This quarterly newsletter provides essential updates onlitigation, regulatory, legislative and other notable developmentsinvolving chemicals of concern to business. Our primary focuscontinues to be matters affecting chemical substances which are thesubject of regulatory activity or scrutiny by various federal andstate government agencies and potential litigants. This includesemerging contaminants, including per- and polyfluoroalkylsubstances (PFAS), as well as substances identified by theEnvironmental Protection Agency (EPA or the Agency) under the 2016amendments to the Toxic Substances Control Act (TSCA) forprioritization, risk evaluation, or regulation.
On December 28, 2021, EPA announced that it had granted a TSCASection 21 petition requesting that the Agency order health andenvironmental effects testing for 54 PFAS that the petitioners saidwere manufactured at a facility in NorthCarolina.1EPA previously denied the petitionin January 2021, but agreed to reconsider the denial in September2021. In its December 2021 letter granting the petition, EPA saidit "generally expects to take some immediate actions and todefer certain other actions pending the development of additionalinformation that will inform future decision-making." EPAstated that most of the chemicals identified in the petition werecovered by categories included in the Agency's National PFASTesting Strategy released in October 2021. In particularly, EPAsaid the Agency's first test orders pursuant to the TestingStrategy would cover 30 of the 54 PFAS and that subsequent testingmight cover nine of the 54 PFAS. EPA said it had decided it was notappropriate to require development of information on the remaining15 PFAS because they did not fit the definition of PFAS used in theTesting Strategy, but the Agency also said it had determined therewas "robust data" on some of them and that the Agencywould be conducting "more in-depth analyses of the existingdata." EPA's response also described EPA's plans withrespect to mixtures studies and human studies. In addition, theletter explained EPA's conclusion that a "narrowsubset" of the petitioners' requests fell outside TSCASection 21 and/or EPA's statutory authority. On January 27,2022, the petitioners and EPA filed a stipulation in the federaldistrict court for the Northern District of California, where thepetitioners' lawsuit challenging the January 2021 denial waspending.2The petitioners contended thatEPA's December 2021 response had in fact rejected"virtually all" of their requests. They therefore soughtto amend their complaint. After the court granted this request, thepetitioners filed an amended complaint on February 1, alleging thatEPA's response to their petition failed to require testing on47 of the 54 PFAS and provided no assurance that all requestedstudies would be conducted the remaining seven PFAS. Thepetitioners also alleged that EPA's response failed to addressrequests for certain studies and rejected other requests fortesting, monitoring, and development of analytical standards andmethods. On March 3, EPA filed its motion to transfer the case tothe Eastern District of North Carolina, noting that all of theplaintiffs are located in the district or have offices there, andthat the facility from which plaintiffs allege the discharges ofPFAS occurred also is located in that district.
On January 20, 2022, three plaintiffs-National PFASContamination Coalition, Sierra Club, and Union of ConcernedScientists-filed a lawsuit against EPA asserting that theAgency's rules adding PFAS to the Toxics Release Inventory(TRI) chemical list violated the statute that required theiraddition, as well as the Emergency Planning and CommunityRight-to-Know Act (EPCRA) and the Administrative Procedure Act(APA).3The plaintiffs alleged that EPAviolated the National Defense Authorization Act for Fiscal Year2020 (NDAA), which mandated the addition of the PFAS to the TRIlist, by making the PFAS reporting obligations subject toexemptions in the EPCRA regulations for substances present inmixtures at de minimis concentrations and for facilitiesthat qualify for an "alternative threshold" because theycertify that reportable releases and disposals were 500 pounds orless combined. The plaintiffs contended that because the NDAAestablished a reporting threshold of 100 pounds for the PFAS,Congress did not intend for the EPCRA exemptions to apply since theexemptions generally do not apply to other chemicals with 100-poundthresholds. The plaintiffs also asserted that application of theexemptions in the PFAS listing rules violated EPCRA because theexemptions themselves-which were established in 1988 and1994-exceeded EPA's authority under EPCRA. In addition, theplaintiffs contended that the PFAS listing rules were arbitrary andcapricious because EPA premised the exemptions "on a view thatrelatively low concentrations or levels of manufacture, processing,use, and/or release will not present danger and do not need to bepublicly disclosed, despite the known fact that PFAS are toxic atvery low levels of exposure." Alternatively, the plaintiffsasserted that if EPA had discretion to apply the exemptions in thePFAS listing rules, the Agency violated APA procedural requirementsby issuing the final rules without providing notice and anopportunity for public comment. On March 3, EPA announced that itplanned to propose a rule in summer 2022 to make PFAS ineligiblefor the de minimis exemption. EPA said the proposal"would also make unavailable the de minimis exemption withregard to providing supplier notifications to downstream TRIfacilities for PFAS and persistent, bioaccumulative, and toxicchemicals."
