Recent Federal Developments

EPA Settles With Syngenta On FIFRA Violation Related To Restricted-Use Pesticide: On February 12, 2018, the U.S. Environmental Protection Agency (EPA) announced it has reached an agreement with Syngenta Seeds, LLC (Syngenta), a pesticide company in Hawaii, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) at its farm in Kekaha, Kauai. The settlement includes two penalty components: a $400,000 Supplemental Environmental Project (SEP) for worker protection standard (WPS) training; and $150,000 as a civil penalty. The Consent Agreement and Final Order (CAFO), issued on February 7, 2018, states the parties are resolving alleged violations under FIFRA Section 12(a)(2)(G) from the use of the registered restricted-use pesticide Lorsban Advanced on an agricultural establishment in Kekaha, Hawaii, “in manners inconsistent with its labeling by not complying with applicable Worker Protection Standard regulations.” More information on FIFRA enforcement issues is available on our blog under key word enforcement. Information on Syngenta’s 2016 CAFO regarding label violations is available in our blog item Syngenta Settles with EPA on Alleged Label Violations.

EPA Settles With Amazon On Distribution Of Unregistered Pesticides: On February 14, 2018, EPA and Amazon Services LLC (Amazon) entered into a CAFO whereby Amazon agreed to pay $1,215,700 in civil penalties for approximately 4,000 alleged violations under FIFRA Section 3 for the distribution of unregistered pesticide products. Amazon neither admitted nor denied the specific factual allegations. Amazon also agreed to implement a SEP consisting of the development, deployment, and operation of a publicly available eLearning course, downloadable educational materials, and test on FIFRA requirements and associated regulations (eLearning Project). More information on FIFRA enforcement issues is available on our blog under key word enforcement.

EPA Posts Videos And FAQs On WPS And AEZ: On February 15, 2018, EPA added resources to its website regarding the WPS and the Application Exclusion Zone (AEZ) requirements of the WPS. As of January 2, 2018, full compliance is required with all of the AEZ-related requirements in the WPS. The new EPA website resources include:

• A WPS Frequently Asked Questions (FAQ) document that includes answers to questions on implementation and applicability; training; notification and hazard communication; designated representative; AEZ; minimum age; personal protective equipment (PPE); decontamination; definitions; and exemptions and exceptions;
• An AEZ Question and Answer Fact Sheet that contains further explanation of the AEZ requirement in the WPS;
• A video that provides a visual representation of an AEZ titled Application Exclusion Zone in Outdoor Production Pesticide Applications; and
• A video that provides a visual representation of an AEZ on field borders titled Application Exclusion Zones on Field Borders for Pesticide Applications.

While many welcome EPA’s guidance on the issues presented by the WPS and AEZ requirements, some believe that the newly issued guidance raises, in places, additional questions and leaves some significant questions unaddressed. Given the controversy over this rule, this new guidance should be reviewed closely. More information on the WPS, including EPA’s December 2017 announcement of its intention to revise the AEZ and other WPS provisions, and current implementation deadlines can be found on our blog under key word WPS and key phrase Worker Protection Standard.

California District Court Vacates EPA Final Rule To Delay Compliance With Formaldehyde Emission Standards: On February 16, 2018, the U.S. District Court for the Northern District of California issued an order granting plaintiffs’, the Sierra Club and A Community Voice-Louisiana, motion for summary judgment. The court determined that EPA’s final rule delaying the compliance date for the formaldehyde emission standards for composite wood products (Delay Rule) exceeded EPA’s authority under the Formaldehyde Standards in Composite Wood Products Act (Formaldehyde Act) codified as TSCA Title VI, vacated the Delay Rule, and set aside the year-long extension to December 12, 2018, of the compliance deadlines set out by EPA in the Delay Rule. Sierra Club v. Pruitt, Case No. 4:17-cv-06293. The Delay Rule, issued on September 25, 2017 (82 Fed. Reg. 44533), sought to extend further the compliance dates set out in its December 12, 2016, final rule that implemented the Formaldehyde Act (Formaldehyde Rule) (81 Fed. Reg. 89674), specifically: the December 12, 2017, manufactured-by date for emission standards, recordkeeping, and labeling provisions until December 12, 2018; the December 12, 2018, compliance date for import certification provisions until March 22, 2019; and the December 12, 2023, compliance date for provisions applicable to producers of laminated products until March 22, 2024. More information on the Formaldehyde Act under the Toxic Substances Control Act (TSCA) is available on our blog.

EPA Publishes TSCA Fees Proposed Rule: On February 26, 2018, EPA published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act, as permissible under TSCA Section 26(b). 83 Fed. Reg. 8212. The rule as proposed will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b). The notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs. In proposing these new TSCA user fees, EPA also proposes amending long standing user fee regulations governing the review of premanufacture notices (PMN), exemption applications and notices, and significant new use notices (SNUN). Comments on the proposed rule are due April 27, 2018. An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C^®) is available on our website “Administrator Pruitt Signs TSCA User Fee Proposal.”

EPA Announces Availability Of Final Test Series 810 Guidelines: On February 28, 2018, EPA announced the availability of the following 810 Series final test guidelines: General Considerations for Testing Public Health Antimicrobial Pesticides — Guidance for Efficacy Testing, OCSPP Test Guideline 810.2000; Sterilants, Sporicides, and Decontaminants — Guidance for Efficacy Testing, OCSPP Test Guideline 810.2100; and Disinfectants for Use on Environmental Surfaces — Guidance for Efficacy Testing, OCSPP Test Guideline 810.2200. 83 Fed. Reg. 8666. These test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols for testing that is intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducting the tests, and are also used by EPA, the public, and companies that are subject to data submission requirements under one or more statutes.

Minutes And Reports From FIFRA SAP On Alternative High-Throughput Screens To Determine Endocrine Disruption Now Available:  On March 1, 2018, EPA announced that the minutes and final reports from the FIFRA Scientific Advisory Panel (SAP) meetings on alternative high-throughput screens to determine endocrine disruption that took place in November 2017 are available online, as specified below. The November 6, 2017, virtual preparatory meeting focused on the charge questions released prior to the meeting. The minutes and final report document from this meeting states that Dr. Seema Schappelle, Director of the EPA Exposure Assessment Coordination and Policy Division (EACPD), gave an overview of the Endocrine Disruptor Screening Program (EDSP); Dr. Ronnie Bever from EACPD gave an overview of the charge questions as related to the white paper topics; and that EPA read each charge question prior to the Panel’s discussion of the scope and clarity. A summary was provided of the six charge questions and answers regarding the white paper topics: (1) androgen receptor (AR) pathway model; (2) steroidogenesis pathway model; and (3) thyroid pathway conceptual framework. The November 28-29, 2017, face-to-face meeting was entitled “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” The minutes and final reportdocument from this meeting states that EPA “is continuing a series of scientific peer reviews focused on evaluation and validation of high-throughput (HT) and computational approaches for prioritization and screening of chemicals in the [EDSP],” and is “committed to the use of validated HT assays and computational models to: 1) prioritize chemicals for further EDSP screening and testing based on predicted bioactivity; 2) use as alternatives to EDSP Tier 1 assays; and 3) contribute to the weight-of-evidence evaluation of the potential endocrine bioactivity of a chemical.” The FIFRA SAP was charged with advising EPA on these areas of interest in relation to the white paper topics specified above; the final report provides an in-depth summary of the Panel’s discussion of each of the white paper topics and charge questions.

