Federal Development Update for July 2017


TSCA/FIFRA

EPA Releases Final Test Guideline For Performance Against Bed Bugs: On June 14, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. 82 Fed. Reg. 27254. According to EPA, the test guideline provides “guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA,” and “recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the common bed bug (Cimex lectularius) in connection with registration of pesticide products under the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” EPA states that the guidance applies to products “in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs.” This guideline provides appropriate laboratory study designs and methods for evaluating the product performance of pesticides against bed bugs and includes statistical analysis and reporting. EPA issued the draft guideline on February 14, 2012. This original document was the subject of FIFRA Scientific Advisory Panel (SAP) review conducted on March 6-7, 2012. EPA states that the final version of the guideline reflects revisions to the original draft based on comments from the SAP and the public. The revisions include the following: decreasing the number of individuals and replicates tested; rescinding the recommendation to test each field strain for its resistance ratio; including a resistance management statement; clarifying the Agency’s Good Laboratory Practices (GLP) requirements; reducing the recommended length of time individuals are exposed to insecticides; recommending individuals to be observed up to 96 hours after treatment; and revising the statistical analyses recommendations. EPA has also placed two other relevant documents in the docket: Product Performance Guideline 810.3900 - Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products, Response to SAP Comments; and Product Performance Guideline 810.3900 - Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products, Response to Public Comments.

EPA Issues Final TSCA Framework Rules: EPA released on June 22, 2017, the pre-publication Federal Register notices of the final framework actions under the Toxic Substances Control Act (TSCA), as revised by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA). The final rules include the prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which risk evaluation is not warranted at this time; the risk evaluation process rule, which establishes EPA’s process for evaluating High-Priority chemicals to determine whether or not they present an unreasonable risk to health or the environment; and the TSCA Inventory active-inactive rule, which requires industry to report chemicals manufactured, imported, or processed in the U.S. over the past ten years. EPA also published pre-publication notices concerning the scopes of the risk evaluations to be conducted for the first ten chemical substances under new TSCA and a guidance document to assist interested persons in developing and submitting draft risk evaluations. More information on our detailed summary and analysis of the rules is available at http://www.lawbc.com/regulatory-developments/entry/epa-issues-final-tsca-framework-rules.

Complaint Filed Against EPA For FOIA Communication Records Related To Chlorpyrifos Order: On June 22, 2017, American Oversight, a nonprofit organization (Plaintiff), filed a complaint against EPA in the United States District Court for the District of Columbia. The complaint asks the court to compel EPA to provide information in response to a Freedom of Information Act (FOIA) request submitted by the Plaintiff on April 11, 2017, “seeking communications between certain individuals at each agency and certain outside entities related to chlorpyrifos or other pesticides.” The records requested included a copy of any decision memoranda and attachments associated with the decision to deny the petition to ban chlorpyrifos; and all communications between certain individuals involved with EPA’s Administration as well as certain transition team members, and the following listed entities: any agricultural or other trade group with an interest in pesticides, including but not limited to CropLife, the American Farm Bureau, the National Corn Growers, or the Oklahoma Farm Bureau; any pesticide manufacturer or anyone acting on behalf of a pesticide manufacturer, including but not limited to Dow Chemical or Dow AgroSciences; any member of Congress or anyone acting on behalf of a member of Congress (including both personal and Committee staff) regarding agricultural issues or pesticides; and any think tanks, including but not limited to the Heritage Foundation, regarding agricultural issues or pesticides.

The complaint asserts that although EPA responded to the FOIA request by stating that it was “proceeding with the search,” EPA “has not taken any additional actions,” and as of June 14, 2017, had not provided any of the requested records. Plaintiff claims that EPA has failed to comply with the applicable time-limit provisions of FOIA and the complaint contains two Counts: Count I: Failure to Conduct Adequate Search for Responsive Records; and Count II: Wrongful Withholding of Non-Exempt Records. Based on these alleged violations, Plaintiff asks the court to order EPA to conduct a search reasonably calculated to uncover all records responsive to the FOIA request; order EPA to produce any and all non-exempt records responsive to the FOIA request and indexes justifying the withholding of any responsive records withheld under claim of exemption; and enjoin EPA from continuing to withhold any and all non-exempt records responsive to the FOIA request. More information is available at http://pesticideblog.lawbc.com/entry/complaint-filed-against-epa-for-foia-communication-records-related-to-chlor.

EPA Updates Literature Review And FQPA Determination: On May 25, 2017, EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document. These documents were signed by EPA scientists on December 29, 2016, prior to the new Administration, but were placed in the docket only last month, under the new Administration. The documents attempt to rebut the various criticisms of EPA’s assessment of the epidemiology studies for chlorpyrifos and the original FQPA safety factor determination for OP pesticides, and they reaffirm the policy embodied in the original Literature Review. Because these new documents were signed in the last days of the Obama Administration, they may be viewed by some industry stakeholders as an effort by some at EPA to “lock in” the prior policy concerning OP pesticides. The public release of the “updated” Literature Review and response to comments must be considered in the context of the ongoing chlorpyrifos battles that have received significant public attention. During the five months between the date that these “update” documents were signed and the date that EPA placed them in the public docket, EPA Administrator Pruitt issued a decision on March 29, 2017, to deny the petition filed by the Pesticide Action Network North America (PANNA) and the National Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos products. See EPA Denies Petition to Ban Chlorpyrifos. In his denial decision, Administrator Pruitt concluded it would be appropriate for EPA to defer determining whether chlorpyrifos is likely to cause neurodevelopmental effects at exposure levels below the levels that cause acetylcholinesterase (AChE) inhibition until the completion of the registration review process for chlorpyrifos. Administrator Pruitt based his decision on the premise that “the science addressing neurodevelopmental effects remains unresolved” and that “significant uncertainty … exists regarding the potential for chlorpyrifos to cause adverse neurodevelopmental effects.” More information is available at http://pesticideblog.lawbc.com/entry/epa-updates-literature-review-and-fqpa-determination.

