Last month, the U.S. Environmental Appeals Board (EAB) issued a rare and much-anticipated opinion interpreting the continuing violations doctrine and section 8(e) of the Toxic Substances Control Act (TSCA) in In re Elementis Chromium, TSCA Appeal No. 13-03 (March 13, 2015). The EAB overturned the November 2013 ruling [PDF] by the Administrative Law Judge (ALJ), which found that Elementis Chromium, Inc., a manufacturer of chromium chemicals, had violated TSCA § 8(e) by failing to report to EPA an epidemiological study on hexavalent chromium. In its March 13 decision, the EAB affirmed the ALJ in finding that the “continuing violations” doctrine applies to § 8(e) violations, thus rejecting Elementis’ statute of limitations argument. However, the EAB also held that Elementis had not violated TSCA § 8(e) because the corroborative information reporting exemption applied, and vacated the $2.5 million penalty imposed by the ALJ.
TSCA § 8(e) requires the immediate reporting to EPA of “information which reasonably supports the conclusion” that a substance “presents a substantial risk of injury to health or the environment.” In this case, a trade group of which Elementis was a member commissioned an epidemiological study on exposure to hexavalent chromium and lung cancer. EPA conducted a similar study in 2000, based on data from one facility, while the Elementis study, which finished in 2002, involved multiple “modernized” manufacturing plants. Both studies concluded that there was a positive association between hexavalent chromium exposure and lung cancer. EPA learned of the Elementis study in a 2006 Washington Post article, subpoenaed the study in 2008, and filed an administrative complaint against Elementis in 2010.
The EAB rejected Elementis’ claim that the general five-year federal statute of limitations barred EPA’s enforcement action. Elementis argued that the alleged violation accrued in 2002, when the company obtained the study, so the statute of limitations expired in 2007. However, the EAB found that the continuing violations doctrine, a special rule of accrual meaning that the period of limitations runs anew each day, applies to TSCA § 8(e), meaning that the limitations period only begins to run once the contested information is finally reported. The EAB concluded that the plain language and substance of § 8(e) imposes a continuing obligation, and violations of such are also continuing in nature. In Elementis, the company’s “last act of non-compliance” occurred on November 17, 2008, when the study was submitted to EPA, so the agency’s 2010 administrative complaint was within the five-year period.
Next, the EAB affirmed that the entire study was presumptively reportable as information which reasonably supports the conclusion that a substance presents a substantial risk of injury, rejecting Elementis’ argument that the only reportable information was “the single sentence conclusion regarding an elevated risk of cancer.” Instead, the EAB adopted a broad interpretation of the terms “information” and “reasonably supports,” concluding that Congress intended to address “the underlying data, assumptions, methodology, and analyses that actually provide the verification, corroboration, and substantiation” of the conclusion that a chemical poses a substantial risk of injury.
Nevertheless, the EAB found that the contested study was ultimately exempt from the reporting obligation because EPA established via guidance an exemption for information that is “corroborative of well-established adverse effects.” The EAB diverged from the ALJ’s analysis in finding that the Elementis study addressed a well-established adverse effect, i.e., increased incidence in lung cancer is a well-established adverse effect of exposure to hexavalent chromium. In contrast, the ALJ focused on the dose-response relationship between chromium and cancer, which the EAB characterized as an inapposite description of the potency of the chemical or conclusion about risk.
The EAB further found that the study was “corroborative” of well-established adverse effects, based not on the ordinary meaning of “corroborative,” but on agency guidance documents. This guidance describes that information is non-corroborative when it shows “the effects of a chemical are of ‘a more serious degree or different kind’ than previously perceived.” Therefore, information would be corroborative “if it shows that effects are less severe, they occur only at higher doses, or they occur in a species or strain of test animal, or by a route of exposure, that has been previously documented.” In this case, the study “only revealed statistically significant lung cancer effects at a substantially higher level” than in EPA’s own study. Thus, the Elementis study qualified for the exemption, although the EAB noted that it would have affirmed the ALJ’s decision but for EPA’s self-imposed limitation on “the broad reach of the statute with its interpretation of what information EPA is ‘adequately informed of’ in its guidance documents.”
The Elementis decision raises several interesting issues under TSCA, especially concerning the breadth of information companies must report under § 8(e) and which other TSCA sections might be interpreted as imposing continuing obligations. How EPA reacts to the decision will be instructive, especially if it chooses to refine or redefine its guidance on the corroborative information reporting exemption. Alternatively, Elementis may be of interest to legislators and stakeholders currently involved in negotiating a new framework for TSCA.
