Butylate, Clethodim, Dichlorvos, Dicofol, Isopropyl Carbanilate, et al.; Proposed Tolerance Actions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing, in follow-up to canceled uses or where a commodity is no longer a significant feed item, to revoke certain tolerances for butylate, clethodim, dichlorvos, dicofol, isopropyl carbanilate, methanearsonic acid, methomyl, naled, primisulfuron-methyl, tralomethrin, and ziram, and tolerance exemptions for rotenone, derris, cube roots, and pine oil. Also, EPA is proposing to make minor revisions to the tolerance expressions for dicofol, methanearsonic acid, methomyl, and tralomethrin, revise the nomenclature of specific tolerances for butylate, methomyl, and tralomethrin, and remove expired tolerances for certain pesticide active ingredients, in accordance with current EPA practice. In addition, EPA is proposing to reinstate popcorn tolerances for metolachlor to remedy an inadvertent omission and cover existing registrations.

DATES:

Comments must be received on or before July 9, 2012.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2012-0171, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2012-0171. EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov,, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: 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., 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 either 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 hours of operation of this Docket Facility are 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; 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. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II.A. 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. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

C. What can I do if I wish the agency to maintain a tolerance that the agency proposes to revoke?

This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance or tolerance exemption proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f), if needed. The order would specify data needed and the timeframes for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

II. Background

A. What action is the agency taking?

EPA is proposing to revoke certain tolerances and to promulgate other tolerances with expiration dates, for the fungicide ziram, the herbicides butylate, clethodim, isopropyl carbanilate, methanearsonic acid, and primisulfuron-methyl; the insecticides dichlorvos, dicofol, methomyl, naled, and tralomethrin, and tolerance exemptions for the pesticides rotenone, derris, cube roots, and pine oil.

Section 321 of FFDCA defines a pesticide residue as including metabolites and degradates of the pesticide. Therefore, EPA is proposing to make minor revisions to the tolerance expressions for dicofol, methanearsonic acid, methomyl, and tralomethrin, in accordance with current Agency practice to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances. The revisions to the tolerance expressions do not substantively change the tolerance or, in any way, modify the permissible level of residues permitted by the tolerance.

In addition, EPA is proposing to revise the nomenclature of specific tolerances for butylate, methomyl, and tralomethrin, and remove expired tolerances for arsanilic acid, cyhexatin, ethion, fenthion, fonofos, lindane, orthoarsenic acid, phosphamidon, and triazamate. In addition, EPA is proposing to reinstate popcorn tolerances for metolachlor.

EPA is proposing to revoke certain tolerances because 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). The proposed revocations for dichlorvos, naled, and pine oil are consistent with the recommendations in the dichlorvos, naled, and pine oil Reregistration Eligibility Decisions (REDs) of 2006. As part of the tolerance reassessment process, EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each RED. REDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-8695; Internet at http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic copies are available on the Internet for the dichlorvos, naled, and pine oil REDs at http://www.epa.gov/pesticides/reregistration/status.htm.

In REDs, Chapter IV on risk management, reregistration, and tolerance reassessment typically describes the regulatory position, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III.

It is EPA's general practice to propose revocation of those tolerances 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 to cover residues in or on imported commodities or legally treated domestic commodities.

Certain tolerances pertaining to the pesticides subject to this proposal have expired due to previous EPA regulation setting expiration dates. Therefore, EPA is proposing to remove the expired tolerances from the Code of Federal Regulations. This rule only corrects the Code of Federal Regulations to conform with the fact that the tolerances already expired, and therefore EPA is not accepting comments regarding the expiration itself.

1. Arsanilic acid. Because the sole tolerance for the plant growth regulator arsanilic acid expired on February 28, 2001, EPA is proposing to remove it from 40 CFR 180.550, and remove that section in its entirety.

