Bergeson & Campbell, P.C. Forms “TSCA New Chemicals Coalition”
Section 5 of the Toxic Substances Control Act (TSCA) addresses new chemical notifications and, as such, is chemical innovation’s regulatory gatekeeper. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amended Section 5. The U.S. Environmental Protection Agency’s (EPA) interpretation of these amendments has changed significantly the Section 5 review process in ways that none of us fully anticipated; the numbers speak for themselves. Under old TSCA, approximately 90 percent of new chemical notifications entered commerce without restriction. Since Lautenberg, this number is in the 20 percent range, a remarkable change given the absence of clear Congressional intent fundamentally to amend the New Chemicals Program.
We recognize and applaud EPA’s commitment to release later this year “draft documents that will provide the public with more certainty and clarity regarding how EPA makes new chemical determinations.” A key reason we believe a coalition needs to be organized now is to prepare meaningful comments and offer constructive, helpful, and informed improvements to the new chemicals review process. It will be nearly impossible to prepare comprehensive comments and address the many issues that we anticipate addressing once EPA distributes the draft documents, and solicits comment, presumably within a relatively short time period. Historically, the Section 5 process has been one uniquely shrouded in secrecy; working around confidential business information (CBI) is challenging. We believe, however, that these challenges are best addressed by a community of stakeholders, rather than individual ones. A coalition of submitters is far better situated to discuss critical issues and common themes without discussing specific details. These discussions will provide greater insight into EPA’s approaches and offer an opportunity to engage with EPA to find workable solutions that meet TSCA’s statutory obligations without causing avoidable commercial disruption or imposing unnecessary testing burdens.
EPA’s hard work in implementing Lautenberg is commendable, especially so given a change in Administration. Nothing stated or implied here is intended to impugn EPA’s efforts. Bergeson & Campbell, P.C. (B&C®) remains committed to ensuring TSCA’s implementation fulfills Congress’s goals. Institutionally, B&C has volunteered considerable time and effort over the past year in analyzing the law and EPA’s interpretation and application of it, and has worked hard to assist EPA and other stakeholders with the implementation process. More information is available here.
Lynn L. Bergeson, James V. Aidala, Jr., Charles M. Auer, Richard Engler, And Oscar Hernandez, “Practitioner Insights: Enhancing TSCA Reform Implementation,” Bloomberg BNA Daily Environment Report, August 2, 2017: Lautenberg significantly amended TSCA. Lautenberg, which has been in force for just over a year, made substantive changes to multiple sections of TSCA that are proving to be even more consequential than anticipated (new TSCA is identified as Pub. L. No. 114-182 and old TSCA is identified as Pub. L. No. 94-469). This paper, authored principally by former EPA officials and a practicing TSCA lawyer, all with long experience under old TSCA, provides suggestions for new approaches or ‘‘fixes’’ that could assist EPA and interested groups in moving toward smoother implementation of the new law, achieving policy goals, and ensuring greater transparency. These suggestions are presented in no particular order and in the spirit of urging other stakeholders to also think of creative ways to ensure that new TSCA fulfills Congress’s mandate to develop an effective domestic chemical management program.
EPA Announced New TRI Data: On July 19, 2017, EPA released the preliminary 2016 Toxics Release Inventory (TRI) dataset, the most current TRI data available. These facility-level data show the chemicals that industrial facilities manufacture, process, or otherwise use and release into the environment. The data also show pollution prevention activities initiated by individual facilities during 2016. The data are available in Envirofacts and in downloadable files on the TRI website. EPA urges users to note that while the preliminary data have undergone the basic data quality checks included in the online TRI reporting software, they have not undergone the complete TRI data quality process. In addition, EPA does not aggregate or summarize these data, or offer any analysis or interpretation of them. EPA intends to update the preliminary dataset several times in August and September based on information from facilities. EPA will publish the complete, quality-checked 2016 dataset in October, followed by the 2016 TRI National Analysis in January 2018.
EPA’s Well-Stocked Regulatory Agenda Released: On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda. EPA’s Agency Rule List included many items under TSCA, including six in the final rule stage, ten in the proposed rule stage, and one in the pre-rule 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 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 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 and published in the Federal Register. The effective date was August 11, 2017. 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 rule has been issued in final and published in the Federal Register. The effective date listed in the Federal Register is 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 TSCA Section 5(a)(2) 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 Registernotice to May 22, 2017, but is listed on the agenda as TBD.
More information is available online.
EPA Promulgates All Three TSCA Framework Final Rules: On July 20, 2017, EPA published two of the three TSCA framework final rules in the Federal Register: Procedures for Chemical Risk Evaluation, 82 Fed. Reg. 33726, and Procedures for Prioritization of Chemicals for Risk Evaluation, 82 Fed. Reg. 33753. These rules will become effective on September 18, 2017. EPA also published the notice of availability of its guidance to assist in developing and submitting draft risk evaluations, Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations. 82 Fed. Reg. 33765.
On August 11, 2017, EPA published the third TSCA framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. 82 Fed. Reg. 37520. This final rule is effective as of August 11, 2017 (the date of publication). As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the ten-year look-back period of June 21, 2006, to June 21, 2016. Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018. The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications. More information on these final rules and the guidance are available in our memorandum “EPA Issues Final TSCA Framework Rules.”