EDF Files Principal Brief In TSCA Framework Rule Inventory Notification Challenge:  On March 6, 2018, in the U.S. Court of Appeals for the D.C. Circuit, the Environmental Defense Fund (EDF) filed its Principal Brief in the litigation case that petitions for review EPA’s TSCA Inventory Notification (Active-Inactive) Requirements final rule (EDF v. EPA, No. 1701 (D.C. Cir.)). EDF’s brief includes, among other required statements, a statement of the issues, a statement of the case, a summary of its argument, and its argument. EDF’s arguments are as follows:

• The Inventory Rule withholds information on chemical substances manufactured or processed in the U.S. from the public; this information is required to be disclosed under amended TSCA; EDF has been harmed by EPA’s failure to disclose this information and to disclose unique identifiers for confidential chemicals; and the court can redress this harm.
• The final rule illegally allows manufacturers and processors to assert certain new claims for nondisclosure of specific chemical identities based on other persons having asserted earlier claims, which is contrary to TSCA’s plain text and the relevant precedent governing confidentiality claims; and EPA’s rationale for its interpretation is arbitrary and capricious.
• The final rule violates both the substantive and procedural requirements of TSCA Section 14, Confidential Information, specifically that: EPA refused to accept that TSCA Section 8, Reporting and Retention of Information, repeatedly incorporates Section 14 requirements for confidentiality claims; the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14; and the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14.
• The final rule fails to implement the unique identifier and other public information requirements in TSCA Section 8(b)(7)(B).
• The final rule exempts chemicals manufactured and processed solely for export from the reporting requirements, even though such chemicals are specifically not exempted from TSCA Section 8.
• Finally, EDF requests the court to set aside the rule in part, stating that vacatur, along with remand, is the appropriate remedy for EPA’s violations of the Administrative Procedure Act (APA). EDF does not seek a complete vacatur, however, stating that “a complete vacatur would postpone the release of some of the very information that EDF seeks, since it would allow EPA to postpone publishing the Inventory based on the information it has already collected. In addition, it would impose costs on the regulated community beyond those necessary to remedy EDF’s harms [and] those manufacturers and processors who have already filed notices without claims of confidentiality should not need to refile the notices.” The portions of the final rule that EDF requests the court to vacate are as follows: the exclusion for export-only manufacturers (40 C.F.R. Section 710.27(a)(4)); Confidentiality Claims (40 C.F.R. Section 710.37); and certain portions of the preamble. EDF states specific instructions on how it would like the court to order EPA to promulgate the regulation on remand that include revisions to regulations on confidentiality claims, public information requirements, and notifications of activities during the lookback period.

EDF has done its usual thorough job and the brief is definitely a must read for TSCA stakeholders. More information on this proceeding and the other challenges to the TSCA framework final rules is available on our blog under key words framework rules.

EPA Releases Draft Strategy To Reduce Use Of Animals In Chemical Testing: On March 7, 2018, EPA released a draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods to reduce the use of vertebrate animals in chemical testing, fulfilling another milestone under the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended TSCA. Under amended TSCA, EPA is required to develop a strategy to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing by June 22, 2018. EPA states the draft document incorporates input from a November 2017 public meeting held on the development of the draft strategy, as well as written comments submitted after the meeting, and draws upon EPA research on test methods. The draft strategy outlines EPA’s Strategic Plan for the reduction of testing in vertebrates for chemicals regulated under TSCA. The organizing framework for EPA’s strategy to reduce vertebrate animal testing relies heavily on what have been termed new approach methodologies (NAM) — a broadly descriptive reference to any nonanimal technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment. More information is available online.

On March 12, 2018, EPA announced a notice of availability of a public meeting on the draft Strategic Plan, which will be available for comment until April 26, 2018, and information obtained will be considered in EPA’s development of the final Strategic Plan that is required to be completed and published in June of 2018. 83 Fed. Reg. 10717. The public meeting will be held on April 10, 2018, from 9:00 a.m. to 5:00 p.m.

EPA Releases Final Guidance On Placement Of First Aid Statements On Pesticide Labels: On March 8, 2018, EPA announced its release of final guidance clarifying where first aid statements should appear on the label of pesticide products. EPA also posted a response to public comments. Links to the final guidance and to the response to public comments documents are below:

• First Aid Guidance Document — EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.
• First Aid Guidance: Response to Public Comments on EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement and Clarification on Definition of Label “Panel” per 40 CFR 156.68.

EPA states that it was prompted to develop this guidance when it learned “that there was a discrepancy in how the ‘location of first aid statement,’ per [40 C.F.R. Section 156.68(d)] is interpreted by EPA and those in the pesticide registrant community.” EPA notes that its review and approval of pesticide labeling is generally of a “master” label and thus does not always include a review of the location or placement of specific language on a label. On December 7, 2016, EPA posted a memorandum for public comment entitled “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement and Clarification on Definition of Label ‘Panel’ per 40 CFR 156.68” to clarify the interpretation of the term “panel” in the context of 40 C.F.R. Section 156.68 and to clarify where first aid statements must appear on pesticide labels, based on their Toxicity Category. In its final guidance, EPA states it “will continue to require that Toxicity Category I products have the first aid statements on the front panel except in cases where a variation has been approved.” Further, based on comments received and the wide reliance by the regulated community on the interpretation that “any panel” includes inside panels, EPA is changing its position from its 2016 memorandum and now “will not require Toxicity Category II and III products to bear the first aid statements on a visible front, back or side panel.” More information is available online.

EPA Seeks Input From Small Entity Representatives On Development Of PBT Chemical Regulation:  On March 9, 2018, as a first step in developing a proposed rule regulating certain persistent, bioaccumulative, and toxic (PBT) chemicals, EPA announced that it is seeking nominations for individuals who represent small businesses, small governments, and small not-for-profit organizations to serve as Small Entity Representatives (SER) to provide input on potential impacts of PBT regulation. EPA states the role of a SER is “to provide advice and recommendations to ensure that the Panel carefully considers small entity concerns regarding the impact of the potential rule on their organizations and to communicate with other small entities within their sector who do not serve as SERs,” and will ask the SERs to provide comments on behalf of their company, community, or organization and advise a soon to be created Small Business Advocacy Review (SBAR) panel regarding potential impacts to small businesses that could result from the regulation of certain identified PBTs. The SBAR panel will include federal representatives from EPA, the Small Business Administration, and the Office of Management and Budget (OMB). After collecting input from the small entities, the panel will make recommendations to the Agency on the development of a proposed rule to regulate these PBT chemicals. Under Section 6(h) of TSCA, EPA is required, not later than three years after the date of enactment (June 22, 2019), to propose rules regarding the regulation of certain PBTs selected from the 2014 update of the TSCA Work Plan for Chemical Assessments that: (1) EPA has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other have been identified; and (2) exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator. The PBT chemicals that EPA has selected are:

• 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 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.

