Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 52591 

which equal 100 percent of total State 

NPDES program costs. 

(2) The maximum share to any State 

under this subsection shall not exceed 

50 percent of the State’s previous year’s 

total Section 106 allotment determined 

under paragraph (b) of this section. 

(3) Any funds left remaining after all 

shares have been allotted under this 

subsection will be re-allotted to the 

States under paragraph (b) of this 

section. 

(4) In order for a State to be eligible 

for this incentive, a State must: be 

authorized by EPA to implement the 

NPDES program by the first day of the 

Federal fiscal year, October 1, for which 

the funds have been appropriated; and 

submit to EPA a certification meeting 

the requirements of paragraph (e)(5) of 

this section. 

(5) The certification required under 

paragraph (e)(4) of this section must 

meet the following requirements: 

(i) The certification must be submitted 

annually to EPA (to the attention of the 

Regional Administrator). For FY 2009, 

the certification must be postmarked by 

November, 14, 2008. For every year 

thereafter the certification must be 

postmarked by October 1; and 

(ii) The certification must include the 

total NPDES State program costs and the 

percentage of NPDES program costs, as 

defined in paragraph (e)(6) of this 

section, recovered by the State through 

permit fee collections during the most 

recently completed State fiscal year, and 

a statement that the amount of permit 

fees collected is used by the State to 

defray NPDES program costs; and 

(iii) The certification must include a 

statement that State recurrent 

expenditures for water quality programs 

have not decreased from the previous 

State fiscal year or indicate that a 

decrease in such expenditures is 

attributable to a non-selective reduction 

of the programs of all executive branch 

agencies of the State government. 

(6) NPDES program costs are defined 

as all permitting, enforcement, and 

compliance costs. 

[FR Doc. E8–21046 Filed 9–9–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2007–0573; FRL–8380–1] 

Bacillus thuringiensis Cry2Ae in 

Cotton; Temporary Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the Bacillus thuringiensis Cry2Ae in 

or on cotton and its food and feed 

commodities when used as a PlantIncorporated Protectant (PIP) in 

accordance with the terms of 

Experimental Use Permit 264–EUP–143. 

Bayer CropScience LP submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting the temporary tolerance 

exemption. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of Bacillus 

thuringiensis Cry2Ae. The temporary 

tolerance exemption expires on 

December 31, 2012. 

DATES: This regulation is effective 

September 10, 2008. Objections and 

requests for hearings must be received 

on or before November 10, 2008, 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–2007–0573. 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: 

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; e-mail address: 

bacchus.shanaz@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 174 

through the Government Printing 

Office’s pilot 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–2007–0573 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 November 10, 2008. 


jlentini on PROD1PC65 with RULES
52592 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 

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–2007–0573, 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. Background and Statutory Findings 

In the Federal Register of August 8, 

2007 (72 FR 44521–44523) (FRL–8139–

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 tolerance petition (PP 7F7192) 

by Bayer CropScience LP, P.O. Box 

12014, 2 T.W. Alexander Dr., Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR be amended by 

establishing a temporary exemption 

from the requirement of a tolerance for 

residues of Bacillus thuringiensis 

Cry2Ae in or on cotton when used as a 

Plant-Incorporated Protectant (PIP). 

Bayer has requested an Experimental 

Use Permit (EUP), EPA File Symbol 

264–EUP–143, under which it seeks to 

use Cry2Ae as a PIP on 1,919 acres of 

cotton. A summary of the petition 

prepared by the petitioner was included 

in the docket. There were no comments 

received in response to the notice of 

filing. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’

Section 408(c)(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. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

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....’’

Additionally, section 408(b)(2)(D) of 

FFDCA requires that 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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information 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. 

The following toxicological profile is 

based on summaries of the Agency’s 

reviews of the petitioner’s data 

submissions (Ref. 1). 

A. Acute Oral Toxicity 

Bayer CropScience has submitted 

acute oral toxicity data demonstrating 

the lack of mammalian toxicity at high 

levels of exposure to the pure Cry2Ae 

protein. An acute oral toxicity study in 

mice indicated that Cry2Ae is non-toxic 

to humans. The acute oral toxicity of 

Cry2Ae was assessed by administering 

Bacillus thuringiensis-produced Cry2Ae 

protein by oral gavage at a dose of 2,000 

milligrams/kilogram of body weight 

(mg/kg b.w.) to groups of five female 

mice. There were no mortalities, and no 

treatment-related adverse effects 

observed. Therefore, the acute oral LD50

of the Cry2Ae protein is greater than 

2,000 mg/kg body weight (Ref. 2). 

For microbial products, further 

toxicity tests and residue data (Tiers II 

and III) are only required to verify and 

clarify adverse effects observed during 

Tier I testing. In the submitted studies 

for this PIP, no adverse acute effects 

were observed in the Tier I acute oral or 

acute injection studies. Therefore, Tier 

II and Tier III studies were not required. 

