Document ID: EPA-HQ-OPP-2007-0555-0003
Agency: epa
Document Type: Rule
Title: Acetic acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester (Cloquintocet-mexyl); Pesticide Tolerance
Posted Date: 2008-03-05T05:00Z

[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Rules and Regulations]               
[Page 11816-11820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr08-4]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0555; FRL-8350-8]

 
Acetic acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester 
(Cloquintocet-mexyl); Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending 40 CFR 180.560 to add a reference to the 
active ingredient pyroxsulam to the tolerance for the inert ingredient 
cloquintocet-mexyl (acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-
methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-
chloro-8-quinolinoxyacetic acid). EPA is also revising existing 
tolerance levels for cloquintocet-mexyl in or on wheat, forage and 
wheat, hay, and is removing the specification of a 1:4 ratio inert 
ingredient safener to active ingredient from the tolerance expression. 
Dow AgroSciences, LLC and Syngenta Crop Protection requested the 
tolerance amendments for the inert ingredient safener cloquintocet-
mexyl under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 5, 2008. Objections and 
requests for hearings must be received on or before May 5, 2008, 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-2007-0555. 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 website 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

[[Page 11817]]

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 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 Docket Facility is open 
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: R. Tracy Ward, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9361; e-mail address: ward.tracyh@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 those 
engaged in the following activities:
     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 to 
provide 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 EPA's tolerance regulations at 
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 FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0555 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 as required by 40 CFR part 178 on or 
before May 5, 2008.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0555, 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 and Statutory Findings

    EPA has received several petitions requesting amendments to the 
existing tolerances for the inert ingredient (safener) cloquintocet-
mexyl (acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; 
CAS Reg. No. 99607-70-2). The most recent final rule that established 
tolerances for this safener was published in the Federal Register of 
December 16, 2005 (70 FR 74679) (FRL-7753-4). That final rule provides 
a description of the toxicity data and risk assessments for 
cloquintocet-mexyl, and the reader is referred to it for additional 
information. The new petitions received by the Agency are summarized 
below.
    In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8121-5), 
the Agency issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a announcing the filing of pesticide petition PP 7E7194 by 
Dow AgroScience, LLC, 9330 Zionsville Rd, Indianapolis, Indiana 46268-
1053. The petition requested that 40 CFR 180.560 be amended by adding 
reference to the active ingredient pyroxsulam for use in pesticide 
formulations with the inert ingredient safener cloquintocet-mexyl 
(acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; CAS 
Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-
quinolinoxyacetic acid) in or on wheat, grain at 0.10 parts per million 
(ppm), wheat, forage at 0.1 ppm, wheat, hay at 0.10 ppm, and wheat, 
straw at 0.10 ppm. In support of the proposed use of cloquintocet-mexyl 
combined with pyroxsulam, Dow AgroSciences submitted four residue 
chemistry studies:
    1. A magnitude of the residue study depicting the residues of 
cloquintocet-mexyl in wheat grain, forage, hay, and straw,
    2. A storage stability study,
    3. An analytical method study, and
    4. An independent laboratory validation (ILV) of the analytical 
method.
Docket ID number EPA-HQ-OPP-2007-0335 was established for this 
petition. No comments were received for this notice. This docket has 
now been linked to the docket established for this final rule (EPA-HQ-
OPP-2007-0555).
    The Agency issued a notice in the Federal Register of August 22, 
2007 (72 FR 47010) (FRL-8145-1) announcing the filing of a pesticide 
petition PP 7E7233 by Syngenta Crop Protection, Inc., P.O. Box 18300, 
Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.560 
be amended by

[[Page 11818]]

increasing the existing tolerances for residues of cloquintocet-mexyl 
and its acid metabolite (5-chloro-8-quinlinoxyacetic acid) when used as 
an inert ingredient safener in or on the raw agricultural commodities 
wheat, forage at 0.20 ppm (from the existing tolerance of 0.10 ppm) and 
wheat, hay at 0.50 ppm (from the existing tolerance of 0.10 ppm). The 
docket for this notice is EPA-HQ-OPP-2007-0555. No comments were 
received for this notice.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.'' 
These provisions were added to FFDCA by the Food Quality Protection Act 
(FQPA) of 1996.

