Monthly Update for March 2020


Navigating The Jurisdictional Tightrope Between Biopesticides, Biostimulants, And Related Emerging Technologies, April 29, 2020, 12:00 pm (EDT), Via Webinar: Register for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell, P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft U.S. Environmental Protection Agency (EPA) guidance intended to clarify the lines between and among those products that are subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.

Lynn L. Bergeson, "The Growing Spectre Of Chemical Product Cancellations, And What To Do About It," Financier Worldwide, February 2020: Effective January 1, 2022, household cleaning, cosmetic, and personal care products containing quantities of 1,4-dioxane over specified trivial levels will be prohibited from sale in the State of New York. The law imposing these restrictions, signed by Governor Andrew M. Cuomo on December 9, 2019, is intended to protect drinking water supplies from contamination by the chemical. This article explains why, and the reasons corporate leaders, brand managers, investors and others in this commercial space need to understand this trend and plan accordingly.

FIFRA Stakeholders: How To Respond To An Enforcement Action Or Inquiry: In a recent B&C advisory memorandum, we noted that enforcement activity under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been increasing during the last couple of years. That memorandum provides guidance to TSCA stakeholders on how to respond to a typical EPA TSCA inspection letter, and notes that it is often unclear why a particular manufacturer or processor has received a TSCA inspection letter. In our TSCA memorandum, we observed that enforcement activity under FIFRA has also been trending upward, and we stated that we would be addressing FIFRA enforcement actions in a separate memorandum.

Although most parties subject to TSCA inspection receive a "boilerplate" letter, FIFRA enforcement actions tend to be more heterogeneous. Potential FIFRA enforcement communications include a notice or letter announcing that EPA has commenced an investigation or will conduct an inspection, a Notice of Warning (NOW), a refused Notice of Arrival (NOA) or a Notice of Detention (NOD), or a Stop Sale, Use, or Removal Order (SSURO).

The type of FIFRA enforcement action that EPA utilizes depends on the circumstances. Recent areas of special interest under FIFRA include imports of pesticide products and devices, product composition issues (e.g., a new active ingredient supplier, foreign or contract manufacturing), Internet sales and pesticidal claims, and “gray areas” such as cleaners with antimicrobial claims or fertilizers with biostimulant claims. More information is available in our March 2, 2020, memorandum.

The Product Stewardship Society Is Accepting Board Nominations: The Product Stewardship Society is now accepting nominations for officials from member companies to serve on its Board of Directors. The Board establishes the organization’s strategic direction and goals, and monitors progress toward reaching those goals. Nominees must be members in good standing; self-nominations are allowed.

“Our Board members are leaders in a diverse range of business sectors. We are looking for leaders who have a passion for the Society and who wish to work with like-minded professionals to grow the profession and make a difference,” stated Lynn Bergeson, President of the Product Stewardship Society.

Deadline for the nominations is April 15, 2020. More information is available in the full press release.

TSCA/FIFRA/TRI

ChemCon The Americas Brought Together TSCA Experts For Key Discussion Of What Is In The Pipeline For 2020: B&C was pleased to sponsor an in-depth TSCA Seminar at ChemCon The Americas 2020 in Philadelphia. First Kathleen M. Roberts, Senior Regulatory Consultant, B&C, hosted a hands-on Chemical Data Reporting (CDR) workshop enabling industry to better understand the updated requirements of the CDR rule as well as guidance on the actual reporting. Lynn L. Bergeson, Managing Partner, B&C, chaired the seminar, “The amended TSCA and its 2020 priorities, implementation and direction for new and existing chemicals” featuring Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP) discussing EPA’s 2020 priorities, and Richard E. Engler, Ph.D., Director of Chemistry, B&C, presenting “New Chemicals: Securing Not Likely Findings.”

Later in the day Bergeson and Dunn sat down with ChemCon director Tjeerd Bokhout to discuss the implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) and what can be expected through 2020. A full video of this informative interview, drawing back the curtain on both EPA and industry’s experience with the implementation of TSCA and details on what to prepare for in the near future, is available to stream now.

EPA Extends Deadline To Self-Identify As A Manufacturer Or Importer Of A High-Priority Chemical: On March 13, 2020, EPA announced that it has extended the deadline to self-identify as a manufacturer or importer of a high-priority chemical to May 27, 2020. 85 Fed. Reg. 14677. EPA states that it is working to address issues identified with implementation of the TSCA Fees Rule and EPA-initiated risk evaluations. EPA “is actively seeking ways to address the many implementation impracticalities that have been brought to our attention and to reduce concerns by affected entities.” During the extended comment period extension, EPA “will continue to receive input from the regulated community and analyze options to address some of the implementation challenges with the final rule and reduce stakeholder concerns.” More information is available in our March 9, 2020, blog.

