Mancozeb, Maneb, Metiram, and Thiram; Tolerance Actions
Federal Register, Volume 79 Issue 93 (Wednesday, May 14, 2014)
Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)
Rules and Regulations
Pages 27496-27502
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-10955
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2009-0431; FRL-9909-80
RIN 2070-ZA16
Mancozeb, Maneb, Metiram, and Thiram; Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is revoking, modifying, and establishing specific tolerances for the fungicide mancozeb and revising the definition for total residue of dithiocarbamates permitted in or on the same raw agricultural commodity. These actions are in follow-up to the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). In addition, EPA is removing expired tolerances for mancozeb and maneb. EPA is taking no further tolerance actions herein on metiram and thiram because proposed changes have since been completed for metiram and the Agency expects to propose tolerance actions for thiram in a future notice in the Federal Register.
DATES: This regulation is effective November 14, 2014. Objections and requests for hearings must be received on or before July 14, 2014, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2009-0431, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review
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the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 308-8037; email address: nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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How can I file an objection or hearing request?
Under the Federal Food, Drug, and Cosmetic Act (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-
2009-0431 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 July 14, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0431, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
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Background
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What action is the agency taking?
In the Federal Register of September 16, 2009 (74 FR 47507) (FRL-
8431-4), EPA issued a proposed rule, in follow-up to reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). EPA proposed to revoke, modify, and establish specific tolerances for mancozeb, maneb, metiram, and thiram. In addition, EPA proposed to revise the definition for total residue of dithiocarbamates permitted in or on the same raw agricultural commodity in 40 CFR 180.3(d)(5). Also, the proposed rule of September 16, 2009 provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards.
In addition, in the Federal Register of September 16, 2009, EPA had proposed in 40 CFR 180.110 to revoke specific tolerances for maneb on apricot; bean, succulent; carrot, roots; celery; nectarine; and peach; and decrease tolerances on bean, dry, seed; broccoli; Brussels sprouts; cauliflower; cucumber; eggplant; kohlrabi; melon; bulb onion (revised from onion); pumpkin; summer squash; winter squash; and tomato; increase the tolerances on cabbage and beet, sugar, tops; establish tolerances on beet, sugar, roots; beet, sugar, dried pulp; fat of cattle, goats, hogs, horses, poultry, and sheep; meat of cattle, goats, hogs, horses, poultry, and sheep; meat byproducts of cattle, goats, hogs, horses, poultry, and sheep; egg; and milk, and revise certain commodity terminologies. However, in the intervening period EPA revoked all tolerances for maneb with expiration dates of December 31, 2012 in a final rule published in the Federal Register of July 12, 2011 (76 FR 40811) (FRL-8878-6) after notice and comment (proposed rule published May 26, 2010 (75 FR 29475) (FRL-8826-2)). Because these tolerances have expired and therefore are no longer needed, EPA is removing 40 CFR 180.110 in its entirety. EPA is removing that section herein without notice and opportunity to comment. Section 553(b)(3)(B) of the Administrative Procedure Act (APA) provides that notice and comment is not necessary ``when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.'' EPA finds good cause here because removing the section does not affect the already expired tolerances.
Also, in the Federal Register of September 16, 2009, EPA had proposed in 40 CFR 180.217 to revise the section heading from its chemical name to metiram, revise the introductory text containing the tolerance expression for metiram, decrease tolerances for metiram on apple to 0.5 ppm and potato to 0.2 ppm, and establish a tolerance on wet apple pomace at 2 ppm. However, in the intervening period EPA finalized these tolerance actions in a final rule published in the Federal Register of April 29, 2011 (76 FR 23882) (FRL-8869-1) after notice and comment (proposed rule published September 16, 2009 (74 FR 47507) (FRL-8431-4)). Therefore, no further changes are being made to 40 CFR 180.217.
In this final rule, EPA is also revoking, modifying, and establishing specific tolerances for mancozeb and revising the definition for total residue of dithiocarbamates permitted in or on the same raw agricultural commodity. However, EPA will not establish a tolerance for mancozeb on rice straw, which was proposed based on the 2005 Mancozeb Registration Eligibility Decision (RED), because since that time EPA has determined that rice straw is no longer a significant feed item in the United States. (The document entitled ``OPPTS Test Guideline 860.1000 Supplement: Guidance on Constructing
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Maximum Reasonably Balanced Diets (MRBD)'' is available at http://www.regulations.gov under docket ID number EPA-HQ-OPPT-2009-0155).
