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Published Document: 2016-12723 (81 FR 34902)
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AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
EPA is revoking certain tolerances in follow-up to canceled product registrations or uses for acephate, aldicarb, azinphos-methyl, etridiazole, fenarimol, imazamethabenz-methyl, tepraloxydim, thiazopyr, and tralkoxydim, and is revoking tolerance exemptions for certain pesticide active ingredients. However, EPA will not revoke the thiacloprid tolerances at this time that had been previously proposed for revocation. Also, EPA is making minor revisions to the section heading and introductory text for
Pythium oligandrum
DV 74. In addition, in accordance with current Agency practice, EPA is making revisions to the tolerance expression for imazamethabenz-methyl, and removing expired tolerances and tolerance exemptions for certain pesticide active ingredients.
DATES:
This regulation is effective November 28, 2016. Objections and requests for hearings must be received on or before August 1, 2016, 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-2015-0212, 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 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:
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. 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).
B. How can I get electronic access to other related information?
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(g), 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-2015-0212 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 August 1, 2016. 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-2015-0212, 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.
II. Background
A. What action is the Agency taking?
In the
Federal Register
of July 22, 2015 (80 FR 43373) (FRL-9929-12), EPA issued a proposed rule to revoke certain tolerances for acephate, aldicarb, azinphos-methyl, etridiazole, fenarimol, imazamethabenz-methyl, tepraloxydim, thiacloprid, thiazopyr, and tralkoxydim, and tolerance exemptions for certain pesticide active ingredients, in follow-up to canceled product registrations or uses. Also, EPA proposed to make minor revisions to the section heading and introductory text for
Pythium oligandrum
DV 74. In addition, in accordance with current Agency practice, EPA proposed to make minor revisions to the tolerance expression for imazamethabenz-methyl, and remove expired tolerances and tolerance exemptions for certain pesticide active ingredients. The proposal provided a 60-day comment period.
Since the proposed rule of July 22, 2015, amendments for the last two acephate labels with succulent bean use (revising succulent bean to a non-food use) were approved by EPA, as anticipated and discussed in the
( printed page 34903)
proposed rule. Therefore, EPA is revoking the acephate tolerances in 40 CFR 180.108(a)(1) and (a)(3) on bean, succulent.
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 comments on the proposal indicating 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:
1. 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.
2. EPA independently verifies that the tolerance is no longer needed.
3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under the Food Quality Protection Act (FQPA).
Among the comments received by EPA are the following:
1.
Aldicarb.—Comment by Ag Logic Chemical LLC (Ag Logic).
The commenter requested that the aldicarb tolerances on sorghum be retained for possible future actions. Ag Logic stated that another registrant requested the voluntary cancellation of its aldicarb products for use on sorghum and now Ag Logic is the sole registrant for aldicarb. Also, Ag Logic stated it is reevaluating all current and potential agricultural uses for aldicarb and if it decides to apply for registration on sorghum it would be extremely beneficial to both Ag Logic and the Agency if the sorghum tolerances remained in place.
Agency response.
The use of aldicarb on sorghum was officially canceled in 2009 (see details in the proposed rule of July 22, 2015) under section 6(f)(1) of FIFRA, 7 U.S.C. 136(d)(f)(1), under which a registrant of a pesticide product may request that the product registration be canceled or amended to terminate one or more uses. Because EPA canceled the sorghum use in response to a registrant's voluntary request, and no other aldicarb products include a use on sorghum, there is currently no legal use of aldicarb on sorghum. EPA will not retain the tolerance based on the possibility that someone may apply for a new use on sorghum in the future. Tolerances are generally maintained for current uses. In addition, no comment specific to the need for retaining tolerances for aldicarb residues of concern on sorghum for import purposes was received by the Agency during the 60-day comment period. Therefore, EPA is revoking the tolerances for aldicarb in 40 CFR 180.269(a) on sorghum, grain, bran; sorghum, grain, grain; and sorghum, grain, stover.
2.
Thiacloprid.—Comments by Bayer CropScience (BCS), BCS in Mexico, Power Farms Inc., the Ontario Apple Growers (OAG), and the Ontario Fruit and Vegetable Growers' Association (OFVGA).
The commenters requested that all the current tolerances for thiacloprid be retained for import purposes with the exception of the OFVGA, which asked that only the specific thiacloprid tolerances on pome fruit and wet apple pomace be maintained for import purposes. Also, BCS stated its intention to provide supporting data where necessary for all of the current thiacloprid tolerances.
Agency response.
In comments to the proposed rule, persons expressed a need for retention of the thiacloprid tolerances for import purposes. Therefore, EPA will not revoke the thiacloprid tolerances in 40 CFR 180.594 at this time. However, because there are no longer any active food-use registrations in the United States and no comments were received by EPA which expressed a need for more time to exhaust existing stocks for domestic use, EPA is not changing its previous determination (as stated in the proposed rule of July 22, 2015) that existing stocks in the United States will be exhausted by February 8, 2017. EPA is noting in 40 CFR 180.594 that the tolerances for thiacloprid have no U.S. registrations as of August 6, 2014. Also, retaining these tolerances may require submission of data to demonstrate their safety. For example, domestic U.S. residue data may not be representative of growing conditions and use patterns in other countries. EPA published guidance on pesticide import tolerances and residue data for imported food in the
Federal Register
notices of April 5, 2006 (71 FR 17099) (FRL-7772-1) and June 1, 2000 (65 FR 35069) (FRL-6559-3).
