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.
Chlorpyrifos Food Tolerance Revoked
/in Chemicals of Concern, EPAEarlier 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
/in UncategorizedOn 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:
Proposed Section 703.5(b)(4) – Additional Substantiation Questions for Chemical Identity-Related Claims
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.
Lawsuit over Coloring Agent in Skittles Dismissed
/in UncategorizedMars Inc. was sued in July 2022 regarding claims related to the titanium dioxide content of its skittles candy. The complaint alleged that the titanium dioxide – a coloring ingredient– was toxic and that its presence made the candy unfit for human consumption. This suit was filed as a proposed class action in the U.S. district court, northern district of California. The lawsuit also claimed titanium dioxide causes DNA damage, chromosomal damage, inflammation, and other adverse health effects.
EPA’s assessment of titanium dioxide in 2005 states that inhalation of the chemical in high concentrations can cause pulmonary effects in rats, however the Agency noted that the possibility that the negative effects might not occur in humans. EPA’s assessment also found that there is no carcinogenic effect associated with exposure to titanium dioxide dust – concentrations up to five percent of the rat’s diet of titanium dioxide did not result in adverse effects.
The lawsuit claimed Mars Inc. failed to inform consumers of the dangers of consuming titanium dioxide and that reasonable consumers did not know that Skittles contained the substance dioxide. Additionally, the suit asserted that Mars Inc. knew about the risks posed by titanium dioxide when it announced a plan to phase out the substance in 2016.
Mars Inc. responded to the complaint with a series of motions to dismiss. The company argued that it was in compliance with FDA regulations that approved titanium dioxide as a safe color additive, and that the complaint failed to identify any harm to the plaintiff. Ultimately the plaintiff agreed to a voluntary dismissal.
EPA Launches Stakeholder Outreach Effort to Help Speed New Chemical Reviews
/in EPA, TSCAOn 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
/in Chemicals of Concern, EPAOn 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
/in EPAOn 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
/in Chemicals of Concern, News & EventsThe 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.
State of Washington Regulates PFAS In Lieu of Cosmetics Ban
/in Chemicals of Concern, News & EventsA proposal in Washington state has stalled in the state House, after passing their Senate, that would have banned cosmetics that contain phthalates, formaldehyde, and PFAS. The proposal, Senate Bill 5703, states that legislature finds certain chemicals in cosmetic products to be linked with various negative health effects, such as cancer, birth defects, and damage to the reproductive system. It further states that if enacted, it would have prohibited the sale and distribution of any cosmetics containing these and an additional 31 different substances such as ortho-phthalates, phenolic compounds, parabens, and lead compounds beginning January 1, 2025.
Although Senate Bill 5703 did not progress, the governor did sign into law House Bill 1694, which allows the state department of ecology to recognize and regulate consumer products containing PFAS. The bill gives the ecology depart the authority to restrict PFAS product to any limit. The state’s department of ecology is directed to determine an initial set of regulatory actions regarding PFAS consumer products by June 1, 2024 and must adopt rules to implement the initial set of determinations of regulatory actions by December 1, 2025. Washington has also created a $266,00 fund for identifying and testing cosmetics for the purpose of determining which cosmetics present harmful effects.
Washington is not the first state to ban hazardous substances from cosmetics. In 2020, California passed a ban on cosmetics containing harmful substances, identifying some PFAS chemicals. Maryland took the same course of action in 2021. In addition, several other states, such as New Hampshire, Minnesota, Michigan, and Maine have begun drafting legislature to restrict PFAS in cosmetics.
EPA Takes Steps to Regulate PFAS in Commerce
/in Chemicals of Concern, EPAOn March 16, 2022, EPA announced that the Agency would be taking two steps to further regulate PFAS in commerce. First, EPA notified manufactures of high-density polyethylene (HDPE) that they are obligated to comply with existing TSCA requirements to prevent unintentional PFAS contamination. Second, EPA stated that the Agency will remove two types of PFAS from the Safer Chemical Ingredients List (SCIL).
EPA provided notice that manufacturers, importers, processors, distributors, users, and other entities who engage in the disposal of HDPE containers and other plastics containing fluorinated polyolefins must adhere to the significant new use notice requirement under TSCA. This notice was provided via an open letter to the HDPE industry that was initially posted on March 16, 2022, and then reissued with minor revisions on March 24, 2022. Here, EPA reminded the HDPE industry that the process of fluorination can lead to the unintentional manufacture of PFAS (e.g., byproducts). Furthermore, EPA stated that the manufacture of certain PFAS, including long-chain perfluoroalkyl carboxylates, via fluorination of polyolefins is considered a significant new use under TSCA because the byproducts exemption provided at 40 CFR § 721.45(e) does not apply. Specifically, this exemption does not apply because these PFAS are not “used only by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes.” Therefore, a significant new use notification (SNUN) must be submitted to EPA at least 90 days before initiating such use so that the Agency can review the potential risks of this new use before industry can place the product into the stream of commerce.
The two PFAS that EPA will be removing from the SCIL, CASRN 449177-94-0 and 452080-67-0, were initially placed on the list in 2012. In October of 2021, EPA began revisiting its previous PFAS endorsements pursuant the PFAS Strategic Roadmap. These two chemicals were subsequently removed from the list based on “a growing understanding of the toxicological profiles for certain PFAS, and incomplete information on the potential health and environmental effects of these substances.” Henceforth, these products that contain these PFAS will not be eligible Safer Choice certification. In addition, existing products containing these substances, that have received the Safer Choice certification, must be reformulated to maintain said certification.
EPA Releases Draft Revised Risk Determination for PV29
/in EPA, TSCAOn March 7, 2022, EPA released a draft revision to the risk determination for C.I. Pigment Violet 29 (PV29). Manufacturers and commercial clients use PV 29 as a weather fast and heat stable pigment in paints and coatings. These paints and coatings are primarily used in automobiles and industrial carpeting. The draft revision comes as part of the path forward EPA released in June 2021 for the first 10 risk evaluations under TSCA.
Risk evaluations are conducted under TSCA section 6. TSCA requires the Agency to conduct risk evaluations to determine whether high priority substances present an unreasonable risk of injury to health or the environment. EPA has determined that PV29, presents an unreasonable risk of injury to health. This determination regarding PV29, evaluated the substance as a “whole chemical,” replaces previous determinations which were based on evaluations of individual conditions of use.
The draft revision risk determination for PV29 does not include an assumption of personal protective equipment (PPE) for workers. Instead, EPA stated that the Agency would consider the use of PPE, and any other potential mitigating factors, during its determination of risk management measures. Note that the January 2021 risk evaluation for PV29found an unreasonable risk to workers, even when proper use of PPE is assumed. The January 2021 risk evaluation identified 14 categories of use and found unreasonable risk exists in 10 of those categories including:
The draft revision states these same conditions of use will continue to drive EPA’s determination of unreasonable risk for PV 29. The categories of use that were not found to present an unreasonable risk are: distribution in commerce, industrial/commercial use in plastic and rubber products, and consumer uses.