On January 4, 2022, Public Employees for EnvironmentalResponsibility (PEER) filed a Freedom of Information Act (FOIA)lawsuit to compel EPA to disclose documents related to submissionsthe Agency received since January 2019 pursuant to TSCA Section8(e)'s requirement that manufacturers, distributors, andprocessors of chemical substances and mixtures submit informationthey obtain that "reasonably supports the conclusion"that a chemical substance of mixture "presents a substantialrisk of injury to health or theenvironment."4PEER alleged that its FOIArequest was prompted by a November 2021 article in TheIntercept, which reported that EPA had received 1,240 Section8(e) submissions since January 2019 but had made only one of thereports available to the public. PEER's FOIA request asked forcopies of all Section 8(e) submissions since January 2019 as wellas documents related to EPA policies and decision-making regardingthe posting of Section 8(e) information. On February 3, EPAannounced that it had resumed publishing Section 8(e) notices toits ChemView database.5EPA said it had begunpublishing notices it had received since the procedure lapsed in2019 due to resource limitations after the staff person responsiblefor publication of the notices to the ChemView database retired.The Agency plans to develop an automated process for publication ofthe notices.
On December 15, 2021, EPA's Environmental Appeals Boardratified a consent agreement that resolved a chemical company'salleged violations of EPCRA TRI reporting requirements, TSCAChemical Data Reporting (CDR) requirements, and TSCA restrictionson exports of elemental mercury. The consent agreement required thecompany to pay a $600,000 civil penalty.6EPAfound that the respondent failed to make TRI submissions for 17chemicals at a New Jersey facility, failed to include 13 chemicalsin its CDR submissions for the New Jersey facility and 16 chemicalsin CDR submissions for a Kentucky facility, and exported betweenone and two pounds of elemental mercury on at least three occasionsthrough the Kentucky facility to Canada, Taiwan, and India inviolation of TSCA Section 12(c). EPA allocated the civil penalty asfollows: $279,000 for the alleged TRI reporting violations;$273,000 for the alleged CDR violations; and $48,000 for thealleged violations of the mercury export ban.
Eight organizations filed a lawsuit in December 2021 to compelthe US Food and Drug Administration (FDA) to respond to a 2016petition asking FDA to restrict the use of ortho-phthalate estersin food packaging and food processingmaterials.7The complaint alleged that"[a] robust body of scientific evidence links human exposureto phthalates with serious harm to human health, including birthdefects, infertility, miscarriage, and irreversible damage to thedeveloping brain," and that "[i]ngestion of food anddrinks contaminated by phthalates is the primary way that mostpeople in the United States-including children-are exposed to mostphthalates." The 2016 petition requested that FDA promulgateregulations prohibiting food contact uses of eight phthalates andthat the agency remove five phthalates from FDA's list of"prior-sanctioned substances" that FDA approved for usein food or food packaging before September 1958. On February 9,2022, FDA filed a motion for a temporary stay of all proceedingsuntil the earlier of July 19, 2022 or the date on which FDA issuesa final decision on the petition. FDA represented that it wouldissue a final decision by July 19.
On November 29, 2021, the Second Circuit Court of Appeals heldin a split opinion that EPA records "reflecting deliberationsabout how to communicate the agency's policies to peopleoutside the agency" qualified for the deliberative processprivilege and could be shielded from disclosure under the Freedomof Information Act.8At issue in the case wererecords related to the role of Dr. Nancy Beck, a former DeputyAssistant Administrator of EPA's Office of Chemical Safety andPollution Prevention, in policymaking related to TSCA and pesticidematters. The Second Circuit reasoned that agencies exercise"policy-oriented judgment" when deciding how tocommunicate their policies. Therefore, otherwise deliberativeagency records "that relate to and precede the agency'sfinal communications decision" qualify for protection. Inaddition, the Second Circuit held that the deliberative processprivilege can be invoked either with respect to a specific decisionor a "specific decisionmaking process." The SecondCircuit concluded that "messaging records" such as drafttalking points for senior agency staff and internal discussions anddraft responses related to inquiries from the press and members ofCongress qualified for protection to the extent they related to theform and content of the communication (i.e., "what to sayabout a policy and how to formulate that message"). The SecondCircuit also considered whether four "briefing documents"created to provide information to a senior manager in response toquestions and comments on the role of epidemiology in human healthrisk assessments were predecisional and therefore protected fromdisclosure. The court held that a record is predecisional "ifit relates to a specific decision or a specific decisionmakingprocess and was generated before the conclusion of thatdecision or process" (emphasis in original) but found thatinformation was insufficient to determine if the briefing documentswere predecisional. The dissenting judge concurred in themajority's analysis regarding the briefing documents butdissented from the majority opinion on the messaging records. Hewrote that in some cases the withholding of messaging records underthe deliberative process privilege is appropriate but said agenciesshould have to "make clear that the communications involvedmore than merely determining how to describe or spin policydecisions the agency had already made."