On August 10, 2017, and on August 11, 2017, petitions for review of two of EPA’s final “framework rules” 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. More information on is available in our blog item “EPA’s TSCA Framework Rules Challenged in Federal Court.”
Ninth Circuit Denies Motion For Further Mandamus Relief In Chlorpyrifos Proceedings: On July 18, 2017, a panel of three judges at the U.S. Court of Appeals for the Ninth Circuit issued an order denying petitioners’ Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) Motion for Further Mandamus in the chlorpyrifos proceedings. In that motion, Petitioners asked the court to grant further mandamus relief, asserting that the EPA’s denial of Petitioners’ petition to revoke all food tolerances and cancel all chlorpyrifos registrations was inadequate because it contained “no new safety findings” and no “final determination as to whether chlorpyrifos food tolerances must be revoked.” More information on the motion is available in our blog items “Petitioners File Motion for Further Mandamus Relief in Response to EPA’s Order Denying Petition to Ban Chlorpyrifos” and “Ninth Circuit Denies Motion for Further Mandamus Relief in Chlorpyrifos Proceedings.”
EPA’s Regulatory Agenda Lists Proposed And Final Pesticide Rulemakings: On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda. EPA’s Agency Rule List included several pesticide rulemakings in the proposed rule stage, as well as the Certification of Pesticide Applicators rulemaking that is in the final rule stage. The five items in the proposed rule stage are:
RIN 2015-AA00: Revision of Procedural Rules for Hearings on Cancellations, Suspensions, Changes in Classifications, and Denials of Pesticide Registrations. The agenda states that this proposed rulemaking is a “revision of the Rules of Practice governing the conduct of licensing adjudications under [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” The issuance of the proposed rule is scheduled for January 2018.
RIN 2070-AK00: Pesticides; Technical Amendments to Data Requirements. The agenda states that to satisfy one of the commitments in a settlement agreement reached with the American Chemistry Council (Docket ID Number EPA-HQ-OPP-2008-0110-0139), EPA is proposing a correction pertaining to the 200 parts per billion (ppb) level described in 40 C.F.R. Section 158.2230(d) that was originally used by the U.S. Food and Drug Administration (FDA) with respect to the “concentration of residues in or on food for tiering of data requirements for indirect food use biocides.” Through this rulemaking, the agenda states that EPA intends to “clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food.” The issuance of the proposed rule was scheduled for July 2017.
RIN 2070-AK06: Pesticides; Procedural Rule Amendment; Requirement for Certain Pesticide Actions to Publish Notices in the Federal Register. In the agenda, EPA states that as the Federal Register is “no longer the most cost effective or efficient way for providing notice or sharing information with the public,” it is considering changing the way that it provides notice on or shares information with the public — specifically, by no longer publishing certain information in the Federal Register, but instead providing the same information on a consolidated website that the agenda states “will be more accessible to the public and other interested parties, as well as a more cost effective and efficient mechanism for providing timely updates.” The agenda lists the following kinds of notification it is considering making this change regarding: (1) reregistration of a pesticide product with a new active ingredient or new use; (2) announcing approvals of specific, quarantine and public health exemptions; and (3) summaries of certain state registrations. For Registration Review, the agenda state that EPA “intends to announce availability of the documents that are currently announced in the Federal Register on the EPA’s Registration Review Website.” For notices of availability announced in the Federal Register, the agenda states that “EPA intends to direct the public to a case-specific docket on Regulations.gov to view pertinent registration review documents and provide comment.” The issuance of the proposed rule is scheduled for April 2018.
RIN 2070-AK40: Extension of Compliance Date(s); Agricultural Worker Protection Standard. As reported in our memorandum summarizing the Worker Protection Standard (WPS) final rule, “EPA Publishes Worker Protection Standard Final Rule,” the WPS final rule was issued on November 2, 2015, but has not yet been made effective. More information on the delay of its effective date is available in our blog item “EPA to Delay Agricultural WPS Indefinitely; Cites Issues with Guidance and Training.” This proposed rulemaking will adjust the compliance date. The issuance of the proposed rule was scheduled for July 2017 and the issuance of the final rule is scheduled for November 2017.
RIN 2080-AA13: Updates to 40 C.F.R. Part 26 Subpart K to Reflect Recent Changes to 40 C.F.R. Part 26 Subpart A (The Common Rule). As reported in our blog item “Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects,” on January 19, 2017, EPA, together with a host of other federal agencies, released a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991, and is now codified in 40 C.F.R. Part 26, Subpart A. These revisions, scheduled to become effective on January 19, 2018, will create a conflict within some of the EPA-specific subparts, in particular, Subpart K of 40 C.F.R. Part 26 (Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intention Exposure of Non-Pregnant, Non-Nursing Adults), which regulates third party pesticide research. The agenda states that this proposed rulemaking is “intended to resolve proposed rulemaking discrepancies created by the recent revision to Subpart A, and will not alter the fundamental protections for human subjects, including vulnerable populations.” The issuance of the proposed rule is scheduled for January 2018.