EPA Announces Final List Of Low-Priority Chemicals Under TSCA: EPA issued on February 26, 2020, the final list of 20 chemical substances designated as low-priority substances for which risk evaluation under TSCA is not warranted at this time. 85 Fed. Reg. 11069. The notice includes the final designation for each of the chemical substances and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the final designation for each chemical substance. EPA notes in its press release that these 20 low-priority chemicals are on its Safer Chemical Ingredients List, “which includes chemicals that meet strict criteria for both human health and the environment.” EPA released in March 2019 a list of 40 chemicals for which it initiated the prioritization process for risk evaluation. EPA selected 20 chemical substances as candidates for designation as low-priority substances, proposed in August 2019 to designate them as low-priority substances, and has now designated these same 20 chemical substances as low-priority:

Chemical Name Docket Number
1-Butanol, 3-methoxy-, 1-acetate EPA-HQ-OPPT-2019-0106
D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)- EPA-HQ-OPPT-2019-0107
D-Gluconic acid EPA-HQ-OPPT-2019-0108
D-Gluconic acid, calcium salt (2:1) EPA-HQ-OPPT-2019-0109
D-Gluconic acid, .delta.-lactone EPA-HQ-OPPT-2019-0110
D-Gluconic acid, potassium salt (1:1) EPA-HQ-OPPT-2019-0111
D-Gluconic acid, sodium salt (1:1) EPA-HQ-OPPT-2019-0112.
Decanedioic acid, 1,10-dibutyl ester EPA-HQ-OPPT-2019-0113
1-Docosanol EPA-HQ-OPPT-2019-0114
1-Eicosanol EPA-HQ-OPPT-2019-0115
1,2-Hexanediol EPA-HQ-OPPT-2019-0116
1-Octadecanol EPA-HQ-OPPT-2019-0117
Propanol, [2-(2-butoxymethylethoxy)methylethoxy]- EPA-HQ-OPPT-2019-0118
Propanedioic acid, 1,3-diethyl ester EPA-HQ-OPPT-2019-0119
Propanedioic acid, 1,3-dimethyl ester EPA-HQ-OPPT-2019-0120
Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate EPA-HQ-OPPT-2019-0121
Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis- EPA-HQ-OPPT-2019-0122
2-Propanol, 1,1'-oxybis- EPA-HQ-OPPT-2019-0123
Propanol, oxybis- EPA-HQ-OPPT-2019-0124
Tetracosane, 2,6,10,15,19,23-hexamethyl-, EPA-HQ-OPPT-2019-0125

EPA states that it used “reasonably available information” to screen each candidate chemical substance against the following criteria and considerations and thereby inform the proposed designation:

  • The chemical substance’s hazard and exposure potential;
     
  • The chemical substance’s persistence and bioaccumulation;
     
  • Potentially exposed or susceptible subpopulations;
     
  • Storage of the chemical substance near significant sources of drinking water;
     
  • The chemical substance’s conditions of use or significant changes in conditions of use;
     
  • The chemical substance’s production volume or significant changes in production volume; and
     
  • Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance’s priority for risk evaluation.
     

For the final priority designation, EPA states that it considered comments and information submitted by the public during two public comment periods (after initiation and after proposed designation) and incorporated them as appropriate in preparing the final list of 20 chemical substances designated as low-priority substances. EPA notes that as required by TSCA Section 6(b)(1)(B)(ii) and 40 C.F.R. Section 702.11(b), it did not consider cost or other non-risk factors in making a priority designation. For more information, read the full memorandum.

EPA Releases Final Rule On Procedures For Review Of CBI Claims For The Identity Of Chemicals On The TSCA Inventory: On March 6, 2020, EPA published its final rule on procedures for review of confidential business information (CBI) claims made under TSCA. 85 Fed. Reg. 13062. The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities. EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year time frame set in TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities. The final rule is effective on May 5, 2020. For more information, please read the full memorandum.

Proposed Supplemental SNUR Would Remove Exemption For LCPFAC Chemical Substances Used As Surface Coatings On Articles: EPA published on March 3, 2020, a proposed supplemental significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. 85 Fed. Reg. 12479. Under the proposed supplemental SNUR, issued under TSCA Section 5(a)(2), this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates. The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR. The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use. Manufacturing (including import) or processing for the significant new use would be prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. Comments are due by April 17, 2020. For more information, please read the full memorandum.

EPA Announces Latest UpdateTo TSCA Inventory: EPA announced on March 11, 2020, the availability of the latest TSCA Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals of which 41,484 are active in U.S commerce. Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
     
  • Updated regulatory flags, such as consent orders and SNURs; and
     
  • Additional unique identifiers.
     

EPA notes that the TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.

EPA Adds Two Microorganisms To List Of Microorganisms Eligible For Exemption From Certain TSCA Reporting Requirements: On March 10, 2020, EPA announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under TSCA. 85 Fed. Reg. 13760. EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees. The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry. The final rule is effective April 9, 2020. More information is available in our blog.

EPA OIG Will Audit EPA’s TSCA Service Fee Fund Financial Statements: The Office of Inspector General (OIG) for EPA announced on February 27, 2020, that it plans to begin its audit of the EPA’s TSCA Service Fee Fund financial statements for the period from inception, June 22, 2016, to September 30, 2018. More information is available in our blog.

Madison Le Will Be Director Of EPA’s Chemical Control Division: Effective March 15, 2020, Madison Le joined EPA’s Office of Pollution Prevention and Toxics (OPPT) as Director of the Chemical Control Division (CCD). Ms. Le will replace Acting Director Lynn Vendinello. Ms. Le was Director of the Fuels Compliance Policy Center within the Office of Air and Radiation. In that capacity, Ms. Le managed the implementation of EPA’s national fuels programs, including the Renewable Fuel Standard Program, Tier 3 Gasoline, Ultra-Low Sulfur Diesel, and Fuels and Fuel Additives Registration. Prior to working for EPA, Ms. Le worked for California’s Los Angeles County on engineering design projects for municipal solid waste landfills and wastewater treatment plants, including air quality modeling and permitting for stationary and mobile sources. Ms. Le holds an M.S. and B.S. in Environmental Engineering from the University of Southern California.

