EPA Cites Chemours for TSCA Violations

On February 14, 2019, EPA sent a Notice of Violation (NOV) to Chemours identifying TSCA violations at the company’s Fayetteville Works facility in Fayetteville, NC and at the company’s Washington Works facility near Parkersburg, WV.  The NOV identifies a number of section 5 violations, including a violation of the TSCA Section 5(e) Consent Order for the manufacture of GenX, a perfluorinated chemical.  The violations include:

  • Failure to submit a SNUN for a CBI substance subject to a SNUR restricting its annual production to 10,000 pounds.
  • Failure to submit a PMN for one chemical substance that was manufactured for a commercial purpose and not listed on the TSCA inventory.
  • Failure to submit a SNUN for hexafluoropropylene oxide (HFPO). (HFPO is manufactured at the Fayetteville facility to be used as part of the manufacture of other perfluoroalkyl substances (PFAS).)
  • Failure to properly control the effluent and emissions during the use of GenX as required by a 2009 TSCA Section 5(e) Consent Order.  (Among other things, the Consent Order states that Chemours “shall recover and capture (destroy) or recycle” GenX chemical substances “at an overall efficiency of 99% from all the effluent process streams and the air emissions (point sources and fugitive).”) 

Chemours was also cited for CDR violations.

The NOV references the July 31, 2018 Compliance Monitoring Inspection Report for Washington Works Facility and the April 24, 2018 Compliance Monitoring Inspection Report for Fayetteville Facility.  Those reports explain that EPA became aware of community concerns about the alleged release of potentially harmful chemicals into the Cape Fear River by Chemours’ Fayetteville Works Facility in June 2017.  The Agency inspected the Fayetteville facility later that month.  The Washington Works facility was inspected as a follow up in October 2017.  Both reports discuss the Consent Order.  In the Consent Order EPA expressed concerns that the GenX substances (perfluorinated alphatic carboxylic acid and perfluorinated alphatic carboxylic acid, ammonium salt) would persist in the environment, could bioaccumulate, and be toxic (“PBT”) to people, wild mammals and birds. 

The Agency’s concerns were based both on data on the GenX substances and on their similarity to perfluorooctanoic acid (“PFOA”) and perfluorooctane sulfonate (“PFOS”).  In addition to discharge restrictions, the Consent Order imposed significant worker personnel protective equipment requirements, including that workers who may be exposed via inhalation must wear respirators with a NIOSH Assigned Protection Factor of 3000, and that Chemours must distribute the substances to only those customers that agree to require those respirators.  The Consent Order also limited the levels of the GenX substances as residuals in polymers to below 200 ppb.

The NOV noted that EPA continues to investigate and review information concerning the compliance status of these facilities.  It reminded the company that the Agency had requested information from Chemours, that it had not yet received, documenting when the company first learned about the GenX-related contamination around the facilities, including GenX contamination in drinking water.  The NOV also reminded the company that submission of that information is significant to Chemours’ compliance with the reporting requirements under TSCA Section 8(e) regarding substantial risk information.  EPA asked the company to, within 30 days, submit an outline of its action plan and time-frame for coming into compliance with TSCA.

EPA Announces Changes to PMN Review – Clearer Policy on “Possible Future Uses”

At the 2019 GlobalChem conference, Greg Schweer, the EPA Chief of the New Chemicals Management Branch said that the Agency now has a clearer policy to identify possible future uses of new chemical substances in its Premanufacture Notification (PMN) evaluations, reports Bloomberg Environment. The Lautenberg amendments to the Toxic Substances Control Act (TSCA) require EPA to consider “conditions of use” in the review and determination of PMNs  The amendments defined conditions of use as “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”  Possible future uses is part of the “conditions of use” review. 

According to Bloomberg Environment, Schweer also stated that “EPA also may be able to allow more new chemicals [to] enter commerce without placing unwarranted manufacturing or use restrictions on the company that originally requested to produce the new compound.” 

When it becomes available, we will post a copy EPA’s new policy on reasonably foreseen uses.  In the interim, information about the EPA PMN process is available here.

