Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
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By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

On March 28, 2018, the Superior Court of California, Los Angeles County, issued its Statement of Decision (Phase II) (Defendants’ Alternative Significant Risk Level (ASRL) Affirmative Defense) that found that the defendants failed to meet their burden of proof on their ASRL affirmative defense.  Council for Education and Research on Toxics (CERT) v. Starbucks Corporation (Starbucks), No. BC435759 (L.A. Super. Ct., filed April 13, 2010).  CERT’s (plaintiff) complaint alleged that Starbucks, along with 18 other defendants (the total later reached 91 defendants when a second action was filed (now consolidated)), that sell ready-to-drink coffee failed to provide warnings to consumers that the coffee sold contained high levels of acrylamide, a carcinogenic chemical, in violation of Proposition 65 (Prop 65).  The defendants denied the material allegations and asserted various affirmative defenses, violation of the First Amendment, and federal preemption.  According to the order, the parties did not dispute that acrylamide, listed as a carcinogen by the International Agency for Research on Cancer (IARC), and under Prop 65 since 1990, is listed by the State of California as a chemical believed to cause cancer; or that they failed to provide warnings to consumers that the ready to drink coffee they sold contained high levels of acrylamide.  

In Phase I of the trial, the court came to a similar conclusion, that defendants failed to meet their burden of proof by preponderance of evidence on their affirmative defenses of “no significant risk level,” First Amendment, and federal preemption to avoid the requirement of cancer warning labels as to the existence of acrylamide in brewed coffee.  The trial on Phase II of the case ran from September 2017 to November 2017 and post-trial briefs were filed in December 2017 and January 2018.  The order states that to have prevailed on their ASRL defense, defendants needed prove all of the below, which they failed to do:

  1. Establish that acrylamide is created by cooking or processing necessary to render the coffee safe or palatable (defendants only argued that acrylamide levels in coffee cannot be reduced at all without negatively affecting safety and palatability);
  2. Demonstrate that “sound considerations of public health” justify applying an alternative (less strict) risk level (defendants did not counter plaintiffs evidence that consumption of coffee increases harm to the fetus, infants, children, and adults; and the court found their proffered evidence that coffee itself confers some benefit to human health to be unpersuasive); and
  3. Present persuasive evidence of what would be an appropriate alternative risk level, taking into account the identified public health considerations (defendants did not conduct a quantitative risk assessment of the risk of cancer from exposure to acrylamide in coffee, necessary to prove an alternative risk level for acrylamide in coffee).

The ASRL affirmative defense is grounded on an exemption to the cancer hazard warning requirement under Prop 65, but as the defendants were not able to prevail on this defense, they will now be required to provide the Prop 65 warning language on their ready-to-drink coffee products, but the order does not specify any details regarding this.  The decision also exposes the defendants to liability in terms of millions in fines.  The defendants have until April 10, 2018, to file objections to the decision.


 
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By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

U.S. Senate Minority Leader Charles E. Schumer (D-NY) on March 20, 2018, announced that, after his intervention, representatives from the U.S. Occupational Safety and Health Administration (OSHA), the U.S. Environmental Protection Agency (EPA), and the Department of Homeland Security (DHS) are working to create new protocols for communicating and training with local governments and first responders.  OSHA, EPA and DHS will convene the Chemical Facility Security and Safety Working Group (Working Group), which will coordinate strategies, activities, policies, and communication to address concerns that there should be an immediate and more thorough improvement of OSHA’s coordination and communication systems to local municipalities and their respective stakeholders.  Specifically, the Working Group is moving forward with a new partnership between the agencies regarding the coordination of communication between state and local governments when there is a serious violation cited.  The protocol will address the lack of communication with local first responders, safety and training agreements, and coordination on information sharing about all the relevant agencies when a local company is cited for serious violations -- like the reported mishandling of Verla International’s (Verla) use of flammable liquids.  

