26300 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Commandant Instruction M16475.lD, 

and Department of Homeland Security 

Management Directive 5100.1 which 

guides the Coast Guard in complying 

with the National Environmental Policy 

Act of 1969 (NEPA) (42 U.S.C. 4321–

4370f), and have concluded that there 

are no factors in this case that would 

limit the use of a categorical exclusion 

under section 2.B.2 of the Instruction. 

Therefore, this rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction, from further 

environmental documentation. This rule 

fits the category selected from paragraph 

(34)(g), as it establishes a safety zone. A 

final ‘‘Environmental Analysis Check 

List’’ and a final ‘‘Categorical Exclusion 

Determination’’ will be available in the 

docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701; 50 U.S.C. 191, 195; 33 CFR 

1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add temporary § 165.T05–040 to 

read as follows: 

§ 165.T05–040 Safety Zone; Pamlico River, 

Washington, North Carolina. 

(a) Regulated area. The safety zone 

includes all waters of Pamlico River 

south of the intersection of the Highway 

17 Swing Bridge south along the west 

river bank to latitude 35°32′19′′ N, 

longitude 077°03′40′′ W, thence across 

the river on a line 045 degrees due 

northeast across the river to the 

intersection of the east river bank at 

position 35°32′30′′ N, longitude 

077°03′25′′ W, thence north along the 

shoreline to the Highway 17 Swing 

Bridge thence west to the point of 

origin. All coordinates reference Datum 

NAD 1983. 

(b) Definitions. The following 

definitions apply to this section: (1) 

Coast Guard Patrol Commander means 

a commissioned, warrant, or petty 

officer of the Coast Guard who has been 

designated by the Commander, Coast 

Guard Sector North Carolina. 

(2) Official Patrol means any vessel 

assigned or approved by the Sector 

Commander, Coast Guard Sector North 

Carolina with a commissioned, warrant, 

or petty officer on board and displaying 

a Coast Guard ensign. 

(c) Regulations. The general 

regulations governing safety zones, 

found in 33 CFR 165.23, apply to the 

safety zone described in paragraph (a) of 

this section. 

(1) Except for persons or vessels 

authorized by the Coast Guard Patrol 

Commander, no person or vessel may 

enter or remain in the regulated area. 

(2) The operator of any vessel in the 

regulated area must: 

(i) Stop the vessel immediately when 

directed to do so by any Official Patrol. 

(ii) Proceed as directed by any official 

patrol. 

(d) Enforcement period. This section 

will be enforced from 8:30 p.m. to 10 

p.m. on June 8 & 9 and July 4, 2007. 

Dated: April 24, 2007. 

Gregory D. Case, 

Commander, U.S. Coast Guard, Captain of 

the Port, Atlantic Beach, North Carolina. 

[FR Doc. E7–8814 Filed 5–8–07; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2006–0913; FRL–8124–6] 

Bacillus thuringiensis Vip3Aa19 

Protein in Cotton; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

extension of the temporary exemption 

from the requirement of a tolerance for 

residues of the Bacillus thuringiensis 

Vip3Aa19 protein in cotton when 

applied/used as a plant-incorporated 

protectant (PIP). Syngenta Seeds, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

requesting the temporary tolerance 

exemption. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of the 

Bacillus thuringiensis Vip3Aa19 protein 

in cotton when applied/used as a PIP on 

cotton. The temporary tolerance 

exemption expires on May 1, 2008. 

DATES: This regulation is effective May 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 2007, 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–2006–0913. 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 

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 


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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26301 

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: 

Alan Reynolds, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 605–0515; e-mail address: 

reynolds.alan@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 an electronic 

copy of this Federal Register document 

through the electronic docket 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, as 

amended by FQPA, 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–2006–0913 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 July 9, 2007. 

