By Lynn L. Bergeson and Margaret R. Graham
On July 7, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of the scope documents for the risk evaluations of the first ten chemicals that it will be conducting under the amended Toxic Substances Control Act (TSCA). 82 Fed. Reg. 31592. The notice states that each scope document includes “the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to consider in conducting the risk evaluation.” The direct links to the scope documents are available in our blog item EPA Issues Much Anticipated Three Final TSCA Framework Rules, Guidance on Draft Risk Evaluations, and Scoping Documents on Risk Evaluations of First Ten Chemicals under Revised TSCA.
The notice also reiterates that EPA is re-opening existing dockets for the first ten chemicals to “allow for the public to provide additional data or information that could be useful to the Agency in conducting problem formulation, the next step in the process of conducting the risk evaluations for these chemicals.” More information on the reopening of the dockets for public comments, including links to the individual dockets, is available in our blog item EPA Opens Comment Period on Risk Evaluations for First Ten Chemicals under Revised TSCA. As stated in the memo reopening the dockets, but curiously not stated in the published notice (no dates were included), comments are due September 19, 2017.
By Lynn L. Bergeson and Margaret R. Graham
On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval. Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator.” While the “framework rules” have been the subject of considerable focus since last June, this guidance is as important, subject to the one year deadline, and likely to provide significant insights into EPA’s thinking on risk evaluations. EPA must publish the final rule in the Federal Register by June 22, 2017.
More information on the final rule on Procedures for Evaluating Existing Chemical Risks under TSCA is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has released a pre-publication version of its direct final rule signed on April 5, 2017, which states that EPA will be promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 37 chemical substances which were the subject of premanufacture notices (PMN). This action will require persons who intend to manufacture or process any of these 37 chemical substances for an activity that is designated as a significant new use (SNU) by this rule to notify EPA at least 90 days before commencing that activity. This final rule will become effective 60 days after publication in the Federal Register. We note that all of these substances were reviewed under old TSCA, prior to June 22, 2016. The 37 chemical substances are:
- PMN Number P-05-436: Ethylene glycol ester of an aromatic substituted propenoic acid (generic);
- PMN Number P-10-504: Phosphoric acid, metal salt (generic);
- PMN Number P-13-289: Alkanoic acid, tetramethylheteromonocycle ester (generic); PMN Number P-13-908: Polyether polyester urethane phosphate (generic);
- PMN Number P-14-129; CAS Number: 35123: Propanamide, 2-hydroxy-N,N-dimethyl-. -06-9;
- PMN Number P-14-260; CAS Number: 1514-82-5: 1-Propene, 2-bromo-3,3,3-trifluoro-
- PMN Number P-14-759: Pyrolysis oil product (generic);
- PMN Number P-15-279; CAS Number: 1613320-81-2: 1-Octanamine, 7 (or 8)-(aminomethyl);
- PMN Number P-15-409: Substituted alkanolamine ether (generic);
- PMN Number P-15-583: Butanedioic acid, alkyl amine, dimethylbutyl ester (generic);
- PMN Number P-15-672: Carbon nanotube (generic);
- PMN Number P-15-678: Metal salt of mineral acid, reaction products with alumina, aluminum hydroxide, aluminum hydroxide oxide (Al(OH)O), silica, titanium oxide (TiO2) and 3-(triethoxysilyl)-1-propanamine (generic);
- PMN Numbers P-15-766 and P-15-767: Halogenated bisphenol A, polymer with epichlorohydrin, alkenoate (generic) (P-15-766); and Halogenated bisphenol A, polymer with bisphenol A diglycidyl ether and epoxidized phenol-formaldehyde resin, alkenoate (generic) (P-15-767);
- PMN Number P-16-14: Silicon, tris[dialkyl phenyl]-dialkyl-dioxoalkane-naphthalene disulfonate (generic);
- PMN Number P-16-40: Tar acids fraction (generic);
- PMN Numbers P-16-59 and P-16-60: Dialkyl fattyalkylamino propanamide alkylamine (generic) (P-16-59) and Fattyalkylaminopropanoate ester (generic) (P-16-60);
- PMN Number P-16-70; CAS Number: 200443-98-7: Boron sodium oxide (B5NaO8), labeled with boron-10;
- PMN Number P-16-94: Perfluoropolyether modified organosilane (generic);
- PMN Number P-16-95: Modified phenol-formaldehyde resin (generic);