TSCA Modernization Act approved by House Energy and Commerce Committee, floor vote expected by end of June.
/in TSCA, TSCA ReformToday, the House Energy and Commerce Committee approved the TSCA Modernization Act (H.R. 2576), setting up the bill for a floor vote currently scheduled for June 23. The vote was 47-0 with one abstention, by Rep. Anna Eshoo (D-CA), who warned of the legislation’s insufficient protections for state chemical laws. Rep. John Shimkus (R-IL), the initial author of the proposal, also won adoption of a technical amendment [PDF] making minor changes to the bill’s language.
The preemption of state laws has been a major sticking point in this year’s proposals to reform the Toxic Substances Control Act (TSCA) in both the House and Senate. Notwithstanding changes to the TSCA Modernization Act designed to address those concerns, environmental and public health advocacy groups have not dropped their opposition to the bill. In addition, a dozen state Attorneys General representing California, Massachusetts, New York, and Maryland, among other states, sent a letter [PDF] last week to Energy and Commerce Committee leaders Fred Upton (R-MI) and Frank Pallone (D-NJ). In the letter, the Attorneys General expressed concern that the bill “scales back the states’ police powers and inhibits the traditional state-federal partnership that protects the public from toxic chemicals.” Following promises from Rep. Upton to negotiate new state preemption language before the floor vote, Rep. Eshoo agreed to withdraw her own proposed amendment [PDF] meant to clarify ambiguities on state authority. Rep. Pallone suggested that the state authority issues might be addressed later, although Rep. Shimkus suggested that the scope of the proposed changes may be too disruptive to win sufficient support for passage.
While the Environmental Working Group criticized the bill’s approval, saying the legislation “falls short,” industry groups responded favorably and continue to push for action in the Senate. Over 140 trade groups ranging from the Alliance of Automobile Manufacturers to the U.S. Chamber of Commerce, organized as the American Alliance for Innovation sent a letter [PDF] to Senate Majority Leader Mitch McConnell (R-KY) urging the swift passage of S. 697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” which they described as a “balanced compromise.” Yesterday, Bloomberg BNA reported that Sen. McConnell had not scheduled floor time for the bill yet, so it would not reach the floor until July or August.
TSCA reform: NYT calls for more high-priority chemical assessments, House bill formally introduced.
/in TSCA, TSCA ReformEven while Congress is in recess this week, the cause of reforming the Toxic Substances Control Act (TSCA) continues to progress. Notably, the New York Times Editorial Board is calling for stronger regulation of chemicals by requiring and empowering EPA to evaluate “at least 20 high-priority chemicals a year of its own choosing.” The editorial describes the current TSCA reform proposals in Congress as “a substantial improvement” while simultaneously decrying the bills’ failure to provide “speedy evaluations of the most worrisome chemicals among tens of thousands that have never been tested for safety.” The Times notes the “remarkable feat” of attracting 20 Republican and 20 Democratic co-sponsors to the Senate bill, but criticizes the legislation’s “slow pace of designating high-priority chemicals that require safety assessments.” The editorial also claims that under the House proposal, EPA would be tied up with conducting industry-initiated assessments instead of “chemicals the agency might regard as posing the highest risk.”
Meanwhile, Rep. John Shimkus (R-IL) formally introduced his bill, the TSCA Modernization Act of 2015 (H.R. 2576), on Tuesday. The legislation’s initial co-sponsors are Representatives Fred Upton (R-MI), Frank Pallone (D-NJ), and Paul Tonko (D-NY). The bill was unanimously approved by the House Subcommittee on Environment and the Economy earlier this month.
Rep. Shimkus’ TSCA reform bill receives unanimous, bipartisan approval in House Subcommittee.
/in TSCA, TSCA ReformThe House Subcommittee on Environment and the Economy unanimously approved the Toxic Substances Control Act Modernization Act of 2015, a revised version of the bill first introduced by Subcommittee Chair Rep. John Shimkus (R-IL) last month to fix key flaws in the Toxic Substances Control Act (TSCA). At today’s markup, Rep. Shimkus said he was “more encouraged than ever” that the outdated law would finally be modernized to meet the public’s expectations and protect human health and the environment.
