Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Rules and Regulations 16277 

Dated: March 21, 2007. 

Patrick G. Gerrity, 

Captain, U.S. Coast Guard, Captain of the 

Port. 

[FR Doc. E7–6145 Filed 4–3–07; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2006–0783; FRL–8120–5] 

Bacillus thuringiensis Vip3Aa20 

Protein and the Genetic Material 

Necessary for its Production in Corn; 

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 Vip3Aa20 

protein and the genetic material 

necessary for its production in corn 

when applied or/used as a plantincorporated protectant. 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 Bacillus thuringiensis Vip3Aa20 

protein and the genetic material 

necessary for its production in corn 

when applied or/used as a plantincorporated protectant on field corn, 

sweet corn, and popcorn. The temporary 

tolerance exemption expires on March 

31, 2008. 

DATES: This regulation is effective April 

4, 2007. Objections and requests for 

hearings must be received on or before 

June 4, 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–2006–0783. 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 

web site 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 

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 

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 the FFDCA, as 

amended by the 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–2006–0783 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 June 4, 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–2006–0783, 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 telephone number is (703) 305–

5805. 


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16278 Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Rules and Regulations 

II. Background and Statutory Findings 

In the Federal Register of November 

1, 2006 (71 FR 64269) (FRL–8095–4), 

EPA issued a notice pursuant to section 

408(d)(3) of the FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 6G7091) 

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

12257, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR part 174 be amended by 

establishing a temporary exemption 

from the requirement of a tolerance for 

residues of the Bacillus thuringiensis 

Vip3Aa20 protein and the genetic 

material necessary for its production in 

corn when applied or used as a plantincorporated protectant on field corn, 

sweet corn, and popcorn. This notice 

included a summary of the petition 

prepared by the petitioner, Syngenta 

Seeds, Inc. One comment was received 

in response to the notice of filing. The 

commenter objected to an exemption 

from the requirement of tolerance and 

expressed opposition to genetic 

alterations. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

genetically modified crops and food 

should be completely banned. However, 

pursuant to its authority under the 

FFDCA, EPA conducted a 

comprehensive assessment of the 

Vip3Aa20 protein and the genetic 

material necessary for its production in 

corn, including a review of acute oral 

toxicity data and amino acid sequence 

comparisons to known toxins and 

allergens. In addition, data were 

reviewed that demonstrate that the 

Vip3Aa20 protein is rapidly degraded 

by gastric fluid in vitro, is not 

glycosylated, and is present in low 

levels in corn tissue. Based on these 

data, EPA concluded that there is a 

reasonable certainty that no harm will 

result from dietary exposure to this 

protein as expressed in genetically 

modified corn. Thus, under the standard 

in FFDCA section 408(c)(2), a tolerance 

exemption is appropriate. 

Section 408(c)(2)(A)(i) of the 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 the 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), 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), which 

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 * * *.’’ Additionally, section 

408(b)(2)(D) of the 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 the 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. 

Data have been submitted 

demonstrating a lack of mammalian 

toxicity at high levels of exposure to the 

pure (microbially-expressed) Vip3Aa20 

protein. These data demonstrate the 

safety of Vip3Aa20 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 plant-incorporated 

protectant 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 order to clarify the discussion that 

follows in the remainder of this Final 

Rule, it is necessary to distinguish the 

various Vip3A designations that are 

used. Vip3Aa20 is the designation 

applicable to Vip3A protein expressed 

in corn. Vip3Aa19 is the designation 

applicable to Vip3A protein expressed 

in cotton. Because the Agency has 

determined that both Vip3Aa19 and 

Vip3Aa20 are functionally equivalent, 

the Agency in establishing this 

temporary tolerance exemption for 

Vip3Aa20 expressed in corn has relied 

on data and analysis specifically 

developed for Vip3Aa20, as well as on 

data and analysis specifically developed 

for Vip3Aa19. A separate temporary 

exemption from the requirement of 

tolerance already has been established 

for Vip3Aa19 as expressed in cotton (71 

FR 24582; 40 CFR 174.452).) 

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 materialrelated clinical signs, and had no test 

material-related findings at necropsy. 

This acute oral toxicity data also 

supports the prediction that the 

Vip3Aa20 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 plantincorporated protectants, even at 

relatively high dose levels, the 

Vip3Aa20 protein is not considered 

toxic. Amino acid sequence 

comparisons showed no similarity 

between the Vip3Aa20 protein and 

known toxic proteins available in public 

protein data bases. According to the 

Codex Alimintarius guidelines, the 

assessment of potential toxicity also 

includes stability to heat (FAO/WHO 

Standards Programme, 2001). A heat 

lability study demonstrated that 

Vip3Aa19 is inactivated against Fall 

Armyworms (FAW), when heated to 55 

°C for 30 minutes. 