The Regulatory Flexibility Act requires agencies to establish a SBAR panel for rules that may have a significant economic impact on a substantial number of small entities. EPA states that the panel process will offer “an opportunity for small businesses, small governments and small not-for-profit organizations … to provide advice and recommendations to ensure that the EPA carefully considers small entity concerns regarding the impact of the potential rule on their organizations.” EPA states eligible SERs are small entities that manufacture, process, distribute in commerce, use, or dispose any of the five selected PBT chemicals. EPA is seeking self-nominations directly from entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations may be submitted through the instructions outlined on EPA’s Potential SBAR Panel website and must be received by March 22, 2018. More information about the SBAR process is available online.

EPA Releases Draft Guidance On TSCA CBI Disclosures; Requests Comments:  On March 13, 2018, EPA released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose TSCA confidential business information (CBI) with an expanded set of people. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. The draft guidance documents are:

• Draft Guide for Access to TSCA CBI for State, Local, and Tribal Governments, TSCA Section 14(d)(4);
• Draft Guide for Access to TSCA CBI for Medical and Environmental Professionals in Non-Emergency Situations, TSCA Section 14(d)(5); and
• Draft Guide for Access to TSCA CBI in Emergency Situations, TSCA Section 14(d)(6).

EPA’s prepublication version of the notice of availability of the draft guidance states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA. In accordance with the requirements of TSCA Section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and includes information on where and how to submit requests to EPA. A 30-day comment period for the draft guidance documents will open after the notice is published in the Federal Register; comments can be submitted to docket EPA-HQ-OPPT-2017-0652 via www.regulations.gov.

On March 12, 2018, EPA also announced that it is collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice. 83 Fed. Reg. 10719. Comments on the ICR are due May 11, 2018. EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.

EPA Announces PPDC Meeting: On March 15, 2018, EPA’s Office of Pesticide Programs (OPP) announced a public meeting of the Pesticide Program Dialogue Committee (PPDC). 83 Fed. Reg. 11514. The meeting will provide advice and recommendations to the EPA Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. The meeting will be held on Wednesday, May 2, 2018, from 9:00 a.m. to 5:00 p.m., and Thursday, May 3, 2018, from 9:00 a.m. to noon. A draft agenda will be posted on or before April 18, 2018.

EPA Requests Comment On Groundwater Discharges:  On February 20, 2018, EPA requested comment on whether pollutant discharges from point sources that reach jurisdictional surface waters via groundwater are subject to regulation under the Clean Water Act (CWA). 83 Fed. Reg. 7126. EPA has previously stated that pollutants discharged from point sources that reach jurisdictional surface waters via groundwater or other subsurface flow that has a direct hydrologic connection to the jurisdictional water may be subject to CWA permitting requirements. EPA has not stated that CWA permits are required for pollutant discharges to groundwater in all cases, but rather that pollutants discharged from point sources to jurisdictional surface waters that occur via groundwater or other subsurface flow that has a direct hydrologic connection to the surface water may require such permits. EPA has made these statements in previous rulemaking, permitting, and guidance documents, although most of these statements were collateral to the central focus of a rulemaking or adjudication. SeeFinal NPDES Permit Application Regulations for Storm Water Discharges. 55 Fed. Reg. 47990 (Dec. 2, 1990). EPA is specifically requesting comment on whether it is necessary to clarify or revise its previous statements on this issue. The comment period closes on May 21, 2018.

EPA Publishes Decision On Financial Assurance For Hardrock Mining: On February 21, 2018, EPA published its decision not to issue final regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) for financial assurance requirements for hardrock mining operations. 83 Fed. Reg. 7556. EPA initially announced the decision on December 1, 2017. EPA stated that “After careful analysis of public comments, the statutory authority, and the record for this rulemaking, EPA is confident that modern industry practices, along with existing state and federal requirements address risks from operating hardrock mining facilities. . . Additional financial assurance requirements are unnecessary and would impose an undue burden on this important sector of the American economy and rural America, where most of these mining jobs are based.” EPA proposed financial assurance regulations under CERCLA Section 108(b) on January 11, 2017. 82 Fed. Reg. 3388. EPA was under a court-ordered deadline to take final action on this rulemaking by December 1, 2017. The final action is effective on March 23, 2018.

EPA Proposes To Add Aerosol Cans To Universal Waste Regulations: EPA on March 6, 2018, proposed to add aerosol cans to the universal waste program under the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations (prepublication version available here). EPA states that the proposed change would benefit the retail and other sectors by easing the regulatory burdens on discarded aerosol cans. The proposal would apply to either spent or pressurized aerosol cans. Under the proposal, generators must manage universal waste aerosol cans in a way that prevents releases of any universal waste or component of a universal waste to the environment. The cans must be accumulated in a container that is structurally sound, compatible with the contents of the aerosol cans, and lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. Generators are allowed to conduct certain activities, provided that each individual aerosol can is not breached and remains intact. These activities include sorting aerosol cans by type, mixing intact cans in one container, and removing actuators to reduce the risk of accidental release. Generators may puncture and drain aerosol cans under the rule but they must do so using a device specifically designed to puncture aerosol cans safely and that effectively contain the residual contents and any emissions. Generators also must establish a written procedure detailing how to puncture and drain universal waste aerosol cans safely (including proper assembly, operation, and maintenance of the unit; segregation of incompatible wastes; and proper waste management practices to prevent fires or releases), maintain a copy of the manufacturer’s specification and instruction onsite, and ensure employees operating the device are trained in the proper procedures. The puncturing must be accomplished so as to prevent fires and to prevent the release of any component of universal waste to the environment. This includes, but is not limited to, locating the equipment on a solid, flat surface in a well ventilated area. Each universal waste aerosol can or a container in which the aerosol cans are contained must be labeled or marked clearly with any of the following phrases: “Universal Waste—Aerosol Can(s),” “Waste Aerosol Can(s),” or “Used Aerosol Can(s).” This proposed rule would be less stringent than the current federal program. Because states are not required to adopt less stringent regulations, they would not have to adopt the universal waste regulations for aerosol cans, although EPA encourages them to do so. Some states have already added aerosol cans to the list of universal wastes in that state, and others may do so in the future. If a state’s standards for aerosol cans are less stringent than those in the final rule, the state would have to amend its regulations to make them at least equivalent to the federal standards and pursue authorization. Comments will be due 60 days after the proposed rule’s publication in the Federal Register.

D.C. Circuit Revises Its Decision On RCRA Definition Of Solid Waste Case: The U.S. Court of Appeals for the D.C. Circuit on March 6, 2018, revised its 2017 decision on EPA’s 2015 revisions to the RCRA Definition of Solid Waste (DSW). American Petroleum Institute v. EPA, D.C. Cir. App., No. 09-1038. The court tweaked its 2017 DSW decision in three ways. First, the court held that spent petroleum catalysts do qualify for the so-called transfer-based exclusion. Second, the court vacated in its entirety “Factor 4” of EPA’s legitimacy criteria. That factor required that, to be considered legitimate recycling, the product of the hazardous waste recycling process must be comparable to a legitimate product or intermediate. Third, as a result of vacating Factor 4, the court also held that the 2015 change to the DSW making the legitimacy factors applicable to all exclusions remains, that “Factor 3” remains mandatory, and that the 2008 version of Factor 4 replaces the now-vacated 2015 version.

