6576 Federal Register / Vol. 75, No. 27 / Wednesday, February 10, 2010 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0923; FRL–8809–4] 

Exemption from the Requirement of a 

Tolerance; Technical Amendment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical 

amendmemt. 

SUMMARY: EPA issued a final rule in the 

Federal Register of June 3, 2009, 

concerning minor technical revisions of 

certain commodity terms listed under 

40 CFR part 180, subpart D. The fungal 

active ingredient Aspergillus flavus 

NRRL 21882 was inadvertently revised. 

This document is being issued to amend 

the section to include text that was 

omitted. 

DATES: This final rule is effective 

February 10, 2010. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008-0923. All documents in the 

docket are listed in the docket index 

available in 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: For 

40 CFR 180.1254 only contact: Shanaz 

Bacchus, Biopesticides and Pollution 

Prevention Division (7511P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington DC 20460–0001; 

telephone number: (703) 308–8097; fax 

number: (703) 308–7026; e-mail address: 

bacchus.shanaz@epa.gov. 

For other matters regarding EPA–HQ– 

OPP–2008–0923: Stephen Morrill, 

Biopesticides and Pollution Prevention 

Division (7511P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington DC 20460–0001; telephone 

number: (703) 308–8319; fax number: 

(703) 308–7026; e-mail address: 

morrill.stephen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. If you have 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

II. What Does this Technical 

Amendment Do? 

This technical amendment revises 

§ 180.1254 to reinstate text that was 

inadvertently omitted in a final rule that 

was published in the Federal Register of 

June 3, 2009 (74 FR 26527) (FRL–8417– 

9). The June 3, 2009 final rule revised 

§ 180.1254, however; the revision 

omitted text which which had been 

added as paragraph (b) in a final rule 

published in the Federal Register on 

October 1, 2008 (73 FR 56995). 

III. Why is this Technical Amendment 

Issued as a Final Rule? 

Section 553 of the Administrative 

Procedure Act (APA), (5 U.S.C. 

553(b)(3)(B)), provides that, when an 

Agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary or contrary to the public 

interest, the Agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making this technical correction 

final without prior proposal and 

opportunity for comment, because the 

omission was the result of clerical error 

and was neither proposed nor 

commented upon. Notice and comment 

is therefore unnecessary. 

IV. Do Any of the Statutory and 

Executive Order Reviews Apply to this 

Action? 

No. This action only corrects the 

omission for a previously published 

final rule and does not impose any new 

requirements. EPA’s compliance with 

the statutes and Executive orders for the 

underlying rule is discussed in Unit III. 

of the final rule published on June 3, 

2009 (74 FR 26527). 

V. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 21, 2010. 

Keith A. Matthews, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR part 180 is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 321(q), 346a and 371. 

■ 2. Section 180.1254 is revised to read 

as follows: 

§ 180.1254 Aspergillus flavus NRRL 21882; 

exemption from the requirement of a 

tolerance. 

(a) An exemption from the 

requirement of a tolerance is established 

for residues of Aspergillus flavus NRRL 

21882 on peanut; peanut, hay; peanut, 

meal; and peanut, refined oil. 

(b) An exemption from the 

requirement of a tolerance is established 

for residues of Aspergillus flavus NRRL 

21882 on corn, field, forage; corn, field, 

grain; corn, field, stover; corn, field, 

aspirated grain fractions; corn, sweet, 

kernel plus cob with husk removed; 

corn, sweet, forage; corn, sweet, stover; 

corn, pop, grain; and corn, pop, stover. 

