TSCA Negotiated Rulemaking Committee Meetings — Inorganic Byproducts and CDR

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On August 18, 2017, EPA announced two upcoming meetings of the TSCA Chemical Data Reporting Negotiated Rulemaking Committee.  These meetings will be held on September 13 – 14 and October 25 – 26, 2017 in Washington, DC.  The public is invited to attend.

EPA issued a Federal Register Notice of its intent to form the committee December 16, 2016.  That notice explained that the objective of the Negotiated Rulemaking Committee will be to negotiate a proposed rule that would limit chemical data reporting requirements under section 8(a) of the amended TSCA for manufacturers of any inorganic byproduct chemical substances, when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.  It also explained that the Negotiated Rulemaking Committee will attempt to reach consensus on proposed regulatory language. The negotiation process is required by section 8(a)(6) of TSCA.

EPA believes the Chemical Data Reporting (CDR) rule is the only current reporting obligation under TSCA section 8(a) that is likely to affect the manufacturers of inorganic byproduct chemical substances.

The December 16, 2016 Federal Register Notice also explained that the Agency intends to conduct the negotiated rulemaking proceedings with particular attention to ensuring full and adequate representation of those interests that may be significantly affected by a rule providing for limiting CDR requirements for inorganic byproduct chemical substances.  EPA initially identified the following groups as representing interests likely to be significantly affected by a rule:

  • Aluminum Association
  • American Chemistry Council
  • American Coal Ash Association
  • Environmental Defense Fund
  • Institute of Scrap Recycling Industries
  • IPC—Association Connecting Electronics Industries
  • North American Metals Council
  • National Mining Association
  • S. Environmental Protection Agency
  • Utility Solid Waste Activities Group

Additional information about the Committee, including information about attending Committee meetings and meeting agendas, can be found on the Committee webpage.

 

EPA Releases Working Guidance for the Nanoscale Material Reporting Rule

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On August 14, 2017, EPA released the Working Guidance for the Nanoscale Material Reporting Rule.  The Working Guidance considerably narrowed the scope of “reportable chemical substance” from the draft Guidance.  EPA considers the Guidance a “working” document because it intends to update the Guidance based on questions the Agency receives.

The Working Guidance also discusses other aspects of what makes a chemical a “reportable chemical substance” and a number of other issues.  It is divided into the following sections:

  • What Chemicals are Reportable?
  • Who is Required to Report?
  • What Information is to be Reported?
  • When is Reporting Required?
  • General Questions.

The most helpful information is found under “What Chemicals are Reportable?” and “Who is Required to Report?”

What Chemicals are Reportable.  A reportable chemical substance is one that it solid at 25º C, 1 – 100 nanometers in size in at least one dimension, and intentionally manufactured or processed to exhibit unique or novel properties because of its size.  The draft Guidance had raised a number of unanswered questions regarding what comprised unique and novel properties.

In the Working Guidance, EPA explicitly states that “size is not considered to be a unique and novel property.”  The Working Guidance differentiates between unique and novel properties and enhanced or continuously scaling properties.  The later are those which do not intrinsically change on the nanoscale and instead scale proportionately with size.  Chemicals that have different functionality at the nanoscale than the form greater than 100 nanometers would be considered substances demonstrating unique and novel properties.

Additional points about “reportable chemical substances” include discussion of discrete chemical substances and coatings.  The Working Guidance notes that some nanoscale materials are engineered to give all the particles a certain morphology or shape.  The change in shape needs to be a specifically engineered change in the shape of particles to be a discrete form of a reportable chemical substances.  EPA explains that coating a nanoscale material results in a nanoscale material with different properties; in other words, by coating a nanoscale material, one has created a reportable chemical substance.

Who is Required to Report.  According to the Working Guidance, each manufacturer and processor in the supply chain must report on the reportable chemical substance.  EPA notes that processors should document the steps they took to determine whether reporting is required.  If processors do not know about specific properties that would allow them to know if they are processing a chemical substance subject to the rule, EPA believes that it would be within the reasonably ascertainable standard to ask their suppliers.

NGOs Challenge Risk Evaluation and Prioritization Rules

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Environmental Defense Fund (EDF), Safer Chemicals Healthy Families, and the Alliance of Nurses for Healthy Environments (ANHE) have filed suit for review of EPA’s Risk Evaluation and Prioritization Rules promulgated under the amended Toxic Substances Control Act (TSCA).  Both rules were required by Section 6 of the amended statute.  The final rules were released by EPA on June 22, 2017.  The Safer Chemicals Healthy Families petitions challenge the Risk Evaluation and Prioritization Rules as arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; in excess of statutory jurisdiction, authority, or limitations; and without observance of procedure required by law.

EDF filed suit on August 11, 2017 in the U.S. Court of Appeals for the Second Circuit; ANHE et al filed suit on August 11, 2017 in the U.S. Court of Appeals for the Fourth Circuit; and Safer Chemicals Healthy Families et al filed suit on August 10, 2017 in the U.S. Court of Appeals for the Ninth Circuit.  Safer Chemicals Health Families was joined on its petition by a number of groups including Environmental Working Group, Union of Concerned Scientists and AFL-CIO.  ANHE was joined on its petition by the Natural Resources Defense Council (NRDC).  The NGOs did not file a Motion for Stay to prevent EPA from moving forward in implementing the Risk Evaluation and Prioritization Rules while the petitions are under review.

Additional insight into the petitioners’ concerns can be found in their statements regarding the final rules and the litigation.  EDF has said that it believes the final risk evaluation rule improperly narrows conditions of use by not including all conditions of use in the risk evaluation.  NRDC expressed concern that the risk evaluation rule introduces loopholes that could lead to incomplete analysis, which could lead EPA to conclude that a chemical doesn’t pose a health or environmental risk when it actually does.  Regarding the prioritization rule, EDF asserts that the final rule describes an information-gathering process that seeks to minimize and undermine EPA’s use of the new testing authorities available to the agency under section 4.

EPA has not commented on the litigation.

CBI Claims under the Amended TSCA

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EPA recently notified many companies that CBI substantiation statements are due September 19, 2017.  This was a surprise to those unfamiliar with the CBI substantiation requirements imposed by the Lautenberg amendments to TSCA and EPA’s Statement of Interpretation regarding these provisions.  The Statement of Interpretation was issued in the Federal Register January, 19, 2017.

The Lautenberg amendments require upfront substantiation of CBI claims.  EPA data systems were not equipped to accept substantiation statements when the statute was first enacted.  CBI claims made in the months between Lautenberg’s enactment and EPA updating its systems must now be substantiated.  At issue are CBI claims made from June 22, 2016 to March 20, 2017.

The Agency has given companies until September 19, 2017 to substantiate claims made from June 22, 2016 to March 20, 2017.  For CBI submissions made on or after March 21, 2017, all claims must be substantiated at the time the assertion is made to EPA – that is at the time the information claimed as CBI is submitted to EPA.  Where there is no substantiation for a CBI claim, EPA is authorized to make the information public.

Under the amended statute, CBI substantiation must address the following:

  • Identify measures the company has taken to protect the confidentiality of the information,
  • Explain how disclosure of the information would harm to the company’s competitive position, and
  • Determine whether or not the information must be disclosed under any other Federal law;

Some categories of information are generally not subject to substantiation requirements (§14(c)(2)) (e.g., specific information describing the processes used in manufacture or processing, marketing and sales information).  Most information from health and safety studies is classified as “information not protected from disclosure” (§14(b)).

EPA provided some helpful guidance on developing CBI substantiation statements in a July 13, 2017 webinar.  In addition, the has developed substantiation templates that may be used as a starting point in preparing CBI substantiations.  In the templates, the EPA asks questions “to elicit facts that will help the Agency understand the basis for the submitter’s belief that a particular data element claimed as CBI is in fact entitled to this status.”  Detailed responses are necessary to demonstrate the following points:

  • The company’s efforts to protect the confidentiality of the information,
  • How disclosure of the information would harm to the company’s competitive position, and
  • That the information claimed as confidential does not appear in any public documents.

EPA has also developed a webpage to address these issues.  Included are lists of CDR and PMN data elements exempt from CBI substantiation under TSCA section 14(c)(2).

It is critical to be very detailed when developing substantiation statements.  Companies get only one chance to articulate the facts that support their CBI claims.  EPA procedures for reviewing CBI substantiation provide no opportunity for companies to revise or amend the statements.  The only avenue for appeal, when claims are denied, is to file a petition for review in federal district court pursuant to TSCA Section 14(g)(2)(D).  In such cases, the court’s review is likely to be limited to the record that was created for the Agency’s review, and additional legal or factual arguments beyond those presented to EPA are unlikely to be allowed.  To ensure that substantiation statements will withstand EPA’s determination process, we encourage companies to seek legal counsel.

EPA Issues Three Final Rules under New TSCA

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On June 22, 2017, the U.S. Environmental Protection Agency (EPA) released pre-publication Federal Register notices of the final framework actions under the new Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The final rules include:

  • The Inventory Reset Rule (AKA the Active-Inactive Rule), which requires industry to report chemicals manufactured, imported, or processed in the U.S. over the past ten years;
  • The Prioritization Process Rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which risk evaluation is not warranted at this time; and
  • The Risk Evaluation Process Rule, which establishes EPA’s process for evaluating High-Priority chemicals to determine whether or not they present an unreasonable risk to health or the environment.