By way of background, on July 7, 2017, the U.S. Court of Appeals for the D.C. Circuit found “unreasonable,” and thus threw out, the “verified recycler” exclusion promulgated by EPA in its 2015 revisions to the DSW under RCRA. The court reinstated the “transfer-based” exclusion promulgated by EPA under the Bush Administration. In the case, American Petroleum Institute v. EPA (D.C. Cir. No. 09-1038), the court also removed one of the provisions of the legitimacy criteria. The court upheld all other portions of the 2015 rule and rejected the environmental groups’ challenges to it.

To RCRA aficionados, the court’s ruling is yet another in a seemingly endless progression of cases. EPA has revised the RCRA DSW dozens of times since its original promulgation in 1980. EPA similarly has been sued over those revisions throughout the lifespan of the regulation. This case arises from EPA’s 2015 effort to delineate when certain recycled items are solid waste under RCRA. On January 13, 2015, EPA promulgated a final rule governing when certain hazardous materials qualify as “discarded” and hence are subject to RCRA. 80 Fed. Reg. 1694. Environmental and industry groups challenged several aspects of the rule. The court in this case ruled in favor of industry petitioners on one aspect of EPA’s legitimate recycling criteria and also found the “Verified Recycler Exclusion” to be unreasonable. All other aspects of the 2015 rule withstood the legal challenges to them. The history of this litigation really begins in 2008, when EPA issued a rule exempting several materials from regulation as solid waste. 73 Fed. Reg. 64668 (Oct. 30, 2008). Specifically, EPA excluded hazardous secondary materials from the DSW in two circumstances: first, if the company that generated the materials controlled the recycling of those materials; and second, if the generator transferred the materials to an off-site recycler that it had audited to ensure compliance with proper recycling practices. These two exemptions were known, respectively, as the “Generator-Controlled Exclusion” and the “Transfer-Based Exclusion.” To qualify for either, secondary materials had to be recycled “legitimately,” a term EPA defined by reference to certain “legitimacy factors.” Several organizations challenged the 2008 rule, including the Sierra Club. EPA eventually entered into a settlement agreement with the Sierra Club. Pursuant to that agreement, the Sierra Club withdrew its petition, and EPA agreed to propose a new rule. EPA did so in July 2011. 76 Fed. Reg. 44094 (July 22, 2011). EPA then promulgated the rule in final in 2015. The 2015 final rule differs from the 2008 rule in several ways. In particular, EPA revised the definition of “legitimate” recycling and expanded the scope of the legitimacy factors to cover all recycling, and replaced the transfer-based exclusion with a new “Verified Recycler Exclusion.” Several organizations filed petitions for review on the 2015 rule, and those petitions were consolidated into the present case. Industry petitioners argued that both the legitimacy test and the Verified Recycler Exclusion exceeded EPA’s RCRA authority. They also challenged EPA’s treatment of spent catalysts and off-specification commercial chemical products. Environmental petitioners argue that the Verified Recycler Exclusion is too permissive and that EPA should have added containment and notification conditions to the pre-2008 exclusions. EPA’s long held position — formally articulated in 1989 — is that recycling must be legitimate and not just a sham to avoid disposal costs and standards. See Memorandum from Sylvia K. Lowrance, Director, Office of Solid Waste (Apr. 26, 1989) (Lowrance memo). The Lowrance memo set forth several criteria that a recycling activity must meet to be considered legitimate. In the 2015 rule, EPA codified these criteria and required that all recycling meet the four factors of this legitimacy test. See 40 C.F.R. Section 260.43(a). These factors are:

• Factor 1 — The hazardous secondary material must provide a useful contribution to the recycling process.
• Factor 2 — The recycling process must produce a valuable product or intermediate.
• Factor 3 — The persons controlling the secondary material must manage the hazardous secondary material as a valuable commodity.
• Factor 4 — The product of the recycling process must be comparable to a legitimate product or intermediate.

Industry petitioners in the case did not challenge EPA’s authority to promulgate the legitimacy test. They instead attacked EPA’s planned means to implement that policy. They argued that mandating Factors 3 and 4 of the legitimacy test across all recycling results in EPA’s unlawfully regulating non-discarded materials. The court rejected this argument for Factor 3, but found that Factor 4 presented more difficulty. EPA explains this factor as an effort to prevent recyclers from loading products with hazardous secondary materials that provide no recognizable benefit to the product. 80 Fed. Reg. at 1722. After a lengthy analysis that weaved between pleadings, EPA studies, and regulatory and preamble language, the court concluded that “Factor 4 is unreasonable as a requirement applied … to all hazardous secondary material recycling.” It thus remanded that factor.

EPA Publishes Final Rule Regarding Nonattainment Areas For The 2015 Ozone NAAQS:  On March 9, 2018, EPA published a final rule establishing the air quality thresholds that define the classifications to all nonattainment areas for the 2015 ozone National Ambient Air Quality Standards (NAAQS). 83 Fed. Reg. 10376. The final rule also establishes the timing of attainment dates for each nonattainment area classification. Under the system, areas with ozone pollution within 10 ppb of the most recent 70 ppb standard have three years to bring down their ozone concentrations to meet the standards. Areas that do not meet the ozone standards are subject to stricter permitting requirements for new and modified industrial facilities. Areas with more severe ozone problems have more time to comply. Areas with the most extreme ozone pollution have up to 20 years. The final rule will take effect May 8, 2018. EPA posted a fact sheet on the final rule.

EPA Proposes To Withdraw CTG For Oil And Natural Gas Industry: EPA on March 9, 2018, proposed to withdraw the Clean Air Act (CAA) Control Techniques Guidelines (CTG) for the Oil and Natural Gas Industry. 83 Fed. Reg. 10478. The final CTG provided recommendations for reducing volatile organic compound (VOC) emissions from existing oil and natural gas industry emission sources in ozone nonattainment areas classified as Moderate or higher and states in the Ozone Transport Region (OTR). The CTG relied upon underlying data and conclusions EPA made in its June 3, 2016, final rule establishing New Source Performance Standards (NSPS) for the sector. On June 5, 2017, however, EPA granted reconsideration in regard to additional provisions of the 2016 NSPS. EPA thus is looking broadly at the 2016 NSPS. In light of the fact that EPA is reconsidering the 2016 NSPS and because the recommendations made in the CTG are fundamentally linked to the conclusions in the 2016 NSPS, EPA states that it believes it is prudent to withdraw the CTG in its entirety. EPA also believes that the withdrawal will be more efficient for states in revising their state implementation plans (SIP). The comment period closes April 23, 2018.