In addition, EPA is also revising 40 CFR 180.176(b) for mancozeb by removing the listing of time-limited tolerances on ginseng and walnut because they have already expired, on December 31, 2010 and December 31, 2013, respectively. Since no other tolerances would remain in that paragraph, the Agency is reserving that paragraph. EPA is making the revisions in 40 CFR 180.176(b) without notice and opportunity to comment. Section 553(b)(3)(B) of the APA provides that notice and comment is not necessary ``when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.'' EPA finds good cause here because removing the listing does not affect the legal status of the already expired tolerances.
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 RED for the active ingredient. REDs 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 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 http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic copies of REDs are available on the Internet at http://www.regulations.gov and http://www.epa.gov/pesticides/reregistration/status.htm.
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 the Federal Insecticide, Fungicide, and Rodenticide Act (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 FFDCA.
This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. Among the comments received by EPA, are the following:
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General comments.--i. Comments by the EBDC Task Force. The task force expressed support for the proposed change in the tolerance expression for ethylenebis dithiocarbamate (EBDC) fungicides from zineb equivalents to carbon disulfide equivalents. However, the task force proposed alternative language for the text proposed by EPA in 40 CFR 180.3(d)(5), which adds carbon disulfide as part of the tolerance definition. In addition, the task force requested that EPA should clarify that thiram is not a member of the EBDC class of fungicides, and thiram does not have a common mechanism of toxicity with the EBDCs. The task force stated that the individual mancozeb, maneb, and metiram REDs document that the EBDCs do not have a common mode of action with any other dithiocarbamate. Therefore the aggregate exposures and risks referred to in Unit II.A.2. of the proposed rule are separate for the EBDC fungicides and for thiram.
Agency response. EPA thanks the EBDC Task Force for its support of the proposed tolerance expression change to carbon disulfide equivalents for EBDC fungicides. The task force is correct regarding the text proposed in 40 CFR 180.3(d)(5) in that the comparison should be on a single basis, and not a combination of zineb and carbon disulfide values. However, instead of comparing the tolerances to the zineb values, as recommended by the task force, EPA is making the comparison to the new expression, carbon disulfide in 40 CFR 180.3(d)(5) to read as set out in the regulatory text at the end of this document. The conversion from zineb to carbon disulfide equivalents allows harmonization of U.S. tolerances with Codex Maximum Residue Limits (MRLs).
Regarding the task force's comment about EBDC fungicides and thiram, EPA presumes that the task force is referring to the following statement in the proposed rule: ``EPA has determined that the aggregate exposures and risks are not of concern for the above-mentioned pesticide active ingredients based upon the data identified in the RED or TRED which lists the submitted studies that the Agency found acceptable.'' This statement is a generic statement included in all tolerance actions based on recommendations in REDs and TREDs, referring to the safety standard in FFDCA. It is meant to imply that the aggregate risks for the individual chemicals are not of concern, which includes the aggregate exposure including food, drinking water, and residential sources. This statement does not refer to the aggregate risk of the metabolite that is common to the EBDCs, ethylene thiourea, nor does it imply that there is a common mode of action among all dithiocarbamates. The Agency has reviewed the dithiocarbamates and has determined that there is insufficient evidence to support grouping them in a common mechanism group (http://www.epa.gov/pesticides/cumulative/dithiocarb.pdf).
ii. Comments by the Natural Resources Defense Council (NRDC). NRDC expressed concern about the effects of the EBDC fungicides on
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women of child-bearing age, stating that for all the EBDCs and their degradate ethylene thiourea (ETU), the thyroid is the target organ. They have noted that a decrease in thyroxine in pregnant and lactating women, such as has been observed in laboratory animals exposed to the EBDC fungicides, can result in neuro-developmental problems in their children. NRDC specifically inquired whether the Agency considered the risks to the infants of low-iodide women, and has recommended that the Agency retain the Food Quality Protection Act (FQPA) factor of at least 10X, and possibly more. Also, NRDC encouraged EPA to fully evaluate the endocrine disrupting activity of the EBDC fumigants, potentially at very low environmentally-relevant exposure levels, using appropriately designed tests such as from the Endocrine Disruptor Screening Program (EDSP). NRDC stated that EPA has the opportunity to obtain reliable data about the endocrine disrupting effects associated with the EBDC fumigants, given the most current understanding about endocrine disruptors. NRDC recommended that EPA require registrants to submit a study properly designed to detect endocrine disruption. Also, NRDC expressed concerns about the potential toxicity of inert ingredients in the end use products made with EBDC fumigants, Agency follow-up on the compliance rate with mitigation measures, or any follow-up on the effectiveness of the mitigation in protecting workers and exposed wildlife, and the availability of non-chemical and reduced-risk chemical alternatives in its benefits assessment for the EBDC fumigants. In addition, NRDC objected to the continued use of the EBDC fungicides, which they described as not reduced-risk pesticides, in Integrated Pest Management (IPM) programs for many foliar disease management programs.