[FR Doc. 2010–2655 Filed 2–9–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0289; FRL–8809–9] 

Acetamiprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acetamiprid in 


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Federal Register / Vol. 75, No. 27 / Wednesday, February 10, 2010 / Rules and Regulations 6577 

or on fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13-07F; and 

tea, dried. It additionally establishes 

tolerances with regional registrations on 

clover, forage and clover, hay. Finally, 

this regulation deletes an existing 

individual tolerance in or on grape, as 

it will be superseded by inclusion in 

subgroup 13-07F. Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 10, 2010. Objections and 

requests for hearings must be received 

on or before April 12, 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–2009–0289. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@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 electronically the OPPTS 

harmonized test guidelines referred in 

this document, please go to http// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

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–2009–0289 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 April 12, 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–2009–0289, 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 August 19, 

2009 (74 FR 41898) (FRL–8426–7), 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 9E7544) by IR-4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.578 be 

amended by establishing a tolerance for 

residues of the insecticide acetamiprid, 

N1-[(6-chloro-3-pyridyl)methyl]-N2- 

cyano-N1-methylacetamidine, in or on 

fruit, small, vine climbing, except fuzzy 

kiwifruit, subgroup 13-07F at 0.35 parts 

per million (ppm); and tolerances with 

regional restrictions in or on clover, 

forage at 0.10 ppm; clover, hay at 0.01 

ppm; and tea at 50 ppm. That notice 

referenced a summary of the petition 

prepared on behalf of IR-4 by Nippon 

Soda Co., Ltd., 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 has 

determined that the petitioned-for 

tolerance with regional registrations on 

tea should be established as a tolerance 

with no U.S. registrations. The reason 

for this change is 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 


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6578 Federal Register / Vol. 75, No. 27 / Wednesday, February 10, 2010 / Rules and Regulations 

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 acetamiprid 

on fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13-07F at 0.35 

ppm; tea, dried at 50.0 ppm; clover, 

forage at 0.10 ppm; and clover, hay at 

0.01 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. 

Acetamiprid is moderately toxic via 

the oral route of exposure and is 

minimally toxic via the dermal and 

inhalation routes of exposure. It is not 

an eye or skin irritant, nor is it a dermal 

sensitizer. Acetamiprid does not appear 

to have specific target organ toxicity. 

Generalized toxicity was observed as 

decreases in body weight, body weight 

gain, food consumption and food 

efficiency in all species tested. 

Generalized liver effects were also 

observed in mice and rats 

(hepatocellular vacuolation in rats and 

hepatocellular hypertrophy in mice and 

rats). 

In the rat developmental study, fetal 

shortening of the 13th rib was observed 

at the same dose level that produced 

maternal effects (reduced body weight 

and body weight gain and increased 

liver weights). No developmental effects 

were observed in the rabbit at doses that 

reduced maternal body weight and food 

consumption. Effects in pups in the 2- 

generation rat reproduction study 

included delays in preputial separation, 

vaginal opening and pinna unfolding as 

well as reduced litter size, decreased 

pup viability and weaning indices; 

offspring effects observed in the 

developmental neurotoxicity (DNT) 

study included decreased body weight 

and body weight gains, decreased pup 

viability and decreased maximum 

auditory startle response in males. 

These effects were seen in the presence 

of less severe effects (decreased body 

weight and body weight gain) in the 

maternal animals. 

In the acute neurotoxicity study, male 

and female rats displayed decreased 

motor activity, tremors, walking and 

posture abnormalities, dilated pupils, 

coldness to the touch and decreased 

grip strength and foot splay at the 

highest dose tested (HDT). There was a 

decrease in the auditory startle response 

in male rats at the HDT in the DNT; 

additionally, tremors were noted in 

female mice at the HDT in the 

subchronic feeding study. 

Based on acceptable carcinogenicity 

studies in rats and mice, EPA has 

determined that acetamiprid is ‘‘not 

likely to be carcinogenic to humans.’’ 

This determination is based on the 

absence of a dose-response or statistical 

significance for the increased incidence 

in mammary adenocarcinomas observed 

in the rat carcinogenicity study, as well 

as the lack of evidence of carcinogenic 

effects in the mouse cancer study. 

Acetamiprid tested positive as a 

clastogen in an in vitro mammalian 

chromosome aberration assay in 

Chinese hamster ovary cells. There was 

no sign of mutagenicity in other 

mutagenicity studies for acetamiprid. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by acetamiprid as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Acetamiprid: Human Health Risk 

Assessment for Proposed Food Uses on 

Clover Grown for Seed, Small Vine 

Climbing Fruits, except Kiwifruit, 

Subgroup 13-07F, Greenhouse Grown 

Tomatoes and Tea,’’ at pages 57-61 in 

docket ID number EPA–HQ–OPP–2009– 

0289. 

