Propanil, Phenmedipham, Triallate, and MCPA; Tolerance Actions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is revoking certain tolerances for the herbicides propanil, triallate, and MCPA. EPA is modifying certain tolerances for the herbicides propanil, phenmedipham, triallate, and MCPA. In addition, EPA is establishing tolerances for the herbicides propanil, phenmedipham, triallate, and MCPA. The regulatory actions in this document are part of the Agency's reregistration program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES:

This regulation is effective May 23, 2007. Objections and requests for hearings must be received on or before July 23, 2007, 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:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0586. To access the electronic docket, go to http://www.regulations.gov , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the Office of Pesticide Programs (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:

Jane Smith, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail address: smith.jane-scott@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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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 Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this “Federal Register” document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

C. Can I File an Objection or Hearing Request?

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0586 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before July 23, 2007.

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 that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0586, by one of the following methods.

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line 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'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.

II. Background

A. What Action is the Agency Taking?

In the Federal Register of September 27, 2006 (71 FR 56425) (FRL-8089-5), EPA issued a proposed rule to revoke, modify and establish specific tolerances for residues of the herbicides propanil, phenmedipham, triallate and MCPA. Also, the proposal of September 27, 2006 (71 FR 56425) (FRL-8089-5) provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under the Federal Food, Drug, and Cosmetic Act (FFDCA) standards.

EPA is revoking, removing, modifying, and establishing specific tolerances for residues of the the herbicides propanil, phenmedipham, triallate and MCPA in or on commodities listed in the regulatory text.

EPA is finalizing these tolerance actions in order to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of reregistration and when taking action on tolerances and exemptions EPA is required to determine whether each of the amended tolerances meets the safety standards under the FQPA. The safety finding determination of “reasonable certainty of no harm” is found 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 certain tolerance actions to be implemented to reflect current use patterns, to meet safety findings and change commodity names and groupings in accordance with new EPA policy. Printed copies of REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419, telephone: 1-800-490-9198; fax: 1-513-489-8695; internet at http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone: 1-800-553-6847 or (703) 605-6000; 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. and in public dockets EPA-HQ-OPP-2003-0348 and EPA-HQ-OPP-2002-0033 (propanil); EPA-HQ-OPP-2004-0384 (phenmedipham); and EPA-HQ-OPP-2004-0156 and EPA-HQ-OPP-2004-0239 (MCPA) at http://www.regulations.gov .

In this final rule, EPA is revoking certain tolerances and tolerance exemptions because these specific tolerances and exemptions correspond to uses no longer current or registered under FIFRA in the United States. 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 revoke 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 domestic commodities legally treated.

EPA's policy is to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.

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 section 408(f) order requesting additional data or issuance of a 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 FQPA.

This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. In response to the proposal published in the Federal Register of September 27, 2006 (71 FR 56425) (FRL-8089-5), EPA received three comments during the 60-day public comment period, as follows:

Comment. The MCPA Task Force Three submitted a comment requesting the published tolerance for “cattle, meat and meat byproducts” be changed from the proposed 0.1 ppm to 0.5 ppm. The Task force has conducted a new Magnitude of the Residues in Meat and Milk Study, according to the Agency guidelines, that supports a 0.5 ppm tolerance. The new study will be submitted to the Agency as soon as it is issued which, according to the MCPA Task Force Three, is well in advance of the due date requested by the Agency in the Data Call-In. The task force did not take issue with any of the proposed tolerances for revocation.

Agency response. The Agency acknowledges the cooperation and effort the MCPA Task Force Three has put forth to fulfill the requirements of the reregistration Data Call-In Notice. When the Magnitude of the Meat and Milk Study is received, reviewed, a risk assessment conducted and safety finding is made, EPA will make a determination as to the whether the current tolerance of 0.1 ppm is still appropriate or should be changed.

Comment. A comment was received from a private citizen that expressed concern with pesticide residues in general and that pesticide residue levels should be zero. Concern was also expressed for the number of chemicals found in the bodies of adults and children.