III. Risk Characterization and Conclusion

    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action and considered its validity, completeness and reliability, and 
the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
cloquintocet-mexyl are discussed in this unit. EPA has sufficient data 
to assess the hazards of and make a determination on aggregate exposure 
for the chemical.
    The following provides a brief summary of the risk assessment and 
conclusions for the Agency's review of cloquintocet-mexyl. The Agency's 
full decision document and risk assessments for this action are 
available on EPA's Electronic Docket at http://www.regulations.gov/ 
under docket ID number EPA-HQ-OPP-2007-0555. For the full toxicity data 
and information on which this risk assessment is based, the reader is 
referred to a final rule establishing tolerances for cloquintocet-mexyl 
that published in the December 16, 2005, Federal Register (70 FR 
74679).

A. Human Health

    In the final rule published in the Federal Register of December 16, 
2005 (70 FR 74679) that established tolerances for cloquintocet-mexyl, 
the Agency reviewed the available information on cloquintocet-mexyl 
submitted by the petitioners as well as additional information 
available to EPA. The toxicity database is sufficient for cloquintocet-
mexyl and has not changed since that time. Therefore, only a brief 
summary is provided here. Cloquintocet-mexyl has a low order of acute 
oral, dermal and inhalation toxicity. It is slightly irritating to the 
eyes and non-irritating to the skin. Cloquintocet-mexyl is a skin 
sensitizer. The chemical is not genotoxic and is not a reproductive and 
developmental toxicant. There is no evidence of neurotoxicity in the 
available studies. Cloquintocet-mexyl is classified as ``not likely to 
be a human carcinogen.'' The main metabolite for cloquintocet-mexyl is 
5-chloro-8-quin-linoxyacetic acid, and testing on the metabolite is 
part of the toxicology database for cloquintocet-mexyl. Based on the 
available information, the Agency concludes that there is no concern 
for increased susceptibility in offspring to cloquintocet-mexyl, and 
the additional tenfold safety factor for the protection of infants and 
children is also unnecessary. For additional information on the Human 
Health toxicity data for cloquintocet-mexyl and its metabolite, see the 
docket and the Federal Register of December 16, 2005 (70 FR 74679).

B. Exposure Assessment

    In examining aggregate exposure, the FFDCA section 408 directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses). In the 2005 rulemaking, EPA 
assessed human exposure to cloquintocet-mexyl from use on wheat and 
barley. EPA assumed that 100 percent of the wheat and barley crops were 
treated with cloquintocet-mexyl and that residues on all wheat and 
barley commodities were at the tolerance level. This assessment is 
sufficient for the current amendments to the cloquintocet-mexyl 
tolerance because (1) no new crops are being added to the tolerance; 
and (2) EPA has determined that higher tolerance levels being 
established for the animal feeds of wheat, hay, and forage will not 
result in finite residues in livestock commodities. For additional 
information on the exposure assessment for cloquintocet-mexyl, see the 
docket and the Federal Register of December 16, 2005 (70 FR 74679).
    The first petition (PP 7E7194) requested that cloquintocet-mexyl be 
used with an additional active ingredient (pyroxsulam), and the second 
petition (PP 7E7233) requested increases in wheat tolerances. The 
Agency's exposure assessments documents are found in this docket. The 
following are summaries of the conclusions.
    PP 7E7194: Adding Pyroxsulam. Dow AgroScience's petition (PP 
7E7194) requested the cloquintocet-mexyl be allowed to be used in 
formulations of the active ingredient pyroxsulam, and that tolerances 
of 0.10 ppm be established on wheat grain, forage, hay, and straw. Dow 
AgroSciences submitted four residue chemistry studies:
     1. A magnitude of the residue study depicting the residues of 
cloquintocet-mexyl in wheat grain, forage, hay, and straw,
    2. A storage stability study,
    3. An analytical method study, and
    4. An independent laboratory validation (ILV) of the analytical 
method. Evaluation of the data was accomplished as part of a joint 
review by Australia, Canada, and the United States.
    The results of the residue field trials did not exceed the 
currently established cloquintocet-mexyl tolerances for wheat 
commodities. All the observed residues were less than half of the 
established tolerances and were not significantly higher than the 
method Level of Quantification (LOQ). Therefore, the active ingredient 
pyroxsulam can be added to the current tolerance for cloquintocet-
mexyl. The current wheat tolerances are adequate and do not need to be 
modified as a result of the addition of the new active ingredient.
    PP 7E7233: Increasing wheat tolerances for cloquintocet-mexyl. 
Syngenta Crop Protection's petition (PP 7E7233) requested that existing 
tolerances for cloquintocet-mexyl and its metabolite be amended to 
increase wheat, forage from 0.10 to 0.20 ppm and wheat, hay from 0.10 
to 0.50 ppm. The Agency is granting the requested increase in 
tolerances for cloquintocet-mexyl and its metabolite on wheat,