EPA Releases PFAS Action Plan

On February 14, 2019, EPA released a Per- and Polyfluoroalkyl Substances (PFAS) Action Plan. The Plan identifies both short- and long-term action items the Agency will take to address current PFAS contamination, preventing future contamination, and effectively communicating with the public about PFAS.  These action items include:

  • Drinking water: EPA is moving forward with the maximum contaminant level (MCL) process outlined in the Safe Drinking Water Act for PFOA and PFOS—two of the most well-known and prevalent PFAS chemicals. By the end of this year, EPA will propose a regulatory determination, which is the next step in the Safe Drinking Water Act process for establishing an MCL.
  • Clean up: EPA has already begun the regulatory development process for listing PFOA and PFOS as hazardous substances and will issue interim groundwater cleanup recommendations for sites contaminated with PFOA and PFOS.
  • Enforcement: EPA will use available enforcement tools to address PFAS exposure in the environment and assist states in enforcement activities.
  • Risk Communications: EPA will work across the agency—and the federal government—to develop a PFAS risk communication toolbox that includes materials that states, tribes, and local partners can use to effectively communicate with the public.
  • Developing toxicity values or oral reference doses (RfDs) for GenX chemicals and perfluorobutane sulfonic acid (PFBS).
  • Developing new analytical methods and tools for understanding and managing PFAS risk.
  • Promulgating Significant New Use Rules (SNURs) that require EPA notification before chemicals are used in new ways that may create human health and ecological concerns.

EPA Proposes Non-Consent-Order SNURs for 13 Chemical Substances

On October 16, 2018, the Environmental Protection Agency (EPA) issued a proposed rule that would establish Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances for which premanufacture notices (PMNs) have been approved during the two years since the statute was amended. A total of 6 SNURs were proposed for these 13 substances. Unlike other recent SNURs enacted after TSCA was amended, the 13 chemical substances are not also subject to consent orders. Indeed, all previously proposed and final SNURs for PMNs under amended TSCA were for substances for which EPA had previously negotiated orders under TSCA Section 5(e).

The proposed SNURs would require that persons who intend to manufacture (including import) or process any of the 13 chemical substances for an activity that is designated as a significant new use submit a “Significant New Use Notice” to EPA at least 90 days before commencing that activity. And, consistent with the SNUR regulations at 40 CFR § 721.25, the proposed rule states that persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice and decided on the notice, and the person has taken any actions as are required as a result of that determination. Comments on the proposed SNURs are due November 15, 2018.

EPA Announces New CASAC Members, Begins Ozone and PM NAAQS Reviews

On October 10, 2018, EPA issued a press release announcing the new members of the Clean Air Scientific Advisory Committee (CASAC) who will participate in the current reviews of the national ambient air quality standards (NAAQS) for ozone and PM. The press release also expands the description of the Committee’s charge, as previewed in the prior NAAQS reform materials issued by the Administration, to include examination of the relative contribution of background to current ambient concentrations and consideration of the potential social, economic and energy effects of various NAAQS implementation strategies.

The press release also announced the first draft of the Integrated Science Assessment (ISA) for PM, which was released a few days later. The ISA is the comprehensive scientific document on which EPA’s decision whether to revise the current standards must be based. The new draft ISA was announced in the Federal Register on October 23, with a comment deadline of December 11. A CASAC meeting to review the draft ISA has not yet been announced, but the Committee reportedly is considering a meeting to review the draft on December 12-13.

With respect to ozone, the press release announced a series of webinar workshops the agency currently is holding to consider new studies that should be included in the new ISA. Following those a draft integrated review plan will be released for public and CASAC review. (These steps have long been completed for the PM review.) EPA is attempting, on a very short time frame compared to past reviews, to complete both the ozone and PM reviews by the end of 2020.

Separately, EPA announced that the expanded scientific review panels that have assisted CASAC in recent ozone and PM reviews have been disbanded. These review panels, which grew over time to include 12-15 members, acted as consultants to CASAC, but only the seven formal Committee members voted on the final language in advice letters to the Administrators. The large CASAC consultant panels were one of the reasons that reviews in recent years have stretched far beyond the statutorily mandated 5-year period. One principle of the Administration’s NAAQS reform policy is to stay on the review schedule and finish both the PM and ozone reviews by the end of 2020.

Amazon Issues Responsible Sourcing Policy

Amazon recently issued a Responsible Sourcing Policy that restricts some chemicals and encourages the use of safer ones.  The policy is comprised of a Supplier Code of Conduct and a Chemicals Policy.

Supplier Code of Conduct

The Supplier Code of Conduct sets out Amazon’s expectations for suppliers of goods and services. The policy notes that Amazon expects its suppliers to hold their suppliers and subcontractors to the standards and practices covered by the code.