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–2006–0913, 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’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 January 12, 

2007 (72 FR 1513) (FRL–8105–3), 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 3G6547) 

by Syngenta Seeds, Inc., P.O. Box 

12257, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 174.452 be amended by 

establishing an extension of the 

temporary exemption from the 

requirement of a tolerance for residues 

of the Bacillus thuringiensis Vip3A 

protein when applied/used as a PIP on 

cotton. This notice included a summary 

of the petition prepared by the 

petitioner Syngenta Seeds, Inc. No 

public comments were received. 

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. 


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1 Alinorm 03/34: Joint FAO/WHO Food Standard 

Programme, Codex Alimentarius Commission, 

Twenty-Fifth Session, Rome, Italy 30 June–5 July, 

2003. Appendix III, Guideline for the conduct of 

food safety assessment of foods derived from 

recombinant-DNA plants and Appendix IV, Annex 

on the assessment of possible allergenicity. Rome, 

Codex Alimentarius Commission, 2003. pp. 47–60. 

Data have been submitted 

demonstrating a lack of mammalian 

toxicity at high levels of exposure to the 

pure (microbially expressed) Vip3Aa19 

protein. These data demonstrate the 

safety of Vip3Aa19 at levels well above 

maximum possible exposure levels that 

are reasonably anticipated in the crops. 

This is similar to the Agency position 

regarding toxicity and the requirement 

of residue data for the microbial 

Bacillus thuringiensis products from 

which this PIP was derived (see 40 CFR 

158.740(b)(2)(i)). For microbial 

products, the need for Tier II and III 

toxicity testing and residue data to 

verify the observed effects and clarify 

the source of these effects is triggered 

only by significant acute effects in 

studies such as the mouse oral toxicity 

study. 

In previously submitted Vip3A 

studies and applications, the 

designation VIP3A or Vip3A was used 

to describe the Vip PIP protein and/or 

test material. In the final rule, it is 

necessary to distinguish the various 

Vip3A designations based on the 

Crickmore Bacillus thuringiensis Vip3A 

nomenclature (see http:// 

www.lifesci.sussex.ac.uk/Home/ 

Neil_Crickmore/Bt/). The original 

Vip3A toxin as expressed in COT102 is 

now known as Vip3Aa19 toxin 

according to the Crickmore 

nomenclature designation. A temporary 

exemption from the requirement of a 

tolerance already has been established 

for the Bacillus thuringiensis Vip3A 

protein and the genetic material 

necessary for its production in cotton 

published in the Federal Register on 

April 26, 2006 (71 FR 24582) (FRL–

7772–7); (40 CFR 174.452). This 

temporary exemption from the 

requirement of a tolerance will be 

modified to reflect the new Crickmore 

designation, Vip3Aa19. 

An acute oral toxicity study was 

submitted for the Vip3Aa19 protein. 

Male and female mice (16 of each) were 

dosed with 3,675 milligrams/kilograms 

bodyweight (mg/kg bwt) of Vip3Aa19 

protein. All mice survived the study, 

gained weight, had no test material 

related clinical signs, and had no test 

material related findings at necropsy. 

This acute oral toxicity data supports 

the prediction that the Vip3Aa19 

protein would be non-toxic to humans. 

When proteins are toxic, they are 

known to act via acute mechanisms and 

at very low-dose levels (Sjoblad, Roy D., 

et al. 1992). Therefore, since no effects 

were shown to be caused by the PIPs, 

even at relatively high-dose levels, the 

Vip3Aa19 protein is not considered 

toxic. Amino acid sequence 

comparisons showed no similarity 

between the Vip3Aa19 protein and 

known toxic proteins available in public 

protein data bases. According to the 

Codex Alimintarius Commission 

(Codex) guidelines, the assessment of 

potential toxicity also includes stability 

to heat (Joint FAO/WHO Food Standard 

Programme, Codex Alimentarius 

Commission, 20031). A heat liability 

study demonstrated that Vip3Aa19 is 

inactivated against fall armyworm when 

heated to 55 °C for 30 minutes. 

Since Vip3Aa19 is a protein, 

allergenic sensitivities were considered. 

