Document ID: EPA-HQ-OPP-2009-0239-0001
Agency: epa
Document Type: Proposed Rule
Title: Proposed Tolerance Actions: Metolachlor, S-Metolachlor, Bifenazate, Buprofezin, and 2,4-D
Posted Date: 2009-06-26T04:00Z

[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Proposed Rules]
[Pages 30487-30493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15139]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0239; FRL-8411-5]

Metolachlor, S-Metolachlor, Bifenazate, Buprofezin, and 2,4-D; 
Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to modify, establish and revoke certain 
tolerances for the herbicides metolachlor and S-metolachlor and correct 
the tolerance guava (from guave) on bifenazate and buprofezin and 2,4-D 
on cranberry. The regulatory actions proposed in this document are in 
follow-up to the Agency's reregistration program under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance 
reassessment program under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), section 408(q).

DATES: Comments must be received on or before August 25, 2009.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2009-0239, 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 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-
2009-0239. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line 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 e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail 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.,

[[Page 30488]]

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).
     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 e-mail. 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.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to modify, revoke, and establish specific 
tolerances for residues of the herbicides metolachlor, S-metolachlor, 
bifenazate, buprofezin, and 2,4-D in or on commodities listed in the 
regulatory text.
    EPA is proposing these tolerance actions 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 these processes, EPA is required to 
determine whether each of the amended tolerances meets the safety 
standard of FFDCA. The safety finding determination of ``reasonable 
certainty of no harm'' is discussed in detail in each Reregistration 
Eligibility Decision (RED) and Report of the Food Quality Protection 
Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision 
(TRED) for the active ingredient. REDs and TREDs recommend the 
implementation of certain tolerance actions, including modifications to 
reflect current use patterns, meet safety findings, and change 
commodity names and groupings in accordance with new EPA policy. 
Printed copies of many REDs and TREDs may be obtained from EPA's 
National Service Center for Environmental Publications (EPA/NSCEP), 
P.O. Box 42419, Cincinnati, OH 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 of REDs and TREDs are available on the Internet at http://www.epa.gov/pesticides/reregistration/status.htm and in the public 
docket, at http://www.regulations.gov.
    The selection of an individual tolerance level is based on crop 
field residue studies designed to produce the maximum residues under 
the existing or proposed product label. Generally, the level selected 
for a tolerance is a value slightly above the maximum residue found in 
such studies, provided that the tolerance is safe. The evaluation of 
whether a tolerance is safe is a separate inquiry. EPA recommends the 
raising of a tolerance when data show that:
    1. Lawful use (sometimes through a label change) may result in a 
higher residue level on the commodity.
    2. The tolerance remains safe, notwithstanding increased residue 
level allowed under the tolerance.
In REDs, Chapter IV on ``Risk management, Reregistration, and Tolerance 
reassessment'' typically describes the regulatory position, FQPA 
assessment, 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. In TREDs, the Agency discusses its evaluation of the dietary 
risk associated with the active ingredient and whether it can determine 
that there is a reasonable certainty (with appropriate mitigation) that 
no harm to any population subgroup will result from aggregate exposure. 
EPA also seeks to harmonize tolerances with international standards set 
by the Codex Alimentarius Commission, as described in Unit III.
    Explanations for proposed modifications in tolerances can be found 
in the RED and TRED document and in more detail in the Residue 
Chemistry Chapter document which supports the RED and TRED. Copies of 
the Residue Chemistry Chapter documents are found in the Administrative 
Record and EPA's

[[Page 30489]]