Defense Authorization Act Required DOD Actions on PFASTesting, Remediation, and Risk Management
The National Defense Authorization Act for Fiscal Year 2022(NDAA)-which President Biden signed on December 27, 2021-containeda subtitle devoted to PFAS.9These provisionsof the NDAA require the Department of Defense (DOD) to take thefollowing actions:
The NDAA also extends funding for the Agency for ToxicSubstances and Disease Registry's study and assessment onhealth implications of PFAS contamination in drinking water andrequires the Comptroller General of the United States to conduct astudy of DOD's procurement of certain PFAS-containing items(furniture or floor waxes, car wax and car window treatments,cleaning products, and shoes and clothing).
EPA Extended TSCA Risk Management Rule's ComplianceDate for PIP (3:1)-Containing Articles to October 2024
On March 3, 2022, EPA Administrator Michael Regan signed a finalrule extending the compliance date until October 31, 2024 for aJanuary 2021 TSCA risk management rule's prohibition onprocessing and distribution in commerce of certain articlescontaining phenol, isopropylated phosphate (3:1) (PIP (3:1)), aswell as the PIP (3:1) used to make thosearticles.10EPA promulgated the January 2021rule as an expedited risk management rule pursuant to TSCA Section6(h). Around the time of the original compliance date for the PIP(3:1) prohibition on March 8, 2021, EPA announced that it wouldexercise its discretion not to enforce the compliance date for upto 180 days due to concerns brought to the Agency's attentionby industry stakeholders that the compliance date would disruptsupply chains for a wide variety of consumer and commercialproducts.11In September 2021, EPA issued afinal rule extending the compliance date to March 8,202212and in October 2021 proposed theextension to October 31, 2024.13The final ruleextending the compliance date to October 31, 2024 for theprohibition also extends the compliance date for relatedrecordkeeping requirements. EPA's notice stated that it wasfurther extending the compliance date to address "thehardships inadvertently created" by the January 2021 rule"due to impacted uses and supply chain challenges that werenot communicated to EPA until after the rule was published,"including concerns raised by the electronics and electricalmanufacturing sector and their customers. EPA stated that theAgency found, based on comments provided by industry stakeholdersregarding steps taken to identify alternatives or continue engagingin phase-outs, that there was a "compelling rationale"for the need to extend the compliance date to October 31, 2024.
EPA Published Update to TSCA Inventory
On March 4, 2022, EPA announced that an updated TSCA Inventorywas available on the Agency's website.14The Agency reported that the Inventory contains 86,631 chemicalsubstances, 42,039 of which are active in US commerce. The updatedInventory also includes the specific chemical identities for 377chemicals that lost their confidential status because the specificchemical identities were reported as non-confidential by at leastone manufacturer during the 2012, 2016, and/or 2020 Chemical DataReporting period. EPA plans to update the Inventory again in summer2022.
EPA to Accept Feedback on TSCA Collaborative ResearchProgram for New Chemical Reviews
On February 25, 2022, EPA announced in the FederalRegister that the Agency would hold a virtual meeting on April20 and 21, 2022 to collect input on its proposed TSCA New ChemicalsCollaborative Research Program.15Inpartnership with EPA's Office of Research and Development andother federal entities, the Office of Chemical Safety and PollutionPrevention (OCSPP) proposes to develop a collaborative researchprogram focused on performing risk assessments for new chemicalsubstances. EPA identified the following key areas of the proposedprogram:
EPA said it would provide more information about these key areasin a draft collaborative research plan that will be available inthe docket by March 14.Written comments must be submitted by April 26, 2022.
