EPA Issues First Test Order for PFAS in Commercial Firefighting Foam

EPA recently issued a test order under TSCA section 4 to select companies requiring that they develop and submit certain information on 6:2 fluorotelomer sulfonamide betaine, a PFAS. The order is part of the Agency’s National PFAS Testing Strategy which will evaluate a large number of PFAS for potential human and ecological effects as “most PFAS lack data for robustly characterizing their potential toxicity.

The test order was issued to Chemours Company, DuPont De Nemours Inc., National Foam Inc., and Johnson Controls Inc.  6:2 fluorotelomer sulfonamide betaine is used to make commercial firefighting foam and certain floor finishes.  The test order explains that EPA found insufficient data on 6:2 fluorotelomer sulfonamide betaine to determine or predict the effects on human health specifically by the inhalation route.  The order applies a tiered testing strategy.  EPA has ordered the companies to generate of data on certain physical-chemical properties (e.g., density, particle size, hydrolysis as a function of pH).  The Agency will use those data to determine whether further testing (e.g., inhalation toxicokinetic study, acute inhalation study) is needed.  Under TSCA section 4(a)(4), EPA is required to employ a tiered screening and testing process under which the results of screening-level tests or assessments of available information inform the decision as to whether additional tests are necessary.

EPA intends to issue additional test orders to other PFAS manufacturers in the coming months. A detailed overview of the activities involved in issuing a TSCA Section 4 order can be found here.

FDA Rejects Phthalate Petition

On May 19, 2022, the US Food and Drug Administration (FDA) announced that it has denied two petitions to ban phthalates in food packaging.  In conjunction with denying the petitions, the FDA accepted a petition requesting that the Agency stops authorizing 23 phthalates for use in food containers as they are no longer used by industry.

In addition to being in food containers, phthalates are used as additives in cosmetics, detergents, and shower curtains.  Industry often uses them to soften plastics.  Although allowed in many products, the 2008 Consumer Product Safety Improvement Act bans a concentration of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); or benzyl butyl phthalate (BBP) in all children’s toy and childcare articles.  Being exposed to concentrated amounts of phthalates can cause reproductive and developmental issues.

Multiple groups, including the Environmental Defense Fund and Earthjustice, have petitioned the FDA in the last decade to block the authorization of phthalates in food packaging, but the petitions have always failed, with the FDA citing a lack of information to justify blocking authorization of phthalates.

FDA’s acceptance of the petition to stop authorizing certain phthalates was due to the industry no longer using those substances. As the industry has abandoned use of those phthalates, the FDA found it appropriate to stop their authorization.  Currently, there are eight phthalates that the FDA still authorizes.  Shortly after the FDA’s announcement, they issued a request for information regarding current uses, levels, dietary exposure, and safety data for those phthalates.

Amendments to SNUR Requirements

On July 5, 2022, EPA finalized the rule Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (87 FR 39756).  EPA made changes to SNUR requirements in the following sections 40 CFR §§ 721.11, 721.63, 721.72, and 721.91. In addition, the Agency has changed when 40 CFR 721.80(j) will be used.  Most amendments only apply to SNURs issued after the rule’s effective date, September 6, 2022. However, retrospective changes are flagged throughout this report.  The amendments in this Federal Register notice will also require the submission of SDS(s) with PMNs, SNUNs, and Low Volume Exemptions (LVEs).

Changes to 40 CFR § 721.63, Protection in the Workplace

EPA updated this regulation so that it will be consistent with NIOSH and OSHA requirements.  For example, the amendment to 40 CFR § 721.63(a)(4) references the updated NIOSH regulations for respirator use, testing, and certification.  EPA believes that most manufacturers and processors are already subject to and complying with the NIOSH regulations. This change will be retroactive and thus will apply to all previously issued SNURs that contain significant new use requirements pertaining to respiratory protection. The amended rule allows manufacturers and processors that are subject to SNURs to follow updated respiratory protection requirements without triggering a SNUN requirement.

EPA has also updated to the NIOSH-certified respirator language in 40 CFR § 721.63(a)(5). Notably, individuals will be allowed to continue using any of the fifteen older-style respirators listed under 40 CFR § 721.63(a)(5)(i-xv) to avoid triggering a SNUN requirement.  In addition, EPA amended 40 CFR § 721.63(a)(6) to update the language for when the airborne form of a chemical substance implicates the respiratory requirements in 40 CFR § 721.63(a)(4).

