Federal Register: September 29, 2010 (Volume 75, Number 188)
DOCID: fr29se10-15 FR Doc 2010-24153
ENVIRONMENTAL PROTECTION AGENCY
Workers Compensation Programs Office
CFR Citation: 40 CFR Part 180
EPA ID: [EPA-HQ-OPP-2010-0262; FRL-8842-1]
NOTICE: Part IV
DOCID: fr29se10-15
DOCUMENT ACTION: Final rule.
SUBJECT CATEGORY:
Acephate, Cacodylic Acid, Dicamba, Dicloran, et al.; Tolerance Actions
DATES: This regulation is effective September 29, 2010. Objections and requests for hearings must be received on or before November 29, 2010, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
DOCUMENT SUMMARY:
EPA is revoking certain tolerances for the fungicides dicloran and thiophanatemethyl; the herbicides EPTC, hexazinone, picloram, and propazine; the defoliant and herbicide cacodylic acid; the plant growth regulator and herbicide diquat, the insecticides disulfoton, methamidophos, methomyl, phosmet, piperonyl butoxide, pyrethrins, and thiodicarb; the fumigant antimicrobial and insecticide methyl bromide, and the nematicides/insecticides ethoprop and fenamiphos, and the tolerance exemptions for the insecticide/miticide pyrethrum and insecticide synergist Noctyl bicycloheptene dicarboximide. However, EPA will not revoke specific malathion tolerances at this time. In addition, EPA is removing certain expired tolerances for disulfoton, fenamiphos, and thiophanatemethyl. Also, EPA is modifying certain tolerances for the fungicide thiophanatemethyl, herbicides dicamba, EPTC, hexazinone and picloram, and insecticide synergist Noctyl bicycloheptene dicarboximide. In addition, EPA is establishing new tolerances for the fungicide thiophanatemethyl and the herbicides EPTC, hexazinone, and picloram. Also, EPA is reinstating specific tolerances for methamidophos residues as a result of the application of the insecticide acephate. The regulatory actions finalized in this document are in followup to the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act (FFDCA), section 408(q).
SUMMARY:
Environmental Protection Agency
SUPPLEMENTAL INFORMATION
I. General Information
A. 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. 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 under FOR 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 eCFR site at http:// www.gpoaccess.gov/ecfr.
C. How Can I File an Objection or Hearing Request?
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 EPAHQOPP2010 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 nonCBI objection or hearing request, identified by docket ID number EPAHQOPP2010 0262, by one of the following methods:
A. What Action is the Agency Taking?
In the Federal Register of May 19, 2010 (75 FR 28155) (FRL88213), EPA
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issued a proposal to revoke, modify, and establish specific tolerances
for residues of the fungicides dicloran and thiophanatemethyl; the
herbicides dicamba, EPTC, hexazinone, picloram, and propazine; the
defoliant and herbicide cacodylic acid; the plant growth regulator and herbicide diquat, the insecticides disulfoton, malathion,
methamidophos, methomyl, phosmet, piperonyl butoxide, pyrethrins, and
thiodicarb; the fumigant, antimicrobial, and insecticide, methyl
bromide, and the nematicides/insecticides, ethoprop and fenamiphos, and
the tolerance exemptions for the insecticide/miticide pyrethrum and
insecticide synergist Noctyl bicycloheptene dicarboximide. In
addition, EPA proposed to remove certain expired tolerances for
disulfoton, fenamiphos, and thiophanatemethyl, and to reinstate
specific tolerances for methamidophos residues as a result of the
application of the insecticide acephate. Also, the proposal of May 19,
2010 (75 FR 28155) provided a 60day comment period which invited
public comment for consideration and for support of tolerance retention under FFDCA standards.
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, N octyl bicycloheptene dicarboximide, phosmet, picloram, piperonyl butoxide, propazine, pyrethrins, pyrethrum, thiodicarb, and thiophanatemethyl in or on commodities listed in the regulatory text of this document. Also, EPA is removing certain expired tolerances for disulfoton, fenamiphos, and thiophanatemethyl, and reinstating specific tolerances for methamidophos residues as a result of the application of the insecticide acephate.
