EPA to Publish Three Final Rules under TSCA
August 1, 2017 •
On June 22, the U.S. Environmental Protection Agency (EPA) made three final rules available on its website, pending official publication. The rules guide the agency’s path for assessing and regulating chemicals in commerce under the amended Toxic Substances Control Act (TSCA). EPA’s issuance of final rules for ‘Prioritization,” “Risk Evaluation,” and “Inventory Reset,” will impact how EPA evaluates chemicals used in the coatings industry. ACA has been actively developing coatings industry positions and comments on these important rulemakings since their proposal in January 2017. ACA is currently working to provide compliance materials for the industry. Since the June 22 pre-publication, EPA officially published the prioritization and risk evaluation rules in the Federal Register on July 20. The inventory reset rule is expected to be officially published soon.
In addition, EPA released its TSCA Risk Evaluation Guidance, outlining the expectations for draft risk evaluations provided by interested parties, and articulating the approach EPA will apply in risk evaluations conducted under the risk evaluation process rule under TSCA Section 6. EPA also published scoping documents that will shape evaluations of the first 10 chemicals for initial risk evaluation: asbestos; pigment violet 29; 1,4-dioxane; cyclic aliphatic bromides cluster; carbon tetrachloride; 1-bromopropane; methylene chloride; n-methylpyrrolidone; trichloroethylene; and tetrachloroethylene.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act, signed into law on June 22, 2016, mandates the agency to restrict chemicals already in commerce that pose unreasonable risks to public health and the environment.
The following outlines the rule’s evolution from proposal to finalization, with ACA’s comments and the rule’s final most salient changes summarized.
Inventory Reset Rule
This rule establishes a process to designate substances on the TSCA Inventory as “active” or “inactive,” also known as the TSCA Inventory Reset. Once the TSCA Inventory has been “reset,” no one would be permitted to manufacture or process an inactive chemical substance without first submitting a notification to EPA prior to manufacturing or processing the substance, provided that notification cannot be more than 90 days prior to the expected date of manufacture or processing.
Under TSCA, Sec. 8(b)(6), EPA is obligated to designate chemicals reported under the 2016 Chemical Data Reporting rule (CDR) as an interim list of active substances. In response to public comment, EPA expanded the interim list to include chemicals reported pursuant to the 2012 CDR rule, in addition to the 2016 CDR rule as required by statute. In effect, manufacturers and processors of chemical substances listed on either the non-confidential or confidential portion of the TSCA inventory would not have to tell the agency that they made a chemical if they or another manufacturer had already reported information required under the 2012 or 2016 CDR rules. In the final rule, EPA determined that this exemption applies regardless of listing as confidential or non-confidential. The CDR rules required companies that produced certain volumes of a chemical (generally 25,000 pounds or more) submit to the EPA information such as the identity of the chemical they make, the volume made or imported, how the chemical was used, and the extent to which workers were exposed to it. EPA issues the CDR rule every four years. With inclusion of chemicals reported during the 2012 and 2016 CDR reporting period in the interim list of active substances, the list now covers substance reported for the last two CDR reporting periods, instead of just the most recent period as instructed in TSCA Section 8(b)(6).
Proposed Rule and ACA Comments
ACA comments supported EPA’s initial proposal to utilize 2012 and 2016 CDR Data to formulate an interim list of active substances. However, ACA comments underscored the need for clarification of reporting requirements for importation of new substances. ACA is concerned that there are situations where manufacturers and processors are working with reportable chemicals where the reporting requirements are unclear. ACA proffered that there could be situations where chemical substances already on the inventory designated as inactive will be imported for use in manufacturing after the final date of the rule. ACA believes that these chemicals should be reported as active. This can be accomplished either by making Notice of Activity (NOA) Form B immediately available on the final date of the rule, or by modifying the reporting procedures for NOA Form A.
Moreover, ACA urged EPA to provide an opportunity to modify or correct notifications where a good faith effort is demonstrated. Particularly because there is no de minimus threshold for notification under the Inventory Reset, it is possible that these “minor use, minor volume” chemical ingredients will be inadvertently overlooked in the information gathering stage.