- PMN Number P-16-101: Disubstituted benzene alkanal (generic);
- PMN Number P-16-102: Phthalic anhydride, polymer with alkylene glycol and alkanepolyol, acrylate (generic);
- PMN Number P-16-104; CAS Number: 1546765-39-2: 2-Pyridinecarboxylic acid, 4,5-dichloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-;
- PMN Numbers P-16-136, P-16-139, and P-16-140: Dialkylamino alkylamide inner salt (generic);
- PMN Number P-16-170: Nanocarbon (generic);
- PMN Number P-16-177; CAS Number: 1440529-21-4: Barium molybdenum niobium tantalum tellurium vanadium zinc oxide;
- PMN Number P-16-179: Alkanoic acids, esters with alkanetriol (generic);
- PMN Number P-16-182: (1) Manganese, tris[.mu.-(2-ethylhexanoato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-62-7; Chemical A); (2) Manganese, [.mu.-(acetato-.kappa.O:.kappa.O’)]bis[.mu.-(2-ethylhexanoato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-63-8; Chemical B); (3) Manganese, bis[.mu.-(acetato-.kappa.O:.kappa.O’)][.mu.-(2-ethylhexanoato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-64-9; Chemical C); and (4) Manganese, tris[.mu.-(acetato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-65-0; Chemical D);
- PMN Number P-16-190: Aryl polyolefin (generic);
- PMN Number P-16-260: Melamine nitrate (generic); and
- PMN Number P-16-272; CAS Number: 308068-11-3: Lecithins, soya, hydrogenated.
By Lynn L. Bergeson and Margaret R. Graham
On June 1, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Evaluating Existing Chemical Risks under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.
EPA’s proposed rule describes 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; and identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. This process would 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. Comments were due March 20, 2017; 87 comments were filed. Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017.
More information on the rule as proposed is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.
By Christopher R. Bryant, Lynn L. Bergeson, and Margaret R. Graham
Facing a government shutdown, late on April 30, 2017, lawmakers reached agreement on a spending bill that funds the federal government through September 2017, which is the end of Fiscal Year (FY) 2017.
President Trump’s budget blueprint sought to slash EPA’s coffers by some 31 percent (and more if certain programs were eliminated from the base). The deal reached by lawmakers, however, would essentially fund EPA at its current levels and retain current staff levels. The bill appropriates $8.058 billion for EPA, paring a little over $80 million -- about one percent -- from EPA’s FY 2016 budget.
Programs targeted for elimination by President Trump remain funded, at least through September, when Congress will face another budget showdown. For example, the bill funds the Great Lakes Restoration Initiative, the Chesapeake Bay Program, and lead elimination programs.
While EPA’s budget is generally unchanged, the bill does contain several policy riders. It would require EPA to treat air emissions from forest biomass as carbon neutral. EPA also would not be allowed to regulate manure and similar agricultural byproducts as wastes under the Resource Conservation and Recovery Act (RCRA), and the bill would bar EPA from requiring Clean Water Act (CWA) permits for certain agricultural practices. The legislation also prohibits funding to regulate lead content of ammunition, ammunition components, and fishing tackle under the Toxic Substances Control Act (TSCA) or any other law.
Senate Report No. 114-281 on the pending FY 2017 budget deal and an accompanying explanatory statement also address specifically TSCA, the Integrated Risk Information System (IRIS), and nanomaterials. The specific language is below.
- Toxic Substances Control Act Modernization -- The Committee notes that legislation to modernize the Toxic Substances Control Act [TSCA] was recently approved by both the Senate and the House of Representatives. This bill includes language that will enable the EPA to collect and spend new fees to conduct additional chemical reviews, consistent with TSCA modernization legislation. Those fees are expected to be $25,000,000 per year once the program is fully implemented. The Congressional Budget Office estimates that in fiscal year 2017, fee collections will begin several months after the beginning of the fiscal year and will total $4,000,000. This bill also includes language ensuring that new fee collections will supplement, not supplant, appropriated resources for these activities.