EPA Publishes Notice Of Availability Of Scope Documents: On July 7, 2017, EPA published a notice in the Federal Register announcing the availability of the scope documents for the risk evaluations of the first ten chemicals that it will be conducting under the amended TSCA. 82 Fed. Reg. 31592. The notice states that each scope document includes “the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to consider in conducting the risk evaluation.” The direct links to the scope documents are available in our blog item EPA Issues Much Anticipated Three Final TSCA Framework Rules, Guidance on Draft Risk Evaluations, and Scoping Documents on Risk Evaluations of First Ten Chemicals under Revised TSCA. More information is available at http://www.tscablog.com/entry/epa-publishes-notice-of-availability-of-scope-documents.

EPA Issues Draft OCSPP National Program Manager Guidance: In June 2017, EPA issued a draft OCSPP National Program Manager Guidance for Fiscal Year (FY) 2018-2019, which sets forth the strategies and actions that EPA and its state and tribal partners will undertake to protect human health and the environment via six key programmatic activities. EPA uses an Annual Commitment System (ACS) to track annual regional performance information and results. Below is a listing of the six programmatic activities and their ACS measures, if applicable:

  • Strengthening state and tribal partnerships through continued effective management of pesticide cooperative agreements. The guidance states that the “National Pesticide Program depends on cooperative agreements with states and tribes to implement many of the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to help ensure [EPA’s] regulatory decisions and programs achieve intended protections.” For the ACS measure, the commitment target is 100 percent of pesticide program required activities included in grantee work plans completed under the pesticide program portion of the FIFRA Grant Guidance. More information on the activities is listed in the guidance.
     
  • Assisting in national, regional, and local pollinator protection efforts. EPA states that “through risk assessment, mitigation, education, and outreach, EPA’s Office of Pesticides Programs’ goal for pollinator protection is to ensure all pollinators, including managed pollinators such as honey bees, and native pollinator including Monarch Butterflies, are protected from adverse effects of pesticide exposure.” More information on the activities is listed in the guidance. EPA is not proposing any ACS measures to be associated with this area of focus for FY 2018-2019.
     
  • Effectively implementing the revised pesticides worker protection standard rule. More information on this rule is available on our blog under key phrase Worker Protection Standard. EPA states that no ACS measure is proposed to be associated with this area of focus for FY 2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.”
     
  • Effectively implementing the revised certification of pesticide applicators rule. Same as above, EPA states that no ACS measure is proposed to be associated with this area of focus for FY 2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.” More information on this rule is available on our blog under key phrase pesticide applicators.
     
  • Focusing region-specific pesticide priorities on those areas of greatest need nationally. EPA states that region-specific pesticide priority areas “support the agency’s national pesticide program efforts. In addition, these projects support one or more of the agency’s Strategic Plan goals and strategies, and directly benefit states and/or tribes.” The region-specific pesticide priority areas to choose from are: (1) promotion of state and tribal pesticide program coordination and communication; (2) bed bug outreach and assistance; (3) promotion, development or support of integrated pest management efforts; (4) support of water quality risk assessment and mitigation; (5) spray drift outreach and incident data collection; and (6) support of emerging public health pesticide issues. The ACS measure commitment target is one project or initiative contributing to the implementation and enhancement of the region-specific pesticide program priority areas.
     
  • Toxics Release Inventory (TRI). For the TRI program, EPA includes three ACS measures on the number of TRI data quality checks:
     
    • The TRI-1 measure allows EPA to track performance of the TRI program, and aid in improving the accuracy and reliability of environmental data. This measure will provide valuable information as more than 21,000 facilities report to the TRI program annually.
       
    • For FY 2018, TRI-1 is a non-commitment measure of data quality calls and e-mails to 600 facilities in total across all regional offices.
       
    • For FY2019, TRI-1 will be a commitment measure of data quality calls and e-mails to 600 facilities in total across all regional offices.
       