More information is available online.
EPA Releases Final Methods And Guidance For Testing The Efficacy Of Antimicrobials Against Public Health Biofilms: On August 1, 2017, EPA announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa (P. aeruginosa) and Staphylococcus aureus (S. aureus): EPA Microbiology Laboratory Branch (MLB) SOP MB-19: Growing a Biofilm using the CDC Biofilm Reactor; and EPA MLB SOP MB-20: Single Tube Method for Determining the Efficacy of Disinfectants against Bacterial Biofilm.
EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically Guidance for Testing the Efficacy of Antimicrobial Products Against Biofilms on Hard, Non-Porous Surfaces. Drafts of the SOPs and the guidance were initially released in October 2016 for comment. EPA received comments from nine entities and revised the drafts to incorporate suggested changes. EPA posted its response to those comments in Docket EPA-HQ-OPP-2016-0357. EPA states that the two methods are adapted from ASTM International (ASTM) standard methods. EPA MLB SOP MB-19 is used to generate the P. aeruginosa or S. aureus biofilm on coupons. EPA MLB SOP MB-20, the Single Tube Method, then is used to determine the effectiveness of an antimicrobial product in reducing bacteria in biofilm on the coupons. Notable aspects of the test criteria and claims guidelines include:
The mean log density for the test organisms of 8.0 to 9.5 for P. aeruginosa and 7.5 to 9.0 for S. aureus; and
Product performance criterion of a minimum 6-log reduction.
The guidance lists several examples of claims for efficacy against public health biofilm that EPA states are acceptable. More information is available in our blog.
EPA Will Host Webinar On Process For Gathering Use And Exposure Information On PBT Chemicals: EPA is hosting a webinar for interested parties to explain the process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended TSCA. This webinar will take place on Thursday, September 7, 2017, at 2:00 p.m. (EDT). It will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on these five chemicals:
Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer, or transformer fluid;
Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as a lubricant, hydraulic fluid, and other industrial uses; and
2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline, or lubricant additive.
Under TSCA Section 6(h), EPA is required to take expedited regulatory action to address risks and exposures from certain PBT chemicals. By June 22, 2019, EPA must propose rules for the above five PBT chemicals that have been identified under TSCA Section 6(h)(1). EPA is currently identifying where these chemicals are used and how people are exposed to them. Following EPA’s presentation, participants will have an opportunity to provide their comments on uses of these five chemicals. To register for this webinar, please visit https://www.eventbrite.com/e/us-epa-use-information-for-pbts-under-tsca-section-6h-tickets-33990779336.
EPA has also established the following public dockets for each PBT chemical that can be found at https://www.regulations.gov: DecaBDE: EPA-HQ-OPPT-2016-0724; PCTP: EPA-HQ-OPPT-2016-0739; HCBD: EPA-HQ-OPPT-2016-0738; Phenol, isopropylated, phosphate (3:1): EPA-HQ-OPPT-2016-0730; and 2,4,6,-Tris(tert-butyl) phenol: EPA-HQ-OPPT-2016-0734. Preliminary information on exposure and use for each of the five PBT chemicals, as well as information that EPA expects to consider in the development of proposed rules, will be made available in each chemical’s docket. EPA is requesting that any information be submitted to the docket by December 9, 2017, so that the information can inform any regulatory action. For more information, visit www.epa.gov/assessing-and-managing-chemicals-under-tsca/persistent-bioaccumulative-and-toxic-pbt-chemicals-under. For more on planned regulatory actions under TSCA, visit EPA’s Assessing and Managing Chemicals under TSCA website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
Four Senators Stall PRIA And Introduce Bill To Amend FFDCA– Asserting “Safety First”: On July 18, 2017, four Senators (Tom Udall (D-NM); Benjamin Cardin (D-MD); Richard Blumenthal (D-CT); and Cory Booker (D-NJ)) submitted a letter to Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI), the Chair and the Ranking Member of the Senate Committee on Agriculture, Nutrition, and Forestry, regarding reauthorizing the Pesticide Registration Improvement Act (PRIA), worker protections, and EPA’s “legal duty to protect the public from unreasonable harm from pesticides.” H.R. 1029, the Pesticide Registration Improvement Extension Act of 2017, which reauthorizes PRIA, was passed by the Agriculture Committee on February 16, 2017. The letter states that it should include a “limited number of improvements” before being approved by the full Senate, including “adequately reflect[ing] important worker safety priorities” via “ensuring that the worker protection rules are implemented in a timely manner” and “finalizing the EPA staff recommended ban on chlorpyrifos.” The letter states the EPA’s decision to deny the petition to ban chlropyrifos should be “reversed immediately.” More information on H.R. 1029 is available in our blog item “House Agriculture Committee Passes Pesticide Registration Enhancement Act of 2017.”
On July 25, 2017, Udall, Blumenthal, Booker, Cardin, and several other Senators introduced S. 1624, the Protect Children, Farmers, and Farmworkers from Nerve Agent Pesticides Act of 2017, which prohibits the use of chlorpyrifos on food and directs EPA to enter into a contract with the National Research Council to “conduct a cumulative and aggregate risk assessment that addresses all populations, and the most vulnerable subpopulations, including infants, children, and fetuses, of exposure to organophosphate pesticides.” S. 1624 proposes to amend Section 402 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to add to the list of adulterated food any food that “bears or contains chlorpyrifos, including any residue of chlorpyrifos, or any other added substance that is present on or in the food primarily as a result of the metabolism or other degradation of chlorpyrifos.”
