USA Regulatory News

On February 20, 2024, the U.S. Environmental Protection Agency (EPA) announced the latest update to the Toxic Substances Control Act (TSCA) Inventory.    Key Findings of the Update  The TS...

On February 20, 2024, the U.S. Environmental Protection Agency (EPA) announced the latest update to the Toxic Substances Control Act (TSCA) Inventory. 

Key Findings of the Update 

The TSCA Inventory includes all existing manufactured, processed, or imported chemicals in the United States. As part of its regular release of non-confidential TSCA Inventory data, EPA updates the public TSCA Inventory every two years. 

The most recent TSCA Inventory contains a total of 86,741 chemical substances, with 42,293 substances classified as active. Updates to the TSCA Inventory also include data on unique identifiers, commercial activities, and regulatory flags including test orders and significant new use requirements (SNURs). 

Transition from Confidential to Public Information 

Furthermore, as part of EPA's ongoing review of TSCA confidential business information, certain substances remain on the list with their unique chemical identities after being moved from the confidential part of the Inventory to the public part. Since the last update of the TSCA Inventory in August 2023 EPA has moved approximately 900 chemicals from the confidential part to the public part of the Inventory.  

For more information on the TSCA Inventory, please visit: https://www.epa.gov/tsca-inventory. 

The Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Integrated Risk Information System (IRIS) Toxicological Review of Perfluorononanoic Acid (PFNA, CASRN 3...

The Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Integrated Risk Information System (IRIS) Toxicological Review of Perfluorononanoic Acid (PFNA, CASRN 375–95–1) and Related Salts. This draft document prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA's Office of Research and Development (ORD), precedes a contracted peer review. Comments received will be shared with the external peer reviewers. A public meeting organized by ERG, an EPA contractor, will be held during Step 4 of the IRIS Process to discuss the draft report. Public comments and feedback from the meeting will be considered by the external peer reviewers. The deadline for submitting comments is May 7, 2024.

Background and Proposed Reference Doses

In 2018, EPA announced its intention to assess five members of the per- and polyfluoroalkyl substance (PFAS) class using IRIS. The Agency had previously established Reference doses (RfDs) for perfluorobutanoic acid (PFBA) and perfluorohexanoic acid (PFHxA) and proposed RfDs for perfluorohexane sulfonate (PFHxS) and perfluorodecanoic acid (PFDA).

EPA has now proposed an RfD for perfluorononanoic acid (PFNA), that is in the mid-range compared to the other PFAS assessed by IRIS. The proposed RfD for PFNA, set at 7x10^-9 milligrams per kilogram per day (mg/kg per day), is significantly more stringent than the final RfDs for PFBA and PFHxA established in 2022 and 2023.

While RfDs generated by IRIS do not have direct legal implications, EPA may use them for regulatory risk assessments.

Concerns

Perfluorononanoic acid (PFNA) and its related salts are part of the group of per- and polyfluoroalkyl substances (PFAS). These synthetic compounds, which do not occur naturally, have found widespread use in consumer goods and industrial processes over the past several decades due to their resistance to heat, oil, stains, grease, and water. Concerns regarding PFNA and other PFAS arise from their resistance to hydrolysis, photolysis, and biodegradation, which leads to their persistence in the environment.

PFNA, commonly used in the production of fluoropolymers, can be found in various products such as carpets, food contact papers, cleaning and polishing products.

Health Effects of PFNA Exposure

Human epidemiologic studies have examined connections between PFNA exposure and several health outcomes, including fetal growth restriction, liver serum biomarkers, antibody responses, infectious diseases, sensitization and allergic responses, semen parameters, reproductive hormones, pubertal development, thyroid hormones, neurodevelopment, serum lipids, cardiovascular disease, metabolic effects, time to pregnancy, female reproductive responses, and urinary effects.

However, with the exception of reduced birth weight and increased serum ALT in adults, the ability to make conclusive judgements about these associations based on human evidence is limited.

Available evidence suggests potential immune, thyroid, neurodevelopmental, and cardiometabolic effects from oral exposure to PFNA under specific exposure conditions but is not sufficient to draw definitive conclusions. Medium-reliability epidemiological studies indicate potential immunosuppression, primarily related to prenatal and childhood exposures, resulting in reduced antibody responses following vaccinations. The evidence is insufficient to conclude that PFNA can cause immunotoxicity.

The Food and Drug Administration (FDA) has initiated an investigation into the cause of benzene contamination in certain drugs, raising concerns about potential health risks associated with the presen...

The Food and Drug Administration (FDA) has initiated an investigation into the cause of benzene contamination in certain drugs, raising concerns about potential health risks associated with the presence of this carcinogenic compound. Benzene contamination has prompted recalls of certain hand sanitizers and aerosol drug products and prompted the FDA to issue warnings to drug manufacturers regarding the dangers posed by benzene in drug components.

