Tolerance Actions: Maneb
This Rule document was issued by the Environmental Protection Agency (EPA)
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Maneb; Tolerance Actions
Environmental Protection Agency (EPA).
EPA is revoking all the tolerances for the fungicide maneb with expiration/revocation dates that provide sufficient time to use existing stocks of the canceled registrations for the last food uses of maneb in the United States.
This regulation is effective July 12, 2011. Objections and requests for hearings must be received on or before September 12, 2011 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of theSUPPLEMENTARY INFORMATION).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2010-0327. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
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; e-mail address: firstname.lastname@example.org.
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an agriculturalproducer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
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 underFOR FURTHER INFORMATION CONTACT.
B. 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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. 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-2010-0327 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 September 12, 2011. 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-2010-0327, by one of the following methods:
A. What action is the Agency taking?
In theFederal Registerof May 26, 2010 (75 FR 29475) (FRL-8826-2), EPA issued a proposal to revoke all the tolerances for residues of the fungicide maneb after receipt and approval of requests for voluntary cancellation by registrants of the last registrations for food uses of maneb in the United States. Also, the proposal provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards.
In this final rule, EPA is revoking all the tolerances for the fungicide maneb, with delayed expiration/revocation dates in response to public comments requesting more time to use existing stocks of the canceled registrations. In addition, EPA had proposed in the May 26, 2010 issue of theFederal Registerto remove the expired tolerance in 40 CFR 180.110(b) for maneb residues in or on walnut, and reserve that paragraph. However, EPA previously removed that expired tolerance and reserved that paragraph in a final rule published in theFederal Registerof June 15, 2011 (76 FR 34883) (FRL-8875-4). Therefore, no further changes are being made to 40 CFR 180.110(b).
In response to the proposal published in theFederal Registerof May 26, 2010 (75 FR 29475), EPA received comments during the 60-day public comment period, as follows:
Comments. Commenters from the Regional Vegetable Extension Agent with the University of Florida, the Pesticide Safety Education Program of Oklahoma State University, and two growers requested that maneb use be extended until exhaustion for pepper, lettuce, grapes grown for wine, and leafy vegetables. One commenter requested that maneb use on broccoli, cabbage, and lettuce be extended for 5 years. Most comments received from multiple individual growers and also from the Cranberry Institute, the Department of Plant and Environmental Protection Sciences, College of Tropical Agriculture and Human Resources of the University of Hawaii, Florida Fruit and Vegetable Association, Arizona Pest Management Center, California's Glenn County Department of Agriculture, California's Tehama County Department of Agriculture, and Colorado Department of Agriculture, requested that maneb use be extended (for use on commodities such as almond, broccoli, cabbage, celery, cranberry, eggplant, lettuce, onion, pepper, potato, and tomato) and for timeframes ranging from a few months to over 2 years; i.e., the end of 2012.
Agency response. In theFederal Registerof May 26, 2010 (75 FR 29475) (FRL-8826-2), EPA proposed to revoke the maneb tolerances on the date of final rule publication in theFederal Register, which the Agency expected to occur in 2010. Based on the comments received, the Agency agrees that there is a need for more time to exhaust existing stocks of maneb. Therefore, EPA is revoking the tolerances for maneb in 40 CFR 180.110 with the expiration/revocation dates of December 31, 2012. The Agency believes the extended time is sufficient and consistent with the general outlook of the public comments received.
B. What is the Agency's authority for taking this action?
EPA may issue a regulation revoking tolerances under FFDCA section 408(e). EPA's general practice is to revoke tolerances for residues of pesticide active ingredients on crops for which the Federal Insecticide, Fungicide, and Rodenticide Act (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 thatrequire these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.
C. When do these actions become effective?
As noted in theDATESsection, this regulation is effective on the date of the publication in theFederal Register. In this final rule, EPA is revoking all the maneb tolerances with expiration/revocation dates of December 31, 2012. Based on the comments received during the 60-day public comment period, the Agency believes that the expiration/revocation dates allow users to exhaust existing stocks and allow sufficient time for passage of treated commodities 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 the Food Quality Protection Act (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.
III. 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 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 maneb per se, but has MRLs for total dithiocarbamates (which includes the dithiocarbamate maneb), determined as carbon disulfide.
IV. Statutory and Executive Order Reviews
In this final rule, EPA revokes specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (i.e., a 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 Reform Act of 1995 (UMRA) (Pub. L. 104-4). 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), Public Law 104-13, section 12(d) (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 revocations of tolerances 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. This analysis was published on December 17, 1997 (62 FR 66020) (FRL-5753-1), and was 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, as mentioned in Unit II.A.). 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 section 408(n)(4) of FFDCA. 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 tribalimplications” 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.
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in theFederal Register. This final rule 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: June 29, 2011.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
Part 180 Amended
1. The authority citation for part 180 continues to read as follows:
21 U.S.C. 321(q), 346a and 371.
2. Section 180.110 is amended by revising the table in paragraph (a) to read as follows:
§ 180.110 Maneb; tolerances for residues.
(a) * * *
* * * * *
[FR Doc. 2011-17365 Filed 7-11-11; 8:45 am]
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Comment Period Closed
Sep 12 2011, at 11:59 PM ET
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Date Posted: Jul 12, 2011
RIN: Not Assigned
CFR: 40 CFR Part 180
Federal Register Number: 2011-17365
This document is contained in
Related RINs: None
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