More information is available in our blog item “Four Senators Stall PRIA and Introduce Bill to Amend FFDCA — Asserting ‘Safety First.’”
EPA Withdraws Delay Of Ozone NAAQS Designations: On August 10, 2017, EPA withdrew its one year extension of the deadline for promulgating area designations for the 2015 ozone National Ambient Air Quality Standards (NAAQS). 82 Fed. Reg. 37318. The decision reverses EPA’s June 28, 2017, announcement that it was extending the area designation deadline for one year. 82 Fed. Reg. 29246. In that notice, EPA Administrator Scott Pruitt announced that he was using his authority under Clean Air Act (CAA) Section 107(d)(1)(B)(i) to extend by one year, to October 1, 2018, the deadline for promulgating initial area designations for the 2015 ozone NAAQS. At the time, EPA explained that it was unclear whether it would be able to complete the designations by the initial deadline of October 1, 2017. EPA now states that “the information gaps that formed the basis of the extension may not be as expansive as we previously believed.” It thus withdrew the one year extension and reinstated the original deadline of October 1, 2017.
Appeals Court Vacates EPA 2015 Rule Banning HFCs: On August 8, 2017, the U.S. Court of Appeals for the D.C. Circuit vacated EPA’s July 2015 CAA rule that banned the use of hydrofluorocarbons (HFC) in certain products. The case arises from President Obama’s 2013 Climate Action Plan (CAP). In 2013, President Obama announced that EPA would seek to reduce emissions of HFCs because they contribute to climate change. The CAP indicated that EPA “will use its authority through the Significant New Alternatives Policy Program” of CAA Section 612 to reduce HFC emissions. EPA promulgated a final rule in 2015 that moved certain HFCs from the list of safe substitutes to the list of prohibited substitutes. 80 Fed. Reg. 42870 (July 20, 2015). EPA prohibited the use of certain HFCs in aerosols, motor vehicle air conditioners, commercial refrigerators, and foams. In the rule, EPA relied on CAA Section 612 as its statutory authority. EPA stated that Section 612 allows it to “change the listing status of a particular substitute” based on “new information.” EPA indicated that new information about HFCs demonstrated that HFCs were greenhouse gases that contribute to climate change. EPA therefore concluded that it had statutory authority to move HFCs from the list of safe substitutes to the list of prohibited substitutes. The court took a different view. The fundamental problem for EPA, the court stated, is that HFCs are not ozone-depleting substances. Because HFCs are not ozone-depleting substances, “Section 612 would not seem to grant EPA authority to require replacement of HFCs,” the court stated, adding that “EPA’s novel reading of [CAA] Section 612 is inconsistent with the statute as written. Section 612 does not require (or give EPA authority to require) manufacturers to replace non-ozone-depleting substances such as HFCs.” The court therefore vacated the 2015 rule. The court also stated that recent Supreme Court cases that have dealt with EPA’s efforts to address climate change “have taught us two lessons that are worth repeating here. First, EPA’s well-intentioned policy objectives with respect to climate change do not on their own authorize the agency to regulate. The agency must have statutory authority for the regulations it wants to issue. Second, Congress’s failure to enact general climate change legislation does not authorize EPA to act. Under the Constitution, congressional inaction does not license an agency to take matters into its own hands, even to solve a pressing policy issue such as climate change.” Emphasis in original. The court offered EPA encouragement, stating that it has other statutory authorities under the CAA and TSCA to ban HFCs.
Court Requires EPA To Provide Further Proof That Three MACT Standards Adequately Regulate HAP Emissions: The U.S. Court of Appeals for the District of Columbia Circuit on July 18, 2017, remanded to EPA portions of its Maximum Achievable Control Technology (MACT) standards for emissions of polycyclic organic matter, polychlorinated biphenyls, and hexachlorobenzene. Sierra Club v. EPA, D.C. Cir., No. 15-1246. In 2015, EPA promulgated a final rule demonstrating that it had met its statutory obligation under the CAA to promulgate emissions standards for source categories accounting for not less than 90 percent of the aggregated emissions of each of seven specific hazardous air pollutants (HAP) enumerated in the CAA. 80 Fed. Reg. 31470 (June 3, 2015). The Sierra Club challenged the final rule, arguing that as to the three HAPs, EPA arbitrarily relied upon standards set previously to regulate other emissions without justifying its decision to treat those previously regulated emissions as “surrogates.” As to each of the three HAPs, the Sierra Club argued that EPA’s final rule does not comply with the requirements of the CAA that EPA must provide sufficient standards for the categories and subcategories of sources accounting for not less than 90 percent of the aggregate emissions of each such pollutant. Sierra Club’s main argument was that the EPA improperly relied on surrogates. Rather than issuing new specific standards, EPA relied on previously set emission limits for another HAP or compound that serves as a surrogate for the targeted HAP, the Sierra Club argued. The court found that although EPA provided some explanation of the surrogacy relationships in this case, it failed to respond adequately to comments disputing those explanations. EPA cannot hide behind the established nature of the standards it uses when it applies new surrogacy relationships, the court ruled. The court did not rule on whether the use of surrogates by EPA is lawful, but instead held that EPA must provide further justification for the use of surrogates for these three HAPs.