Agency response. On August 16, 2010, EPA sent a letter to NRDC which constituted a partial response by EPA to a letter dated November 16, 2009, submitted to the docket on behalf of NRDC, commenting on the September 16, 2009 proposed tolerance rule. EPA's response of August 16, 2010 addressed NRDC's concerns regarding the toxicity of inert ingredients in EBDC products, compliance with and effectiveness of mitigation measures, and consideration of non-chemical and reduced-risk alternatives in the benefits assessments for the EBDCs. The matters discussed in the August 16, 2010 response pertain to registration of EBDCs under FIFRA and are not relevant to setting of tolerances under FFDCA. That response is available in the docket of this final rule.
In a document dated July 9, 2010, EPA revised its responses of earlier documents (March 30, 2010 and May 14, 2010) to address NRDC's comments on the FQPA safety factor and the risks to infants of low-
iodide women of child-bearing age and potential endocrine-disrupting activity of EBDCs. EPA believes that the tolerances are safe for the reasons identified in the July 9, 2010 response. In addition, that response discussed the Endocrine Disruptor Screening Program as it applies to EBDCs and how existing endocrine disruption data regarding EBDCs is already taken into account in the FFDCA safety finding for EBDCs. The three EPA response documents are available in the docket of this final rule.
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Specific chemical comments.--i. Mancozeb.--a. Comments by the Mancozeb Task Force (MTF). The MTF expressed support for the proposed change in the mancozeb tolerance expression from zineb equivalents to carbon disulfide equivalents. The MTF stated that because the tolerance for sweet corn (kernel plus cob removed) was proposed by EPA to be decreased to 0.1 ppm and EPA determined that data for sweet corn can be translated to popcorn grain, the tolerance for popcorn grain should not be decreased to 0.06 ppm as EPA proposed, but instead should also be set at 0.1 ppm. Also, the MTF stated that no member of the MTF is supporting the carrot use on a regional basis and the existing tolerance could be revoked. In addition, the MTF commented on the mancozeb RED recommendations for certain grain, bran, flour, and hay tolerances.
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Comment by Argentine Department of Agriculture. The Argentine Department of Agriculture expressed deep concern over the Agency's proposed decrease to 1.5 ppm for the mancozeb tolerance on grape, and requested a copy of the risk assessment.
Agency response. EPA thanks the MTF for its support of the proposed tolerance expression change for mancozeb. EPA proposed to decrease the tolerance on sweet corn (kernel plus cob with husks removed) to 0.1 ppm in order to harmonize with a Codex MRL of 0.1 expressed as milligrams (mg) carbon disulfide/killigram (kg) for dithiocarbamates. Because EPA determined that the data for sweet corn can be translated to popcorn grain, EPA agrees with the MTF that the popcorn grain tolerance should be decreased to 0.1 ppm. Regarding the mancozeb tolerance for carrot roots, there is an existing FIFRA section 24(c) registration, and therefore EPA is redesignating that tolerance from 40 CFR 180.176(a) to (c) and decreasing it to 1 ppm. However, EPA is also revising the introductory text there to include a reference for the definition of a regional tolerance in 40 CFR 180.1(l). EPA is including that reference herein without notice and opportunity to comment. Section 553(b)(3)(B) of the APA provides that notice and comment is not necessary ``when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.'' EPA finds good cause here because including a reference does not affect the legal status of the tolerance.
As stated in the Federal Register of September 16, 2009, EPA did not propose certain tolerance actions (cottonseed; field corn grain; papaya; grain and straw of barley, oat, rye, and wheat; and milling feed fractions of barley, oat, and wheat) at that time because it had not verified that all mancozeb registrations for them had been revised or that required data had been received and approved. The Agency expects to address other mancozeb tolerance actions in a future publication in the Federal Register.
Concerning the Argentine Department of Agriculture's request, EPA did send a risk assessment and would be happy to address any specific questions.
ii. Thiram.--Comment by VJP Consulting, Inc. VJP Consulting commented on behalf of Taminco, Inc., a registrant of thiram, whose request for voluntary cancellation for thiram use on apples in the United States had been approved by EPA. VJP stated that the most recent dietary risk assessments for thiram in 2009 continued to include apple use and the acute and chronic dietary risks were acceptable. VJP noted that although EPA proposed to revoke the thiram tolerance on apple in the Federal Register of September 16. 2009, Taminco wanted the tolerance on apple maintained for importation purposes. In communication with the Agency in 2007, Taminco had declared such an interest and the Agency had notified Taminco that it must provide justification that the U.S. data is comparable to data that would have likely been gathered from trials in Canada and encouraged Taminco to submit at least some foreign data (at least 1 Canadian field trial). The Agency suggested that if thiram is being used in Canada, then some residue data should exist. The Agency noted that apples were removed at the time of the RED due to acute dietary concerns, and
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therefore, Taminco should also submit percent crop treated information in Canada and the percentage of thiram treated apples being imported for additional consideration. Further, the registrant was told to contact the Agency if there were additional questions.