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-term, intermediate-term, 

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 acetamiprid used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document ‘‘Acetamiprid: Human Health 

Risk Assessment for Proposed Food 

Uses on Clover Grown for Seed, Small 

Vine Climbing Fruits, except Kiwifruit, 

Subgroup 13-07F, Greenhouse Grown 

Tomatoes and Tea,’’ at pages 25-26 in 

docket ID number EPA–HQ–OPP–2009– 

0289. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to acetamiprid, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing acetamiprid tolerances in 40 

CFR 180.578. EPA assessed dietary 

exposures from acetamiprid 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 


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Federal Register / Vol. 75, No. 27 / Wednesday, February 10, 2010 / Rules and Regulations 6579 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA utilized 

maximum percent crop treated (PCT) 

data for several commodities and 100 

PCT for all proposed uses; anticipated 

residues derived from field trial data for 

apples, broccoli, cabbage, celery, 

grapefruit, grapes, lettuce, oranges, 

pears, peppers, spinach, tomatoes, stone 

fruit and cucurbit vegetables; tolerancelevel residues for livestock 

commodities; and empirical processing 

factors for apple juice, orange juice, 

grapefruit juice, raisins, dried prunes, 

tomato paste and tomato puree. Dietary 

Exposure Evaluation Model (DEEM) 

default processing factors were used for 

all other processed commodities. 

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 

utilized average PCT data for several 

commodities and 100 PCT for all 

proposed uses, tolerance-level residues 

for all commodities and empirical 

processing data for grape juice and 

raisins. DEEM default processing factors 

were used for all other processed 

commodities. 

iii. Cancer. Based on the evidence 

discussed in Unit III.A., EPA has 

determined that acetamiprid is ‘‘not 

likely to be carcinogenic to humans.’’ 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such Data CallIns as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

For the acute assessment, EPA used 

maximum PCT information as follows: 

Apples at 30%; broccoli at 15%; 

cabbage at 10%; cauliflower at 15%; 

celery at 45%; cotton at 5%; grapefruit 

at 5%; lettuce at 20%; oranges at 5%; 

peaches at 2.5%; pears at 60%; peppers 

at 5%; potatoes at 2.5%; pumpkins at 

2.5%; spinach at 15%; and squash at 

2.5%. 

For the chronic assessment, EPA used 

average PCT information as follows: 

Apples at 20%; broccoli at 5%; 

cabbage at 5%; cauliflower at 10%; 

celery at 25%; cotton at 5%; grapefruit 

at 2.5%; lemons at 5%; lettuce at 10%; 

oranges at 2.5%; peaches at 1%; pears 

at 35%; peppers at 2.5%; potatoes at 2.5; 

pumpkins at 1%; spinach at 5%; and 

squash at 2.5%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (NASS), proprietary 

market surveys, and the National 

Pesticide Use Database for the chemical/ 

crop combination for the most recent 6 

years. EPA uses an average PCT for 

chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which acetamiprid may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for acetamiprid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of acetamiprid. 

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 

acetamiprid for surface water are 

estimated to be 20.1 parts per billion 

(ppb) for acute exposures and 4.9 ppb 

for chronic exposure. For ground water, 

the EDWC is 0.0016 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 20.1 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

4.9 ppb was used to assess the 

contribution to drinking water. 

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, 


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indoor pest control, termiticides, and 

flea and tick control on pets). 

Acetamiprid is currently registered for 

use in indoor and outdoor residential 

settings, including crack and crevice 

applications on carpet and hard surfaces 

and applications to residential turf. EPA 

assessed residential exposures for adults 

applying bait and gel products; for 

postapplication exposure for adults 

(from short-term dermal exposure) and 

toddlers (from short-term dermal and 

incidental exposure) following indoor 

crack and crevice treatments; and 

postapplication exposure for adults 

(from short- and intermediate-term 

dermal exposure) and toddlers (from 

short-term and intermediate-term 

dermal and incidental oral exposures, 

including hand-to-mouth, object-tomouth and incidental ingestion of soil) 

following treatments on turf. 

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.’’ 