EPA And Corps Propose Recodification Of Definition Of “Waters Of The United States” (WOTUS) And Other WOTUS Developments: On July 27, 2017, EPA and the U.S. Army Corps of Engineers (Corps) published the proposal to rescind the 2015 “Clean Water Rule” (CWR) entitled, “Definition of ‘Waters of the United States’ – Recodification of Pre-Existing Rules.” 82 Fed. Reg. 34899. The rule proposal is the first step in the EPA/Corps two-step rulemaking process to rescind and replace the CWR, which re-defined WOTUS for the purposes of clarifying the boundaries of Clean Water Act (CWA) jurisdiction over the nation’s rivers, streams, and wetlands. The current proposal would remove the CWR language from the Code of Federal Regulations and replace it with the regulatory text that predates the 2015 rule. The CWR has been the subject of litigation and implementation has been stayed nationwide since October 2015. Step one of the rulemaking would maintain the regulatory status quo while EPA and the Corps work on step two — the replacement rule. EPA and the Corps request that comments be limited to the appropriateness of the rescission and refrain from substantive comments on the replacement rule, which will have a separate notice-and-comment process subsequent to its anticipated late 2017/early 2018 proposal. The rule rescission proposal does hint at a few key features of the future replacement rule, including greater emphasis on the preservation of state/tribal authority and an adherence to the elements of the late Justice Antonin Scalia’s opinion in the 2006 Rapanos decision. The rescission and recodification proposal is currently open for a 30-day comment period closing on August 28, 2017. More background on the Rapanos decision is available in this B&C blog post. While EPA and the Corps are working to pull back the CWR, the U.S. Supreme Court may resolve a dispute over which court should serve as the venue in litigation over WOTUS rules. Parties to the litigation over the 2015 CWR petitioned for Supreme Court review of a U.S. Court of Appeals for the Sixth Circuit decision holding that federal appellate courts, rather than U.S. district courts, were the appropriate venue to review rules clarifying CWA jurisdiction. The Supreme Court granted review of the Sixth Circuit ruling and recently set oral arguments for October 11, 2017. The venue dispute turns on the Court’s interpretation of CWA Section 509(b), which sets forth the circumstances where CWA challenges should be brought directly to the U.S. Courts of Appeal. Resolving the venue question will expedite any future litigation over a replacement WOTUS rule and could set precedent implicating litigation over other CWA rules and issues.
Eleven States Sue EPA Over Delay Of RMP Rule: On July 24, 2017, the Attorneys General of eleven states filed suit against EPA for its decision to delay the Risk Management Program (RMP) rule. In the suit, filed in the U.S. Court of Appeals for the D.C. Circuit, New York, Illinois, Iowa, Maine, Maryland, Massachusetts, New Mexico, Oregon, Rhode Island, Vermont, and Washington contend that the RMP rule is necessary to protect workers, first-responders, and communities. In June, EPA announced that it would delay implementation of the RMP rule until 2019. 82 Fed. Reg. 27133 (June 14, 2017). The states further argue that EPA’s delay of the rule is unlawful under CAA Section 307(d)(9).
Superfund Task Force Releases Recommendations: On July 25, 2017, the Superfund Task Force created by EPA Administrator Scott Pruitt on May 22, 2017, released its recommendations and proposals for revitalizing the Superfund program. The task force considered nearly every aspect of the Superfund program, from site identification to remedy selection and implementation and subsequent reuse. It issued 42 recommendations grouped under five broad goals. These goals include: expediting cleanup and remediation; reducing financial burdens on all parties; encouraging private investment; promoting redevelopment and community revitalization; and building and strengthening partnerships. Administrator Pruitt also on July 25, 2017, issued a memorandum authorizing EPA to “take the following . . . specific actions expeditiously.” These actions include, among others:
Prioritize and take action control over any site where the risk of human exposure is not fully controlled.
Utilize early or interim response actions, including removal authority or interim remedies, more frequently as appropriate to address immediate risks, prevent source migration and return portions of sites to reuse while more-detailed evaluations of other portions of sites are ongoing.
Prioritize development of Remedial Investigations and Feasibility Studies for those sites and projects that require more immediate action to focus the use of available funds and resources.
Identify potential pilot contaminated sediment or complex groundwater sites where Adaptive Management strategies can be implemented.
EPA Proposes Revisions To NESHAP For Off-Site Waste Recovery Actions: EPA on August 7, 2017, proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Off-Site Waste and Recovery Operations. 82 Fed. Reg. 36713. The proposed amendments address the monitoring of pressure relief devices (PRD) on containers. This issue was raised in a petition for reconsideration of the amendments to the NESHAP issued in 2015. Among other things, the 2015 amendments established additional monitoring requirements for PRDs on containers. These monitoring requirements were in addition to the inspection and monitoring requirements for containers and their closure devices, which include PRDs that were already required by the NESHAP. EPA is proposing to remove the additional monitoring requirements for PRDs on containers because it believes they are not necessary. Comments on the proposal are due on or before September 21, 2017.