Currently, no definitive tests exist for 

determining the allergenic potential of 

novel proteins. Therefore, EPA uses a 

weight of the evidence approach where 

the following factors are considered: 

Source of the trait; amino acid sequence 

similarity with known allergens; 

prevalence in food; and biochemical 

properties of the protein, including in 

vitro digestibility in simulated gastric 

fluid (SGF), and glycosylation. This 

approach was described by the Codex 

guidelines for the conduct of food safety 

assessment of food derived from 

recombinant-DNA plants including the 

assessment of possible allergenicity in 

2003 (Joint FAO/WHO Food Standard 

Programme, Codex Alimentarius 

Commission, 2003). 

Data have been submitted that 

demonstrate that the Vip3A from 

recombinant maize (LPPACHA-0199) 

and E. coli (VIP3A-0100) proteins are 

rapidly degraded by gastric fluid in 

vitro. (VIP3A-0100 refers to a 

microbially expressed Vip3A that has 

been shown to be the equivalent of the 

plant-expressed Vip3A protein.) In a 

solution of simulated gastric fluid 

(containing pepsin) and either 80 μL of 

LPPACHA-0199 or 320 μL of VIP3A0100 test protein, both were shown to be 

susceptible to pepsin degradation. 

These data support the conclusion that 

Vip3A proteins expressed in transgenic 

plants will be readily digested as a 

conventional dietary protein under 

typical mammalian gastric conditions. 

Further data demonstrate that Vip3Aa19 

is not glycoslylated and a comparison of 

amino acid sequences of known 

allergens uncovered no evidence of any 

homology with Vip3Aa19, even at the 

level of eight contiguous amino acid 

residues. These data demonstrated that 

the mean Vip3Aa19 concentration in 

cotton seed ranged from ca. 2.51 to 3.23 

μg Vip3A/g dry weight. Vip3Aa19 was 

not detected in cotton fiber or nectar. 

Analysis of the refined oil and de-fatted 

meal by Enzyme-Linked Immunosorbent 

Assay (ELISA) detected Vip3Aa19 

protein in COT102 meal, but not in oil. 

Therefore, based on the data provided 

for the specific Vip3Aa19 protein, one 

can conclude that the Vip3Aa19 protein 

is present in low levels in cotton seed 

and not detected in cotton fiber. 

Therefore, the potential for the 

Vip3Aa19 protein to be a food allergen 

is minimal. As noted in Unit III., toxic 

proteins typically act as acute toxins at 

low-dose levels. Therefore, since no 

effects were shown to be caused by this 

PIP, even at relatively high-dose levels, 

the Vip3Aa19 protein is not considered 

toxic. 

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). 

The Agency has considered available 

information on the aggregate exposure 

levels of consumers (and major 

identifiable subgroups of consumers) to 

the pesticide chemical residue and to 

other related substances. These 

considerations include dietary exposure 

under the tolerance exemption and all 

other tolerances or exemptions in effect 

for the PIP chemical residue, and 

exposure from non-occupational 

sources. Exposure via the skin or 

inhalation is not likely since the PIP is 

contained within plant cells, which 

essentially eliminates these exposure 

routes or reduces these exposure routes 

to negligible. The amino acid homology 

assessment revealed no similarities to 

known aeroallergens, indicating that 

Vip3Aa19 has a low potential to be an 

inhalation allergen. It has been 

demonstrated that there is no evidence 

of occupationally related respiratory 

symptoms, based on a health survey on 

migrant workers after exposure to 

Bacillus thuringiensis pesticides 

(Berstein, et al. 1999), which provides 

further evidence of the negligible 

respiratory risks of Bacillus 

thuringiensis PIPs. Exposure via 

residential or lawn use to infants and 

children is also not expected because 

the use sites for the Vip3Aa19 protein 

are all the agricultural for control of 

insects. Oral exposure, at very low 

levels, may occur from ingestion of 


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processed corn products and, 

theoretically, drinking water. 