Agency response. Because in a comment to the proposed rule, Taminco expressed a need for retention of the apple tolerance for import purposes and intends to support the tolerance with data, EPA will not revoke the tolerance for thiram in 40 CFR 180.132 on apple at this time. After the data have been reviewed, EPA will re-evaluate that tolerance under FFDCA. If data adequate to support a safety finding are lacking, EPA intends to revoke the tolerance on apple in 40 CFR 180.132.
Also, in the intervening period since the proposed rule published in the Federal Register of September 16, 2009, EPA has published several final rules which established tolerances for thiram expressed in residues of thiram (September 23, 2009 (74 FR 48386) (FRL-8431-9), February 12, 2014 (79 FR 8295) (FRL-9904-22), and April 4, 2014 (79 FR 18818) (FRL-9909-02)). Recently, EPA determined how all the existing tolerance levels for thiram should be expressed as carbon disulfide equivalents. Therefore, EPA will not take any tolerance actions on thiram in this final rule. Instead, EPA expects to propose them in a future notice in the Federal Register.
With the exception of the changes described in Unit II.A. and in the Agency responses to comments in this final rule, EPA is finalizing the amendments proposed concerning the pesticide active ingredient mancozeb in the Federal Register of September 16, 2009 and for good cause is removing expired maneb tolerances. For a detailed discussion of the Agency's rationale for the finalized tolerance actions, refer to the proposed rule of September 16, 2009.
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What is the Agency's authority for taking this action?
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 in the REDs for the active ingredients during the reregistration and tolerance reassessment processes, and as follow-up on canceled uses of pesticides.
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When do these actions become effective?
As stated in the DATES section, this regulation is effective 180 days after the date of publication in the Federal Register. EPA is delaying the effective date of these finalized actions to allow a reasonable interval for producers in exporting members of the World Trade Organization's Sanitary and Phytosanitary Measures Agreement to adapt to the requirements of a final rule. EPA believes that existing stocks of the canceled or amended pesticide products labeled for the uses associated with the revoked tolerances have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade.
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:
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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.
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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.
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International Residue Limits
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 United Nations 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 total dithiocarbamates determined as carbon disulfide in or on celery, fennel, oat bran, flax seed, rice, and sorghum.
The Codex has established MRLs for total dithiocarbamates determined as carbon disulfide in or on banana at 2 mg/kg, cranberry at 5 mg/kg, peanut at 0.1 mg/kg, and sweet corn (corn-on-the-cob) at 0.1 mg/kg. These MRLs will be the same as the tolerances modified herein for mancozeb in the United States.
The Codex has established MRLs for total dithiocarbamates determined as carbon disulfide in or on bulb onions at 0.5 mg/kg, sugar beets at 0.5 mg/kg, and tomato at 2 mg/kg. These MRLs will remain covered by U.S. tolerances at higher levels for mancozeb. These MRLs are different than the tolerances established for mancozeb in the United States because of differences in use patterns and/or good agricultural practices.
The Codex has established MRLs for total dithiocarbamates determined as carbon disulfide in or on various other commodities, including grapes at 5 mg/kg and pome fruits at 5 mg/kg. These MRLs are different than the tolerances modified herein for mancozeb in the United States because of differences in use patterns and/or good agricultural practices.
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Statutory and Executive Order Reviews
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 ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates
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Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). Nor does it require any special considerations as required by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis and available information concerning the pesticides listed in this rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket of the proposed rule). Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
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Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: May 7, 2014.
Jack Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
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The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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In Sec. 180.3, revise paragraph (d)(5) to read as follows:
Sec. 180.3 Tolerances for related pesticide chemicals.
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(d) * * *
(5) Where tolerances are established for more than one member of the class of dithiocarbamates listed in paragraph (e)(3) of this section on the same raw agricultural commodity, the total residue of such pesticides shall not exceed that permitted by the highest tolerance established for any one member of the class, calculated both as zinc ethylenebisdithiocarbamate and carbon disulfide. The tolerance based on zinc ethylenebisdithiocarbamate shall first be multiplied by 0.6 to convert it to the equivalent carbon disulfide tolerance, and then the carbon disulfide tolerance levels will be compared to determine the highest tolerance level per raw agricultural commodity.