EPA is finalizing these tolerance actions in order to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including followup 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 452422419; telephone number: 18004909198; fax number: 1513489 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: 18005536847 or (703) 6056000; Internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the Internet at 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 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:
In response to the proposal published in the Federal Register of May 19, 2010 (75 FR 28155), EPA received comments during the 60day public comment period, as follows:
1. Disulfoton comment by Bayer CropScience. The commenter requested that the Agency delay revocation of the disulfoton tolerances proposed in the Federal Register of May 19, 2010 (75 FR 28155) because of communications received from trade channels and growers who claim that they will not exhaust their existing stocks for disulfoton use on those crops by EPA's proposed revocation dates. Therefore, Bayer CropScience requested that the Agency delay tolerance revocation by an additional 5 years.
Agency response. In a followup communication with the Agency, Bayer CropScience provided disulfoton sales information over a recent period of years. The Agency has considered the information that Bayer provided together with the Agency's data on disulfoton production, sales, inventory, and use, and determined that there is a need for more time to exhaust existing stocks. The Agency believes that extending tolerance revocation by 1 additional year for lima and succulent snap beans, broccoli, Brussels sprouts, cabbage, cauliflower, cotton, coffee green beans, and asparagus, and by 2 additional years for head and leaf lettuce would allow sufficient time to exhaust existing stocks. Therefore, EPA is revoking the tolerances in 40 CFR 180.183(a) on bean, lima; bean, snap, succulent; broccoli; Brussels sprouts; cabbage; cauliflower; and cotton, undelinted seed with expiration/revocation dates of December 31, 2013, the tolerances in 40 CFR 180.183(a) on lettuce, head and lettuce, leaf with expiration/revocation dates of December 31, 2014, the tolerance in 40 CFR 180.183(a) on coffee, green bean with an expiration/revocation date of June 30, 2014, and the tolerance in 40 CFR 180.183(c) on asparagus with an expiration/ revocation date of December 31, 2013.
In addition, EPA is finalizing all other amendments proposed concerning disulfoton in the Federal Register of May 19, 2010 (75 FR 28155).
2. EPTCcomment by Gowan Company. The commenter from Gowan requested that EPA delay revocation of
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the EPTC tolerance on vegetable, root at 0.1 ppm until the Agency has
reviewed residue data on carrots, which it had earlier submitted to the
California Department of Pesticide Regulation (CDPR) to support a
Special Local Need (SLN) in California. The commenter stated that CDPR
had reviewed the carrot data and granted the SLN in 2008, and that the
company would submit the residue data for EPTC on carrots to the Agency by July 30, 2010.
Agency response. Recently, the Agency received magnitude of
residue data for EPTC in/on carrots from Gowan Company. The Agency will
consider the data for carrots and therefore, will not take any action
on the vegetable, root tolerance in 40 CFR 180.117(a) at this time.
Also, the Agency will not establish any of the proposed individual
tolerances for beet, garden, roots; beet, sugar, roots; potato; and
sweet potato, roots at this time. However, EPA is finalizing all other
amendments proposed concerning EPTC in the Federal Register of May 19, 2010 (75 FR 28155).
3. Ethopropcomment by Bayer CropScience. The commenter requested that the Agency not revoke the tolerance for ethoprop on pineapple. The commenter stated that there is still a need for the tolerance to cover pineapples imported into the United States. Bayer CropScience is also prepared to support an import tolerance where necessary.