EPA Revised Guidelines for Making Corrections to theTSCA Inventory and Set April 26 Deadline for Submissions Under OldGuidelines
On February 25, 2022, EPA published notice that it will nolonger accept corrections of specific chemical identities forchemical substances submitted to EPA in 1978 using the originalTSCA Inventory form.16EffectiveMay 31, 2022, EPA will revoke its 1980 Inventory Correctionguidelines17that provided a mechanism torequest corrections of specific chemical identity errors. EPAnotified the public that it must receive any final Inventorycorrections under the 1980 guidance by April 26, 2022. After thatdate, a manufacturer that discovers an error in the specificchemical identity of a substance submitted for the originalInventory may need to submit a Premanufacture Notice or exemptionnotice if the substance is not listed on the Inventory. In theFederal Register notice, EPA stated that the Agencyretained the authority to initiate corrections at its discretion.EPA also said revocation of the guidance did not impact its regularmaintenance of the Inventory, which includes nomenclature updatesand corrections of minor errors. EPA's notice explained thatthe Agency had not intended to establish a correction mechanismthat would be "open-ended in time" and that it had become"increasingly evident that the 1980 guidelines have outlivedthe purpose for which they were intended." EPA cited thedifficulty that original submitters and their successors now havewith providing necessary documentation for correction requests,which EPA described as a "major concern and obstacle" toreview and acceptance of correction requests. In addition, EPAmentioned potential misuse of the process to avoid submission of aPMN in cases where, for example, the original submission wascorrect but a change in the supply of a feedstock or in aperformance requirement changes the manufacture of the originalsubstance and results in a different specific chemical identity. Asan additional basis for revoking the corrections policy, EPA citednumerous opportunities that manufacturers have had over the past 40years to review their Inventory listings, discover good-faitherrors, and request corrections (e.g., Inventory Update Rule/CDRsubmissions and the Notice of Activity reporting after the 2016amendments to TSCA); however, it is unclear whether EPA has everpublicly invited submitters to use such periodic reportingrequirements as an appropriate vehicle for correcting chemicalnomenclature or identity issues related to the InitialInventory.
EPA Released Mercury Inventory Reporting ComplianceGuide
On February 22, 2022, EPA announced the release of an updatedcompliance guide on the triennial mercury inventory reportingrequirements.18The guide has been updated to"reflect the new requirement to report pre-assembled productsthat contain mercury-added components, such as a watch with amercury-added battery," a change made after the Second Circuitinvalidated an exemption for such products. Such pre-assembledproducts might be deeply embedded in a complex piece of equipment(such as a display light or an internal sensor), and the presenceof mercury in such a component is highly unlikely to be known to animporter who is not the actual manufacturer of the equipment,thereby presenting compliance challenges under the revisedrequirements. EPA said the updated compliance guide "explainsthe requirements for manufacturers and importers to report to EPAinformation about the supply, use, and trade of mercury; providesan overview of the legal requirements; and describes how the Agencyintends to use the information it collects. Diagrams and examplesare provided to help companies determine whether they must reportinformation about mercury to EPA." EPA also released theupdated Mercury Electronic Reporting (MER) application, which canbe accessed through the Central Data Exchange. The reportingdeadline for calendar year 2021 is July 1, 2022.
Science Advisory Board to Consult with EPA on Improvingthe Science for Cumulative Impact Assessment
The EPA Science Advisory Board (SAB) scheduled a public meetingon March 2 and 7, 2022 to conduct a consultation with EPA onresearch needed to improve the state of the science supportingcumulative impact assessments.19In advance ofthe meeting, EPA released an external review draft of a white paperthat provides operational definitions of "cumulativeimpacts" and "cumulative impact assessment" anddescribes research gaps and barriers to implementing cumulativeimpact research at EPA. The white paper also makes recommendationsfor advancing cumulative impact research within ORD's sixnational research programs over the next four years, including the"Chemical Safety for Sustainability" (CSS) and"Health and Environmental Risk Assessment" (HERA)programs. The white paper is available here.