EPA Announces Grant Opportunity Supporting Innovative Solutions For Reducing Pollution, Including In The Chemical Manufacturing, Processing, And Formulation Sector: On March 5, 2020, EPA announced that it is seeking grant applications through the Source Reduction Assistance Grant Program from states, federally recognized tribes, universities, local governments, and other groups to support innovative solutions for source reduction or pollution prevention (P2) through research, education, training, or certain other methods. EPA notes that as it highlights chemical safety during the month of March, “these grants support that goal by providing information, training, and tools to improve public health and the surrounding environment, reduce pollutants, and decrease resource use (e.g., water and energy).” EPA anticipates awarding individual grants in the range of $20,000 - $200,000 for a two-year funding period (or between $10,000 - $100,000 per year), though award amounts may vary based on EPA region. EPA anticipates awarding 20 grants in total. EPA states that grant applications should focus on at least one of the following P2 priority areas, also referred to as National Emphasis Areas (NEA) that support several of the EPA’s Smart Sectors. Through these grants, technical assistance and projects should encourage businesses to identify, develop, and adopt P2 practices and reduce waste in the following sectors:

  • Food and Beverage Manufacturing and Processing (NEA #1);
     
  • Chemical Manufacturing, Processing, and Formulation (NEA #2);
     
  • Automotive Manufacturing and Maintenance (NEA #3);
     
  • Aerospace Product and Parts Manufacturing and Maintenance (NEA #4); and
     
  • Metal Manufacturing and Fabrication (NEA #5).
     

Proposals are due by April 30, 2020. Additional information is available on www.grants.gov, under Funding Opportunity Announcement EPA-HQ-OPPT-2020-002.

Comments On Draft Risk Evaluation For Trichloroethylene Due April 27: EPA published a notice in the Federal Register on February 26, 2020, announcing the availability of the draft risk evaluation for trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.” 85 Fed. Reg. 11079. EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings:

  • EPA did not find risk to the environment; and
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.
     

EPA notes that the draft risk evaluation and the initial risk determinations are not a final action. The draft represents EPA’s preliminary conclusions, findings, and determinations on TCE and will be peer reviewed by independent scientific experts. According to EPA, the draft risk evaluation includes input from other EPA offices, as well as other federal agencies.

The TSCA Science Advisory Committee on Chemicals (SACC) will meet March 24-26, 2020, to peer review the draft risk evaluation of TCE’s conditions of use. EPA asks that comments on the draft risk evaluation be submitted by March 18, 2020, to allow SACC time to review and consider them before the peer review meeting. EPA states that comments received after March 18, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for its consideration. EPA held a preparatory virtual meeting on March 3, 2020, for SACC and the public to comment on the clarity and scope of the draft charge questions for the March 24-26, 2020, meeting.

Comments on the draft risk evaluation are due April 27, 2020. More information on the draft risk evaluation is available in our February 26, 2020, memorandum, “EPA Releases Draft Risk Evaluation for TCE, Announces SACC Peer Review Meeting.”

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Publishes Proposed Rule Regarding Disposal Of CCR From Electric Utilities: EPA published a proposed rule on February 20, 2020, that would establish a streamlined and efficient federal permitting program for the disposal of coal combustion residuals (CCR) in surface impoundments and landfills. 85 Fed. Reg. 9940. The proposal includes requirements for federal CCR permit applications, content, and modification, as well as procedural requirements. EPA would implement the permit program directly in Indian Country, as it does other Resource Conservation and Recovery Act (RCRA) programs, and at CCR units located in states that have not submitted their own CCR permit program for approval. EPA will hold a virtual public hearing on April 15, 2020. Comments are due April 20, 2020.

EPA Proposes Not To Impose Financial Responsibility Requirements For Facilities In The Chemical Manufacturing Industry: On February 21, 2020, EPA published in the Federal Register a proposed rule that would not impose financial responsibility requirements for facilities in the chemical manufacturing industry under Section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 85 Fed. Reg. 10128. Section 108(b) addresses the promulgation of regulations that require classes of facilities to establish and maintain evidence of financial responsibility consistent with the degree and duration of risk associated with the production, transportation, treatment, storage, or disposal of hazardous substances. As required by CERCLA Section 108(b), the proposed rule assesses the need for financial responsibility requirements for the chemical manufacturing industry. EPA has posted a fact sheet for the proposed rule.

EPA And Partners Announce Collaborative Implementation Of The National Water Reuse Action Plan: On February 27, 2020, EPA Administrator Andrew Wheeler, U.S. Department of the Interior Secretary David Bernhardt, U.S. Department of Agriculture Secretary Sonny Perdue, and White House Council on Environmental Quality Chair Mary B. Neumayr joined federal, state, tribal, local, and water sector partners to announce the National Water Reuse Action Plan: Collaborative Implementation (Version 1). According to EPA’s press release, the actions that EPA and its partners commit to in the Action Plan will help strengthen the sustainability and security and resilience of U.S. water resources by creating new partnerships, providing accountability, and promoting communication and transparency with a new online platform. The press release states that the Action Plan supports the Presidential Memorandum on Promoting the Reliable Supply and Delivery of Water in the West and will help advance water reuse technology that has the potential to ensure the viability of U.S. water economy for generations to come. The Action Plan frames the business case that water reuse is a viable and growing means of supporting the U.S. economy and improving the availability of freshwater for farmers, industry, communities, and ecosystems. The Action Plan identifies 37 specific actions across 11 strategic themes to be led by a spectrum of federal, state, local, and private sector interests. The Action Plan reflects new partnerships, generates action through more than 200 initial implementation milestones, and provides accountability through transparency and routine progress updates.