The amendments to the SNUR regulations also include new paragraphs 40 CFR § 721.63(a)(7) and 40 CFR § 721.63(a)(8).  When implicated by a SNUR, these new requirements make it a significant new use not to implement a hierarchy of controls to protect workers. These changes will require any person subject to a SNUR that calls out these requirements to identify and implement appropriate engineering and administrative controls for respiratory protection before using PPE for workers protection.

Changes to 40 CFR § 721.72, Hazard Communication Program

EPA updated the language in 40 CFR § 721.72(a) through (h) to be consistent with current OHSA requirements and the United Nations’ Globally Harmonized System of Classification and Labeling (GHS). The amendments will apply retroactively to previously issued SNURs that cite 40 CFR § 721.72(a), (c), or (d).

Paragraphs (g) and (h) were amended to include new hazard and precautionary statements to make these provisions consistent with OSHA requirements and GHS recommendations.  EPA also added two new paragraphs to 40 CFR § 721.72, (i) and (j).  These new paragraphs impose new hazard communication requirements. Paragraph (i) requires a written hazard communication program to be developed and implemented for the SNUR substance in each workplace. The written hazard communication program would need to meet OSHA requirements in 29 CFR 1910.1200, OSHA’s Hazard Communication Standard (HCS). Paragraph (j) provides specific statements and warnings that could be incorporated in hazard communications.

Under the revisions to § 721.72, whenever the statements in paragraphs (g), (h), and (j) are required, manufacturers and processors subject to the SNUR will also need to consider if they trigger any other corresponding hazard communication under the OSHA HCS.  Any hazard and/or precautionary statements required by the SNUR would need to include a minimum set of hazard warnings.

Changes to 40 CFR § 721.80, Industrial Commercial and Consumer Activities

EPA has changed the circumstance in which it will cite 40 CFR § 721.80(j) which defines a significant new use as, “[u]se other than as described in the premanufacture notice references in subpart E of this part for the substance.” No language would be changed.  Instead, the Agency is clarifying when it will identify a new use using this verbiage.  The Federal Register notice explains that “To better identify the significant new use, EPA has changed this procedure to only cite 40 CFR 721.80(j) when the use described in the PMN is confidential.”

 Changes to 40 CFR § 721.91, Computation of Estimated Surface Water Concentrations: Instructions

EPA has modified the instructions in 40 CFR § 721.91 for computation of estimated surface water concentrations to allow for a certain percentage of removal of a chemical substance from wastewater after undergoing control technology in accordance with the requirements in 40 CFR § 721.90.

Changes to 40 CFR § 721.11, Applicability Determination When a Specific Chemical Identity is Confidential

The amendments to 40 CFR § 721.11 subpart A modify the bona fide procedure so that it applies to all SNURs containing any CBI, including the significant new use.

Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVEs), Low Release, and Exposure Exemptions (LoREXs), and Test Marketing Exemption (TME) Applications

EPA has amended sections 40 CFR § 720.38, 40 CFR § 720.45, and 40 CFR § 723.50 to require that any safety data sheets (SDSs) that has been developed, even if it is in draft form, be submitted as part of any notification or exemption application (PMN, SNUN, LVE, LoREX, or TME).  Submitters are not required to develop an SDS if one does not already exist.

 

PFAS From Certain Plastic Can Violate Chemicals Law, EPA Says

Earlier this year, EPA released a letter to manufacturers, processors, distributors, users, and those that dispose of fluorinated high-density polyethylene (HDPE), informing them of possible violations of the Toxic Substances Control Act (TSCA).  EPA determined through recent testing that certain PFAS have unintentionally formed during or following the process of fluorinating polyolefins. Manufacturers and processors of fluorinated polyolefins modify polymers with fluorine to create high-performance barriers.  These barriers are then used in the storage and transport of various products to keep the product inside the container without notable permeation.  During some methods of fluorination, such as in the presence of oxygen, PFAS can occur as a byproduct.

EPA first noticed the unintentional formation of PFAS in containers used in storing and transporting pesticides, and it is researching whether this problem occurs in other HDPE products. This effort to restrict human health and environmental exposure to PFAS is one of many steps the Agency has outlined in its PFAS Strategic Roadmap.

EPA’s letter reminds the HDPE industry that certain long-chain PFAS are subject to a TSCA Significant New Use Rule (SNUR) (See 40 CFR § 721.10536). Generally, chemical substances created during the manufacturing process that does not have a separate commercial purpose are considered byproducts and are exempt from SNUR requirements under 40 CFR § 721.45(e). But certain long-chain PFAS byproducts produced during the manufacture of fluorinated polyolefins do not meet the requirements of the byproducts exemption and therefore require a SNUR. These rules require the manufacturer to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemicals for significant new use.

