By Lynn L. Bergeson
On August 14, 2017, Bergeson & Campbell, P.C. (B&C®) announced it would be forming a Toxic Substances Control Act (TSCA) New Chemicals Coalition. That the U.S. Environmental Protection Agency (EPA) is now required to make a determination on all new chemicals (or significant new uses of existing chemicals) is at the heart of the changes in EPA’s review of new chemicals, and the new policies and practices that have emerged since June of 2016. What is less clear is how EPA is making these determinations. The coalition’s mission is to prepare meaningful comments and offer constructive, helpful, and informed improvements to the new chemicals review process.
Joining the coalition is easy. We are asking for a flat fee of $1,000 per company for a 12 month period. We are not currently allowing trade associations to join. The chemical community has participated in ad hoc coalitions for years, so the drill is familiar. Dues will be used to:
- Convene meetings and calls;
- Develop advocacy positions on crucial issues to be decided and prioritized, including preparing for EPA’s Fall 2017 release of documents on how it reviews new chemicals; and
- Provide informed and effective comment on these issues and meet with EPA leadership to advocate for the Coalition’s views on these issues.
More information is available in our memorandum Bergeson & Campbell, P.C. Forms “TSCA New Chemicals Coalition.”
By Lynn L. Bergeson and Carla N. Hutton
As reported in our January 11, 2017, blog item, the January 12, 2017, final rule establishes reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. Under the 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 August 14, 2017, 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. More information regarding the final rule is available in our January 12, 2017, memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.
By Lynn L. Bergeson and Margaret R. Graham
On August 10, 2017, and on August 11, 2017, petitions for review of two of the U.S. Environmental Protection Agency’s (EPA) final “framework rules” issued under the amended Toxic Substances Control Act (TSCA) were filed in federal court. These six lawsuits seek review of the final rule Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA. The petitions were filed by Safer Chemicals, Healthy Families, et al. on August 10, 2017 (Cases 17-72260 and 17-72259); the Alliance of Nurses for Healthy Environments, et al. (including the Natural Resources Defense Council) on August 11, 2017 (Cases 17-1926 and 17-1927 (consolidated)); and the Environmental Defense Fund (EDF) on August 11, 2017 (Cases 17-2464 and 17-2403), in the U.S. Court of Appeals for the Ninth, Fourth, and Second Circuits, respectively. In the Ninth Circuit, the Petitioner’s Briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017; in the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017; in the Second Circuit, a briefing schedule has not been posted yet.
In its petitions for review, Safer Chemicals, Healthy Families, et al. state that they challenge the rules as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; in excess of statutory jurisdiction, authority, or limitations; and without observance of procedure required by law.” On the Safer Chemicals, Healthy Families’ website, the organization states that the petitions allege the rules “fail to provide the protections against unsafe chemicals that Congress required in the critical priority-setting and risk evaluation provisions of the new law, which are intended to ensure that unreasonable risks to health and the environment are fully assessed and eliminated.” In its petitions for review, EDF does not list any details as to why it is seeking review (nor do the rules require petitioners to do so), but on its website it states that “EPA has issued framework rules that violate the letter and intent of the law,” and that EDF has filed lawsuits challenging those rules and “will continue to monitor EPA’s actions to ensure EPA complies with the law and protects public health.” The petitions for review filed by the Alliance of Nurses for Healthy Environments, et al. do not list any details as to why they are seeking review.
By Lynn L. Bergeson and Margaret R. Graham
On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a notice on further nominations to the Science Advisory Committee on Chemicals (SACC). EPA’s notice provides the names and affiliations of 64 additional candidates currently under consideration for appointment to SACC. Biographical sketches for these candidates will be are posted on EPA’s website.
EPA will also be considering the 29 candidates for membership previously identified in the December 9, 2016, Federal Register notice -- their biographical sketches are available here. EPA states that it “anticipates selecting approximately six additional SACC members with specific expertise and perspectives representing industry, labor, animal protection, government, public health, and public interest groups.” EPA is inviting comments on the candidates to be used to assist in the selection process. Comments are due September 5, 2017.
More information on these new nominations is available in our memorandum EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals. More information on the SACC is available on our blog under key word SACC.
By Lynn L. Bergeson and Margaret R. Graham
On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda. The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included many items under the Toxic Substances Control Act (TSCA), including six in the final rule stage, ten in the proposed rule stage, and one in the prerule stage. The six items in the final rule stage are:
- RIN 2070-AK20: Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act. This final rule has been issued in final and published in the Federal Register. The effective date is September 18, 2017. More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
- RIN 2070-AK23: Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act. This final rule has been issued in final and published in the Federal Register. The effective date is September 18, 2017. More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
- RIN 2070-AK24: TSCA Inventory Notification Active-Inactive Reporting Requirements. This rule has been issued in final but is still awaiting publication in the Federal Register. The expected effective date is the date of publication. More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
- RIN 2070-AJ54: The Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements. This final rule has been issued in final and published in the Federal Register. The effective date listed in the Federal Register was May 12, 2017, but the effective date listed in the agenda is TBD. More information on this final rule is available in our memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.
- RIN 2070-AJ91: Significant New Use Rule for Toluene Diisocyanates (TDI) and Related Compounds. The agenda states that EPA is developing a significant new use rule (SNUR) under Section 5(a)(2) of TSCA for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers and related compounds. This rule is still awaiting issuance in final and publication in the Federal Register. It was scheduled to be issued in June 2017.