EPA Proposes Amendments To Closure Provisions For Disposal Of CCR: On March 3, 2020, EPA proposed to amend its regulations for the disposal of CCR from electric utilities under RCRA. 85 Fed. Reg. 12456. EPA is proposing procedures to allow facilities to operate with an alternate liner for existing CCR surface impoundments. EPA is also co-proposing two options to allow the use of CCR during unit closure, and it is also proposing an additional closure option for CCR units that are being closed permanently by removal of CCR for exceeding groundwater protection standards. Finally, EPA is proposing requirements for annual closure progress reports. EPA will hold a public hearing on April 9, 2020. Comments are due April 17, 2020.

EPA Announces Preliminary Regulatory Determination For Contaminants On The Fourth Drinking Water Contaminants Candidate List: On March 10, 2020, EPA announced the preliminary regulatory determination for contaminants on the fourth drinking water contaminants list. 85 Fed. Reg. 14098. The Safe Drinking Water Act (SDWA), as amended in 1996, requires EPA to make regulatory determinations every five years on at least five unregulated contaminants. A regulatory determination is a decision about whether or not to begin the process to propose and promulgate a national primary drinking water regulation (NPDWR) for an unregulated contaminant. A preliminary regulatory determination lays out and takes comment on EPA's view about whether certain unregulated contaminants meet three statutory criteria. After EPA considers public comment, EPA makes a final determination. The unregulated contaminants included in a regulatory determination are chosen from the Contaminant Candidate List (CCL), which the SDWA requires that EPA tublish every five years. EPA published the fourth CCL (CCL 4) on November 17, 2016. This document presents the preliminary regulatory determinations and supporting rationale for the following eight of the 109 contaminants listed on CCL 4: perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), 1,1-dichloroethane, acetochlor, methyl bromide (bromomethane), metolachlor, nitrobenzene, and Royal Demolition eXplosive (RDX). The Agency is making preliminary determinations to regulate two contaminants (i.e., PFOS and PFOA) and to not regulate six contaminants (i.e., 1,1-dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene, and RDX). EPA seeks comment on these preliminary determinations. EPA is also presenting an update on three other CCL 4 contaminants (strontium, 1,4-dioxane, and 1,2,3-trichloropropane). Comments must be received on or before May 11, 2020.

FDA

Pre-Submission Consultation Process For Animal Food Additive Petitions Or Generally Recognized As Safe (GRAS) Notices: The U.S. Food and Drug Administration (FDA) announced on February 13, 2020, the availability of draft guidance for industry (GFI) #262. 85 Fed. Reg. 8297. The draft guidance is intended to assist industry with the collection of data for “effective and efficient consultations with FDA regarding investigational animal food substances.” The draft GFI includes details on the types of information FDA is seeking when preparing a pre-submission consultation for a food additive petition for food additives intended for use in animal food; a GRAS notification for animal food; or for a permit to use, in human or animals foods, animal products derived from animals that have been administered an investigational substance. FDA is accepting comments on the draft GFI until April 13, 2020.

Supplemental Guidance For The Intentional Adulteration FSMA Rule: FDA announced on February 14, 2020, the availability of supplemental draft guidance for industry titled “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.” 85 Fed. Reg. 8599. The Food Safety Modernization Act (FSMA) enables FDA to protect public health better by helping to ensure the safety and security of the food supply. The draft guidance includes the following additions:

  • Chapter 5 -- Mitigation Strategies Management Components: Food Defense Corrective Actions;
     
  • Chapter 6 -- Mitigation Strategies Management Components: Food Defense Verification;
     
  • Chapter 7 -- Reanalysis;
     
  • Chapter 9 -- Records;
     
  • Appendix 2 -- Mitigation Strategies in the Food Defense Mitigation Strategies Database; and
     
  • Appendix 3 -- Determination of Status as a Very Small Business or Small Business Under Part 121: Mitigation Strategies to Protect Food Against Intentional Adulteration.
     

FDA is accepting comments on the draft guidance, which must be submitted by June 15, 2020.

Food Additive Petition For Potassium Iodate: On February 25, 2020, FDA announced the submission of a food additive petition (FAP) submitted by Unilever for potassium iodate. 85 Fed. Reg. 10632. The FAP proposes to amend 21 C.F.R. Part 172, Food Additives Permitted for Direct Addition to Food for Human Consumption, to allow use of the substance in various foods at the maximum level of 40 milligrams of potassium iodate per kilogram of salt (sodium chloride).

Extended Comment Period For FSMA Rule: On February 28, 2020, FDA extended the comment period for the proposed FSMA rule, titled “Laboratory Accreditation for Analyses of Foods,” to April 6, 2020. 85 Fed. Reg. 11893. The proposed rule would establish a program for the testing of food by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act.