2. Butylate. In the Federal Register notice of July 28, 2010 (75 FR 44240) (FRL-8835-2), EPA published a notice of cancellation of pesticides for non-payment of year 2010 registration maintenance fees, which included the announcement of cancellations for both an end-use product registration and last technical chemical registration for butylate. The cancellation orders permitted the registrant to sell and distribute existing stocks of affected products until January 15, 2011, one year after the date on which the fee was due. Persons other than registrant are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products. In the Federal Register notice of January 26, 2011 (76 FR 4692) (FRL-8856-9), EPA published a notice of receipt of voluntary requests by registrants to cancel certain pesticide registrations, including an end-use registration for butylate, the last butylate product registered for use in the United States. In the Federal Register notice of March 23, 2011 (76 FR 16417) (FRL-8867-8), EPA issued a cancellation order which granted the requested cancellation for the last butylate registration and permitted the registrant to sell and distribute existing stocks of the affected product containing butylate for 1 year after the date of publication of the cancellation order in the Federal Register; i.e., until March 23, 2012. Persons other than registrant are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products.

EPA believes that existing stocks are likely to be exhausted by March 23, 2013. Therefore, EPA is proposing to revoke the tolerances for butylate in 40 CFR 180.232(a) on corn, field, forage; corn, field, grain; corn, field, stover; corn, pop, forage; corn, pop, grain; corn, sweet, forage; and corn, sweet, kernel plus cob with husks removed; each with an expiration/revocation date of March 23, 2013.

Also, in order to conform to current Agency practice, EPA is proposing in 40 CFR 180.232(a) to revise the commodity terminology for “corn, pop, forage” to “corn, pop, stover.”

3. Clethodim. The commodity “soybean soapstock” is no longer considered by the Agency to be a significant animal feed item and therefore the tolerance is no longer needed. Consequently, EPA is proposing to revoke the tolerance in 40 CFR 180.458(a) on soybean, soapstock.

4. Cyhexatin. Because the sole tolerance for the insecticide cyhexatin expired on June 13, 2009, EPA is proposing to remove it from 40 CFR 180.144, and remove that section in its entirety.

5. Dichlorvos. On February 5, 1998 (63 FR 5907) (FRL-5743-9), EPA published a proposed rule in the Federal Register concerning a number of pesticide active ingredients and proposed tolerance actions, including the proposed revocation of the tomato tolerance for dichlorvos in 40 CFR 180.235 because there were no active registrations for use of dichlorvos on tomatoes in the United States, and therefore the tolerance was no longer needed. However, during the public comment period and as described in the final rule published in the Federal Register on October 26, 1998 (63 FR 57067) (FRL-6035-6), EPA received comment from the Canadian Horticultural Council (CHC). Consequently, EPA did not revoke the dichlorvos tolerance on tomato at that time. The CHC stated that revocation of the tomato tolerance would create a barrier to Canadian exports and requested that tolerances be maintained until pesticide alternatives were available to producers in Canada. EPA believes that there is no longer a need for the dichlorvos tolerance on tomato. Possible alternative insecticides such as fenpropathrin, deltamethrin, chlorantraniliprole, spinetoram, spinosad, permethrin, acetamiprid, imidacloprid, and lambda-cyhalothrin have both Canadian MRLs and U.S. tolerances on tomato or vegetable, fruiting, group 8, where a U.S. tolerance is at or exceeds the level of the corresponding Canadian MRL for the pesticide. Therefore, EPA is proposing to revoke the dichlorvos tolerance in 40 CFR 180.235(a)(1) on tomato, postharvest (residues expressed as naled).

6. Dicofol. As a result of on an agreement in principle signed by the EPA and the technical registrants of dicofol on May 17, 2011, registrants requested voluntary product cancellation and amendment. The cancellations included the last products containing dicofol registered for use in the United States. Dicofol registrants agreed to cease all production of dicofol as of May 17, 2011, cease all sales and distribution of dicofol end-use products by October 31, 2013, and amend end-use products to add a condition of registration that as of August 31, 2011, registrants will not sell or distribute dicofol end-use products that do not bear a prominent sticker prior to sale or distribution by the dicifol registrants that declares: “It is unlawful to use this product after October 31, 2016.”

