By Lynn L. Bergeson and Margaret R. Graham
On December 15, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice requesting public comment on whether a revision of the current size standard definitions for small manufacturers and processors, that are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA), is warranted at this time. Under amended TSCA Section 8(a)(3)(C), the EPA Administrator, after consultation with the Administrator of the Small Business Administration (SBA), is required to “(i) review the adequacy of the standards prescribed under subparagraph (B); and (ii) after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted.”
EPA states in the notice that its preliminary determination is that revisions to currently codified size standards for TSCA Section 8(a) are indeed warranted due to “the magnitude of the increase in the [Producer Price Index (PPI) for Chemicals and Allied Products] since the last revision of the size standards and the current annual sales standard is comparatively low given current revenue-based size standards developed by SBA.”
The need to review and update the definition is long overdue. Stakeholders have been seeking a more appropriate definition for years recognizing that the existing metric is dated and has not kept pace with the passage of time, posing unintended regulatory consequences. EPA is to be commended for its rapid response to yet another new TSCA mandate.
Comments must be received on or before January 17, 2017.
By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On December 7, 2016, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture, processing, and distribution in commerce of trichloroethylene (TCE) for certain uses under Section 6 of the Toxic Substances Control Act (TSCA), due to its determination that there are significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities. The proposed action is significant for several reasons, including that it represents the first use in a very long time of TSCA Section 6 as well as the first Section 6 control action taken under new TSCA. Specifically, EPA is proposing to prohibit the use of TCE in “aerosol degreasing and for use in spot cleaning in dry cleaning facilities; to prohibit commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.” We look forward to a close reading of the proposed rule and to evaluating the arguments, the policy points, and the evidence provided by EPA to satisfy the various legal requirements, including those under Section 6(c) and Section 26.
EPA’s online Fact Sheet on TCE lists questions and answers as related to the proposed rule. In response to Question 3, What are the potential risks of TCE to people?, EPA states that its 2014 risk assessment found TCE to be “carcinogenic to people through all routes of exposure, which include inhalation, dermal (skin), and ingestion.” The pre-publication of the proposed rule is available on EPA’s website. Once it has been published in the Federal Register, comments must be submitted within 60 days of publication.
By Lynn L. Bergeson and Molly R. Blessing
As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA). Note the time change from EPA’s previous announcement of this public meeting; the meeting time has been extended to end at 3:00 p.m. instead of the original 12:00 p.m. Reportedly, the response to EPA’s earlier notice was quite robust so EPA has extended the public meeting by three hours.
EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.” Interested parties will have the opportunity to comment “on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) under section 5 of the law.” Information obtained during this meeting and from submitted written comments will be considered as EPA works to “implement the new requirements and improve the efficiency of its review process under TSCA.”
In-person and webinar registration is available now. EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658 and must be submitted by January 14, 2017.
More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, as well as on the Bergeson & Campbell, P.C. website under Regulatory Developments: TSCA.
As noted in our earlier blog, given the considerable impact of new TSCA on EPA’s New Chemicals Program, this public meeting is a must attend for TSCA stakeholders. Interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can usefully share with EPA at the meeting. This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.
One point in particular that we draw attention to is a sentence at the top of page 86714 in the Federal Register notice describing the affirmative determinations that initially are tied to unreasonable risk determinations, then goes on to claim that there is an alternative concerning “insufficient information to allow for a determination.”
Pursuant to the amended law, EPA is now required to make an affirmative determination as to whether or not the new use or new chemical presents, may present, or is not likely to present an unreasonable risk of injury to health or the environment, or, alternatively, if there is insufficient information to allow for a determination.
This reading of the law is plainly at odds with the text that clearly states (Section 5(a)(1)(B)) that EPA has to “make a determination under subparagraphs (A), (B), or (C) of paragraph (3).” The insufficient information provision appears at Section 5(a)(3)(B)(i). and, thus, “insufficient information” is both included within (B) and is a determination. We also note that in discussing the affirmative determinations, EPA has omitted discussion of the substantial production/exposure determination at Section 5(a)(3)(ii)(II).