Agency response. The private citizen's comment did not take issue with the Agency's conclusion that specific tolerances in this action should be revoked, established and/or modified. The Agency conducts a detailed risk assessment to determine whether establishing and/or increasing tolerances is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Also, it is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist.

Comment. A comment was received from the California Rice Commission (CRC). CRC expressed concern that the increased U.S. tolerance for propanil in/on rice grain from 2 ppm to 10 ppm could result in a trade irritant with Japan, a major importer of California rice whose Maximum Residue Limit (MRL) on rice grain is 2 ppm. According to the CRC propanil is the most important herbicide to the California rice industry; a significant percentage of the rice grown in California is exported to Japan; propanil residues on California grown rice are non-detectable for propanil; and the tolerance level of 10 ppm is based on an outlier residue level of 8.7 ppm.

Agency response. The CRC brought this important issue to the attention of the Agency when the RED Amendment was released in 2006. The U.S. tolerance is a national level based on uses and residue data generated on rice grown in Arkansas, California, Louisiana, and Texas showing multiple residue detections above 2 parts per million (ppm) up to 8.7 ppm supporting a tolerance level of 10 ppm. Avoiding potential trade irritants is of paramount interest, unfortunately, no new data have been generated or submitted to the Agency to change the basis of the tolerance level. If additional propanil field trial residue data on rice were generated and provided to the Agency, the tolerance level on rice grain would be reconsidered.

1. Propanil. Currently, in 40 CFR 180.274(a)(1) and (2), tolerances are established for the combined residues of propanil and its metabolites (calculated as propanil) in or on both raw agricultural commodities (RACs) and processed foods and feeds. EPA is revising the tolerance expression to specify the residues of concern and combine the RACs and processed foods and feed tolerances in accordance with FFDCA 408 as amended by FQPA (1996) in 40 CFR 180.274(a) to read as follows: Tolerances are established for the combined residues of the herbicide propanil (3', 4'-dichloropropionanilide) and its metabolites convertible to 3, 4-dichloroaniline (3, 4-DCA).

Tolerances currently exist for rice milling fractions and rice polishings. Rice milling fractions are no longer considered significant animal feed items as delineated in “Table 1. - Raw Agricultural and Processed Commodities and Feedstuffs Derived from Crops” which is found in Residue Chemistry Test Guidelines OPPTS 860.1000 dated August 1996, available at http://www.epa.gov/opptsfrs/ publications/OPPTS_Harmonized/860_Residue_Chemistry_Test_Guidelines/Series/. Therefore, EPA is removing the tolerances in 40 CFR 180.274(a) for the combined residues of propanil in/on rice milling fractions and rice, polishings at 10 ppm.

The registered uses on barley, oat, and wheat (small grains) have been voluntarily cancelled December 10, 2003; 68 FR 68901, FRL-7332-5, June 27, 2003; 68 FR 38328, FRL 7310-6. In the absence of registered uses, the tolerances associated with the small grains should be revoked. Therefore, EPA is revoking the tolerances in 40 CFR 180.274(a) for the combined propanil residues of concern in/on barley, straw; oat, straw; and wheat, straw at 0.75 ppm; barley, grain at 0.2 ppm; oat, grain at 0.2 ppm; and wheat, grain at 0.2 ppm.

Two studies depicting the magnitude of regulated propanil residues in/on rice grain exceeded the established tolerance of 2 ppm in/on treated rice grain samples demonstrating residues ranging from 0.03 ppm to 8.7 ppm. Based on these data, the EPA determined the tolerance should be 10 ppm on rice grain. Therefore, EPA is increasing the tolerance in 40 CFR 180.274(a) for the combined propanil residues of concern in/on rice, grain from 2 ppm to 10 ppm. The Agency determined that the increased tolerance is safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

