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– 

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17574 Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 

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: 

Mindy Ondish, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 605-0723; e-mail address: 

ondish.mindy@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 

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

You may also access the OPPTS 

harmonized test guidelines referenced 

in this document electronically at 

http://www.epa.gov/oppts and select 

‘‘Test Methods and Guideline.’’ 

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–2009–0057 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 7, 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 

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–2009–0057, 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 April 8, 

2009 (74 FR 15971) (FRL–8407–4), 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 8F7501) by E. I. 

du Pont de Nemours and Company, P.O. 

Box 80038, Wilmington, DE 19880– 

0038. The petition requested that 40 

CFR 180.454 be amended by 

establishing tolerances for residues of 

the herbicide nicosulfuron, 3- 

Pyridinecarboxamide, 2-[[[[(4,6- 

dimethoxy-2-pyrimidinyl)amino] 

carbonyl]amino]sulfonyl]-N,Ndimethyl-, in or on grass, forage at 9.0 

parts per million (ppm); grass, hay at 

25.0 ppm; fat (of cattle, goat, hog, horse, 

and sheep) at 0.05 ppm; meat (of cattle, 

goat, hog, horse, and sheep) at 0.05 

ppm; meat byproducts (of cattle, goat, 

hog, horse, and sheep) at 0.05 ppm; milk 

at 0.05 ppm; and milk, fat at 0.02 ppm. 

That notice referenced a summary of the 

petition prepared by E. I. du Pont de 

Nemours and Company, 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. 

Based upon review of the data 

supporting the petition, EPA is not 

establishing the proposed tolerances for 

hog, fat; hog, meat; hog, meat 

byproducts; and milk, fat. The proposed 

tolerance levels for cattle, fat; cattle, 

meat; goat, fat; goat, meat; horse, fat; 

horse, meat; milk; sheep, fat; and sheep, 

meat are being established at 0.01 ppm, 

not 0.05 ppm. The reasons for these 

changes are explained in Unit IV.C. 

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 petitioned-for 

tolerances for residues of nicosulfuron 

and its metabolites and degradates in or 

on cattle, fat at 0.01 ppm; cattle, meat 

at 0.01 ppm; cattle, meat byproducts at 

0.05 ppm; goat, fat at 0.01 ppm; goat, 

meat at 0.01 ppm; goat, meat byproducts 

at 0.05 ppm; grass, forage at 9.0 ppm; 

grass, hay at 25.0 ppm; horse, fat at 0.01 

ppm; horse, meat at 0.01 ppm; horse, 

meat byproducts at 0.05 ppm; milk at 

0.01 ppm; sheep, fat at 0.01 ppm; sheep, 

meat at 0.01 ppm; and sheep, meat 

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Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17575 

byproducts at 0.05 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

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 nicosulfuron as well as the noobserved-adverse-effect-level (NOAEL) 

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

can be found at http:// 

www.regulations.gov in document 

‘‘Nicosulfuron Human Health Risk 

Assessment for the Proposed Use on 

Grasses,’’ p. 30 in docket ID number 

EPA–HQ–OPP–2009–0057. 

Nicosulfuron has low acute toxicity 

by oral, dermal, and inhalation routes of 

exposure. It is a moderate eye irritant 

and is not a dermal sensitizer. No 

adverse effects were observed following 

subchronic or chronic dietary 

administrations of doses exceeding the 

limit dose in rats and mice. Chronic 

dietary administration to dogs produced 

mild effects (decreased body weight 

gains in males, increased relative liver 

and kidney weights) at the limit dose. 

No findings were reported in dogs 

following subchronic dosing at 

comparable dietary levels. 

There was no evidence of potential 

immunotoxicity or neurotoxicity in the 

submitted studies. 