Yesterday, Rep. Shimkus was joined by new co-sponsors Rep. Paul Tonko (D-NY), Ranking Member of the Subcommittee; Rep. Fred Upton (R-MI), Chair of the Energy and Commerce Committee; and Rep. Frank Pallone (D-NJ), Ranking Member of the full Committee, in unveiling changes to the draft bill and calling for the legislation’s passage. The changes addressed some of the most criticized and controversial aspects of the original draft and TSCA reform, including timelines for chemical assessments and federal preemption of state laws.
Rep. Shimkus emphasized that the revised legislation’s basic approach remained the same as in his original draft: empowering EPA to review existing chemicals on the market and “make science-based decisions about whether they pose an unreasonable risk of injury to human health or the environment.” Under the bill, EPA would first assess the safety of a chemical based on hazard and exposure. Cost and other economic factors, including benefits, would not be considered until the second step, when EPA chooses how to regulate the assessed chemical, and a “reasonable transition period” would be required.
Changes from the original bill include:
While subpanel members were all supportive of the new draft, some remaining issues were highlighted. Rep. Shimkus encouraged a bipartisan effort to amend TSCA section 8, which the current draft does not address.
Both industry and environmental groups have voiced support for the new version of the bill. The American Chemistry Council called it “balanced” and “pragmatic,” while the Safer Chemicals Healthy Families coalition said the changes brought the legislation “within striking distance of meaningful, if limited, reform.”
The bill now proceeds to the full Energy and Commerce Committee, which may schedule a markup as soon as next week.
Udall-Vitter TSCA reform bill gains momentum on the way to Senate floor; House markup expected soon.
/in TSCA, TSCA ReformThe bipartisan Senate bill to modernize the Toxic Substances Control Act (TSCA) conforms to the Obama Administration’s principles for TSCA reform, said EPA Administrator Gina McCarthy, thus adding momentum to Congress’ protracted effort to overhaul the nation’s outdated chemical safety laws. While appearing last week before the Senate Subcommittee on Appropriations for Interior, Environment and Related Agencies, McCarthy lauded recent changes to S. 697, which was approved by the Senate Environment and Public Works Committee last week. Responding to questions from Senator Tom Udall (D-NM), who introduced the legislation along with Senator David Vitter (R-LA), McCarthy noted that EPA Assistant Administrator for Chemical Safety and Pollution Prevention Jim Jones had previously identified the proposal’s shortcomings, but “the most recent amendments really addressed those issues.” McCarthy also confirmed that the Udall-Vitter bill would provide EPA with the “tools it needs” to effectively regulate asbestos, saying the agency could designate asbestos as a high priority chemical subject to assessment and regulatory determinations.
After meeting with Senate Majority Leader Mitch McConnell (R-KY) to schedule floor time for the bill, Sen. Udall expects S. 697 to reach the Senate floor in June, where it might take three to six weeks to pass as other legislators, including Senator Barbara Boxer (D-CA), are likely to offer several amendments. Senators Vitter and Jim Inhofe (R-LA) are also expected to discuss the matter with the Majority Leader soon, although Sen. McConnell’s office says no decision on scheduling has been made yet.
On the House side, Sen. Udall said that the Subcommittee on Environment and the Economy would hold a markup on May 18, calling it “a very good sign” that both bodies were “moving in tandem.” The legislation in the House, introduced by Rep. John Shimkus (R-IL), provides for a more limited overhaul of TSCA and does not currently contain the controversial state preemption provisions found in the Senate bill. Rep. Shimkus told E&E Daily that he is a “big fan” of the compromise amendments made to S. 697 which won over support from Democrats.
Critics of S. 697, including the Environmental Working Group and Safer Chemicals Healthy Families coalition, are more sanguine about Rep. Shimkus’ bill because it does not present the “regulatory void” problem found in S. 697, where states would be prevented from banning chemicals while EPA is in the process of reviewing the substances for potential regulatory action. Other stakeholders are skeptical of the House legislation’s limited scope; E&E Daily reports that Environmental Defense Fund senior scientist Richard Denison said the bill fails to fix “even the core problems of TSCA.” American Chemistry Council spokesperson Ann Kolton told E&E Daily that the industry group “will be ready to support efforts in any way we can be helpful to find the right balance between the two bills.”
If both the House and Senate bills pass, legislators would face significant challenges in reconciling the two proposals in conference committee, particularly regarding the issue of state preemption.
EPA releases interim guidance on data requirements for antimicrobial pesticides and food contact surfaces.