International Cooperation On Cosmetics Regulation Preparation Meeting Set: FDA, on March 3, 2020, announced that a public meeting titled “International Cooperation on Cosmetics Regulation (ICCR -- Preparation for ICCR-14 Meeting” will be held on April 14, 2020. The purpose of the preparation meeting is to solicit public input to help FDA prepare for the ICCR-14 meeting that will be held June 8 to 10, 2020, in Brussels, Belgium. Interested parties should register with FDA by March 31, 2020.

NANOTECHNOLOGY

Germany Publishes English Translation Of TRGS 527: Activities With Nanomaterials: The Federal Institute for Occupational Safety and Health (BAuA) has published an English translation of Technical Rules for Hazardous Substances (TRGS) 527: “Activities with nanomaterials.” TRGS 527 contains rules for protection of employees at the workplace during activities with substances, mixtures, and products consisting of or containing nanomaterials. More information is available in our March 2, 2020, blog item.

EU Publishes NanoDefine Methods Manual: On January 28, 2020, the European Union (EU) published The NanoDefine Methods Manual, a collection of three Joint Research Center (JRC) reports developed within the NanoDefine project “Development of an integrated approach based on validated and standardized methods to support the implementation of the European Commission (EC) recommendation for a definition of nanomaterial.” The Manual consists of three parts:

  • Part 1: The NanoDefiner Framework and Tools;
     
  • Part 2: Evaluation of Methods; and
     
  • Part 3: Standard Operating Procedures.
     

NIOSH Publishes Science Blog Item On Nano- And Microplastics In The Workplace: On February 19, 2020, the National Institute for Occupational Safety and Health (NIOSH) posted a Science Blog item entitled “Are There Nano- and Microplastics in the Workplace?” that reviews workplace exposure to microplastics and nanoplastics. According to NIOSH, its Nanotechnology Research Center (NTRC) has developed approaches for exposure measurement, assessment and mitigation, and hazard characterization for nanomaterials, and many of these approaches would also be applicable to characterize and minimize risk of nano- and microplastics in the workplace. In the absence of occupational exposure limits for nano- and microplastics, NIOSH states that workplace safety efforts should focus on minimizing potential exposure through appropriate engineering controls such as isolation cabinets, exhaust ventilation, and utilizing good industrial hygiene practices.

ECHA Urges Companies To Provide More Data On Nanoforms: The European Chemicals Agency (ECHA) issued a press release on February 24, 2020, stating that it has received only 95 unique submissions for 36 substances covering nanoforms according to the updated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements. According to the press release, ECHA is working closely with key industry associations and Member States to understand better the additional actions needed to raise awareness on the legal obligations. ECHA reminds companies that without a valid registration, nanomaterials that fall within the scope of REACH are currently illegally on the market.

EPA Extends Comment Period For Proposed Registration Decision For New Nanosilver Product: According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days on a proposal to incorporate a new nanosilver pesticide product into textiles to allow additional time to review the documentation contained in the docket. The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.” As reported in our February 13, 2020 blog item, EPA announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear. Comments are now due March 30, 2020.

ISO Standard Specifies Characteristics And Measurement Methods For Carbon Nanotube Suspensions: The International Organization for Standardization (ISO) has published standard ISO/TS 19808:2020, “Nanotechnologies -- Carbon nanotube suspensions -- Specification of characteristics and measurement methods.” The standard specifies the characteristics to be measured of suspensions containing multi-walled carbon nanotubes (carbon nanotube suspensions). The standard includes the essential and additional characteristics of the carbon nanotube suspension, and the corresponding measurement methods. ISO notes that characteristics specific to health, environmental, and safety issues are excluded from the standard.

SCCS Guidance On Safety Assessment Of Nanomaterials In Cosmetics Published In Regulatory Toxicology And Pharmacology: The EC’s Scientific Committee on Consumer Safety (SCCS) announced on March 3, 2020, that the April 2020 issue of Regulatory Toxicology and Pharmacology includes “The SCCS guidance on the safety assessment of nanomaterials in cosmetics.” The article is available for purchase through the Regulatory Toxicology and Pharmacology website.

EUON Publishes Nanopinion On Use Of The Term “Nanoplastics”: On March 3, 2020, the EU Observatory for Nanomaterials (EUON) published a Nanopinion entitled “‘Nanoplastics’ -- it’s a name game.” Claire Skentelbery, Director General, Nanotechnology Industries Association (NIA), reviews the difference between engineered (manufactured) nanomaterials and naturally originating (incidental) nanomaterials. Rapid advances in characterizing and understanding engineered nanomaterials will help scientists worldwide to find, identify, and understand the biological interactions of incidental nanoplastics and address their impact on the environment. Skentelbery concludes that “[t]his can enable all measures necessary to reduce their occurrence, reaching back up through the long industrial and societal pathway through which they were produced.” B&C is a proud NIA member.

NIOSH CIB On Practices In Occupational Risk Assessment Addresses Nanomaterials: On March 4, 2020, NIOSH published a Federal Register notice announcing the availability of its Current Intelligence Bulletin 69: NIOSH Practices in Occupational Risk Assessment. 85 Fed. Reg. 12786. Appendix C of the Current Intelligence Bulletin (CIB) includes sections addressing nanomaterials risk assessment and alternative methods for nanomaterials. The CIB section on nanomaterials risk assessment includes subsections on dose normalization in vitro and in vivo and correlation of in vitro and in vivo responses. The section on alternative methods for nanomaterials includes subsections on comparative potency estimation, hazard classification/clustering, and validation. The CIB notes that a key challenge to using alternative test strategies data is the development and application of validation criteria. More information is available in our

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.