Nicosulfuron was classified by EPA as 

a ‘‘not likely’’ human carcinogen based 

on the lack of evidence of 

carcinogenicity in studies conducted in 

rats and mice and in the in vitro and in 

vivo genotoxicity studies. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing 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. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for nicosulfuron used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Nicosulfuron Human Health Risk 

Assessment for the Proposed Use on 

Grasses,’’ p. 15 in docket ID number 

EPA–HQ–OPP–2009–0057. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to nicosulfuron, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing nicosulfuron tolerances in 40 

CFR 180.454. EPA assessed dietary 

exposures from nicosulfuron in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for nicosulfuron; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed tolerance-level residues and 

100 percent crop treated (PCT) for all 

existing (corn) and new uses (meat and 

milk commodities) of nicosulfuron. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity observed in 

the 2–year rat and 18–month mouse 

carcinogenicity studies and a lack of 

evidence of mutagenicity in the in vitro 

and in vivo genotoxicity studies, EPA 

does not expect nicosulfuron to pose a 

cancer risk to humans. Therefore, an 

exposure assessment for evaluating 

cancer risk is not needed for this 

chemical. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for nicosulfuron. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for nicosulfuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

nicosulfuron. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

nicosulfuron for chronic exposures for 

non-cancer assessments are estimated to 

be 0.685 ppb for surface water and 0.056 

ppb for ground water. EDWCs of 

nicosulfuron for acute exposures and 

chronic exposures for cancer 

assessments are not relevant to this 

dietary exposure assessment as 

explained in unit III.C.1. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 0.685 ppb 

was used to assess the contribution to 

drinking water. The surface water value 

was used in the chronic, non-cancer 

dietary risk assessment since it was 

higher than the ground water value and, 

therefore, more protective. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

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Nicosulfuron is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. 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 nicosulfuron to 

share a common mechanism of toxicity 

with any other substances, and 

nicosulfuron does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that nicosulfuron 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. 

In the developmental toxicity in rats, no 

developmental toxicity was seen at the 

highest dose tested (6,000 mg/kg/day). 

In the developmental study in rabbits, 

developmental toxicity (decreased fetal 

body weight, post-implantation loss) 

occurred at the same dose (500 mg/kg/ 

day) as the dose (500 mg/kg/day) 

resulting in maternal toxicity (abortions, 

clinical signs, decreased body weight 

gain, post-implantation loss). In the 2- 

generation reproductive toxicity study 

in rats, F2a offspring effects (decreased 

litter size at birth, decreased pup 

weights at postpartum day 14 through 

21) also occurred at the same dose (1265 

mg/kg/day) as the dose (1265 mg/kg/ 

day) resulting in parental toxicity 

(decreased body weight gain in F1 

females during the last week of 

gestation). Consequently, there is no 

quantitative or qualitative evidence of 

increased susceptibility following preand/or postnatal exposure to 

nicosulfuron. 

3. Conclusion. EPA has determined 

that reliable data show 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 

nicosulfuron is adequate to assess 

potential pre- and/or postnatal toxicity. 

In accordance with 40 CFR part 158 

Toxicology Data Requirements, an 

immunotoxicity study (870.7800), and 

acute and subchronic neurotoxicity 

studies (870.6200) are required for 

nicosulfuron. Despite the absence of 

specific immunotoxicity and 

neurotoxicity studies, EPA has 

evaluated the available toxicity data and 

has determined that there is no evidence 

that nicosulfuron either causes 

neurotoxic effects or targets the immune 

system, and, therefore, EPA does not 

expect that these studies will result in 

a lower NOAEL than the NOAEL 

currently used in assessing nicosulfuron 

risk. 

ii. There is no indication that 

nicosulfuron is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

nicosulfuron results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no significant residual 

uncertainties identified in the exposure 

databases for nicosulfuron. Additional 

storage stability studies are required for 

residues of nicosulfuron in grass forage 

and hay, and in livestock tissues. 

However, as explained in this Unit, EPA 

does not expect these studies to have a 

measurable impact on exposure 

estimates for nicosulfuron. 

a. Data must be submitted on the 

stability of nicosulfuron and its 

metabolite in grass forage and hay 

stored frozen for intervals of up to 9.6 

and 12.4 months, respectively. Interim 

data are available showing that residues 

of nicosulfuron in grass hay and forage 

are stable when stored frozen up to 3 

months. Additionally, storage stability 

data are available for corn, a related 

crop, which indicate that nicosulfuron 

residues are stable when stored frozen 

up to 12 months. Based on these data, 

EPA expects nicosulfuron to be stable in 

grass forage and hay stored frozen for 

the required 9.6 and 12.4 month 

intervals but is requiring submission of 

the final study reports as confirmation. 