“The complexity of identifying all these reportable chemicals is compounded when many of the notifications will be designated Confidential Business Information (CBI) co-submissions and 4 submitters will be required to consider acquisitions/merger activity over the last 10 years,” stated ACA comments. “Consequently, we believe that EPA is vastly underestimating the complexity of this request, and thus should allow for companies to make corrections for up to one year after the submittal deadline.”
ACA also stressed that the proposal should have greater protections for CBI. ACA noted that chemical substances designated as CBI and filed by Pre-Manufacture Notice (PMN) but not produced in the 10 years prior to TSCA reform will automatically lose their confidentiality. “It is problematic that there is currently no mechanism to address this. Materials on the 2012 CDR and the anticipated 2016 CDR will be interim active chemicals not subject to reporting unless they are on the confidential inventory. Even if reported in the CDR, materials on the confidential inventory will require reporting with confidentiality assertion and substantiation.” ACA urged EPA to specify a mechanism to protect the confidentiality of materials not in production during the “look-back period.”
Final Rule Highlights on The Reset – “Retrospective” Reporting
- Final Rule retains mandatory reporting for manufacturers, voluntary reporting for processors.
- “One and Done” alternative added. A manufacturer doesn’t have to submit a retrospective notice under the Reset, if it obtains a CDX receipt of a Form A submitted by another manufacturer for the same chemical.
- Date range removed. The proposed requirement that notifiers must specify dates of manufacture during the lookback period has been removed. The proposed requirement to specify information about commercial activity has also been removed.
- EPA will not require reporting for:
- Mixtures as defined in 40 CFR 710.3(d)
- Naturally occurring substances
- Rule exempts entire category from reporting
- Impurities and byproducts with no subsequent commercial purpose
- Articles: import or processing of substances solely as part of articles
- Substances not considered “chemical substances” under 3(2)(B) of TSCA
- Substances that “are not listed on the Inventory” due to 5(h) exemptions:
- Test marketing
- Low release/low exposures
- EPA will not require reporting for chemical substances where agency already has equivalent notice of active status, such as chemicals reported during the 2012 and 2016 Chemical Data Reporting rule periods.
- Reporting format and platform stays the same. Reporting will be on CDX using a “Form A” for retrospective reporting (the “Reset”) and Form B for prospective reporting (notifications of inactive to active). These elements are retained from the proposed rule.
- Time extended for processors to participate from 360 days to 420 days.
- Manufacturers must complete their reporting within 180 from publication of final rule.
- EPA will publish a “draft” Inventory after the 180-day manufacturer reporting period has closed. EPA intends to publish the “draft” inventory within 60 days of deadline for manufacturer reporting.
- Regardless of exemptions, a Form A will need to be filed to maintain a CBI claim for chemical identity.
Prioritization Proposed Rule
This rule establishes a process and criteria for identifying high-priority and low-priority chemicals for evaluation. A chemical designated as “High-Priority” must undergo evaluation. Chemicals designated as “Low-Priority” are not required to undergo further evaluation. The TSCA amendments require that the prioritization process will last between nine months and one year. Once the prioritization process has been triggered, there is no authority to stop this process or pause this timeline. Consequently, EPA intends to gather a complete set of data prior to the pre-prioritization stage, before any deadline is triggered. Section 702.7(e) describes the general methodology.
Proposed Rule and ACA Comments
ACA noted that this section does not provide for any transparency in this process. While the proposal indicates that EPA will be working initially on the list of candidates from the 2014 Update of the TSCA Work Plan for Chemical Assessments, there is no notification requirement for stakeholders. ACA is concerned that the screening process may lead to a pool of chemicals that EPA plans to seek information on without any deadline or action plan, and asked EPA to provide clarification on the screening process and scope.
