Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39543 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

X. 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 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 27, 2009. 

W. Michael McDavit, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

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

■ 2. Section 174.502 is revised to read 

as follows: 

§ 174.502 Bacillus thuringiensis Cry1A.105 

protein; exemption from the requirement of 

a tolerance. 

(a) Residues of Bacillus thuringiensis 

Cry1A.105 protein in or on the food and 

feed commodities of corn; corn, field, 

flour; corn, field, forage; corn, field, 

grain; corn, field, grits; corn, field, meal; 

corn, field, refined oil; corn, field, 

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

kernel plus cob with husk removed; 

corn, sweet, stover; and corn, pop, grain 

and corn, pop, stover are exempt from 

the requirement of a tolerance when the 

Bacillus thuringiensis Cry1A.105 

protein is used as a plant-incorporated 

protectant in these food and feed corn 

commodities. 

(b) A time-limited exemption from the 

requirement of a tolerance is established 

for residues of Bacillus thuringiensis 

Cry1A.105 protein in or on the food and 

feed commodities of cotton; cotton, 

forage; cotton, gin byproducts; cotton, 

hay; cotton, hulls; cotton, meal; cotton, 

refined oil; and cotton, undelinted seed 

when the Bacillus thuringiensis 

Cry1A.105 protein is used as a plantincorporated protectant in these food 

and feed cotton commodities. The 

exemption from the requirement of a 

tolerance expires and is revoked on 

November 22, 2010. 

[FR Doc. E9–18860 Filed 8–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0601; FRL–8431–8] 

Inert Ingredients; Extension of 

Effective Date of Revocation of Certain 

Tolerance Exemptions with Insufficient 

Data for Reassessment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: This document moves the 

effective date of the revocation of six 

inert ingredient tolerance exemptions 

with insufficient data for reassessment 

as set forth in the Federal Register on 

August 4, 2008 (73 FR 45312). 

DATES: In the final rule published 

August 9, 2006 (71 FR 45415), and 

delayed on August 4, 2008 (73 FR 

45312): 

1. The effective date is delayed from 

August 9, 2009, to October 9, 2009, for 

the following amendments to § 180.910: 

2.m., n., and cc. 

2. The effective date is delayed from 

August 9, 2009, to October 9, 2009, for 

the following amendments to § 180.930: 

4.t., u., and v. 

Objections and requests for hearings 

must be received on or before October 

6, 2009, 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–2009–0601. All documents in the 

docket are listed in the index for the 

docket. 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: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. 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. 

II. Background and Statutory Findings 

A. Background 

In a final rule published in the 

Federal Register on August 9, 2006 (71 

FR 45415) (FRL–8084–1), EPA revoked 

inert ingredient tolerance exemptions 

because insufficient data were available 

to the Agency to make the safety 

determination required by Federal Food, 

Drug, and Comestic Act (FFDCA) 

section 408(c)(2). In reassessing the 

safety of the tolerance exemptions, EPA 

considered the validity, completeness, 

and reliability of the data that are 

available to the Agency [FFDCA section 

408 (b)(2)(D)] and the available 

information concerning the special 

susceptibility of infants and children 

(including developmental effects from 

in utero exposure) [FFDCA section 408 


pwalker on DSK8KYBLC1PROD with RULES
39544 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 

(b)(2)(C)]. EPA concluded it had 

insufficient data to make the safety 

finding of FFDCA section 408(c)(2) and 

revoked the inert ingredient tolerance 

exemptions identified in the final rule 

under 40 CFR 180.910, 180.920, 

180.930, and 180.940, with the 

revocations effective on August 9, 2008. 

In a subsequent direct final rule 

published in the Federal Register on 

August 4, 2008 (73 FR 45312) (FRL– 

8372–7), EPA moved the effective date 

of the revocation of certain inert 

ingredient tolerance exemptions from 

August 9, 2008, until August 9, 2009. 