In the Federal Register of June 22, 2011 (76 FR 36535) (FRL-8875-7), EPA announced its receipt of the requests from registrants to voluntarily cancel the last product registrations for use of dicofol in the United States. In the Federal Register of December 14, 2011 (76 FR 77824) (FRL-9326-5), EPA published a cancellation order in follow-up to the June 22, 2011 Notice of Receipt of Requests. The cancellation order allowed registrants of dicofol end-use products to sell and distribute existing stocks until October 31, 2013, persons other than the registrants to sell and distribute existing stocks until December 31, 2013, and use of existing stocks of any of the dicofol end-use products until October 31, 2016. Therefore, EPA is proposing to revoke the dicofol tolerances in 40 CFR 180.163(a)(1) on apple, wet pomace; bean, dry, seed; bean, succulent; butternut; caneberry subgroup 13A; chestnut; citrus, dried pulp; citrus oil; cotton, refined oil; cotton, undelinted seed; fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12; grape; grape, raisin; hazelnut; hop, dried cones; nut, hickory; nut, macadamia; pecan; peppermint, oil; peppermint, tops; spearmint, oil; spearmint, tops; strawberry; tea, dried; tea, plucked leaves; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; and walnut; each with an expiration/revocation date of October 31, 2016.

Also, EPA is proposing to revoke the dicofol tolerances in 40 CFR 180.163(a)(2) on cattle, fat; cattle, liver; cattle, meat; cattle, meat byproducts, except liver; egg; goat, fat; goat, liver; goat, meat; goat, meat byproducts, except liver; hog, fat; hog, liver; hog, meat; hog, meat byproducts, except liver; horse, fat; horse, liver; horse, meat; horse, meat byproducts, except liver; milk, fat (reflecting 0.75 ppm in whole milk); poultry, fat; poultry, meat; poultry, meat byproducts; sheep, fat; sheep, liver; sheep, meat; and sheep, meat byproducts, except liver; each with an expiration/revocation date of October 31, 2016.

In addition, EPA is proposing to revise the section heading in 40 CFR 180.163 from “1,1-bis(4-chlorophenyl)-2,2,2-trichloroethanol” to “dicofol.” Also, in order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expressions for dicofol in 40 CFR 180.163(a)(1) and (a)(2) to read as set out in the proposed regulatory text at the end of this document.

7. Ethion. Because all the tolerances for the insecticide ethion expired on October 1, 2008, EPA is proposing to remove them from 40 CFR 180.173, and remove that section in its entirety.

8. Fenthion. Because all the tolerances for the insecticide fenthion expired, some on April 1, 2006 and some on April 1, 2003, EPA is proposing to remove them from 40 CFR 180.214, and remove that section in its entirety.

9. Fonofos. Because all the tolerances for the insecticide O-ethyl S-phenyl ethylphosphonodithioate, also known as fonofos, expired on December 31, 2002, EPA is proposing to remove them from 40 CFR 180.221, and remove that section in its entirety.

10. Isopropyl carbanilate. Because there have been no active registrations in the United States for isopropyl carbanilate (also called propham) since 1991, the interim tolerances are no longer needed and therefore should be revoked. Therefore, EPA is proposing to revoke the interim tolerances for isopropyl carbanilate in 40 CFR 180.319 on alfalfa, hay; clover, hay; grass, hay; alfalfa, forage; clover, forage; grass, forage; flax, seed; lentil; lettuce, head; lettuce, leaf; pea; safflower, seed; spinach; beet, sugar, roots; beet, sugar, tops; egg; cattle, fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; milk; sheep, fat; sheep, meat; sheep, meat byproducts; poultry, fat; poultry, meat; and poultry, meat byproducts.

11. Lindane. Because all the tolerances for the insecticide lindane expired on October 2, 2009, EPA is proposing to remove them from 40 CFR 180.133, and remove that section in its entirety.