[[Page 11819]]

forage at 0.20 ppm and wheat, hay at 0.50 ppm.
    EPA has no objection to raising the tolerances for wheat, forage 
from 0.1 ppm to 0.20 ppm and wheat, hay from 0.1 to 0.50 ppm. EPA 
developed livestock secondary residue calculations assuming levels of 
0.20 ppm for wheat, forage and 0.50 ppm for wheat, hay. Because of the 
low levels of total radioactive residues found in livestock commodities 
in the ruminant and poultry metabolism studies and the corresponding 
low radioactive residues calculated for the 1X feeding levels, ruminant 
and poultry feeding studies are not needed, tolerances on livestock 
commodities are not needed, and analytical methods for livestock 
commodities are not needed. The uses on wheat fall under 40 CFR 
180.6(a)(3) since no secondary residues are expected to occur in 
livestock commodities.
    The results of field residue trial show that when used with the 
active ingredient pyroxsulam, residues of cloquintocet-mexyl were less 
than half of the established tolerances and not significantly higher 
than the method LOQ. And no secondary residues are expected to occur in 
livestock commodities from the increase of cloquintocet-mexyl wheat, 
hay, and forage tolerances. Therefore, the previously conducted 
cloquintocet-mexyl aggregate exposure assessments can be used in 
evaluating the addition of this active ingredient and the increase to 
wheat, hay, and forage tolerances. The following summary of aggregate 
exposure risks of cloquintocet-mexyl from acute and chronic dietary 
exposures and drinking water exposures is taken from the ``Aggregate 
Risks and Determination of Safety'' section of the final rule for 
cloquintocet-mexyl (70 FR 74679) published December 16, 2005.
    There are no residential uses for cloquintocet-mexyl at this time. 
Therefore, the acute aggregate risk assessment includes exposure 
estimates from food and drinking water only.
    ``The food and water exposure estimates for females 13-49 yrs old 
is <1% of the acute population adjusted dose (aPAD). The acute risk 
estimate for females 13-49 years, resulting from aggregate exposure to 
cloquintocet-mexyl in food and drinking water is below EPA's level of 
concern.''
    The following summarizes the chronic aggregate exposure risks of 
cloquintocet-mexyl:
    ``The aggregate chronic risk assessment takes into account average 
exposure estimates from dietary consumption of cloquintocet-mexyl (food 
and drinking water) and residential uses. Since there are no 
residential uses for cloquintocet-mexyl (either established or pending) 
at this time, the aggregate chronic assessment included exposures from 
food and drinking water only. Since the dietary exposure assessment 
already includes the highest chronic exposure from the drinking water 
modeling data, no further calculations are necessary. The general U.S. 
population and all population subgroups have exposure and risk 
estimates which are below the Agency's level of concern (i.e., the 
percentages of the chronic population adjusted doses (cPADs) are all 
below 100%). The exposure to the U.S. population is <1% cPAD and the 
most highly exposed subgroup, children 3-5 yrs old, is 1% cPAD. 
Therefore, chronic risk estimates resulting from aggregate exposure to 
cloquintocet-mexyl in food and drinking water are below the Agency's 
level of concern from all population subgroups.''
    There are no residential or non-pesticidal uses for cloquintocet-
mexyl. Therefore, no further aggregate assessment is necessary. For 
additional information on the Exposure Assessment for cloquintocet-
mexyl, see the docket and the Federal Register of December 16, 2005 (70 
FR 74679).