Agency response. Because Bayer CropScience has stated a continued need for the tolerance on pineapple in 40 CFR 180.262(a), the Agency will not take any action on the tolerance at this time with a footnote to denote that there are no registrations on pineapple in the United States as of July 23, 2009, except for existing stocks bearing old labeling whose sale, distribution, and use is allowed, provided it is consistent with the terms of the cancellation order of July 9, 2009. The proposed revocation, with a proposed effective date of January 9, 2011, had been based on the Agency's belief that pineapple treated with existing stocks of ethoprop bearing old labeling whose sale, distribution, and use is allowed, provided it is consistent with the terms of the cancellation order of July 9, 2009, would have cleared the channels of trade by that time, about 1 year after the registrant was last permitted to sell and distribute stocks of the amended registration (concerning pineapple use deletion). Under that amended registration, the Agency will continue to allow the registrant to sell and distribute existing stocks of products bearing the old labeling for 18 months after July 9, 2009; i.e., until January 9, 2011. Also, the Agency will continue to allow persons other than the registrant to sell and distribute those existing stocks of products bearing the old labeling and use of them until exhaustion, consistent with the terms of the cancellation order of July 9, 2009.
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).
4. Malathioni. comment by Cheminova, Inc.. The commenter from Cheminova requested that the Agency not revoke any existing tolerance in 40 CFR 180.111 for malathion until the Agency can establish a tolerance for inadvertent residues to cover critical uses including public health mosquito and fly control, exotic/imported pest suppression and eradication programs, grasshopper/mormon cricket suppression programs, and other quarantine programs administered or directed by the United States Department of Agriculture and Individual states. In addition to its general concerns, Cheminova requested that animal tolerances for malathion in 40 CFR 180.111 be retained since the Agency's human health risk assessment did not have a healthrelated concern that necessitated revocation of animal tolerances and to avoid trade irritant issues that may arise from mistaken views about use of malathion on animal feed products. Also, the commenter requested that the tolerances on nonmedicated cattle feed concentrate blocks (residues resulting from malathion application to paper used in packaging) and citrus, dried pulp (residues resulting from malathion application to bagged citrus pulp during storage) in 40 CFR 180.111 not be revoked to avoid trade barriers concerning preharvest use of malathion related to any animal feed commodity, and cited orange processing data that showed a need for the establishment of a citrus, dried pulp tolerance as a result of foliar application of malathion to citrus.
ii. Comments by American Mosquito Control Association (AMCA), the Texas Boll Weevil Eradication Foundation, Inc., and the National Cotton Council of America (NCC). The commenters requested that the Agency not revoke existing tolerances in 40 CFR 180.111 for malathion because of boll weevil and public health mosquito control use of malathion in the vicinity of crop commodities, including cotton, and the potential for inadvertent deposition of malathion residues on adjacent crops.
iii. Comment by the United States Department of Agriculture's Animal and Public Health Inspection Service. The commenter requested that the Agency not revoke existing tolerances for bagged citrus pulp and peanut, hay in 40 CFR 180.111 for malathion because of pest control use of malathion in citrus groves and areas adjoining cotton and peanut fields; and the potential for inadvertent deposition of malathion residues on adjacent crops.
Agency response. Malathion tolerances for animal commodities were originally based on use patterns involving direct animal treatments with malathion. Subsequently, direct animal treatment uses were not supported for reregistration, eliminating this exposure pathway. In the malathion Reregistration Eligibility Decision (RED), tolerances on livestock commodities were recommended to be revoked based on no active registrations for direct animal treatment and available ruminant and poultry metabolism data at exaggerated feeding rates of malathion treated livestock feeds, from which EPA concluded that no residues of malathion or malaoxon occur in eggs, milk, and animal tissues as a result of dietary exposure to these animals. However, the Agency intends to reevaluate its decision on whether livestock commodity tolerances may be needed based on pending and recently reviewed livestock feed item residue data that were not available at the time of the RED. Therefore, the Agency will defer its decision of whether to revoke the livestock commodity tolerances until all required livestock feed residue data have been received and reviewed.
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 Federal Register on May 19, 2010 (75 FR 28155). However, the Agency is revising the commodity terminology for ``bean, dry seed'' to ``bean, dry, seed.''
5. Methamidophoscomment by Bayer CropScience. The commenter requested that the Agency delay revocation of the methamidophos tolerances on cotton, potato, and tomato because of communications received from trade channels and growers who claim that they will not exhaust their existing stocks for methamidophos use on those crops by EPA's proposed revocation dates. Therefore, Bayer CropScience requested that the Agency delay tolerance revocation for the three crop commodities from December 31, 2012 by an additional 3 years.