electronic copies are available through EPA's electronic public docket 
and comment system, regulations.gov at http://www.regulations.gov. You 
may search for docket ID number EPA-HQ-OPP-2009-0239, EPA-HQ-OPP-2002-
0223, EPA-HQ-OPP-2007-0445, EPA-HQ-OPP-2007-0674, EPA-HQ-OPP-2007-0097, 
and EPA-HQ-OPP-2007-1170, then click on that docket ID number to view 
its contents.
    EPA has determined that the aggregate exposures and risks are not 
of concern for the above-mentioned pesticide active ingredients based 
upon the data identified in the RED or TRED which lists the submitted 
studies that the Agency found acceptable.
    EPA has found that the tolerances that are proposed in this 
document to be modified, are safe; i.e., that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residues, in accordance 
with FFDCA section 408(b)(2)(C). (Note that changes to tolerance 
nomenclature do not constitute modifications of tolerances). These 
findings are discussed in detail in each RED or TRED. The references 
are available for inspection as described in this document under 
SUPPLEMENTARY INFORMATION.
    In the Federal Register notices published August 8, 2007 (72 FR 
44439) (FRL-8138-8) and May 21, 2008 (73 FR 29456) (FRL-8362-1), EPA 
proposed to revoke, modify, and establish specific tolerances for 
residues of the herbicides metolachlor and S-metolachlor as well as 
tolerances for other pesticide chemicals. These proposals provided a 
60-day comment period which invited public comment for consideration 
and for support of tolerance retention under FFDCA standards. These 
proposed actions were finalized on September 10, 2008 (73 FR 52607) 
(FRL-8379-3) and September 17, 2008 (73 FR 53732) (FRL-8375-2). The 
Agency received comments to the proposal published August 8, 2007 on S-
metolachlor in which we indicated we would respond in the future. This 
action responds to those comments and addresses other tolerance actions 
associated with metolachlor, S-metolachlor, bifenazate and buprofezin. 
The proposal published May 21, 2008 provides related information on 
metolachlor and S-metolachlor.
    1. Metolachlor/S-metolachlor. The Agency received comments from 
Syngenta (EPA-HQ-2007-0445-0013) in response to the Federal Register 
proposal published August 8, 2007 (73 FR 53732) as follows:
    (i) Revocation of tolerance in stone fruit-Use of S-Metolachlor 
in stone fruit is an important tool for Canadian fruit producers and 
therefore, it would be beneficial to maintain U.S. tolerances to 
avoid any trade irritant issues for these crops being exported from 
Canada to the U.S. Canada currently has a tolerance of 0.1 ppm for 
S-metolachlor in apples, apricots, cherries, peaches/nectarines, 
pears and plums.
    (ii) Increase in tolerance for Crop Group 6A from 0.3 ppm to 0.5 
ppm-Canada currently has a tolerance of 0.3 ppm for S-metolachlor in 
peas and snap beans. An increase in the U.S. tolerance could result 
in a trade irritant for these crops exported from the U.S. to 
Canada.
    (iii) Decrease in tolerance for Crop Group 6C from 0.3 ppm to 
0.1 ppm-Canada currently has a tolerance of 0.3 ppm for S-
metolachlor in dry beans. A decrease in the U.S. tolerance could 
result in a trade irritant for these crops exported from Canada to 
the U.S.
    (iv) Increase in tolerance for egg and meat from 0.02 pm to 0.04 
ppm-Canada currently has a tolerance of 0.02 ppm for S-metolachlor 
in eggs, meat of cattle, goats, hogs, poultry and sheep. An increase 
in the U.S. tolerance could result in a trade irritant for these 
animal products exported from the U.S. to Canada.
    (v) Increase tolerance in animal liver from 0.05 ppm to 0.1 ppm-
Canada currently has a tolerance of 0.05 ppm for S-metolachlor in 
liver of cattle and poultry. An increase in the U.S. tolerance could 
result in a trade irritant for these animal products exported from 
the U.S. to Canada.

