Feedback Sought On Regulation Of Inert Ingredients In Pesticides For Organic Production – Food and Drugs Law

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  • On September 2, 2022, the USDA Agricultural Marketing Service
    (AMS), which administers the National Organic Program (NOP), issued
    an advanced notice of proposed rulemaking (ANPR) in which it
    requested the public’s comments on alternatives to the current
    organic regulations on inert ingredients (inerts). 87 Fed. Reg. 54173.

  • Currently, the organic regulations allow EPA List 3 and List 4
    inerts to be used in pesticide products when the product includes
    active ingredients permitted by the organic regulations (List 3
    substances may only be used in passive pheromone dispensers in crop
    7 CFR 205.601(m) and
    7 CFR 205.603(e). List 3 inerts are of unknown toxicity, List 4
    inerts pose a minimal risk or will not adversely public health or
    the environment, while Lists 1-2, which are not allowed as inerts
    in the organic program, pose a greater toxicological concern.
    EPA Categorized Lists of Inert Ingredients. Although the lists
    were originally added to the organic program to limit disruption to
    the organics industry and limit the administrative burden of
    evaluating each substance individually, the EPA has since moved
    away from the categorical list system and the EPA lists are no
    longer updated.

  • AMS has proposed five alternatives:

    1. Replace the reference to List 4 with an allowance for inerts
      allowed by EPA regulations in “minimum risk pesticides.”
      These inerts are listed in Table 2 at 40 CFR 152.25(f).

    2. Replace the reference to List 4 with an allowance for an inert
      that is exempt from the requirement of a tolerance. These are
      listed at 40 CFR, part 180, subpart D (active
      ingredients listed in these sections would not be permitted).

    3. Replace the reference to List 3 with reference to the current
      framework for inerts in “semiochemical dispensers,” which
      are chemicals released by plants and animals which modify the
      behavior of the receiving species. Special conditions for the
      exemption of these ingredients appear at 40 CFR 180.1122.

    4. Replace List 3 and/or List 4 with individualized listings in
      the organic regulations following review by the National Organic
      Standards Board (NOSB).

    5. Maintain the status quo (no action).

  • The ANPR includes a detailed list of questions which AMS hopes
    to receive feedback on, including (1) the disadvantages of relying
    on external lists, (2) NOSB and AMS resource constraints (in
    conducting individual evaluations), and (3) statutory requirements
    under the Organic Foods Production Act. Comments are due by
    November 1, 2022.

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