A rice processing study showed no concentration of residues in polished rice and average concentration factors of 3.5x for rice hulls and 4.6x for rice bran. The highest average field trial (HAFT) propanil residues found in rice were 8.7 ppm. Based on this HAFT and the observed concentration factors, the maximum expected residues are 30.45 ppm in/on rice hulls (8.7 ppm x 3.5) and 40.02 ppm in/on rice bran (8.7 ppm x 4.6). These expected residues are higher in the processed commodities than the reassessed tolerance of 10 ppm for rice, grain. Based on these data, EPA has determined that the tolerances should be 30 ppm on rice, hulls and 40 ppm on rice, bran. Therefore, EPA is increasing tolerances in 40 CFR 180.274(a) for the combined propanil residues of concern in or on rice, hulls from 10 to 30 ppm and rice, bran from 10 to 40 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

The potential for secondary transfer of propanil residues to animal commodities exists because the herbicide is registered for use on rice, which may be used as animal feed. Based on a maximum theoretical dietary burden (x) and using the residue levels found in dairy cattle and milk fed 15 ppm (0.75x) resulted in residues of: 0.035 ppm in milk, 0.31 ppm in liver, 0.77 ppm in kidney, <0.05 ppm (non-detectable) in muscle, and 0.10 ppm in fat. Based on these data, the Agency determined the tolerances should be 0.05 ppm in cattle, meat; goat, meat; hog, meat; horse, meat; and sheep, meat and 1.0 ppm in cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts; horse, meat byproducts; and sheep, meat byproducts. In addition, the term “negligible residue” and its designation, “(N)” associated with the milk and animal tissue tolerances is being removed to conform to current Agency policy and practice. Therefore, EPA is maintaining and revising tolerances in 40 CFR 180.274(a) for the combined propanil residues of concern in/on milk from 0.05(N) ppm to 0.05 ppm and cattle, fat; goat, fat; hog, fat; horse, fat; and sheep, fat from 0.1(N) ppm to 0.10 ppm; decreasing and revising the tolerances in/on cattle, meat; goat, meat; hog, meat; horse, meat; and sheep, meat from 0.1(N) to 0.05 ppm; and increasing and revising the tolerances in/on cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts; horse, meat byproducts; and sheep, meat byproducts from 0.1(N) to 1.0 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Maximum propanil residues were 0.212, and 0.372 ppm, respectively, in eggs from hens dosed with propanil 15 ppm (0.9x), and 50 ppm (3.1x). Residues in liver from hens in the 15 ppm (0.9x), and 50 ppm (3.1x) dose groups were 0.183 - 0.236, and 0.824 - 1.755 ppm, respectively. Residues in muscle were <0.050 - 0.076 and 0.087 - 0.161 ppm from the 0.9x and 3.1x dose groups, respectively. In fat, propanil residues of concern were <0.05 ppm (<non-detectable) up to 0.9x feeding levels, and <0.139 - 0.348 ppm at 3.1x. Based on these data, the Agency has determined that the propanil tolerances should be 0.30 ppm for eggs, 0.50 ppm for meat byproducts, 0.05 ppm for poultry fat, and 0.10 ppm for poultry meat. In addition, the term “negligible residue” and its designation, “(N)” associated with the egg and animal tissue tolerances is being removed to conform to current Agency policy and practice. Therefore, EPA is revising tolerances in 40 CFR 180.274(a) for the combined propanil residues of concern to increase and revise the tolerance for eggs from 0.05(N) to 0.30 ppm and poultry, meat byproducts from 0.1(N) to 0.50 ppm; to decrease and revise the tolerances in/on poultry, fat from 0.1(N) to 0.05 ppm; and revise tolerances in/on poultry, meat from 0.10(N) to 0.10 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Residues of propanil and its metabolites, determined as base-releasable 3, 4-DCA and expressed as propanil equivalents, were <0.01 - 0.03 ppm in/on the edible portions of crayfish (1x maximum season rate). Based on these data, the Agency determined the tolerance should be 0.05 ppm on crayfish. Therefore, EPA is establishing a tolerance in 40 CFR 180.274(a) for the combined propanil residues of concern in/on crayfish at 0.05 ppm.