    The Agency responded to Syngenta's first comment (i) on September 
17, 2008 (73 FR 53732). In response to the remaining comments (ii)-(v), 
the Agency has re-evaluated new and existing data for the legume crop 
group 6, and existing data for cattle meat, fat and liver, poultry 
meat, fat and egg for both metolachlor and S-metolachlor which, in 
general, the Agency agrees with the comments. The maximum S-metolachlor 
residue field trial data in/on legume vegetables support the 
harmonization of the corresponding legume vegetable crop group 6 
tolerances with the Canadian MRLs at 0.3 ppm for existing S-metolachor 
tolerances and the establishment of a tolerance of 0.3 ppm in/on pea 
and bean, succulent shelled, subgroup 6B where maximum residues were 
0.14 ppm. Extrapolating the residue data from the ruminant feeding 
study to a 1x feeding level for cattle, goats, horses, and sheep the 
maximum combined residues of concern for metolachlor and S-metolachlor 
would be 0.01 ppm in meat and fat and 0.03 ppm in liver; and 
considering the harmonization of tolerances with Canadian MRLs under 
the North American Free Trade Agreement (NAFTA), the Agency determined 
that the tolerances should be decreased for cattle, goat, horse, and 
sheep liver to 0.05 ppm and meat and fat to 0.02 ppm. Based on feeding 
studies in hens dosed up to 3.9x the maximum theoretical dietary 
burden, metolachlor and S-metolachlor residues of concern were not 
detected (< 0.02 ppm the levels of quantitation (LOQ)) in eggs, liver, 
fat, meat and meat byproducts and the importance of harmonizing MRLs 
with Canada, the Agency determined the tolerances for eggs and poultry 
meat and fat should be 0.02 ppm and poultry meat byproducts (which 
includes liver) should be 0.05 ppm The Agency inadvertently published 
the harmonized tolerances for residues of S-metolachlor in/on cattle 
meat and liver, poultry meat and egg in the Federal Register published 
September 17, 2008 (73 FR 53732) before proposing and receiving comment 
which we are correcting with this action. Therefore, EPA proposes the 
tolerances in 40 CFR 180.368(a)(2) for the combined S-metolachlor 
residues of concern be established for pea and bean, succulent shelled, 
subgroup 6B at 0.30 ppm; increased in/on pea and bean, dried shelled, 
except soybean, subgroup 6C from 0.10 ppm to 0.30 ppm; decreased in/on 
vegetable, legume, edible podded, subgroup 6A from 0.50 ppm to 0.30 
ppm; cattle, goat, horse, and sheep, liver from 0.10 to 0.05 ppm; 
cattle, goat, horse, and sheep, meat and fat from 0.04 to 0.02 ppm; egg 
and poultry, meat and fat from 0.04 to 0.02 ppm; and poultry, meat 
byproducts from 0.04 to 0.05 ppm. Also, EPA proposes the tolerances in 
40 CFR 180.368(a)(1) for the combined metolachlor residues of concern 
be increased in/on pea and bean, dried shelled, except soybean, 
subgroup 6C from 0.10 ppm to 0.3 ppm; decreased in/on vegetable, 
legume, edible podded, subgroup 6A from 0.50 ppm to 0.30 ppm; cattle, 
goat, horse, and sheep, liver from 0.10 to 0.05 ppm; cattle, goat, 
horse, and sheep, meat and fat from 0.04 to 0.02 ppm; egg and poultry, 
meat and fat from 0.04 to 0.02 ppm; and poultry, meat byproducts from 
0.04 to 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.
    Additional rotational crop field trials conducted with S-
metolachlor on wheat and oats indicate that the maximum residues levels 
were 0.40 ppm in/on oat forage, 0.50 ppm in/on oat hay, 0.09 ppm in/on 
oat straw, <0.08 ppm in/on wheat and oat grain, 0.47 ppm in/on wheat 
forage, 0.26 ppm in/on wheat hay, and 0.28 ppm in/on wheat straw.

[[Page 30490]]