The Agency encourages the industry to review the relevant regulations at 40 CFR § 721. Any questions on the topic can be directed to the Existing Chemicals Risk Management Division in the Office of Pollution Prevention and Toxics at TSCA_PFAS@epa.gov.

Chlorpyrifos Food Tolerance Revoked  

Earlier this year, EPA denied all objections to and hearing requests for a rule that terminates the use of the chlorpyrifos pesticide on food crops. As a result of the new rule, producers may no longer apply any chlorpyrifos to food or feed products, although there is an exemption for farmers to use the pesticide on certain exported food products.

Following its registration in 1965, farmers have used chlorpyrifos as an insecticide on food crops such as soybeans, corn, fruit and nut trees, and vegetables. It has also been used for agricultural purposes such as cattle ear tags, poultry houses, turkey, swine, and dairy barns.

There is significant potential for the pesticide to cause neurological effects, particularly in pregnant women and children. Children who are exposed to chlorpyrifos may experience lifelong intellectual disabilities and lowered IQ levels. Farmworkers who use the pesticide or work in fields where the pesticide has been used are also at increased risk of adverse health effects from exposure with including effects on the nervous system such as headaches, blurred vision, muscle weakness, and seizures. The chemical has been the focus of environmental advocacy groups because of its toxicity to wildlife, particularly birds, fish, aquatic vertebrates, and bees. For example, these groups argue that the chemical impacts the health and existence of nearly 1,400 animals and plants protected under the Endangered Species Act.

In 2000, the EPA banned chlorpyrifos for residential indoor use but continued allowing the use of these chemicals on food products. In 2014 and 2016, the EPA published data confirming that all toddlers were being exposed to chlorpyrifos at levels 140 times greater than the Agency had determined was safe.  However, the Agency did not take actions to limit chlorpyrifos pesticide use at that time. In 2017, the EPA again failed to take action to ban chlorpyrifos. The Agency decision argued that additional scientific evidence was needed. Meanwhile, beginning in 2019, some states banned or restricted the use of chlorpyrifos, including California, Maryland, New York, and Hawaii. In recent years, many toxic torts lawsuits have been filed against chlorpyrifos manufacturers and distributors. Many of these cases are still ongoing.

The EPA’s current final rule banning chlorpyrifos in food was issued in response to the Ninth Circuit Court of Appeals’ order directing the EPA to issue a final rule after the Natural Resources Defense Council and the Pesticide Action Network North America filed a petition with the Court. These organizations had previously petitioned the Agency for a ban, which was denied under the Trump administration in 2017 and again in 2019, leading to its Ninth Circuit challenge. EPA administrator Michael S. Regan addressed the delay in EPA’s action against the chemical, stating, “[t]oday EPA is taking an overdue step to protect public health. Ending the use of chlorpyrifos on food will help to ensure children, farmworkers, and all people are protected from the potentially dangerous consequences of this pesticide.”

 

 

Proposed Rule Changes to TSCA CBI

On May 12, 2022, EPA proposed a rule (87 FR 29078) that would update requirements for making confidential business information (CBI) claims under TSCA. According to the proposal, the focus of the rule is to enhance transparency and modernize reporting and review procedures for CBI claims.  In addition, the rule will impose some additional requirements for making CBI claims to better comport with the Lautenberg amendments. These new requirements include changes to the following areas detailed below.

Substantiation and Exemptions

Two changes are proposed for the substantiation requirements. First, proposed section 703.5 provides further clarification and reiterates that where a TSCA submission identifies a chemical substance listed on the confidential portion of the TSCA Inventory but does not assert a confidentiality claim, the specific chemical identity would no longer be eligible for confidential treatment on the TSCA Inventory. Second, proposed rule section 703.5(b)(1) would require claimants to assert their CBI claims at the time of submission.  It would also require that such claims are accompanied by the requisite substantiation.  Here-to-fore, substantiation at the time of submission has been required for some but not all TSCA submissions. The proposed rule, sections 703.5(b)(3) and (4), also specifies the standard set of substantiation questions that will apply to TSCA CBI claims. These questions include:

Proposed Section 703.5(b)(3) Substantiation Questions for all Claims:

  • What harm to the competitive position of your business would be likely to result from the release of the information claimed as confidential? How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable?
  • Has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures.
  • Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
  • Does any of the information claimed as confidential otherwise appear in any public documents? If yes, please explain why the information should be treated as confidential.
  • Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential.

