Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
On January 13, 2017, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. The process would not consider costs or other nonrisk factors. Risk evaluation is the second step, after prioritization, in a new process of existing chemical substance review and management established under recent amendments to the Toxic Substances Control Act (TSCA). The proposed rule identifies the steps of a risk evaluation process, including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. EPA proposes that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required “form and criteria” applicable to such manufacturer requests. EPA posted a pre-publication version of the proposed rule on its website. When the proposed rule is published in the Federal Register, it will begin a 60-day comment period. This is the third foundational rule released during the week of January 9, 2017. An in-depth memorandum on the proposed risk evaluation process, as well as memoranda regarding EPA’s proposed requirements for TSCA Inventory notification and prioritization process for reviewing existing chemicals, will be available on our website under the key phrase TSCA.
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule in the January 17, 2017, Federal Register that would establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The pre-publication version of the proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and finalizing designations of priority. EPA notes that prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to the Toxic Substances Control Act (TSCA). Publication of the notice will begin a 60-day comment period. More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.
On January 11, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture (including import), processing, and distribution in commerce of trichloroethylene (TCE) for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; 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. EPA is proposing under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit these uses due to its determination that there are “significant health risks associated with TCE use in vapor degreasing,” and they present “an unreasonable risk to human health.” 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. More information on the final rule is available in our memorandum on our website under the key phrase TSCA.
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule on January 13, 2017, that would require a retrospective electronic notification of chemical substances on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. EPA would also accept such notices for chemical substances that were processed. The recent TSCA amendments require EPA to designate chemical substances on the TSCA Inventory as either “active” or “inactive” in U.S. commerce. EPA states in the pre-publication version of the proposed rule that it would use these notifications to distinguish active substances from inactive substances. EPA would include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory. EPA also proposes to establish procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for non-exempt commercial purposes is expected to resume. According to the proposed rule, upon receipt of a valid notice, EPA would change the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active. The proposed rule includes the procedures to submit retrospective and forward-looking activity notifications, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality. Publication of the proposed rule will begin a 60-day comment period. More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.
On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. According to a pre-publication version of the final rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA. The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the effective date of the final rule must report to EPA one year after the effective date of the final rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacture or processing of that discrete form. The final rule will be effective 120 days after publication in the Federal Register. The final rule states that EPA has prepared a detailed response to public comments that will be available in the rulemaking docket. More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase nanotechnology.
The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016 (as measured by clicks, reads, and shares by readers of our blogs and e-mails), a year that was full of surprises and dramatic shifts -- many of which will play out well into the new year.
June 22, 2016
September 22, 2016
August 8, 2016
June 29, 2016
April 8, 2015
December 20, 2016
January 6, 2016
January 8, 2016
February 10, 2016
October 19, 2016
October 6, 2015
September 28, 2016
January 13, 2016
December 1, 2016
Top Articles Authored by B&C:
Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.
Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.
Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.
L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, "The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?," Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.
Coming first quarter 2017 from ABA Books:
Lynn L. Bergeson, Charles M. Auer, New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, American Bar Association (2017).
On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA). The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.” The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.
The changes to test guidelines are varied. Some of the changes include:
The final test guidelines may be of unique interest to TSCA stakeholders. The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing. This change facilitates test plan design, including tiered approaches for initial testing for premanufacture notices (PMN). EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines. In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.
Bergeson & Campbell, P.C (B&C®) will prepare a more detailed comparison soon.
On December 21, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) in the Federal Register. Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow. As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural requirements, and this rulemaking removes the regulations specifying those procedures. The final rule is effective on the date of publication, December 21, 2016.
The final rule appears to amend the Section 6 procedural requirements such that they align with the amended requirements under new TSCA. While the procedural simplifications in new TSCA were a useful change that should better enable regulatory action on existing chemicals, EPA will need to exercise care in its future rulemaking to meet the procedural requirements that remain in Section 6, as well as satisfy the relevant provisions in Section 26. More information regarding this final rule is available in our memorandum TSCA: EPA Amends Procedures for TSCA Section 6 Rulemaking.
On December 15, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act. 81 Fed. Reg. 90843. The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”
In a webinar presented by Bergeson & Campbell, P.C. (B&C®) earlier this fall, we noted the significance of this rulemaking for many entities subject to reporting requirements under TSCA’s Chemical Data Reporting (CDR) provisions under Section 8(a). A “byproduct” is defined as a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture. EPA is of the view that byproducts without a separate commercial value are nonetheless produced for the purpose of obtaining commercial advantage since they are part of the manufacture of a chemical substance produced for commercial purpose. Accordingly, byproducts are considered manufactured substances under TSCA and must be listed on the TSCA Inventory and, therefore, reportable under the CDR -- unless they are exempt. Byproducts are exempt from Inventory listing and CDR reporting if their only commercial purpose is use by public or private organizations that burn it as a fuel, dispose of it as a waste, or extract component chemical substances from it for commercial purposes.
EPA has interpreted “extract component chemical substances from it” narrowly and has determined the exemption is voided if an extraction process involves a chemical reaction. Stakeholders have long asserted that this interpretation discourages recycling programs that necessarily involve a chemical reaction, processes that are frequently used to extract commercially valuable metals or other materials from byproducts that would otherwise be destined for disposal. The speed with which EPA has moved to implement this provision reflects EPA’s interest in ensuring this regulatory disconnect is addressed before the next CDR reporting cycle in 2020.
The notice states that the main purpose of the NRC is to conduct discussions in a good faith attempt to reach consensus on proposed regulatory language. The notice provides a clear and comprehensive discussion of the negotiated rulemaking process and procedures, initially identifies specific parties that may be interested in participation, and requests comment on the extent to which the approaches described in the notice are adequate and appropriate. The notice should be carefully reviewed by any entity having an interest in this issue. Comments are due by January 17, 2017.
We note in addition that the notice specifically discusses the Section 8(a) CDR rule as being relevant to the negotiation. While we agree that the CDR is clearly of interest, we note that the negotiation as structured applies to any rule under Section 8(a), such as the Preliminary Assessment Information Rule (PAIR) (40 C.F.R. Part 712) and any chemical-specific Section 8(a) rules (40 C.F.R. Part 711). At the same time, the negotiation as described in new TSCA is limited to Section 8(a) and does not address the issues of Inventory listing and potentially associated Section 5 notification requirements for inorganic byproducts. We note also that as a FACA Committee, the NRC can consider and, by consensus, determine its interest in also picking up these closely related issues for discussion and attempt to develop a consensus approach.
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.
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.
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.”
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.
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:
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.
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.
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.