The new protocol is intended to ensure that emergency response agencies are notified when a facility receives a serious health or environmental violation, so that they can proactively prevent accidents and prepare to respond when accidents and fires occur.  Specifically, the Working Group is tasked with:

  • Developing appropriate means for sharing information with first responders to enhance their ability to safely and effectively plan for and respond to incidents in their jurisdiction;
  • Developing tools, training, and resources to strengthen State Emergency Response Commissions and Local Emergency Planning Committees;
  • Coordinating with agencies beyond DHS, EPA, and OSHA by working with the U.S. Department of Justice, the U.S. Department of Transportation, and, in this instance, the U.S. Food and Drug Administration, as appropriate, to address incidents involving hazardous materials and the effects these incidents have on workers and communities;
  • Coordinating information sharing across the interagency community and with state, local, tribal, territorial, and private sector partners; and
  • Leveraging limited resources across all levels of government by conducting and facilitating cross-training to raise awareness of other programs.

In April 2017, OSHA cited Verla’s cosmetic factory in New Windsor, New York for improper storage of flammable liquids that resulted in several serious violations, and in November 2017 there was an explosion and fire at the factory where one worker was killed and 40 people, including seven firefighters, were injured -- a tragedy that may have been avoided had the first responders been notified of the violations and known better how to handle the situation.  Senator’s Schumer’s concerns about the lack of communication and notification stem from these events.  He states the new protocols “will provide technical expertise and tighter coordination with federal and regional first responder operations to try to make sure the lack of communication and awareness of preexisting issues faced by first responders back in November is a thing of the past.”


 
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By Lynn L. Bergeson and Margaret R. Graham

On February 8, 2018, the U.S. Government Accountability Office (GAO) issued a technology assessment report to congressional requestors entitled Chemical Innovation:  Technologies to Make Processes and Products More Sustainable.  GAO states it conducted this technology assessment “to explore, among other things, the opportunities, challenges, and federal roles in sustainable chemistry.”  This report discusses (1) how stakeholders define and assess sustainable chemistry; (2) available or developing technologies to make chemical processes and products more sustainable; and (3) how the federal government, industry and others contribute to the development and use of such technologies.  GAO states it is not making recommendations in this report, but is identifying strategic implications.

As part of its assessment, GAO interviewed stakeholders from government, industry, and academia; convened a meeting of experts on sustainable chemistry technologies and approaches; and surveyed a non-generalizable sample of chemical companies.  GAO identified three categories of more sustainable chemistry technologies -- catalysts, solvents, and continuous processing -- that demonstrate both progress and potential:

  • Catalysts reduce the energy input required for a chemical process and allow for more efficient use of materials.  Stakeholders suggested future research be directed at developing less toxic or renewable catalysts, including those that are metal-free or those from earth-abundant metals such as iron. 
  • Solvents are used in many chemical processes but can create waste issues and be toxic.  Alternatives include solvents from renewable, non-petroleum raw materials and solvents such as water that are less hazardous to human health and the environment, among other qualities. 
  • An alternative to traditional batch processing is continuous processing, in which materials react as they flow along a system of channels, pipes, or tubes. Compared to batch processing, continuous processing uses materials more efficiently, generates less waste, and has a smaller physical footprint.

GAO also identified, through its interaction with stakeholders, the following strategic implications of sustainable chemistry; and potential options to address these challenges and realize the full potential of these technologies:

  • Breakthrough technologies in sustainable chemistry could transform how the industry thinks about performance, function, and synthesis.  Sustainable chemistry creates opportunities to use a different conceptual framework that allows industry to create molecules with better performance. 
  • The establishment of an organized constituency, with the involvement of both industry and government, could help make sustainable chemistry a priority.  An industry consortium, working in partnership with a key supporter at the federal level, could lead to an effective national initiative or strategy.
  • A national initiative that considers sustainable chemistry in a systematic manner could be useful.  Such an effort could encourage collaborations among industry, academia and the government, similar to other national technology Initiatives.
  • There are opportunities for the federal government to address industry-wide challenges.  Federal attention that facilitates development of standard tools for assessment and a robust definition could help clarify relevant participants in the field and improve information available for decision-makers at all levels

More information on the report and its strategic implications is available on GAO’s website.


 
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By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham

On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people.  Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop.  The draft guidance documents are:

EPA’s prepublication version of the notice of availability of the draft guidance states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI.  In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA.  In accordance with the requirements of TSCA section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA.  A 30-day comment period for the draft guidance documents will open upon the notice’s publication in the Federal Register; comments can be submitted to docket EPA-HQ-OPPT-2017-0652 via www.regulations.gov.

