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.

EPA Proposes Revision of AP42 Emission Factors for Liquid Storage Tanks

As a result of widespread interest EPA recently extended the comment deadline for proposed revisions to AP42 chapter 7, which specifies emission factors for organic liquid storage tanks. The AP42 emission factors are used to estimate emissions from specific industrial facilities and processes when no site-specific emissions data are available. They are used in a wide array of regulatory applications ranging from emissions inventories to permit applicability determinations to compliance and enforcement. The proposed changes for liquid storage tanks, which were prepared by the American Petroleum Institute, are extensive; in effect Chapter 7 is being rewritten. The results are unclear and may vary significantly among different types of tanks and facilities. Anyone who has relied on the AP42 factors for storage tanks, or may need to do so in the future, should evaluate the new emission factors and equations EPA is proposing. Comments are due by November 26.

EPA Proposed Regulations for Scientific Integrity in Contracting

On September 26, EPA published a proposal addressing scientific integrity in the context of agency contractors who perform scientific research or analyses. It would create a new standard contract clause designed to ensure that all scientific work performed for the Agency is done consistently with the agency’s scientific integrity policy, which dates from 2009. The proposal also includes regulations for addressing loss of scientific integrity, including steps for mitigation or termination in appropriate cases.

Contractors who become aware of “an actual or potential” loss of integrity would be required to report it to the contracting officer, who would ultimately decide on the remedy, if any. Contractors would bear the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with its own institution. However, EPA would retain the ultimate oversight authority for EPA-supported research.

This could be a useful tool in addressing any noncompliance with EPA’s integrity policies that may come to light in research sponsored by EPA. However, there are a couple of apparent holes in the proposal. It does not clearly state that the contractor or contracting officer must investigate a loss (or potential loss) of integrity brought to their attention by a third party, such as a potentially regulated stakeholder. In addition, it focuses on EPA’s 2009 integrity policy but does not mention compliance with the regulations for strengthening integrity in regulatory science that EPA proposed earlier this year. Comments on this proposal are due by November 26.

EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory

On June 27, 2018, the Environmental Protection Agency (EPA) published the final “Reporting Requirements for the TSCA Mercury Inventory” Rule. As required under section 8(b)(10)(D) of the Toxic Substances Control Act (TSCA), EPA finalized reporting requirements for regulated entities to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States.”

The requirements apply to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process. The reporting requirements apply to “mercury” as both “elemental mercury” and “a mercury compound.” EPA provides a list of these compounds in the final rule. Reporting requirements vary based on whether the entity is manufacturing mercury, manufacturing a mercury added product, or intentionally using mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product. EPA will collect data through the Mercury Electronic Reporting (MER) application of its CDX system.

Based on the inventory of information collected, the Agency is directed to “identify any manufacturing processes or products that intentionally add mercury; and . . . recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.” EPA stated in the final rule that it is not making such identifications or recommendations at this time.

EPA will use data from the 2018 reporting year for the 2020 mercury inventory. The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019.