12. Methanearsonic acid. As a result of an agreement in principle signed by the EPA and the technical registrants of the organic arsenicals on January 16 and February 5, 2009, registrants requested voluntary product cancellation and amendment. Some of the cancellations included the last products containing disodium methanearsonate (DSMA) registered for use in the United States, and cancellation and amendment of products for monosodium methanearsonate (MSMA) which would terminate its citrus, bearing and non-bearing, uses. In the Federal Register of July 8, 2009 (74 FR 32596) (FRL-8422-6), EPA announced its receipt of the requests and provided a public comment period. In the Federal Register of September 30, 2009 (74 FR 50187) (FRL-8437-7), EPA published a cancellation order in follow-up to the July 8, 2009, Notice of Receipt of Requests. The cancellation order prohibited registrants from selling or distributing existing stocks (with citrus uses) after December 31, 2009, and persons other than the registrants from selling or distributing existing stocks after December 31, 2010, but allowed their use until exhaustion. EPA believes that existing stocks (with citrus use) will be exhausted 2 years after December 31, 2010; i.e., by December 31, 2012. Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.289(a) for methanearsonic acid, from application of DSMA and MSMA, in or on fruit, citrus with an expiration/revocation date of December 31, 2012.

Also, in order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expression for methanearsonic acid in 40 CFR 180.289(a) to read as set out in the proposed regulatory text at the end of this document.

13. Methomyl. In the Federal Register notice of October 24, 2007 (72 FR 60364) (FRL-8153-3), EPA published a notice of receipt of voluntary requests for amendments by registrants to delete the grape use in methomyl registrations. In the Federal Register notice of December 8, 2010 (75 FR 76456) (FRL-8855-6), EPA issued a cancellation order granting the requested amendments to terminate use and permitted the registrant to sell and distribute existing stocks of the affected products containing methomyl for 18 months after the date of the cancellation order; i.e., until June 8, 2012. Persons other than the registrant are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products.

EPA believes that existing stocks will be exhausted by June 8, 2013. Therefore, EPA is proposing to revoke the tolerance for methomyl in 40 CFR 180.253(a) on grape with an expiration/revocation date of June 8, 2013.

In order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expressions for methomyl in 40 CFR 180.253(a) and (c) to read as set out in the proposed regulatory text at the end of this document.

Also, in order to conform to current Agency practice, EPA is proposing in 40 CFR 180.253(a) to revise the commodity terminology for “cucurbits” to “vegetable, cucurbit, group 9;” “orange, sweet” to “orange;” “pepper” to “pepper, bell” and “pepper, nonbell;” “sorghum, forage” to “sorghum, grain, forage;” “sorghum, grain” to “sorghum, grain, grain;” “soybean” to “soybean, seed;” “vegetable, fruiting” to “vegetable, fruiting, group 8;” and “vegetable, root” to “vegetable, root and tuber, group 1;” and to remove the “(N)” designation, which means negligible residues, wherever it appears in 40 CFR 180.253(a).

14. Metolachlor. In the Federal Register of September 17, 2008 (73 FR 53732) (FRL-8375-2), EPA finalized tolerance actions for specific active ingredients including metolachlor, for which the Agency completed a number of actions, including decreasing tolerance levels in 40 CFR 180.368(a)(1) on corn fodder and forage to 6.0 parts per million (ppm) and revising the commodity terminology of the tolerances on corn, grain to corn, field, grain; and corn, fodder to corn, field, stover and corn, sweet, stover. However, the Agency inadvertently omitted corn, pop, grain (previously covered by corn, grain) and corn, pop, stover (previously covered by corn, fodder) as part of the commodity terminology revisions for metolachlor in the final rule. Nor did the Agency include the popcorn tolerances for metolachlor in the Federal Register of August 8, 2007 (72 FR 44439) (FRL-8138-8) for the proposed rule. To remedy this inadvertent error and to cover existing popcorn registrations for metolachlor, the Agency proposes to correct the revisions and reinstate the tolerances in 40 CFR 180.368(a)(1) for corn, pop, grain at 0.10 ppm and corn, pop, stover at 6.0 ppm.