In its comments, ACA also urged EPA to focus solely on intentional uses of chemical substances during the prioritization process. ACA noted that when chemicals are not intentionally added and are only present as residuals in trace amounts, accurate concentration data of such substances in finished formulated products is often not available. Coatings formulators rely on information provided by their raw material suppliers to disclose whether the chemical in question is present in their products. Because the levels are so low, the substance’s identity may not be disclosed, or the concentration may not be disclosed on the Safety Data Sheet (“SDS”).
“Alternatively, if disclosed, the concentration stated may represent theoretical maximums, based on manufacturing process or other limits, rather than actual concentrations. Residual levels and byproducts are typically present at trace levels, with very little potential exposure to human health and the environment. There is no need for the agency to consider these unintentional uses when making Prioritization determinations.” ACA suggested that EPA use the Globally Harmonized System (GHS) reporting thresholds as the de minimus value for consideration of a “use” for this purpose.
ACA requested that EPA work to ensure that the public understands that “High-Priority” does not equal high risk. To make that abundantly clear, ACA proffered the inclusion of a single statement that the High Priority designation merely indicates that EPA will be conducting a risk evaluation on a chemical. Any determination of risk associated with a chemical would only be made after a Risk Evaluation has been completed. ACA believes that this clarification in the rule is critical.
Final Rule Highlights
- Regarding scope of priority designation, EPA will designate the priority of a chemical substance as a whole, and will not limit any designation to a specific use or subset of uses.
- “EPA believes the addition of the phrase “the conditions of use” (emphasis added) was intended to move the agency away from its past practice of assessing only narrow uses of a chemical substance, towards a more inclusive approach to chemical substance management.
- EPA is including without revision the statement that nothing shall be construed as a limitation on EPA’s authority to take action with respect to categories of chemical substances.
- EPA states that it will not adopt a regulatory definition of “category of chemical substances.”
EPA will still consider “inactive” chemical substances as subject to prioritization, as they are “still chemical substances on the TSCA inventory, and therefore subject to prioritization. However, the agency does note that “such chemicals may be less likely to be selected as early High-Priority candidates.” EPA also states that whether a chemical substance is actively manufactured “would generally be relevant to informing EPA’s exposure judgments during the prioritization process.”
- The agency only further mentions that EPA will continue its commitment to basing decisions on Best Available Science (BAS) and Weight of the Evidence (WoE).
- EPA has provided no definition of these terms in the final rule.
- EPA also provides no description of the type, relevance, quality, rigor in methods, etc. of science and information that will be relied upon.
Risk Evaluation Rule
The final regulation, called the risk evaluation rule (RIN:2070-AK20), describes how the EPA will evaluate the risks posed by high-priority chemicals. The final rule identifies components of an EPA risk evaluation, affecting data that stakeholders must submit and parameters for public comment during the risk evaluation process. A risk evaluation consists of: 1) a statement of scope (that includes conditions of use, a conceptual model and an analysis plan); 2) a hazard assessment; 3) an exposure assessment; 4) a risk characterization; and 5) a risk determination (40 CFR 702.41). The rule includes a procedure for manufacturers to request a risk evaluation and criteria for EPA evaluation of requests. The rule implements statutory requirements for evaluation of data, including best available science and weight of the scientific evidence. EPA also has the option to conduct a risk evaluation on a category of chemical substances instead of a single chemical substance.
Proposed Rule and ACA Comments
ACA’s comments focused on bringing clarity and transparency to the risk evaluation process, maintaining that EPA should balance the need for clear procedures and standards to evaluate data against providing enough flexibility to allow for variations in risk evaluation required on a case-by-case basis, depending on the chemical undergoing evaluation. Procedures and definitions must be flexible enough to also allow EPA to adopt to changes in the science of risk evaluation over time. One example demonstrating these competing policy objectives is in EPA’s proposed principles to evaluate whether a chemical causes a certain harmful effect, called “systematic review.” ACA supported adding regulatory text with elements for systematic review, particularly for hazard identification, to provide transparency in the review process. ACA also believes that specific regulatory text enables stakeholders to provide better quality information by having a deeper knowledge of EPA’s review process. In the final rule, EPA does not adopt specific criteria or elements of systematic review, so it can maintain flexibility in conducting risk assessments while adapting to developments over time.
