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, Charles M. Auer, Richard E. Engler, Ph.D., and Oscar Hernandez, Ph.D.

The U.S. Environmental Protection Agency’s (EPA) release of its Toxic Substances Control Act (TSCA) Section 5(a)(3)(C) determination for P-16-0510 represents a significant step in EPA’s implementation of the New Chemicals Program under new TSCA.  The substance is a polymer (a copolymer of ethylene glycol and propylene glycol end-capped with acrylamide groups).  It is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays, and other consumer products.

Notably, EPA’s determination document specifies the conditions of use that are intended, known, and reasonably foreseen.  EPA states that there are no known or reasonably foreseen conditions of use other than those intended by the submitter.  This may appear to be a controversial statement.  Based on EPA’s interpretation of “conditions of use,” it would not pass legal muster to speculate that “anybody could manufacture or use it for anything” and, hence, impose use restrictions to prevent purely speculative applications with no basis in fact or reality.  EPA has repeatedly stated that it would base what is reasonably foreseen on information, knowledge, or experience, not on any conceivable condition of use.

EPA identifies the new chemical’s potential health hazard endpoints based on the acrylate/acrylamide category.  The concerns are based on acrylamide itself and some low molecular acrylamide analogs and include mutagenicity, developmental toxicity, reproductive effects, neurotoxicity, and a “marginal potential” for oncogenicity.  This too may sound alarming.  The real question, however, is how toxic is the new chemical and are exposures expected to exceed a “safe” level. 

In this case, EPA specifically considers the low-molecular weight (LMW) components of the polymer (i.e., the “worst case”) in its assessment and identifies two analogs of the LMW components.  Both analogs have similar structural features (they are end-capped with acrylates), so both are expected to share the same mode of action, and have similar molecular weights as the LMW components of the premanufacture notification (PMN) substance.  EPA states that it also considered the toxicity of acrylamide in its assessment.  We note, however, that acrylamide is not a good analog because it is substantially lower molecular weight than the LMW components of the PMN substance.  Based on the identified analogs, EPA set a no observable adverse effect level (NOAEL) of 250 mg/kg/day for systemic toxicity based on a combined repeat dose/reproductive/developmental toxicity screening test (OECD 422).  This study tests for a chemical’s potential to cause toxicity and the primary endpoints of concern relevant to the category (developmental, reproductive, and neurotoxicity).  This NOAEL would put the substance in the low-to-moderate toxicity category.  Note that despite the nominally alarming set of health endpoints identified in EPA’s category assessment, the 422 study shows the analog is not especially toxic to mammals.  By way of contrast, EPA’s most recent Integrated Risk Information System (IRIS) assessment of acrylamide identified a NOAEL of 0.5 mg/kg-day.

EPA also identifies ecotoxicity concerns.  Using its predictive models, EPA predicts toxicity levels for both acute and chronic effects to aquatic species and sets concentrations of concern (CoC) at 425 ppb for acute exposures and 43 ppb for chronic exposures.  These levels put the substance in the “moderate” category for environmental hazard.

EPA then applies exposure modeling to predict exposures to workers, the general population, and consumers.  EPA found that predicted exposures are sufficiently below EPA’s concern level to not present an unreasonable risk to workers, the general population, or consumers.  EPA even found that at the “worst case” of 100 percent PMN substance, exposures would still be sufficiently below EPA’s concern level.  EPA also evaluated surface water concentrations and found that the estimated maximum acute and chronic concentrations did not exceed the CoCs.

Summary

EPA reviewed the PMN, reviewed likely and potential exposures to workers, the general population, consumers, and aquatic species, and did not identify any foreseeable conditions of use that would lead EPA to predict that unreasonable risk was likely. 

This is a marked and welcomed departure from previous TSCA Section 5(a)(3)(C) decisions. In nearly all cases in the past, EPA only made a not likely determination if it identified a low hazard for both health and ecological effects (“low/low” cases).  Absent a low/low finding, EPA seemingly believed that there could be some conditions of use that could contribute exposures that could exceed EPA’s concern levels. Based on our review, EPA did not explain how it differentiated between “any possible/foreseeable” and “reasonably foreseeable” conditions of use.  Instead, if EPA could imagine a set of circumstances that could elicit an exceedance, EPA was of the view that new TSCA precluded it from making a Section 5(a)(3)(C) finding. (While some stakeholders might applaud an approach based on concepts such as the European Union’s Precautionary Principle, this is not how new TSCA, or U.S. environmental legislation more generally, is structured.) 

In the case of P-16-0510, EPA more carefully applied new TSCA as written when it identified a low/moderate health concern and a moderate eco concern, and nevertheless took a reasonable approach grounded on the law to go beyond mere consideration of potential hazard and to interpret the “reasonably foreseen” conditions of use and assess unreasonable risk as new TSCA requires.  We support this more measured approach and believe it better meets the statutory intent and requirements. As we have written previously, in our view, a “not likely” finding is not limited to cases in which toxicity is so low that exceedances are unimaginable.  Rather, EPA must limit its consideration to those conditions of use that are reasonably likely to occur and must evaluate unreasonable risks, not merely hazard, and regulate to protect to the “extent necessary” to protect against such unreasonable risks. 

We applaud EPA’s more measured approach that likely indicates a maturation of its understanding of what is needed to meet a not likely determination. We urge EPA to articulate its thinking on what is and is not “reasonably foreseeable” and what PMN submitters can do to help EPA understand not only what is intended, but what might be reasonably foreseen to occur.


 
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By Lynn L. Bergeson

On August 7, 2018, EPA is expected to announce the extension of the comment period on the problem formulations for the risk evaluations for the first 10 chemicals under Toxic Substances Control Act (TSCA) Section 6.  The notice extends the comment period on the problem formulations and the document titled Application of Systematic Review of TSCA Risk Evaluations, an additional 21 days, until August 16, 2018.  Reportedly EPA received several requests to extend the deadline.


 
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By Jessie Nguyen and Lynn L. Bergeson

On August 1, 2018, the U.S. Senate Committee on Environment and Public Works (EPW Committee) held a hearing entitled “Examining EPA’s Agenda:  Protecting the Environment and Allowing America’s Economy to Grow.”  Testifying at the hearing was Andrew Wheeler, the U.S. Environmental Protection Agency’s (EPA) Acting Administrator.  Witness testimony and an archive of the hearing are available online.  The hearing was intended to provide Wheeler with the opportunity to present himself for the first time in front of the EPW Committee as the Acting Administrator, and to update the EPW Committee on EPA’s agenda since the resignation of Scott Pruitt, EPA’s former Administrator.  Wheeler’s testimony highlighted three main priorities for EPA moving forward:  (1) regulatory certainty between EPA and state/local governments; (2) improvement of programs within EPA; and (3) increased transparency in risk communication.

During the questioning, Wheeler informed the EPW Committee that the clean-up of the Chesapeake Bay and the prevention of future lead contamination are high priorities for the Agency.  When questioned by Senator John Boozman (R-AR) about EPA’s relationship with stakeholders, Wheeler stated that clear communication between EPA and its stakeholders is essential before implementing any regulatory action.  EPA is also committed to working with other government agencies to enhance their regulatory process.

Next, the Trump Administration’s decision to roll back auto fuel efficiency and emissions standards, as well as the partial revocation of California’s ability to set its own emissions standards, was met with strong objection from Democratic Senators.  Senator Edward Markey (D-MA) stated that the oil industry is “scared to death that $1 trillion will stay stranded in the pockets of consumers.  That’s why the Trump Administration is moving to roll back these standards.”  Wheeler stated his belief that the roll back in emissions standards has saved American consumers $500 billion dollars and 12,000 lives.  Moving forward, Wheeler wants to come up with a “50-states solution” for emissions standards to address the issue of air pollutants and reduce cross-state pollution.

The topic of chemicals was brought up by Senator Cory Booker (D-NJ) as he is concerned that EPA’s failure to consider all sources of exposure for risk assessment will pose an unreasonable risk to human health -- especially to vulnerable populations such as children, pregnant women, and the elderly.  Senator Booker urged EPA to ban trichloroethylene (TCE) on the applications for which proposed rules were issued and ban methylene chloride since they are known carcinogens with recognized health hazards.  Wheeler said EPA is moving forward with the assessment of these chemicals, but he declined to promise on a definitive timeframe.  Similarly, Senator Shelley Moore Capito (R-WV) urged EPA to release the toxicological report on perfluorooctane sulfonate (PFOS) and set a safety level for PFOS in soil and water.

In response to a question on clean energy by Senator Sheldon Whitehouse (D-RI), Wheeler stated he will not give preferential treatment for one source of energy over another; EPA’s role is to regulate pollutants, not to identify a preferential fuel source.  Other miscellaneous topics included Wheeler’s commitment to not abuse his hiring authority.  He expressed a willingness to notify the EPW Committee on EPA’s hiring process.  In response to Senator Tammy Duckworth’s (D-IL) request, EPA will also make a commitment to reduce lead exposure. 


 
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By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton

On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 37702.  EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of these 145 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination.  The rule will be effective on October 1, 2018.  Written adverse comment must be received by August 31, 2018.  If EPA receives timely written adverse comment on one or more of the SNURs, it will withdraw the relevant section(s) of the direct final rule.

Please see the full memorandum for more information on this rulemaking and a commentary that details a few of the differences specific to these SNURs.


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

On July 20, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit of EPA’s implementation of the OIG recommendations for the Presidential Green Chemistry Challenge Awards (PGCCA) Program.  The PGCCA Program is sponsored by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) to promote the environmental and economic benefits of developing and using green chemistry by recognizing industry innovations.  In 2015, OIG reported that award results submitted to the EPA’s Pollution Prevention (P2) Program from PGCCA recipients were not adequately supported or transparent.  In its audit, OIG found that EPA discontinued the use of unverified PGCCA results in EPA performance metrics, but “a lack of documented controls presents risk that these data may be used in the future.”

Please see the full memorandum for more information including a short history on performance metrics of the Green Chemistry Program.


 
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By Lynn L. Bergeson and Margaret R. Graham

On July 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment periods for all ten problem formulation documents and the systematic review approach document in Toxic Substances Control Act (TSCA) risk evaluations that were published on June 11, 2018, by 21 days;  comments on these documents are now due by August 16, 2018.  EPA states that although the comment period will end in 21 days (August 16, 2018), “EPA will try to consider any additional comments received after this date.  However, incorporation of late comments may not be included in the documents for peer review.  There will be an additional comment period following the publication of each of the draft risk evaluations.”

Links to the problem formulation dockets are available in our blog item “EPA Releases Problem Formulations Documents on First Ten Chemicals; Systematic Review Approach Document; and Asbestos SNUR” and a more detailed analysis is available in our memorandum “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety.”


 
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By Charles M. Auer, Oscar Hernandez, Ph.D., and Lynn L. Bergeson

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.  Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment.  Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to the Toxic Substances Control Act (TSCA).

The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA.  EPA describes alternative test methods and strategies as different descriptors that have a common goal.  The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard.  The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints. 

Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM).  The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.”

A much more detailed summary and analysis of this important issue is available in our memorandum.


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

Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018.  Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.

On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.”  EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance.  The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”).  EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance.  EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity.  More information on this guidance is available in our full memorandum


 
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By Kathleen M. Roberts, Jason E. Johnston, M.S., Sheryl Lindros Dolan, and Margaret R. Graham

On June 25, 2018, the U.S. Environmental Protection Agency (EPA) held a preparatory meeting for experts selected to serve as letter peer reviewers for EPA's Exposure and Use Assessment and Human Health and Environmental Hazard Summary for five persistent, bioaccumulative, and toxic (PBT) chemicals.  A list of those chemicals is available here.  Although the meeting was scheduled for four hours, it adjourned after only two hours, as there were only a few questions from peer reviewers and only two outside stakeholders providing oral comments.  Below are some highlights/takeaways from the meeting:

  • All five PBT chemicals being reviewed scored high for hazard;
  • Two PBT chemicals were pulled from EPA action under the Toxic Substances Control Act (TSCA) Section 6 because manufacturers requested risk evaluations for them prior to the September 19, 2016, deadline;
  • Four of the PBT chemicals scored high or moderate for exposure; one scored low (pentachlorothiophenol (PCTP));
  • For exposure assessment, EPA split up information as “core exposure data” or “supplemental exposure data”:  core exposure data would be environmental data, monitoring, biomonitoring, modeled concentrations, or modeled dose; and supplemental exposure data would be environmental fate, engineering data, or other information related to exposure information or pathways;
  • EPA identified exposure scenarios -- looking at source/use, environmental pathways, and receptors;
  • EPA did not conduct any new modeling on the chemicals but did use modeled data from published literature;
  • EPA did not conduct an exhaustive literature search, review, or assessment of hazard data, it used data readily available, as described in the Human Health and Environmental Hazard Summary; the EPA document “Supplemental Information for the Exposure and Use Assessment of Five Persistent, Bioaccumulative and Toxic Chemicals” outlines the literature search process used for exposure data; and
  • Exposure scenarios include both quantitative and qualitative information.

No written comments were submitted prior to the peer review webinar. Only three people signed up for oral comments, and one was not present online.  The two public commenters noted concerns regarding the likelihood of exposure, including the potential for accidental exposures; the lack of EPA focus on susceptible subpopulations; EPA’s intent not to address exposures that are already regulated under other EPA programs; and the need to assess the risk of bias.

Per the language in amended TSCA, EPA must issue risk management proposals to reduce exposures to the extent practicable by June 19, 2019.