On March 12, 2018, EPA also announced that it collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice.  83 Fed. Reg. 10719.  Comments on the ICR are due May 11, 2018.  EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.

Tags: CBI, EPA, guidance, TSCA

 
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By Lynn L. Bergeson and Margaret R. Graham

On March 9, 2018, as a first step in developing a proposed rule regulating certain persistent, bioaccumulative, and toxic (PBT) chemicals, the U.S. Environmental Protection Agency (EPA) announced that it is seeking nominations for individuals who represent small businesses, small governments, and small non-for-profit organizations to serve as Small Entity Representatives (SER) to provide input on potential impacts of PBT regulation.  EPA states the role of a SER is “to provide advice and recommendations to ensure that the Panel carefully considers small entity concerns regarding the impact of the potential rule on their organizations and to communicate with other small entities within their sector who do not serve as SERs,” and will ask the SERs to provide comments on behalf of their company, community, or organization and advise a soon to be created Small Business Advocacy Review (SBAR) panel regarding potential impacts to small businesses that could result from the regulation of certain identified PBTs.  The SBAR panel will include federal representatives from EPA, the Small Business Administration, and the Office of Management and Budget (OMB).  After collecting input from the small entities, the panel will make recommendations to the Agency on the development of a proposed rule to regulate these PBT chemicals.

Under Section 6(h) of the Toxic Substances Control Act (TSCA), EPA is required, not later than three years after the date of enactment (June 22, 2019), to propose rules regarding the regulation of certain PBTs selected from the 2014 update of the TSCA Work Plan for Chemical Assessments that:  (1) EPA has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other have been identified; and (2) exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator.  The PBT chemicals that EPA has selected are:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
  • Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer or transformer fluid;
  • Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
  • Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as lubricant, hydraulic fluid, and other industrial uses; and
  •  2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline or lubricant additive. 

The Regulatory Flexibility Act requires agencies to establish a SBAR panel for rules that may have a significant economic impact on a substantial number of small entities.  EPA states that the panel process will offer “an opportunity for small businesses, small governments and small not-for-profit organizations … to provide advice and recommendations to ensure that the EPA carefully considers small entity concerns regarding the impact of the potential rule on their organizations.” 

EPA states eligible SERs are small entities that manufacture, process, distribute in commerce, use, or dispose any of the five selected PBT chemicals.  EPA is seeking self-nominations directly from entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted through the instructions outlined on EPA’s Potential SBAR Panel website and must be received by March 22, 2018.  More information about the SBAR process is available online. 


 
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By Lynn L. Bergeson and Margaret R. Graham

On March 6, 2018, in the U.S. Court of Appeals for the D.C. Circuit, the Environmental Defense Fund (EDF) filed its Principal Brief in the litigation case that petitions for review the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule (EDF v. EPA, No. 1701 (D.C. Cir.)).

EDF’s brief includes, among other required statements, a statement of the issues, a statement of the case, a summary of their argument, and their argument.  EDF’s arguments are as follows:

  1. The Inventory Rule withholds information on chemical substances manufactured or processed in the U.S. from the public; this information is required to be disclosed under amended TSCA; EDF has been harmed by EPA’s failure to disclose this information and to disclose unique identifiers for confidential chemicals; and the court can redress this harm.  
  2. The final rule illegally allows manufacturers and processors to assert certain new claims for nondisclosure of specific chemical identities based on other persons having asserted earlier claims, which is contrary to TSCA’s plain text and the relevant precedent governing confidentiality claims; and EPA’s rationale for its interpretation is arbitrary and capricious.
  3. The final rule violates both the substantive and procedural requirements of TSCA Section 14, Confidential Information, specifically that:  EPA refused to accept that TSCA Section 8, Reporting and Retention of Information, repeatedly incorporates Section 14 requirements for confidentiality claims; the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14; and the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14.
  4. The final rule fails to implement the unique identifier and other public information requirements in TSCA Section 8(b)(7)(B).
  5. The final rule exempts chemicals manufactured and processed solely for export from the reporting requirements, even though such chemicals are specifically not exempted from TSCA Section 8.
  6. Finally, EDF requests the court to set aside the rule in part, stating that vacatur, along with remand, is the appropriate remedy for EPA’s violations of the Administrative Procedure Act (APA).  EDF does not seek a complete vacatur, however, stating that “a complete vacatur would postpone the release of some of the very information that EDF seeks, since it would allow EPA to postpone publishing the Inventory based on the information it has already collected.  In addition, it would impose costs on the regulated community beyond those necessary to remedy EDF’s harms [and] those manufacturers and processors who have already filed notices without claims of confidentiality should not need to refile the notices.”  The portions of the final rule that EDF requests the court to vacate are as follows:  the exclusion for export-only manufacturers (40 C.F.R. Section 710.27(a)(4)); Confidentiality Claims (40 C.F.R. Section 710.37); and certain portions of the preamble. EDF states specific instructions on how it would like the court to order EPA to promulgate the regulation on remand that include revisions to regulations on confidentiality claims, public information requirements, and notifications of activities during the lookback period.

EDF has done its usual thorough job and the brief is definitely a must read for TSCA stakeholders.  More information on this proceeding and the other challenges to the TSCA framework final rules is available on our blog under key words framework rules.


 
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By Lynn L. Bergeson and Margaret R. Graham

On March 7, 2018, the U.S. Environmental Protection Agency (EPA) released a draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods to reduce the use of vertebrate animals in chemical testing, fulfilling another milestone under the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA).  Under amended TSCA, EPA is required to develop a strategy to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing by June 22, 2018.  EPA states the draft document incorporates input from a November 2017 public meeting held on the development of the draft strategy, as well as written comments submitted after the meeting, and draws upon EPA research on test methods.

The draft strategy outlines EPA’s Strategic Plan for the reduction of testing in vertebrates for chemicals regulated under TSCA. The organizing framework for the EPA’s strategy to reduce vertebrate animal testing relies heavily on what have been termed new approach methodologies (NAM) -- a broadly descriptive reference to any nonanimal technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment.  The strategy describes a multi-year process with incremental steps for adoption and integration of NAMs that are appropriate and fit-for-purpose for making TSCA decisions, and has three core components:

  • Identifying, developing, and integrating NAMs for TSCA decisions;
  • Building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions; and
  • Implementing the reliable and relevant NAMs for TSCA decisions. The EPA has identified seven current/near-term (less that three years) needs and activities.

EPA states that completing these activities will result in moving towards four intermediate-term (three to five years) objectives and these time frames, needs, and activities provide the basis for developing NAMs, establishing reliability and relevance criteria for the NAMs, and implementing NAMs to inform decisions made under TSCA.

Comments on the draft strategy will be due 45 days after the notice of availability is published in the Federal Register.  EPA has scheduled a public meeting to obtain input on the draft strategy for April 10, 2018, from 9:00 a.m. (EDT) to 5:00 p.m. (EDT) in Washington, D.C.  Registration is available online and is requested by April 3, 2018.


 
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By Lynn L. Bergeson and Margaret R. Graham

On February 26, 2018, the U.S. Environmental Protection Agency (EPA) published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act (TSCA), as permissible under TSCA Section 26(b).  83 Fed. Reg. 8212.  The rule as proposed will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  The notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, EPA also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  Comments on the proposed rule are due April 27, 2018.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) is available in our memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 
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By Lynn L. Bergeson and Margaret R. Graham