- Integrated Risk Information System -- The Committee is aware of efforts by the Agency to implement the 2011 National Academy of Science’s [NAS] Chapter 7 and 2014 NAS report recommendations for the Integrated Risk Information System [IRIS] but remains concerned that the recommendations have not been fully implemented. In published appendices that accompany final IRIS assessments, EPA has detailed some of the Agency’s deficiencies in meeting the NAS high-priority reforms. The Committee directs the Agency to convene an interagency working group to be Co-Chaired with the Office of Information and Regulatory Affairs and to include relevant executive branch stakeholders to review compliance with the NAS recommendations in IRIS assessments issued since the 2014 NAS report. The working group shall focus specifically on transition from the use of single point estimates of hazard and exposure to presenting more complete information on the distribution of estimated hazards, exposures, and/or risks, including central tendency values; on processes for evaluating study quality, relevance, and risk of bias; the use of a transparent and reproducible weight-of-evidence process for applying scientific findings; the selection of an adverse outcome; and the use of default linear low-dose extrapolation and other default modeling approaches to hazard determinations. The Committee directs the Agency to issue a report to the Committees of Appropriations of the House and Senate on the findings of the working group and the implementation plans of its findings within 180 days of enactment of this act. The working group report shall also include a timetable for EPA’s full implementation of the NAS recommendations for all IRIS assessments issued since the 2014 NAS report.
- Nanomaterials Research -- The Committee notes the increased capabilities that the Food and Drug Administration [FDA] has developed to study environment, health, and safety of nanomaterials [nanoEHS] within FDA’s Jefferson Laboratory Campus, including the National Center for Toxicological Research, and its consolidated headquarters at White Oak, Maryland. The FDA can and should be more involved in nanoEHS research with other agencies, particularly in activities involving human health. Out of the amounts appropriated, the [EPA} Administrator shall seek to involve the FDA in nanoEHS research to the maximum extent possible, including participation in EPA funded research.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that 28 new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.” 82 Fed Reg. 19044 (Statement of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017). The statements of findings list premanufacture notices (PMN) and microbial commercial activity notices (MCAN) regarding new polymer and biodegradable chemicals submitted to EPA under Section 5 of the Toxic Substances Control Act (TSCA). The notices listed in the December 2016 statement of findings are:
- EPA Case Number (MCAN): J-16-0033: Chemical identity: Saccharomyces cerevisiae modified to express glucoamylase activity (generic name);
- EPA Case Number (MCAN): J-16-0034: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Number (MCAN): J-16-0035: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Numbers (MCANs): J-16-0036 to J-16-0041: Chemical identity: Biofuel producing modified microorganism(s), with chromosomally-borne modifications (generic name);
- EPA Case Number (PMN): P-17-0009: Chemical identity: Depolymerized waste plastics (generic name);
- EPA Case Numbers (PMNs): P-17-0016, P-17-0017, P-17-0019, and P-17-0020: Chemical identity: Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated (generic name); and
- EPA Case Numbers (PMNs): P-17-0018 and P-17-0021: Chemical identity: Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, Azobis [aliphatic nitrile] initiated (generic name).
The notices listed in the February 2017 statement of findings are:
- EPA Case Numbers (MCANs): J-17-0001 to J-17-0005: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Number (MCAN): J-17-0006: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Number (PMN): P-17-0144: Chemical identity: Amines, C36- alkylenedi-, polymers with octahydro- 4,7-methano-1H-indenedimethanamine and pyromellitic dianhydride, maleated (CASRN: 2020378-57-6);
- EPA Case Number (PMN): P-17-0158: Chemical identity: Perylene bisimide (generic name);
- EPA Case Number (PMN): P-17-0160: Chemical identity: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2- propenoate, dialkyloxoalkyl-2- propenamide and alkyl 2-propenoate (generic name);
- EPA Case Number (PMN): P-17-0161: Chemical identity: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2- propenoate, dialkyloxoalkyl-2- propenamide, ethenylbenzene and alkyl 2-propenoate (generic name);
- EPA Case Number (PMN): P-17-0182: Chemical identity: Alkyldioic acid, polymer with 2,2-dimethyl-1,3- propanediol, heteropolycyclic carboxy acid anhydride and 1,3-propanediol (generic name); and
- EPA Case Number (PMN): P-17-0185: Chemical identity: Fatty acids, C18- unsatd., dimers, hydrogenated, polymers with C18-unsatd. fatty acid trimers, alkylenediamine and hydroxyalkanoic acid (generic name).
