By Lynn L. Bergeson, James V. Aidala, and Margaret R. Graham
On February 2, 2017, Dominic J. Mancini, Acting Administrator of the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) issued interim guidance in a questions and answers format (Q&A) to implement President Trumps’s recent Executive Order (EO) regarding the costs of agency rulemaking, Memorandum: Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, Titled “Reducing Regulation and Controlling Regulatory Costs.” More information on the EO is available in our blog item EPA Issues Report to Congress on Implementing Amended TSCA Provisions, President Trump Issues Memo and Order on Reducing Federal Regulations.
The OMB memorandum, issued for regulatory policy officers and executive departments and agencies and managing and executive directors of certain agencies and commissions, states that it explains three requirements specified in the EO:
- That every agency must identify two existing regulations to be repealed when they promulgate a new rulemaking;
- That there can be no incremental costs (no greater than zero) for any new regulations or for the repeal of any regulations for fiscal year (FY) 2017, unless otherwise required by law or consistent with advice provided in writing by the OMB Director; and
- In furtherance and in relation to # 1, if there are any new incremental costs, they will be offset by the elimination of the existing costs of at least two prior regulations.
Agencies planning to issue one or more significant regulatory action on or before September 30, 2017 (the end of FY 2017), are directed to provide: (1) “[a] reasonable period of time before the agency issues that action, identify two existing regulatory actions the agency plans to eliminate or propose for elimination on or before September 30, 2017”; and (2) “[f]ully offset the total incremental cost of such new significant regulatory action as of September 30, 2017.”
The memorandum’s Q&As cover 23 questions under three categories: Coverage; Accounting Questions; and Process and Waiver Questions. A few of the stated answers include:
- The requirements only apply to significant regulatory actions issued between noon on January 20, 2017, and September 30, 2017;
- New significant guidance or interpretive documents will be addressed on a case-by-case basis;
- Regulatory actions issued before January 20 that are vacated or remanded by a court after that date will not qualify for savings, but regulatory actions overturned by subsequently enacted laws will qualify, on a general basis;
- Costs should be measured as the opportunity cost to society, and be annualized as defined in and in accordance with OMB Circular A-4, a Memorandum on Regulatory Analysis issued in 2003;
- Regulatory actions should be eliminated before or on the same schedule as the new regulatory action they offset (to the extent feasible);
- Regulatory savings by a component in one agency can be used to offset a regulatory burden by a different component in that same agency; and
- An agency that is not able to generate sufficient savings to account for its regulatory actions may submit a request to the OMB Director to request a transfer of savings from another agency.
This guidance about the meaning and implementation of the EO will provide greater direction to the broad goals of the Trump Administration’s desire to “reduce regulation.” On its face, this “2 for 1” directive is a clear message to the agencies to reduce the regulatory burdens of their work, mostly regardless of the particular mission or underlying legislative requirements of the affected programs.
One obvious target of such effort is the U.S. Environmental Protection Agency (EPA), widely criticized during the Trump campaign and in the party platform as causing harm to the economy and hindering economic growth. Like any broad campaign rhetoric that becomes more substantive as the specifics are rolled out, it is interesting to see what the possible exceptions are or to speculate where implementing the broad rhetorical goal will lead to unpredictable outcomes. An example might be how reductions in record-keeping costs in one EPA program might offset new regulatory costs in another: this ironically may give new internal value to some parts of EPA which have routinely been more heavy-handed in imposing regulatory requirements. “Burdensome and unnecessary” requirements imposed by the enforcement office may be of help in the ability to propose new water program regulations -- or any number of odd fellow combinations may come to the surface.
Other unanticipated consequences will also include those regulations that are actively supported by the affected regulated entity. The pesticide industry is one example where a regulation establishing the allowable amount of a pesticide used on food -- the tolerance -- is essential for completing the registration process allowing the use of a new pesticide. So this kind of regulation fosters innovation and economic return to the industry, and without this regulation, the product will not make it to market. So the new Administration policies must allow for and distinguish between a sort of “good” regulation and a “bad” regulation -- all fitting within the broad rhetorical directive of a “2 for 1” approach to reducing regulatory burdens.