Agency response. In a followup communication with the Agency, Bayer
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CropScience agreed that 1 additional year for methamidophos use would
allow sufficient time to exhaust existing stocks; i.e., tolerance
revocation on December 31, 2013. Because there is a need for more time
to exhaust existing stocks of methamidophos for use on cotton, potato,
and tomato, EPA is extending the time by 1 year and revoking the
tolerances in 40 CFR 180.315 on cotton, undelinted seed, potato, and
tomato with expiration/revocation dates of December 31, 2013. Also, EPA
is redesignating 40 CFR 180.315(b) as 40 CFR 180.315(c), removing the
tolerance on tomato from 40 CFR 180.315(a) and transferring it to newly
designated and revised 40 CFR 180.315(c), and increasing the tolerance on tomato to 2.0 ppm.
In addition, EPA is finalizing all other amendments proposed concerning methamidophos in the Federal Register of May 19, 2010 (75 FR 28155).
6. Methomylcomment by DuPont Crop Protection. Regarding the proposed revocation of the methomyl tolerance on leeks at 3.0 ppm, a commenter asked if in the future, DuPont submits an action to add leeks to the methomyl labels whether that use on leeks would be covered per 40 CFR 180.1(g) by the existing tolerance of 3 ppm on onion, green in 40 CFR 180.253.
Agency response. There have been no active fooduse registrations for use of methomyl on leeks in the United States for more than 10 years, and therefore the tolerance is no longer needed. Therefore, EPA is revoking the tolerance in 40 CFR 180.253(a) on leeks. If in future, DuPont submits an action to add leeks to methomyl labels, the Agency would consider if data are needed, and whether a tolerance level of 3 ppm for onion, green in 40 CFR 180.253 is appropriate per 40 CFR 180.1(g) to cover use on leeks or a new tolerance should be established separately on leeks.
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 60day comment period, on the following pesticide active ingredients: Acephate, cacodylic acid, dicamba, dicloran (DCNA), diquat, fenamiphos, hexazinone, methyl bromide, Noctyl bicycloheptene dicarboximide (MGK 264), phosmet, picloram, piperonyl butoxide, propazine, pyrethrins, pyrethrum, thiodicarb, and thiophanatemethyl. Therefore, EPA is finalizing the amendments proposed concerning these pesticide active ingredients in the Federal Register of May 19, 2010 (75 FR 28155). For a detailed discussion of the Agency's rationale for the establishments, revocations, and modifications to the tolerances/tolerance exemptions, refer to the proposed rule of May 19, 2010 (75 FR 28155).
B. 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 during the reregistration and tolerance reassessment processes, and as followup 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 postFQPA 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, Noctyl bicycloheptene dicarboximide, phosmet, picloram, piperonyl butoxide, pyrethrins, pyrethrum (see pyrethrins), thiodicarb, and thiophanatemethyl, and TREDs for hexazinone, methyl bromide, and propazine. REDs and TREDs contain the Agency's evaluation of the database for these pesticides, including statements regarding additional data on the active ingredients that may be needed to confirm the potential human health and environmental risk assessments associated with current product uses, and REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FFDCA standard of ``reasonable certainty of no harm.'' However, tolerance revocations recommended in REDs and TREDs that are made final in this document do not need such assessment when the tolerances are no longer necessary.
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)).
