which states that “[s]ubject to the availability of appropriations,” EPA shall initiate “10 or more risk evaluations” in each fiscal year after the enactment of the Act. While this would represent a considerable increase over the number of TSCA risk assessments EPA initiated in the past, depending on the level of appropriations, it might be achievable. Better yet, it seems to us, would be to include these costs within those covered by industry fees under Section 26(b).
TMA2 DD retains most of TMA1’s changes to TSCA Section 6(c) Promulgation of Subsection (a) Rules, including deleting a number of procedural requirements in TSCA that otherwise allowed informal hearings and cross-examination. TMA2 DD expands (beyond those in TSCA) the points to be considered and published in promulgating a Section 6(a) rule, albeit with some important changes from TMA1. These additional points include:
- Imposing controls that EPA determines are “cost-effective, except where the Administrator determines that it is not practicable to protect against the identified risk using cost-effective requirements” (redlining shows the changes). The effect of this provision at Section 6(c)(1)(B) is somewhat clarified by a new provision at Section 6(h), discussed below, concerning critical use exemptions that cross references the subsection;
- Determining whether technically and economically feasible alternatives “will be” reasonably available when the action takes effect;
- Exempting replacement parts for articles that are “designed
manufactured” (redlining shows change) prior to the effective date unless EPA makes significant risk determinations concerning such replacement parts. While we believe we understand the intent of the change to “designed,” we wonder about the clarity of its meaning; and
- In restricting chemicals in articles, limiting such actions to the extent necessary to mitigate the identified risk.
Consistent with TMA1, TMA2 DD Section 6(d) requires that Section 6(a) rules provide for a “reasonable transition period.”
TMA2 DD includes three new subsections at the end of Section 6. The first, Section 6(g), states that EPA shall not consider costs or other non-risk factors when deciding whether to initiate a Section 6(a) rule.
Section 6(h) Critical Use Exemptions outlines criteria, procedures, duration, and conditions in granting exemptions from a Section 6(a) rule for “a specific use” of the chemical. This exemption is available in cases where EPA makes the “controls are not cost-effective” determination noted above at Section 6(c)(1)(B). EPA is given discretion to grant an exemption in these cases if EPA can also find that the specific use is a “critical or essential use” (this term is not further defined) or that the requirement regarding the specific use “would significantly disrupt the national economy, national security, or critical infrastructure.” The exemption is required to be “supported by clear and convincing evidence” and requires public notice.
If the exemption is granted, EPA is required to notify the public and the manufacturers and processors of the chemical are required to notify known commercial purchasers to which the exemption applies. Such exemptions are limited to five years in duration but may be renewed for additional periods if EPA finds that the requirements continue to be met. Finally, in granting the exemption, EPA is required to impose conditions that reduce risks “to the greatest extent feasible.”
The net effect of proposed Sections 6(c)(1)(B) and 6(h) is that if EPA determines that the needed controls are not cost-effective, the controls would nonetheless go into effect unless the exemption requirements can be satisfied. If, on the other hand, the exemption requirements can be met (clear and convincing evidence that the specific use is “critical or essential” or the action would cause significant disruption to the national economy, etc.), EPA could grant an exemption under which risks are required to be reduced to the greatest extent feasible. While the exemption procedure may be helpful as a “safety valve” to avoid undue disruption, it is difficult to assess how workable or practicable the exemption may be, particularly when it involves “critical or essential uses” (whatever that covers).
Finally, new Section 6(i) concerns persistent, bioaccumulative, and toxic (PBT) chemicals. It involves a relatively complicated process wherein EPA identifies PBT chemicals within nine months of enactment and within two years confirms the chemicals that satisfy the criteria specified. In such cases, EPA then has two years to promulgate a Section 6(a) rule to reduce exposure, although, as discussed below, an off-ramp is available. More specifically, the provision requires that:
- EPA within nine months publish a “list of those chemical substances that the Administrator has a reasonable basis to conclude are” PBTs, except that the list cannot include any metal, metal compound, or PCB. The provision appears to give EPA a lot of discretion in whether to consider all non-excluded chemicals on the Inventory versus some smaller subset of the TSCA Inventory for purposes of identifying PBTs. It also appears to be a “one-off” requirement with no need for EPA to undertake additional or on-going efforts to identify PBTs.