EPA Issues NSR Guidance Allowing Facilities To Base Emission Estimates On “Real World Impacts”: EPA on March 13, 2018, issued a guidance memorandum clarifying the process for evaluating projects under the major New Source Review (NSR) program. The guidance streamlines permitting processes and procedures. NSR provisions require covered facilities to obtain a preconstruction permit prior to the construction of a new major stationary source or a “major modification” to an existing stationary source. Determining whether a proposed project triggers the threshold to obtain an NSR permit is a two-step process. The first step determines whether a proposed project will, by itself, result in a significant emissions increase. If an increase is projected to occur, the process moves to the second step to determine whether the project, combined with other unrelated recent projects, will result in a significant net emissions increase. EPA states that, given previous inconsistent application and interpretation of the first step, this process has prevented environmentally beneficial projects from moving forward. The memorandum clarifies that companies can consider projected decreases in emissions of air pollution, as well as projected emissions increases, during the first step. If the Step 1 evaluation shows that the proposed project will not result in a significant emissions increase, the project then proceeds under a state-issued minor source permit and avoids the complex multi-year evaluation to obtain a major NSR permit. The memorandum is available online.

EPA Proposes Revisions To RCRA Standards For Coal Combustion Residues: On March 15, 2018, EPA issued a proposed rule revising its criteria for existing and new coal combustion residuals (CCR) landfills and existing and new CCR surface impoundments. 83 Fed. Reg. 11584. EPA is proposing to amend the regulations for the disposal of CCR in landfills and surface impoundments to: (1) address provisions of the final rule that were remanded on June 14, 2016, by the U.S. Court of Appeals for the D.C. Circuitin USWAG et al v EPA, No. 15-1219 (D.C. Cir. 2015); (2) provide states with approved CCR permit programs (or EPA where it is the permitting authority) under the Water Infrastructure Improvements for the Nation (WIIN) Act the ability to set certain alternative performance standards; and (3) address the use of CCR during certain closure situations. The comment period closes on April 30, 2018.

FDA

FDA Launches Catalog Of Food Safety, Nutrition, And Cosmetic Safety Education Materials: On February 22, 2018, the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) announced it had transformed its Education Resource Library into a catalog of nearly 300 publications and videos covering food safety, nutrition, cosmetic safety, dietary supplements, and industry information, including food defense. FDA states its Education Resource Library catalog has been designed to make CFSAN’s wide range of public health education information more accessible for individuals seeking science-based food safety, nutrition, and cosmetic safety information, whether for professional or personal reasons. The content has been indexed and organized alphabetically, users can use a system of filters to quickly drill down to items that meet their needs, and the materials found in users’ searches are available for download or available to be ordered.
 
FDA Deputy Commissioner Issues Statement On Draft BPA Report: On February 23, 2018, FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., issued a statement on the National Toxicology Program’s (NTP) draft report on Bisphenol A (BPA). Dr. Ostroff’s statement announced NTP’s release of a pre-Peer Review of the Draft NTP Research Report on the findings of a comprehensive two-year rodent study examining the potential effects of BPA on health for public comment that was also noticed in the Federal Register on February 21, 2018. 83 Fed. Reg. 7488. The study was conducted by senior scientists at FDA’s National Center for Toxicological Research (NCTR) as part of a collaborative effort called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) established by the FDA and the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health after a 2008 NTP report raised some concerns about developmental effects in rodents exposed to relatively low doses of BPA. FDA will be conducting a comprehensive review of the report as part of its continued assessment of BPA safety, but states its initial review “supports [its] determination that currently authorized uses of BPA continue to be safe for consumers,” and “builds upon the already extensive data collected in the FDA’s 2014 assessment of the safety of BPA.” NTP is accepting comments on the draft report but no set deadline was given. NTP also announced that the peer-review meeting will be open to the public. It is scheduled for April 26, 2018, from 8:30 a.m. to 5:00 p.m. (EDT) in Research Triangle Park, North Carolina. Registration is requested for attendance at the meeting either in-person or by webcast and to present oral comments. Information about the meeting and registration is available here.

FDA Releases Guidance Documents Addressing Requirements Under The Drug Supply Chain Security Act (DSCSA): On March 2, 2018, FDA announced the release of a draft guidance document entitled “Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry.” 83 Fed. Reg. 9004. The notice state the draft guidance “elaborates on the standards for the interoperable exchange of transaction information, transaction history, and transaction statements (product tracing information) provided under the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” and “is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners must provide, capture, and maintain under the FD&C Act.” FDA requests comments by May 1, 2018, to ensure they are considered prior to FDA’s work on the final version. Also announced on March 2, 2018, was FDA’s release of another draft guidance document entitled “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry.” 83 Fed. Reg. 8998. FDA states that this draft guidance is intended “to describe FDA’s interpretation of terms used in the definition of ‘suspect product’ and ‘illegitimate product’ in the [DSCSA], for purposes of trading partners’ verification obligations (including notification).” FDA requests comments by April 2, 2018, to ensure they are considered prior to FDA’s work on the final version.

FDA Announces ANSI As Accreditation Body Under FSMA Program:  On March 9, 2018, FDA announced the recognition of the American National Standards Institute (ANSI) of Washington, D.C. as the second accreditation body to be recognized under the Accredited Third-Party Certification Program for a period of five years. FDA states ANSI is being recognized because it meets the applicable FDA requirements, validated through application review and on-site assessment. ANSI is being recognized as having the authority to accredit certification bodies with the ability to conduct food safety audits as they pertain to the following regulations: Current Good Manufacturing Practice; Hazard Analysis and Risk Based Preventive Controls for Human Food; Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption; Hazard Analysis and Critical Control Point Systems; and Fish and Fishery Products. More information about the Accredited Third-Party Certification Program and the Public Registry of Accreditation Bodies is available at FDA.gov.

FDA Issues 2017 Voluntary National Retail Food Regulatory Program Standards: On March 7, 2018, FDA issued the 2017 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) that define the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory agencies. FDA states the Retail Program Standards “provide recommendations for designing and managing these retail food regulatory programs and help these regulatory agencies (or other responsible organizations) identify program areas in need of improvement, and facilitate more effective inspections and foodborne illness prevention strategies” and the 2017 edition “incorporates changes based on recommendations discussed at the Conference for Food Protection 2016 Biennial Meeting and other minor editorial changes,” which include:

• Updates to the Training Standard definition;
• Clarification to the standardizing and re-standardizing criteria for Food Safety Inspection Officers (FSIO);
• Alignment of program elements in Retail Program Standard 4 with the performance elements and competencies contained in Retail Program Standard 2, resulting in 20 program elements and an increase in the minimum number of required field assessments;
• Incorporation of additional methods of recognizing communication efforts with industry and the community;
• Consolidation of the facility categories that can be used when conducting a risk factor study; and
• Consolidation of reporting forms, FDA Forms 3519 and 3520, into one single FDA Form 3598.

The procedure for enrolling is available at Administrative Procedures for Voluntary National Retail Food Regulatory Program Standards and a complete list of jurisdictions enrolled in the Retail Program Standards is available at Listing of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory Program Standards.