EPA Released Draft IRIS Toxicological Review ofPFHxA
On February 2, 2022, EPA announced a 60-day public commentperiod on the draft Integrated Risk Information System (IRIS)Toxicological Review of Perfluorohexanoic Acid (PFHxA) and RelatedSalts.20The draft assessment (available here) derived a chronic oral reference dose(RfD) for noncancer effects (hepatic, hemapoietic, anddevelopmental toxicity) of 5 x 10-4mg/kg-day. Aless-than-lifetime subchronic RfD of 5 x 10-4mg/kg-daywas also derived. There were no studies or models to supportderivation of an RfD for inhalation exposure, and EPA concludedthat there was inadequate information to assess carcinogenicpotential for PFHxA by either oral or inhalation routes ofexposure. EPA is preparing IRIS assessments for five PFAS (PFBA,PFHxS, PFHxA, PFNA, and PFDA). The draft PFHxA assessment is thesecond draft assessment EPA has released for public review.
EPA Added Four PFAS to Toxics Release Inventory for2022
On January 24, 2022, EPA announced that four PFAS had beenautomatically added to the Toxics Release Inventory list pursuantto the requirements of the 2020 NDAA, which identified certainregulatory activities that trigger the addition of PFAS to the TRIlist.21Two substances-perfluorobutane sulfonicacid (PFBS) and perfluorobutane sulfonate-were added because EPAfinalized toxicity values for them in April2021.22A third PFAS was added because EPAdetermined that it was designated "active" on the TSCAInventory and was covered by the existing significant new use rulefor long-chain perfluoroalkyl carboxylate (LCPFAC) chemicalsubstances finalized in July 2020.23A fourthPFAS that meets the NDAA criteria was added after EPA completedreview of a confidential business information claim relating to it.The four substances are on the TRI list effective January 1, 2022.Reports for calendar year 2022 data will be due by July 1,2023.
TSCA Risk Evaluation Update: HBCD and PV29 Revised RiskDetermination, Asbestos Part 2 Scope, Fenceline Screening Approach,and Related Developments
Over the past several months, EPA has taken actions to moveforward on its plans to revisit the first 10 risk evaluations itcompleted in 2020 and 2021 as well as to establish themethodologies it will use to conduct future risk evaluations underTSCA Section 6.
HBCD: EPA's actionsincluded the Agency's first issuance, in draft form, of arevised risk determination for one of the initial 10 chemicalsubstances: cyclic aliphatic bromide cluster(HBCD).24The revisions to the HBCD riskdetermination were made to incorporate two policy changes relatedto risk evaluations that EPA announced in June. First, EPA proposedto make its determination that HBCD presents an unreasonable riskto health and the environment "as a whole chemicalsubstance" rather than making separate unreasonable riskdeterminations for each individual condition of use evaluated. Inthe original risk determination, six conditions of use were foundto present an unreasonable risk, and six were found not to presentan unreasonable risk. Second, EPA proposed to make explicit thatthe risk determination did not rely on assumptions regarding theuse of personal protective equipment (PPE) in making theunreasonable risk determination. Instead, EPA would consider PPEduring the risk management phase. The draft revised riskdetermination for HBCD did not reflect a third policy changeannounced in June-EPA's decision to use a "fencelinescreening" approach to assess whether the exclusion ofexposure pathways in the original risk evaluations will lead to afailure to identify exposures to people located in communities nearmanufacturing and processing facilities. EPA, in its announcementof the policy changes, indicated that the Agency did not plan toundertake this screening-level approach for HBCD. The originalcomment period for the revised HBCD risk determination closed onFebruary 14, 2022, but EPA reopened the comment period with a newdeadline of March 4, 2022.25It remains unclearhow the "whole chemical approach," and policy withrespect to PPE, will affect the terms of the risk mitigation rulethat EPA will be required to promulgate on the basis of the finalrisk evaluation for HBCD.
Pigment Violet 29 (PV29): Inthe March 7, 2022 issue of the Federal Register, EPApublished notice of the availability of its draft revision to therisk determination for Colour Index Pigment Violet29.26EPA proposed to find that PV29, "asa whole chemical substance," presents an unreasonable risk ofinjury to human health. As with HBCD, the draft revised riskdetermination does not reflect an assumption that workers alwaysappropriately wear PPE. Comments on the draft revised determinationare due by April 21, 2022.