The code addresses:

  • Health and safety in production areas and any living quarters
  • The right to legal wages and benefits
  • Appropriate working hours and overtime pay
  • Prevention of child labor or forced labor
  • Fair and ethical treatment, including non-discrimination

The company notes that it conducts risk assessments and audits supplier compliance with the program.

Amazon Chemicals Policy

Amazon announced that the company is committed to avoiding chemicals of concern in its products.  The policy identifies chemicals of concern as those that can affect human health and/or the environment.  Amazon specified that chemicals of concern are those that: 1) meet the criteria for classification as a carcinogen, mutagen, reproductive, or other systemic toxicant; or 2) are persistent, bioaccumulative, and toxic. The company notes that it prioritizes chemicals of concern to focus on product types, customer concerns, and the availability of safer alternatives.

A baseline list of chemicals of concern comprise the company’s Restricted Substance List (RSL).   These are chemicals that Amazon seeks to avoid in its own private brand for baby, household cleaning, personal care, and beauty products in the U.S. The company notes that this policy has been imposed in addition to applicable local legal requirements and associated compliance plans. Amazon plans to expand the plan over time to additional brands, product categories, and geographies.

Elements of the policy include the following:

  • Reduce Usage of Chemicals of Concern. Amazon explained that it encourages manufacturers to phase out potentially hazardous chemistries and adopt green chemistry alternatives, such as those defined in U.S. EPA’s Safer Choice Safer Chemicals Ingredients List.  As noted above, Amazon has begun to reformulate its own Private Brand products to phase out RSL chemicals.
  • Enable Transparency.  The company announced that it is working on website features that will make it easier for customers to access comprehensive information about product ingredients and third-party certifications (e.g., Safer Choice, Made Safe, Green Seal, and Cradle to Cradle).  It explained that it hopes that by making this information more readily available for customers, it will encourage additional brands to move away from potentially hazardous chemistries in their products.
  • Implement a Restricted Substance List. The RSL will apply to all consumer private brand for baby (shampoo, lotion, wipes), household cleaning (all-purpose, kitchen, and bathroom cleaners), personal care (shampoo, sanitizers, moisturizers), and beauty products (make-up).  It focuses on paraben preservatives, formaldehyde donor preservatives, phthalate solvents, nonylphenol (NP) and nonylphenol ethoxylate (NPE) surfactants, toluene, and triclosan. The RSL chemicals will be reviewed and updated periodically.
  • Enhance Transparency with Customers and Stakeholders. The company has reformatted “Amazon Pages” and its “A+ Enhanced Marketing Content” to allow brands to explain the steps they are taking to ensure that their product selection is safe and healthy.  Amazon notes that the framework developed to enable this display employs guidelines to maintain high quality content that is comprised of factual, easily verifiable, and objective information. The company announced that it plans to work to achieve fuller ingredient disclosure on its Private Brand product detail pages in 2019.

The company also reports that it has joined the Retail Leadership Council of the Green Chemistry and Commerce Council (GC3) and the Beauty and Personal Care Products Sustainability Project (BPC), which encourage the retail sector to use safer formulations and produce more sustainable products.

California Bans Flame-Retardant Chemicals from Mattresses, Upholstered Furniture and Children’s Home Products

California bill AB 2998 prohibits the sale of mattresses, upholstered furniture, and children’s products containing flame retardants at levels above 1,000 parts per million (ppm) after December 31, 2019.  With some limited exceptions, the bill prohibits “persons,” including manufacturers, from selling or distributing these products at levels above 1,000 ppm, and prohibits custom upholsterers from repairing upholstered furniture or reupholstered furniture using replacement components that contain the covered chemicals at levels above 1,000 ppm.

The bill authorizes the Bureau of Electronic and Appliance Repair, Home Furnishings, and Thermal Insulation (Bureau) to assess fines up to $10,000 against manufacturers for violation of the flame retardant prohibitions.

The bill defines “mattress” as  a ticking filled with a resilient material used alone or in combination with other products intended or promoted for sleeping upon, including, but not limited to, adult mattresses, youth mattresses, crib mattresses, bunk bed mattresses, futons, convertible sofa bed mattresses, corner group mattresses, day bed mattresses, roll-a-way bed mattresses, high risers, and trundle bed mattresses.  (See 16 CFR §1632.1 for further details.)

“Upholstered furniture” is defined as any flexible polyurethane foam or upholstered or reupholstered furniture sold in California that is required to meet certain test requirements set forth in Technical Bulletin 117-2013.