15. Naled. On February 5, 1998 (63 FR 5907)(FRL-5743-9), EPA published a proposed rule in the Federal Register concerning a number of pesticide active ingredients and proposed tolerance actions, including the proposed revocation of the lettuce tolerance for naled in 40 CFR 180.215 because there were no active registrations for use of naled on lettuce in the United States, and therefore the tolerance was no longer needed. However, during the public comment period and as described in the final rule published in the Federal Register on October 26, 1998 (63 FR 57067) (FRL-6035-6), EPA received comment from Valent USA Corporation, on behalf of Amvac Chemical Corporation, and the Canadian Horticultural Council (CHC). Consequently, EPA did not revoke the naled tolerance on lettuce at that time. Amvac requested that the lettuce tolerance be retained for import purposes and that it would support that import tolerance. However, recently, Amvac notified the Agency that it was no longer interested in supporting the lettuce tolerance for import purposes. The CHC stated that revocation of the lettuce tolerance would create a barrier to Canadian exports and requested that tolerances be maintained until pesticide alternatives were available to producers in Canada. EPA believes that there is no longer a need for the naled tolerance on lettuce. Possible alternative insecticides such as chlorantraniliprole, spinetoram, spinosad, permethrin, acetamiprid, imidacloprid, lambda-cyhalothrin, tebufenozide, and thiamethoxam have both Canadian MRLs and U.S. tolerances on lettuce, crop subgroup 4A (including lettuce), or vegetable, leafy, except brassica, group 4, where a U.S. tolerance is at or exceeds the level of the corresponding Canadian MRL for the pesticide. Therefore, EPA is proposing to revoke the naled tolerance in 40 CFR 180.215(a)(1) on lettuce.

16. Orthoarsenic acid. Because the sole tolerance for the defoliant orthoarsenic acid expired on July 1, 1995, EPA is proposing to remove it from 40 CFR 180.180, and remove that section in its entirety.

17. Phosphamidon. Because the sole tolerance for the insecticide phosphamidon expired on December 31, 2002, EPA is proposing to remove it from 40 CFR 180.239, and remove that section in its entirety.

18. Pine oil. Because there have been no active registrations in the United States for more than 10 years regarding the use of pine oil in honey and honeycomb, the exemption from the requirement of a tolerance for pine oil (also known as 1-methyl-4-isopropyl-1-cyclo-hexen-8-ol) residues in or on honey and honeycomb, when present as a result of its use as a deodorant at no more than 12 percent in formulation with the bee repellent butanoic anhydride applied in an absorbent pad over the hive, is no longer needed and therefore should be revoked. The revocation of the tolerance exemption is consistent with the recommendation in the pine oil RED of 2006. Consequently, EPA is proposing to revoke the tolerance exemption for pine oil in 40 CFR 180.1035 on honey and honeycomb.

19. Primisulfuron-methyl. Because there have been no active registrations for use of primisulfuron-methyl on sweet corn for more than 10 years and, for at least 10 years, active registrations have shown a label prohibition of its use on sweet corn, the tolerances on sweet corn are no longer needed. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.452 on corn, sweet, forage and corn, sweet, stover.