C. When Do These Actions Become Effective?
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 Federal Register. With the exception of the
revocation of specific tolerances for cacodylic acid, dicloran,
disulfoton, methamidophos, and methyl bromide, the Agency believes that
existing stocks of 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. EPA is revoking the cacodylic acid tolerance on
cotton, undelinted seed with an expiration date of January 1, 2012;
dicloran tolerance on carrot, roots, postharvest with an expiration/ revocation date of November 2, 2011;
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disulfoton tolerances on bean, lima; bean, snap, succulent; broccoli;
Brussels sprouts; cabbage; cauliflower; cotton, undelinted seed; and
asparagus with expiration dates of December 31, 2013; disulfoton
tolerances on lettuce, head and lettuce, leaf wtih expiration/
revocation dates of December 31, 2014; disulfoton tolerance on coffee,
green bean with an expiration/revocation date of June 30, 2014;
methamidophos tolerances on broccoli and cabbage with expiration/
revocation dates of December 31, 2012 and cotton, undelinted seed;
tomato; and potato with expiration/revocation dates of December 31,
2013; methyl bromide tolerance on timothy, hay, postharvest with an
expiration/revocation date of October 19, 2010; and methyl bromide
tolerances on alfalfa, hay, postharvest and cotton, undelinted seed
with expiration/revocation dates of October 31, 2011. The Agency
believes that these revocation dates allow users to exhaust 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 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
standardssetting 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, Noctyl bicycloheptene dicarboximide, picloram,
propazine, pyrethrum, thiodicarb, and thiophanatemethyl, or MRL in or
on corn, pop, grain; corn, pop, stover; or pineapple for ethoprop; or
MRL in or on citrus, dried pulp; citrus, oil; fruit, citrus, group 10;
or garlic for fenamiphos; or MRL for citrus, dried pulp; cranberry;
peanut, hay; peanut, postharvest; raisins; safflower, seed; safflower,
refined oil; sunflower, seed, postharvest; fat, meat, and meat
byproducts of cattle, goats, hogs, horses, poultry, and sheep; egg;
milk, fat; or nonmedicated cattle feed concentrate blocks for
malathion; or MRL in or on alfalfa, hay, postharvest; cotton,
undelinted seed; mango, postharvest; papaya, postharvest; or timothy,
hay, postharvest for bromide ion or methyl bromide; or MRL in or on
leek; strawberry; or watercress for methomyl; or MRL in or on broccoli;
Brussels sprouts; cabbage; lettuce; or tomato for methamidophos.
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 reinstating 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.
IV. 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
[[Page 60237]]
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
1044). Nor does it require any special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and LowIncome
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 10413, 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
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) (FRL57531), 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, 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 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.
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 the Federal 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: September 10, 2010.
Steven Bradbury,
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:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.108 is amended as follows:
a. Revise the introductory text to paragraph (a)(1).
b. Revise footnote 1 to the table in paragraph (a)(1).
c. Revise paragraph (a)(2).
d. Add paragraph (a)(3).
e. Revise paragraph (c).
The revised and added text reads as follows:
Sec. 180.108 Acephate; tolerances for residues.
(a) * * * (1) Tolerances are established for residues of acephate,
O,Sdimethyl acetyl phosphoramidothioate, including its metabolites and
degradates other than methamidophos, in or on the commodities in the
following table. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only acephate, O,Sdimethyl acetyl phosphoramidothioate, in or on the commodity.
Parts per
Commodity\1\ million * * * * *
\1\ Where there is a direct use of methamidophos on the commodity,
residues of methamidophos resulting from methamidophos application are regulated under 40 CFR 180.315.
[[Page 60238]]
(2) A tolerance of 0.02 ppm is established for residues of
acephate, O,Sdimethyl acetyl phosphoramidothioate, including its
metabolites and degradates other than methamidophos, in or on all food
items (other than those already covered by a higher tolerance as a
result of use on growing crops) in food handling establishments where
food and food products are held, processed, prepared and served,
including food service, manufacturing and processing establishments,
such as restaurants, cafeterias, supermarkets, bakeries, breweries,
dairies, meat slaughtering and packing plants, and canneries, where
application of acephate shall be limited solely to spot and/or crack
and crevice treatment (a coarse, lowpressure spray shall be used to
avoid atomization or splashing of the spray for spot treatments;
equipment capable of delivering a pinstream of insecticide shall be
used for crack and crevice treatments). Spray concentration shall be
limited to a maximum of 1.0 percent active ingredient. Contamination of
food or foodcontact surfaces shall be avoided. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only acephate, O,Sdimethyl acetyl phosphoramidothioate, in or on the commodity.