However, oral toxicity testing done in 

rats at a dose in excess of 3 gram(g)/kg 

showed no adverse effects. Furthermore, 

the expected dietary exposure from 

cotton is several orders of magnitude 

lower than the amounts of Vip3Aa19 

protein shown to have no toxicity. 

Therefore, even if negligible aggregate 

exposure should occur, the Agency 

concludes that such exposure would 

present no harm due to the lack of 

mammalian toxicity and the rapid 

digestibility demonstrated for the 

Vip3Aa19 proteins. 

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 include 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, the Agency 

concludes that there are no cumulative 

effects arising from Vip3Aa19 protein 

residues in cotton. 

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 

Vip3Aa19 protein include the 

characterization of the expressed 

Vip3Aa19 protein in cotton, as well as 

the acute oral toxicity, heat stability, 

and in vitro digestibility of the proteins. 

The results of these studies were 

determined applicable to evaluate 

human risk, and the validity, 

completeness, and reliability of the 

available data from the studies were 

considered. 

Adequate information was submitted 

to show that the Vip3A protein test 

material derived from microbial cultures 

(designated VIP3A-0100) was 

biochemically and functionally similar 

to the Vip3Aa19 protein expressed in 

cotton. Microbially produced protein 

was chosen in order to obtain sufficient 

material for testing. 

The acute oral toxicity data submitted 

supports the prediction that the 

Vip3Aa19 protein would be non-toxic to 

humans. As mentioned Unit III., when 

proteins are toxic, they are known to act 

via acute mechanisms and at very low 

dose levels (Sjoblad, Roy D., et al. 1992). 

Since no effects were shown to be 

caused by Vip3Aa19 protein, even at 

relatively high dose levels (3,675 mg 

Vip3Aa19/kg bwt), the Vip3Aa19 

protein is not considered toxic. This is 

similar to the Agency position regarding 

toxicity and the requirement of residue 

data for the microbial Bacillus 

thuringiensis products from which this 

PIP was derived. (See 40 CFR 

158.740(b)(2)(i)). Moreover, Vip3Aa19 

showed no sequence similarity to any 

known toxin. 

Protein residue chemistry data for 

Vip3Aa19 were not required for a 

human health effects assessment of the 

subject PIP ingredients because of the 

lack of mammalian toxicity. Expression 

data demonstrated that mean Vip3Aa19 

concentrations in cotton seed ranged 

from approximately 2.51 to 3.23 μg 

Vip3Aa19/g dry weight. Vip3Aa19 was 

not detected in cotton fiber or nectar. 

Analysis of the refined oil and de-fatted 

meal by ELISA detected Vip3Aa19 

protein in COT102 meal, but not in oil. 

Therefore, Vip3Aa19 is present in low 

levels in cotton seed and not detect in 

cotton fiber. 

Since Vip3Aa19 is a protein, its 

potential allergenicity is also considered 

as part of the toxicity assessment. 

Information considered as part of the 

allergenicity assessment included data 

demonstrating that the Vip3Aa19 

protein came from a Bacillus 

thuringiensis which is not a known 

allergenic source, showed no sequence 

similarity to known allergens, was 

readily degraded by pepsin, and was not 

glycosylated when expressed in the 

plant. Therefore, there is a reasonable 

certainty that the Vip3Aa19 protein will 

not be an allergen. 

Neither available information 

concerning the dietary consumption 

patterns of consumers (and major 

identifiable subgroups of consumers 

including infants and children), nor 

safety factors that are generally 

recognized as appropriate for the use of 

animal experimentation data were 

evaluated. The lack of mammalian 

toxicity at high levels of exposure to the 

Vip3Aa19 protein, as well as the 

minimal potential to be a food allergen, 

demonstrate the safety of Vip3Aa19 at 

levels well above possible maximum 

exposure levels anticipated in the crop. 