Any public comments submitted by July 23, 2018, will be shared with peer reviewers. Comments submitted between July 23, 2018, and August 17, 2018, will be available to EPA for consideration.  All comments are due by August 17, 2018.  A recording of the webinar, slides, and other materials from the meeting will be posted in Docket EPA-HQ-OPPT-2018-0314.  There are currently six supporting documents posted:

Stay up-to-date on TSCA implementation issues via our Recent Regulatory Developments web page and our TSCAblog.


 
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By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton

On June 22, 2018, the U.S. Environmental Protection Agency published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury).  The final rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides).  EPA will use data from the 2018 reporting year for the 2020 mercury inventory.  The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019.  The final rule will be effective 60 days after publication in the Federal Register, which is scheduled for June 27, 2018

The reporting requirements include activities that are established TSCA terms, including manufacture, import, distribution in commerce, storage, and export.  EPA notes that the reporting requirements also apply to the otherwise intentional use of mercury in a manufacturing process.  Persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, are required to report amounts of mercury in pounds (lbs.) used in such activities during a designated reporting year.  Reporters must also identify specific mercury compounds, mercury-added products, manufacturing processes, and how mercury is used in manufacturing processes, as applicable, from preselected lists.  For certain activities, reporters must provide additional, contextual data.

The final reporting requirements do not apply to:  (1) persons who do not first manufacture, import, or otherwise intentionally use mercury; (2) persons who only generate, handle, or manage mercury-containing waste; (3) persons who only manufacture mercury as an impurity; and (4) persons engaged in activities involving mercury not with the purpose of obtaining an immediate or eventual commercial advantage.  Within the category of persons who must report, there are certain persons who are not required to provide specific data elements.  To avoid reporting that is unnecessary or duplicative, the final rule includes certain exemptions for persons who already report for mercury and mercury-added products to the TSCA Section 8(a) Chemical Data Reporting (CDR) rule and the Interstate Mercury Education and Reduction Clearinghouse (IMERC) Mercury-Added Products Database, respectively.

More detail is provided in our June 25, 2018, memorandum regarding the provisions of the final rule, including EPA’s rationale for fulfilling specific statutory provisions and terms.  While the final rule includes summaries of public comments received and EPA’s responses and determinations, EPA notes that some of these issues are discussed in greater detail in its Response to Comments.  EPA states that its Response to Comments will be available in Docket EPA-HQ-OPPT-2017-0421, although it is not there at this time.


 
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By Lynn L. Bergeson and Carla N. Hutton

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule.  As noted in our June 29, 2016, memorandum, “TSCA Reform:  EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA).  EPA lists the following milestones that it has completed at the two-year anniversary:

In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.”  Speakers will include:

  • Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
  • Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
  • Michael Gould, EH&S Committee Chairman, RadTech North America; and
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.

More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.


 
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By Lynn L. BergesonCharles M. Auer, and Carla N. Hutton

On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).”  EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to better move chemicals through the evaluation process.”  EPA incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the document into its guidance.  EPA also issued a “Response to Comments Received on Points to Consider Posted for Comment November 2017.”  EPA states that it expects that use of the guidance will result in “more robust submissions.”  EPA encourages companies to contact its new chemicals program to set up a pre-submission (or “pre-notice”) meeting before submitting their premanufacture notices (PMN).  According to EPA, the pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand EPA’s approach to reviewing new chemicals for potential risks early in the process.

More information will be available in our detailed analysis to be issued in a memorandum later today and posted to our Recent Regulatory Developments web page.


 
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By Lynn L. Bergeson and Margaret R. Graham

On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals.  Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified in EPA’s TSCA Work Plan for Chemical Assessments: 2014 update.  The selected chemicals are:

  • Decabromodiphenyl ethers (DECA);
  • Hexachlorobutadiene (HCBD);
  • Pentachlorothiophenol (PCTP);
  • Phenol, isopropylated, phosphate (3:1) (PIP3/ITPP); and
  • 2,4,6-Tris(tert-butyl) phenol (2, 4, 6 TRIS).

EPA prepared an Exposure and Use Assessment and a Human Health and Environmental Hazard Summary in response to the requirements under TSCA Section 6(h) to summarize conclusions of toxicity and whether there is likely exposure to these PBT chemicals and EPA organized letter peer reviews for the Exposure and Use Assessment and the Human Health and Environmental Hazard Summary.  The Federal Register notice announcing the meeting states that during the preparatory meeting, “the individual letter peer reviewers will have the opportunity to comment on and ask questions regarding the scope and clarity of the draft charge questions.”  EPA’s background papers, related supporting materials, and charge/questions for these letter peer reviews are now available in Docket No. EPA-HQ-OPPT-2018-0314 on www.regulations.gov

The meeting is scheduled for June 25, 2018, from 1:00 p.m. to 5:00 p.m. (EDT) and will be held via teleconference and webcast only.  Registration is available online.  Those requesting to provide oral comments (approximately five minutes) are asked to register by June 21, 2018.  Though the peer reviewers may not be able to consider fully written comments submitted after July 23, 2018, EPA will consider all comments submitted on or before August 17, 2018

More information, including the list of experts, is available on EPA’s TSCA Peer Review website.