In addition, the “N” (negligible residues) designation correlated with tolerances is being removed to conform to current Agency practice. Therefore, EPA is revising the tolerance in 40 CFR 180.278(a) for the combined propanil residues of concern in/on rice, straw from 75(N) ppm to 75 ppm.

2. Phenmedipham. The current tolerance expression in 40 CFR 180.278(a) refers to phenmedipham as methyl m-hydroxycarbanilate methyl carbanilate which should be changed to the more appropriate chemical name, 3-methoxycarbonylaminophenyl-3′-methylcarbanilate. Therefore, EPA is changing the chemical name in 40 CFR 180.278(a) for residues of the herbicide phenmedipham to 3-methoxycarbonylaminophenyl-3′-methylcarbanilate.

Spinach field trial residue data generated at the 1x seasonal application rate and 14-22 day pre-harvest interval (PHI) resulted in residues ranging from 2.1 - 3.6 ppm. Additional trials conducted at similar rates and PHIs yielded residues ranging from <0.05 to 0.17 ppm. Based on the more recent residue data and use pattern, EPA has determined the tolerance on spinach should be 4.0 ppm. Therefore, EPA is increasing the tolerance in 40 CFR 180.278(a) for residues of phenmedipham in/on spinach from 0.5 ppm to 4.0 ppm. The Agency determined that the increased tolerance is safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Sugar beet processing studies indicate that phenmedipham residues of concern concentrated 3x in dried pulp, 1.3x in molasses, and did not concentrate in sugar. Because of the concentration factors associated with dried pulp and molasses, the current tolerance of 0.1 ppm for raw beet, sugar, roots and tops is not adequate to cover the dried pulp and molasses from sugar beets; therefore, the Agency has determined that tolerances should be established for beet, sugar, dried pulp at 0.5 ppm and beet, sugar, molasses at 0.2 ppm. EPA is establishing tolerances in 40 CFR 180.278(a) for residues of phenmedipham in/on beet, sugar, dried pulp at 0.5 ppm and beet, sugar, molasses at 0.2 ppm.

In addition, the “N” (negligible residues) designation that is correlated with some of the tolerances is being removed to conform to current Agency practice. Therefore, EPA is revising the tolerances in 40 CFR 180.278(a) for residues of phenmedipham in/on beet, garden at 0.2(N) ppm to beet, garden, roots at 0.2 ppm and beet, garden, tops at 0.2 ppm; beet, sugar, roots at 0.1(N) ppm to 0.1 ppm and beet, sugar, tops at 0.1(N) ppm to 0.1 ppm.

3. Triallate. The available data, reflecting the maximum registered use patterns, indicate that the maximum combined triallate residues of concern were 0.26 ppm in or on barley straw; 0.12 ppm in or on the seed and pods of succulent peas; 0.39 ppm in or on the vines of succulent peas; 0.27 ppm in or on the vines of dried peas; 0.73 ppm in or on the straw (hay) of succulent peas; 0.36 ppm in or on the straw of dried peas; and 0.94 ppm in or on wheat straw in the states of California, Colorado, Idaho, Kansas, Minnesota, Montana, Nebraska, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. In addition, the term “negligible residue” and its designation, “(N)” associated with the barley, grain tolerance is being removed to conform to current Agency policy and practice. Based on these data, the Agency determined the tolerances should be 0.3 ppm on barley, straw; 1.0 ppm on pea, field, hay; 0.5 ppm on pea, field, vines; 0.2 ppm on pea, succulent; and 1.0 ppm on wheat, straw and recodified under 40 CFR 180.314(c) as regional tolerances. Therefore, EPA is increasing and recodifying the tolerances in 40 CFR 180.314(a) to 40 CFR 180.314(c) for the combined triallate residues of concern in/on barley, straw from 0.05 to 0.3 ppm; pea, field, hay from 0.05 to 1.0 ppm; pea, field, vines from 0.05 to 0.5 ppm; pea, succulent from 0.05 to 0.2 ppm; wheat, straw from 0.05 to 1.0 ppm; and recodifying tolerances from 40 CFR 180.314(a) to 40 CFR 180.314(c) for barley, grain at 0.05 ppm and wheat, grain at 0.05 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