Based on these residues levels and translating these data to the other 
small grains, the Agency has determined that the tolerances should be 
0.50 ppm for barley, oat, wheat and millet hay; 0.10 ppm for millet, 
grain; and 0.50 ppm for millet, forage and straw. Based on residue data 
conducted on soybean, corn, wheat and sorghum, the maximum residues 
found on aspirated grain fractions were 0.63 ppm; therefore, the Agency 
has determined that the tolerance for aspirated grain fractions (AGF) 
should be 0.7 ppm. Rice straw is no longer considered a significant 
animal feed item, therefore, tolerances are no longer required for rice 
straw. Therefore, EPA proposes tolerances in 40 CFR 180.368(a)(2) be 
established for the combined S-metolachlor residues of concern in/on 
grain, aspirated fractions at 0.70 ppm; and in 40 CFR 180.368(d)(2) be 
revoked on rice, straw at 0.50 ppm; decreased on barley, oat, and 
wheat, hay from 1.0 ppm to 0.50 ppm; established on millet, grain at 
0.10 ppm; millet, forage at 0.50 ppm; millet, hay at 0.50 ppm; and 
millet, straw at 0.50 ppm.
    Additional rotational crop field trials conducted on wheat and oats 
with metolachlor indicate that the maximum total residue levels were 
0.35 ppm in/on forage, 0.45 ppm in/on hay, 0.42 ppm in/on straw, and 
0.03 ppm in/on grain. Based on these residue levels and translating 
these data to the other small grains, the Agency has determined that 
the tolerances for metolachlor residues should be 0.80 ppm for barley, 
millet, oat, and wheat hay; 0.10 ppm for barley, buckwheat, millet, 
oat, rice, rye, and wheat grain; and 0.50 ppm for millet, oat, rye, and 
wheat forage and 0.80 ppm for barley, millet, oat, rye, and wheat 
straw. Rice straw is no longer considered a significant animal feed 
item, therefore, tolerances are no longer required for rice straw. 
Currently, since there are no active registrations with uses of 
metolachlor on spinach, the tolerance on spinach at 0.50 ppm should be 
revoked. Therefore, EPA proposes the tolerances in 40 CFR 180.368(d)(1) 
for the combined residues of concern for metolachlor be established on 
barley, millet, oat, and wheat, hay at 0.80 ppm; increased on barley, 
millet, oat, rye, and wheat straw from 0.50 ppm to 0.80 ppm; and 
revoked on rice, straw at 0.50 ppm and in 40 CFR 180.368(a)(1) revoked 
on spinach at 0.50 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.
    In this action, the Agency has proposed modifications to the 
tolerances for the legume vegetable subgroups (6A, 6B, and 6C) such 
that all of the subgroups (6A, 6B, and 6C) have the same tolerance of 
0.30 ppm for both metolachlor and S-metolachlor consequently, these 
tolerances should be consolidated as the vegetable, legume, group 6 at 
0.30 ppm. Therefore, EPA proposes the tolerances be revised in 40 CFR 
180.368(a)(1) and (a)(2) for the combined residues of concern for 
metolachlor and S-metolachlor from vegetable, legume, edible-podded, 
subgroup 6A; pea and bean, succulent shelled, subgroup 6B; and pea and 
bean, dried shelled, except soybean, subgroup 6C to vegetable, legume, 
succulent or dried, group 6.
    2. Bifenazate. The Agency proposes the tolerance in 40 CFR 
180.572(a) be corrected to read guava rather than guave.
    3. Buprofezin. The Agency proposes the tolerance in 40 CFR 
180.511(a) be corrected to read guava rather than guave.
    4. 2,4-D. In the Federal Register of June 6, 2007 (72 FR 31221) 
(FRL-8122[dash]7), the Agency incorrectly proposed a tolerance action 
that included the commodity cranberry in berry, group 13 at 0.2 ppm in 
40 CFR 180.142(a). That action removed the individual cranberry 
tolerance at 0.5 ppm in 40 CFR 180.142(a). The proposal was finalized 
September 12, 2007 (72 FR 52013) (FRL-8142-2). The berry crop group 13 
is not inclusive of cranberries. Further, reestablishing the cranberry 
tolerance at 0.5 ppm will harmonize with the Canadian maximum residue 
level (MRL) under the North American Free Trade Agreement (NAFTA). 
Therefore, the Agency proposes reestablishing the tolerance in 40 CFR 
180.142(a) for residues of 2,4-D in/on cranberry at 0.5 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.

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 section 402(a) of FFDCA, 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.

C. When Do These Actions Become Effective?

    EPA is proposing that the actions herein become effective on the 
date of publication of the final rule in the Federal Register.
    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 the requirement of a 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. Are the Proposed Actions Consistent With International 
Obligations?

    The tolerance actions in this proposal are not discriminatory and 
are designed to ensure that both domestically produced and imported 
foods meet the food safety standards established by FFDCA. The same 
food safety standards apply to domestically produced and imported 
foods.
    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

[[Page 30491]]

Alimentarius is a joint U.N. Food and Agriculture Organization/ World 
Health Organization food standards program, and it is recognized as an 
international food safety standards-setting organization in trade 
agreements to which the United States is a party. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain the reasons for departing from the 
Codex level 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 Unit II.A. 
Specific tolerance actions in this proposed rule and how they compare 
to Codex MRLs (if any) are discussed in Unit II.A.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to establish tolerances 
under FFDCA section 408(e), and also modify and revoke specific 
tolerances established under FFDCA section 408. The Office of 
Management and Budget (OMB) has exempted these types of actions (e.g., 
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 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) (Public Law 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 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) (FRL-5753-1), 
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 
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 pesticide 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 section 408(n)(4) of FFDCA. 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.