LEGISLATIVE

Environmental Justice Legislation Introduced In The House: On February 27, 2020, Representatives Raúl M. Grijalva (D-AZ), Chair of the Natural Resources Committee, and A. Donald McEachin (D-VA) introduced the Environmental Justice for All Act at a press conference. According to Grijalva’s February 27, 2020, press release, the Act includes the following features:

  • Creates a Federal Energy Transition Economic Development Assistance Fund -- paid for through new fees on oil, gas, and coal companies -- to support communities and workers as they transition away from greenhouse gas-dependent economies;
     
  • Requires federal agencies to consider cumulative health impacts under the Clean Air Act (CAA) and Clean Water Act (CWA) in making permitting decisions and ensures that permits will not be issued if projects cannot demonstrate a reasonable certainty of no harm to human health;
     
  • Strengthens the Civil Rights Act to permit private citizens and organizations facing discrimination to seek legal remedies, overturning the Alexander v. Sandoval ruling; and
     
  • Provides $75 million in annual grants for research and program development to reduce health disparities and improve public health in environmental justice communities.
     

House Subcommittee Holds Hearing On FY 2021 EPA Budget: The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on February 27, 2020, on the fiscal year (FY) 2021 EPA budget. The February 24, 2020, memorandum from Representative Frank Pallone, Jr. (D-NJ), Chair of the Committee on Energy and Commerce, notes that President Trump’s (R) FY 2021 budget requests $6.658 billion for EPA, a $2.399 billion (26 percent) decrease from the EPA’s FY 2020 enacted appropriations. EPA’s budget proposal outlines three overarching goals, each of which would be funded well below FY 2020 enacted levels:

  • “A Cleaner, Healthier Environment” (including measures related to clean air, clean water, land contamination, and chemical safety) would incur a $2.005 billion cut (29 percent) from the FY 2020 enacted level;
     
  • “More Effective Partnerships” (including measures to improve cooperation with states and enhance public transparency) would incur an $80.023 million cut (25 percent) from the FY 2020 enacted level; and
     
  • “Greater Certainty, Compliance, and Effectiveness” (including measures to improve enforcement of environmental laws, permitting processes, efficiency of EPA’s operations, and the use of science in policymaking) would incur a $154.716 million cut (eight percent) from the FY 2020 enacted level.
     

Bipartisan Energy Innovation Package Introduced In The Senate: On February 27, 2020, Senators Lisa Murkowski, (R-AK) and Joe Manchin (D-WV) released the text of the American Energy Innovation Act (AEIA), a bill intended to modernize domestic energy laws to ensure the United States remains a global energy leader while also strengthening national security, increasing international competitiveness, and investing in clean energy technologies. The key provisions in the AEIA focus on energy efficiency; renewable energy; energy storage; carbon capture, utilization, and storage; advanced nuclear; industrial and vehicle technologies; the Department of Energy; mineral security and cyber and grid security and modernization; and workforce development. The Senate Energy and Natural Resources Committee held legislative hearings and business meetings throughout 2019 and, following regular order, reported more than 50 energy-related bills to the full Senate on an individual basis. Most of those measures have now been compiled in the AEIA.

On February 27, 2020, Senate Majority Leader Mitch McConnell (R-KY) filed cloture on the motion to proceed to S. 2657, a Murkowski-Manchin geothermal research and development bill that will serve as the legislative vehicle for the bipartisan energy innovation package. Murkowski filed a modified substitute amendment on March 5, 2020. Although Senators tried to attach more than 185 amendments to Murkowski’s bill, the modified substitute amendment included the text of only 18 amendments -- nine from Senators on each side of the aisle -- that were filed during the floor debate that began on March 4, 2020. Senators John Kennedy (R-LA) and Tom Carper (D-DE) introduced an amendment that would direct EPA to implement a phase down of the production and consumption of hydrofluorocarbons (HFC) over the next 15 years. The amendment contains the text of American Innovation and Manufacturing (AIM) Act (S. 2754), which Kennedy introduced on October 30, 2019. Although the AIM Act has bipartisan support, the amendment was not among the 18 that Murkowski included. Senator John Barrasso (R-WY), Chair of the Senate Committee on Environment and Public Works, opposed the amendment, stating that it should have passed through the Committee. Kennedy has threated to hold up the entire bill to include the proposal, while the White House stated that it “strongly objects” to the amendment. On March 9, 2020, the Senate failed to end debate on the AEIA and the package of amendments. Murkowski expressed frustration with both Kennedy and Barrasso. On March 11, 2020, the Senate Committee on Environment and Public Works announced that it would hold a legislative hearing on the AIM Act on March 25, 2020.

Carper Asks EPA OIG To Investigate Process Irregularities And Potential Illegalities Associated With The SAFE Vehicles And Secret Science Rules: Senator Tom Carper (D-DE), Ranking Minority Member of the Senate Environment and Public Works Committee, announced on March 2, 2020, that he asked the EPA OIG to open an investigation into “potentially unlawful efforts and procedural problems related to the preparation and review of both the draft final Safer Affordable Fuel-Efficient (SAFE) Vehicles rule and the draft supplemental proposal for the Strengthening Transparency in Regulatory Science rule (the so-called ‘secret science’ rule).” According to Carper’s March 2, 2020, press release, he made the request after his office “received reports of seemingly purposeful and potentially unlawful efforts on the part of EPA political officials to avoid the standard processes and statutory requirements associated with proposing and finalizing these two high-profile rules, including potential efforts to conceal documents that should eventually be made public.”