- RIN 2070-AJ44: Formaldehyde Emission Standards for Composite Wood Products. The agenda states that this final rule implements the Formaldehyde Standards for Composite Wood Products Act, which added Title VI to TSCA, and its purpose is to reduce formaldehyde emissions from composite wood products. This rule has been issued in final and published in the Federal Register. Its effective date was delayed per a subsequent Federal Register notice to May 22, 2017, but is listed on the agenda as TBD.
The ten items in the proposed rule stage are:
- RIN 2070-AJ65: Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions. The agenda states that EPA is developing a revised proposal that will address concerns raised by commenters in response to its preliminary determination that certain strains of Trichoderma reesei and Bacillus amyloliquefaciens will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met. EPA is also considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA 5(h)(4) exemption. This second proposed rule was scheduled to be issued in June 2017.
- RIN 2070-AJ99: Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule. The agenda states that EPA is re-proposing a significant new use rule (SNUR) under TSCA Section 5(a)(2) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, and for perfluorooctanoic acid (PFOA) or its salts following changes under amended TSCA. This second proposed rule is scheduled to be issued in October 2017 and is scheduled to be issued in final in October 2018.
- RIN 2070-AK07: N-Methylpyrrolidone (NMP) and Methylene Chloride; Rulemaking Under TSCA Section 6(a). The agenda states that EPA is developing a supplemental proposed rulemaking to address the risks from methylene chloride, specifically in commercial furniture refinishing as an industry. This rulemaking is separate and apart from the proposed rule to ban certain uses of NMP and methylene chloride that was issued in January 2017. The issuance of this supplemental proposed rule is TBD.
- RIN 2070-AK11: Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a); Vapor Degreasing. More information on this rulemaking is available in our blog item EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a). The comment period for this proposed rule ended in May 2017. The issuance of the final rule is TBD.
- RIN 2070-AK22: Mercury; Reporting Requirements for the TSCA Mercury Inventory. The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 8(b)(10)(D) which requires EPA to issue a final rule no later than two years after the enactment of the TSCA amendments to establish reporting deadline(s) and information requirements for the purpose of assisting EPA's statutorily-mandated periodic update and publication of the inventory of mercury supply, use, and trade in the U.S. This proposed rule is scheduled to be issued in October 2017 and is scheduled to be issued in final in June 2018.
- RIN 2070-AK27: Service Fees for the Administration of the Toxic Substances Control Act. The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 26(b)(1) which authorizes EPA to issue a rule to establish fees to defray the cost of administering TSCA Sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under Section 14 information on chemical substances (including contractor costs incurred by the Agency). More information on this rulemaking is available in our memoranda TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA. The proposed rule is scheduled to be issued in August 2017 and the final rule is scheduled to be issued in June 2018.
- RIN 2070-AK31: TSCA Chemical Data Reporting; Requirements for Inorganic Byproducts. The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 8(a)(6)(A) which requires EPA to enter into a negotiated rulemaking and develop and publish a proposed rule within three years of enactment that addressed chemical data reporting requirements for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed. The proposed rule is scheduled to be issued in May 2018.
- RIN 2070-AK30: Labeling Relief; Formaldehyde Emission Standards for Composite Wood Products. On July 11, 2017, EPA issued a direct final rule and a parallel proposed rule that the agenda states “clarify requirements for labeling composite wood products and finished goods made entirely of composite wood products,” in response to stakeholders’ concerns that certain new requirements resulting from the implementation of the Formaldehyde Standards for Composite Wood Products Act (via final rule issued on December 12, 2016) may give rise to unintended supply chain disruptions as the compliance deadline established approaches. The direct final rule is scheduled to become effective on August 25, 2017, unless adverse comments are received by July 26, 2017. Comments on the proposed rule were due on July 26, 2017.
- RIN 2070-AK35: Compliance Date Extension; Formaldehyde Emission Standards for Composite Wood Products. On May 24, 2017, EPA issued a direct final rule and a parallel proposed rule that intended to extend the Formaldehyde Emission Standards for Composite Wood Products final rule (issued Dec. 12, 2016) compliance dates, and extend the California Air Resources Board Third Party Certifiers transitional period. On July 6, 2017, EPA withdrew the direct final rule and the proposed rule after it received adverse comment. The Federal Register notice withdrawing the final rule and the proposed rule states that EPA will proceed with a final rule based on the proposed rule after considering all public comments, but no further updates were provided.
- RIN 2070-AK36: Voluntary Consensus Standards Update; Formaldehyde Emission Standards for Composite Wood Products. The agenda states that EPA intends to issue a direct final rule and a parallel proposed rule to amend the December 2016 final rule on Formaldehyde Emission Standards for Composite Wood Products to correctly reference the current voluntary consensus standards as some of them have been updated, superseded or withdrawn. The voluntary consensus standards that were incorporated in the final rule address a variety of topics, including material performance requirements and construction, test methods, and conformity assessments. This proposed rule and direct final rule were scheduled to be issued in June 2017.
The one item in the prerule stage is:
- RIN 2070-AK29: TSCA Reporting and Recordkeeping Requirements; Standards for Small Manufacturers and Processors. The agenda states that under amended TSCA, EPA is developing an action to implement TSCA Section 8(a)(3)(C) which requires that EPA, after consultation with the Administrator of the Small Business Administration, to review the adequacy of the standards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of TSCA Sections 8(a)(1) and 8(a)(3), and, after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted. More information on this action and the initial notice issued in December 2016 is available in our blog item EPA Requests Public Comment on Revision of Current Size Standard Definitions Under TSCA. A second notice was scheduled to be issued in June 2017.
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.