On February 16, 2018, the U.S. District Court for the Northern District of California issued an order granting plaintiffs’, the Sierra Club and A Community Voice-Louisiana, motion for summary judgment.  The court determined that the U.S. Environmental Protection Agency’s (EPA) final rule delaying the compliance date for the formaldehyde emission standards for composite wood products (Delay Rule) exceeded EPA’s authority under the Formaldehyde Standards in Composite Wood Products Act (Formaldehyde Act) codified as Title VI of the Toxic Substances Control Act (TSCA), vacated the Delay Rule, and set aside the year-long extension to December 12, 2018, of the compliance deadlines set out by EPA in the Delay Rule.  Sierra Club v. Pruitt, Case No. 4:17-cv-06293.  The Delay Rule, issued on September 25, 2017 (82 Fed. Reg. 44533), sought to extend further the compliance dates set out in its December 12, 2016, final rule that implemented the Formaldehyde Act (Formaldehyde Rule) (81 Fed. Reg. 89674), specifically:  the December 12, 2017, manufactured-by date for emission standards, recordkeeping, and labeling provisions until December 12, 2018; the December 12, 2018, compliance date for import certification provisions until March 22, 2019; and the December 12, 2023, compliance date for provisions applicable to producers of laminated products until March 22, 2024.  

As stated in the order, the Formaldehyde Act set out emission standards for domestically manufactured and imported composite wood products and directed EPA, by no later than July 1, 2013, to promulgate implementing regulations that would ensure compliance with the new emission standards; based on the Delay Rule’s further extension of deadlines, which sets both the manufacturing and emission standards compliance dates to December 12, 2018, EPA would have delayed the implementation for more than three years after the Formaldehyde Act had originally directed EPA to require compliance.

The order also denies defendant EPA’s cross-motion for summary judgment in which EPA states three arguments against plaintiffs’ motion:  (1) plaintiffs’ challenge is waived, as plaintiffs did not comment on the proposed extension by raising the sole issue plaintiffs raise in their motion; (2) the statute upon which plaintiffs base their claim expressly provides for EPA to set the manufactured-by date more than 180 days from promulgation of the implementing regulations; and (3) EPA’s extension of the manufactured-by date was reasonable, supported by the record, and not arbitrary or capricious.

In its analysis, the court offered the following to support its holdings:

  1. The designation of a manufacturing date “no earlier than 180 days following promulgation of the regulations” found in the sell-through provision of the Formaldehyde Act must fall on the 180th day after the regulations take effect.   EPA’s interpretation to set the manufacture date beyond 180 days from promulgation of the regulations effectively resets the compliance date in violation of the Formaldehyde Act’s mandatory expedient compliance deadline and the prohibition against stockpiling.
  2. EPA’s interpretation that it can designate the manufacture date beyond the 180 days limit for compliance with the emission standards is contrary to law and beyond the grant of authority bestowed upon it by Congress in the Formaldehyde Act.
  3. EPA’s interpretation creates inconsistency within the full text of the Formaldehyde Act, renders the 180-day compliance deadline superfluous, leads to the “absurd” result of permitting the perpetual delay of the effectiveness of the Formaldehyde Rule, and fails to satisfy the stated purpose of the Formaldehyde Act. 

The court concluded that the issue of whether EPA should extend the deadline for compliance with the emission standards of the Formaldehyde Rule was adequately before it for consideration. The court stayed the order vacating the Delay Rule until the parties address the implementation of the compliance guidelines and the court directs them to provide, by March 9, 2018, a joint proposed submission or simultaneous briefing to address the timing for lifting the stay and expeditious implementation of the court’s order. 

The ruling is one of several expected that will inform stakeholders on the scope of EPA’s authority under the Administrative Procedure Act (APA) and the underlying Act at issue, here the Formaldehyde Act, in undoing Obama-era regulations and the extent of Agency discretion in deciding whether and to what extent such rules can be unilaterally delayed or eliminated entirely.  The Trump Administration has in unprecedented ways sought to roll back rules under a host of laws, environmental and otherwise, in ways that detractors claim are illegal and contrary to the APA and other laws.  Here, the court emphasized the Formaldehyde Act’s “expeditious” emission compliance standards and reasoned that the repeated delays were simply inconsistent with Congress’ intent.

More information on the Formaldehyde Act under TSCA is available on our blog.


 
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By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) announced it is releasing a third alternative approach for assigning and applying unique identifiers (UID) to reconcile the competing requirements of Toxic Substances Control Act (TSCA) Section 14(g) for comment.  83 Fed. Reg. 5623.  EPA’s first and second alternative approaches were released for comment in its notice on May 8, 2017 (82 Fed. Reg. 21386).  Under amended TSCA, EPA is required to develop a system to assign a “unique identifier” whenever it approves a Confidential Business Information (CBI) claim for the specific chemical identity of a chemical substance, to apply this unique identifier to other information concerning the same substance, and to ensure that any non-confidential information received identifies the chemical substance using the unique identifier while the specific chemical identity of the chemical substance is protected from disclosure.