20. Rotenone. In the Federal Register of July 28, 2010 (75 FR 44256) (FRL-8831-7), February 3, 2010 (75 FR 5643) (FRL-8807-6) and January 26, 2010 (75 FR 4072) (FRL-8808-2), EPA announced its receipt of requests for voluntary cancellation of certain pesticide registrations, including ones for rotenone (and other associated cube root resins) with agricultural uses, and provided public comment periods. In the Federal Register of March 23, 2011 (76 FR 16415) (FRL-8865-9), August 11, 2010 (75 FR 48669) (FRL-8839-9) and May 11, 2010 (75 FR 26227) (FRL-8822-4), EPA published cancellation orders in follow-up to the July 28, 2010, January 26, 2010 and February 3, 2010 Notice of Receipt of Requests, respectively. The cancellation order of March 23, 2010 allowed registrants to sell and distribute existing stocks until May 2011 and persons other than the registrants to sell, distribute, or use existing stocks until May 2011. The cancellation order of August 11, 2010 allowed registrants to sell and distribute existing stocks until August 11, 2011 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. The cancellation order of May 11, 2010 allowed registrants to sell and distribute existing stocks until May 11, 2011 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. EPA believes that existing stocks will be exhausted by August 11, 2012. Therefore, in 40 CFR 180.905, EPA is proposing to redesignate existing paragraph (b) as new paragraph (c) and recodify the tolerance exemptions for rotenone or derris or cube roots from existing paragraph (a) into newly designated paragraph (b) with expiration/revocation dates of August 11, 2012.

21. Tralomethrin. In the Federal Register of May 4, 2011 (76 FR 25334) (FRL-8870-5), November 17, 2010 (75 FR 70256) (FRL-8850-1), and November 10, 2010 (75 FR 69073) (FRL-8851-5), EPA announced its receipt of requests for voluntary cancellation of certain pesticide registrations, including ones for tralomethrin associated with agricultural and food/feed handling establishment uses, and provided public comment periods. In the Federal Register of July 8, 2011 (76 FR 40359) (FRL-8878-7) and February 25, 2011 (76 FR 10587) (FRL-8863-4), EPA published cancellation orders in follow-up to the May 4, 2011, and the November 17, 2010 and November 10, 2010 Notice of Receipt of Requests, respectively. The cancellation order of February 25, 2011 allowed registrants to sell and distribute existing stocks until February 25, 2012 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. The cancellation order of July 8, 2011 allowed registrants to sell and distribute existing stocks until July 9, 2012 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. EPA believes that existing stocks will be exhausted by July 9, 2013. Therefore, EPA is proposing to revoke tralomethrin tolerances in 40 CFR 180.422(a)(1) on broccoli; cotton, undelinted seed; cotton, oil; lettuce, head; lettuce, leaf; soybean; and sunflower, seed; each with an expiration/revocation date of July 9, 2013. Also, in order to conform to current Agency practice, EPA is proposing in 40 CFR 180.422(a)(1) to revise the commodity terminology for “soybean” to read “soybean, seed.”

Also, EPA is proposing to revoke the tralomethrin tolerance in 40 CFR 180.422(a)(2) on food commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food-handling establishments at 0.02 ppm with an expiration/revocation date of July 9, 2013.

In addition, EPA is proposing to revoke the tralomethrin tolerance in 40 CFR 180.422(a)(3) on feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in feed-handling establishments at 0.02 ppm with an expiration/revocation date of July 9, 2013.

In order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expressions for tralomethrin in 40 CFR 180.422(a)(1), (a)(2), and (a)(3) to read as set out in the proposed regulatory text at the end of this document.

22. Triazamate. Because the sole tolerance for triazamate expired on December 31, 2001, EPA is proposing to remove it from 40 CFR 180.536, and remove that section in its entirety.

23. Ziram. In the Federal Register notice of December 1, 2010 (75 FR 74714) (FRL-8854-3), EPA published a notice of receipt of voluntary requests for amendments by registrants to delete certain uses, including the last blackberry uses in ziram registrations. In the Federal Register notice of May 11, 2011 (76 FR 27317) (FRL-8871-2), EPA issued a cancellation order, which included granting the requested amendments to terminate the last ziram registrations for blackberry use and permitted the registrant to sell and distribute existing stocks of the affected products containing ziram for 12 months after the date of the cancellation order; i.e., until May 11, 2012. Persons other than the registrants are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products.

EPA believes that existing stocks are likely to be exhausted by May 11, 2013. Therefore, EPA is proposing to revoke the tolerance for ziram in 40 CFR 180.116(a) on blackberry with an expiration/revocation date of May 11, 2013.