Lentil hay is no longer considered significant livestock feed item and has been removed from Table 1 (OPPTS GLN 860.1000) and lentil, seed is covered by the established pea tolerance in accordance with 40 CFR 180.1(g). As a result, EPA is removing the tolerances in 40 CFR 180.314(a) for the combined triallate residues of concern in/on lentil, hay at 0.05 ppm and lentil seed at 0.05 ppm.

Sugar beet processing studies were conducted on sugar beets treated at 5x the seasonal application rate resulting in maximum residues of 0.14 ppm in root, 0.30 ppm in dried pulp and <0.03 ppm in sugar and molasses. Therefore, EPA is maintaining the tolerances and correcting the terminology for sugar beets to include roots in 40 CFR 180.314(c) for the combined triallate residues of concern in or on beet, sugar, dried pulp at 0.2 ppm; beet, sugar, roots at 0.1 ppm and beet, sugar, tops at 0.5 ppm.

The available data, reflecting the maximum registered use patterns, indicate that the maximum combined triallate residues of concern were <0.02 ppm in/on the seed and pods of dry peas; and 0.94 ppm on wheat straw. Because of similar cultural practices and identical use rates, wheat straw data are used to support tolerances for barley hay and wheat hay. Based on these data, the Agency determined the tolerances should be 0.2 ppm for pea, dry and 1.0 ppm for barley, hay and wheat, hay by translating the data from wheat straw. Therefore, EPA is establishing tolerances in 40 CFR 180.314(c) for the combined triallate residues of concern in/on barley, hay at 1.0 ppm; pea, dry at 0.2 ppm; and wheat, hay at 1.0 ppm. The Agency determined that the establishment of these tolerances is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

4. MCPA. The current tolerance expression in 40 CFR 180.339(a) regulates residues of the herbicide 2-methyl-4-chlorophenoxyacetic acid (MCPA) from application of the herbicide in acid form or in the form of its sodium, ethanolamine, diethanolamine, triethanolamine, isopropanolamine, diisopropanolamine, triisopropanolamine, or dimethylamine salts or isooctyl or butoxyethyl esters and in 40 CFR 180.339(b) tolerances are established for combined negligible residues (N) of the herbicide 2-methyl-4-chlorophenoxyacetic acid and its metabolite 2-methyl-4-chlorophenol. Based on toxicity data for 2-methyl-4-chlorophenol, a currently regulated livestock metabolite, EPA determined that it is of significantly less concern than the parent compound and therefore can be excluded from the tolerance expression. Although the chemical name for MCPA has been presented as “(2-methyl-4-chlorophenoxy)acetic acid”, under current chemical naming conventions the “(4-chloro-2-methylphenoxy)acetic acid” designation is preferred. EPA determined the residues to be regulated in plant commodities (40 CFR 180.339(a)) are parent, free and conjugated MCPA. When MCPA is applied in various forms (e.g. ethanolamine and other salts and esters), a single common moiety is released that is the pesticidally active component and serves as the basis for tolerance regulation. Therefore, EPA is changing the tolerance expression in 40 CFR 180.339(a) to read as follows: Tolerances are established for residues of the herbicide MCPA [(4-chloro-2-methylphenoxy)acetic acid)], both free and conjugated, resulting from the direct application of MCPA or its sodium or dimethylamine salts or its 2-ethylhexyl ester and in 40 CFR 180.339(b) to read as follows: Tolerances are established for residues of the herbicide MCPA [(4-chloro-2-methylphenoxy)acetic acid)] resulting from the direct application of MCPA or its sodium or dimethylamine salts or its 2-ethylhexyl ester. EPA is revising 40 CFR 180.339(a) and (b) to 180.339 (a)(1) and (2) for consistency. Lastly, the term “negligible residue” and its designation, “(N)”, associated with some tolerances is being removed to conform to current Agency policy and practice.