Senate Committee Holds Hearing On Securing U.S. Leadership In The Bioeconomy: On March 3, 2020, the Senate Committee on Commerce, Science, and Transportation held a hearing on “Securing U.S. Leadership in the Bioeconomy.” The hearing examined the bioeconomy, the federal government’s role in the bioeconomy, and the potential risks from such research. Witnesses also discussed the necessary policies and practices for the advancement of biotechnology.

House Committee Holds Hearing On Recycling And Waste Management And Its Impacts On Climate Change And The Environment: On March 4, 2020, the House Energy and Environment Subcommittee on Environment and Climate Change held a hearing on “Reduce, Reuse, Recycle, Reform: Addressing America’s Plastic Waste Crisis.” The Subcommittee heard testimony about recycling and waste management in the United States, including its impacts on climate and the environment.

Senate Committee Holds Hearing On Nomination Of Douglas Benevento To Be EPA Deputy Administrator: The Senate Committee on Environment and Public Works held a hearing on March 11, 2020, on several nominations, including the nomination of Douglas Benevento to be EPA Deputy Administrator. According to EPA’s February 13, 2020, press release on the nomination, Mr. Benevento served as EPA Region 8 Administrator from October 2017 through March 2019. He then moved to EPA Headquarters where he has served as Senior Counselor for Regional Management and State Affairs and later as Associate Deputy Administrator. The press release states that he was previously executive director for the Colorado Department of Public Health and Environment, where he managed the state’s environmental and public health programs. He also served as the Department’s director of environmental programs, where he managed the state’s air, water, waste, and consumer protection programs. The press release notes that from 2010 to 2017, Mr. Benevento was working on energy and environmental issues in the private sector at Xcel Energy in various roles, and practiced law at Greenberg Traurig.

House Subcommittee Holds Markup On CFATS And HFCS Legislation: On March 12, 2020, the House Energy Commerce Subcommittee on Environment and Climate Change held a markup session on legislation (H.R. 6160) to reauthorize the Chemical Facility Anti-Terrorism Standards (CFATS) program and on the American Innovation and Manufacturing Leadership Act of 2020 (H.R. 5544). The Subcommittee passed H.R. 6160, which would reauthorize the CFATS program for 18 months. Without the bill, CFATS will expire in April 2020. The Subcommittee also passed H.R. 5544, which would phase down HFCs over 15 years by limiting production and consumption of regulated HFCs to 15 percent of baseline levels beginning in 2036. The legislation directs EPA to implement an allowance allocation and trading program to do so, and to establish standards governing the management of HFCs used as refrigerants, including to recover and reclaim used HFCs. It further authorizes EPA to establish schedules for specific sectors to transition to next-generation technologies. H.R. 5544 is a companion bill to S. 2754.

Senate Legislation Would Fund PFAS Cleanup: On March 12, 2020, Senator Jeanne Shaheen (D-NH) introduced legislation with Senators Tom Carper (D-DE) and Chuck Schumer (D-NY) to help communities combat per- and polyfluoroalkyl substances (PFAS) contamination and exposure in drinking water and groundwater. According to Shaheen’s March 12, 2020, press release, the Providing Financial Assistance to States (PFAS) for Testing and Treatment Act would provide substantial federal funding for PFAS remediation in drinking water, and groundwater, including private wells. The press release states that the legislation would:

  • Increase funding for a newly created grant program within the SDWA State Revolving Loan Fund to $1 billion per year over the next ten years to go towards the clean-up of PFAS and other emerging contaminants in drinking water. EPA is directed to prioritize this funding to states according to the prevalence and remediation costs associated with PFAS. The eligible use of funds is also extended to the testing and treatment of private wells, which supply drinking water for over 43 million Americans; and
     
  • Create a new grant program under the CWA that provides funding to states to help remediate groundwater contamination from PFOA and PFOS. This section of the bill requires that groundwater contamination be addressed in accordance with interim guidance issued by EPA in August 2018 or an applicable state, tribal, or other standard, where those exist. These interim requirements will remain in place until EPA acts to designate these chemicals as “hazardous substances” under Superfund. This program would be authorized at $1 billion per year over the next ten years. EPA is directed to prioritize funding to states according to the prevalence and remediation costs associated with PFAS.
     
MISCELLANEOUS

CSB Promulgates Final Rule On Accidental Release Reporting: On February 21, 2020, the U.S. Chemical Safety Board and Hazard Investigation Board (CSB) promulgated a final rule on accidental release reporting. 85 Fed. Reg. 10074. The final rule describes when an owner or operator is required to file a report of an accidental release, and the required content of such a report. CSB states that the purpose of the rule is to ensure that CSB “receives rapid, accurate reports of any accidental release that meets established statutory criteria.” CSB notes that the accidental release reports will require only information that is already known or should be available to an owner/operator soon after an accidental release. To provide the owner/operator more time to gather the necessary information, the final rule has increased the reporting window from four to eight hours. CSB states that the required information is also limited in scope to critical information required for it to make informed decisions about its jurisdiction, interagency coordination, and deployment decision-making. The rule will be effective March 23, 2020.