- Within two years, EPA “shall” designate as a “PBT chemical of concern” each chemical on the list:
- That scores “high” for persistence and bioaccumulation, or high for one and moderate for the other; and
- For which exposure is likely to the general population or to a potentially exposed subpopulation identified by EPA.
- That scores “high” for persistence and bioaccumulation, or high for one and moderate for the other; and
Similar to the approach in S. 697, TMA2 DD cites the TSCA Work Plan Methods Document as the source for “high” or “moderate” scoring criteria (these are discussed in our memorandum on the version of S. 697 that was reported out to the Senate Floor). Depending on the size of the list generated in the prior step, two years might or might not be reasonable.
- Subject to the availability of appropriations, EPA is required to promulgate, within two years after designating a chemical as a PBT, a Section 6(a) rule to “reduce likely exposure to the extent practicable” (emphasis added). Depending on the number of chemicals involved, this requirement could range from difficult to daunting for EPA to achieve.
- Subsection (4) provides a bit of an off-ramp from the PBT procedure. If within 90 days after EPA publishes the list of PBTs, EPA makes the Section 6(b)(3)(A)(i) determination that a risk evaluation is required on such a listed chemical, or a manufacturer requests that EPA conduct a risk evaluation under subsection (ii), such chemical “shall not be subject” to the PBT provision.
Considered within the context of TMA2 DD Section 6 and assuming that an off-ramp is not used, the effect of this provision seems to involve the following:
- EPA can initiate control actions on chemicals that are confirmed to be PBTs of concern without conducting a risk evaluation under Section 6(b). Thus, there is no need for EPA to show that the chemical presents an unreasonable risk nor would EPA have to satisfy the Section 6(b)(4) requirements that otherwise apply to a risk evaluation.
- In taking control actions under Section 6(a), EPA would still have to meet the terms of Section 6(c) except that the rule would be required to be promulgated within two years (versus three to five years otherwise) and would need to reduce likely exposure to the extent practicable (versus the requirement that otherwise applies under Section 6(a) that actions be taken “to the extent necessary to protect adequately against such risk”).
Given the challenges to EPA in meeting the PBT regulatory deadline, as well as the potential interest of industry in avoiding the designation of chemicals as PBTs of concern, the shorter two-year regulatory deadline, as well as the requirement that control actions reduce likely exposure to the extent practicable, and the absence of a requirement for EPA to conduct a risk evaluation on such chemicals, one wonders how many chemicals would actually be dealt with via this process versus being off-ramped one way or the other.
Regarding PBTs, the approach in S. 697 is somewhat narrower and does not deviate from the standard process that requires development of a safety assessment and safety determination and regulation of PBTs that do not meet the safety standard. It includes provisions that give a preference in the prioritization step to identifying such existing chemicals as high-priority, and, for chemicals that fail to meet the safety standard and that rank high for persistence and bioaccumulation, EPA is required to take control actions that reduce exposure to “the maximum extent practicable.”
More generally, the approach to Section 6 in S. 697 is markedly different from that in TMA2 DD.
Section 8: Reporting and Retention of Information
Whereas TMA1 retained TSCA Section 8 with the addition of a new requirement for EPA to implement periodically a “hard” Inventory “reset” to remove from the TSCA Inventory any chemical that, based on reporting, is no longer manufactured or processed, this provision does not appear in TMA2 DD. Section 8 was identified in the mark-up hearing as one of the areas needing additional attention.
S. 697 proposes several Section 8 provisions, such as recognizing certain chemical nomenclatures and the Inventory status of “statutory mixtures.” It would also create lists of “active” versus “inactive” Inventory chemicals. These provisions, among others, do not appear in TMA2 DD.