(3) Tolerances are established for residues of methamidophos, O,S
dimethyl phosphoramidothioate, including its metabolites and
degradates, in or on the commodities in the following table as a result
of the application of acephate. Compliance with the tolerance levels
specified in this paragraph is to be determined by measuring only
methamidophos, O,Sdimethyl phosphoramidothioate, in or on the commodity.
Parts per
Commodity million
Bean, dry, seed............................................ 1
Bean, succulent............................................ 1
Brussels sprouts........................................... 0.5
Cauliflower................................................ 0.5
Celery..................................................... 1
Cranberry.................................................. 0.1
Lettuce, head.............................................. 1
Pepper..................................................... 1
Peppermint, tops........................................... 1
Spearmint, tops............................................ 1 * * * * *
(c) Tolerances with regional registrations. A tolerance with a
regional registration is established for residues of acephate, O,S
dimethyl acetyl phosphoramidothioate, including its metabolites and
degradates other than methamidophos, in or on the commodity in the
following table. Compliance with the tolerance level specified in this
paragraph is to be determined by measuring only acephate, O,Sdimethyl acetyl phosphoramidothioate, in or on the commodity.
Parts per
Commodity\1\ million
Nut, macadamia............................................. 0.05
\1\ Where there is a direct use of methamidophos on the commodity,
residues of methamidophos resulting from methamidophos application are regulated under 40 CFR 180.315.
* * * * *
3. In Sec. 180.111 revise the table in paragraph (a)(1) to read as follows:
Sec. 180.111 Malathion; tolerances for residues.
(a) * * * (1) * * *
Parts per
Commodity million
Alfalfa, forage............................................ 135
Alfalfa, hay............................................... 135
Almond, hulls.............................................. 50
Almond, postharvest........................................ 8
Apple...................................................... 8
Apricot.................................................... 8
Asparagus.................................................. 8
Avocado.................................................... 8
Barley, grain, postharvest................................. 8
Bean, dry, seed............................................ 8
Bean, succulent............................................ 8
Beet, garden, roots........................................ 8
Beet, garden, tops......................................... 8
Beet, sugar, roots......................................... 1
Beet, sugar, tops.......................................... 8
Blackberry................................................. 8
Blueberry.................................................. 8
Boysenberry................................................ 8
Carrot, roots.............................................. 8
Chayote, fruit............................................. 8
Chayote, roots............................................. 8
Cherry..................................................... 8
Chestnut................................................... 1
Clover, forage............................................. 135
Clover, hay................................................ 135
Corn, field, forage........................................ 8
Corn, field, grain, postharvest............................ 8
Corn, pop, grain, postharvest.............................. 8
Corn, sweet, forage........................................ 8
Corn, sweet, kernel plus cob with husks removed............ 2
Cowpea, forage............................................. 135
Cowpea, hay................................................ 135
Cranberry.................................................. 8
Cucumber................................................... 8
Currant.................................................... 8
Date, dried fruit.......................................... 8
Dewberry................................................... 8
Eggplant................................................... 8
Fig........................................................ 8
Flax, seed................................................. 0.1
Garlic, bulb............................................... 8
Gooseberry................................................. 8
Grape...................................................... 8
Grapefruit................................................. 8
Guava...................................................... 8
Hazelnut................................................... 1
Hop, dried cones........................................... 1
Horseradish................................................ 8
Kumquat.................................................... 8
Leek....................................................... 8
Lemon...................................................... 8
Lentil, seed............................................... 8
Lespedeza, hay............................................. 135
Lime....................................................... 8
Loganberry................................................. 8
Lupin, seed................................................ 8
Mango...................................................... 8
Melon...................................................... 8
Mushroom................................................... 8
Nectarine.................................................. 8
Nut, macadamia............................................. 1
Oat, grain, postharvest.................................... 8
Okra....................................................... 8
Onion, bulb................................................ 8
Onion, green............................................... 8
Orange..................................................... 8
Papaya..................................................... 1