b. Data must also be submitted on the 

stability of nicosulfuron and its 

metabolite in livestock tissues stored 

frozen up to 9.4 months. Despite the 

absence of data, EPA has assumed that 

nicosulfuron is stable in frozen livestock 

tissues, based on data for similar 

sulfonylurea (SU) pesticides, such as 

prosulfuron, where studies have shown 

residues to be stable for up to 25 

months. In addition, EPA notes that 

dietary exposure to nicosulfuron is low 

(< 1% of the cPAD for all population 

subgroups), and that the contribution of 

residues in livestock to overall dietary 

exposure to nicosulfuron is minor, 

accounting for only 2.5% of total 

exposure for children 1-2 years old, the 

population subgroup with the highest 

estimated dietary exposure to 

nicosulfuron. Therefore, any 

adjustments in livestock residue 

estimates that might be necessary 

following submission of the required 

storage stability data would have little 

impact on overall dietary exposure 

estimates. 

The dietary food exposure 

assessments were performed based on 

100 PCT and tolerance-level residues. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to nicosulfuron in drinking water. There 

are no residential uses for nicosulfuron; 

therefore, residential exposure is not 

expected. These assessments will not 

underestimate the exposure and risks 

posed by nicosulfuron. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

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consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, nicosulfuron is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to nicosulfuron 

from food and water will utilize <1% of 

the cPAD for the general population and 

all population subgroups, including 

children 1-2 years old, the population 

group receiving the greatest exposure. 

There are no residential uses for 

nicosulfuron. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Nicosulfuron is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

short-term aggregate risk is the sum of 

the risk from exposure to nicosulfuron 

through food and water and will not be 

greater than the chronic aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Nicosulfuron is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to nicosulfuron through food 

and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on a lack of evidence 

for carcinogenicity in mice and rats 

following long-term dietary 

administration and lack of evidence for 

mutagenicity in a battery of genotoxicity 

studies, nicosulfuron is not expected to 

pose a cancer risk. 

6. Determination of safety. 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 nicosulfuron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with tandem mass 

spectrometric (HPLC/MS/MS) detection 

method) 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 currently no established 

Codex or Mexican maximum residue 

limits (MRLs) for residues of 

nicosulfuron. Canadian MRLs are 

established on blueberries and corn, and 

are expressed in terms of nicosulfuron. 

There are no Canadian MRLs 

established on the grass and livestock 

commodities associated with this 

petition. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is not establishing the proposed 

tolerances for hog, fat; hog, meat; and 

hog, meat byproducts because there are 

no swine feed items associated with the 

proposed use on grasses, and the dietary 

burden to swine resulting from 

registered use on corn is low enough 

that there is no reasonable expectation 

of finite residues in hog commodities. 

The proposed tolerance for milk fat is 

not being established because residues 

did not concentrate in cream and thus 

the tolerance for milk will be sufficient 

to cover residues in milk fat from legal 

uses of nicosulfuron. The proposed 

tolerances for cattle, fat; cattle, meat; 

goat, fat; goat, meat; horse, fat; horse, 

meat; milk; sheep, fat; and sheep, meat 

were lowered from 0.05 ppm to the level 

of quantitation (LOQ) at 0.01 ppm, since 

the maximum adjusted residue for meat 

and fat was at 0.008 ppm. 

EPA has also revised the tolerance 

expression for all existing and new 

nicosulfuron tolerances. The revised 

tolerance expression makes clear that 

the tolerances cover ‘‘residues of 

nicosulfuron, including its metabolites 

and degradates’’ and that compliance 

with the tolerance levels will be 

determined by measuring only 

nicosulfuron, 3-Pyridinecarboxamide, 2- 

[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] 

carbonyl]amino]sulfonyl]-N,N-dimethyl- 

. EPA has determined that it is 

reasonable to make this change in the 

tolerance expression 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. 

Finally, EPA is removing the 

redundant and obsolete tolerance for 

residues of nicosulfuron on ‘‘corn, 

forage’’ at 0.1 ppm. ‘‘Corn, forage’’ is an 

obsolete commodity term that has been 

replaced by the terms ‘‘corn, field, 

forage’’ and ‘‘corn, sweet, forage.’’ Since 

there are existing tolerances for residues 

of nicosulfuron on ‘‘corn, field, forage’’ 

and ‘‘corn, sweet, forage’’ at 0.1 ppm, the 

tolerance on ‘‘corn, forage’’ at the same 

level is unnecessary. EPA is making this 

change final without prior proposal and 

opportunity for comment because it 

merely corrects a redundancy in the 

nicosulfuron tolerances and has no 

substantive effect on them. 

