Daily Rules, Proposed Rules, and Notices of the Federal Government
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010- 0262 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 29, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010- 0262, by one of the following methods:
In this final rule, EPA is revoking, modifying, and establishing specific tolerances/tolerance exemptions for residues of cacodylic acid, dicamba, dicloran, diquat, disulfoton, EPTC, ethoprop, fenamiphos, hexazinone, methamidophos, methomyl, methyl bromide,
EPA is finalizing these tolerance actions in order to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each Reregistration Eligibility Decision (RED) and Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision (TRED) for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications, to reflect current use patterns, to meet safety findings and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-8695; Internet at
In this final rule, EPA is revoking certain tolerances and/or tolerance exemptions because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA in the United States. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide active ingredient. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to issue a final rule revoking those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or legally treated domestic commodities.
EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States.
Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies:
• Prior to EPA's issuance of a FFDCA section 408(f) order requesting additional data or issuance of a FFDCA section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.
• EPA independently verifies that the tolerance is no longer needed.
• The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.
In response to the proposal published in the
In addition, EPA is finalizing all other amendments proposed concerning disulfoton in the
However, EPA is revoking the tolerances for ethoprop in 40 CFR 180.262(a) on corn, pop, grain and corn, pop, stover and revising the introductory text containing the tolerance expression in 40 CFR 180.262(a).
Also, the Agency is not finalizing tolerance actions at this time on plant commodity tolerances in 40 CFR 180.111 which had been proposed for revocation in the
In addition, EPA is finalizing all other amendments proposed concerning methamidophos in the
Also, EPA is revoking the tolerances for methomyl in 40 CFR 180.253(a) on strawberry and watercress.
The Agency did not receive any specific comments, during the 60-day comment period, on the following pesticide active ingredients: Acephate, cacodylic acid, dicamba, dicloran (DCNA), diquat, fenamiphos, hexazinone, methyl bromide,
EPA may issue a regulation establishing, modifying, or revoking a tolerance under FFDCA section 408(e). In this final rule, EPA is establishing, modifying, and revoking tolerances to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes, and as follow-up on canceled uses of pesticides. As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standards under FFDCA. The safety finding determination is found in detail in each post-FQPA RED and TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, to meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed and electronic copies of the REDs and TREDs are available as provided in Unit II.A.
EPA has issued REDs for acephate, cacodylic acid, dicamba, dicloran (DCNA), diquat, disulfoton, EPTC, ethoprop, malathion, methamidophos, methomyl, methyl bromide,
EPA's general practice is to revoke tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.
When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, the Agency gives consideration to possible pesticide residues in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticides residues (40 CFR 180.6). If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, then tolerances do not need to be established for these commodities (40 CFR 180.6(b) and 180.6 (c)).
With the exception of certain tolerances for cacodylic acid, dicloran, disulfoton, methamidophos, and methyl bromide for which EPA is revoking with specific expiration/revocation dates, the Agency is revoking, modifying, and establishing specific tolerances, and revising specific tolerance nomenclatures effective on the date of publication of this final rule in the
Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for cacodylic acid, dicamba, EPTC, hexazinone,
The Codex has established MRLs for dicloran in or on commodities including carrot, postharvest at 15 mg/kg. This MRL is different than the current tolerance established for dicloran at 10 ppm in the United States, which EPA is revoking in this final rule. The tolerance was reassessed in the RED at 10 ppm and was harmonized with Codex at that time.
The Codex has established MRLs for diquat in or on commodities including sorghum at 2 mg/kg and soya bean (dry) at 0.2 mg/kg. These MRLs are the same as the current tolerances for diquat in or on sorghum, grain, grain and soybean, seed in the United States, which EPA is revoking in this final rule.
The Codex has established MRLs for disulfoton in or on commodities including asparagus at 0.02 mg/kg; cotton seed at 0.1 mg/kg. These MRLs are different than the current tolerances established for disulfoton in or on asparagus at 0.1 ppm and cotton, undelinted seed at 0.75 ppm in the United States, both of which EPA is revoking in this final rule. The tolerances were reassessed in the RED and were not harmonized with Codex levels because of differences in good agricultural practices. The Codex MRL for disulfoton in or on coffee beans is the same as the current tolerance for disulfoton in or on coffee, green bean, which EPA is revoking in this final rule.
The Codex has established MRLs for methamidophos in or on commodities including cauliflower at 0.5 mg/kg; cotton seed at 0.2 mg/kg; chili peppers at 2 mg/kg; sweet peppers at 1 mg/kg; and potato at 0.05 mg/kg. These MRLs are different than the current tolerances established for methamidophos from methamidophos application in or on cauliflower at 1.0 ppm; cotton, undelinted seed at 0.1 ppm; pepper at 1.0 ppm; and potato at 0.1 ppm in the United States, all of which EPA is revoking in this final rule. The tolerances were reassessed in the RED and were not harmonized with the Codex levels because of differences in good agricultural practices. While methamidophos is a metabolite of acephate and EPA is re-instating certain methamidophos tolerances as a result of the application of acephate, Codex has established MRLs for acephate but for compliance purposes has defined them as only acephate residues.
The Codex has established MRLs for phosmet in or on commodities including cotton seed at 0.05 mg/kg. This MRL is different than the current tolerance established for phosmet in or on cotton, undelinted seed at 0.1 ppm in the United States, which EPA is revoking in this final rule. The tolerance was reassessed in the RED and was not harmonized with the Codex level because of differences in good agricultural practices and tolerance expression where total residues for U.S. tolerances included phosmet's oxygen analog.
In this final rule, EPA establishes tolerances under FFDCA section 408(e), and also modifies and revokes specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (i.e., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a and 371.
(2) A tolerance of 0.02 ppm is established for residues of acephate,
(3) Tolerances are established for residues of methamidophos,
(a) * * * (1) * * *