The publication of these two notices fulfills EPA’s obligation under TSCA Section 5(g) to publish its findings; all of these determinations had previously been posted to the EPA website. It is to EPA’s credit that EPA has made its determinations public as soon as practicable by posting those determinations on its website. We recognize that publication in the Federal Register often lags behind EPA’s decisions because of resource constraints and competition with other Federal Register notices. We are pleased to see new chemicals cleared for production.
Nevertheless, EPA’s pace of approving new chemicals for the marketplace has slowed tremendously since enactment of TSCA reform. Furthermore, these notices do not provide any line of sight on the reasons contributing to the delays, or EPA’s resolution of these issues. To date, EPA has only published its final determinations for substances with low concerns for heath and ecological hazards. With only 28 new chemicals approved from the time period of December 1, 2016, to February 28, 2017, EPA will need to work much faster to even come close to its annual average number of 700-800 PMN reviews and keep the backlog of cases under review from continuing to grow.
By Christopher R. Bryant and Lynn L. Bergeson
According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Dr. Beck holds a doctorate in environmental health from the University of Washington. For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC). For a decade prior to ACC, she was an analyst within the White House’s Office of Management and Budget (OMB).
Despite Dr. Beck’s compelling credentials, the appointment has displeased some stakeholders. Dr. Beck has been a staunch critic of how EPA conducts chemical risk assessments and its Integrated Risk Information System (IRIS). President Trump is proposing to eliminate IRIS; it thus is unlikely that Dr. Beck would revive or rely upon it in implementing the recently revised Toxic Substances Control Act (TSCA). Less than two months ago, Dr. Beck provided testimony before the Senate Homeland Security and Government Affairs Subcommittee on Regulatory Affairs and Federal Management calling for changes to EPA’s risk assessment processes.
By Christopher R. Bryant and Lynn L. Bergeson
A trio of recent internal U.S. Environmental Protection Agency (EPA) memoranda are providing insight into how EPA intends to implement President Trump’s review and potential pogrom of EPA regulations. Virtually no program or regulation appears to be secure from the chopping block. Many stakeholders in industry and other sectors may be alarmed to see programs that are of benefit to them assigned a slot in the guillotine. Supporters of these programs, thus, would be wise to educate senior EPA officials to help them understand the benefits of those programs or regulations, and save them from elimination. These internal memoranda demonstrate that the regulatory dismantling of EPA’s programs is being robustly carried out by EPA. Those stakeholders who wish to save a program benefitting their interests should act immediately to educate EPA. The three memoranda are:
- March 21, 2017, Memorandum -- FY 2018 President’s Budget: Major Policy and Final Resources Decisions;
- March 24, 2017, Memorandum -- Executive Order 13777: Enforcing the Regulatory Reform Agenda; and
- March 24, 2017, Memorandum -- Improved Management of Regulatory Actions.
More information on these memoranda are available in our full memorandum Internal EPA Memoranda Outline Approach for Regulatory Deconstruction; Stakeholders Have the Opportunity to Seek to Protect Programs at Risk.
On Wednesday, April 12, 2017, from 11:00 a.m. to 12:30 p.m. (EDT), the American Bar Association’s Section of Environment, Energy, and Resources will be hosting a teleconference on this very topic, entitled “What Happens Now at EPA: Assessing the Executive Orders and Upcoming Regulatory Reform.” Registration is available online.