ACA also commented that EPA should codify definitions of terms such as best available science, weight of evidence, sufficiency of information, unreasonable risk, and reasonably available information. ACA believes codified definitions would inform both EPA and the public about risk evaluation requirements, affecting all aspects of the risk evaluation procedure and the quality of information that EPA ultimately uses in reaching its conclusions. EPA agreed with comments in support of codifying certain definitions of terms commonly used in the statute, including, best available science, reasonably available information and weight of evidence. In the final rule, EPA is not codifying definitions of sufficiency of information and unreasonable risk, since the case-by-case nature of risk evaluation would best be served by not having an overarching definition of these terms, providing more flexibility during risk evaluation. Regarding unreasonable risk, although EPA is not defining unreasonable risk, it is providing a revised list of consideration for a risk determination based on public comment.
EPA received several comments, from ACA and others, requesting that manufacturers be allowed to submit information for an identified use when proposing a chemical for risk evaluation. EPA proposed manufacturers submit information for all conditions of use when proposing a chemical for risk evaluation. ACA and others commented that this would discourage companies from bringing proposals to EPA since the amount of information required would be unduly high. EPA modified the final rule to allow manufacturers to submit requests for risk evaluation only on conditions of use that are of interest to the manufacturer, rather than all conditions of use. EPA can then conduct the risk evaluation solely based on conditions of use identified by the manufacturer, or it can identify additional conditions of use.
ACA also commented that EPA should focus its risk evaluation efforts on intentional uses of chemicals, in order to focus evaluation on uses with the most potential for harm. In the final rule, EPA allows for a phased-in approach to risk evaluation, where it can exclude certain conditions of use from evaluation, including uses of de minimis amounts. EPA intends to list certain conditions of use as posing no unreasonable risk early in the risk evaluation, probably when publishing a proposed scope. If EPA receives no objection during public comment, it would then publish an interim notification accepting certain conditions of use as posing no unreasonable risk. However, these are not final rules until EPA publishes its final risk evaluation for the chemical — a process that takes three to three-and-a half years.
Final Rule Highlights
The final rule embraces a more flexible, case-by-case view of what will constitute “conditions of use” (COU):
- COU will be identified on a case-by-case basis.
- EPA need not include all conditions of use in the scope of a risk evaluation, and EPA need not evaluate all conditions of use in the risk evaluation. For most chemical substances, these circumstances will primarily be determined during prioritization.
- The rule identifies certain activities that may generally not be considered to be conditions of use.
- The rule indicates that EPA may, on a case-by-case basis, exclude certain activities from risk evaluation that it has otherwise determined to be conditions of use.
- Example: de minimis exposures – e.g., uses that occur in a closed system; uses as an intermediate.
- Conditions of use adequately assessed by another regulatory agency, particularly where the other agency has effectively managed the risks.
The final rule outlines a number of exclusions from COU:
- Isolated, unsubstantiated or anecdotal statements (e.g., on the Internet that a chemical can be used for a particular purpose) will not be COU.
- Intentional misuses.
- Legacy uses, associated disposal, and disposals that have already occurred.
- EPA will focus on ongoing and prospective uses.
- Note the caveat that in a particular risk evaluation “EPA may consider background exposures from legacy use, associated disposal, and legacy disposal as part of an assessment of aggregate exposure or as a tool to evaluate the risk of exposures resulting from non-legacy uses.”
- At any point after EPA has issued its final scope document, EPA may issue an early determination for a subset of conditions of use where it has sufficient information to determine whether the chemical substance presents an unreasonable risk under particular conditions of use.
- EPA has defined terms in the final rule that appear in the statute including aggregate exposure, best available science, reasonably available information, weight of the scientific evidence.
- EPA does not define unreasonable risk in the final rule. It does identify a revised list of some of the considerations EPA will use in making a risk determination. EPA has removed consideration of cumulative exposure, margin of exposure (MOE) from the final rule, and has added environmental risks. The agency says that “to make a risk determination, EPA may weigh a varietya variety of factors in determining unreasonable risk.