“Juvenile product” means a product designed for residential use by infants and children under 12 years of age, including, but not limited to, bassinets, booster seats, changing pads, floor playmats, highchairs, infant carriers, infant seats, infant swings, nursing pads, nursing pillows, strollers, and children’s nap mats.

A “covered flame retardant chemical” means any chemical that meets both of the following criteria:

  • A functional use for the chemical is to resist or inhibit the spread of fire or as a synergist to chemicals that resist or inhibit the spread of fire, including, but not limited to, any chemical for which the term “flame retardant” appears on the Occupational Safety and Health Administration substance safety data sheet pursuant to subdivision (g) of Section 19100.1200 of Title 29 of the Code of Federal Regulations as it reads on January 1, 2019.
  • The chemical is one of the following:
    • A halogenated, organophosphorus, organonitrogen, or nanoscale chemical,
    • A chemical defined as a “designated chemical” in Section 105440 of the Health and Safety Code, or
    • A chemical listed on the Washington State Department of Ecology’s list of Chemicals of High Concern to Children in Section 173-334-130 of Title 173 of the Washington Administrative Code as of January 1, 2019, and identified as a flame retardant or as a synergist to flame retardants in the rationale for inclusion in the list.

The bill makes a number of findings about flame retardants, including that:

  • Scientists have found that many of the flame-retardant chemicals commonly used in furniture exhibit one or more of the key characteristics of Persistent Organic Pollutants, and that these chemicals accumulate in our bodies and in the environment, persist in the environment for long periods of time, are capable of long-range transport, and are toxic to humans and animals.
  • Children living in California have some of the highest documented blood concentrations of certain flame retardant chemicals compared to other children in the United States.
  • The State of California has found that flame retardant chemicals are not needed to provide fire safety.

The bill also discusses the 2017 guidance document issued by the United States Consumer Product Safety Commission (Commission). That document found that, based on the overwhelming scientific evidence, the Commission should alert the public to serious concerns about the toxicity of organohalogen flame retardants added to children’s products, furniture, mattresses, and plastic casings surrounding electronics. The Commission requested that manufacturers eliminate the use of these chemicals in their products. It also recommended that retailers obtain assurance from manufacturers that their products do not contain these chemicals and that consumers, especially those who are pregnant or with young children, avoid products containing these chemicals.

Gov. Jerry Brown (D) signed the measure into law on September 29, 2018.

EPA Publishes A Working Approach for Identifying Potential Candidate Chemicals for Prioritization

On September 28, 2018 EPA released the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA).  The approach is documented in the publication A Working Approach for Identifying Potential Candidate Chemicals for Prioritization (A Working Approach). EPA also announced that the Agency will be looking for input from the public on which chemicals should be prioritized for risk evaluation and which chemicals may be low priorities under TSCA.   By December 2019, EPA must designate at least 20 chemical substances as High-Priority for risk evaluation and 20 chemical substances as Low-Priority for which risk evaluation is not currently warranted.

A Working Approach lays out EPA’s near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA.  The Agency notes that it expects its approach for identifying candidates for prioritization to evolve over time as it develops expertise in identifying chemicals to enter prioritization, as well as in conducting prioritization and risk evaluations.

EPA’s working approach is to primarily look to the 2014 Work Plan for high-priority potential candidates.  The Agency explains that it generally intends to consider the three factors described below for selecting potential chemicals for prioritization.

  • In selecting chemicals as potential candidates for prioritization EPA expects to consider overarching Agency priorities. This may include, but is not limited to, a chemical or group of chemicals that are priorities for the Agency, including chemicals that other EPA program offices have deemed a priority for their program and suitable for current prioritization. In addition, EPA is committed to engaging and collaborating with partner federal agencies prior to and during the prioritization process.
  • Quantity and Quality of Information. EPA intends to consider the quantity and quality of information when identifying potential candidate chemicals for prioritization and risk evaluation.
  • Work Load. To address workload issues, EPA could use diverse approaches to consider current expertise or facilitate the analysis of candidate chemicals. For example, EPA could identify potential candidate chemicals that share certain characteristics with the first 10 chemical substances undergoing risk evaluation, 15 such as solvents, since focusing on the solvents remaining on the 2014 Work Plan would take advantage of the expertise developed on the six solvents currently undergoing risk evaluation (e.g., development of exposure scenarios).