By Lynn L. Bergeson and Margaret R. Graham
On March 1, 2017, President Trump’s Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda, issued on February 24, 2017, was published in the Federal Register. 82 Fed. Reg. 12285. This EO follows closely on the heels of his previous EO concerning government regulations (EO 13771), but is different in that it is intended to further and enforce President Trump’s EO as well as EO’s issued in prior administrations, instead of creating an entirely new set of directives. EO 13777 directs the head of every agency (except those receiving a waiver) to designate an agency official as its Regulatory Reform Officer (RRO), who will “oversee the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out regulatory reforms,” including the following initiatives and policies:
- EO 13771 of January 30, 2017 (Reducing Regulation and Controlling Regulatory Costs), regarding offsetting the number and cost of new regulations;
- EO 12866 of September 30, 1993 (Regulatory Planning and Review), as amended, regarding regulatory planning and review;
- Section 6 of Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review), regarding retrospective review; and
- The termination, consistent with applicable law, of programs and activities that derive from or implement EOs, guidance documents, policy memoranda, rule interpretations, and similar documents, or relevant portions thereof, that have been rescinded.
The EO also establishes Regulatory Reform Task Forces (RRTF), consisting of the agency RROs and other designated agency officials, which will evaluate existing regulations and make recommendations to the agency head regarding their repeal, replacement, or modification. Each RRFT is tasked with identifying regulations that:
- Eliminate jobs, or inhibit job creation;
- Are outdated, unnecessary, or ineffective;
- Impose costs that exceed benefits;
- Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
- Are inconsistent with the requirements of Section 515 of the Treasury and General Government Appropriations Act of 2001, or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
- Derive from or implement EO’s or other Presidential directives that have been subsequently rescinded or substantially modified.
Within 90 days of the EO, the RRTFs are also directed to provide a report to the agency head detailing the agency’s progress toward the following goals:
- Improving implementation of regulatory reform initiatives and policies pursuant to Section 2 of this order; and
- Identifying regulations for repeal, replacement, or modification.
Agencies that generally issue very few or no regulations may be eligible for a waiver, but the agency head must file a request with the Director of the Office of Management and Budget (OMB) for a waiver, and waivers can be revoked at any time. More information on EO 13771 and OMB’s Guidance on same is available in our blog items EPA Issues Report to Congress on Implementing Amended TSCA Provisions, President Trump Issues Memo and Order on Reducing Federal Regulations and OMB Issues Guidance on Implementation of “One In, Two Out” Executive Order.
Charles M. Auer and Oscar Hernandez, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on its website on February 9, 2017, that it has established the Science Advisory Committee on Chemicals (SACC). EPA was required to form the SACC within one year after enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The timing is interesting given that the deadline for public comments on the nominees was January 9, 2017, and the EPA Administrator appointed the 18 experts a mere eight days later on January 17 (a full five months ahead of the Congressional deadline), yet the announcement was held until its posting, over three weeks later, on February 9. It thus is the case that the Obama Administration took very prompt steps to ensure that formation was completed during its period in office, perhaps in an effort to select a membership more to its liking and preferences.
Based on our quick review of the affiliations of the 18 experts selected for the SACC, this seems to be the case. Of the members, nine are associated with academic institutions, four with industry (with two from the pharmaceutical industry, one from a trade association (Toy Industry Association), and one a former Dow Chemical Company employee currently with Underwriters Laboratories), two with non-governmental institutions (American Cancer Society and the Humane Society), and three with federal and state government. While there are no members hailing from an environmental advocacy group, similarly there are no members currently affiliated with a chemical company.
Regarding backgrounds, there is an emphasis on expertise associated with exposure and response research on susceptible populations, with nine members having explicit or related expertise on this topic, six of which are experts from academia. In contrast, the panel does not seem to include a breadth of experience in exposure or risk assessment. There are two members who previously chaired EPA’s Children’s Health Protection Advisory Committee, a group that in our view is better known for advocacy than rigorous science.
As many readers will know, the chemical industry had offered critical comments on the slate of nominees that was announced by EPA in the December 9, 2016, Federal Register notice, but little consideration seems to have been given to those comments. At a minimum, it seems self- evident that the current membership would not have been the selection made under the Trump Administration. How all of this will play through under the new Trump Administration is yet to be seen but could get interesting.