The genetic material necessary for the 

production of the PIP active ingredients 

are the nucleic acids (DNA, RNA) which 

comprise genetic material encoding 

these proteins and their regulatory 

regions. The genetic material (DNA, 

RNA) necessary for the production of 

Vip3Aa19 protein already are exempted 

from the requirement of a tolerance 

under a blanket exemption for all 

nucleic acids (40 CFR 174.475). 

B. Infants and Children Risk 

Conclusions 

Section 408(b)(2)(C) of FFDCA 

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 data base, 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 Vip3Aa19 protein and 

the genetic material necessary for its 

production in cotton. Because there are 

no threshold effects of concern, the 

Agency has determined that the 

additional tenfold margin of safety is 

not necessary to protect infants and 

children. Further, the provisions 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 to the U.S. population, 

including infants and children, from 

aggregate exposure to residues of the 

Vip3Aa19 protein and the genetic 

material necessary for its production in 

cotton, when it is applied/used in 

accordance with good agricultural 

practices. 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 previously 

discussed, no toxicity to mammals has 

been observed, nor has there been any 

indication of allergenicity potential for 

this PIP. 

VII. Other Considerations 

A. Endocrine Disruptors 

The pesticidal active ingredient is a 

protein, derived from sources that are 

not known to exert an influence on the 

endocrine system. Therefore, the 

Agency is not requiring information on 

the endocrine effects of the PIP at this 

time. 


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B. Analytical Method(s) 

A method for extraction and ELISA 

analysis of the Vip3Aa19 protein in 

cotton has been submitted and is under 

review by the Agency. For the 

temporary tolerance exemption, the 

ELISA method described with the 

expression data is sufficient. 

C. Codex Maximum Residue Level 

No Codex maximum residue levels 

exist for the PIP Bacillus thuringiensis 

Vip3Aa19 protein and the genetic 

material necessary for its production in 

cotton. 

VIII. Statutory and Executive Order 

Reviews 

This final rule establishes 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 rule has 

been exempted from review under 

Executive Order 12866, 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) 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 6, 2000) do not apply 

to this rule. In addition, this 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). 

IX. 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: April 26, 2007. 

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: 7 U.S.C. 136-136y; 21 U.S.C. 

346a and 371. 

■ 2. Section 174.452 is revised to read 

as follows: 

§ 174.452 Bacillus thuringiensis Vip3Aa19 

protein in cotton; temporary exemption 

from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Vip3Aa19 protein in cotton are 

temporarily exempt from the 

requirement of a tolerance when used as 

a plant-incorporated protectant (PIP) in 

the food and feed commodities of 

cotton; vegetative-insecticidal protein in 

cotton seed, cotton oil, cotton meal, 

cotton hay, cotton hulls, cotton forage, 

and cotton gin byproducts. This 

temporary exemption from the 

requirement of tolerance will permit the 

use of the food commodities in this 

section when treated in accordance with 

the provisions of the experimental use 

permit (EUP) 67979–EUP–7, which is 

being issued in accordance with the 

provisions of the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), as amended (7 U.S.C. 136). 

This temporary exemption from the 

requirement of a tolerance expires and 

is revoked May 1, 2008. However, if the 

EUP is revoked, or if any experience 

with or scientific data on this pesticide 

indicate that the temporary tolerance 

exemption is not safe, this temporary 

exemption from the requirement of a 

tolerance may be revoked at any time. 

[FR Doc. E7–8951 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0965; FRL–8124–2] 

Flufenacet; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

pesticide tolerances under the Federal 

Food, Drug, and Cosmetic Act (FFDCA) 

for combined residues of flufenacet and 

its metabolites containing the 4-fluoroN-methylethyl benzenamine moiety in 

or on grass (forage, hay), sweet corn 

(forage, kernel plus cob with husk 

removed, stover), wheat (bran, forage, 

grain, hay, straw), cattle kidney, goat 

kidney, hog kidney, horse kidney, and 

sheep kidney. Bayer Cropscience 

petitioned EPA to establish these 

tolerances. 

DATES: This regulation is effective May 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 2007, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 


rmajette on PROD1PC67 with RULES