Parsnip.................................................... 8
Passionfruit............................................... 8
Pea........................................................ 8
Pea, field, hay............................................ 8
Pea, field, vines.......................................... 8
Peach...................................................... 8
Peanut, hay................................................ 135
Peanut, postharvest........................................ 8
Pear....................................................... 8
Pecan...................................................... 8
Pepper..................................................... 8
Peppermint, tops........................................... 8
Pineapple.................................................. 8
Plum....................................................... 8
Plum, prune................................................ 8
Potato..................................................... 8
Pumpkin.................................................... 8
Quince..................................................... 8
Radish..................................................... 8
Raspberry.................................................. 8
Rice, grain, postharvest................................... 8
Rice, wild................................................. 8
Rutabaga................................................... 8
Rye, grain, postharvest.................................... 8
Safflower, seed............................................ 0.2
Salsify, roots............................................. 8
Salsify, tops.............................................. 8
Shallot, bulb.............................................. 8
Sorghum, grain, forage..................................... 8
Sorghum, grain, grain, postharvest......................... 8
Soybean, forage............................................ 135
Soybean, hay............................................... 135
Soybean, seed.............................................. 8
Soybean, vegetable, succulent.............................. 8
Spearmint, tops............................................ 8
Squash, summer............................................. 8
Squash, winter............................................. 8
Strawberry................................................. 8
Sunflower, seed, postharvest............................... 8
Sweet potato, roots........................................ 1
Tangerine.................................................. 8
Tomato..................................................... 8
Trefoil, forage............................................ 135
Trefoil, hay............................................... 135
Turnip, greens............................................. 8
Turnip, roots.............................................. 8
Vegetable, brassica, leafy, group 5........................ 8
Vegetable, leafy, except brassica, group 4................. 8 [[Page 60239]]
Vetch, hay................................................. 135
Walnut..................................................... 8
Wheat, grain, postharvest.................................. 8 * * * * *
4. Revise Sec. 180.117 to read as follows:
Sec. 180.117 SEthyl dipropylthiocarbamate; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide Sethyl dipropylthiocarbamate, including its metabolites and
degradates, in or on the commodities in the following table. Compliance
with the tolerance levels specified in this paragraph is to be
determined by measuring only the sum of Sethyl dipropylthiocarbamate, Sethyl (2hydroxypropyl)propylcarbamothioate, S(2
hydroxyethyl)dipropylcarbamothioate, and Sethyl (3
hydroxypropyl)propylcarbamothioate, calculated as the stoichiometric
equivalent of Sethyl dipropylthiocarbamate, in or on the commodity.
Parts per
Commodity million
Alfalfa, forage............................................ 0.2
Alfalfa, hay............................................... 0.6
Almond..................................................... 0.08
Almond, hulls.............................................. 0.08
Bean, dry, seed............................................ 0.08
Bean, succulent............................................ 0.08
Beet, garden, tops......................................... 0.5
Beet, sugar, molasses...................................... 0.4
Beet, sugar, tops.......................................... 0.5
Clover, forage............................................. 0.1
Clover, hay................................................ 0.1
Corn, field, forage........................................ 0.08
Corn, field, grain......................................... 0.08
Corn, field, stover........................................ 0.08
Corn, pop, grain........................................... 0.08
Corn, pop, stover.......................................... 0.08
Corn, sweet, forage........................................ 0.08
Corn, sweet, kernel plus cob with husks removed............ 0.08
Corn, sweet, stover........................................ 0.08
Cotton, gin byproducts..................................... 0.20
Cotton, undelinted seed.................................... 0.08
Fruit, citrus, group 10.................................... 0.1
Lespedeza, forage.......................................... 0.1
Lespedeza, hay............................................. 0.1
Pea, succulent............................................. 0.08
Safflower, seed............................................ 0.08
Sunflower, seed............................................ 0.08
Tomato..................................................... 0.08
Trefoil, forage............................................ 0.1
Trefoil, hay............................................... 0.1
Vegetable, root............................................ 0.1
Walnut..................................................... 0.08 (b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved]
5. In Sec. 180.123 revise the table in paragraph (a)(1) to read as follows:
Sec. 180.123 Inorganic bromide residues resulting from fumigation with methyl bromide; tolerances for residues.