Legislation Introduced To Repeal Safer Consumer Product Regulations: On February 21, 2020, California Assembly Member Laura Friedman (D) introduced legislation (A.B. 3354) that would repeal the provisions of the California Health and Safety Code requiring the California Department of Toxic Substances Control to adopt regulations to establish a process to identify and prioritize those chemicals or chemical ingredients in consumer products that may be considered as being a chemical of concern and to adopt regulations to establish a process for evaluating chemicals of concern in consumer products and their potential alternatives.

New Guidance Portal Provides Public Access To EPA Guidance Documents: On February 28, 2020, EPA announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents. According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance. On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, to promote transparency by ensuring that all active guidance documents are made available to the public. The portal provides an indexed database that allows the public to search for documents based on a range of criteria that include date of issuance, general subject matter, and summary of contents. EPA states that prior to the launch of the portal, it conducted an exhaustive review of its current guidance documents and withdrew those documents that it determined to be no longer relevant. The guidance portal provides a mechanism for the public to request modification or withdrawal of any documents. EPA notes that it uses guidance documents “to clarify existing obligations for interested parties, but not as a vehicle for implementing new, binding requirements on the public.” According to EPA, it will release by August 28, 2020, a regulation that establishes the processes and procedures for issuance of new guidance documents.

EPA Releases Updated IRIS Program Outlook: On February 28, 2020, EPA announced the release of an updated Integrated Risk Information System (IRIS) Program Outlook on the IRIS website. The document describes assessments that are currently in development and their projected public milestones. EPA states that it identified these assessments as high priority needs. The anticipated dates of the IRIS activities communicated in the Outlook are based on several factors, including complexity of the assessment products and the availability of resources.

GAO Recommends Additional Action To Improve EPA Data On Informal Enforcement And Compliance Assistance Activities: On March 2, 2020, the U.S. Government Accountability Office (GAO) issued a report entitled Environmental Protection: Additional Action Needed to Improve EPA Data on Informal Enforcement and Compliance Assistance Activities. GAO states that it was asked to review EPA’s enforcement efforts. It examined, among other objectives, the types of information EPA collects on its compliance assistance, compliance monitoring, and enforcement actions. GAO notes that the Office of Enforcement and Compliance Assurance (OECA) does not require regional offices to collect data on compliance assistance or complete data on informal enforcement actions. According to GAO, “[h]aving complete information about its compliance assistance activities and informal enforcement is essential because EPA has elevated the role of such activities in its overall enforcement efforts. However, because EPA is not consistently collecting these data, the agency cannot be sure it is achieving its strategic objectives.” GAO made three recommendations:

  1. The OECA Assistant Administrator should clearly document in guidance to the regional offices how they should use the definition of informal enforcement actions to collect data on these actions;
     
  2. The OECA Assistant Administrator should clearly document in guidance to the regional offices that they should collect data on compliance assistance activities and specify which mechanism to use to maintain the data, such as the Integrated Compliance Information System (ICIS); and
     
  3. The OECA Assistant Administrator should include the known limitations of data in its annual reports and provide information on the intended use of EPA’s data.
     

GAO states that EPA agreed with its recommendations and stated that the Agency has either begun to or plans to implement them.

Trump Announces Intent To Nominate Dr. Nancy Beck To Chair CPSC: President Trump announced on March 2, 2020, that he intends to nominate Dr. Nancy Beck, Principal Deputy Assistant Administrator for EPA’s OCSPP, to be Chair and Commissioner of CPSC. Trump’s press release notes that Dr. Beck has spent the majority of her career in the federal government, serving as a career employee under former Presidents Clinton (D), Bush (R), and Obama (D). Before joining the federal government, Dr. Beck worked for the Washington State Department of Health preparing health and exposure assessments for communities concerned about environmental exposures. Dr. Beck also has experience working in regulatory science policy for the American Chemistry Council. According to the press release, Dr. Beck has a B.S. from Cornell University and a M.S. and Ph.D. in environmental health from the University of Washington.

FTC And FDA Send Warning Letters To Seven Companies About Unsupported Claims That Products Can Treat Or Prevent Coronavirus: On March 10, 2020, the Federal Trade Commission (FTC) and FDA announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent COVID-19/coronavirus. More information is available in our blog.

OSHA Publishes Guidance On Preparing Workplaces For COVID-19: The Occupational Safety and Health Administration (OSHA) has published a document entitled Guidance on Preparing Workplaces for COVID-19. OSHA states that it developed the COVID-19 planning guidance based on traditional infection prevention and industrial hygiene practices. The guidance focuses on the need for employers to implement engineering, administrative, and work practice controls and personal protective equipment (PPE), as well as considerations for doing so. OSHA intends the guidance for planning purposes. According to OSHA, employers and workers should use the planning guidance to help identify risk levels in workplace settings and to determine any appropriate control measures to implement. OSHA notes that additional guidance may be needed as COVID-19 outbreak conditions change, including as new information about the virus, its transmission, and impacts, becomes available. OSHA states that the guidance is advisory in nature and informational in content. It is not a standard or a regulation, and it neither creates new legal obligations nor alters existing obligations created by OSHA standards or the Occupational Safety and Health Act. The U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC) provides the latest information about COVID-19 and the global outbreak at https://www.cdc.gov/coronavirus/2019-ncov/. The OSHA COVID-19 webpage offers information specifically for workers and employers at https://www.osha.gov/covid-19.

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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