Currently, tolerances exist reflecting uses of MCPA on rice, sorghum, flax (straw) and canarygrass. The uses on rice, sorghum, and canarygrass are no longer registered uses June 30, 2004; 69 FR 39467; FRL 7363-4, April 26, 2006; 71 FR 24687; FRL 8059-2. EPA policy no longer requires tolerances be established for flax straw. Therefore, EPA is revoking tolerances in 40 CFR 180.339(a)(1) for the combined MCPA residues of concern in or on flax, straw at 2 ppm; grass, canary, annual, hay at 0.1 ppm; grass, canary, annual, seed at 0.1 ppm; rice, grain at 0.1(N) ppm; rice, straw at 2 ppm; sorghum, grain at 0.1 ppm; sorghum, forage at 20 ppm; and sorghum, grain, stover at 20 ppm.

The crop field trial data indicate that the maximum combined residues of MCPA and its metabolites are <0.29 ppm in or on alfalfa forage and <1.07 ppm in or on alfalfa hay. Alfalfa forage and alfalfa hay data will also be used to satisfy crop field trial requirements for the clover, forage; clover, hay; lespedeza, clover; lespedeza, hay; trefoil, forage; trefoil, hay; vetch, forage; and vetch, hay. Ordinarily, the Agency would not translate data from alfalfa to support uses on clover, lespedeza, trefoil, and vetch; however, because the only supported use of MCPA on these crops is to the crops underseeded to small grains it is reasonable to use alfalfa forage and alfalfa hay data to support these uses. Based on these data, EPA has determined the tolerance should be 0.5 ppm in or on alfalfa, forage; clover, forage; lespedeza, forage; trefoil, forage; and vetch, forage and 2.0 ppm in or on alfalfa, hay; clover, hay; lespedeza, hay; trefoil, hay; and vetch, hay. Therefore, EPA is increasing and revising tolerances in 40 CFR 180.339(a)(1) for residues of MCPA in/on alfalfa, forage; clover, forage; lespedeza, forage; trefoil, forage; and vetch, forage from 0.1 to 0.5 ppm and alfalfa, hay; clover, hay; lespedeza, hay; trefoil, hay; and vetch, hay from 0.1 to 2.0 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

The crop field trial data indicate that the maximum combined residues of MCPA and its metabolites are 0.72 ppm in or on wheat grain and 21.4 ppm in or on wheat straw. Based on the HAFT residue of 0.08 ppm for wheat grain, expected MCPA residues of concern in/on wheat bran and germ will not exceed the established tolerance of 0.1 ppm for wheat grain and for wheat processed commodities. Because of similar cultural practices and identical use rates, wheat residue field trial data are used to support tolerances for barley, oat and rye. Based on these data, EPA has determined the tolerance should be 1.0 ppm in/on barley, grain; oat, grain; rye, grain and wheat, grain and 25 ppm in or on barley, straw; oat, straw; rye, straw; and wheat, straw. Therefore, EPA is increasing the tolerances in 40 CFR 180.33(a)(1) for residues of MCPA in/on barley, grain; oat, grain; rye, grain; and wheat, grain from 0.1(N) to 1.0 ppm and barley, straw; oat, straw; rye, straw; and wheat, straw from 2 to 25 ppm. The Agency determined that these increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.

The crop field trial data indicate that the maximum combined residues of MCPA and its metabolites are 19.4 ppm (7 day PHI) in or on wheat forage, 39.5 ppm and 111 ppm (7 and14 day PHIs, respectively) in or on wheat hay. Also these data are translated to support tolerances for barley, hay; oat, hay; oat, forage; and rye, forage. Based on these data, EPA determined the tolerances should be 20 ppm on oat, forage; rye, forage; and wheat, forage; 40 ppm on barley, hay; and 115 ppm in/on oat, hay; and wheat hay. EPA is establishing tolerances in 40 CFR 180.339(a)(1) for residues of MCPA in/on wheat, forage at 20 ppm; barley, hay at 40 ppm and oat, hay; and wheat, hay at 115 ppm. The Agency determined that these newly established tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemicals residue.