/in EPA, FIFRA, PesticidesLast week, EPA released interim guidance on the agency’s toxicology data requirements for antimicrobial pesticides on food contact surfaces. The interim guidance clarifies that the 200 parts per billion (ppb) threshold that triggers different data requirements is based on “total estimated daily dietary intake” for an individual and not the total amount of residue on a food item, which interpretation is in line with the policy of the U.S. Food and Drug Administration (FDA). Generally, if pesticide residues from food contact services are found in food at 200 ppb or less, EPA requires the submission of certain toxicology data, and additional data may be required if residues are greater than 200 ppb.
The interim guidance was issued as part of a March 2, 2015 settlement reached between the EPA and the American Chemistry Council (ACC) resolving the trade group’s challenge of EPA’s 2013 Final Rule on “Data Requirements for Antimicrobial Pesticides.” The settlement also requires that EPA propose, by July 2, 2015, a guidance document called the “Antimicrobial Pesticide Use Site Index,” which will be subject to public comment. In addition, by September 2, 2017, the agency must propose a “correction” to 40 C.F.R. § 158.2230(d) clarifying that the 200 ppb level relates to total estimated daily dietary intake, consistent with the FDA policy.
Udall-Vitter TSCA reform bill approved by Senate EPW Committee.
/in TSCA, TSCA ReformThe prospects for passing legislation to modernize the Toxic Substances Control Act (TSCA) have improved considerably with the approval of S. 697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” by the Senate Environment and Public Works Committee. In a 15-5 vote, the Senate panel passed a compromise version of the legislation, called a “manager’s amendment,” following weeks of negotiation which won over the support of Senators Sheldon Whitehouse (D-RI), Jeff Merkley (D-CO), and Cory Booker (D-NJ). Lawmakers announced late yesterday that they had reached an agreement on changes to the bill, which was originally introduced in March by Senators Tom Udall (D-NM) and David Vitter (R-LA). According to E&E Daily and the Huffington Post, the compromise changes include:
Senator Barbara Boxer (D-CA), who had introduced a competing TSCA reform proposal, offered several amendments in Committee, but none attracted sufficient votes to pass. While vowing to continue lobbying for her amendments – which would give states more power, set tighter deadlines, and require EPA to target asbestos and track and act on local disease clusters, etc. – Sen. Boxer praised the compromises, saying, “We got rid of a horrible bill. We have a bill that makes progress.” Most environmental and health advocacy groups have also applauded the Senate panel’s work, calling it “an important milestone,” but are continuing to call for changes.
The bill is expected to proceed to the full Senate in the coming weeks.
EPA releases initial analysis for TSCA Work Plan assessment of 1,4-dioxane.
/in EPA, Risk Assessment, TSCAEPA today announced the release of its Problem Formulation and Initial Assessment for 1,4-dioxane, a widely used industrial solvent and ingredient in a variety of products, including cleaners, cosmetics, dyes and paint strippers, which the EPA has classified as “likely to be carcinogenic to humans.” The Problem Formulation and Initial Analysis, part of the agency’s Toxic Substances Control Act (TSCA) Work Plan risk assessment program, concludes that there is no concern for inhalation exposure of ambient air emissions by the general population. However, EPA plans to further assess potential risks to both workers exposed via inhalation during product formulation and use as a cleaning agent and to workers and consumers that use products containing 1,4-dioxane as a contaminant, such as paints, varnishes, adhesives, cleaners and detergents. EPA intends to use existing data and methods to conduct additional risk analysis, review previous health and exposure studies, and “develop margins of exposure and cancer risk estimates.” The Problem Formulation and Initial Assessment also concluded that assessing risk from drinking water exposure is not currently necessary due to ongoing monitoring by EPA’s Office of Water, so “decisions as to whether or not to regulate the contaminant in drinking water will be considered as part of the EPA’s Regulatory Determination process.” In addition, the agency announced that further environmental risk analysis would not be pursued because of the low hazard profile for 1,4-dioxane to aquatic organisms and the lack of hazard data for sediment and soil organisms.
California’s Safer Consumer Products program finalizes Priority Products Work Plan.
/in California, DTSC, Safer Consumer ProductsLast week, California’s Department of Toxic Substances Control (DTSC) released its final 2015-17 Priority Product Work Plan outlining the agency’s policy priorities and product categories to be evaluated over the next three years. The Work Plan implements the Safer Consumer Products program, the part of California’s Green Chemistry Initiative that serves to “accelerate the quest for safer products.” In its final form, the Work Plan retains the same seven product categories as were included in the draft Work Plan released in September, although DTSC made changes like adding example products and clarifying or modifying the scope of certain categories.