While this may only represent an error in drafting the notice, it is also possible that it indicates a basic misunderstanding of the new chemicals provisions, a view that may find support in some of the decisions recently communicated to our clients in “action letters” on Section 5 notices.
By Lynn L. Bergeson and Charles M. Auer
On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the initial ten chemical substances on which risk evaluations will be conducted under Toxic Substances Control Act (TSCA) Section 6(b)(2)(A). The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments, are:
Pigment violet 29
EPA is required under TSCA Section 6(b)(2)(A) to announce the chemicals within 180 days of enactment, or by December 19, 2016.
Interestingly, several of the chemicals are the subject of Section 6 rules that are currently undergoing review by the Office of Management and Budget (OMB). These include TCE, methylene chloride, and NMP. Assuming that EPA continues with these rules (relying on the savings provision at TSCA Section 26(p)(3) to use the completed risk evaluations on these chemicals in taking the Section 6 actions), the inclusion of the chemicals on the list may suggest that EPA will broaden the risk evaluations to include other conditions of use beyond those in the completed risk assessments.
For more on the chemicals listed and additional information: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/evaluating-risk-existing-chemicals-under-tsca.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has just announced that its Office of Pollution Prevention and Toxics (OPPT) is holding a meeting on December 14, 2016, from 9:00 a.m. to 12:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.” During the meeting, interested parties will have the opportunity to provide input on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMN), microbial commercial activities notices (MCAN), and significant new use notices (SNUN), under TSCA Section 5. EPA states that information obtained during this meeting and from submitted written comments will be considered as it works to implement the new requirements and increase efficiency in its review process under TSCA.
There has been considerable concern with the impact of new TSCA on EPA’s New Chemicals Program. EPA is to be recognized for seeking stakeholder input, and interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can reasonably achieve from the meeting. This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.
In-person and webinar registration is available now. EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658. More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.
By Lynn L. Bergeson and Margaret R. Graham
On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act. This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called “high priority” chemicals. This is the second rule of three Framework Action rules that amended TSCA has directed EPA to issue in final within one year of enactment, or by mid-June 2017. The Inventory rule, which will require industry reporting of chemicals manufactured/processed in the previous ten years, is expected to be sent to OMB soon. Whether election transition issues will complicate and perhaps slow the review process is unclear but certainly not unlikely.
More information on the implementation of amended TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.
The November 14, 2016, BNA Daily Environment Report featured comments from James V. Aidala, Senior Government Affairs Consultant for Bergeson & Campbell, P.C. (B&C®), in the story “Trump Transition Team Expected Soon at EPA To Begin Review of Agency Actions, Priorities” (paid subscription):
- Trump’s EPA transition team will likely receive "massive briefing books" on each of the agency’s programs, including air pollution, water, waste and pesticides, according to Jim Aidala, a senior government affairs consultant with Bergeson & Campbell P.C. in Washington D.C. Aidala, who worked at the EPA from 1993 through 2001, including a stint as Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances (now Office of Chemical Safety and Pollution Prevention), told Bloomberg BNA in an interview conducted before the election that those briefing books will need to include updates on pending litigation and decisions that need to be made early in the administration. Aidala highlighted a number of pending decisions that need to be made under the amended Toxic Substances Control Act (Pub. L. No. 114-182) that was signed into law in 2016. For the new chemicals law, the incoming EPA team will need to be briefed on necessary implementation activities, including prioritization of chemicals for review and new hiring to expand the agency’s chemicals program, Aidala said.
Career Staff Cooperation Expected
- Aidala, in a follow-up interview conducted Nov. 9, said that there may be some ‘‘initial skepticism’’ between some at the EPA and the Trump transition team. During the primaries, Trump said he’d like to eliminate the agency, but later backed off on that promise and said he planned to refocus the EPA on its ‘‘core mission’’ of focusing on clean air and safe drinking water. However, Aidala noted many of the mid-level and senior career staff at the EPA have been at the agency long enough that they’ve seen Administrations of both political parties come and go. ‘‘Career staff across the government are professionals,’’ he said. ‘‘There is a general duty to tell the leadership what is important and what is not.’’