In identifying potential candidates for low priority chemical designation, A Working Approach explains that EPA will use the best available science.  The document reports that EPA may identify substances from multiple sources, including one or more of the following chemical information resources:

  • EPA’s Safer Chemical Ingredients List;
  • EPA’s Chemical Assessment Management Program; and
  • Organization for Economic and Co-Operation Development Screening Information Data Sets assessment documents.

A Working Approach states that EPA intends to preferentially select CAS numbers that represent discretely defined structures, which can be more confidently associated with information on hazard, conditions of use, and exposure.

The document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape which, according to the TSCA Inventory, is composed of more than 40,000 active chemicals. This longer-term approach proposes parsing chemicals into “bins” that can be used to inform multiple activities and priorities throughout EPA, including within the TSCA program.  In the near future, EPA will open a public docket to accept comments on this longer-term strategy.  In addition, the Agency plans to hold a public meeting on the strategy in early 2019.

EPA will also open 73 chemical-specific public dockets, one for each of the remaining chemicals on the 2014 TSCA Work Plan.  Additionally, there will be a general docket open for the public to suggest chemicals for risk evaluation that are not on the Work Plan.  Through these dockets, the public will have the opportunity to submit use, hazard, and exposure information on these chemicals.  The Agency will use this data to inform TSCA prioritization and risk evaluation for these chemicals.

EPA Publishes Direct Final Rules for 29 Significant New Use Rules

On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA). The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. All 29 chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The rules require persons who intend to manufacture (including import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that new use.

The covered chemicals vary, but include several substances intended for use as coatings additives. The requirements for each of the substances differ, but may include limitations on the uses of the substance, hazard communication, personal protective equipment use, and the submission of certain toxicity testing data. Both direct final rules will be effective on October 26, 2018.

EPA Issues Second Draft “Eco ISA” for NOx, SOx and PM

EPA recently released the second draft of an Integrated Science Assessment (ISA) for “ecological effects” from NOx, SOx and PM, which include effects on flora, fauna and water resources.  The ISA will be used to determine the need for revising the current secondary national ambient air quality standards (NAAQS) for these pollutants. Other welfare effects that could be caused by these substances, such as effects on visibility, climate or building materials, will be addressed in the ISAs for the primary (health-based) standards for the substances.

The NOx and SOx ecological effects previously were addressed in a 2008 ISA. The specific effects considered are too numerous to discuss here, but they are listed in a table in the new draft ISA that compares the 2008 conclusions with those presented in the new draft. All of the effects analyzed in the 2008 ISA were determined to be “causal” pursuant to EPA’s classification scheme (meaning that they are caused by the pollutants at issue). However, those determinations did not result in a change in the secondary standards, owing to the uncertainties involved in identifying ambient concentrations necessary to alleviate the effects. EPA took the position that the existing suite of primary and secondary standards also would provide adequate protection against these ecological effects.

In the new draft, all the effects determined to be causal in 2008 retain that classification. However, the new draft addresses the following five effects not classified in 2008:

  1. N deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems;
  2. Acidifying N and S deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems;
  3. N deposition and increased nutrient-enhanced coastal acidification;
  4. N deposition and changes in biota, including altered physiology, species richness, community composition, and biodiversity due to nutrient-enhanced coastal acidification;
  5. S deposition and changes in biota due to sulfide phytotoxicity, including alteration of growth and productivity, species physiology, species richness, community composition, and biodiversity in wetland and freshwater ecosystems.

All these effects, most of which were discussed in the 2008 ISA but not classified, would now be classified in the new ISA as causal on the basis of more recent information. The general conclusion is that new evidence supports the prior classifications and improves quantification of dose-response relationships. However, there is no clear statement that quantification has improved sufficiently to allow use of ecological effects as a basis for revising the standards, and in many cases the draft ISA finds that quantification remains subject to significant uncertainty.

Unlike the 2008 ISA, the new draft includes ecological effects from ambient PM. EPA’s last discussion of this issue, in the 2009 PM ISA, concluded that there is likely a causal relationship between PM deposition and various ecological effects, but that the specific relationships cannot be quantified as a result of a number of uncertainties. As a result, the PM secondary standards were not revised at the conclusion of the last review.  The new draft ISA draws the same conclusions on the basis of the more recent studies.

The Clean Air Scientific Advisory Committee (CASAC) will review this new draft of the Eco ISA, after which EPA is likely to finalize the ISA and prepare a draft Policy Assessment (PA) that makes recommendations for retaining or revising the current secondary standards based on the science presented in the ISA.