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Sec. 180.110 Removed
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Remove Sec. 180.110.
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In Sec. 180.176, revise the table in paragraph (a) and revise paragraphs (b), and (c) to read as follows:
Sec. 180.176 Mancozeb; tolerances for residues.
(a) * * *
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Parts per
Commodity million
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Almond..................................................... 0.1
Almond, hulls.............................................. 4
Apple...................................................... 0.6
Asparagus.................................................. 0.1
Atemoya.................................................... 3.0
Banana..................................................... 2
Barley, bran............................................... 20
Barley, flour.............................................. 20
Barley, grain.............................................. 5
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Barley, pearled barley..................................... 20
Barley, straw.............................................. 25
Beet, sugar, dried pulp.................................... 3.0
Beet, sugar, roots......................................... 1.2
Beet, sugar, tops.......................................... 60
Broccoli................................................... 7
Cabbage.................................................... 9
Canistel................................................... 15.0
Cattle, kidney............................................. 0.5
Cattle, liver.............................................. 0.5
Cherimoya.................................................. 3.0
Corn, field, forage........................................ 40
Corn, field, grain......................................... 0.1
Corn, field, stover........................................ 15
Corn, pop, grain........................................... 0.1
Corn, pop, stover.......................................... 40
Corn, sweet, forage........................................ 70
Corn, sweet, kernel plus cob with husks removed............ 0.1
Corn, sweet, stover........................................ 40
Cotton, undelinted seed.................................... 0.5
Crabapple.................................................. 0.6
Cranberry.................................................. 5
Custard apple.............................................. 3.0
Fennel..................................................... 2.5
Flax, seed................................................. 0.15
Ginseng.................................................... 1.2
Goat, kidney............................................... 0.5
Goat, liver................................................ 0.5
Grape...................................................... 1.5
Hog, kidney................................................ 0.5
Hog, liver................................................. 0.5
Horse, kidney.............................................. 0.5
Horse, liver............................................... 0.5
Lettuce, head.............................................. 3.5
Lettuce, leaf.............................................. 18
Mango...................................................... 15.0
Oat, flour................................................. 20
Oat, grain................................................. 5
Oat, groats/rolled oats.................................... 20
Oat, straw................................................. 25
Onion, bulb................................................ 1.5
Papaya..................................................... 10
Peanut..................................................... 0.1
Peanut, hay................................................ 65
Pear....................................................... 0.6
Pepper..................................................... 12
Potato..................................................... 0.2
Poultry, kidney............................................ 0.5
Poultry, liver............................................. 0.5
Quince..................................................... 0.6
Rice, grain................................................ 0.06
Rye, bran.................................................. 20
Rye, grain................................................. 5
Rye, straw................................................. 25
Sapodilla.................................................. 15.0
Sapote, mamey.............................................. 15.0
Sapote, white.............................................. 15.0
Sheep, kidney.............................................. 0.5
Sheep, liver............................................... 0.5
Sorghum, grain, forage..................................... 0.15
Sorghum, grain, grain...................................... 0.25
Sorghum, grain, stover..................................... 0.15
Star apple................................................. 15.0
Sugar apple................................................ 3.0
Tangerine \1\.............................................. 10
Tomato..................................................... 2.5
Vegetable, cucurbit, group 9............................... 2.0
Walnut..................................................... 0.70
Wheat, bran................................................ 20
Wheat, flour............................................... 20
Wheat, germ................................................ 20
Wheat, grain............................................... 5
Wheat, middlings........................................... 20
Wheat, shorts.............................................. 20
Wheat, straw............................................... 25
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\1\ There are no U.S. registrations for use of mancozeb on tangerine.
(b) Section 18 emergency exemptions. Reserved
(c) Tolerances with regional registrations. A tolerance with regional registrations, as defined in Sec. 180.1(l), is established for residues of the fungicide mancozeb, (a coordination product of zinc ion and maneb (manganese ethylenebisdithiocarbamate)), including its metabolites and degradates, in or on the commodity in the following table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only those mancozeb residues convertible to and expressed in terms of the degradate carbon disulfide.
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Parts per
Commodity million
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Carrot, roots.............................................. 1
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Sec. 180.319 Amended
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In Sec. 180.319, remove the entry for ``Coordination product of zinc ion and maneb'' from the table in paragraph (a).
FR Doc. 2014-10955 Filed 5-13-14; 8:45 am
BILLING CODE 6560-50-P
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