Selected changes from the draft to final versions of the Work Plan include:
DTSC stresses that the Work Plan is only “the first step in identifying the next set of Priority Products.” The Work Plan does not identify specific Priority Products or Chemicals of Concern, nor does it establish any new compliance requirements. Rather, the Work Plan is intended to help DTSC “move from these broad [product] categories to specific product-chemical combinations that warrant consideration as potential Priority Products.” Moreover, the Plan is meant to provide “a level of predictability to potential manufacturers, importers, retailers, and other stakeholders.”
According to the Work Plan, the number of Priority Products to be identified in 2015 “will likely be as many as three,” the same number as was announced in 2014. DTSC anticipates ramping up to more than five products in 2016 and 2017.
The Work Plan covers January 2015 through December 2017, and will be updated in 2017 with the next Work Plan, covering 2018 through 2010. However, DTSC could be required to revise this Work Plan before its expiration in the case of two scenarios: if instructed to take action on a particular chemical, product, or product-chemical combination by legislative mandate or executive order; or if the agency grants a petition to add a product-chemical combination to the Priority Products list.
DTSC encourages stakeholders to stay engaged with the Safer Consumer Products program through its “newly enhanced information management system,” CalSAFER. The system facilitates reading or writing comments on proposed regulations, filing petitions, and submitting other documents to DTSC.
House panel considers Rep. Shimkus’ TSCA reform proposal.
/in TSCA, TSCA ReformOn Tuesday, members of the House Energy and Commerce Subcommittee reviewed the draft proposal introduced last week by Rep. John Shimkus (R-IL) to modernize the Toxic Substances Control Act (TSCA). The “TSCA Modernization Act of 2015,” takes a narrower approach to TSCA reform compared to previous proposals, and was crafted with input from members of both parties. The current bill is a “discussion draft,” and Rep. Shimkus announced that he planned to incorporate changes to it before holding a markup on May 14.
Lawmakers and witnesses alike agreed that significant progress had been made in working toward a much-needed update of the nation’s primary chemicals law, which was signed into law in 1976. The Subcommittee heard testimony from officials representing the Alliance of Automobile Manufacturers, American Chemistry Council, and Society of Chemical Manufacturers and Affiliates, and Safer Chemicals, Healthy Families, as well as Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention.
Industry representatives were generally supportive of the bill, particularly its provisions on testing existing chemicals and improving risk management, and concluded that the sections on state preemption and co-enforcement were appropriate. However, because the proposal does not provide a detailed prioritization plan for screening chemicals or specific timelines for risk assessment, the industry witnesses emphasized the need for Congress and the White House to provide EPA with sufficient resources to accelerate the review of existing chemicals and that the bill should be amended to direct TSCA fee revenue to EPA for implementing TSCA, rather than to the general treasury. The chemical trade group representatives also called for various changes to the proposed TSCA Inventory “reset,” so, e.g., manufacturers would not have to submit new Pre-Manufacture Notices for substances that EPA removes from the Inventory and processors would be subject to reporting requirements on use and exposure data.
Assistant Administrator Jones acknowledged that the proposal complies with the Obama Administration’s principles for TSCA reform, but called for clarity on various issues, including the prioritization process and how EPA should consider cost when evaluating risk. Jones emphasized that funding was a major constraint on how many chemicals EPA can review each year, and even assessments requested and paid for by industry could not be completed within the “unrealistically optimistic” six-month timeframe proposed in the discussion draft. Jones expressed concern that by letting industry request unlimited assessments without a prioritization scheme or required minimum for agency-initiated assessments, the review process could be exploited to “delay evaluations for some of the most dangerous chemicals indefinitely.”
Andy Igrejas, director of the Safer Chemicals, Healthy Families coalition of environmental, public health, labor and other organizations, testified on several positive elements he saw in the draft as well as several areas of concern. According to Igrejas, the bill would not “fix the fundamental barrier in current law to EPA imposing risk management on an unsafe chemical,” because EPA would be required to conduct a cost-effectiveness analysis as to whether a chemical’s risk should be mitigated. Igrejas also testified that the legislation should include a “grandfather clause” for state laws that have “become settled matters of public health policy.” Despite these and other problems, Igrejas said the bill could be fixed with small changes to the language.
Environmental Appeals Board interprets TSCA § 8(e).
