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  The Working Guidance considerably narrowed the scope of “reportable chemical substance” from the draft Guidance.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  The draft Guidance had raised a number of unanswered questions regarding what comprised unique and novel properties.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.

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).

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.

Implementing the 2016 TSCA Amendments – Progress & Prognosis

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Verdant Attorney Irene Hantman will speak on Wednesday, February 22 at a panel discussion among experts on implementing the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA). The program includes a panel of legal experts, current and former EPA officials, and representatives from environmental NGOs and trade groups. The panel will discuss topics including:

  • The potential effects of the change in Administration
  • Congress’ oversight role
  • Regulatory actions already taken by EPA
  • Regulatory actions required during 2017

The program includes an informal brown bag lunch for in-person participants in Washington, D.C., as well as dial-in participation. If attending in person, please RSVP to Gina Dean at gina.dean@apks.com; teleconference information is forthcoming. This event is sponsored by the Pesticide, Chemical Regulation, and Right-to-Know Committee of the ABA Section of Environment, Energy, and Resources (SEER), with co-sponsorship by the Environmental Law Institute and SEER’s Special Committee on Congressional Relations, and hosted by Arnold & Porter Kaye Scholer LLP.

Please see the announcement [PDF] for more details.

GENERAL INFORMATION:

Location: Arnold & Porter LLP, 601 Massachusetts Avenue, NW, Washington, DC 20001

Arrival Time: 11:45 am; plan to arrive in advance to check in and pass through security; the dialogue will begin promptly at noon and will conclude at 2:00 pm.

Moderator: Larry Culleen, Partner, Arnold & Porter Kaye Scholer LLP

Panelists:

  • Jim Jones, Former Assistant Administrator, US EPA [invited]
  • Wendy Cleland-Hamnet, Office Director, Office of Pollution Prevention & Toxics, US EPA
  • Mike Walls, VP Regulatory & Technical Affairs, American Chemistry Council [invited]
  • Richard Denison, Lead Scientist, Environmental Defense Fund
  • Ernie Rosenberg, President & CEO, American Cleaning Institute
  • Lynn Bergenson, Managing Partner, Bergeson & Campbell
  • Martha Marrapese, Partner, Keller & Heckman
  • Irene Hantman; Verdant Law

 

The Trump Administration’s regulatory freeze and its effects on TSCA.

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On January 20, the new White House Chief of Staff Reince Priebus released a memorandum to agency and department heads announcing a freeze on new or pending regulations. The agencies and departments are asked to not send any regulation to the Office of the Federal Register until a Presidential appointee/designate reviews and approves it. The Office of Management and Budget (OMB) Director can make exceptions to the freeze for “emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters, or otherwise.” The freeze is similar to one put in place by President Obama upon his inauguration in 2009.

In addition, the White House requested the withdrawal of submissions to the Federal Register that have not yet been published. The memo also asks for the temporary postponement of rules that have already been published but have not yet taken effect. The effective date of those rules would be postponed “for 60 days from the date of this memorandum …for the purpose of reviewing questions of fact, law, and policy they raise.” Both the withdrawn and postponed rules would be subject to the same exceptions for emergencies and urgent circumstances as for new rules. Agency and department heads are instructed to consider proposing for notice and comment further delays beyond the 60-day period, or further notice-and-comment rulemaking.

The memo specifically excludes “any regulations subject to statutory or judicial deadlines,” and asks that such exclusions be identified to the OMB Director. Agency and department heads are also asked to notify the OMB Director of any regulations that should be excluded from the freeze because they “affect critical health, safety, financial, or national security matters, or for some other reason.”

As we have discussed on this blog, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which modernizes the Toxic Substances Control Act (TSCA), requires that EPA promulgate a variety of implementing regulations. EPA has already proposed and finalized several of these implementing rules in recent months. Most of these actions should be excluded from the announced regulatory freeze, as they are subject to deadlines specified in the Lautenberg Act. However, while EPA had planned to develop a proposed rule on new fees by mid-December, that rule has yet to be released and is not subject to a statutory deadline. EPA had set finalizing the fees rule as a goal for mid-June 2017, but the final rule is also not required by statute, although the agency’s First Year Implementation Plan notes that
“authority to require fees will be needed ASAP.”

The regulatory freeze seems likely to affect the nanoscale reporting and recordkeeping rule which was finalized earlier this month. Although that rule’s effective date is not until May 12, 2017, EPA may consider delaying the effective date or re-opening the rulemaking process to review questions of fact, law, or policy.

EPA Issues Proposed Rule on TSCA Inventory “Reset”

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According to the EPA, there are currently over 85,000 chemicals on EPA’s Toxic Substances Control Act (TSCA) Chemical Substance Inventory (Inventory), many of which are no longer actively produced. 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). EPA is proposing to require use of the Agency’s electronic reporting portal, Central Data Exchange (CDX), for notification under this rule. The proposal details notification requirements and establishes exemptions and procedures for handling confidentiality claims.

The notification, to be entered into CDX no later than 180 days after the final rule is published, is retrospective in nature and is required for substances listed on the Inventory and that were manufactured or imported into the U.S. for non-exempt commercial purposes in the last ten years (between June 21, 2006 and June 21, 2016). Notifications for substances that were “processed” during this period would not be required, however, the proposal allows processors to report no later than 360 days after the final rule is published.

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. Thus, EPA also is proposing “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.

TSCA Section 8 requires EPA to compile an “interim list” of active substances before promulgation of the final rule. The proposed rule would not require manufacturers to report chemical substances that are on the “interim list.” Indeed, in the proposal, manufacturers and processors of chemical substances on the non-confidential portion of the Inventory would be exempt from reporting if the manufacture of that chemical substance was already reported (by any party) in response to 2012 or 2016 Chemical Data Reporting (CDR).

Comments on the proposal must be received by March 14, 2017.