FDA To Host Public Workshop On Voluntary Medical Device Manufacturing: On July 25, 2017, FDA announced it would be hosting a public workshop titled Voluntary Medical Device Manufacturing and Product Quality Program. FDA states that the “purpose of the workshop is to announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality” and is intended to “discuss the framework of the voluntary pilot program, information on the independent assessment, details of participation, rules of engagement, monitoring and performance expectations, as well as potential modifications to FDA’s oversight actions in response to demonstrated manufacturing quality performance.” FDA further states it is soliciting public feedback to aid in the development of science-based approaches to regulatory decision making, specifically for assessing manufacturing quality, extent of manufacturing related submissions, and how to better allocate resources to lower the regulatory burden on manufacturers and FDA. The workshop will be held on October 10, 2017, from 8:00 a.m. – 5:00 p.m. (EDT) at the FDA White Oak Campus. The workshop will be webcast but registration is not required to view the webcast. To attend in person, registration is required by September 28, 2017. Comments on this public workshop are due by October 18, 2017.
IFSAC Releases Strategic Plan For 2017-2021 And Materials From May 31, 2017, Webinar: On July 28, 2017, the Interagency Food Safety Analytics Collaboration (IFSAC), a collaboration between FDA, the Centers for Disease Control and Prevention (CDC), and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) to improve coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use, released its strategic plan for 2017-2021 and related documents, and materials from its webinar held on May 31, 2017. These documents and materials include:
The 2012-2016 Wrap-Up, an overview of IFSAC’s accomplishments from the first Strategic Plan for Foodborne Illness Source Attribution (FY2012-2016);
The 2017-2021 Action Plan, which addresses the implementation of IFSAC’s new Strategic Plan (2017-2021) and focuses on IFSAC’s ongoing and future projects; their alignment with the goals, strategies, and objectives of the Plan; how projects relate to each other; and tentative initiation timelines; and
The webinar presentation materials, including the presentation slides, transcript with agenda, and a link to a recording of the webinar.
FDA Releases Three Guidance Documents To Explain Certain Exemptions From FSMA: On August 7, 2017, FDA published three guidance documents to help producers of food commodities covered by earlier regulations understand which parts of the Food Safety Modernization Act (FSMA) rules apply to them and how the FSMA rules may affect their operations, specifically FDA’s HACCP (Hazard Analysis and Critical Control Point) and Low-Acid Canned Foods (LACF) regulations that were in place long before the FSMA rules became final:
FDA states that the HACCP regulations for juice and seafood processors require processors to “perform a hazard analysis and develop a HACCP plan to address biological, chemical, and physical hazards, monitor the conditions and practices, and make corrections as needed” and its low-acid canned foods regulation addresses “biological hazards such as Clostridium botulinum unique to such foods, which include canned vegetables.” Further, the new guidance documents aim to “help industry identify these exemptions and understand the juice, seafood, and LACF regulations in connection with some of the new FSMA requirements,” and the overarching goal of many of the new FSMA requirements is “to reduce the number of foodborne illnesses attributed to the preventable contamination of FDA-regulated food products.” FDA is accepting comments on these guidance documents via www.regulations.gov under Docket Number FDA-2017-D-3176.
FDA Issues Reminder Regarding Compliance Dates For FSMA’s Preventive Controls For Animal Food Final Rule: On August 10, 2017, FDA issued a reminder regarding the second major compliance dates that will soon arrive for the Preventive Controls for Animal Food final rule under the FSMA:
On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by the FSMA; these facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016; and
Also on September 18, 2017, small animal food facilities — those with fewer than 500 full-time equivalent employees — will be required to meet the CGMPs; they have an additional year to meet the preventive controls requirements.
As part of this reminder, FDA posted What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule: A Conversation with Jenny Murphy. Murphy is a consumer safety officer at FDA’s Center for Veterinary Medicine.
EC Publishes NanoData Landscape Compilation Reports: On June 8, 2017, the European Commission (EC) published eight NanoData Landscape Compilationreports. The EC states that the reports offer a snapshot of the environment for nanotechnology in different application fields: health, manufacturing, information and communication technologies, transport, energy, construction, environment, and photonics. The reports describe policies and programs for nanotechnology in the European Union (EU) and provide an overview of publications, patenting, research and innovation, industry, products, and markets. More information is available in our August 7, 2017, blog item, “EC Publishes NanoData Landscape Compilation Reports.”
Journal Of Nanobiotechnology Publishes Special Issue On Swiss National Research Program On The “Opportunities And Risks Of Nanomaterials”: The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64). The editorial states that the Program’s primary goal was to investigate potential applications of existing nanomaterials in healthcare, the consumer industry, and in the environment, and to identify, characterize, and minimize the possible risks associated with their use. More information is available in our , 2017, blog item, “Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the ‘Opportunities and Risks of Nanomaterials.’”