Section 9: Relationship to Other Federal Laws
TMA2 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 “with respect to a chemical substance or mixture” (clarifying phrase added to this provision in TMA2 DD) rather than under another EPA administered law, shall compare the relative risks, estimated costs, and efficiencies of the action to be taken under TSCA versus the other law. This provision does not have a counterpart in S. 697.
Section 14: Disclosure of Data
TMA2 DD largely retains the approach in TSCA Section 14 but, in an important change from TMA1, would protect from disclosure information on “molecular structures” and require EPA to give notice to companies prior to the expiration of CBI claims. It also includes a new “Savings” provision.
As with TMA1, TMA2 DD 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.
In an important change, TMA2 DD would amend Section 14(b) to make clear that this subsection “does not authorize the release of any data
which discloses that disclose formulas (including molecular structures) of a chemical substance or mixture, processes used in the manufacturing or processing of a chemical substance or mixture, or, in the case of a mixture, the release of data disclosing the portion of a mixture comprised by any of the chemical substances in the mixture” (redlining to show changes from TSCA). Although the term “molecular structures” is not defined in TMA2 DD, it is used in TSCA Section 8(a)(2)(A) (in the phrase “[t]he common or trade name, the chemical identity, and molecular structure of each chemical substance or mixture…”) and Section 26(c) concerning categories of chemical substances. The provision in TMA2 DD is broader than the corresponding provision at Section 14(b)(7) in S. 697 that explicitly limits protection of chemical identity to the period prior to commercial distribution.
Under TMA2 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. TMA2 DD adds a new provision at Section 14(c)(1)(C), which requires EPA to give 60 days advance notice to companies prior to releasing CBI in the case of expiring claims.
TMA2 DD Section 14(f) Prohibition 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 S. 697.
TMA2 DD includes a new Section 14(g) Savings, which makes clear that Section 14 does not “affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding.” A similar provision appears in the chapeau to S. 697 Section 14(b).
S. 697 Section 14 is much more elaborate than that in TMA2 DD and includes a number of concepts not appearing in TMA2 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
TMA2 DD generally provides the same effective date as in TMA1 for when preemption takes place regarding safety assessments. This is once EPA makes a final determination under Section 6(b) that a chemical substance does, or does not, present an unreasonable risk of injury to health or the environment under the intended condition of use. There are some changes to TMA2 DD from TMA1. First, TMA2 DD clarifies that the preemption applies to a State requirement for a chemical substance under the intended conditions of use “considered by the Administrator in the risk evaluation under section 6(b)” or in the case of a Section 5(a) rule, “from a use identified in a notice received by the Administrator under section 5(a).” In addition, when listing the exemptions from preemption when EPA issues a Section 5 or 6 rule (other than a requirement described in Section 6(a)(6)), TMA2 DD includes another exemption when the State requirement “is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, expressly conflicts with the requirement.” Finally, TMA2 DD clarifies that the exemption from preemption for a State requirement that is “identical” to the EPA requirement does not allow a State to assess a penalty for a violation when EPA has already assessed a penalty, and does not allow EPA to assess a penalty for a violation when a State has already assessed a penalty if the penalty total combined would exceed the maximum amount that EPA could itself assess.
For comparison purposes regarding the effective date, “Lautenberg1” (the bill proposed in the Senate in March 2015) has the effective date as once EPA commences its safety assessment, while Lautenberg2 (otherwise identifiable as S. 697 proposed in April 2015) has the effective date as once EPA defines the scope of a Section 6(a)(2) safety assessment. Considering the time it is expected to take EPA to complete a Section 6(b) safety assessment, the timing in TMA2 DD would significantly expand the amount of time until relevant State laws are affected.