By Lynn L. Bergeson and Margaret R. Graham
In January, the U.S. Environmental Protection Agency (EPA) issued its initial report to Congress on its capacity to implement certain provisions of the amended Toxic Substances Control Act (TSCA). The report, prepared by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for the Committees on Energy and Commerce, and appropriations of the U.S. House of Representatives, and the Committees on Environment and Public Works, and Appropriations of the U.S. Senate, was directed to be provided within six months of enactment under Section 26(m)(1) of amended TSCA. In the report, EPA states that it anticipates “ramping up from 10 risk evaluations in FY2017 to 15 in FY2018, reaching 20 by the end of FY2019,” which is necessary “to accomplish an ongoing pace of at least 20 EPA-initiated risk evaluations underway” by the end of calendar year (CY) 2019. EPA also provides a table on page five, Table 1: TSCA Risk Evaluations, Numbers Underway and Resources Estimates, which presents estimates for its annual costs, calculated by dividing the average lifecycle costs of the actions by the number of years the statute provides for the agency to complete those actions, and then multiplying the result by the numbers of actions required/anticipated to be underway each year. The total annual costs range from $12.3 million for FY2017 to $35.8 million for FY2021. The report refers to the rule to implement the fee collection provisions, stating it is “currently under development,” but does not provide any more details on when it will be issued.
On January 30, 2017, President Trump issued a Memorandum for the Heads of Executive Departments and Agencies in the Federal Register which directs federal agencies to “support the expansion of manufacturing in the United States through expedited reviews of and approvals for proposals to construct or expand manufacturing facilities and through reductions in regulatory burdens affecting domestic manufacturing.” 82 Fed. Reg. 8667. The memo will require the Secretary of the Department of Commerce (DOC) to conduct outreach to stakeholders concerning the impact of federal regulations on domestic manufacturing and to solicit comments for 60 days concerning “Federal actions to streamline permitting and reduce regulatory burdens for domestic manufacturers.” DOC is also instructed to coordinate this process with the Secretaries of EPA, the U.S. Department of Agriculture (USDA), the U.S. Department of Energy (DOE), and the Administrator of the Small Business Administration (SBA), among others, and within 60 days after the process is completed, to submit a report setting forth a plan to streamline federal permitting processes for domestic manufacturing and “to reduce regulatory burdens affecting domestic manufacturers,” identifying “priority actions as well as recommended deadlines for completing actions.”
Also on January 30, 2017, President Trump issued an Executive Order on reducing regulation and controlling regulatory costs casually referred to as the “one in, two out” order which states that when executive departments and agencies “publicly propos[e] for notice and comment or otherwise promulgat[e] a new regulation, [they] shall identify at least two existing regulations to be repealed.” The order also states that no incremental costs can be accrued for any new regulations unless required by law or advised in writing by the Director of the Office of Management and Budget (OMB). For any costs that are accrued, it is directed for them to be “offset by the elimination of existing costs associated with at least two prior regulations.” In the order, the OMB Director is tasked with providing guidance on implementation, as well as identifying the total amount of costs allowed for each agency “in issuing new regulations and repealing regulations for the next fiscal year.” The regulations exempt from this order are: regulations issued with respect to a military, national security, or foreign affairs function; regulations related to agency organization, management, or personnel; and other categories exempted by the OMB Director.
By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, and Oscar Hernandez, Ph.D.
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.
By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, and Oscar Hernandez, Ph.D.
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.
By Lynn L. Bergeson and Carla N. Hutton
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
TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA
September 22, 2016
Proposition 65: OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations
August 8, 2016
TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors
June 29, 2016
TSCA Reform: EPA Publishes First Year Implementation Plan
April 8, 2015
K-REACH: List of Priority Existing Substances Submitted for Consultation
December 20, 2016
TSCA: EPA Amends Procedures for TSCA Section 6 Rulemaking
January 6, 2016
EPA Releases Preliminary Risk Assessment for Neonicotinoid Insecticide Imidacloprid
January 8, 2016
EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA
February 10, 2016
Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide
October 19, 2016
Brazil Delays Promulgation of Final Industrial Chemicals Regulation
October 6, 2015
EPA Announces Revisions to Its Worker Protection Standard
September 28, 2016
EPA Announces Regulatory Determinations on MCANs and PMNs
January 13, 2016
EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open
December 1, 2016
Brexit -- An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws
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).
By Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham
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:
- Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
- Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
- The addition of a limit test option to several acute invertebrate toxicity tests;
- Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
- Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.
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.
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 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.