D.C. Circuit Remands EPA’s Cyantraniliprole Registration Decision: On June 30, 2017, the U.S. Court of Appeals for the D.C. Circuit issued its opinion in Center for Biological Diversity, et al. v. U.S. Environmental Protection Agency, Case No. 14-1036, resolving jurisdictional and substantive issues following complaints alleging that EPA violated Section 7(a)(2) of the Endangered Species Act (ESA) by failing to make an effects determination or to consult with the U.S. Fish and Wildlife Service (FWS) or the National Marine Fisheries Service (NMFS) before registering cyantraniliprole (CTP) under FIFRA. Regarding the jurisdictional issue and the appropriate court in which to bring such a challenge, the U.S. District Court for the District of Columbia on May 14, 2015, had dismissed the ESA complaint of the Center for Biological Diversity (CBD), the Center for Food Safety, and the Defenders of Wildlife (Conservation Groups), finding that the Conservation Groups’ “Complaint gives rise to an ‘actual controversy as to the validity’ of the FIFRA Registration Order and is therefore governed by that Act’s jurisdictional grant.” The D.C. Circuit affirmed the U.S. District Court’s ruling to dismiss the ESA petition on jurisdictional grounds, concluding that FIFRA “grants the court of appeals exclusive jurisdiction to review an ESA claim that is ‘inextricably intertwined’ with a challenge to a pesticide registration order.” The D.C. Circuit also, however, granted the Conservation Groups’ FIFRA petition, finding that EPA registered CTP without having made an effects determination or consulting with the FWS and/or the NMFS as required under ESA Section 7(a)(2). The court remanded the case to EPA for further proceedings, but allowed the CTP registration order to remain in effect until it is replaced by an order consistent with the court’s opinion. Considering the growing number of complaints that allege a failure to consult with the FWS and/or the NMFS under the ESA, this decision could have broad reaching implications for how these complaints are filed and reviewed. More information is available at http://pesticideblog.lawbc.com/entry/d.c.-circuit-remands-epas-cyantraniliprole-registration-decision.

EPA Issues Direct Final Rule On SNURs For 29 Chemicals: On July 10, 2017, EPA issued a pre-publication version of a direct final rule, Significant New Use Rule on Certain Chemical Substances, noting the issuance of significant new use rules (SNUR) under TSCA for 29 chemical substances that were the subject of premanufacture notices (PMN) and subject to consent orders under TSCA Section 5(e). These are the first rules with consent orders negotiated under new TSCA. Persons who intend to manufacture or process any of the chemicals for an activity that is designated as a significant new use by this rule must notify EPA at least 90 days before commencing that activity, and the notification will initiate EPA’s evaluation of the intended use within the applicable review period. Further, “[p]ersons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.” EPA will be accepting comments on these SNURs; comments will be due 30 days after publication in the Federal Register. If comment deemed adverse is submitted after the rules are published in the Federal Register as to any of the 29 chemical substances, EPA will withdraw the rule and propose it for comment. Comment will be due 30 days after publication. More information is available at http://www.tscablog.com/entry/epa-issues-direct-final-rule-on-snurs-for-29-chemicals.

RCRA/CERCLA/CWA/CAA/OSHA

Court Of Appeals Overturns Stay Of Oil And Gas Methane Rules: On July 3, 2017, the U.S. Court of Appeals for the D.C. Circuit rebuked the Trump Administration for delaying a Clean Air Act (CAA) rule limiting methane emissions from oil and natural gas drilling. The decision, Clean Air Council, et al., v. EPA, vacated EPA’s stay of the rule and immediately reinstated it. EPA on June 3 2016, issued a final rule establishing new source performance standards (NSPS) for fugitive emissions of methane and other pollutants by the oil and natural gas industries. 81 Fed. Reg. 35824. The rule required regulated entities to conduct an “initial monitoring survey” by June 3, 2017, to identify fugitive emission leaks. 40 C.F.R. Section 60.5397a(f). After EPA published the rule, several industry groups filed administrative petitions under the CAA seeking reconsideration of the rule. EPA Administrator Scott Pruitt on April 18, 2017, announced that EPA “[found] that the petitions have raised at least one objection to the fugitive emissions monitoring requirements” that warrants reconsideration. On June 5, 2017, EPA issued a notice of reconsideration and 90-day stay of several provisions of the rule. 82 Fed. Reg. 25730. On June 16, 2017, EPA issued a proposed rule announcing its intention to extend the stay for two years and to “look broadly at the 2016 Rule” during the reconsideration proceeding. 82 Fed. Reg. 27645. In coming to this decision, EPA concluded that the rule did not seek comment on portions of the rule that became final. The court found otherwise. “The administrative record . . . makes clear that industry groups had ample opportunity to comment on all four issues on which EPA granted reconsideration, and indeed, that in several instances the agency incorporated those comments directly into the final rule.” “Because it was thus not ‘impracticable’ for industry groups to have raised such objections during the notice and comment period [the CAA] did not require reconsideration and did not authorize the stay.”

RCRA Hazardous Waste Generator Improvements Rule Becomes Effective: On May 30, 2017, the Resource Conservation and Recovery Act (RCRA) Hazardous Waste Generator Improvements Rule became effective. 81 Fed. Reg. 85732 (Nov. 28, 2016). The rule will not become effective in RCRA-authorized states, however, until the states adopt the provisions and EPA approves those state programs that adopt the rule. See our Monthly Update for December 2016 for additional detail on the rule. The potential scope of the revised regulatory program is significant: the changes are expected to impact almost 700,000 facilities that generate hazardous waste. The rule is the most comprehensive overhaul of the RCRA generator requirements in 30 years. The rule consists of over 60 changes to the existing regulations and the inclusion of new requirements for generators of hazardous waste, along with a handful of technical corrections. The changes include a reorganization of the hazardous waste generator requirements in an effort to make them more user-friendly and, thus, easier for the regulated community to be in compliance with.

OSHA To Hold Public Meeting On Voluntary Protection Programs: The Occupational Safety and Health Administration (OSHA) on June 23, 2017, announced that it will hold a stakeholder meeting on July 17, 2017, in Washington, D.C., to discuss the future direction of the Voluntary Protection Programs (VPP). In the announcement, OSHA stated that it is seeking “to reshape VPP so that it continues to represent safety and health excellence, leverages partner resources, further recognizes the successes of long-term participants, and supports smart program growth.” OSHA has also opened a docket to receive comments: https://www.regulations.gov/docket?D=OSHA-2017-0009. The docket closes on September 15, 2017.