 

Proposed Section 703.5(b)(4) – Additional Substantiation Questions for Chemical Identity-Related Claims

  • Is this chemical substance publicly known to be in U.S. commerce? If yes, please explain why the specific chemical identity should still be afforded confidential status.
  • Does this specific chemical substance leave the site of manufacture (including import) in any form, e.g., as a product, effluent, emission? If yes, please explain what measures have been taken to guard against the discovery of its identity.
  • Would disclosure of the specific chemical identity release confidential process information? If yes, please explain.

The substantiation requirements will not apply to information exempt under TSCA section 14(c)(2)(G), including specific information describing the processes used to manufacture or process a chemical; and marketing and sales information.

Public Copies of Submissions

EPA proposes changes to section 703.5(c), requiring the submitter to prepare a separate public copy of a submission where the reporting form or application contains CBI. These changes explicitly state that a public copy of a submission that redacts all or substantially all content within the original submission would most likely not meet the requirements of the rule because it is unlikely that all the information in a form or attachment can appropriately claimed as CBI.

Reporting

Pursuant to proposed section 703.5(f), nearly all TSCA confidentiality claims must be asserted electronically using the reporting tools within the Chemical Information Submission System (CISS).

Generic Name Criteria

The proposed rule addresses generic names for chemicals not on the TSCA inventory. It outlines the criteria for the masking of portions of the chemical name.  In addition, the proposed rule would require an accompanying explanation request for extensive masking. The proposed changes would be included in sections 703.5(d)(2)-(4).

Reporting Health and Safety Data Using Harmonized Templates

The proposed rule also addresses confidentiality claims and health and safety studies. Under TSCA section 14(b)(2), confidentiality claims cannot be asserted in health and safety studies. However, TSCA section 14(b)(2) does permit withholding specified information contained in these studies that do not apply to human or environmental health. Previously, the treatment of this information lacked uniformity. Accordingly, proposed section 703.5(g) mandates that health and safety information be reported using harmonized templates. Additionally, under section 703.3 of the proposed rule, EPA has identified the types of information within health and safety studies for which confidentiality claims may be asserted.

Administrative Changes

Proposed section 703.5(e) addresses deficient claims (e.g., submissions that include a generic name that does not meet the requirements of proposed section 703.5(d) or rely on inappropriate substantiation exemption assertions).  When EPA identifies a claim as deficient, the Agency will provide notice of the deficiency to the submitter.  Confidentiality claims identified as deficient will be held for ten business days after the claimant has been notified. If the deficiency is not remedied during the suspension, EPA may proceed with reviewing the submission as is and may subsequently deny the claim. Proposed section 703.5(i) refers to the procedures for withdrawing confidentiality claims.

* * *

These proposed changes are intended to narrow the scope of CBI claims. EPA contends that these changes will provide the public with greater access to up-to-date information regarding the status of CBI claims and the data supporting said claims. EPA also anticipates the guidance provided by the new rule will enhance the clarity and uniformity of CBI claim submissions. This is expected to expedite the CBI claim review process and help EPA meet the statutory review deadlines.

 

EPA Launches Stakeholder Outreach Effort to Help Speed New Chemical Reviews

On June 27, 2022, EPA announced its TSCA New Chemical Engineering Initiative.  EPA seeks to increase efficiency and transparency in the new chemical review process by inviting stakeholders to learn more about how the agency evaluates submitted information.  EPA plans to focus the initiative specifically on issues surrounding “engineering” information, including, but not limited to, occupational exposures and environmental releases.

The initiative has been launched in response to significant delays in new chemical reviews.  Frequently, submitters will provide additional information after the safety review process of a chemical under Section 5 of the Toxic Substances Control Act (TSCA) has already begun.  When EPA receives this additional information, it must revise its risk assessment (known as a “rework”) which causes delays in completing its review process and finalizing its risk assessment.  In an analysis of previous cases, EPA determined that an individual case may be reworked anywhere from one to five times, delaying the process at least several months.

EPA will be conducting a series of webinars providing an in-depth look at how the Agency analyzes submissions, including EPA’s written methodology of how its conducts analysis.  EPA intends to present case studies to stakeholders to further demonstrate what it considers acceptable in submissions.  Webinars will also communicate EPA’s considerations in evaluating qualitative claims or quantitative data, particularly in circumstances in which they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER).  Webinars will also discuss EPA’s considerations in evaluating information about sites that are not controlled by the submitter.