By Lynn L. Bergeson
On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency. Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA's process and criteria for identifying high priority chemicals for risk evaluation and low priority chemicals. As stated in our memorandum TSCA Reform: EPA Publishes First Year Implementation Plan, this rule is the first of three “Framework Action” rules that the Frank L. Lautenberg Chemical Safety for the 21st Century Act (new TSCA) has directed EPA to issue in final within one year of enactment, or by mid-June 2017. For all three of these rules, the interim milestone for the proposed rules is mid-December 2016; therefore, it is anticipated that the three other rules will soon be sent to OMB for review as well. The two others are:
- Risk Evaluation Process Rule: A Procedural rule to establish EPA's process for evaluating the risk of high priority chemicals; and
- Inventory Rule: Rule to require industry reporting of chemicals manufactured/processed in the previous ten years. Results will be used to designate active and inactive chemicals on the TSCA Inventory of existing chemicals.
There is a fourth Framework Action rule that new TSCA has directed EPA to issue as well, but it does not have a deadline for issuance in final; new TSCA only species the mid-June 2017 date as a goal:
- Fees Rule: EPA is authorized to collect fees to help defray the cost of implementing certain provisions and to fully defray the cost of industry-requested risk evaluations, but must put a rule in place to require fees. There is no deadline in the bill, but authority to require fees will be needed as soon as possible.
More information on the implementation of new TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.
By Zameer Qureshi
Lynn L. Bergeson, Managing Partner at Bergeson & Campbell, P.C. (B&C®), presented at Chemical Watch Enforcement Summit Europe in Brussels on November 4, 2016. Topics covered by Ms. Bergeson included “A New [Toxic Substances Control Act (TSCA)] and Expanded Enforcement and Product Liability Opportunities,” “Next Generation Compliance and Implications for Businesses,” and “eDisclosure -- The New Normal?”
Ms. Bergeson informed attendees of the significant amendments made to chemical regulation in the U.S. by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA). She indicated that new TSCA amends TSCA in a number of ways and provided delegates with useful detail on the significant amendments made by new TSCA, stating that new TSCA:
- Resets the Chemical Inventory based on industry-supplied data;
- Requires screening assessments for all “active substances”;
- Mandates risk evaluation for all “high-priority” substances and risk management for some substances;
- Compels substantiation of confidential business information (CBI) claims; and
- Authorizes testing order authority (i.e., the U.S. Environmental Protection Agency (EPA) can compel chemical testing in addition to the more traditional test rule and consent order testing procedures).
Ms. Bergeson utilized a slide entitled “New Compliance Mandates = New Enforcement Opportunities” to address EPA’s expanded authority under new TSCA (e.g., Section 4 test orders, Section 5 new chemical safety “determinations,” and Section 6 prioritization). She expressed that EPA’s expanded authority under new TSCA gives rise to significant opportunities for enforcement of allegations of non-compliance when Section 4 test orders are issued.
Regarding testing, Ms. Bergeson stated “the [U.S.] testing program has relevance for people anywhere in the world” as chemical manufacturers can be expected to be ordered to test, and manufacturers include importers. Ms. Bergeson expressed that more testing will trigger an enhanced need to consider reporting under new TSCA Section 8(e). She described the possible outcomes of new chemical safety “determinations” by EPA under Section 5 and indicated that as a consequence of new TSCA “we’re going to see lots and lots of new [Significant New Use Rules (SNUR)].” Additionally, Ms. Bergeson stated “[Chemical Data Reporting (CDR)] requirements and Section 8 requirements are much more robust now.”