OSHA Proposes Revisions To Beryllium Rule: On June 27, 2017, OSHA proposed revisions to its January 9, 2017, beryllium exposure final rule. 82 Fed. Reg. 29182. OSHA is requesting comment on a proposal to revoke the ancillary provisions in the construction and shipyard sectors while retaining the permissible exposure limit (PEL) of 0.2 micrograms per cubic meter of air (μg/m3) as an 8-hour time weighted average and the short-term exposure limit (STEL) of 2.0 μg/m3 (15 minutes) for these two sectors. Comments are due by August 28, 2017.

OSHA Proposes To Delay Compliance Date For Electronic Submission Of Injury And Illness Reports: On June 28, 2017, OSHA proposed to delay the deadline for the electronic submission of injury and illness reports. 82 Fed. Reg. 29261. The delay extends the deadline from July 1, 2017, to December 1, 2017. OSHA stated that the proposed delay will allow it to review and consider the rule. Comments were due by July 13, 2017.

EPA And Corps Initiate Rescission Of “Waters Of The U.S.” (WOTUS) Rule: On June 27, 2017, EPA Administrator Scott Pruitt signed a proposed rule entitled, “Definition of ‘Waters of the United States’ – Recodification of Pre-Existing Rules,” which is currently pending publication in the Federal Register. The proposed rule is the first step in the joint EPA/U.S. Army Corp of Engineers (Corps) two-step rulemaking process to rescind and replace the 2015 WOTUS rule known as the “Clean Water Rule” (CWR), which defines the scope of Clean Water Act (CWA) jurisdiction over the nation’s rivers, streams, and wetlands. EPA and the Corps finalized the CWR in June 2015, and its language replaced the prior WOTUS definition in the Code of Federal Regulations (C.F.R.). The CWR has been the subject of litigation and implementation has been stayed nationwide since October 2015.

The current proposal would remove the CWR language from the C.F.R. and re-codify the same regulatory text that existed prior to the 2015 rule. The proposal states, “[‌i]f this proposed rule is finalized, the agencies would continue to implement those prior regulatory definitions), informed by applicable agency guidance documents and consistent with Supreme Court decisions and longstanding agency practice.” Essentially the proposal would maintain the regulatory status quo while EPA and the Corps work on step two -- the replacement rule. Once published in the Federal Register, the proposed rule rescission will be open for a 30-day public comment period. EPA and the Corps are requesting commenters limit their feedback to the appropriateness of the rescission and recodification and reserve their comments on the elements of a future replacement rule for step two.

The rule rescission proposal does provide some indication of a few elements that we can expect to see in a future proposal for a replacement rule. The proposed replacement rule is expected to place more emphasis on the importance on the federalism principles contained in CWA Section 101(b), which recognizes that states and tribes have primary responsibilities and rights to preserve and protect their land and water resources. Indeed, many states regulate waters that are beyond the boundaries of WOTUS. The replacement rule is also expected to add clarity to the late Justice Antonin Scalia’s opinion in the 2006 Rapanos decision, which focused on waters that are “relatively permanent” and exhibit a “continuous surface connection” to traditionally navigable waters. Administrator Pruitt recently sought input from states on how EPA should approach interpreting these key terms from Scalia’s opinion.

A pre-publication version of the proposed rescission and re-codification is available here until publication in the Federal Register. More background on the CWR and Rapanos decision is available in this B&C blog post.

FDA

FDA Announces Opportunity To Comment On The Proposed Collection Of Information Regarding Existing FDA Regulations That Concern FDA-Regulated Human Food And Cosmetics Containing Material Derived From Cattle: On June 15, 2017, the U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register announcing an opportunity for public comment on the information collection provisions of its regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle. 82 Fed. Reg. 27501. The notice states that FDA is inviting comments on these topics:

  • Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
     
  • The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
     
  • Ways to enhance the quality, utility, and clarity of the information to be collected; and
     
  • Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
     

Comments are due August 14, 2017.

FDA Signs Memorandum Of Understanding With China To Outline Certification Process For Certain Exports: On June 15, 2017, FDA signed a Memorandum of Understanding (MOU) with the Certification and Accreditation Administration of the People’s Republic of China (CNCA), formally establishing a registration process for U.S. food manufacturers who export certain foods to China. FDA signed the MOU in response to China’s State General Administration of the People’s Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ) issuance of Administrative Measures for Registration of Overseas Manufacturers, known as AQSIQ Decree 145. AQSIQ Decree 145 requires that CNCA receive certification of compliance with the relevant standards, laws, and regulations of China for the following products as of June 15, 2017: milk and milk products, seafood, infant formula, and/or formula for young children. The MOU provides for a third-party certification process to ensure that manufacturers and products satisfy relevant food safety requirements of China, as specified in Decree 145. Additionally, FDA has published Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China to further explain what information exporting establishments should provide to FDA to register under this new arrangement. FDA will use the information received to establish and update a list of eligible exporters in a manner consistent with the MOU.

FDA Announces Launch Of Accredited Third-Party Certification Website: On June 21, 2017, FDA announced the launch of a website where organizations can apply and be recognized as a third-party accreditation body. The website launch implements the Accredited Third-Party Certification Program, a voluntary program founded by FDA’s Food Safety Modernization Act (FSMA) to expand FDA’s oversight of imported foods. FDA recognizes that accreditation bodies will be able to accredit third-party certification bodies, also known as third-party auditors. FDA states that these accredited certification bodies will then carry out food safety audits of foreign food entities, and may issue certification of those entities and the foods for both humans and animals that they produce based on their findings in the audit. Private third parties and foreign governments and agencies may apply to be recognized as an accreditation body; this process entails filling out a web-based application with user fee.

FDA Extends Comment Period For Interim Final Rule Requiring Disclosure Of Certain Nutrition Information For Standard Menu Items In Certain Restaurants And Retail Food Establishments: On July 3, 2017, FDA announced that it would be extending the comment period on the interim final rule published May 4, 2017, which requires disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. 82 Fed. Reg. 30730. The interim final rule invites comment on specific questions on how FDA “might further reduce the regulatory burden or increase flexibility while continuing to achieve [its] regulatory objectives to provide consumers with nutrition information so that they can make informed choices for themselves and their families.” Comments are due by August 2, 2017.

NANOTECHNOLOGY

Germany Publishes Meeting Report From Expert Dialogue On Application Of Nanotechnologies In The Construction Sector: On June 1, 2017, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety published meeting documents from the Expert Dialogue on “Opportunities and Risks of the Application of Nanotechnologies in the Construction Sector.” The documents include a summary of discussion, meeting agenda, and report, Regulation of construction products and possibilities to address (new) risks from nanomaterials. The summary states that “[‌a] comprehensive assessment and an understandable communication of benefits from nanomaterial-containing products as well as the potentially related risks from them, including from their disposal, was stated to be important for the acceptance of such products.”

EC Publishes Catalog Of Nanomaterials Used In Cosmetic Products Placed On The EU Market: On June 15, 2017, the European Commission (EC) published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market. Regulation (EC) No. 1223/2009 on cosmetic products requires the EC to publish a catalog of all nanomaterials used in cosmetics placed on the market, indicating the categories of products and the reasonably foreseeable exposure conditions. The EC based the catalog on information notified electronically to the EC through the Cosmetic Products Notification Portal. The functions of the nanomaterials listed in the catalog (12 as colorants, six as ultraviolet (UV)-filters, and 25 as other functions) are based on the names of substances notified and, generally, on the corresponding functions that are displayed in the CosIng database and where relevant on other information at the disposal of the EC. Some substances may have more than one function. The EC notes that the catalog “has an informative value only and is not in any case a list of authorised nanomaterials.” The EC is required to update the catalog regularly and make it publicly available.

WHO Seeks Comment On Draft Document Concerning Assessing The Risk Of Immunotoxicity Associated With Exposure To Nanomaterials: The World Health Organization’s (WHO) International Program on Chemical Safety (IPCS) published a draft Environmental Health Criteria (EHC) Document, Principles and Methods to Assess the Risk of Immunotoxicity Associated with Exposure to Nanomaterials. According to IPCS, the target audience is risk assessors in a regulatory setting, researchers, and industry that needs to provide the data for assessment. In general terms, according to the draft EHC Document, risk assessment of nanomaterials should follow the risk assessment paradigm for chemicals -- hazard identification, hazard characterization, exposure assessment, and risk characterization. The draft EHC Document states that the design to perform risk analysis should be done on a case-by-case basis, flexibly including the components most appropriate for the material and its proposed use. The draft EHC Document includes case studies for carbon nanotubes and silver nanoparticles. Comments are due July 21, 2017.

ISO Standard Describes Aerosol Generation For Air Exposure Studies Of Nano-Objects And Their Aggregates And Agglomerates: The International Organization for Standardization (ISO) recently published standard ISO/TR 19601:2017, “Nanotechnologies -- Aerosol generation for air exposure studies of nano-objects and their aggregates and agglomerates (NOAA).” ISO states that, to evaluate the inhalation toxicity of NOAA, it is important to consider certain parameters that make the toxicity testing relevant to human exposure. The standard describes methods for producing NOAA aerosols for in vivo and in vitro air exposure studies. The purpose of the standard is to aid in selecting an appropriate aerosol generator to fulfill a proposed toxicology study design. The standard describes characteristics of aerosol generation methods, including their advantages and limitations. ISO notes that the standard does not provide guidance for aerosolization of specific nano-objects.

CEINT Seeks Comments On Proposed ISA-TAB-Nano Templates: The Center for the Environmental Implications of NanoTechnology (CEINT) seeks comments on the NANoREG-proposed ISA-TAB-nano templates. According to CEINT, to create the templates, NANoREG followed the logic of the original ISA-TAB-nano formatting, but drew upon relevant existing ontologies and extended it to incorporate additional endpoints and methods not addressed in the original standard. CEINT is working with researchers at Oregon State University and the National Cancer Informatics Program Nanotechnology Working Group to update and extend the ISA-TAB-nano templates. CEINT seeks comments on the following proposed templates:

  • Physical-chemical characterizations comment forms;
     
  • In vivo mammalian toxicity comment forms;
     
  • In vitro mammalian toxicity comment forms; and
     
  • General feedback regarding expanded (nonstandard) ISA-TAB-nano templates.
     

Comments are due August 1, 2017.

ECHA Announces Two Decisions On Appeals Related To Nanomaterials: On June 30, 2017, the European Chemicals Agency (ECHA) Board of Appeal published two decisions related to nanomaterials. In the July 5, 2017, issue of ECHA Weekly, ECHA states that the Board of Appeal “largely upheld the appeals and annulled most of the requests for information.” In Cases A-014-2015 and A-015-2015, registrants appealed the same 2015 ECHA decision requesting information on synthetic amorphous silica (SAS) following a substance evaluation by the Netherlands Competent Authority. ECHA requested information on the physicochemical properties and uses of different types of SAS and surface-treated SAS. According to ECHA, the Board of Appeal annulled these requests “as it was not clear how the information would be used to clarify the potential concerns which in any case had not been sufficiently demonstrated.” ECHA notes that the Board of Appeal upheld one request in the contested decision -- for information on the inhalation toxicity of one type of SAS, following repeat exposure.

Canada Intends To Publish Nanoscale Prioritization Results In 2018: According to the July 7, 2017, issue of the Chemicals Management Plan Progress Report, Health Canada and Environment and Climate Change Canada are in the process of prioritizing nanoscale forms of substances on the Domestic Substances List. As reported in our July 27, 2015, blog item, Canada conducted a mandatory information-gathering survey under Section 71 of the Canadian Environmental Protection Act, 1999. Canada states that the survey identified 53 substances as being manufactured and/or imported at the nanoscale in Canada. Canada expects to publish the results of prioritization in spring 2018. According to the item, Canada is working towards developing a scientific risk assessment framework for nanomaterials, and continues to work with the Organization for Economic Cooperation and Development to promote consistency with other jurisdictions. The goal of Canada’s initiative is to identify the potential risks to human health and the environment that may be posed by nanomaterials in commerce in Canada.

NanoDefine Will Hold Workshop On Measurement And Classification Of Nanomaterials According To The EC Definition: On October 24, 2017, NanoDefine will hold a one-day workshop in Frankfurt/Main, Germany. The main purpose of the workshop is to provide a practical demonstration of newly developed measurement techniques to end-users who have to implement the EC’s recommendation on the definition of a nanomaterial (2011/696/EU). NanoDefine experts have developed a wide panel of new validated measurement methods, techniques, instruments, and software to classify existing and new advanced materials, including a two-tiered analytical approach consisting of: (1) rapid and cost-effective screening methods; and (2) more in-depth confirmatory methods. In particular, according to NanoDefine, the NanoDefiner e-Tool will help practitioners to determine reliably “whether a material or product is or contains nano.” Registration is free but spaces are limited. According to the May-June 2017 issue of the NanoDefine Bulletin, an open beta version of the NanoDefiner e-Tool will be available online later in 2017. Users will be invited to test the beta version and to provide feedback that will be used to prepare the final public version.

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (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.

LEGISLATIVE DEVELOPMENTS

Appropriations Subcommittee Passes EPA FY 2018 Spending Bill: The House Appropriations Subcommittee on the Interior, Environment and Related Agencies on July 12, 2017, approved the FY 2018 appropriations bill for EPA. Lawmakers shunned the severe budget cuts requested by the Trump Administration. Instead, the bill funds EPA at $7.5 billion, a reduction of $528 million below the FY 2017 level and some $1.9 billion above the Administration’s request. The level represents a seven percent cut compared to EPA’s FY 2017 funding level. President Trump sought to eliminate the Chemical Safety and Hazard Investigation Board (CSB), but the bill would keep the CSB alive and provided $11 million to fund it, which is equivalent to the FY 2017 funding level. The bill contains three riders directly affecting major EPA regulations. One provision would allow EPA and the Secretary of the Army to rescind without notice and comment the WOTUS rule. The bill also would delay the implementation of the 2015 National Ambient Air Quality Standards (NAAQS) for ozone until 2018 and prohibit the use of funds to implement the rule establishing financial responsibility requirements under Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Section 108(b) for the hardrock mining industry. 82 Fed. Reg. 3388 (Jan. 11, 2017).

Energy And Commerce Committee Approves Bill Delaying Ozone NAAQS Implementation: On June 28, 2017, the House Energy and Commerce Committee approved legislation that would delay for eight years the implementation of EPA’s 2015 NAAQS for ozone. The Ozone Standards Implementation Act of 2017 (H.R. 806) was approved by a 29-22 party-line vote. The legislation would phase in implementation of the 2008 and 2015 ozone NAAQS,extending for eight years (i.e., to 2025) the date for final designations under the 2015 standards. It also would correspondingly align permitting requirements under the phased implementation schedule. Currently, the CAA requires EPA to review existing NAAQS every five years; this bill would extend that to a ten-year review cycle, but allow the EPA Administrator discretion to issue revised standards earlier. EPA also would be authorized to consider technological feasibility as a secondary consideration when revising NAAQS. Before revising NAAQS, EPA would be required to seek and obtain advice from its scientific advisory committee regarding potential adverse effects relating to implementation of the standards. The bill also would ensure that, for certain ozone and particulate matter nonattainment areas, states are not required to include economically infeasible measures in their plans.

Brownfields Bill Passes House Committee: The House Energy and Commerce Committee on June 28, 2017, passed legislation reauthorizing the Brownfields cleanup program. Congress has not reauthorized the program since 2006. The Brownfields Enhancement, Economic Redevelopment, and Reauthorization Act of 2017 (H.R. 3017) boosts funding for the program by $200 million. The bill also would allow petroleum spill sites to be eligible for brownfields grants, under certain circumstances. It also would increase the funding limit for cleanup grants from $200,000 to $500,000. The bill now moves to the House Transportation and Infrastructure Committee for consideration. A companion bill is working its way through the Senate Environment and Public Works Committee.