In addition, EPA is revising commodity terminology and tolerances to conform to current Agency practice in 40 CFR 180.339 as follows: “grass, pasture and grass, rangeland at 300 ppm to grass, forage at 300 ppm:” “peavines at 0.1(N) ppm to pea, field, vines at 0.1 ppm;” “peavines, hay at 0.1(N) ppm to pea, field, hay at 0.1 ppm;” “vegetable, seed and pod at 0.1 ppm to pea, dry at 0.1 ppm and pea, succulent at 0.1 ppm;” flax seed at 0.1(N) to 0.1 ppm; “cattle, fat; goat, fat; hog, fat; horse, fat; and sheep, fat; cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts; horse, meat byproducts; and sheep, meat byproducts; and cattle, meat; goat, meat; hog, meat; horse, meat; and sheep, meat at 0.1(N) ppm to 0.1 ppm;” and milk at 0.1(N) ppm to 0.1 ppm.

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 follow-up 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 the Food Quality Protection Act (FQPA). The safety finding determination is found in detail in each Reregistration Eligibility Document (RED) and Tolerance Reassessment Document (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 post-FQPA REDs for propanil, phenmedipham, triallate, and MCPA, and a TRED for propanil. REDs and TREDs contain the Agency's evaluation of the data base 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 FQPA 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. 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?

These actions become effective on the date of publication of this final rule in the Federal Register because their associated uses have been canceled for several years. The Agency believes that treated commodities have had sufficient time for passage through the channels of trade.

Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this section, 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 that the pesticide was applied to such food.

III. Are There Any International Trade Issues Raised by this Final Action?

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 MRLs established by the Codex Alimentarius Commission, as required by section 408(b)(4) of FFDCA. The Codex Alimentarius is a joint U.N. food and agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, section 408(b)(4) of FFDCA requires that EPA explain the reasons for departing from the Codex level in a notice published for public comment. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs and TREDs, and in the Residue Chemistry document which supports the RED and TRED, as mentioned in the proposed rule cited in Unit II.A.

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, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. 104-13, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether 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), 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 this 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 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 6, 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 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 the rule in the Federal Register. This 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

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 180.274 is amended by revising paragraph (a) to read as follows:

(a) General. Tolerances are established for the combined residues of the herbicide propanil (3′, 4′-dichloropropionanilide) and its metabolites convertible to 3, 4-dichloroaniline (3, 4-DCA) in or on the following food commodities:

3. Section 180.278 is revised to read as follows:

(a) General. Tolerances are established for the combined residues of the herbicide phenmedipham (3-methoxycarbonylaminophenyl-3′-methylcarbanilate) in or on the following food commodities:

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]

4. Section 180.314 is revised to read as follows:

(a) General. [Reserved]

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. Tolerances with a regional registration, as defined in 180.1(m),are established for residues of the herbicide (S-2, 3, 4-trichloroallyl diisopropylthiocarbamate) and its metabolite 2, 3, 3-trichloroprop-2-enesulfonic acid (TCPSA) in or on the following food commodities:

(d) Indirect or inadvertent residues. [Reserved]

5. Section 180.339 is revised to read as follows:

(a) General. (1) Tolerances are established for residues of the herbicide MCPA ((4-chloro-2-methylphenoxy)acetic acid), both free and conjugated, resulting from the direct application of MCPA or its sodium or dimethylamine salts, or its 2-ethylhexyl ester in or on the following food commodities:

(2) Tolerances are established for residues of the herbicide MCPA ((4-chloro-2-methylphenoxy)acetic acid) resulting from the direct application of MCPA or its sodium or dimethylamine salts, or its 2-ethylhexyl ester in or on the following food commodities:

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]