/in EAB, Enforcement, TSCALast month, the U.S. Environmental Appeals Board (EAB) issued a rare and much-anticipated opinion interpreting the continuing violations doctrine and section 8(e) of the Toxic Substances Control Act (TSCA) in In re Elementis Chromium, TSCA Appeal No. 13-03 (March 13, 2015). The EAB overturned the November 2013 ruling [PDF] by the Administrative Law Judge (ALJ), which found that Elementis Chromium, Inc., a manufacturer of chromium chemicals, had violated TSCA § 8(e) by failing to report to EPA an epidemiological study on hexavalent chromium. In its March 13 decision, the EAB affirmed the ALJ in finding that the “continuing violations” doctrine applies to § 8(e) violations, thus rejecting Elementis’ statute of limitations argument. However, the EAB also held that Elementis had not violated TSCA § 8(e) because the corroborative information reporting exemption applied, and vacated the $2.5 million penalty imposed by the ALJ.
TSCA § 8(e) requires the immediate reporting to EPA of “information which reasonably supports the conclusion” that a substance “presents a substantial risk of injury to health or the environment.” In this case, a trade group of which Elementis was a member commissioned an epidemiological study on exposure to hexavalent chromium and lung cancer. EPA conducted a similar study in 2000, based on data from one facility, while the Elementis study, which finished in 2002, involved multiple “modernized” manufacturing plants. Both studies concluded that there was a positive association between hexavalent chromium exposure and lung cancer. EPA learned of the Elementis study in a 2006 Washington Post article, subpoenaed the study in 2008, and filed an administrative complaint against Elementis in 2010.
The EAB rejected Elementis’ claim that the general five-year federal statute of limitations barred EPA’s enforcement action. Elementis argued that the alleged violation accrued in 2002, when the company obtained the study, so the statute of limitations expired in 2007. However, the EAB found that the continuing violations doctrine, a special rule of accrual meaning that the period of limitations runs anew each day, applies to TSCA § 8(e), meaning that the limitations period only begins to run once the contested information is finally reported. The EAB concluded that the plain language and substance of § 8(e) imposes a continuing obligation, and violations of such are also continuing in nature. In Elementis, the company’s “last act of non-compliance” occurred on November 17, 2008, when the study was submitted to EPA, so the agency’s 2010 administrative complaint was within the five-year period.
Next, the EAB affirmed that the entire study was presumptively reportable as information which reasonably supports the conclusion that a substance presents a substantial risk of injury, rejecting Elementis’ argument that the only reportable information was “the single sentence conclusion regarding an elevated risk of cancer.” Instead, the EAB adopted a broad interpretation of the terms “information” and “reasonably supports,” concluding that Congress intended to address “the underlying data, assumptions, methodology, and analyses that actually provide the verification, corroboration, and substantiation” of the conclusion that a chemical poses a substantial risk of injury.
Nevertheless, the EAB found that the contested study was ultimately exempt from the reporting obligation because EPA established via guidance an exemption for information that is “corroborative of well-established adverse effects.” The EAB diverged from the ALJ’s analysis in finding that the Elementis study addressed a well-established adverse effect, i.e., increased incidence in lung cancer is a well-established adverse effect of exposure to hexavalent chromium. In contrast, the ALJ focused on the dose-response relationship between chromium and cancer, which the EAB characterized as an inapposite description of the potency of the chemical or conclusion about risk.
The EAB further found that the study was “corroborative” of well-established adverse effects, based not on the ordinary meaning of “corroborative,” but on agency guidance documents. This guidance describes that information is non-corroborative when it shows “the effects of a chemical are of ‘a more serious degree or different kind’ than previously perceived.” Therefore, information would be corroborative “if it shows that effects are less severe, they occur only at higher doses, or they occur in a species or strain of test animal, or by a route of exposure, that has been previously documented.” In this case, the study “only revealed statistically significant lung cancer effects at a substantially higher level” than in EPA’s own study. Thus, the Elementis study qualified for the exemption, although the EAB noted that it would have affirmed the ALJ’s decision but for EPA’s self-imposed limitation on “the broad reach of the statute with its interpretation of what information EPA is ‘adequately informed of’ in its guidance documents.”
The Elementis decision raises several interesting issues under TSCA, especially concerning the breadth of information companies must report under § 8(e) and which other TSCA sections might be interpreted as imposing continuing obligations. How EPA reacts to the decision will be instructive, especially if it chooses to refine or redefine its guidance on the corroborative information reporting exemption. Alternatively, Elementis may be of interest to legislators and stakeholders currently involved in negotiating a new framework for TSCA.