NIOSH Submits Proposed Survey To OMB, Will Accept Comments For 30 Days: On July 17, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing it submitted a proposed information collection to the Office of Management and Budget (OMB) for review and approval. The proposed project is “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.” As reported in our February 14, 2017, blog item, NIOSH invited comment on the proposed survey on February 10, 2017. NIOSH will survey companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials. NIOSH will compile a sample of 600 companies from lists of industry associations, research reports, marketing databases, and web-based searches. Of the 600 selected companies, NIOSH states that it anticipates that 500 will complete the survey within two years. The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace. The intended use of the data is to inform NIOSH’s research agenda to enhance its relevance and impact on worker safety and health in the context of engineered nanomaterials. Publication of the July 17, 2017, Federal Register notice began a 30-day comment period.
USDA Awards $4.6 Million In Nanotechnology Research Grants: On July 20, 2017, the USDA National Institute of Food and Agriculture (NIFA) announced 13 grants worth $4.6 million for research on the next generation of agricultural technologies and systems to meet the growing demand for food, fuel, and fiber. NIFA states that funded projects support nanotechnology-based solutions that improve food production, nutrition, sustainable agriculture, and food safety. NIFA notes that previously funded grants include an Iowa State University project in which a low-cost and disposable biosensor made out of nanoparticle graphene that can detect pesticides in soil was developed. University of Minnesota researchers created a sponge that uses nanotechnology to absorb quickly mercury, as well as bacterial and fungal microbes from polluted water.
NIOSH Publishes Chapter On Analysis Of Carbon Nanotubes And Nanofibers On Filters By Transmission Electron Microscopy: NIOSH has published a chapter in the fifth edition of the NIOSH Manual of Analytical Methods (NMAM) entitled “Analysis of Carbon Nanotubes and Nanofibers on Mixed Cellulose Ester Filters by Transmission Electron Microscopy.” The draft chapter provides standardized approaches for the analysis of carbon nanoparticles. The chapter provides detailed guidance on effective means to perform transmission electron microscopic analysis on carbon nanotubes and nanofibers that are sampled from occupational atmospheres. The chapter notes that, with respect to quantification, it is important to recognize the limitations of a particle counting method. According to the chapter, because of the heterogeneity of carbon nanotube powders, particles in the same size bin can vary greatly in their properties. Complex structures of varying mass, density, shape, and composition (e.g., amorphous carbon, residual catalyst) can fall into the same size bin, and dissimilar particles (e.g., cluster and matrix) in a given bin may have different toxicological effects. Thus, the chapter states, “even for a given material, particle envelope size alone may not be an adequate risk indicator.” Given the heterogeneity and variety of the carbon nanotube/carbon nanofiber products to which workers are exposed, “it is important to apply several methods to assess worker exposure, through inhalation and other routes.”
NIEHS Using Survey To Update 2012-2017 Strategic Plan: Dr. Linda S. Birnbaum, Director, National Institute of Environmental Health Sciences (NIEHS), wrote an editorial in Environmental Health Perspectives on “Updating the NIEHS Strategic Plan.” According to Birnbaum, NIEHS is developing a plan to guide its next five years and seeks broad input. NIEHS has created an online survey, “Trends & Insights: Next Steps for NIEHS,” through which stakeholders can provide feedback on the existing Strategic Plan, as well as offer any other relevant comments. The 2012-2017 Strategic Plan includes 11 Strategic Goals. Goal Five, “Identify and respond to emerging environmental threats to human health, on both a local and global scale,” includes “[f]ocus[ing] on research needs to help inform policy responses in public health situations in which lack of knowledge hampers policymaking, e.g., health effects of exposures related to hydrofracking or climate change, or exposures to engineered nanomaterials.” The survey was available until August 11, 2017. Birnbaum states that the results, along with input collected in other venues, will help to inform a draft Strategic Plan that NIEHS anticipates making available for review later in 2017.
EC Publishes Final Report Of Nanocomput Project: In July 2017, the EC’s Joint Research Center (JRC) published a report entitled Evaluation of the availability and applicability of computational approaches in the safety assessment of nanomaterials: Final report of the Nanocomput project. The main aims of the Nanocomput Project were to review and assess the current status of computational methods that are potentially useful for predicting the properties of engineered nanomaterials to provide advice on the use of these approaches for the purposes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. In addition, the Nanocomput Project assessed the status of a diverse array of compartment-based mathematical models. These models comprised toxicokinetic, toxicodynamic, in vitro and in vivo dosimetry, and environmental fate models. The report includes overall conclusions from the Nanocomput Project, including lessons learned in conducting literature reviews and research-based case studies on grouping and read-across. It offers a number of recommendations intended to overcome current shortcomings in the knowledge of nanomaterial behavior and in the availability of tools (such as databases and predictive models) and practical guidance to use such tools in the regulatory assessment of nanomaterials.
