FR 2025-05173

The Environmental Protection Agency (EPA) has finalized a rule that exempts the pesticide residues of Pseudomonas oryzihabitans strain SYM23945 from needing a tolerance level in food, provided they are used according to label directions and good agricultural practices. The exemption was granted because EPA's assessment determined that this bacterial strain is non-toxic, and thus safe, under the conditions specified. According to EPA's findings, there is no significant health risk to humans, including vulnerable groups like infants and children, when exposed to this strain.

General Summary of the Document

The rule, published in the Federal Register, details that no maximum permissible residue level is required for this bacterial strain when used appropriately. This decision was reached following a petition by Indigo Ag, Inc. and reflects a safety assessment that demonstrated the bacterium does not pose toxicity, pathogenicity, or infection risks at predicted exposure levels. The rule's effective date is March 27, 2025, with provisions for objections and hearings under specific regulatory guidelines.

Significant Issues or Concerns

There are several notable considerations in the document:

• Complex Language: The scientific and legal jargon may be challenging for a general audience to understand. The references to toxicological profiles and specific statutory requirements assume familiarity with technical regulatory language.

• Regulatory References: The document makes multiple references to the Federal Food, Drug, and Cosmetic Act (FFDCA) and Code of Federal Regulations (CFR), which may not be intuitive for individuals unfamiliar with these codes.

• Objection Protocol: The process for filing objections or requesting hearings is governed by specific regulations (40 CFR part 178), implying that specialized legal knowledge may be necessary to navigate these processes effectively.

• Change Clarification: The removal of the term "nematicide" lacks a detailed explanation of potential impacts on agricultural or environmental practices, leading to possible ambiguity regarding regulatory scope and application.

Impact on the Public

Broadly, the exemption may lead to an increased application of Pseudomonas oryzihabitans strain SYM23945 in agricultural practices, given its recognized safety and lack of need for tolerance levels. This could contribute to more sustainable pest management approaches by offering a non-toxic alternative to traditional chemical pesticides.

Impact on Specific Stakeholders

• Agricultural Producers: Farmers and crop producers are likely to benefit from this rule as it permits the use of a biologically-based management option that is not subject to the same restrictions as conventional chemicals. This could reduce compliance burdens and potentially lower costs.

• Food and Pesticide Manufacturers: These industries might face reduced regulatory obstacles, allowing for faster deployment and integration of similar biopesticides into their production systems.

• Consumer Safety Groups: While the rule assures no significant health risks from exposure, some safety-focused organizations may express concerns about the lack of tolerance requirements and the long-term impact on ecosystem health despite EPA's assessment.

In conclusion, the EPA's rule on Pseudomonas oryzihabitans strain SYM23945 represents a step towards integrating safer, biologically-derived substances into agricultural practices. However, the rule's complexity means that stakeholders will need to carefully understand its implications, particularly the legal and regulatory aspects, to fully benefit from its implementation.

The document from the Environmental Protection Agency (EPA) primarily establishes an exemption from tolerance requirements for a specific bacterial strain and does not directly involve explicit financial appropriations, spending, or allocations. Instead, the document includes a financial reference in the context of regulatory requirements under U.S. law.

Unfunded Mandates Reform Act (UMRA) Reference

The document briefly discusses the Unfunded Mandates Reform Act (UMRA), which plays a role in assessing the financial implications of regulatory actions. Specifically, it asserts that this action "does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation)". This important clause implies that the regulatory action being discussed does not impose substantial direct costs or financial burdens exceeding this threshold on governmental bodies or the private sector. The absence of such a mandate is noteworthy because it suggests that compliance with the rule is not expected to lead to significant financial strain on small governments or entities.

Relation to Identified Issues

The financial reference to the UMRA is related to the broader regulatory framework governing how federal actions impact funding and financial responsibilities of different levels of government. This consideration might resonate with some of the more complex regulatory language observed in the document.

A key issue identified is that the language surrounding regulatory requirements, like mentions of 40 CFR part 178, might require specialized knowledge to interpret fully. Similarly, understanding the implications of the UMRA clause might not be straightforward for all readers unless they are familiar with federal regulatory financial requirements.

Despite these complexities, the UMRA reference provides reassurance that this rule is not expected to significantly or uniquely affect small governments financially. By explicitly noting the absence of a major unfunded mandate, the document emphasizes that it avoids imposing substantial unexpected costs on entities, aligning with statutory and executive order considerations aimed at evaluating the financial impacts of regulatory actions.

Overall, while the document does not directly discuss specific financial allocations or costs, referencing the UMRA standard ensures compliance with legislative requirements designed to protect smaller entities from overwhelming financial burdens due to new regulations.