EPA also published pre-publication notices concerning the scopes of the risk evaluations to be conducted for the first ten chemical substances under new TSCA, and a guidance document to assist interested persons in developing and submitting draft risk evaluations.

EPA Grants First ‘Conditional’ Approval Under TSCA Reform

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EPA recently approved a new chemical additive subject to the conditions of the polymer exemption criteria.  The Agency found that the chemical substance is “not likely to present an unreasonable risk” under TSCA (5(a)(3)(C)), so long as it meets the requirements of the polymer exemption as described under 40 CFR §723.250(e)(1).  Specifically the Agency found that the substance presents both a low human hazards and a low environmental hazard.  The requirement that “the chemical must be manufactured such that it meets the polymer exemption criteria” gives little insight into restrictions that EPA might impose on future conditional approvals.

EPA’s Determination for Premanufacture Notice explains that although the agency estimates that the new chemical substance will be very persistent, it is unlikely that the chemical substance would present an unreasonable risk, given that it has low potential for bioaccumulation, low human health hazard, and low environmental hazard.  The Determination’s discussion of potential exposures is particularly interesting.  The Agency explained that, although the exposure to a new chemical substance is potentially relevant to whether a new chemical substance is likely to present unreasonable risks, EPA did not estimate the exposure.  The Agency elected not to estimate exposure because the substance present low health and environmental hazard.  The Determination concludes that, “Due to low hazard, EPA believes that this chemical substance would be unlikely to present an unreasonable risk even if exposures were high.”

The name of the substance was claimed confidential business information, as was the manufacturers name. The generic substance name is 2–alkenoic acid, 2–alkyl–, alkyl ester, polymer with 2–alkyl 2–propenoate and a-(2–alkyl-1-oxo-2-alken-1-yl-[iquest]-alkoxypoly(oxy-1,2-alkanediyl), ester with a–2–alken–1–yl–[iquest]–hydroxypoly(oxy–1,2–alkanediyl).

The approval, announced online on May 12, 2017, was the first time EPA has approved a new chemical with a condition since the Toxic Substances Control Act was amended in June 2016.

EPA Reopens Consultation on TSCA Small Manufacturer and Small Processor Definition

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The EPA reopened its consultation with the public regarding the definition of “small manufacturer” and “small processor” under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA).

TSCA, as amended, requires EPA to review the size standards for small manufacturers and processors, which are currently used in connection with reporting regulations under TSCA Section 8(a). EPA preliminary decided that a revision in the size standards was warranted, but it wanted the public’s input as well. As such, EPA requested public comment on whether a revision of the current size standard definitions is necessary. It also requested a consultation with the Small Business Association to review the definition.

The comment period ended in January, but EPA is now accepting further comment on this issue until May 24, 2017.

Petition for Toxicity and Exposure Testing on Flame Retardants Denied

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On April 12, 2017, EPA published a notice in the Federal Register denying a TSCA section 21 petition regarding a group of flame retardants.  EPA explained that the petition did not demonstrate that there was insufficient data on these chemicals, and therefore the EPA found that the testing requested was not necessary.   The petition was submitted by Earthjustice, Natural Resources Defense Council, Toxic-Free Future, Safer Chemicals, Health Families, BlueGreen Alliance, and Environmental Health Strategy Center (“Earthjustice Petition”).

Under TSCA section 21, any person can petition EPA to initiate a rulemaking for the issuance, amendment, or repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA section 4 or 5(e) or (f).  The Earthjustice petition asked EPA to issue an order under section 4, requiring toxicity and exposure tests testing on particular flame retardants.  The flame retardants at issue are chlorinated phosphate esters (“CPE”).  The CPE Cluster is comprised of

  • tris(2-chloroethyl) phosphate ((“TCEP”) (CAS No. 115-96-8),
  • 2-propanol, 1-chloro-, phosphate (“TCCP”) (CAS No. 13674-84-5), and
  • 2-propanol, 1,3- dichloro, phosphate (“TDCPP”) (CAS No 13674-87-8).

These substances had previously been evaluated during EPA’s TSCA Work Plan Chemical Problem Formulation and Initial Assessment.  Millions of pounds of the substances are manufactured and imported annually.