Asbestos: EPA also releasedfor public comment a draft scope for the second part of its riskevaluation of asbestos.27EPA initially focusedthe risk evaluation for asbestos on chrysotile asbestos because itwas the only asbestos fiber type that is currently imported,processed, or distributed in the US. However, after a November 2019decision of the Ninth Circuit Court ofAppeals28that held that EPA should not haveexcluded legacy uses and associated disposals, EPA determined thatit would issue the asbestos risk evaluations in two parts, with thesecond part focused on legacy uses and associated disposals. Thedraft scope indicated that EPA intends to evaluate legacy uses andassociated disposals or chrysotile asbestos, other types ofasbestos fibers in addition to chrysotile, and conditions of use ofasbestos in talc and talc-containing products. EPA will be lookingat a wide range of uses, including construction and buildingmaterials, machinery and electronic articles, fillers and putties,toys, textiles and fabrics, aerospace applications, paints, andlawn and garden products. In addition, EPA plans to includefenceline analyses where appropriate to screen for potentialeffects, with emphasis on potentially exposed and susceptiblesubpopulations and environmental justice communities, followed bymore in-depth analysis where warranted. In addition, Part 2 willnot rely on assumptions regarding the use of PPE in workplace. Thedeadline for submission of comments on the draft scope is March 1,2022 (extended from February 14, 2022).29
D4: In the March 7, 2022issue of the Federal Register, EPA announced theavailability of the final scope of the risk evaluation foroctamethylcyclotetra-siloxane (D4), for which EPA granted amanufacturer request for risk evaluation in October2020.30
Fenceline Screening: Asmentioned above, EPA in June 2021 reversed an earlier policydecision not to assess air and water exposure pathways in the 10initial risk evaluations and decided to undertake a fencelinescreening level approach to determine whether there are potentialrisks to fenceline communities from air and/or water routes ofexposure that were not previously assessed in seven of the first 10risk evaluations (1-bromopropane (1-BP), n-methylpyrrolidone (NMP),methylene chloride, carbon tetrachloride, trichloroethylene,tetrachloroethylene, 1,4-dioxane). EPA also intends to use thescreening level approach for future chemical substances thatundergo Section 6 risk evaluations. In January 2022, EPA releasedits "Draft TSCA Screening Level Approach for Assessing AmbientAir and Water Exposures to Fenceline Communities Version 1.0"(available here), which presents the proposed methodologyfor assessing potential air and water chemical exposures tofenceline communities. The draft screening methodology alsopresents the results of applying the screening methodology to therisk evaluations for 1-BP (air pathway), NMP (water pathway), andmethylene chloride (air and water pathway). The three case studiesincluded in the draft screening level approach identifiedadditional risks for 1-BP and methylene chloride and no additionalrisks for NMP. EPA noted that these results were not final agencyactions and would not be used as presented to support riskmanagement actions. The Science Advisory Committee on Chemicals(SACC) will meet on March 15-17, 2022 to consider and review thedraft.31
Miscellaneous: Otherdevelopments related to TSCA risk evaluations included EPA'snotice of an April 19-21, 2022 SACC meeting for consideration andreview of the draft TSCA Systematic Review Protocol, whichdocuments specific systematic review approaches EPA uses foridentifying and evaluating evidence for the hazard and exposureassessments supporting risk evaluations.32Thedraft protocol is available here. EPA said the protocol responded torecommendations received from the National Academies of Sciences,Engineering, and Medicine. EPA also reopened the dockets for 20chemicals designated in December 2019 as "high priority"substances for risk evaluations. The dockets will remain open untilJune 9, 2022. EPA invited the public to submit use, hazard, orexposure information to inform EPA's risk evaluation process.The list of dockets can be found here.
Biden Administration Prioritized Reduction inProcurement of PFAS-Containing Items
In December 2021, President Biden issued Executive Order 14057on "Catalyzing Clean Energy Industries and Jobs ThroughFederal Sustainability,"33which setsustainability goals for federal government procurement that wereprimarily focused on reduction of greenhouse gas emissions but thatalso required agencies to purchase sustainable products andservices identified by EPA "to the maximum extentpracticable." The White House simultaneously published amemorandum that noted the executive order's requirements forsustainable acquisition and procurement, and directed agencies to"prioritize substitutes for products that contain[PFAS]."34Moreover, the memorandumprovided that agencies should avoid the procurement of"PFAS-containing covered items." Such "covereditems" include PFAS-containing nonstick cookware or cookingutensils and upholstered furniture, carpets, and rugs that havebeen treated with stain-resistant coatings.35In addition, the White House issued a Federal Sustainability Planthat included prioritization of the purchase of "sustainableproducts" (including products without added PFAS) as one ofits "principles and goals."36Morerecently, EPA published a webpage that compiles how private sectorstandards and ecolabels in EPA's "Recommendations ofSpecifications, Standards, and Ecolabels for FederalPurchasing"-which identify private sector environmentalperformance standards or ecolabels that "most effectivelyaddress the environmental impacts of products and service and areverified to be appropriate for federalprocurement"-specifically address PFAS in various productcategories.37The PFAS webpage lists ninestandards or ecolabels from the Recommendations that includecriteria specifically focused on PFAS content. The productcategories covered by the PFAS-related standards include carpet,flooring, furniture, interior latex paint, take-out service items,trash bags, adhesives, and certain construction materials. Whilethe criteria in some of these standards pertain only to PFOS orPFOA, the certification criteria for at least five of the standardsrestrict a broader array of PFAS. EPA also released an update ofthe "Framework for the Assessment of Environmental PerformanceStandards and Ecolabels for Federal Purchasing" that theAgency uses to assess the marketplace of more than 460 privatesector standards and ecolabels to determine which to include in theRecommendations. The update increases the Framework's emphasison chemical content of products. For more information on how theupdate does so and on the Biden administration's other relatedactions, see our February 28 Environmental Edgeblog post.