Senate Agriculture Committee Approves Bill Revising FIFRA: The Senate Agriculture Committee on June 29, 2017, passed legislation that would amend FIFRA registration requirements. The Committee approved the Pesticide Registration Enhancement Act of 2017 (H.R. 1029) by voice vote. The bill amends FIFRA to revise requirements for pesticide registration applications and their corresponding pesticide maintenance fees and pesticide registration service fees. The bill specifically extends EPA’s authority to collect the annual fees for registering pesticides, increases the maximum amount of registration fees, extends a prohibition on EPA levying other fees for registering pesticides, and revises requirements concerning the use of the Pesticide Registration Fund. The bill also adds new categories of pesticide registration applicants who are subject to the registration service fees, such as applications for inert ingredients. EPA also would be required to identify opportunities for streamlining the review of applications to register a new active ingredient in a pesticide or a new use of a pesticide and for providing prompt feedback to applicants during the review process. An amendment adopted by the Committee moved the reauthorization date of the bill from 2023 to 2020. The bill heads to the Senate floor for a vote and then will return to the House for a vote on the amended legislation.

Social Cost Of Carbon Bill Reintroduced In Both Houses: On June 29, 2017, Representative Evan Jenkins (R-WV) and Senator James Lankford (R-OK) reintroduced their legislation to prohibit the federal government from using the social cost of carbon and social cost of methane metrics in the rulemaking process. The Transparency and Honesty in Energy Regulations Act (H.R. 3117) would bar the use of the social cost of carbon, methane, and nitrous oxide in energy and environment rules. President Trump on March 28, 2017, issued an Executive Order that barred the government’s use of these metrics. “The bill would ensure that future administrations cannot use similar estimates unless subsequently authorized by Congress,” Mr. Jenkins stated. The lawmakers had previously introduced this legislation in the 114th Congress.

Saving America’s Pollinators Act Of 2017 Would Suspend Use Of Neonicotinoids: On June 28, 2017, two dozen Democrats in the House introduced legislation seeking to suspend the use of neonicotinoids. The Saving America’s Pollinators Act of 2017 (H.R. 3040) requires EPA to “take swift action to prevent mass bee die-offs and protect the health of honey bees and other critical pollinators by suspending the use of . . . neonicotinoids.”

Climate Change Security Bill Introduced In House: Representative James Lynch (D-MA) on June 15, 2017, introduced legislation to blunt the effects of President Trump’s decision to pull the U.S. from the Paris Accord as they relate to national security impacts of climate change. The Climate Change National Security Strategy Act of 2017 (H.R. 2908) seeks to ensure that the federal government appropriately considers climate change in the development of national security strategies and policies. The bill would restore the directives on national security and climate change included in President Obama’s September 2016 memorandum entitled Climate Change and National Security. The bill requires the federal government to consider the impacts of climate change in the development of relevant national security policies. In addition, the bill requires the establishment of a Climate and National Security Working Group made up of intelligence, defense, security, and other agency officials, to develop an action plan on climate change and national security. Furthermore, the bill requires federal agencies to develop corresponding plans to address the impact of climate change on their national security missions and to update these plans at least annually.

Bill Would Limit EPA’s CWA Veto Authority: On June 16, 2017, Representative Robert Gibbs (R-OH) introduced legislation to curb EPA’s authority to veto CWA dredge-and-fill permits under CWA Section 404. The Regulatory Certainty Act of 2017 (H.R. 2917) would prohibit EPA from vetoing a CWA Section 404 permit before the permit application begins or after a final permit has issued. Mr. Gibbs introduced the legislation after a 2013 decision in the U.S. Court of Appeals for the District of Columbia Circuit in Mingo Logan Coal Company v. EPA that there are no temporal restrictions on when EPA can exercise its 404(c) authority.

Bills Introduced Amending New Source Review Permitting Thresholds: On June 29, 2017, Representatives Morgan Griffith (R-VA), David McKinley (R-WV), and Evan Jenkins (R-WV) introduced two bills that would limit the scope of new source review (NSR) permitting requirements under the CAA. H.R. 3127 would amend the definition of “modification” in Section 11(a) of the CAA to exclude energy efficiency, pollution control, or reliability projects. The bill defines an energy efficiency project to mean a project that results in carbon dioxide emissions from an affected source that are “lower than it was immediately before such project or activity, or such group of projects, activities, or changes, was undertaken; and after which the maximum hourly emission rate for any other regulated pollutant is no more than either the facility wide or unit-specific permitted emission rate.” A pollution control project is defined as any activity undertaken at a stationary source to reduce the emission of any pollutant. A reliability project is defined in the bill to mean a project “to supply the aggregate electric power and energy requirements of the electricity consumers at all times, taking into account scheduled and reasonably expected unscheduled outages of system components; and to withstand sudden disturbances such as electric short circuits, the unanticipated loss of system components, or disturbances caused by manmade physical or cyber attacks.” The second bill, H.R. 3128, would revise the definition of emissions increases to determine whether NSR permitting has been triggered. The bill would amend the definition to clarify that an emissions increase has occurred -- and NSR permitting has been triggered -- only if the maximum achievable hourly emissions rate after the change will be higher than the hourly rate “of the source as it was originally designed,” and also higher than “the maximum hourly emissions rate of such source that was actually achieved during the 10-year period preceding such change.”