The Federal Register notice explained that EPA must make several findings in order to issue a rule or order to require testing under section 4.  EPA must find that information and experience are insufficient to reasonably determine or predict the effects of a chemical substance on health or the environment and that testing is necessary to develop the missing information.  EPA must also find that the chemical substance may present an unreasonable risk of injury under section 4.  EPA did find that the manufacture, distribution in commerce, processing, use, or disposal of the CPE Cluster chemicals may present an unreasonable risk of injury to health or the environment.  However, EPA stated that the petitioners failed to demonstrate that the information and experience available to EPA are insufficient to reasonably determine or predict the effects on health or the environment from “manufacture, distribution in commerce, processing, use, or disposal” (or any combination of such activities) of the CPE Cluster chemicals, and therefore the Agency found that the testing requested by the petitioners is unnecessary.

In March, EPA denied a section 21 petition by Earthjustice and others to require additional testing on the flame retardant tetrabromobisphenol A (CAS No. 79-94-7).

Irene Hantman to present at American Chemical Society 253rd National Meeting in San Francisco April 4

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The symposium is titled, “Recent Developments in TSCA Regulation — New Requirements for Chemicals in Commerce.” Ms. Hantman will be presenting with:

  • Maria Doa, Director, Chemical Control Division, Office of Chemical Safety and Pollution Prevention, EPA
  • David Liu, Principal Ramboll Environ
  • Keith Matthews, Counsel, Wiley Rein LLP

The symposium will include an overview of TSCA and the Lautenberg Amendments, discuss regulatory updates from EPA including changes to how the Agency evaluates new chemicals, and discuss implications for chemicals in commerce such as changes to CBI protections and the Nanomaterials Reporting Rule. The program abstract is provided below.

The June 22, 2016 enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act effectuated a sea change in U.S. chemicals regulatory policy and imposed many new requirements on EPA and the manufacturers, importers, and processors of chemical substances. Some requirements took effect the moment President Obama signed the Act; other changes will be implemented over the next few years. Lautenberg mandates that the Agency issue a number of new rules by June 2017. To meet this schedule, EPA will be taking and responding to comments on its proposals during the spring of 2017. Proposed rules will affect the identification of chemicals currently in commerce through a TSCA “Inventory Reset,” and how EPA assesses the risks presented by these chemicals. The Inventory Reset process could have significant impacts on a company’s ability to continue routine manufacturing activities (for example, substances classified as inactive will not be allowed in commerce, or there may be questions about the actual identity of compounds now in commerce). Importantly, the final rules implementing the Prioritization and Risk Assessment processes will determine the processes and criteria that EPA will use to identify high priority chemicals for risk evaluation, how it will evaluate the risks presented by these chemicals and the amount of flexibility that EPA will allow in these processes. In addition, the Agency will revisit the Confidential Business Information (CBI) claims on chemicals presently in commerce, including claims that withhold the actual identity of chemicals. Submitters will be required to substantiate past claims to continue receiving CBI protections.

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For a copy of the presentations contact Ms. Hantman at ihantman@verdantlaw.com.

Processors and Downstream Users Comment on the Inventory Reset Proposed Rule, Asking for Clarity

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On January 13, 2017, the EPA published a proposed rule to reset the TSCA Inventory into separate lists of “active” and “inactive” substances (i.e., inventory reset). The proposal details notification requirements and establishes exemptions and procedures for handling confidentiality claims. Properly notified substances would be designated by EPA as “active,” whereas substances without a valid notification would be designated as “inactive.”

Once designated, “inactive” substances could not properly be manufactured, imported, or processed for a non-exempt commercial purpose under TSCA. For inactive substances, EPA proposed “forward-looking” procedures for notifying inactive substances if and when non-exempt manufacture, import, or processing would resume in the future. Properly notified substances would be converted by EPA to “active” substances.

Many comments to the proposed rule were received from interested parties, including coalitions and trade associations – examples are provided below.

A downstream user coalition has questioned the proposed requirement under the TSCA inventory reset proposed rule that a processor of an inactive substance submit notification to the EPA prior to its use. The Chemical User Coalition (CUC), a cross-industry group of nine major companies, including Intel, Boeing, Honda and Procter & Gamble, said in its comments that the inventory reset provisions should only be relevant to reporting, and a failure to adhere to the notification deadline should constitute a reporting violation, not affect a company’s ability to process substances on the inventory.

IPC, the Association Connecting Electronics Industries, in its comments requested clarification of the term “processors” stating that the definition currently in place is “overly simple and prone to misinterpretation.” Specifically, IPC requested that EPA clarify that processing does not include assembling parts into articles, when it does not involve the preparation of a chemical substance or mixture.

Others pointed out that because processors are not required to report pre-manufacture notices or under the Chemical Data Reporting rule, that many would be wholly unfamiliar with the EPA’s CDX reporting system.

The comment period on the inventory rest proposed rule ended March 14, 2017.