TMA2 DD also contains a “Savings” provision not previously proposed in TMA1. This provision allows States to “continue to enforce any action taken before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance, or any action taken pursuant to a State law that was in effect on August 31, 2003, unless an action or determination made by the Administrator under this title expressly conflicts with the action taken pursuant to such a State law.” A second “Savings” provision states that TMA2 DD will not “preempt or otherwise affect either Federal or State tort law or the law governing the interpretation of contracts of any State, including any remedy for civil relief, whether under statutory or common law, including a remedy for civil damages, and any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory related to tort law.” These provisions are similar in part to savings provisions in Lautenberg1 and Lautenberg2, with some differences, including but not limited to, Lautenberg1 preserving State actions taken before January 1, 2015, and TMA2 DD specifying tort and contract law. In addition, TMA2 DD, as with TMA1, does not include several proposed sections in Lautenberg1 and Lautenberg2 regarding the scope of preemption, exemptions from preemption, and requirements for State waivers.
Finally, TMA2 DD has a provision stating that it is not the intent of Congress that this Act be “interpreted as influencing in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title expressly conflicts with the State court action.” This provision, which was not in TMA1, is similar to a provision in Lautenberg1 and Lautenberg2 with regard to the fact that this Act is not intended to have an effect on private remedies.
Section 26: Administration of the Act
TMA2 DD tweaks the language in TMA1 Section 26(h), retains Sections 26(i), (j), and (k) as proposed in TMA1, and proposes to delete TMA1 Section 26(l) Savings (the matters covered in this provision are otherwise dealt with under TMA2 DD Section 18).
TMA2 DD clarifies TSCA Section 26(b)(1) as follows (redlining shows the changes from TSCA):
The Administrator may, by rule, require the payment
of a reasonable feefrom any person required to submit data under section 4 or 5 of a fee that is sufficient and not more than reasonably necessary, or who requests a risk evaluation under section 6(b)(3)(A)(ii), to defray the cost of administering this Actthe provision of this title for which such fee is collected. Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. Such rules shall provide for lower fees for small business concerns.
Thus, the proposal would allow EPA, by rule, to require fees for dealing with data submissions under Sections 4 and 5 and for industry requests for EPA to conduct Section 6 risk evaluations. As worded, the provision seems to cover the costs of reviewing data submissions under Section 4 (but would not cover the costs to EPA in developing rules, orders, or consent agreements to require testing) and for review of new chemical notices and exemption requests, presumably also including the costs associated with EPA’s regulatory determinations and actions under Section 5. Regarding Section 6 risk evaluations and control actions, fees are available only for industry-requested risk evaluations and not for other EPA activities and regulatory actions under this section. This interpretation is reinforced by the inclusion of the phrase “subject to the availability of appropriations” that appears in TMA2 DD Sections 6(b)(7) (concerning the minimum number of risk evaluations initiated by EPA per year) and 6(i)(3) (concerning expedited control actions on PBTs). Under S. 697, the fee provisions are considerably broader and cover EPA costs associated with, among others, Section 4A prioritization decisions and Section 6 safety assessments and determinations and rulemaking actions.
TMA2 DD Section 26(b)(3) Fund deals with one of the issues identified by EPA in the April 14, 2015, hearing on TMA1 held by the House Energy and Commerce Subcommittee on Environment and the Economy. This new section establishes a fund in the U.S. Treasury to receive fees collected by EPA and to disburse funds to EPA to cover its costs, “including contractor costs,” in carrying out the activities noted in the preceding paragraph. The provision goes on to discuss accounting and auditing requirements on EPA.
TMA2 DD clarifies several of the provisions found in TMA1 Section 26(h) Scientific Standards. The section (redlining generally shows changes) 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 “in making a decision about a chemical substance or mixture;” 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 or peer review of the information or the procedures, measures, methods, or models.
TMA2 DD Section 26(i) Weight of Scientific Evidence states that EPA shall make decisions under Sections 4, 5, and 6 based on the weight of the scientific evidence.
TMA2 DD Section 26(k) Policies, Procedures, and Guidance imposes deadlines on EPA for development and periodic review of policies, procedures, and guidance. EPA would have two years after enactment of the bill 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.