Benzene:

Benzene, a known human carcinogen, has been linked to leukemia and other blood disorders. Contamination can occur from inactive ingredients such as carbomers (thickening agents) or isobutane (a spray propellant), as well as other drug components derived from hydrocarbons. More than 60% of FDA-approved small molecule drugs contain at least one benzene ring motif. These include acetylsalicylic acid (Aspirin), acetaminophen (Tylenol), and ibuprofen (Advil) which are all painkillers sold over the counter. It is used primarily as a solvent in the chemical and pharmaceutical industries, as a starting material, and as an intermediate in the synthesis of numerous chemicals.

Action taken:

In light of these findings, the FDA emphasizes the need for drug manufacturers to establish scientifically sound specifications and testing procedures to ensure that both active and inactive ingredients, as well as finished drug products, meet appropriate quality standards. This includes rigorous testing of raw materials and finished product batches prior to release, to ensure conformity to specified criteria for identity, strength, quality, and purity.

Manufacturers are encouraged to use risk assessments to identify potential sources of contamination and implement appropriate risk mitigation measures. Specifically, the FDA has worked with manufacturers to conduct risk assessments focusing on ingredients derived from hydrocarbons or manufactured with benzene or other related compounds. Additionally, the FDA recognizes the potential for benzene formation from interactions between certain ingredients, such as sodium benzoate and antioxidants, which requires thorough testing throughout the shelf life of a drug product.

The International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents guidance and its companion document Q3C Tables and List provide guidance on limited cases where the presence of benzene may be tolerated. 

To address concerns regarding benzene contamination, drug manufacturers are advised to conduct testing and not release any product batch containing benzene levels above 2 parts per million (ppm). Manufacturers that identify batches that exceed this threshold must immediately initiate a recall and communicate with the FDA for further guidance.

Furthermore, manufacturers are urged to provide the FDA with comprehensive test results and information concerning the potential sources of benzene contamination to facilitate ongoing investigations.

On February 28, 2024, the U.S. Food and Drug Administration (FDA) made a significant announcement, declaring that manufacturers have ceased selling grease-proofing substances containing Per- and Polyf...

On February 28, 2024, the U.S. Food and Drug Administration (FDA) made a significant announcement, declaring that manufacturers have ceased selling grease-proofing substances containing Per- and Polyfluoroalkyl Substances (PFAS) for food contact coatings in the U.S. market. The completion of the voluntary market phase-out marks a critical step in eliminating the primary source of dietary exposure to PFAS from authorized food contact uses.

History:

In 2020 in an effort to protect public health, the FDA secured commitments from manufacturers to discontinue the sale of grease-proofing substances containing specific types of PFAS for food contact uses in the United States. The recent announcement signals the fulfilment of these voluntary commitments. Additionally, the FDA has confirmed that other manufacturers have voluntarily stopped selling various food contact grease-proofing substances containing different types of PFAS in the U.S.

PFAS In Food Packaging:

Grease-proofing substances are essential for preventing grease and oil leakage and providing water-resistant properties to paper and paperboard packaging. These PFAS-containing substances were commonly used in fast food wrappers, microwave popcorn bags, take-out containers, pet food bags, and similar packaging materials.

Most companies have exited the market ahead of the expected phase-out, despite an 18-month timeline. The FDA is also developing a validated analytical method to monitor the market for PFAS-containing food contact materials in packaging.

The FDA reaffirms its commitment to food chemical safety and the ongoing re-evaluation of authorized chemicals for use in food. Post-market safety evaluations will continue to ensure that risk determinations remain accurate and based on current scientific knowledge.

On February 8, 2024, the Environmental Protection Agency (EPA) finalized amendments to the 2018 Toxic Substances Control Act (TSCA) Fees Rule, which will increase fees and double the cost of new subst...

On February 8, 2024, the Environmental Protection Agency (EPA) finalized amendments to the 2018 Toxic Substances Control Act (TSCA) Fees Rule, which will increase fees and double the cost of new substance applications. The final rule aims to recover more program costs through industry-submitted fees. The agency cites the need for funding due to expanded TSCA responsibilities. Increased fees will increase resources for efficient chemicals, allowing for better protection of communities and supporting American innovation.

The final rule will become effective 60 days after its official publication in the Federal Register.

Key Changes

The final rule sets a fee of $37,000 for filing a Pre-Manufacture Notice (PMN) or Significant New Use Notice (SNUN), and $10,870 for filing a new chemicals exemption notice under TSCA Section 5. The EPA-initiated risk evaluation fee will increase from $1.605 million to $4.287 million which will be shared among responsible companies. Meanwhile, test orders will be priced at $25,000. Small businesses are eligible for an 80% fee reduction in each category. Some fees were reduced from the 2022 supplemental proposal due to adjustments in program costs.

Comparison to Previous Proposals 

• The final rule excludes extra fee categories proposed in 2021, such as filing a bona fide notice or Notice of Commencement (NOC) for new substance manufacturing.
• EPA maintains its approach of allocating risk evaluation fees based on production volume, with top producers covering 80% of the total fee.
• Despite suggestions for a REACH-like tonnage band system, the agency rejected it due to potential difficulties in estimating future manufacturers, resulting in a 25% program cost gap.
• EPA dismissed addressing the issue of 'free riders' entering the market after invoicing, acknowledging a competitive disadvantage for companies that already submitted fees. The agency plans to monitor this issue for potential inclusion in future TSCA fee rules.
• However, EPA is backing away from refunding fees to PMN submitters who withdraw before risk management, citing resource constraints and staff burden.