Drawing on her experience and current information from EPA, Ms. Bergeson analyzed “Next Generation Compliance” and provided insights to attendees on what it means for industry. She relied on a diagram from EPA that indicates Next Generation Compliance encompasses an intersection of “Regulation and Permit Design,” “Advanced Monitoring,” “Electronic Reporting,” “Transparency,” and “Innovative Enforcement.” Ms. Bergeson stated “Next Gen Compliance is an Obama Administration initiative” and emphasized the relevance of the U.S. presidential election for the future of Next Generation Compliance by stating “Next Generation Compliance will likely grow under the Clinton Administration or may die on the vine under a Trump Administration.” She then discussed each of the individual components of Next Generation Compliance.
Regarding Regulation and Permit Design, Ms. Bergeson stated that EPA’s goals were to “make permits clearer,” promote self-monitoring and third-party reporting, make compliance easier than non-compliance, and leverage market forces and incentives.
Ms. Bergeson stated that the expansion of “Advanced Monitoring Technologies” means there are new tools that can assist industry. She described the usefulness of real-time monitoring (i.e., knowing about releases into the environment on a real-time basis), facility feedback loops, fenceline and community monitoring, and remote sensing. Ms. Bergeson noted, as a potential drawback of Advanced Monitoring, that “technologies that have not necessarily been vetted” are finding their way into enforcement consent agreements. She then indicated that while this may be fine, the reliability of such technologies for regulatory purposes is untested and reliance on such technologies in regulatory contexts should not replace more traditional notice and comment rulemaking.
Ms. Bergeson stated “Electronic Reporting is a huge part of Next Generation Compliance; the era of submitting paper [is over],” and informed delegates that “information technologies enable new solutions, but invite concerns regarding accuracy and regulatory reliability.” She stated “Electronic Reporting does not always go as intended and greatly facilitates finding non-compliance.” Ms. Bergeson referenced the relevant EPA memorandum and informed attendees that Electronic Reporting is the default mechanism for providing information under new TSCA, and stated that Ohio Discharge Monitoring Report Electronic Reporting “checks submissions overnight and sends notices” if there are problems, thereby allowing the permittee to make corrections and resubmit.
Regarding Innovative Enforcement, Ms. Bergeson expressed that EPA is using Next Generation tools in enforcement settlements, and that Innovative Enforcement enhances targeting and data analysis to identify and address the most serious violations. She stated “we really like new technologies, but if a technology is new it may not be standardized, making reliance on it necessarily more focused to enforcement and not rulemaking purposes.” Additionally, Ms. Bergeson informed delegates that there is “a little concern in the regulated community in the U.S.” that some of the new technologies evolving from Innovative Enforcement efforts could undermine the notice and comment rulemaking process if these technologies are used for purposes beyond consent orders.
Ms. Bergeson stated that EPA’s “eDisclosure” portal provides companies with a new way to self-report violations of environmental law and is intended to “streamline confessions” by the “legal and corporate community,” and described the two-tier system within EPA’s eDisclosure portal and stated that for some violations “you can get on with your life.”
Ms. Bergeson stated “we always urge [B&C] clients to fix the problem immediately … The issue arises in some contexts of ‘do we tell EPA?’” She then informed delegates of the underpinning principles of eDisclosure by stating “it is believed that self-confessing should be rewarded.” Ms. Bergeson advised that companies can seek to reduce penalties by self-confessing, but the decision to self-confess is always fact dependent, and then indicated that the future of eDisclosure could be significantly impacted by the outcome of the U.S. presidential election.
Ms. Bergeson addressed “Design and Use of Safer Chemicals” and told attendees that EPA has “tried very hard” to promote Safer Chemicals through Green Chemistry, Safer Choice Labels, and the Safer Chemical Ingredient List, and that “creative technologies that are better, cheaper, and less toxic” are actively encouraged by EPA and welcomed by the U.S. chemical regulatory community.
Ms. Bergeson expressed that the implications of new TSCA are significant for the chemical manufacturing, importing, and downstream user sectors and provided beneficial “Closing Thoughts” to attendees. She stated that chemical manufacturers, importers, and downstream users need to:
- Read and understand the law and engage in “trade associations’ implementation activities”;
- Assess chemical product inventories;
- Manage the “business and optics” of chemical assessment, management, and substitution;
- Assess CBI options; and
- Manage chemical data information carefully.