    Dated: June 19, 2009
Steven Bradbury,
Acting Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

[[Page 30492]]

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 180.142 is amended by adding alphabectically the 
following commodity to the table in paragraph (a) to read as follows:

Sec.  180.142  2,4-D; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Cranberry..................................................          0.5
                                * * * * *
------------------------------------------------------------------------

* * * * *
    3. Section 180.368 is amended by revising the table in paragraph 
(a)(1), (a)(2), (d)(1) and (d)(2) to read as follows:

Sec.  180.368  Metolachlor; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         0.30
Animal feed, nongrass, group 18............................          1.0
Cattle, fat................................................         0.02
Cattle, kidney.............................................         0.20
Cattle, liver..............................................         0.05
Cattle, meat...............................................         0.02
Cattle, meat byproducts, except kidney and liver...........         0.04
Corn, field, forage........................................          6.0
Corn, field, grain.........................................         0.10
Corn, field, stover........................................          6.0
Corn, sweet, forage........................................          6.0
Corn, sweet, kernel plus cob with husks removed............         0.10
Corn, sweet, stover........................................          6.0
Cotton, gin byproducts.....................................          4.0
Cotton, undelinted seed....................................         0.10
Dill.......................................................         0.50
Egg........................................................         0.02
Goat, fat..................................................         0.02
Goat, kidney...............................................         0.20
Goat, liver................................................         0.05
Goat, meat.................................................         0.02
Goat, meat byproducts, except kidney and liver.............         0.04
Grass, forage..............................................           10
Grass, hay.................................................         0.20
Horse, fat.................................................         0.02
Horse, kidney..............................................         0.20
Horse, liver...............................................         0.05
Horse, meat................................................         0.02
Horse, meat byproducts, except kidney and liver............         0.04
Milk.......................................................         0.02
Nut, tree, group 14........................................         0.10
Okra.......................................................         0.50
Peanut.....................................................         0.20
Peanut, hay................................................           20
Peanut, meal...............................................         0.40
Potato.....................................................         0.20
Poultry, fat...............................................         0.02
Poultry, meat..............................................         0.02
Poultry, meat byproducts...................................         0.05
Safflower, seed............................................         0.10
Sheep, fat.................................................         0.02
Sheep, kidney..............................................         0.20
Sheep, liver...............................................         0.05
Sheep, meat................................................         0.02
Sheep, meat byproducts, except kidney and liver............         0.04
Sorghum, grain, forage.....................................          1.0
Sorghum, grain, grain......................................         0.30
Sorghum, grain, stover.....................................          4.0
Soybean, forage............................................          5.0
Soybean, hay...............................................          8.0
Soybean, seed..............................................         0.20
Tomato.....................................................         0.10
Vegetable, foliage of legume, subgroup 7A, except soybean..         15.0
Vegetable, legume, succulent or dried, group 6.............         0.30
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Asparagus..................................................         0.10
Beet, sugar, molasses......................................          2.0
Beet, sugar, roots.........................................          0.5
Beet, sugar, tops..........................................         15.0
Brassica, head and stem, subgroup 5A.......................         0.60
Cattle, fat................................................         0.02
Cattle, kidney.............................................         0.20
Cattle, liver..............................................         0.05
Cattle, meat...............................................         0.02
Cattle, meat byproducts, except kidney and liver...........         0.04
Corn, field, grain.........................................         0.10
Corn, field, forage........................................          6.0
Corn, field, stover........................................          6.0
Corn, pop, grain...........................................         0.10
Corn, pop, stover..........................................          6.0
Corn, sweet, forage........................................          6.0
Corn, sweet, kernel plus cob with husks removed............         0.10
Corn, sweet, stover........................................          6.0
Cotton, gin byproducts.....................................          4.0
Cotton, undelinted seed....................................         0.10
Egg........................................................         0.02
Garlic, bulb...............................................         0.10
Grain, aspirated fractions.................................         0.70
Goat, fat..................................................         0.02
Goat, kidney...............................................         0.20
Goat, liver................................................         0.05
Goat, meat.................................................         0.02
Goat, meat byproducts, except kidney and liver.............         0.04
Grass, forage..............................................         10.0
Grass, hay.................................................         0.20
Horse, fat.................................................         0.02
Horse, kidney..............................................         0.20
Horse, liver...............................................         0.05
Horse, meat................................................         0.02
Horse, meat byproducts, except kidney and liver............         0.04
Milk.......................................................         0.02
Onion, bulb................................................         0.10
Onion, green...............................................          2.0
Peanut.....................................................         0.20
Peanut, hay................................................         20.0
Peanut, meal...............................................         0.40
Poultry, fat...............................................         0.02
Poultry, meat..............................................         0.02
Poultry, meat byproducts...................................         0.05
Pumpkin....................................................         0.10
Safflower, seed............................................         0.10
Shallot, bulb..............................................         0.10
Sheep, fat.................................................         0.02
Sheep, kidney..............................................         0.20
Sheep, liver...............................................         0.05
Sheep, meat................................................         0.02
Sheep, meat byproducts, except kidney and liver............         0.04
Sorghum, grain, forage.....................................          1.0
Sorghum, grain, grain......................................          0.3
Sorghum, grain, stover.....................................          4.0
Soybean, forage............................................          5.0
Soybean, hay...............................................          8.0
Soybean, seed..............................................         0.20
Spinach....................................................         0.50
Squash, winter.............................................         0.10
Sunflower, seed............................................         0.50
Sunflower, meal............................................          1.0
Tomato, paste..............................................         0.30
Vegetable, foliage of legume, except soybean, subgroup 7A..         15.0
Vegetable, fruiting, except tabasco pepper, group 8........         0.10
Vegetable, leaf petioles, subgroup 4B......................         0.10
Vegetable, legume, succulent or dried, group 6.............         0.30
Vegetable, root, except sugar beet, subgroup 1B............         0.30
Vegetable, tuberous and corm, subgroup 1C..................         0.20
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18............................          1.0
Barley, grain..............................................         0.10
Barley, hay................................................         0.80
Barley, straw..............................................         0.80
Buckwheat, grain...........................................         0.10
Millet, forage.............................................         0.50
Millet, grain..............................................         0.10
Millet, hay................................................         0.80
Millet, straw..............................................         0.80
Oat, forage................................................         0.50
Oat, grain.................................................         0.10
Oat, hay...................................................         0.80
Oat, straw.................................................         0.80
Rice, grain................................................         0.10
Rye, forage................................................         0.50
Rye, grain.................................................         0.10
Rye, straw.................................................         0.80
Wheat, forage..............................................         0.50
Wheat, grain...............................................         0.10
Wheat, hay.................................................         0.80
Wheat, straw...............................................         0.80
------------------------------------------------------------------------

