By Charles M. Auer and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization. The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions. OPPT’s other functions are proposed to be distributed into a mission operations division and a division that sweeps together chemical right-to-know, economics, information reporting, and the Safer Choice/Design for the Environment (DfE) program. In an internal memo, OPPT Director Jeffery Morris, Ph.D., noting the thoughtful and insightful staff comments received on the earlier proposed reorganization, provides a two-week internal commenting period for the new proposal ending on May 9, 2018.
How to organize OPPT has been a perpetual conundrum with shifting “best approaches” over time. From our perspective, merging the existing chemicals function of the Chemical Control Division (CCD) with those of the National Program Chemicals Division (NPCD) into an Existing Chemicals Management Division makes sense. The existing NPCD branches that cover legacy chemical issues (e.g., lead, polychlorinated biphenyls (PCB), mercury, and asbestos) will presumably become risk management branches tasked with overseeing risk management activities for those chemicals under the amended Toxic Substances Control Act (TSCA or new TSCA). The other “first ten” risk evaluation chemicals that are currently being managed by the existing chemicals staff in CCD will become other risk management branches in the new structure. Creating a separate New Chemicals Management Division also makes sense in light of the challenges encountered by the office in its early implementation of Section 5 under new TSCA. Such a division will ensure a tight management focus on new chemicals issues without the need to also juggle complex existing chemicals issues. While this could present concerns regarding divergent decisions and policies between the two divisions, this seems to be less of an issue since the requirements in Sections 5 and 6 differ so much.
More information and commentary on this reorganization is available in our memorandum.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available. For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:
- Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
- Notices of Commencement received by EPA since June 21, 2006; and
- Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.
EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule. EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018. According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date. Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent. The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.
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 the key phrase TSCA Inventory and on our TSCA Reform News & Information web page. More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.” Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances. EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations -- Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada. EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs. The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada. According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements. The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself. The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.
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:
- 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);
- 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
- 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.
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.
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:
- 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.
- 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.
- 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.
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.
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.
By Charles M. Auer and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency (EPA) has updated its eNOA upload template that was initially released in 2017 to assist filers with the Central Data Exchange (CDX) system. The eNOA, or electronic Notice of Activity (NOA) Form, is used for retrospective reporting under the amended Toxic Substances Control Act’s (TSCA) Inventory notification requirements. The eNOA template, available for download from within the eNOA system on CDX, assists users to upload many substance identities in a batch. The template file is a comma separated value (CSV) file, CSV-NAA.csv, that is readable by most spreadsheet and database programs. The change means that if submitters attempt to use the old template, the CSV file will not upload properly and will generate errors in CDX.
The template was updated by adding a new field name. The new field name that will be added to the CSV file is “Isjoint,” and the field explanation is “NOA is joint with another submitter;” which permits filers to upload and start multiple joint submissions in a batch. The field names required, along with their field explanations, are:
- Isjoint: NOA is joint with another submitter.
- CASRN: CASRN with our without dashes; after upload, dashes will be present. Must be “TRUE” or “FALSE”;
- Accession Number: Accession number for substances listed on the confidential portion of the Inventory;
- Chemical Cbi: Submitter seeking to maintain CBI claim for substance identity. Must be “TRUE” or “FALSE”;
- Submitter Cbi: Submitter claiming CBI for submitter identity. Must be “TRUE” or “FALSE”;
- Company Details Cbi: Submitter claiming CBI for submitting company details. Must be “TRUE” or “FALSE”;
- Technical [Contact] Cbi: Submitter claiming CBI for technical contact identity. NB: “Contanct” is misspelled in the template. Must be “TRUE” or “FALSE”;
- Substantiation CBI: Submitter claiming CBI for substantiation statement(s). Must be “TRUE” or “FALSE”; and
- ShowCbiQuestions: Set to TRUE to substantiate CBI claims. This is required for submitter, company, and technical contact claims. Must be “TRUE” or “FALSE.”
By Lynn L. Bergeson
Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, "Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018," is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.
Happy New Year and enjoy reading our predictions!