EPA Updated New Approach Methods (NAMs) WorkPlan
In December 2021, EPA updated the Agency's "NewApproach Methods Work Plan," which describes steps EPA plansto take to reduce the use of vertebrate animals for toxicitytesting.38The updated Work Plan sets forthnear- and long-term strategies for achieving five objectives andthe deliverables on which the Agency will focus through 2024. Thefive objectives are: (1) evaluate regulatory flexibility foraccommodating the use of NAMs; (2) develop baselines and metricsfor assessing progress; (3) establish scientific confidence in NAMsand demonstrate application to regulatory decisions; (4) developNAMs to address scientific challenges and fill importantinformation gaps; and (5) engage and communicate with stakeholders.EPA identified the following primary changes in the updated WorkPlan:
New York Enacted Bans on Flame Retardant Chemicals inFurniture, Mattresses, and Electronic Displays
On December 31, 2021, New York enacted the Family and FireFighter Protection Act, which will prohibit sale of upholsteredfurniture and mattresses containing flame retardant chemicals thatare halogenated, organophosphorus, organonitrogen, or nanoscalechemicals.39The law also will bar customupholsterers from using components that contain the regulatedchemicals. In addition, the law will prohibit sale of electronicdisplays containing an organohalogen flame retardant chemical inthe enclosure or stand. The law also will require electronicdisplay manufacturers to submit reports identifying flameretardants used in the enclosure or stand of the displays. The laworiginally provided that the furniture, mattress, and electronicdisplay prohibitions would take effect on January 1, 2024, with theupholstery ban taking effect a year earlier, but in January 2022amendments were adopted that extended the sales prohibitions'effective date to December 1, 2024 and the upholsterer prohibitioneffective date to December 1, 2025. As amended, the prohibitionsapply where the regulated chemicals are present "[a]to orabove levels set by [DEC] in regulation" or are"intentionally added." The law provides that sellers ofcovered products will not be found to have violated the law if theycan show good-faith reliance on a manufacturer's certificate ofcompliance.
New York Law Requires Lead Warning for CertainDecorative Lighting Products
On November 30, 2021, New York Governor Kathy Hochul signedlegislation that requires warning labels for "seasonal anddecorative lighting products" containing an electrical cordcasing in which lead is present in a quantity greater than 100parts per million.40The requirement applies to"portable, plug-connected, temporary-use lighting products andaccessories that have a nominal 120-volt input voltagerating," which includes products such as holiday stringlights, pre-lit artificial Christmas trees, and other pre-litobjects. Pursuant to an agreement between the legislature and thegovernor, the law was amended in February 24 to modify the penaltyprovision to clarify that penalties were applicable only tomanufacturers and to reduce the maximum penalty to $500 (from$1,000).
*Margaret Barry contributed to this newsletter.
1. Press Release, EPA, EPA Grants Petition toOrder Testing on Human Health Hazards of PFAS (Dec. 28,2021).
2. Ctr. for Env't Health v. Regan, No. 4:21-cv-01535(N.D. Cal.).
3. Nat'l PFAS Contamination Coal. v. EPA, No.1:22-cv-00132 (D.D.C., filed Jan. 20, 2022).
4. Pub. Emps. for Env't Resp. v. EPA, No.1:22-cv-00014 (D.D.C., filed Jan. 4, 2022).
5. Press Release, EPA, EPA Re-initiatesPublication of Chemical Health and Safety Notices to ChemView,Enhancing Public Accessibility (Feb. 3, 2022).