This determination was made based on 

requests for an extension of the 

revocation date from pesticide 

registrants and inert ingredient 

manufacturers who had demonstrated 

their intent to support certain inert 

ingredient tolerance exemptions and 

who had provided data development 

plans and schedules for data submission 

to the Agency. 

B. Moving the Effective Date of the 

Revocation for Six Tolerance 

Exemptions 

In the case of six of the revoked 

tolerance exemptions, EPA has received 

petitions for the establishment of 

tolerance exemptions which included 

the submission of data for these inert 

ingredients. Notices of filing of these 

petitions (PP 8E7466 and PP 8E7478) 

were published in the Federal Register 

on March 25, 2009 (74 FR 12856) (FRL– 

8399–4). The Agency has not yet fully 

completed the risk assessments needed 

to evaluate these petitions and to make 

a safety finding. EPA, therefore, 

concludes that additional time is 

necessary to complete the safety 

determinations for these six tolerance 

exemptions and that the effective date of 

the revocation of the these tolerance 

exemptions should be moved by two 

months to October 9, 2009. 

C. What is the Agency’s Authority for 

Taking this Action? 

A ‘‘tolerance’’ represents the 

maximum level for residues of pesticide 

chemicals legally allowed in or on raw 

agricultural commodities and processed 

foods. Section 408 of FFDCA, 21 U.S.C. 

346a, as amended by FQPA, Public Law 

104–170, authorizes the establishment 

of tolerances, exemptions from tolerance 

requirements, modifications in 

tolerances, and revocation of tolerances 

for residues of pesticide chemicals in or 

on raw agricultural commodities and 

processed foods. Without a tolerance or 

exemption, food containing pesticide 

residues is considered to be unsafe and 

therefore ‘‘adulterated’’ under FFDCA 

section 402(a), 21 U.S.C. 342(a). Such 

food may not be distributed in interstate 

commerce (21 U.S.C. 331(a)). For a fooduse pesticide to be sold and distributed, 

the pesticide must not only have 

appropriate tolerances under FFDCA, 

but also must be registered under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136 

et seq.). Food-use pesticides not 

registered in the United States must 

have tolerances in order for 

commodities treated with those 

pesticides to be imported into the 

United States. Under FFDCA section 

408(e)(1)(B), 21 U.S.C. 346a(e)(1)(B), 

EPA may take action establishing, 

modifying, suspending, or revoking a 

tolerance exemption. 

III. Delayed Effective Date for Certain 

Tolerance Exemptions 

The amendatory designations listed in 

this unit are reprinted from the final 

rule published in the Federal Register 

issue of August 4, 2008 (73 FR 45312) 

for the convenience of the user. The 

structure mirrors the amendatory 

designations in the original document. 

The amendatory designations shown are 

those with the effective date delayed 

until October 9, 2009. 

Section 180.910 

m. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene) mixture of 

dihydrogen phosphate and 

monohydrogen phosphate esters and the 

corresponding ammonium, calcium, 

magnesium, monoethanolamine, 

potassium, sodium, and zinc salts of the 

phosphate esters; the nonyl group is a 

propylene trimer isomer and the poly 

(oxyethylene) content averages 4-14 

moles or 30 moles. 

n. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene) sulfate, 

ammonium, calcium, magnesium, 

potassium, sodium, and zinc salts; the 

nonyl group is a propylene trimer 

isomer and the poly(oxyethylene) 

content averages 4 moles. 

cc. a-[p-(1,1,3,3- 

Tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene) produced by 

the condensation of 1 mole of p- 

(1,1,3,3-tetramethylbutyl)phenol with a 

range of 1–14 or 30–70 moles of 

ethylene oxide: if a blend of products is 

used, the average range number of moles 

of ethylene oxide reacted to produce 

any product that is a component of the 

blend shall be in the range of 1–14 or 

30–70. 