JRC Opens Call To Access JRC Nanobiotechnology Laboratory: The European Commission (EC) Joint Research Center (JRC) has opened a call to access its Nanobiotechnology Laboratory. Offering access to the Nanobiotechnology Laboratory is part of JRC’s strategy to enhance dissemination of scientific knowledge; boost competiveness; bridge the gap between research and industry; and provide training and capacity building. To be eligible, the lead user institution and user institutions must be from a European Union (EU) Member State, candidate country, or country associated with the EU Research Program Horizon 2020. The lead user institution must be from a university, research, or public institution, or from a small- or medium-sized enterprise (SME). The call will close April 13, 2018.

CPSC Will Continue To Use Agency Collaborations To Focus On The Environmental Health And Safety Of Nanomaterials: On February 12, 2018, the U.S. Consumer Product Safety Commission (CPSC) posted its Fiscal Year 2017 Annual Performance Report. According to the Report, in FY 2017, CPSC exceeded its target of five collaborations by establishing seven research collaborations on the environmental health and safety of nanomaterials. The Report states that to help advance nanotechnology research and development, CPSC continued collaborative work during FY 2017 through established Interagency Agreements with the National Institute of Standards and Technology (NIST), the National Nanotechnology Coordination Office (NNCO), and the National Institute for Occupational Safety and Health (NIOSH). Regarding its plans for improving performance, the Report states that in FY 2018, CPSC “has fewer resources for nanomaterial efforts and will continue to focus on environmental health and safety issues through collaborations with other federal agencies.”

EPA Intends To Conduct Nanoparticle Research Over Next Five Years: EPA released its FY 2019 budget proposal on February 12, 2018. According to EPA’s press release, the proposed budget will provide $6.146 billion to support EPA’s new FY 2018-2022 Strategic Plan and mission of protecting human health and the environment. EPA states that the “Back-to-Basic” agenda set out in the Strategic Plan has three over-arching goals reflecting EPA Administrator Scott Pruitt’s core philosophies: (1) refocus EPA back to its core mission; (2) restore power to the states through cooperative federalism; and (3) lead EPA through improved processes and adhere to the rule of law. Under the third goal, Objective 3.3 is to “Prioritize Robust Science: Refocus the EPA’s robust research and scientific analysis to inform policy making.” According to the Strategic Plan, over the next five years, EPA will “[c]onduct nanoparticle research by using life-cycle analyses, evaluating impacts on ecosystem health, and supporting the development of safer nanomaterials in private industry.”

EUON Issues Call For Study Topics On Nanomaterials: On February 26, 2018, the EU Observatory for Nanomaterials (EUON) issued a call for study topics on nanomaterials. EUON states that it intends to conduct up to three studies annually to address knowledge gaps about nanomaterials on the EU market. The studies should be considered of interest for either a specific audience, such as regulators or researchers, but can also be for a wider use such as the general public. Proposals should address an issue/question relevant to nanomaterials on the EU market. The study can focus on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. The study should be possible to execute within three to nine months, be computer-based, and not require experimental facilities.

Switzerland Adopts Disclosure Requirements For Synthetic Nanomaterials In Fibrous Or Tubular Form: On March 1, 2018, amendments to Switzerland’s Chemicals Ordinance took effect. The amendments, adopted by the Federal Council on January 31, 2018, include new disclosure requirements for synthetic nanomaterials of fibrous or tubular form. Switzerland states that the specified nanomaterials can cause lesions in the lungs if inhaled.

CPSC Will Hold Public Hearing On Agenda And Priorities For FYs 2019-2020: CPSC published a Federal Register notice on March 1, 2018, announcing that it will hold a public hearing on April 11, 2018, to receive comments about CPSC’s agenda and priorities for FYs 2019-2020. CPSC’s Fiscal Year 2019 Performance Budget Request to Congress states that CPSC “will continue supporting nanotechnology research, coordinating with other federal agencies to extend limited agency resources by leveraging other research efforts.” According to CPSC’s budget request, in FYs 2018 and 2019, CPSC intends to establish or maintain three collaborations with other organizations to work on nanotechnology research or issues affecting consumer products. Written comments and requests to make oral presentations at the public hearing are due March 28, 2018.

EC Committee Begins Public Consultation On Certain Styrene/Acrylates Copolymer And Sodium Styrene/Acrylates Copolymer: On March 2, 2018, the EC Scientific Committee on Consumer Safety (SCCS) began a public consultation on its preliminary opinion on certain styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano). According to the preliminary opinion, the EC has concerns over the safety of the use of sodium styrene/acrylates copolymer (nano) and styrene/acrylates copolymer (nano) in cosmetic products. SCCS states that data should be provided separately for all of the three styrene/acrylate nanospheres, including any encapsulated substances. The EC asked SCCS to address any further scientific concerns with regard to the use of styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano form in cosmetic products. SCCS states: “For applications as evaluated in this Opinion, it is imperative that the safety assessment not only considers safety of the individual components (e.g. the encapsulating material and the encapsulated contents), but also the safety of all the components when put together in the form of a nano-sized entity.” The deadline for comments is May 11, 2018.

EC Review Of REACH Examines How REACH Addresses Nanomaterials: On March 5, 2018, the EC announced the availability of a Communication to the European Parliament (EP), the Council of the EU, and the European Economic and Social Committee on the operation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. According to Part 1 of the EC staff working document, although REACH is able to address emerging issues such as the risks from nanoforms of substances, the lack of specific information about nanoforms covered by REACH registration dossiers remains an issue. The document notes that several compliance check decisions by the European Chemicals Agency (ECHA) on the registrations of substances with nanoforms were appealed to the Board of Appeal, and four were annulled. According to the document, the proposed revision of the REACH Annexes will address these shortcomings. As reported in our October 11, 2017, blog item, on October 9, 2017, the EC began a public consultation on a draft regulation that would amend several REACH Annexes to address nanoforms of substances. The EC will discuss the outcomes and follow-up actions of its REACH review with the EP, EU Member States, and stakeholders at a public conference planned for June 2018.

NIOSH Publishes Workplace Design Solutions Addressing Nanomaterials: On March 9, 2018, NIOSH published three documents in its Workplace Design Solutions series. NIOSH recommends that manufacturers and downstream users of nanomaterials develop Prevention through Design (PtD) strategies to protect workers during the handling of engineered nanomaterials. NIOSH states that engineering controls protect workers by removing hazardous conditions or placing a barrier between the worker and the hazard, and along with good material handling techniques, they are likely to be the most effective control strategy for nanomaterials. According to NIOSH, the identification and adoption of effective control technologies is an important first step in reducing the risk associated with worker exposure to engineered nanomaterials and associated byproducts. The publications are:

• Protecting Workers during Nanomaterial Reactor Operations;
• Protecting Workers during the Handling of Nanomaterials; and
• Protecting Workers during Intermediate and Downstream Processing of Nanomaterials.

NIOSH Publishes Poster Regarding Controlling Health Hazards When Working With Nanomaterials: On March 12, 2018, NIOSH announced the availability of the new Workplace Design Solutions documents, as well as a poster, “Controlling Health Hazards When Working with Nanomaterials: Questions to Ask Before You Start.” According to NIOSH, the poster poses questions that employers and workers should consider before starting work with a nanomaterial. NIOSH notes that the poster can be displayed in a lab or work environment, “making it an easily accessible reminder of the important health and safety considerations for working with nanomaterials.”