(a) * * * (1) * * *
Commodity Parts per million Expiration/Revocation Date
Alfalfa, hay, postharvest........................... 50.0 10/31/11
Almond, postharvest................................. 200.0 None
Apple, postharvest.................................. 5.0 None
Apricot, postharvest................................ 20.0 None
Artichoke, jerusalem, postharvest................... 30.0 None
Asparagus, postharvest.............................. 100.0 None
Avocado, postharvest................................ 75.0 None
Barley, grain, postharvest.......................... 50.0 None
Bean, lima, postharvest............................. 50.0 None
Bean, postharvest................................... 50.0 None
Bean, snap, succulent, postharvest.................. 50.0 None
Bean, succulent, postharvest........................ 50.0 None
Beet, garden, roots, postharvest.................... 30.0 None
Beet, sugar, roots, postharvest..................... 30.0 None
Blueberry, postharvest.............................. 20.0 None
Butternut, postharvest.............................. 200.0 None
Cabbage, postharvest................................ 50.0 None
Cacao bean, roasted bean, postharvest............... 50.0 None
Cantaloupe, postharvest............................. 20.0 None
Carrot, roots, postharvest.......................... 30.0 None
Cashew, postharvest................................. 200.0 None
Cherry, sweet, postharvest.......................... 20.0 None
Cherry, tart, postharvest........................... 20 None
Chestnut, postharvest............................... 200.0 None
Cippolini, bulb, postharvest........................ 50.0 None
Citron, citrus, postharvest......................... 30.0 None
Coconut, copra, postharvest......................... 100.0 None
Coffee, bean, green, postharvest.................... 75.0 None
Corn, field, grain, postharvest..................... 50.0 None
Corn, pop, postharvest.............................. 240.0 None
Corn, sweet, kernel plus cob with husks removed, 50.0 None postharvest........................................
Cotton, undelinted seed, postharvest................ 200.0 10/31/11
Cucumber, postharvest............................... 30.0 None
Cumin, seed, postharvest............................ 100.0 None
Eggplant, postharvest............................... 20.0 None
Garlic, postharvest................................. 50.0 None
Ginger, postharvest................................. 100.0 None
Grape, postharvest.................................. 20.0 None
Grapefruit, postharvest............................. 30.0 None
Hazelnut, postharvest............................... 200.0 None
Horseradish, postharvest............................ 30.0 None
Kumquat, postharvest................................ 30.0 None
Lemon, postharvest.................................. 30.0 None
Lime, postharvest................................... 30.0 None [[Page 60240]]
Melon, honeydew, postharvest........................ 20.0 None
Muskmelon, postharvest.............................. 20.0 None
Nectarine, postharvest.............................. 20.0 None
Nut, brazil, postharvest............................ 200.0 None
Nut, hickory, postharvest........................... 200.0 None
Nut, macadamia, postharvest......................... 200.0 None
Oat, postharvest.................................... 50.0 None
Okra, postharvest................................... 30.0 None
Onion, bulb, postharvest............................ 20.0 None
Onion, green, postharvest........................... 20.0 None
Orange, postharvest................................. 30.0 None
Parsnip, roots, postharvest......................... 30.0 None
Peach, postharvest.................................. 20.0 None
Peanut, postharvest................................. 200.0 None
Pear, postharvest................................... 5.0 None
Pea, blackeyed, postharvest......................... 50.0 None
Pea, postharvest.................................... 50.0 None
Pecan, postharvest.................................. 200.0 None
Pepper, postharvest................................. 30.0 None
Pimento, postharvest................................ 30.0 None
Pineapple, postharvest.............................. 20.0 None
Pistachio, postharvest.............................. 200.0 None
Plum, postharvest................................... 20.0 None
Pomegranate, postharvest............................ 100.0 None
Potato, postharvest................................. 75.0 None
Pumpkin, postharvest................................
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) 3088037; email address:
nevola.joseph@epa.gov.