With the exception of aldicarb and thiacloprid, the Agency did not receive any specific comments in the docket, during the 60-day comment period, concerning proposed tolerance actions associated with pesticide active ingredients, as described in the
Federal Register
of July 22, 2015. Therefore, with the exception of thiacloprid, EPA is finalizing revocations and amendments in the proposed rule of July 22, 2015. For a detailed discussion of the Agency's rationale for the finalized tolerance actions, refer to the proposed rule of July 22, 2015.
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 revoking tolerances and tolerance exemptions as follow-up on canceled uses of pesticides.
C. When do these actions become effective?
As stated in the
DATES
section, this regulation is effective November 28, 2016. 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. With the exception of fenarimol, imazamethabenz-methyl, and thiacloprid, 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. EPA is revoking certain tolerances for fenarimol, imazamethabenz-methyl, and tepraloxydim with expiration/revocation dates. EPA believes that these revocation dates allow users to exhaust stocks and allow sufficient time
( printed page 34904)
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 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 etridiazole, imazamethabenz-methyl, tepraloxydim, thiazopyr, and tralkoxydim.
The Codex has established MRLs for acephate, in or on various commodities, including beans, except broad bean and soya bean at 5 milligrams/kilogram (mg/kg). The beans, except broad bean and soya bean MRL is different than the tolerance established for acephate on succulent bean in the United States, which EPA is revoking in this final rule.
The Codex has established MRLs for aldicarb, in or on various commodities, including sorghum at 0.1 mg/kg, which is covered by a current U.S. tolerance at a higher level than the MRL, and sorghum straw and fodder, dry at 0.5 mg/kg, which is the same as the U.S. tolerance. The sorghum MRL is different than the tolerance established for aldicarb in the United States. In this final rule EPA is revoking the tolerances for aldicarb on sorghum, grain, bran; sorghum, grain, grain; and sorghum, grain, stover.
The Codex has established MRLs for azinphos-methyl in or on various commodities, including almond hulls and blueberries at 5 mg/kg, cherries, peach, and plums (including prunes) at 2 mg/kg, and walnuts at 0.3 mg/kg. These MRLs are the same as the tolerances established for azinphos-methyl in the United States. In this final rule EPA is revoking the tolerances for azinphos-methyl on almond, hulls; blueberry; cherry; peach; plum, prune; and walnut.
The Codex has established MRLs for azinphos-methyl, in or on various commodities, including almonds and apple at 0.05 mg/kg (which are covered by current U.S. tolerances at a higher level than the MRLs), and pear at 2 mg/kg. These MRLs are different than the tolerances established for azinphos-methyl in the United States. In this final rule EPA is revoking the tolerances for azinphos-methyl on almond; apple; and pear.
The Codex has established MRLs for fenarimol in or on various commodities, including cattle, liver at 0.05 mg/kg, cherries at 1 mg/kg, hops, dry at 5 mg/kg, and pecan at 0.02 mg/kg. These MRLs are the same as the tolerances established for fenarimol in the United States. In this final rule EPA is revoking the tolerances for fenarimol residues in or on cattle, meat byproducts, except kidney; cherry, sweet; cherry, tart; hop, dried cones; and pecan; each with an expiration/revocation date.
The Codex has established MRLs for fenarimol, in or on various commodities, including cattle kidney and cattle meat at 0.02 mg/kg; and grapes at 0.3 mg/kg. These MRLs are different than the tolerances established for fenarimol in the United States. In this final rule EPA is revoking the tolerances for fenarimol residues in or on cattle, kidney; cattle, meat; and grape; each with an expiration/revocation date.
The Codex has established MRLs for thiacloprid in or on various commodities, including cotton seed at 0.02 mg/kg, peppers, sweet at 1 mg/kg, and stone fruits at 0.5 mg/kg (for U.S. tolerances on cherry subgroup and peach subgroup). These MRLs are the same as the tolerances established for thiacloprid in the United States.
The Codex has established MRLs for thiacloprid, in or on various commodities, including milks at 0.05 mg/kg; pome fruits at 0.7 mg/kg, and stone fruits at 0.5 mg/kg (for U.S. tolerance on plum subgroup). These MRLs are different than the tolerances established for thiacloprid in the United States because of differences in use patterns and/or agricultural practices.
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 (
e.g.,
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. 3501et seq.), or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501et 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 (NTTAA) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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 in the
Federal Register
of December 17, 1997 (62 FR 66020) (FRL-5753-1), and was provided to the Chief
( printed page 34905)
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 action.
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801et 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).
4. In § 180.269, remove the entries for “Sorghum, grain, bran,” “Sorghum, grain, grain,” and “Sorghum, grain, stover,” from the table in paragraph (a).
(a)
General.
Tolerances are established for residues of the herbicide imazamethabenz-methyl, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only imazamethabenz-methyl (methyl 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
H
-imidazol-2-yl]-4-methylbenzoate) or (methyl 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
H
-imidazol-2-yl]-5-methylbenzoate), as the sum of its para- and meta-isomers in or on the commodity.
Commodity
Parts per
million
Expiration/
revocation
date
Barley, grain
0.10
12/31/16
Barley, straw
2.00
12/31/16
Sunflower, seed
0.10
12/31/16
Wheat, grain
0.10
12/31/16
Wheat, straw
2.00
12/31/16
(b)
Section 18 emergency exemptions.
[Reserved]
(c)
Tolerances with regional registrations.
[Reserved]
Kaolin; exemption from the requirement of a tolerance.
Kaolin is exempted from the requirement of a tolerance for residues when used on or in food commodities to aid in the control of insects, fungi, and bacteria (food/feed use).
Pythium oligandrum DV 74; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established on all food/feed commodities for residues of
Pythium oligandrum
DV 74 when the pesticide is used on food crops.