Acetamiprid is a member of the 

neonicotinoid class of pesticides which 

also includes thiamethoxam, 

clothianidin, imidacloprid and several 

other active ingredients. Structural 

similarities or common effects do not 

constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same sequence of 

major biochemical events. Although the 

neonicotinoids bind selectively to insect 

nicotinic acetylcholine receptors 

(nAChR), the specific binding site(s)/ 

receptor(s) are unknown at this time. 

Additionally, the commonality of the 

binding activity itself is uncertain, as 

preliminary evidence suggests that 

clothianidin operates by direct 

competitive inhibition, while 

thiamethoxam is a non-competitive 

inhibitor. Furthermore, even if future 

research shows that neonicotinoids 

share a common binding activity to a 

specific site on insect nAChRs, there is 

not necessarily a relationship between 

this pesticidal action and a mechanism 

of toxicity in mammals. Structural 

variations between the insect and 

mammalian nAChRs produce 

quantitative differences in the binding 

affinity of the neonicotinoids towards 

these receptors, which, in turn, confers 

the notably greater selective toxicity of 

this class towards insects, including 

aphids and leafhoppers, compared to 

mammals. Additionally, the most 

sensitive toxicological effect in 

mammals differs across the 

neonicotinoids (e.g., testicular tubular 

atrophy with thiamethoxam; 

mineralized particles in thyroid colloid 

with imidacloprid). Thus, there is 

currently no evidence to indicate that 

neonicotinoids share common 

mechanisms of toxicity, and EPA is not 

following a cumulative risk approach 

based on a common mechanism of 

toxicity for the neonicotinoids. In 

addition, acetamiprid does not appear to 

produce a toxic metabolite produced by 

other substances. Therefore, for the 

purposes of this tolerance action, EPA 

has not assumed that acetamiprid has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism 

released by EPA’s Office of Pesticide 

Programs on 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 safty factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for acetamiprid includes rat 

and rabbit developmental toxicity 

studies, a 2-generation reproduction 

toxicity study in rats and a DNT study 

in rats. There was no evidence of 

quantitative or qualitative susceptibility 

of rat or rabbit fetuses following in utero 

exposure to acetamiprid in the 

developmental toxicity studies. 

However, both the DNT and 2- 

generation reproduction studies showed 

an increase in qualitative susceptibility 

of pups. Effects in pups in the 

reproduction study included delays in 

preputial separation, vaginal opening 

and pinna unfolding, as well as reduced 

litter size, decreased pup viability and 

weaning indices; offspring effects 

observed in the DNT study included 

decreased body weight and body weight 

gains, decreased pup viability and 

decreased maximum auditory startle 

response in males. These effects were 

seen in the presence of decreased body 

weight and body weight gain in the 

maternal animals, indicating increased 

qualitative susceptibility of fetuses and 

offspring to acetamiprid. Quantitative 

evidence of increased susceptibility was 

not observed in any study. 

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 

acetamiprid is complete except for 

immunotoxicity testing. Recent changes 

to 40 CFR part 158 make 

immunotoxicity testing (OPPTS 

Guideline 870.7800) required for 

pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. 

Acetamiprid does not show any 

evidence of treatment-related effects on 

the immune system and the overall 

weight of evidence suggests that this 

chemical does not directly target the 

immune system. Therefore, EPA does 

not believe that conducting the 

immunotoxicity study will result in a 

dose less than the point of departure 

currently used for overall risk 

assessment, and an additional database 

uncertainty factor for potential 

immunotoxicity does not need to be 

applied. 

ii. There is evidence of increased 

qualitative susceptibility of the young 

following in utero exposure to 

acetamiprid in the rat reproduction 

study. Additionally, a rat DNT study is 

available that shows evidence of 

increased qualitative susceptibility of 

offspring (a decrease in the auditory 

startle response in male rats) at the 

HDT. Therefore, EPA performed a 

degree of concern analysis to determine 

the level of concern for the effects 

observed when considered in the 

context of all available toxicity data, and 

to identify any residual uncertainties 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the acetamiprid risk assessment. 