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 https://www.braginfo.org.

Legislation Would Exempt Agricultural Producers From Reporting Requirements For Animal Waste Emissions: Senator Deb Fischer (R-NE) on February 13, 2018, introduced the Fair Agricultural Reporting Method (FARM) Act (S. 2421). The bill, which has bipartisan cosponsors, would exempt farmers, ranchers, and livestock markets from EPA reporting requirements for animal waste emissions. The bill would amend Section 103 of CERCLA to maintain the exemption for certain federally registered pesticides from reporting requirements. It also would exempt air emissions from animal waste on a farm from reporting requirements under CERCLA.

Bill Would Require EPA To Suspend Uses Of Neonicotinoid Pesticides: Representatives Earl Blumenauer (D-OR) and Jim McGovern (D-MA) on February 14, 2018, introduced the Saving America’s Pollinators Act to protect the health of honey bees and other critical pollinators. The legislation (H.R. 5015) would suspend the use of neonicotinoids, which have been linked to declining pollinator populations. It also requires EPA to complete an assessment to ensure that any uses of these insecticides do not cause unreasonable and adverse effects on pollinators.

Bipartisan Senate Bill Seeks To Create Global Agreement On Refrigerants: On February 15, 2018, Senators John Kennedy (R-LA) and Tom Carper (D-DE) introduced the American Innovation and Manufacturing Act “to provide much-needed certainty for businesses in Louisiana and other states on the worldwide transition towards next generation coolants.” The legislation (S. 2448) would require EPA to establish a market-based system to meet goals to limit hydrofluorocarbons (HFC) that are used as coolants in refrigerators and air conditioners. The HFC industry employs 593,000 workers in the U.S. and generates annual sales of $206 billion. “Because of changing global policy, countries are moving away from using hydrofluorocarbons,” Senator Kennedy stated. The bill is intended to ensure that EPA has the authority to ensure a phasedown of the manufacturing of HFCs in the U.S.

Bill Would Amend TSCA To Ban Asbestos: On February 27, 2018, Representative Suzanne Bonamici (D-OR) introduced legislation to amend TSCA and ban asbestos. When Congress revised TSCA in 2016, it included a provision requiring EPA to undertake a safety assessment of asbestos; EPA has not yet completed that assessment. The Alan Reinstein Ban Asbestos Now Act (H.R. 5114) would amend TSCA to require EPA to identify and assess known uses of and exposures to all forms of asbestos. It would further require that, within 18 months of enactment, EPA impose restrictions on the use of asbestos necessary to eliminate human or environmental exposure to all forms of asbestos. Within one year of rule issuance, no person will be permitted to manufacture, process, use, or distribute in commerce asbestos other than described in EPA’s rule. The bill provides for limited national security exemptions so long as no reasonable alternative to asbestos exists, and the use does not result in unreasonable health risks.

House Passes Legislation Delaying Air Standards For Certain Kilns: On March 7, 2018, the House of Representatives approved a bill that would delay the implementation of CAA standards applicable to certain brick and ceramic tile kilns. On October 26, 2015, EPA issued a final rule establishing National Emission Standards for Hazardous Air Pollutants (NESHAP) for the clay ceramics manufacturing sector. 80 Fed. Reg. 65469. The NESHAP rule required all major sources in this industry sector to meet maximum achievable control technology (MACT) standards for mercury (Hg), non-mercury (non-Hg) metal hazardous air pollutants (HAP) (or particulate matter (PM) surrogate), and dioxins/furans (Clay Ceramics only); health-based standards for acid gas HAP; and work practice standards, where applicable. The final rule became effective on December 28, 2015. The bill, the Blocking Regulatory Interference from Closing Kilns (BRICK) Act of 2017 (H.R. 1917) would delay compliance dates for the rule from taking effect until lawsuits challenging the NESHAPs are resolved.

House Committee Approves Bill Streamlining Mine Permitting: On March 7, 2018, the House Natural Resources Committee passed by party-line vote the National Strategic and Critical Minerals Production Act (H.R. 520). The bill seeks to streamline the process by which mines are approved. Under the bill, projects that provide minerals vital to job creation, energy infrastructure, American economic competitiveness, and national security must be considered “infrastructure projects” as described in the March 22, 2012, Executive Order (EO) 13604, entitled “Improving Performance of Federal Permitting and Review of Infrastructure Projects.” This EO directed federal agencies to reduce significantly the time required to make permitting and review decisions on infrastructure projects. Under the bill, the Bureau of Land Management (BLM) or the Forest Service would be required to appoint a project lead for the mine permitting process to coordinate with other agencies to ensure that the agencies: minimize delays, set and adhere to timelines for completion of the permitting process, set clear permitting goals, and track progress against goals. The bill states that the requirements of the National Environmental Policy Act (NEPA) are satisfied if the BLM or the Forest Service determines that the agency issuing the permit will address specified factors, such as environmental impact, alternatives to issuance of the permit, or any irreversible and irretrievable commitment of resources that would be involved in the proposed action. The bill limits the period for the mine permitting review process to 30 months, except by mutual agreement that deadline is extended. The bill now moves to the House floor for consideration.

House Passes Bill Easing CAA Standards For Certain Power Plants: On March 8, 2018, the House of Representatives passed legislation that would ease CAA standards for power plants that burn refuse coal. The Satisfying Energy Needs and Saving the Environment (SENSE) Act (H.R. 1119), introduced by Keith Rothfus (R-PA), passed on a 215-189 vote. This bill eases emission limits for HAPs from electric utility steam generating units (electric power plants) that convert coal refuse into energy. EPA would be required to allow utilities to select a standard for either hydrogen chloride or sulfur dioxide, but not both.

Senator Udall And Representative Welch Introduce Bills To Reform The Renewable Fuel Program: On March 8, 2018, Senator Tom Udall (D-NM) and Representative Peter Welch (D-VT) introduced companion bills in the House and Senate to reform the Renewable Fuel Standard (RFS) under the CAA by mitigating harmful environmental impacts and advancing the next generation of biofuels. The GREENER Fuels Act (Growing Renewable Energy through Existing and New Environmentally Responsible Fuels Act) (S. 2519, H.R. 5212) is the first bill in Congress to reform the RFS. The legislation would phase out the corn ethanol mandate and immediately reduce the amount of ethanol in fuel by as much as 1 billion gallons by capping the amount of ethanol that can be blended into conventional gasoline at 9.7 percent. It also would seek to help farmers return cornfields to pasture and wildlife habitat through a 10 cents per renewable identification number (RIN) fee to fund a new Private Land Protection and Restoration Fund in the U.S. Treasury. The fund will help pay for Department of Interior programs that pay for easements on private lands to keep them out of agricultural production; keep the lands in conservation uses like grass, forest, stream buffers, or pollinator habitat; and help farmers transition land currently in crop production into other uses. The bill also would extend the cellulosic next generation biofuel mandate until 2 billion gallons of annual production is achieved or 2037, whichever is soonest, and improve the way the mandate is implemented to produce liquid transportation fuels that dramatically reduce greenhouse gas emissions. In a statement, Representative Welch stated that “Despite its early promise, the RFS has been a well-intentioned flop that is harming our environment by contributing to the conversion of millions of acres of grasslands, wetlands and forests into crop production while failing to bring about the widespread use of truly sustainable fuels.”