Exemptions

The new rule adds exemptions not included in the 2018 fee rules: 

(1) An exemption for research and development activities 

(2) An exemption for companies that manufacture less than 2,500 pounds (lbs) of a chemical subject to an EPA-initiated risk evaluation, or 1,100 lbs for TSCA Section 4 test rules.

(3) An exemption for manufacturers of chemical substances produced as non-isolated intermediates.

(4) Exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, manufactured as a by-product, or manufactured or imported as an impurity.

Companies that fall into the first three categories must certify to the agency that they meet the exemption criteria. 

On February 5, 2024, the U.S. Environmental Protection Agency (EPA) reinstated all chlorpyrifos tolerances, overturning a previous rule that had halted its use on all food and feed commodities in earl...

On February 5, 2024, the U.S. Environmental Protection Agency (EPA) reinstated all chlorpyrifos tolerances, overturning a previous rule that had halted its use on all food and feed commodities in early 2022.

Additionally, EPA announced in a posting on its website its intent to revoke all but specific uses of chlorpyrifos: alfalfa, apple, asparagus, cherry (tart), citrus, cotton, peach, soybean, strawberry, sugar beet, wheat (spring), and wheat (winter). 

Affected Parties and Industries

The reinstatement of chlorpyrifos tolerances will primarily affect agricultural producers, food manufacturers, pesticide manufacturers, and others who use these products.

Recommended Actions

Stakeholders are advised to closely monitor developments and be prepared to adjust chlorpyrifos manufacturing, distribution, and growing practices, given the anticipated fluctuations in the regulatory landscape. Distributors and growers should check the current Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and state registration status of existing chlorpyrifos stocks before selling, distributing, or using them.

Although all chlorpyrifos tolerances were in effect at the time, EPA confirmed that growers could use registered chlorpyrifos products on relevant crops, adhering to labeled instructions. However, numerous registered chlorpyrifos products were canceled in 2022, with no provisions for continued use on food or feed crops. EPA emphasized that existing final cancellation orders for chlorpyrifos products, including terms for sale, distribution, and use, remained in place until further notice.

Background on Chlorpyrifos

Chlorpyrifos is a widely used organophosphate insecticide, acaricide and miticide used primarily to control foliage and soil-borne insect pests. In August 2021, in response to a court order EPA revoked all tolerances for chlorpyrifos residues, impacting various crops. This decision followed the Ninth Circuit Court's directive to either revoke or modify the tolerances within a limited timeframe. Consequently, as of February 28, 2022, any residues from chlorpyrifos applications after that date would render food adulterated. However, on November 2, 2023, the Eighth Circuit Court overturned EPA's revocation, citing insufficient consideration for certain crop uses identified for potential modification in 2020.

Next Steps

Many chlorpyrifos product registrations were revoked in 2022, and existing revocation orders remain in place unless amended by EPA. EPA plans to promptly propose a new rule to revoke tolerances for most uses, with additional restrictions to address safety concerns and protect sensitive populations and species. This proposal will be subject to a 60-day public comment period before being finalized, as required by the Federal Food, Drug, and Cosmetic Act.

Conclusion

The regulatory situation surrounding chlorpyrifos products is expected to remain uncertain. While EPA's recent action reaffirms the current legal status of chlorpyrifos tolerances, it suggests that this reinstatement may be reversed in the future for most uses. Additionally, EPA plans to introduce further restrictions for the remaining uses. During this transitional period, all chlorpyrifos product applications must adhere to existing cancellation orders, including provisions for existing stocks.

On January 17, 2024, the Food and Drug Administration (FDA) announced the filing of a food additive petition on behalf of the Environmental Defense Fund and others, requesting that the food additive r...

On January 17, 2024, the Food and Drug Administration (FDA) announced the filing of a food additive petition on behalf of the Environmental Defense Fund and others, requesting that the food additive regulations be amended to eliminate four specific solvents. The food additive petition was filed on December 21, 2023. Comments are due March 11, 2024. 

Content of the food additive petition 

The petition seeks to eliminate the solvents benzene, trichloroethene, ethylene dichloride, and methylene chloride under the procedures for amending or repealing a food additive regulation in § 171.130 (21 CFR 171.130). The petitioners allege that these substances are not safe under the Delaney Clause because they have been found to induce cancer in humans and animals. 

According to the Delaney Clause, no food additive may be considered safe if it is found to cause cancer in humans or animals when consumed, or if it is found to cause cancer in humans or animals after studies appropriate for determining the safety of food additives. The petitioners have argued that 21 CFR 25.32(m), which refers to actions intended to restrict, or reduce the use of a substance in food, food packaging, or cosmetics, clearly excludes this action. 

Further details can be found here.  

Electronic Submissions 

 Electronic comments may be submitted as follows:  

• Submit either electronic or written comments on the filing notice by March 11, 2024. 

• Late, untimely filed comments will not be considered. The electronic filing system at https:// www.regulations.gov. will accept comments until 11:59 p.m. Eastern Time at the end of March 11, 2024. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date.