C. Safety Factor for Infants and Children

    Section 408 of the FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans. The toxicity database is 
sufficient for cloquintocet-mexyl and potential exposure is adequately 
characterized based on modeling. In terms of hazard, there are low 
concerns and no residual uncertainties regarding pre-natal and/or post-
natal toxicity. Accordingly, EPA concludes that the additional tenfold 
safety factor for the protection of infants and children is 
unnecessary. For additional information on the Safety Factor 
determination for infants and children for cloquintocet-mexyl, see the 
docket and the Federal Register of December 16, 2005 (70 FR 74679).

D. Cumulative Exposure

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to cloquintocet-mexyl and any other substances, and the 
chemical does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that cloquintocet-mexyl has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
http://www.epa.gov/pesticides/cumulative.

E. Other Considerations

1. Analytical Methods

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov. For the complete description of 
Analytical Methods for cloquintocet-mexyl, see the docket and the 
Federal Register of December 16, 2005 (70 FR 74679).

2. Storage Stability

    The petitioner submitted the results of a storage stability study 
that was performed to support the field trials. Samples of wheat grain, 
wheat straw, wheat forage, spinach, tomatoes, potatoes, and soybeans 
were fortified with cloquintocet-mexyl and cloquintocet acid to levels 
of 0.01 and 0.10 ppm. After 9 months of storage at temperatures of <=-
20 C, percent recoveries of cloquintocet-mexyl ranged from 74-107% and 
percent recoveries of cloquintocet acid ranged from 72-101%. The 
storage stability data are adequate to support the storage durations 
used in the field trials.

3. International Tolerances

    There are no Codex tolerances for cloquintocet-mexyl. Australia has 
established maximum residue limits

[[Page 11820]]

(MRLs) for cloquintocet-mexyl on wheat and barley at 0.1 ppm.

F. Determination of Safety and Conclusions

    The Agency is granting the requested increase in tolerances for 
cloquintocet-mexyl and its metabolite on wheat, forage at 0.20 ppm and 
wheat, hay at 0.50 ppm. The Agency is also granting the requested 
addition of reference to the active ingredient pyroxsulam for use with 
the inert ingredient safener cloquintocet-mexyl on wheat. In addition, 
the Agency is removing the specification of a 1:4 ratio of 
cloquintocet-mexyl to active ingredient from the existing tolerance 
expression of 40 CFR 180.560. The specification is not necessary when 
numerical tolerances are already established.
    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm to the general population, 
including infants and children, from aggregate exposure to residues of 
cloquintocet-mexyl and its metabolite. Accordingly, EPA finds that the 
tolerances described above for residues of cloquintocet-mexyl and its 
metabolite will be safe.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to petitions submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions 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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, this 
rule does not 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).
    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).

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: February 20, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.560 is amended by revising paragraph (a) to read as 
follows:

Sec.  180.560   Cloquintocet-mexyl (acetic acid [(5-chloro-8-
quinolinyl) oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-2); 
tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of cloquintocet-mexyl (acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-
methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-
chloro-8-quinlinoxyacetic acid) when used as an inert ingredient 
(safener) in pesticide formulations containing the active ingredients 
pinoxaden (wheat or barley), clodinafop-propargyl (wheat only), or 
pyroxsulum (wheat only) in or on the following food commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Barley, grain.............................  0.1
Barley, hay...............................  0.1
Barley, straw.............................  0.1
Wheat, forage.............................  0.2
Wheat, grain..............................  0.1
Wheat, hay................................  0.5
Wheat, straw..............................  0.1
------------------------------------------------------------------------

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[FR Doc. E8-4023 Filed 3-4-08; 8:45 am]

BILLING CODE 6560-50-S