    (2) * * *

[[Page 30493]]

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18............................          1.0
Barley, grain..............................................         0.10
Barley, hay................................................         0.50
Barley, straw..............................................         0.50
Buckwheat, grain...........................................         0.10
Millet, forage.............................................         0.50
Millet, grain..............................................         0.10
Millet, hay................................................         0.50
Millet, straw..............................................         0.50
Oat, forage................................................         0.50
Oat, grain.................................................         0.10
Oat, hay...................................................         0.50
Oat, straw.................................................         0.50
Rice, grain................................................         0.10
Rye, forage................................................         0.50
Rye, grain.................................................         0.10
Rye, straw.................................................         0.50
Wheat, forage..............................................         0.50
Wheat, grain...............................................         0.10
Wheat, hay.................................................         0.50
Wheat, straw...............................................         0.50
------------------------------------------------------------------------

* * * * *
    4. Section 180.511 is amended by removing the entry for ``Guave'' 
and adding the following commodity to the table in paragraph (a) to 
read as follows:

Sec.  180.511  Buprofezin; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Guava......................................................          0.3
------------------------------------------------------------------------

* * * * *
    5. Section 180.572 is amended by removing the entry for ``Guave'' 
and adding the following commodity to the table in paragraph (a) to 
read as follows:

Sec.  180.572  Bifenazate; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Guava......................................................          0.9
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-15139 Filed 6-25-09; 8:45 am]
BILLING CODE 6560-50-S