Butylated Hydroxytoluene (BHT); Request for Information

The Food Contact Safety Council (FCSC), with support from America's Plastic Makers, supports the FDA's effort to establish a science-based, risk-informed framework for post-market chemical safety assessments. They argue that the FDA should prioritize current-use data over conservative assumptions and clearly distinguish between direct food uses, food-contact uses, and impurity scenarios to ensure a rigorous and accurate assessment of BHT.

The Center for Science in the Public Interest (CSPI) supports the FDA's initiation of a post-market evaluation of BHT. They argue that because BHT shows evidence of carcinogenicity in animals, the FDA should use its regulatory authority to ban the substance from the food supply.

The Food & Beverage Issue Alliance (FBIA), a coalition of 48 food and beverage trade associations, argues that the FDA should not revoke its authorizations for the use of BHT in foods. They contend that scientific evidence, including assessments by EFSA and JECFA, supports BHT's safety as an antioxidant and urge the agency to use a risk-based approach that considers modern scientific principles.

The National Pork Producers Council (NPPC) supports the continued authorization of Butylated Hydroxytoluene (BHT) as a safe and technologically necessary antioxidant in the food supply. They argue that BHT is essential for maintaining product quality, reducing food waste, and supporting international trade, particularly within the pork industry.

The Environmental Working Group (EWG) urges the FDA to revoke the approval of butylated hydroxytoluene (BHT) as a food additive. They argue that experimental animal studies provide strong evidence of liver toxicity, tumor-promoting activity, and potential endocrine disruption, which do not meet the standard of reasonable certainty of no harm.

The National Grain and Feed Association (NGFA) is providing information in response to the FDA's Request for Information on BHT. They urge the FDA to consider the interconnected nature of human and animal food supply chains, noting that regulatory changes for human food could cause operational disruptions and increased costs for animal feed producers.

The American Feed Industry Association (AFIA) supports the continued approval of BHT, highlighting its essential role as an antioxidant in animal feed and its superiority over current alternatives. They urge the FDA to include an assessment of BHT's role in the animal food industry to avoid unintended supply disruptions and economic challenges.

The Edible Oil Producers Association (EOPA) submitted information regarding the use, regulation, and safety of Butylated Hydroxytoluene (BHT) in the food industry. They emphasize their commitment to regulatory compliance and highlight BHT's role as an antioxidant in preserving food quality and safety.

The Flexible Packaging Association (FPA) argues that BHT used in food contact materials has a significantly lower safety risk and exposure profile than BHT used as a direct food additive. They urge the FDA to conduct a bifurcated safety review that recognizes these distinctions and accounts for realistic industry transition timelines for any potential regulatory changes.

The commenter, a registered nurse and consumer, supports a rigorous and transparent post-market review of BHT. They argue that the FDA should account for cumulative dietary exposure and scientific uncertainties rather than relying on outdated safety assumptions.