Ms. Bergeson stated that the “implications of new TSCA are paradigm shifting … In the next two to five years we’re going to see opportunities for non-compliance.” Regarding CBI, Ms. Bergeson stated “we need to be very cognizant … Some of the changes are very subtle and it is an area ripe for enforcement … Assertion of CBI is at a higher standard -- EPA will be very vigilant.” Ms. Bergeson emphasized EPA’s “much richer implementation authority” under new TSCA and informed delegates that Next Generation enforcement and eDisclosure tools “add to the pressure” on the U.S. chemical industry to monitor carefully chemical portfolios.
Ms. Bergeson answered a number of questions on new TSCA and EPA’s likely enforcement of it. In response to a delegate’s question relating to the capacity of EPA to manage enforcement of new TSCA, she stated that EPA requires greater resources and is currently recruiting. Ms. Bergeson answered questions from attendees on timelines for pending rules from EPA and highlighted EPA’s interest in expediting its rulemaking on fees. She indicated that fees will be higher under new TSCA. Ms. Bergeson responded to a question regarding the scope of new TSCA by clarifying that new TSCA relates to industrial chemicals and that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) will continue to maintain their previous regulatory scope. Ms. Bergeson indicated that the only exception is found under TSCA Section 8(b)(10), which requires any or all mercury or mercury compounds, or any intentional use of mercury in a manufacturing process to be reported to EPA under the mercury inventory and reporting provisions, regardless of whether the use of the mercury or mercury compound is regulated under FIFRA or FFDCA.
By Lynn L. Bergeson, Charlie M. Auer, and Margaret R. Graham
On October 21, 2016, the U.S. Environmental Protection Agency (EPA) reopened the comment period on a proposed rule revising regulations governing significant new uses (SNU) of chemical substances under the Toxic Substances Control Act (TSCA), per a request from a commenter. EPA states in its Federal Register notice that this request was “reasonable and is therefore reopening the comment period … [for] all interested persons.” The proposed rule would amend the TSCA SNU regulations to align them with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as occasioned by OSHA's March 2012 final rule modifying the HCS to conform to the United Nations' (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. The proposed rule would also amend regulations for SNU rules (SNUR) previously proposed and issued and make a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices.
The brief notice reopening the comment period does little to reinforce the magnitude and consequences of these proposed changes. Our memorandum TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards provides a detailed account of the significant and complex issues that these changes raise, briefly reiterated here:
- The challenges in aligning labeling, as well as legal and regulatory ambiguities. EPA has devoted considerable effort to clarifying the application of HCS/GHS requirements to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) but unresolved issues still remain. The implementation of these revisions will most likely present similar challenges.
- EPA’s use of the hierarchy of controls (HOC) approach in the significant new use provisions, even though Congress did not include this approach in new TSCA. The wisdom of the inclusion of the HOC approach, even though we recognize and appreciate the importance of HOC as an element in a system to manage or eliminate occupational risks, is questionable and inconsistent.
- Whether or not EPA's review considered the possibility that new TSCA may materially impact the content of the proposal. There are signs, such as EPA’s inclusion of old TSCA citations, that point to them not having done this review, and there are no reassurances from EPA that new TSCA’s potential impacts were considered.
Our memorandum TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors also brings to light another important legal issue, concerning interesting anomalies that appear in the proposal's discussion of bona fide requests and the disclosure of information potentially considered confidential. EPA proposes to modify the procedures for determining if a specific substance or chemical use is subject to a SNUR when the substance, production volume, or use is claimed as confidential business information (CBI). The source of EPA’s authority to disclose CBI in the ways described in the proposed rule is unclear, as neither old nor new TSCA specifies them, such as the statutory basis and rationale for informing a bona fide intent notice (BFN) submitter of confidential use or production volume conditions. Also, EPA does not justify why disclosure to the BFN submitter is necessary. The current proposed SNUR provides for neither equal disclosure nor equal confidentiality as a result of BFN submission.