Section 180.930 

t. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene) mixture of 

dihydrogen phosphate and 

monohydrogen phosphate esters and the 

corresponding ammonium, calcium, 

magnesium, monoethanolamine, 

potassium, sodium, and zinc salts of the 

phosphate esters; the nonyl group is a 

propylene trimer isomer and the 

poly(oxyethylene) content averages 4– 

14 moles. 

u. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene) sulfate, and 

its ammonium, calcium, magnesium, 

potassium, sodium, and zinc salts; the 

nonyl group is a propylene trimer 

isomer and the poly(oxyethylene) 

content averages 4 moles. 

v. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene) sulfate, and 

its ammonium, calcium, magnesium, 

monoethanolamine, potassium, sodium, 

and zinc salts; the nonyl group is a 

propylene trimer isomer and the 

poly(oxyethylene) content averages 4– 

14 or 30–90 moles of ethyiene oxide. 

IV. Statutory and Executive Order 

Reviews 

This rule changes the effective date of 

the revocation of certain tolerance 

exemptions under section 408(d) of 

FFDCA. The Office of Management and 

Budget (OMB) has exempted tolerance 

exemption actions from review under 

Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993). Because this 

rule has been exempted from review 

under Executive Order 12866 due to its 

lack of significance, this rule is not 

subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This rule does not contain 

any information collections subject to 

OMB approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., or 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). 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); or OMB review or 

any Agency action under Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997). 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). 


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Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39545 

Pursuant to the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601 et seq.), the 

Agency hereby certifies that this action 

will not have a significant negative 

economic impact on a substantial 

number of small entities. 

In addition, the Agency has 

determined that this action will not 

have a substantial direct effect on States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This rule directly 

regulates growers, food processors, food 

handlers, and food retailers, not States. 

This action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. For these 

same reasons, the Agency has 

determined that this rule does not have 

any ‘‘tribal implications’’ as described 

in Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249, November 9, 2000). Executive 

Order 13175 requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 4, 2009. 

G. Jeffrey Herndon, 

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. 

§180.910 [Amended] 

■ 2. In the final rule published August 

9, 2006 (71 FR 45415), and delayed on 

August 4, 2008 (73 FR 45312), the 

effective date is delayed from August 9, 

2009, to October 9, 2009, for the 

following amendments to § 180.910: 

2.m., n., and cc. 

§180.930 [Amended] 

■ 3. In the final rule published August 

9, 2006 (71 FR 45415), and delayed on 

August 4, 2008 (73 FR 45312), the 

effective date is delayed from August 9, 

2009, to October 9, 2009, for the 

following amendments to § 180.930: 

4.t., u., and v. 

[FR Doc. E9–19057 Filed 8–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0806; FRL–8427–7] 

Avermectin B1 and its delta-8,9-isomer; 

Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

avermectin B1 and its delta-8,9-isomer 

in or on stone fruit crop group 12, tree 

nut crop group 14, pistachio, tuberous 

and corm vegetable crop subgroup 01C, 

goat fat, hog fat, horse fat, sheep fat, 

cattle fat, and cattle meat byproducts. 

Existing tolerances for cattle, fat and 

cattle, meat byproducts are revised. 

Existing individual crop tolerances on 

almond, plum, potato, and walnut are 

deleted and replaced by the 

establishment of new crop group 

tolerances. Existing tolerances on 

almond, hulls and plum, prune, dried 

are retained. This regulation also makes 

a technical correction to correctly 

express the existing tolerances for mint 

(replace term ‘‘mint’’ with the more 

specific terms ‘‘peppermint, tops’’ and 

‘‘spearmint, tops’’). Syngenta Crop 

Protection, Inc. and Y-TEX Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 7, 2009. Objections and requests 

for hearings must be received on or 

before October 6, 2009, 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–2008–0806. 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: 

Thomas C. Harris, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308-9423; e-mail address: 

harris.thomas@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: 


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