The kick-off meeting for the series was held on July 27, 2022.  The meeting detailed background on rework analysis, causes of reworks, examples of rework cases, and general observations.  EPA will be releasing information including the dates for two additional webinars in this fall.

Flame Retardant Rule Do-Over Sought By EPA Granted in Federal Case

On June 23, 2022, the Ninth Circuit Court of Appeals granted EPA a request for voluntary remand on a risk management rule for decabromodiphenyl ether (decaBDE).  This allows EPA to reconsider the rule at issue and make changes they deem necessary.  DecaBDE is a flame retardant added to the plastics used in many products on the market, such as televisions, computers, and upholstered articles. The January 2021 risk management rule prohibits manufacturing or importing decaBDE for all products after February 28, 2022, 60 days after the publication of the final rule.  The rule gives the hospital curtain industry 18 months to come into compliance, and 3 years for new aerospace vehicles. Replacement parts for motor and aerospace vehicles were granted an exclusion from the prohibition of manufacturing, processing, and distribution of decaBDE.

Petitioners opposing EPA in this matter are a coalition consisting of the Alaska Community Action on Toxics, Yurok Tribe, the Consumer Federation of America, Learning Disabilities Association of America, and the Center for Environmental Transformation.  the coalition, argues that EPA has had more than a year to review unidentified provisions of the final rule.  The coalition also asserts that EPA’s Final Rule is inadequate because it lacks 1) risk management measure to reduce exposure of decaBDE generally, 2) an exclusion for unrestricted recycling of plastics containing decaBDE, and 3) restrictions on releases of the chemical to the air, water, or land.

In 2021, the Ninth Circuit Court of Appeals had also granted EPA’s request to revisit two other chemical risk evaluations, including the one for hexabromocyclododecane (HBCD which is also a flame retardant).  Along with granting EPA’s request to reconsider the rule, the Ninth Circuit denied the petitioners request to impose deadlines on the reconsideration and potential amendment of the rule.

EPA orders e-commerce platform Wish to stop selling illegal disinfectants

On July 5, 2022, EPA ordered the e-commerce platform Wish (ContextLogic Inc.) to stop selling
a variety of unregistered disinfectants on its website including disinfectant sprays, tablets, and air
sterilization cards. EPA’s “Stop Sale” order prevents the company from selling unregistered disinfectants
which is a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Under FIFRA, all disinfectants must be registered with the Environmental Protection Agency
which requires testing and determination that the product will not pose an unreasonable risk to human
health when used according to the label directions. Violations of this nature have increased during the
Covid-19 pandemic. Allowing products like this to stay on the market is particularly concerning as
unregistered products make be harmful to human health and may not be effective against the spread of
germs. The EPA Pacific Southwest Regional Administrator Martha Guzman commented on the Stop Sale
order and the overall issue stating, “As our nation continues to grapple with Covid-19, today’s stop sale
order is critical to protecting Americans from misleading and harmful claims from a large e-commerce
platform. EPA remains vigilant and will keep removing these illegal disinfectants from circulation.”

Biological Opinion Proposes Malathion Mitigation Measures

The U.S. Fish and Wildlife Service’s (FWS) nationwide final biological opinion (BiOp) for Malathion has prompted EPA to take steps to protect a number of endangered species that were identified as being threatened by the insecticide.  Malathion is an organophosphate insecticide use on a wide variety of food and non-food crops to kill insects systemically and on contact.  It is also used as a mosquito adulticide.  The BiOp was prompted after EPA released a biological evaluation on malathion in January 2017EPA’s evaluation found the insecticide was likely to affect both aquatic and terrestrial animals by inhibiting and enzyme necessary for synapse and neuromuscular function, leading to sublethal effects and mortality.

FWS collaborated with EPA and the malathion technical registrants to create the BiOp.  The BiOp also includes information provided by stakeholders, non-governmental organization, and members of the public who commented on EPA’s initial evaluation.  The BiOp states that malathion is likely to jeopardize 78 different species and destroy or adversely affect 23 habitats.  FWS proposed mitigation measures that would reduce the application rates, create no spray zones, and apply label changes for the pesticide users to follow.  One proposed mitigation measure for reducing the application rates would restrict application when rain is predicted and when certain types of crops are in bloom. The purpose of these mitigation measures is to minimize the likelihood of exposure to different species and reduce the affects to their development and habitats.

The BiOp states specific measures and mandatory label instructions will be available through EPA’s Bulletins Live! Two website, which provides information on endangered species, along with other relevant information.  Registrants were asked to submit amended labels to EPA by June 29, 2022.