6. In re AvantorPerformance Materials, LLC, Docket Nos. TSCA-02-2022-9142,EPCRA-02-2022-9142 (EAB Dec. 15, 2021).
7. Env't Def. Fund v. U.S. Food & Drug Admin.,No. 1:21-cv-03190 (D.D.C. Dec. 7, 2021).
8. Nat. Res. Def. Councilv. EPA, No. 20-422 (2d Cir. Nov. 29, 2021).
9. Pub. L. No. 117-81,§§ 341–349, 135 Stat. 1541,1640–50.
10. 87 Fed. Reg. 12984 (Mar. 8,2022).
11. 86 Fed. Reg. 14398 (Mar. 16,2021).
12. 86 Fed. Reg.51823 (Sept. 17, 2021).
13. 86 Fed. Reg. 59684 (Oct. 28,2021).
14. The updated Inventory is available here.
15. 87 Fed. Reg.10784 (Feb. 25, 2022).
16. 87 Fed. Reg. 10781 (Feb. 25,2022).
17. 45 Fed. Reg. 50544 (July 29, 1980).
18. Press Release, EPA, EPA Announces Updates toResources on Mercury Inventory Reporting Rule (Feb. 22,2022); EPA, EPA-740-B-22-001, Compliance Guide:Reporting Requirements for the Mercury Inventory of the ToxicSubstances Control Act (Jan. 2022).
19. 87 Fed. Reg. 4886 (Jan. 31,2022). The meeting's agenda also included discussion ofrecommendations from the SAB Work Group for Review of ScienceSupporting EPA Decisions with regard to SAB review of planned EPAactions and conducting a quality review of the draft SAB report,"Review of the Multi-Agency Radiation Survey and SiteInvestigation Manual, Revision 2."
20. 87 Fed. Reg. 5819 (Feb. 2,2022).
21. Press Release, EPA, EPA Requires Reportingon Releases and Other Waste Management of Certain PFAS, IncludingPFBS (Jan. 24, 2022); see(Jan.24, 2022); see 15 U.S.C.§ 8921(c).
22. See News Release, EPA, EPA Releases UpdatedPFBS Toxicity Assessment After Rigorous ScientificReview (Apr. 8, 2021).
23. See 85 Fed. Reg. 45109 (July 27,2020).
24. 86 Fed. Reg. 74082 (Dec. 29,2021).
25. 87 Fed. Reg. 9047 (Feb. 17,2022).
26. 87 Fed. Reg. 12690 (Mar. 7,2022).
27. 86 Fed. Reg. 74088 (Dec. 29,2021).
28. Safer Chemicals, HealthyFamilies v. EPA, 943 F.3d 397 (9th Cir. 2019).
29. 87 Fed. Reg. 7833 (Feb. 10,2022).
30. 87 Fed. Reg. 12696 (Mar. 7,2022).
31. 87 Fed. Reg. 3294 (Jan. 21,2022).
32. 86 Fed. Reg. 71891 (Dec. 20,2021).
33. 86 Fed. Reg. 70935 (Dec. 13,2021).
34. Memorandum from ActingDirector, Office of Mgmt. & Budget et al. regarding CatalyzingClean Energy Industries and Jobs Through FederalSustainability (Dec. 8, 2021).
35. These "covered item" restrictions build onrequirements the National Defense Authorization Act for Fiscal Year2021. Pub. L. No. 116-283,§ 333, 134 Stat. 3388, 3531.
36. Federal SustainabilityPlan, Office of Fed. Chief SustainabilityOfficer/CEQ (last visited Mar. 3, 2022).
37. How EPA'sRecommended Standards and Ecolabels Address Per- andPolyfluoroalkyl Substances (PFAS), EPA (last updated Feb.15, 2022); Recommendations ofSpecifications, Standards, and Ecolabels for FederalPurchasing, EPA (last updated Feb. 28, 2022).
38. EPA, EPA 600/X-21/209, New Approach MethodsWork Plan (Dec. 2021).
39. 2022 N.Y. Laws ch.11 and 2021 N.Y. Laws ch.829 (codified at N.Y. Env't Conserv. Law§§ 37-1001 to 37-1013).
40. 2022 N.Y. Laws ch.40 and 2021 N.Y. Laws ch.634 (codified at N.Y. Gen. Bus.Law § 389-s).
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