Under the third alternative approach, EPA would assign one UID per chemical substance.  EPA states that in most cases it would apply the UID to all non-confidential information concerning the same chemical substance from any company except in cases where doing so might reveal the identity of confidential substance.  In those cases, which EPA expects to be rare, EPA would not apply the UID to non-confidential documents if doing so would result in a linkage that undermines the CBI claim.  EPA reiterates that the basic criterion for application of the UID to submissions made by different submitters is that EPA’s act of applying the UID must not disclose to the public the confidential specific chemical identity that the UID was assigned to protect.

Comments are due by March 12, 2018.  More information on CBI under TSCA is available on our blog.  


 
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By Lynn L. Bergeson and Margaret R. Graham

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) issued the prepublication version of its long-anticipated fees rule under amended Toxic Substances Control Act (TSCA) Section 26(b) entitled User Fees for the Administration of the Toxic Substances Control Act.  EPA states that the proposed rule will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  

EPA’s notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, the Agency also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  

EPA states the proposed fees on certain chemical manufacturers, including importers, would go towards developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and information; reviewing Confidential Business Information (CBI); and making determinations regarding the safety of new chemicals before they enter the marketplace.

Comments on the proposed rule will be due 60 days after its publication in the Federal Register.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) will soon be available on our Regulatory Developments webpage.


 
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By Lynn L. Bergeson and Margaret R. Graham

On February 7, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to issue in the Federal Register a final rule on Voluntary Consensus Standards Update; Formaldehyde Emission Standards for Composite Wood Products that will revise the formaldehyde standards for composite wood products regulations.  The revision updates the incorporation by reference of multiple voluntary consensus standards originally published in the Toxic Substances Control Act (TSCA) Title VI formaldehyde emission standards for composite wood products final rule on December 12, 2016, that have been updated, superseded, or withdrawn, and provides a technical correction to allow panel producers to correlate their approved quality control test method to the ASTM E1333-14 test chamber, or, upon showing equivalence, the ASTM D6007-14 test chamber.  EPA withdrew its direct final rule to update voluntary consensus standards for composite wood products in December 2017 due to its receipt of adverse comment on the rule.  The final rule will be effective upon publication.

More information on composite wood products under TSCA is available on our blog.


 
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By Lynn L. Bergeson and Margaret R. Graham

On January 31, 2018, the U.S. Environmental Protection Agency (EPA) announced the release of its 2018 Annual Report on Risk Evaluations.  Pursuant to Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year. The plan is to include both risk evaluations that will be initiated and that will be completed, the resources necessary for completion, and the status and schedule for ongoing evaluations.  The 2018 annual plan identifies the next steps for the first ten chemical reviews currently underway and describes EPA’s work in 2018 to prepare for future risk evaluations.

EPA issued scoping documents on the first ten chemical reviews in June 2017.  The plan states that in early calendar year 2018, EPA will be making refinements to these scope documents in the form of “problem formulation documents” that will include additional elements such as conceptual models.  EPA will publish a notice in the Federal Register announcing the release of these problem formulation documents and will invite comments for 45 days.  

The plan also states that EPA will initiate prioritization for 40 chemicals (at least 20 Low-Priority and 20 High-Priority candidates) by the end of calendar year 2018.  By December 22, 2019, EPA plans to have designated 20 substances as Low-Priority and initiated risk evaluations on 20 High-Priority substances.  Further, EPA will be proposing the much-anticipated TSCA Fees Rule in early-mid fiscal year (FY) 2018, and anticipates issuing a final rule in late FY2018.

Information on EPA’s 2017 Annual Report is available in our blog item EPA Publishes 2017 Annual Report on Chemical Risk Evaluations.