Thus, EPA concluded that these data 

demonstrate the safety of the product at 

a level well above maximum possible 

exposure levels that are reasonably 

anticipated in the crop. Basing this 

conclusion on acute oral toxicity data 

without requiring further toxicity testing 

and residue data is similar to the 

Agency position regarding toxicity 

testing and the requirement of residue 

data for the microbial Bacillus 

thuringiensis products from which this 

PIP was derived (See 40 CFR 158.2140). 

When proteins are toxic, they are 

known to act via acute mechanisms and 

at very low dose levels (Ref. 3). 

Therefore, since no acute effects were 

shown to be caused by Cry2Ae, even at 

relatively high dose levels, the Cry2Ae 

protein is not considered toxic. Further, 

amino acid sequence comparisons 

showed no similarities between the 

Cry2Ae and known toxic proteins in 

protein databases that would raise a 

safety concern. 

B. Cry2Ae Allergenicity Assessment 

Since Cry2Ae is a protein, allergenic 

potential was also considered. 

Currently, no definitive tests for 

determining the allergenic potential of 

novel proteins exist. Therefore, EPA 

uses a weight-of-evidence approach 

where the following factors are 

considered: Source of the trait; amino 

acid sequence comparison with known 

allergens; and biochemical properties of 

the protein, including in vitro 

digestibility in simulated gastric fluid 

(SGF) and glycosylation. This approach 

is consistent with the approach outlined 

in the Annex to the Codex Alimentarius 

‘‘Guideline for the Conduct of Food 

Safety Assessment of Foods Derived 

from Recombinant-DNA Plants.’’ The 

allergenicity assessment for Cry2Ae is 

based on the potential of the source of 

the protein, the similarity of its amino 

acid sequence to known allergens, its 

glycosylation and its digestibility. The 

applicant submitted data to demonstrate 

that Cry2Ae: (1) Originates from a nonallergenic source (Ref. 4); (2) has no 

sequence similarities with known 


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Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 52593 

allergens (Ref. 5); (3) is not glycosylated 

(Ref. 6); and (4) is rapidly digested in 

simulated gastric fluid (Ref. 7). Thus 

EPA has concluded that the potential for 

Cry2Ae to be an allergen is minimal 

(Ref. 1). 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure—Food and 

Drinking Water 

As discussed in Unit III, laboratory 

tests show that Cry2Ae demonstrates a 

very low to minimal acute oral toxicity 

and allergenicity potential. Thus, EPA 

does not expect any harm to human 

adults, infants and children exposed to 

Cry 2Ae via consumption of food 

commodities related to cotton. 

Oral exposure, at very low levels, may 

occur from ingestion of processed cotton 

products and, theoretically, drinking 

water. Based on the lack of adverse 

effects during the acute oral toxicity 

study conducted in mice (LD50 greater 

than 2,000 mg/kg), the Agency does not 

expect any harm via dietary exposure, 

including exposure to drinking water. 

B. Other Non-Occupational Exposure—

Dermal and Inhalation 

Non-occupational dermal and 

inhalation exposure is expected to be 

negligible or non-existent. 

Exposure via the skin or inhalation is 

not likely since the Plant-Incorporated 

Protectant is contained within plant 

cells. Thus, exposure and risk via 

dermal and inhalation routes are 

essentially negligible or eliminated. In 

addition, even if exposure can occur 

through inhalation, the potential for 

Cry2Ae to be an allergen is low, as 

discussed above in Unit III. Although 

the allergenicity assessment focuses on 

potential to be a food allergen, the data 

also indicate a low potential for Cry2Ae 

to be an inhalation allergen. 

Furthermore, non-occupational dermal 

and inhalation exposure via residential 

or lawn use to human adults, infants 

and children is also not expected 

because the use sites for the Cry2Ae 

protein are agricultural. 

V. Cumulative Effects 

Pursuant to FFDCA section 

408(b)(2)(D)(v), EPA has considered 

available information on the cumulative 

effects of such residues and other 

substances that have a common 

mechanism of toxicity. These 

considerations included the cumulative 

effects on infants and children of such 

residues and other substances with a 

common mechanism of toxicity. 

Because there is no indication of 

mammalian toxicity from the PlantIncorporated Protectant, we conclude 

that there are no cumulative effects for 

the Cry2Ae protein. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

A. Toxicity and Allergenicity 

Conclusions 

The data submitted and cited 

regarding potential health effects for the 

Cry2Ae protein include the 

characterization of the expressed 

Cry2Ae protein in cotton, as well as the 

acute oral toxicity study, amino acid 

sequence comparisons to known 

allergens and toxins, and in vitro 

digestibility of the protein. The results 

of these studies were used to evaluate 

human risk, and the validity, 

completeness, and reliability of the 

available data from the studies were also 

considered. 

The acute oral toxicity data submitted 

support the prediction that the Cry2Ae 

protein would be non-toxic to humans. 