Brownfields And Diesel Grant Bills Pass Senate Committee: The Senate Environment and Public Works Committee on July 12, 2017, easily passed a Brownfields bill and legislation reauthorizing the Diesel Emissions Reduction Act (DERA). The Brownfields Utilization, Investment and Local Development Act of 2017 (BUILD Act; S. 822) reauthorizes the Brownfields program at current funding levels through 2020. The program provides grants and technical assistance to states, local governments, tribes, and redevelopment agencies to support the assessment, cleanup, and reuse of brownfield sites. Among other things, the BUILD Act would provide funding for technical assistance grants to small communities and rural areas, expand the scope of eligible grant recipients to include non-profit community groups, and authorize funding for multi-purpose grants to tackle more complex sites. DERA (S. 1447) reauthorizes the Diesel Emissions Reduction Program through FY 2022 at current funding levels. The program is administered by EPA and uses federal funding to leverage state and other non-federal funding sources to finance the voluntary replacement or installation of retrofits on existing heavy-duty diesel vehicles and engines. Since its initial enactment, DERA has enjoyed overwhelming bi-partisan support. In 2010, the DERA reauthorization bill passed unanimously in the Senate and by voice vote in the House.

House Committee Passes Bill To End “Sue And Settle” Rulemaking: On July 12, 2017, the House Judiciary Committee voted along party lines to approve a bill that would essentially prohibit federal agencies from engaging in so-called “sue and settle” rulemaking. The Sunshine for Regulatory Decrees and Settlements Act of 2017 (H.R. 469) specifically provides for greater transparency by requiring federal agencies to publish sue-and-settle notices of intent to sue, complaints, decrees, settlements, and attorneys’ fee awards and report on them to Congress. Agencies cannot propose sue-and-settle decrees and settlements to the courts until parties affected by the proposed regulations can intervene and participate in settlement negotiations and the proposed decrees and settlements are published for public notice and comment. Also, courts weighing proposed decrees and settlements must assure compliance with normal rulemaking procedures and account for agencies’ competing mandatory duties not within the litigation. Courts also will be allowed to review any new administration’s motion to modify a consent decree in light of changed facts and circumstances or competing duties.

Senate Committee Approves EPA Enforcement Assistant Administrator: By an 11-10 party line vote, the Senate Environment and Public Works Committee approved the nomination of Susan Bodine to serve as EPA’s Assistant Administrator for the Office of Enforcement and Compliance Assurance.

MISCELLANEOUS

NAS Releases Final Report On Preparing For Future Products Of Biotechnology: On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.” This report is a collaboration among a committee of experts, including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by EPA, the U.S. Department of Agriculture (USDA), and FDA. Lynn Bergeson presented before the Committee and was an extensive expert on the chapter that addressed the biotechnology regulations framework. More information is available at http://blog.braginfo.org/entry/nas-releases-final-report-on-preparing-for-future-products-of-biotechnology.

Two Sets Of Implementation Rules Under China’s New Pesticide Regulations Released: On June 1, 2017, in the People’s Republic of China (China), the newly revised Regulation on Pesticide Administration (RPA) became effective. The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017, and published (in Chinese only) as Decree Number 677 of the State Council of China (China Decree 677) on April 1, 2017. It requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation. The first set of five implementation rules was initially released for public comment on March 17, 2017, and made final on June 21, 2017. The five implementation rules include (in Chinese only): Pesticide Registration Management Measures (MOA Order No. 3, 2017), Measures for the Management of Pesticide Production License (MOA Order No. 4, 2017), Measures for the Administration of Pesticide Business License (MOA Order No. 5, 2017), Measures for the Management of Tests Used for Pesticide Registration (MOA Order No. 6, 2017), and Measures for the Administration of Pesticide Labels and Manuals (MOA Order No. 7, 2017). They will become effective on August 1, 2017.

On June 30, 2017, the MOA released the second set of six implementation rules for public comment under the new RPA, which include Data Requirements on Pesticide Registration (Draft); List of Pesticides with Restricted Uses (Draft); Measures for the Management of QR Code Pesticide Label (Draft); Review Rules of Pesticide Production License (Draft); Review Rules of the Test Institutes that Conduct Tests Used for Pesticide Registration (Draft); and Quality Management Practices of Tests Used for Pesticide Registration (Draft). The comment period will end on July 30, 2017, but an implementation date was not provided. More information is available at http://pesticideblog.lawbc.com/entry/two-sets-of-implementation-rules-under-chinas-new-pesticide-regulations-rel.

CSB To Hold Public Meeting On July 26, 2017: CSB will convene a public meeting on July 26, 2017, at 1:00 p.m. at the CSB offices located at 1750 Pennsylvania Avenue, N.W., Suite 910, Washington, D.C. CSB board members are slated to discuss open investigations, the status of audits from the Office of the Inspector General, financial and organizational updates, and a review of CSB’s action plan. CSB members are also scheduled to discuss the ExxonMobil Baton Rouge investigation. The meeting is open to the public and there will be an opportunity for public comment. Interested parties may also listen in to the meeting through the following dial-in number to join the conference: (888) 466-9863, Confirmation Number 8812164#. Although President Trump’s budget framework seeks to defund the CSB, House appropriators on July 12, 2017, passed a funding bill at the Subcommittee level that retains the current level of CSB’s funding.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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