FR 2024-29132

The document is a final rule issued by the Environmental Protection Agency (EPA) regarding a specific protein, Bacillus thuringiensis Cry1Da2, used in corn as a plant-incorporated protectant. The EPA has granted an exemption from the requirement of a tolerance for residues of this protein on corn, meaning there is no need to set a maximum permissible level for these residues on food and feed commodities of corn. This exemption was requested by Pioneer Hi-Bred International, Inc., and the EPA determined that the protein is safe, presenting no significant risk of toxicity or allergenicity based on its comprehensive review.

General Summary

For those not deeply entrenched in regulatory language or scientific jargon, the rule essentially concludes that the Bacillus thuringiensis Cry1Da2 protein is safe for use in corn. This decision means that farmers and food producers using this protein do not need to worry about the legal thresholds of it being present in corn products, a decision expected to streamline regulatory processes and potentially reduce costs associated with regulatory compliance.

Significant Issues and Concerns

There are notable issues within the document that may warrant closer scrutiny. Firstly, the document does not mention any cost analysis or financial impact assessment related to the implementation of this regulation. Often, federal rules would include some economy-focused evaluation to ensure that benefits outweigh costs and that undue burdens are not imposed on various stakeholders. Absence of this discussion leaves readers without a clear understanding of any economic implications.

Furthermore, while Pioneer Hi-Bred International, Inc., is recognized as the petitioner for this exemption, the document does not clarify whether other organizations had access to a similar process for exemptions. This absence might suggest an appearance of favoritism, potentially affecting perceptions of transparency and fairness in regulatory practices.

Scientific and regulatory terminology can be dense and complex, potentially hindering the public's ability to engage meaningfully with the document. The lack of simplified explanations or accessible data summaries further compounds this issue, making it difficult for those without specialized knowledge to fully understand the rationale behind the exemption.

Broader Public Impact

The public's interaction with corn products, whether through consumption or other industries relying on corn, will likely not see any immediate changes due to this rule. The EPA's decision is based on safety evaluations that show no expected harm from the exposure to this protein, thus maintaining public health assurances.

Impact on Stakeholders

Positive Impact:

For agricultural producers and the pesticide industry, this ruling represents a positive development. By eliminating the need for specific tolerance levels, these stakeholders can potentially reduce costs associated with regulatory compliance. Such cost reductions could lead to improved efficiency and potentially lower prices for consumers in the long run.

Negative Impact:

However, the lack of a detailed financial impact analysis or public competitive process for similar exemptions can be seen as a limitation or a missed opportunity for these industries. Some stakeholders might feel disadvantaged or left out of the policy-making process, especially if they perceive an exclusive benefit granted to a single company without disclosure of a broader framework for similar considerations.

In summary, while the EPA's ruling is technically sound and aligned with existing safety standards, its presentation and process may leave questions unanswered for those affected by or interested in agricultural biotechnology regulations. The document navigates a significant regulatory space yet could benefit from an approach that might enhance public transparency and understanding.