House Bill Would Exempt Certain Agricultural Operations From CERCLA Release Reporting: Missouri Republican Billy Long and California Democrat Jim Costa introduced the Agricultural Certainty for Reporting Emissions Act (ACRE Act; H.R. 5275). The bill would amend CERCLA to exempt air emissions from animal waste at farms from CERCLA release reporting requirements. In 2008, EPA issued a final rule that generally exempts farms from CERCLA release reporting requirements for air releases from animal waste. 73 Fed. Reg. 76948 (Dec. 18, 2008). A number of environmental groups objected, claiming that the final rule ran afoul of the underlying statutes (and was therefore outside EPA’s delegated authority). In April 2017, the U.S. Court of Appeals for the D.C. Circuit ruled in favor of the environmental petitioners and vacated EPA’s 2008 rule. Waterkeepers Alliance v. EPA, Case No. 09-1017. H.R. 5275 would essentially reinstate the exemption but do so by amending CERCLA directly.

EPA Releases FY 2018 – 2022 Strategic Plan: On February 12, 2018, EPA released its FY 2018 – 2022 Strategic Plan. EPA refers to the plan as a “back to basics” agenda. The plan sets forth three over-arching goals which reflect the Administrator’s core philosophies: refocus EPA to its core mission; restore power to the states through cooperative federalism; and lead EPA through improved processes and adhere to the rule of law. EPA states that, taken together, these goals are designed to transform the way EPA does business and more efficiently deliver human health and environmental results. With respect to its core mission, the plan states that EPA will deliver real results to provide Americans with clean air, land, and water, and ensure chemical safety. The plan also calls for enhanced shared accountability and increased transparency and public participation to achieve the goal of cooperative federalism. Regarding the rule of law and process, the plan provides that EPA will comply with the law, create consistency and certainty, prioritize robust science, streamline and modernize its operations, and improve efficiency and effectiveness. One of the objectives of the plan is to ensure the safety of chemicals in the marketplace. To that end, the plan calls for EPA to implement TSCA, and FIFRA, to ensure new and existing chemicals and pesticides are reviewed for their potential risks to human health and the environment and actions are taken when necessary. EPA sets forth five strategic measures to achieve this objective:

• By September 30, 2022, complete all EPA-initiated TSCA risk evaluations for existing chemicals in accordance with statutory timelines.
• By September 30, 2022, complete all TSCA risk management actions for existing chemicals in accordance with statutory timelines.
• By September 30, 2022, complete all TSCA PMN final determinations in accordance with statutory timelines.
• By September 30, 2022, complete all cases of FIFRA-mandated decisions for the pesticides registration review program.
• By September 30, 2022, reduce the Pesticide Registration Improvement Act (PRIA) registration decision timeframe by an average of 60 days.

Eastern District Of California Rules On Motion To Enjoin Prop 65 Listing And Warning On Glyphosate: On February 26, 2018, the U.S. District Court for the Eastern District Court of California issued a memorandum and order on the plaintiff’s motion for preliminary injunction (Order) to “enjoin the listing of glyphosate under Proposition 65 (Prop 65) and the application of its attendant warning requirement pending a final judgment in this case and set a schedule for expedited final resolution of the case.” The Order (1) grants plaintiffs’ request for a preliminary injunction enjoining the warning requirement of California Health & Safety Code Section 25249.6 as to glyphosate; and (2) denies the request for a preliminary injunction enjoining defendants from listing glyphosate as a chemical known to the State of California to cause cancer under California Health & Safety Code Section 25249.8. Specifically, the Order states: “[P]ending final resolution of this action, defendants … are hereby ENJOINED from enforcing as against plaintiffs … California Health & Safety Code § 25249.6’s requirement that any person in the course of doing business provide a clear and reasonable warning before exposing any individual to glyphosate.” Although this is only a preliminary injunction while the case continues further resolution, it is extremely significant that, for now, glyphosate will continue to be listed on California’s Prop 65 list as a “chemical known to the State of California to cause cancer,” but products containing glyphosate will not be required to comply with the warning requirement. More information is available in our blog.

OSHA Will Enforce Beryllium Standard Starting In May: The Occupational Safety and Health Administration (OSHA) on March 2, 2018, announced that it will start enforcement of the final rule on occupational exposure to beryllium in general, construction, and shipyard industries on May 11, 2018. OSHA states that this timeframe will ensure that stakeholders are aware of their obligations and that OSHA provides consistent instructions to its inspectors. The start of enforcement had previously been set for March 12, 2018. The final rule on occupational exposure to beryllium, published on January 9, 2017, established new Permissible Exposure Limits (PEL), Short Term Exposure Limits (STEL) and contained several other ancillary provisions that apply to general industry, construction, and shipyards. This rule was codified in three separate standards at 29 CF.R. Sections 1910.1024, 1915.1024, and 1926.1124, and became effective on May 20, 2017. Under the general industry standard, almost all obligations were to commence on March 12, 2018. On June 27, 2017, however, OSHA proposed to revoke the ancillary provisions of the construction and shipyard standards but retain the new PEL and STEL. In that notice, OSHA announced that it would not enforce the new construction and shipyard standards without further notice while that rulemaking was underway. 82 Fed. Reg. 29183. On August 24, 2017, OSHA noted on its website that it would not enforce the ancillary provisions of those standards without further notice, but did not state whether it would enforce the PEL or STEL. In the meantime, OSHA has been in settlement discussions with several parties that have filed legal actions challenging the general industry standard. To provide additional time to conclude those negotiations, OSHA decided to delay enforcement of the general industry standard until May 11, 2018. Furthermore, to ensure employers have adequate notice before OSHA begins enforcing them, as well as in the interest of uniform enforcement and clarity for employers, OSHA has decided to delay enforcement of the PEL and STEL in the construction and shipyard standards until May 11, 2018. No other parts of the construction and shipyard beryllium standards will be enforced without additional notice.

Peter Wright Nominated To Lead EPA’s Office Of Land And Emergency Management: On March 2, 2018,President Trump announced his intention to nominate Peter C. Wright as Assistant Administrator for EPA’s Office of Land and Emergency Management (OLEM). Since 1999, Mr. Wright has worked at The Dow Chemical Company where he serves as managing counsel for environmental health and safety and principle counsel for all significant mergers and acquisitions. Throughout his career, Mr. Wright has provided legal support for Superfund and other remediation sites. In 2017, he was recognized with a special award for the oversight and reorganization efforts of the remediation portfolio. “Peter is exceptionally qualified to lead the Office of Land and Emergency Management,” stated EPA Administrator Scott Pruitt. “He has the expertise and experience necessary to implement our ambitious goals for cleaning up the nation’s contaminated lands quickly and thoroughly.”
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