In considering the overall toxicity 

profile and the endpoints and doses 

selected for the acetamiprid risk 

assessment, EPA characterized the 


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degree of concern for the effects 

observed in the acetamiprid DNT and 

the 2-generation reproduction study as 

low, noting that there is a clear NOAEL 

for the offspring effects in both studies, 

and regulatory doses were selected to be 

protective of potential offspring effects 

in both the DNT and the 2-generation 

study. No other residual uncertainties 

were identified. Based on the available 

data, EPA determined that changes in 

motor activity, auditory startle reflex, 

learning and memory assessments and 

changes in the brain morphometrics can 

occur as the result of a single exposure 

at a critical junction during pregnancy 

or from multiple exposures throughout 

pregnancy and lactation. Therefore, the 

NOAEL for offspring effects observed in 

the DNT was selected as the dose for 

acute dietary exposures (co-critical with 

the acute neurotoxicity study), as well 

as short-term and long-term non-dietary 

risk assessment. Use of the DNT NOAEL 

is protective of effects seen in the 2- 

generation study (the NOAEL from the 

DNT is 10.0 milligrams/kilogram/day 

(mg/kg/day) and the NOAEL from the 2- 

generation study is 17.9 mg/kg/day). 

The chronic dietary study in rats 

yielded a lower long-term NOAEL (7.1 

mg/kg/day) and was, therefore, used for 

assessing chronic dietary risk. EPA 

believes that the endpoints and doses 

selected for acetamiprid are protective 

of adverse effects in both offspring and 

adults; therefore, there are no residual 

concerns regarding effects in the young. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on tolerance-level 

residues or anticipated residues derived 

from reliable field trial data. The PCT 

estimates used in the dietary 

assessments were derived from valid 

and reliable data and are unlikely to be 

exceeded. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to acetamiprid in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by acetamiprid. 

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. Shortterm, intermediate-term, and chronicterm 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

acetamiprid will occupy 43% of the 

aPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to acetamiprid 

from food and water will utilize 15% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

acetamiprid is not expected. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Acetamiprid is currently registered for 

uses that could result in short-term and 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term and intermediate-term 

residential exposures to acetamiprid. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded that the combined short-term 

and intermediate-term food, water, and 

residential exposures aggregated result 

in an aggregate MOE of 270 for toddlers, 

the population group receiving the 

greatest combined short-term and 

intermediate-term risk (from the 

combined dermal and incidental oral 

postapplication exposures following 

indoor crack and crevice treatments). As 

the aggregate MOEs for short-term and 

intermediate-term exposure are greater 

than 100 (the LOC) for all population 

subgroups assessed, short-term and 

intermediate-term aggregate exposures 

to acetamiprid are not of concern to 

EPA. 

4. Aggregate cancer risk for U.S. 

population. Based on the adequate 

cancer studies in rats and mice, EPA has 

concluded that acetamiprid is not 

expected to pose a cancer risk to 

humans. 

5. 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 acetamiprid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The following adequate enforcement 

methodologies are available to enforce 

the tolerance expression: A gas 

chromatography with electron capture 

detection (GC/ECD) method and a high 

performance liquid chromatography 

with ultraviolet detection (HPLC/UV) 

method. These methods 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 Codex or Mexican 

maximum residue limits (MRLs) 

established for residues of acetamiprid 

on commodities associated with this 

petition. EPA is establishing a tolerance 

on tea, dried at 50.0 ppm, which will 

harmonize with a Japanese MRL 

established for tea at 50 ppm. Canada 

has established a MRL for acetamiprid 

residues on grape at 0.20 ppm; however, 

the tolerance for subgroup 13-07F 

(including grape) cannot be harmonized 

with the Canadian MRL on grape at this 

time because field trial data shows 

residue levels for grape that are higher 

than 0.20 ppm. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA has 

determined that the petitioned-for 

tolerance with regional registrations on 

tea at 50 ppm should be established as 

a tolerance with no U.S. registrations on 

tea, dried at 50.0 ppm. At least one U.S. 