 
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By Lynn L. Bergeson, Carla N. Hutton, and Jessie Nguyen

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to the Toxic Substances Control Act (TSCA):

  • Microorganisms:  General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions (RIN 2070-AJ65):  EPA promulgated a final rule under TSCA Section 5 to establish notification procedures for review of certain new microorganisms before they are introduced into commerce.  EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms to qualify for the exemption from full notification and reporting.  Based on EPA’s evaluation of these petitions, EPA states that it made a preliminary determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met, and issued a proposed rule.  EPA is developing a revised proposal that will address concerns raised by commenters, and is considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA Section 5(h)(4) exemption.  EPA intended to issue a notice of proposed rulemaking (NPRM) in May 2018;
  • Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate (PFAS) Chemical Substances; Significant New Use Rule (SNUR) (RIN 2070-AJ99):  EPA is developing a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances, and for perfluorooctanoic acid (PFOA) or its salts.  On January 21, 2015, EPA proposed to amend a SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses.  EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles.  In addition, EPA proposed to amend a SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets.  EPA intended to issue a supplemental NPRM in May 2018 following changes to TSCA brought about by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  EPA plans to issue a final rule in July 2019;
  • Procedural Rule:  Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the TSCA Inventory -- Amended TSCA Section 8(b)(4)(C) (RIN 2070-AK21):  EPA is developing a proposed rule to implement TSCA Section 8(b)(4)(C), which requires EPA to establish a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the active  TSCA Inventory.  EPA intends to publish an NPRM in January 2019 and a final rule in December 2019;
  • TSCA Chemical Data Reporting (CDR) Revisions (RIN 2070-AK33):  EPA will revise the reporting requirements to align better with new TSCA requirements.  EPA intends to issue an NPRM in September 2018 and a final rule in September 2019;
  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (RIN 2070-AJ94):  On July 28, 2016, EPA issued a rule proposing changes to the applicable Significant New Uses of Chemical Substances regulations to align EPA’s regulations, where possible, with the final revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standards.  EPA intends to issue a final rule in September 2018;
  • Certain Nonylphenols (NP) and Nonylphenol Ethoxylates (NPE); SNUR (RIN 2070-AJ96):  On October 1, 2014, EPA issued a proposed SNUR under TSCA Section 5(a)(2) for certain NPs and NPEs.  EPA intends to issue a final SNUR in December 2018;
  • Mercury; Reporting Requirements for the TSCA Mercury Inventory (RIN 2070-AK22):  On October 26, 2017, EPA issued a rule proposing reporting requirements under TSCA Section 8(b)(10)(D) for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where mercury is defined as “elemental mercury” and “a mercury compound.”  EPA intends to issue a final rule in June 2018; and
  • Service Fees for the Administration of TSCA (RIN 2070-AK27):  On February 26, 2018, EPA issued a rule proposing to implement TSCA Section 26(b)(1), which authorizes EPA to issue a rule to establish fees to defray the cost of administering Sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under Section 14 information on chemical substances.  EPA intends to issue a final rule in August 2018.

 
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By Lynn L. Bergeson and Carla N. Hutton

On June 6, 2018, the New York State Department of Environmental Conservation (NYSDEC) released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program.  The Disclosure Program is similar to the recently enacted California Cleaning Product Right to Know Act of 2017 which requires the disclosure of cleaning product ingredients by way of website or product label.  The Household Cleansing Product Information Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative lists of chemicals of concern on their websites.  New York states that it “will be the first state in the nation to require such disclosure and the State’s program goes beyond initiatives in other states by requiring the robust disclosure of byproducts and contaminants, as well as chemicals with the potential to trigger asthma in adults and children.”  NYSDEC has posted the Household Cleansing Product Information Disclosure Program Certification Form and Program Policy and a response to comments.

Our recent memorandum provides an in-depth review of important information from the Disclosure Program Certification Form and Program Policy, including covered products and definitions, information to be disclosed, the lists of chemicals of concern covered by the Program, and the effective dates.  With the first disclosures due July 1, 2019, manufacturers need to review the Program Policy and begin compiling information concerning the ingredients of their products.


 
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