Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Rules and Regulations 16017 

■ 10. Effective April 1, 2010 through 

October 3, 2011, amend 40 CFR 52.21 to 

add (i)(l)(vii) to read as follows: 

§ 52.21 Prevention of significant 

deterioration of air quality. 

* * * * * 

(i) * * * 

(1) * * * 

(vii) The source or modification 

would be a major stationary source or 

major modification only if fugitive 

emissions, to the extent quantifiable, are 

considered in calculating the potential 

to emit of the stationary source or 

modification and the source does not 

belong to any of the following 

categories: 

(a) Coal cleaning plants (with thermal 

dryers); 

(b) Kraft pulp mills; 

(c) Portland cement plants; 

(d) Primary zinc smelters; 

(e) Iron and steel mills; 

(f) Primary aluminum ore reduction 

plants; 

(g) Primary copper smelters; 

(h) Municipal incinerators capable of 

charging more than 250 tons of refuse 

per day; 

(i) Hydrofluoric, sulfuric, or nitric 

acid plants; 

(j) Petroleum refineries; 

(k) Lime plants; 

(l) Phosphate rock processing plants; 

(m) Coke oven batteries; 

(n) Sulfur recovery plants; 

(o) Carbon black plants (furnace 

process); 

(p) Primary lead smelters; 

(q) Fuel conversion plants; 

(r) Sintering plants; 

(s) Secondary metal production 

plants; 

(t) Chemical process plants—The term 

chemical processing plant shall not 

include ethanol production facilities 

that produce ethanol by natural 

fermentation included in NAICS codes 

325193 or 312140; 

(u) Fossil-fuel boilers (or combination 

thereof) totaling more than 250 million 

British thermal units per hour heat 

input; 

(v) Petroleum storage and transfer 

units with a total storage capacity 

exceeding 300,000 barrels; 

(w) Taconite ore processing plants; 

(x) Glass fiber processing plants; 

(y) Charcoal production plants; 

(z) Fossil fuel-fired steam electric 

plants of more than 250 million British 

thermal units per hour heat input; 

(aa) Any other stationary source 

category which, as of August 7, 1980, is 

being regulated under section 111 or 

112 of the Act; or 

* * * * * 

[FR Doc. 2010–7036 Filed 3–30–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0714; FRL–8816–3] 

Cloquintocet-mexyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is amending 40 CFR 

180.560 to add a reference to the active 

ingredient flucarbazone-sodium (wheat 

only) 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-chloro8-quinolinoxyacetic acid) on wheat 

forage, wheat grain, wheat hay, and 

wheat straw. Arysta LifeScience North 

America, LLC requested this tolerance 

amendment under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 31, 2010. Objections and requests 

for hearings must be received on or 

before June 1, 2010, 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–2009–0714. 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., 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: 

Karen Samek, Registration division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8825; e-mail address: 

samek.karen@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). 

• 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 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 Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, 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–2009–0714 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 June 1, 2010. 

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 


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16018 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Rules and Regulations 

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–2009–0714, 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. 

II. Petition for Tolerance 

EPA has received a petition from 

Arysta LifeScience North America, LLC, 

15401 Weston Parkway, Cary, NC 

27513, requesting an amendment to the 

existing tolerances for the inert 

ingredient (safener) (acetic acid [(5- 

chloro-8-quinolinyl) oxy]-, 1- 

methylhexyl ester; CAS Reg. No. 99607– 

70–2) and its acid metabolite (5-chloro8-quinolinoxyacetic acid). For ease of 

reading this document, acetic acid [(5- 

chloro-8-quinolinyl) oxy]-, 1- 

methylhexyl ester will be referred to as 

cloquintocet-mexyl. EPA published two 

final rules to establish tolerances for the 

safener under 40 CFR 180.560 in the 

Federal Register of June 22, 2000 (65 FR 

38757) (FRL–6592–4) and the Federal 

Register of December 16, 2005 (70 FR 

74679) (FRL–7753–4). These tolerances 

establish tolerances for cloquintocetmexyl when used as an inert ingredient 

(safener) in pesticide formulations 

containing the active ingredients 

pinoxaden (wheat or barley) or 

clodinafop-propargyl (wheat only). In 

addition, a final rule that established 

tolerances for this safener was 

published in the Federal Register of 

March 5, 2008 (73 FR 11816) (FRL– 

8350–8). That final rule amended 40 

CFR 180.560 by adding a reference to 

the active ingredient pyroxsulam (wheat 

only), and increased the existing 

tolerances for residues of cloquintocetmexyl in or on wheat, forage and wheat, 

hay, and removed the specification of a 

1:4 ratio inert ingredient safener to 

active ingredient from the tolerance 

expression. 

In the Federal Register of October 7, 

2009 (74 FR 51597) (FRL–8792–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of the 

above-referenced pesticide petition (PP 

9E7592) by Arysta LifeScience North 

America, LLC. The petition requested 

that 40 CFR 180.560 be amended by 

expanding the tolerance to cover 

cloquintocet-mexyl residues when used 

in formulation with the active 

ingredient flucarbazone-sodium on 

wheat. No numerical change to the 

tolerances for the specific wheat 

commodities was sought. That notice 

referenced a summary of the petition 

prepared by Arysta LifeScience North 

America, LLC, the registrant, which is 

available to the public in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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. . . .’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the chemical. 

The Agency’s decision document for 

this action is available on EPA’s 

Electronic Docket at http:// 

www.regulations.gov/ under docket ID 

number EPA–HQ–OPP–2009–0714. For 

the full toxicity data and information on 

which this risk assessment is based, the 

reader is referred to the final rules 

establishing tolerances for cloquintocetmexyl that published in in the Federal 

Register of March 5, 2008, December 16, 

2005, and June 22, 2000. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by cloquintocet-mexyl as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in the final rules 

published on March 5, 2008, December 

16, 2005, and June 22, 2000. In these 

final rules, the Agency reviewed the 

available information on cloquintocetmexyl 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 the time of those 

publications. 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 cloquintocetmexyl. For additional information on 

the human health toxicity data for 

cloquintocet-mexyl and its metabolite, 

see EPA’s Electronic Docket at http:// 

www regulations.gov and the Federal 

Register of March 5, 2008, December 16, 

2005, and June 22, 2000. 

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 nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 


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Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Rules and Regulations 16019 

uses). In the 2008 rulemaking, EPA 

assessed human exposure to 

cloquintocet-mexyl from use on wheat 

and barley. EPA assumed that 100% 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. 

The Agency has determined that this 

assessment is sufficient for the current 

amendment to the cloquintocet-mexyl 

tolerance expression because no new 

crops are being added and the label 

requirements limit the total number of 

applications from all of the various 

cloquintocet-mexyl safener products to 

one application from this group of 

pesticides on a crop per growing season. 

For additional information on the 

exposure assessment for cloquintocetmexyl, see the docket and the Federal 

Register of March 5, 2008. 

C. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of 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.’’ 

EPA has not found cloquintocetmexyl to share a common mechanism of 

toxicity with any other substances, and 

cloquintocet-mexyl does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that cloquintocet-mexyl does 

not have 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. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) 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 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility of in utero or post-natal 

exposure to rats or rabbits in the 

prenatal developmental studies or in 

rats in the 2-generation reproduction 

study. NOAELs for maternal/parental 

toxicity were either less than or equal to 

the NOAELs for fetal or reproductive 

toxicity. 

3. Conclusion. EPA has determined 

that reliable data show that the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

cloquintocet-mexyl is complete, except 

for immunotoxicity and neurotoxicity 

studies. EPA began requiring these 

studies on December 26, 2009. In the 

absence of specific immunotoxicity 

studies, EPA has evaluated the available 

toxicity data for cloquintocet-mexyl and 

determined that an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity. 

EPA’s determination is based on the 

following considerations. 

There was some indication of possible 

immunotoxicity in the form of 

lymphoid hyperplasia of the thymus in 

male rats (without any histopathology 

changes in the study) at the LOAEL of 

73.5 milligrams/kilogram/day (mg/kg/ 

day) in the combined chronic/ 

oncogenicity study in rats (with a 

NOAEL of 36.4 mg/kg/day). This effect 

was observed only in males. No blood 

parameters were affected. In addition, 

cloquintocet-mexyl does not belong to a 

class of chemicals that would be 

expected to be immunotoxic. A clear 

NOAEL was established for these effects 

(36.4 mg/kg/day), and the regulatory 

endpoint of 4.3 mg/kg/day (the NOAEL 

from the combined chronic/ 

oncogenicity study) is nearly 10X below 

the NOAEL for the possible 

immunotoxic effect. Therefore, based on 

the considerations in this unit, EPA 

does not believe that conducting 

immunotoxicity testing will result in a 

NOAEL significantly less than the 

NOAEL of 4.3 mg/kg/day already 

established for cloquintocet-mexyl, and 

an additional factor (UFDB) for database 

uncertainties is not needed to account 

for potential immunotoxicity. A 

confirmatory immunotoxicity study will 

be required as a condition of the 

registration. 

No acute and subchronic 

neurotoxicity studies are available, 

however, there is no evidence of 

neurotoxicity in the toxicology database 

on cloquintocet-mexyl. Therefore, based 

on the considerations in this unit, the 

Agency does not believe that conducting 

acute and subchronic neurotixicty 

studies will result in a NOAEL less than 

the NOAEL of 4.3 mg/kg/day. Therefore, 

there is no need for additional 

uncertainty factors (UF). Confirmatory 

acute and subchronic neurotoxicity 

studies will be required as a condition 

of registration. 

ii. There is no indication of 

quantitative or qualitative increased 

susceptibility of rats or rabbits to in 

utero and/or postnatal exposure to 

cloquintocet-mexyl in the available 

toxicity database. 

iii. There is no indication that 

cloquinocet-mexyl is a neurotoxic 

chemical and thus there is no need for 

a developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iv. The dietary (food and drinking 

water) exposure assessments will not 

underestimate the potential exposures 

for infants and children from the use of 

cloquintocet-mexyl (currently there are 

no proposed residential uses and 

therefore non-occupational exposure is 

not expected). 

For additional information on the 

Safety Factor determination for infants 

and children for cloquintocet-mexyl, see 

the docket and the Federal Register of 

March 5, 2008. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate safty 

factors (SFs). EPA calculates the aPAD 

and cPAD by dividing the point of 

departure (POD) by all applicable UFs. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given the estimated aggregate 

exposure. Short-term, intermediateterm, and chronic-term risks are 

evaluated by comparing the estimated 

aggregate food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. 

In the 2005 and 2008 rulemakings for 

cloquintocet-mexyl, EPA concluded that 

aggregate risks from exposure to 

cloquintocet-mexyl did not exceed 1% 

of the aPAD or cPAD for the most 

exposed population groups. (73 FR 

11819); (70 FR 74685). These findings 

are applicable to this tolerance 

amendment. 


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16020 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Rules and Regulations 

Based on these risk assessments, EPA 

concludes that there is a reasonable 

certainty that no harm will result to the 

general population, or to infants and 

children from aggregate exposure to 

cloquintocet-mexyl and its acid 

metabolite (5-chloro-8- 

quinolinoxyacetic acid). 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Enviromental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; 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. 

B. International Residue Limits 

There are no Codex tolerances for 

cloquintocet-mexyl. 

V. Conclusions 

Therefore, 40 CFR 180.560 is 

amended by establishing a tolerance for 

the combined residues of cloquintocetmexyl (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 

flucarbazone-sodium (wheat only), 

pinoxaden (wheat or barley), 

clodinafop-propargyl (wheat only), or 

pyroxsulum (wheat only) in or on 

barley, grain at 0.1 ppm; barley, hay at 

0.1 ppm; barley, straw at 0.1 ppm; 

wheat, forage at 0.2 ppm; wheat, grain 

at 0.1 ppm; wheat, hay at 0.5 ppm; and 

wheat, straw at 0.1 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition 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 final rule 

has been exempted from review under 

Executive Order 12866, this final 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) 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 9, 2000) do not apply 

to this final rule. In addition, this final 

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). 

VII. 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: March 22, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ 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 180.560, revise paragraph 

(a) to read as follows: 

§ 180.560 Cloquintocet-mexyl; 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-chloro8-quinlinoxyacetic acid) when used as 

an inert ingredient (safener) in pesticide 

formulations containing the active 

ingredients, flucarbazone-sodium 

(wheat only), 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 

* * * * * 

[FR Doc. 2010–6890 Filed 3–30–10; 8:45 am] 

BILLING CODE 6560–50–S 


erowe on DSK5CLS3C1PROD with RULES