V. Conclusion 

Therefore, tolerances are established 

for residues of nicosulfuron, including 

its metabolites and degradates, in or on 

cattle, fat at 0.01 ppm; cattle, meat at 

0.01 ppm; cattle, meat byproducts at 

0.05 ppm; goat, fat at 0.01 ppm; goat, 

meat at 0.01 ppm; goat, meat byproducts 

at 0.05 ppm; grass, forage at 9.0 ppm; 

grass, hay at 25.0 ppm; horse, fat at 0.01 

ppm; horse, meat at 0.01 ppm; horse, 

meat byproducts at 0.05 ppm; milk at 

0.01 ppm; sheep, fat at 0.01 ppm; sheep, 

meat at 0.01 ppm; and sheep, meat 

byproducts at 0.05 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 

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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 180.454 is revised to read 

as follows: 

§ 180.454 Nicosulfuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

nicosulfuron, including its metabolites 

and degradates, in or on the 

commodities in the following table 

[below]. Compliance with the tolerance 

levels specified in the following table 

[below] is to be determined by 

measuring only nicosulfuron, 3- 

Pyridinecarboxamide, 2-[[[[(4,6- 

dimethoxy-2-pyrimidinyl)amino] 

carbonyl]amino]sulfonyl]-N,Ndimethyl-. 

Commodity Parts per million 

Cattle, fat 0.01 

Cattle, 

meat 0.01 

Cattle, 

meat 

byproducts 0.05 

Corn, 

field, 

forage 0.1 

Corn, 

field, 

grain 0.1 

Corn, 

field, 

stover 0.1 

Corn, pop, 

grain 0.1 

Corn, pop, 

stover 0.1 

Corn, 

sweet, 

forage 0.1 

Commodity Parts per million 

Corn, 

sweet, 

kernel 

plus cob 

with 

husks 

removed 0.1 

Corn, 

sweet, 

stover 0.1 

Goat, fat 0.01 

Goat, 

meat 0.01 

Goat, 

meat 

byproducts 0.05 

Grass, forage 9.0 

Grass, 

hay 25.0 

Horse, fat 0.01 

Horse, 

meat 0.01 

Horse, 

meat 

byproducts 0.05 

Milk 0.01 

Sheep, fat 0.01 

Sheep, 

meat 0.01 

Sheep, 

meat 

byproducts 0.05 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table [below] are established 

for residues of the herbicide 

nicosulfuron, 3-Pyridinecarboxamide, 2- 

[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] 

carbonyl]amino]sulfonyl]-N,N-dimethyl- 

, in or on the specified agricultural 

commodities, resulting from use of the 

pesticide pursuant to FFIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the table. 

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Commodity Parts per 

million 

Expiration/ 

Revokation 

Date 

Bermuda 

grass, forage 10 12/31/11 

Bermuda 

grass, hay 25 12/31/11 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2010–7745 Filed 4–6–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0141; FRL–8808–9] 

Aminopyralid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of aminopyralid, 

including its metabolites and 

degradates, in or on corn, field, forage; 

corn, field, grain; and corn, field, stover. 

Dow AgroSciences requested these 

tolerances 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–2009–0141. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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. 

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left-side 

navigation menu. 

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–2009–0141 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 7, 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 

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–2009–0141, 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 May 6, 2009 

(74 FR 20947) (FRL–8412–7), 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 8F7455) by Dow 

AgroSciences, 9330 Zionsville Rd., 

Indianapolis, IN 46268. The petition 

requested that 40 CFR 180.610 be 

amended by establishing tolerances for 

combined residues of the herbicide 

aminopyralid, 4-amino-3,6-dichloro-2- 

pyridinecarboxylic acid, and its glucose 

conjugate, expressed as total parent, in 

or on corn, forage at 0.30 parts per 

million (ppm); corn, grain at 0.20 ppm; 

and corn, stover at 0.20 ppm. That 

notice referenced a summary of the 

petition prepared by Dow AgroSciences, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. Comments were 

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