residue field trial study is required to 

establish a domestic registration on tea; 

however, no U.S. residue field trial data 

were submitted in support of the use of 

acetamiprid on tea. Therefore, the 

Agency has established a tolerance with 

no U.S. registrations on tea, dried at 

50.0 ppm. EPA has also revised the 

tolerance expression in paragraphs 

(a)(1), (a)(2) and (c) of §180.578 to 

clarify (1) that, as provided in FFDCA 

section 408(a)(3), the tolerance covers 

metabolites and degradates of 


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acetamiprid not specifically mentioned; 

and (2) that compliance with the 

specified tolerance levels is to be 

determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acetamiprid, N1-[(6- 

chloro-3-pyridyl)methyl]-N2-cyano-N1- 

methylacetamidine, in or on fruit, small, 

vine climbing, except fuzzy kiwifruit, 

subgroup 13-07F at 0.35 ppm; tea, dried 

at 50.0 ppm; clover, forage at 0.10 ppm; 

and clover, hay at 0.01 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 tolerances 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: February 1, 2010. 

Daniel J. Rosenblatt, 

Acting 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 180.578 is amended by 

revising the introductory text in 

paragraphs (a)(1) and (a)(2); removing 

the entry for ‘‘Grape’’ from the table in 

paragraph (a)(1); alphabetically adding 

‘‘Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13-07F’’ and 

‘‘Tea, dried’’ to the table in paragraph 

(a)(1); and revising paragraph (c). The 

added and revised text reads as follows: 

§ 180.578 Acetamiprid; tolerances for 

residues. 

(a) * * *

(1) Tolerances are established for 

residues of the insecticide acetamiprid 

N1-[(6-chloro-3-pyridyl)methyl]-N2- 

cyano-N1-methylacetamidine, including 

its metabolites and degradates, in or on 

the commodities in the table below as 

a result of the application of 

acetamiprid. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

acetamiprid in or on the following 

commodities. 

Commodity Parts per million 

*****

Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F ............................................................... 0.35 

*****

Tea, dried1 ....................................................................................................................................................... 50.0 

*****

1There are no U.S. registrations as of February 10, 2010, for the use of acetamiprid on dried tea. 

(2) Tolerances are established for 

residues of the insecticide acetamiprid 

N1-[(6-chloro-3-pyridyl)methyl]-N2- 

cyano-N1-methylacetamidine, including 

its metabolites and degradates, in or on 

the commodities in the table below as 

a result of the application of 

acetamiprid. Compliance with the 

tolerance levels specified below is to be 

determined by measuring acetamiprid 

and N1-[(6-chloro-3-pyridyl)methyl]-N2- 

cyano-acetamidine in or on the 

following commodities. 

*****


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Federal Register / Vol. 75, No. 27 / Wednesday, February 10, 2010 / Rules and Regulations 6583 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations are established for residues 

of the insecticide acetamiprid N1-[(6- 

chloro-3-pyridyl)methyl]-N2- cyano-N1- 

methylacetamidine, including its 

metabolites and degradates, in or on the 

commodities in the table below as a 

result of the application of acetamiprid. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only acetamiprid in or on the 

following commodities. 

Commodity Parts per million 

Clover, forage .................................................................................................................................................. 0.10 

Clover, hay ....................................................................................................................................................... 0.01 

*****

[FR Doc. 2010–2803 Filed 2–9–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0480; FRL–8807–8] 

Poly(oxy-1,2-ethanediyl), α-hydro-whydroxy-, polymer with 1, 1′- 

methylene-bis-[4- 

isocyanatocyclohexane]; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of poly(oxy-1,2- 

ethanediyl), a-hydro-w-hydroxy-, 

polymer with 1, 1′-methylene-bis-[4- 

isocyanatocyclohexane]; when used as 

an inert ingredient in a pesticide 

chemical formulation under 40 CFR 

180.960. UDL Laboratories, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of poly(oxy-1,2-ethanediyl), 

a-hydro-w-hydroxy-, polymer with 1, 1′- 

methylene-bis-[4- 

isocyanatocyclohexane] on food or feed 

commodities. 

DATES: This regulation is effective 

February 10, 2010. Objections and 

requests for hearings must be received 

on or before April 12, 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–2009–0480. 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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site 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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2009–0480 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 

on or before April 12, 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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009–0480, 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 


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