B. What is the agency's authority for taking this action?

A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under FFDCA section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States.

EPA's general practice is to propose revocation of 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.

Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under FFDCA section 408, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops for which FIFRA registrations no longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities.

Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue.

C. When do these actions become effective?

EPA proposes that these regulations become effective on the date of publication of the final rule in the Federal Register. With the exception of certain tolerances for butylate, dicofol, methanearsonic acid (and salts), methomyl, tralomethrin, and ziram, and tolerance exemptions for rotenone, derris, and cube roots for which EPA is proposing specific expiration/revocation dates, the Agency is proposing that these tolerance revocations and reinstatements, and revisions of tolerance nomenclatures and tolerance expressions become final on the date of publication of the final rule in the Federal Register. With the exception of the specific tolerances for which EPA is proposing expiration/revocation dates, the Agency believes that existing stocks of pesticide products labeled for the uses associated with the tolerances proposed for revocation have been completely exhausted and that treated commodities have cleared the channels of trade. EPA is proposing an expiration/revocation date of March 23, 2013 for all of the tolerances for butylate, October 31, 2016 for all of the tolerances for dicofol, December 31, 2012 for the methanearsonic acid tolerance on fruit, citrus, June 8, 2013 for the methomyl tolerance on grape, July 9, 2013 for all of the tolerances for tralomethrin, May 11, 2013 for the ziram tolerance on blackberry, and August 11, 2012 for the tolerance exemptions for rotenone (or derris or cube roots). The Agency believes that these revocation dates allow users to exhaust stocks and allows sufficient time for passage of treated commodities through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider extending the expiration date of the tolerance. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION.

Any commodities listed in this proposal treated with the pesticides subject to this proposal, and 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, and

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 when 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 butylate, isopropyl carbanilate (also called propham), methanearsonic acid (and salts), metolachlor, naled, pine oil, primisulfuron-methyl, rotenone (or derris or cube roots), tralomethrin, clethodim in or on soybean soapstock, or for dichlorvos on tomato.

The Codex has not established a MRL for ziram per se, but has MRLs for total dithiocarbamates (which includes the dithiocarbamate ziram), determined as carbon disulfide. However, there is no MRL for total dithiocarbamates in or on blackberry.

The Codex has established a MRL for methomyl in or on grapes at 5 milligrams/kilogram (mg/kg). This MRL is the same as the tolerance established for methomyl on grapes in the United States.

The Codex has established MRLs for dicofol in or on cattle meat at 3 mg/kg, eggs at 0.05 mg/kg, poultry meat and cottonseed at 0.1 mg/kg, and cherries at 5 mg/kg. These MRLs and some others are the same as the tolerances established for dicofol in the United States.

The Codex has established MRLs for dicofol in or on various other commodities, including beans, dry at 0.1 mg/kg, citrus fruits at 5 mg/kg, hops, dry at 50 mg/kg, melons, except watermelon at 0.2 mg/kg, pecans and walnuts at 0.01 mg/kg, and peppers, summer squash, and tomato at 1 mg/kg. These MRLs are all covered by U.S. tolerances at higher levels. These MRLs are different than the tolerances established for dicofol in the United States because of differences in use patterns and/or good agricultural practices.

IV. Statutory and Executive Order Reviews

In this proposed rule, EPA is proposing to revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (e.g., 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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 proposed 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 104-113, 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 proposed rule, the Agency hereby certifies that this proposed rule will not have a significant negative 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 this proposed rule). Furthermore, for the pesticides named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change the EPA's previous analysis. Any comments about the Agency's determination should be submitted to the EPA along with comments on the proposal, and will be addressed prior to issuing a final rule. 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 proposed 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 proposed 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 proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

Therefore, it is proposed that 40 CFR chapter I be 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 180.116 is amended by revising the table in paragraph (a) to read as follows: