Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17571 

flutolanil, N-(3-(1- 

methylethoxy)phenyl)-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates, in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only flutolanil and its 

metabolites converted to 2- 

(trifluoromethyl) benzoic acid and 

calculated as flutolanil, in or on the 

following commodities. 

Commodity Parts per million 

Wheat, bran .................... 0.20 

Wheat, forage ................. 2.5 

Wheat, grain ................... 0.05 

Wheat, hay ..................... 1.2 

Wheat, straw ................... 0.20 

* * * * * 

[FR Doc. 2010–7624 Filed 4–6–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0673; FRL–8817–4] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

current tolerance for combined residues 

of pendimethalin and its metabolite, 

expressed as pendimethalin equivalents, 

in or on alfalfa forage. BASF 

Corporation requested this tolerance 

amendment under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

7, 2010. Objections and requests for 

hearings must be received on or before 

June 7, 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– 0673. 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: Jim 

Tompkins, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5697; e-mail address: 

tompkins.jim@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–2009–0673 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 7, 2010. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

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–2009–0673, 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 

In the Federal Register of January 6, 

2010 (75 FR 864) (FRL–8801–5), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 9F7576) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR 180.361 be 

amended by increasing the tolerance for 

the combined residues of the herbicide 

pendimethalin, [N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine], and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, in 

or on alfalfa, forage from 3.0 parts per 

million (ppm) to 3.5 (ppm). That notice 

referenced a summary of the petition 

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17572 Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 

prepared by BASF Corporation, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.D. 

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 combined 

residues of pendimethalin and its 

metabolite including exposure resulting 

from the tolerance established by this 

action. EPA’s assessment of exposures 

and risks associated with 

pendimethalin, [N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine] and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol 

follows. 

On January 27, 2010, the Agency 

published a final rule (75 FR 4279, FRL– 

8804–2) establishing tolerances for 

combined residues of pendimethalin 

and its metabolite in or on various grass 

commodities in crop group 17. When 

the Agency conducted the risk 

assessment in support of the January, 

2010 tolerance action, it considered the 

use of pendimethalin on alfalfa, 

including potential residues of 

pendimethalin and its metabolite in or 

on alfalfa hay and forage. EPA also 

considered the potential for secondary 

residues of pendimethalin in livestock 

commodities from consumption of 

treated alfalfa hay and forage and 

determined that there was no reasonable 

expectation of finite residues to occur. 

Since alfalfa hay and alfalfa forage are 

both categorized as roughage, EPA 

assessed the pendimethalin dietary 

burden of livestock using the higher 

(more conservative) of the two 

tolerances (alfalfa hay at 4.0 ppm). 

Increasing the tolerance for alfalfa forage 

to 3.5 ppm will not affect the estimated 

livestock dietary burden or the 

estimated aggregate risks resulting from 

use of pendimethalin, as discussed in 

the January 27, 2010 (75 FR 4279–4284, 

FRL–8804–2) Federal Register. Refer to 

this Federal Register document, 

available at http://www.regulations.gov, 

for a detailed discussion of the aggregate 

risk assessments and determination of 

safety. EPA relies upon those risk 

assessments and the findings made in 

the Federal Register document in 

support of this action. 

Therefore, based on the risk 

assessments discussed in the final rule 

published in the Federal Register of 

January 27, 2010 (75 FR 4279, FRL– 

8804–2), 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 pendimethalin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

using liquid chromatography/mass 

spectrometry analysis (LC/MS/MS), 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 

B. International Residue Limits 

There are no established or proposed 

Codex maximum residue limits (MRLs) 

for pendimethalin. 

C. Revisions to Petitioned-for Tolerances 

EPA has revised the pendimethalin 

tolerance expression for the new and 

existing tolerances to clarify the 

chemical moieties that are covered by 

the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 

tolerances cover residues of 

pendimethalin and its metabolites and 

degradates, but that compliance with 

the tolerance levels will be determined 

by measuring only pendimethalin, [N- 

(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine], and its metabolite 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol, calculated as the 

stoichiometric equivalent of 

pendimethalin. 

EPA has determined that it is 

reasonable to make this change final 

without prior proposal and opportunity 

for comment, because public comment 

is not necessary, in that the change has 

no substantive effect on the tolerance, 

but rather is merely intended to clarify 

the existing tolerance expression. 

D. Response to Comments 

EPA received comments from an 

anonymous submitter objecting to 

pesticides and other ‘‘toxic’’ chemicals 

generally and recommending against 

any tolerances greater than zero for this 

product. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

the Federal Food, Drug and Cosmetic 

Act (FFDCA) contemplates that 

tolerances greater than zero may be set 

when persons seeking such tolerances 

or exemptions have demonstrated that 

the pesticide meets the safety standard 

imposed by that statute. This 

submitter’s comments appear to be 

directed at the underlying statute and 

not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of pendimethalin, including 

its metabolites and degradates, in or on 

the alfalfa, forage at 3.5 ppm. 

Compliance with the tolerance level is 

to be determined by measuring only 

pendimethalin, [N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine], and 

its metabolite, 4-[(ethylpropyl) amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, 

calculated as the stoichiometric 

equivalent of pendimethalin, in or on 

alfalfa, forage. 

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, 

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Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17573 

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 26, 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 180.361, revise the 

introductory text and the entry for 

Alfalfa, forage in the table in paragraph 

(a) to read as follows: 

§ 180.361 Pendimethalin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

pendimethalin, including its 

metabolites and degradates, in or on the 

commodities. Compliance with the 

tolerance levels specified in the 

following table below is to be 

determined by measuring only 

pendimethalin, [N- (1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine], and 

its metabolite, 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, 

calculated as the stoichiometric 

equivalent of pendimethalin, in or on 

the following commodities: 

Commodity Parts per million 

Alfalfa, forage ................................................................................................................................................... 3.5 

* * * * * 

* * * * * 

[FR Doc. 2010–7740 Filed 4–6–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0057; FRL–8818–4] 

Nicosulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of nicosulfuron 

in or on cattle, fat; cattle, meat; cattle, 

meat byproducts; goat, fat; goat, meat; 

goat, meat byproducts; grass, forage; 

grass, hay; horse, fat; horse, meat; horse, 

meat byproducts; milk; sheep, fat; 

sheep, meat; and sheep, meat 

byproducts. E. I. du Pont de Nemours 

and Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation also removes the existing 

tolerance for residues of nicosulfuron on 

corn, forage. 

DATES: This regulation is effective April 

7, 2010. Objections and requests for 

hearings must be received on or before 

June 7, 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–2009–0057. 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– 

WReier-Aviles on DSKGBLS3C1PROD with RULES