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.

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.

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.

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.

On April 26, 2018, EU Member States voted to implement new REACH registration requirements for nanomaterials.  The European Commission announced that the draft regulation will be reviewed by Parliament and Council for three months before being adopted.  The requirement to provide more information on nanomaterials under REACH (Regulation No. 1907/2006) would apply from Jan. 1, 2020.

The European Commission reported that the proposed amendments will significantly clarify REACH registration requirements with regard to nanomaterials. According to the Commission, REACH always applied to nanomaterials but did not contain specific provisions for them.  The Commission explained that this meant companies often did not know how to register substances in nanoform.  It noted that the specific requirements will address the current knowledge gap on which substances registered under REACH are placed on the market as nanomaterials and in which quantities.

Under the new requirements, manufacturers and importers will be obligated to assess and document in the chemical safety report that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled. To ensure clarity, the chemical safety report should describe whether and which different nanoforms are covered by the assessment and how the information is compiled in the report.  The proposed regulation can be accessed here.