As mentioned above in Unit III no 

treatment-related adverse effects were 

shown to be caused by the Cry2Ae 

protein, even at relatively high dose 

levels and Tier I studies showed no 

adverse effects. Thus, Tiers II and III 

studies were not required and the 

Cry2Ae protein is not considered toxic. 

Since Cry2Ae is a protein, potential 

allergenicity is also considered as part 

of the toxicity assessment. Considering 

all of the available information: (1) 

Cry2Ae originates from a non-allergenic 

source; (2) Cry2Ae has no sequence 

similarities with known allergens; (3) 

Cry2Ae is not glycosylated; and (4) 

Cry2Ae is rapidly digested in simulated 

gastric fluid; EPA has concluded that 

the potential for Cry2Ae to be an 

allergen is minimal. 

The lack of mammalian toxicity at 

high levels of exposure to the Cry2Ae 

protein, as well as the minimal potential 

to be a food allergen, demonstrate the 

safety of the product at levels well 

above possible maximum exposure 

levels anticipated. 

B. Infants and Children Risk 

Conclusions 

FFDCA section 408(b)(2)(C) provides 

that EPA shall assess the available 

information about consumption patterns 

among infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, FFDCA section 

408(b)(2)(C) also provides that EPA shall 

apply an additional tenfold 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 unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. 

In this instance, based on all the 

available information, the Agency 

concludes that there is a finding of no 

toxicity for the Cry2Ae protein. Thus, 

there are no threshold effects of concern 

and, as a result, the provision requiring 

an additional margin of safety does not 

apply. Further, the considerations of 

consumption patterns, special 

susceptibility, and cumulative effects do 

not apply. 

C. Overall Safety Conclusion 

There is a reasonable certainty that no 

harm will result from aggregate 

exposure to the U.S. population, 

including infants and children, to the 

Cry2Ae protein. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. The Agency has 

arrived at this conclusion because, as 

discussed above, no toxicity to 

mammals has been observed, nor any 

indication of allergenicity potential for 

the Plant-Incorporated Protectant. 

VII. Other Considerations 

A. Endocrine Disruptors 

The pesticidal active ingredient is a 

protein, derived from a source that is 

not known to exert an influence on the 

endocrine system. Therefore, the 

Agency is not requiring information on 

the endocrine effects of the PlantIncorporated Protectant, Bacillus 

thuringiensis Cry2Ae protein at this 

time. 

B. Analytical Method(s) 

Because this is only a temporary 

exemption from the requirement of a 

tolerance, EPA is not requiring an 

analytical detection method at this time. 

C. Codex Maximum Residue Level 

No Codex Maximum Residue Level 

(MRL) exists at this time for the PlantIncorporated Protectant Bacillus 

thuringiensis Cry2Ae protein. 


jlentini on PROD1PC65 with RULES
52594 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 

VIII. References 

1. USEPA BPPD memorandum dated 

February 12, 2008 from Rebecca 

Edlestein to Shanaz Bacchus. 

2. Master Record Identification 

Number (MRID No.) 47076902, USEPA, 

BPPD memo 2/12/2008). 

3. Sjoblad, Roy D., et al., 

‘‘Toxicological Considerations for 

Protein Components of Biological 

Pesticide Products,’’ Regulatory 

Toxicology and Pharmacology 15, 3–9 

(1992). 

4. MRID 47125101. 

5. MRID 46708903. 

6. MRIDs 46708903 and 46708907. 

7. MRIDs 46708905 and 47125102. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance under section 408(d) of 

FFDCA in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

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: August 25, 2008. 

Marty Monell, 

Acting Director, 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: 7 U.S.C. 136–136y; 21 U.S.C. 

346a and 371. 

■ 2. Section 174.530 is added to subpart 

W to read as follows: 

§ 174.530 Bacillus thuringiensis Cry2Ae 

protein in cotton; Temporary exemption 

from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry2Ae protein in or on the food 

commodities of cotton, cotton; cotton, 

undelinted seed; cotton, refined oil; 

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

cotton, forage; and cotton, gin 

byproducts are exempt temporarily from 

the requirement of a tolerance when 

Bacillus thuringiensis Cry2Ae protein in 

cotton plants is used as a PlantIncorporated Protectant in accordance 

with the terms of Experimental Use 

Permit 264–EUP–143. This temporary 

exemption from the requirement of a 

tolerance will expire on December 31, 

2012. 

[FR Doc. E8–20728 Filed 9–9–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0507; FRL–8378–8] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

established tolerances for combined 

residues of hexythiazox in or on citrus 

dried pulp; citrus oil; pome fruit, crop 

group 11; wet apple pomace; and meat 

byproducts of cattle, goat, horse, and 

sheep. Gowan Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 10, 2008. Objections and 

requests for hearings must be received 

on or before November 10, 2008, 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–2007–0507. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 


jlentini on PROD1PC65 with RULES