NanoEHS Webinar Addresses How NNCI Nodes Support Environmental Research: The National Nanotechnology Initiative (NNI) held a webinar on July 27, 2017, entitled “The National Nanotechnology Coordinated Infrastructure (NNCI) Nodes and Environmental Research: Examples from the Field.” The National Science Foundation (NSF) supports NNCI, which includes 16 user facility sites, their affiliated partners, and a coordinating office. NNCI sites provide researchers, academics, small and large businesses, and government scientists with access to university user facilities with leading-edge fabrication and characterization tools, instrumentation, and expertise within all disciplines of nanoscale science, engineering, and technology. The webinar provided information on how the NNCI nodes can support research. The webinar was moderated by Larry Goldberg, Senior Engineering Advisor, Directorate for Engineering, NSF. Speakers included:
Bruce Clemens, Walter B. Reinhold Professor in the School of Engineering and Professor of Photon Science, and Applied Physics, Stanford University; and
Michael Hochella, University Distinguished Professor, Geosciences, Virginia Tech; Laboratory Fellow, Geosciences, Pacific Northwest National Laboratory.
ClientEarth Files Complaint With EU Ombudsman Over EC Catalog Of Nanomaterials Used In Cosmetic Products: ClientEarth announced on July 31, 2017, that it filed a complaint with the EU Ombudsman about the EC’s “unlawful handling of a long-delayed list of nano-chemicals in cosmetics.” As reported in our June 19, 2017, blog item, the EC published June 15, 2017, a catalog of nanomaterials used in cosmetic products on the EU market. ClientEarth states that “[d]espite the lengthy delay, the list still does not let people identify which cosmetics contain potentially harmful nanomaterials, or assess the threat they may pose to human health.” ClientEarth calls on the EU Ombudsman — “an independent and impartial EU body” — to “open an investigation into these acts of maladministration and hold the Commission to account for frustrating consumers’ and civil society’s rights to know about the risks of products people use every day.”
EPA Publishes Final Guidance As Final TSCA Section 8(a) Rule Takes Effect: On August 14, 2017, as the final TSCA Section 8(a) information gathering rule on nanomaterials took effect, EPA published “working guidance” intended to assist stakeholders in complying with the rule. The working guidance notes that it “will not provide answers to all of the potential questions that will arise as manufacturers and processors seek to comply with the rule. Commenters to the draft guidance asked several questions that would require more details or information before EPA could respond to their question.” If the guidance does not answer questions about the rule, companies are directed to contact Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, email@example.com. EPA states that it will answer questions on a case-by-case basis. EPA intends to add further questions/answers and revisions to the guidance based on questions identified by persons who may be subject to the rule. 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.”
BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
House Passes Bill Delaying Ozone NAAQS Implementation And Review: By a vote of 229-199, the House of Representatives on July 18, 2017, passed the Ozone Standards Implementation Act of 2017 (H.R. 806). Introduced by Representative Pete Olson (R-TX), the bill is intended to provide states with “tools to meet important new upcoming ozone and other air quality standards.” EPA revised the ozone NAAQS in 2008, but did not publish implementing regulations for it until March 2015. EPA then in October 2015 lowered the ozone NAAQS to 70 ppb. The bill delays by eight years (to 2025) the date by which EPA must determine the nonattainment areas for the 2015 ozone NAAQS, thereby providing states with additional time to come into attainment. The CAA requires EPA to review and, if necessary, revise NAAQS every five years. H.R. 806 would extend this review deadline to every ten years. The bill now heads to the Senate for consideration, where its fate is uncertain.
House Committee Approves Brownfields Bill: The House Transportation and Infrastructure Committee on July 27, 2017, approved the Brownfields Reauthorization Act (H.R. 1758). The bill would reauthorize EPA’s brownfields remediation program through 2022. It also would increase the funding limit for grants to $600,000, and authorize non-profit groups to receive grants. The bill would fund the program $200 million annually. The House Energy and Commerce Committee in June also passed legislation reauthorizing the program, as did the Senate Environment and Public Works Committee.
Congress Passes FDA Reauthorizaton Act Of 2017: On August 3, 2017, Congress passed the bipartisan FDA Reauthorization Act of 2017 (FDARA), which reauthorizes the user fee programs necessary for the continued support of FDA’s pre-market evaluation of prescription drugs, medical devices, generic drugs, and biosimilar products. On August 7, 2017, it was presented to President Trump and he is expected to sign it. FDA states that the timely reauthorization of these programs “ensures continuity for [its] medical product review programs and is crucial to supporting [its] mission of protecting and promoting public health.”
OSHA Launches App For Electronic Submission Of Injury And Illness Data: The Occupational Safety and Health Administration (OSHA) on August 1, 2017, launched the Injury Tracking Application (ITA). The application allows employers to submit electronically required injury and illness data from their completed 2016 OSHA Form 300A. The application is accessible from the ITA web page. In June 2017, OSHA published a proposed rulemaking to extend the deadline for submitting the 2016 Form 300A to December 1, 2017, to allow affected entities sufficient time to familiarize themselves with the electronic reporting system. The data submission process involves four steps: (1) creating an establishment; (2) adding 300A summary data; (3) submitting data to OSHA; and (4) reviewing the confirmation e-mail. The secure website offers three options for data submission. One option enables users to manually enter data into a web form. Another option gives users the ability to upload a CSV file to process single or multiple establishments at the same time. A third option allows users of automated recordkeeping systems to transmit data electronically via an application programming interface.
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