 
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By Lynn L. Bergeson, Susan M. Kirsch, and Margaret R. Graham

On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt.  In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.”  In opening remarks, Senator Tom Carper (Ranking Member of the EPW Committee) (D-DE)) challenged Pruitt’s record on implementing TSCA reform, stating that EPA has not truly used the authority bestowed on it through TSCA to declare that products being sold on the market are safe, therefore, consumers do not have the confidence that they deserve and that Congress intended in passing TSCA.  Pruitt did not respond to this comment, and did not go on to address TSCA implementation in his brief opening remarks.  Instead, Pruitt devoted the bulk of his opening statement to highlighting specific areas where EPA’s environmental protection goals dovetail well with opportunities for economic growth.  These issues/economic opportunities included:  investment in infrastructure to eradicate lead from drinking water within a decade; advancing initiatives that incentivize private companies to take on clean-up projects at abandoned mines; and remediation activities at “Superfund” sites -- hazardous waste sites regulated under the  Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

Senator Jeff Merkley (D-OR) expressed concern that EPA’s chemical reviews under TSCA were only focusing on new “items” (chemicals) being made, but overlooking “legacy” chemicals already in the environment (e.g., asbestos).  Merkley cited a report that claimed that review of the ten chemicals on the priority list were being “slow-walked.”  In response, Pruitt stated “it is an absolute priority during [EPA’s] first year,” the three TSCA final rules were issued consistent with the implementation schedule in the first year, and the backlog of chemical reviews has been addressed through the addition of resources. 

Senator Kirsten Gillibrand (D-NY) expressed her concerns regarding the toxic levels of perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) that have been found throughout New York State, stating that EPA was not using its TSCA authority to regulate these chemicals, as the implementation final rules “ignored the public’s exposure to the past uses of chemicals called legacy uses” that could still have the potential to contaminate groundwater.  She also stated her concern that due to this oversight, EPA will not likely study the health risks of widespread exposure to chemicals such as PFOS/PFOS.  She requested of Pruitt to revise the TSCA implementation rules to address legacy issues, so that “all uses of a chemical, including legacy uses, are studied.”  Pruitt stated that as PFOA and PFOS have not been manufactured since early 2000, they are in fact legacy uses, and that EPA was “very much going to focus” on this issue.  Gillibrand appeared to be content with his answer, as she did not demand a further commitment from him.  In regards to the Hudson River, Gillibrand requested that data from the sediment sampling be integrated into EPA’s five year review plan regarding the effectiveness of dredging for removing polychlorinated biphenyl (PCB) from the Hudson River.  Pruitt stated that EPA was reviewing the samples currently and that there is more work to be done to get clarity on this issue.  Gillibrand requested Pruitt to personally review the final report to ensure that all issues have been addressed and Pruitt confirmed that he would.

Near the close of the hearing, Senator Carper further stated that EPA has failed to follow through on its proposed ban of three highly toxic chemicals that Congress gave it the authority to ban when it enacted TSCA reform:  specifically methylene chloride, tricholoroethylene (TCE), and methylpyrrolidone (NMP), and asked Pruitt to commit to using EPA’s authority to ban them within the next 30 days.  Pruitt responded that they are on the priority list and that he will confirm this with the agency (that they are priorities, not that they will be banned in 30 days).  EPA’s delay in finalizing the bans was among the failures cited in the Senate EPW Minority Staff report, released January 29, 2018, “Basically Backward:  How the Trump Administration is Erasing Decades of Air, Water and Land Protections and Jeopardizing Public Health.”

Several Senators indicated their intention to submit additional questions for the record.  Pruitt has until February 13, 2018, to submit written responses, which will be made available on the EPW Committee website.  The full hearing is available on the EPW Committee’s website.  


 
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By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On February 7, 2018, manufacturers that manufactured (including imported) chemicals for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, will be required to report to the U.S. Environmental Protection Agency (EPA) for the retrospective reporting period that began on August 11, 2017, per the Toxic Substances Control Act (TSCA) Inventory Notification (Active/Inactive) Requirements final rule that established a retrospective electronic notification of chemical substances on the TSCA Inventory.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.  Specific information on the upcoming reporting deadline and changes in the CDX system is available in our blog items EPA Offers Assistance to Manufacturers Reporting for the TSCA Inventory February 7, 2018, Deadline and EPA Updates eNOA Template in CDX System.


 
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