Since Vip3Aa20 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. Current 

scientific knowledge suggests that 

common food allergens tend to be 

resistant to degradation acids and 


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proteases; may be glycosylated; and 

present at high concentrations in the 

food. 

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 

microliters (μL) of LPPACHA–0199 or 

320 μL of VIP3A–0100 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 Vip3Aa20 is not 

glycoslylated and a comparison of 

amino acid sequences of known 

allergens uncovered no evidence of any 

homology with Vip3Aa20, even at the 

level of 8 contiguous amino acid 

residues. Preliminary data of the 

quantification of Vip3Aa20 protein in 

various maize tissues were also 

submitted. This data demonstrated that 

mean Vip3Aa20 concentrations in corn 

kernels ranged from approximately 24.6 

- 40.3 micrograms (μg) Vip3Aa20/dry 

weight, representing approximately 

0.003% of the total protein in grain 

(assuming that corn grain contains 10% 

total protein by weight). Therefore, 

Vip3Aa20 is present in low levels in 

corn tissue and the protein expression is 

much lower than the amounts of 

allergen protein found in commonly 

allergenic foods. In those foods, the 

allergens can be 10 to 50% of the total 

protein found. 

Therefore, the potential for the 

Vip3Aa20 protein to be a food allergen 

is minimal. As noted above, toxic 

proteins typically act as acute toxins 

with low dose levels. Therefore, since 

no effects were shown to be caused by 

this plant-incorporated protectant, even 

at relatively high dose levels, the 

Vip3Aa20 protein is not considered 

toxic. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of the FFDCA directs EPA 

to consider available information 

concerning exposures from the pesticide 

residues 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 plant-incorporated protectant 

chemical residue, and exposure from 

non-occupational sources. Exposure via 

the skin or inhalation is not likely since 

the plant-incorporated protectant 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 

Vip3A 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 Bt 

pesticides (Berstein et al. 1999), which 

provides further evidence of the 

negligible respiratory risks of Bt plantincorporated protectants. Exposure via 

residential or lawn use to infants and 

children is also not expected because 

the use sites for the Vip3Aa20 protein 

are all agricultural for control of insects. 

Oral exposure, at very low levels, may 

occur from ingestion of processed corn 

products and, theoretically, drinking 

water. 

However, oral toxicity testing done at 

a dose in excess of 3 gm/kg showed no 

adverse effects. Furthermore, the 

expected dietary exposure from both 

cotton and corn are several orders of 

magnitude lower than the amounts of 

Vip3Aa20 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 

Vip3Aa20 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 Vip3Aa20 protein 

residues in corn. 

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 

Vip3Aa20 protein include the 

characterization of the expressed 

Vip3Aa20 protein in corn, 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 Vip3Aa20 protein expressed in 

corn. Microbially produced protein was 

chosen in order to obtain sufficient 

material for testing. 

The acute oral toxicity data submitted 

supports the prediction that the 

Vip3Aa20 protein would be non-toxic to 

humans. As mentioned above, 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 Vip3Aa20 protein, even at 

relatively high dose levels (3,675 mg 

Vip3Aa19/kg bwt), the Vip3Aa20 

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 

plant-incorporated protectant was 

derived. (See 40 CFR 158.740(b)(2)(i)). 

Moreover, Vip3Aa20 showed no 

sequence similarity to any known toxin. 

Protein residue chemistry data for 

Vip3Aa20 were not required for a 

human health effects assessment of the 

subject plant-incorporated protectant 

ingredients because of the lack of 

mammalian toxicity. However, 

preliminary data (that were submitted 

with administrative materials for an 

Experimental Use Permit application for 

corn expressing the Vip3Aa20 protein) 

demonstrated low levels of Vip3Aa20 in 

corn tissues with less than 40 μg 

Vip3Aa20 protein/gram dry weight in 

kernels and less than 75 μg Vip3Aa20 

protein/gram dry weight of whole corn 

plant. 

Since Vip3Aa20 is a protein, its 

potential allergenicity is also considered 

as part of the toxicity assessment. 

Information considered as part of the 


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allergenicity assessment included data 

demonstrating that the Vip3Aa20 

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 Vip3Aa20 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 

Vip3Aa20 protein, as well as the 

minimal potential to be a food allergen, 

demonstrate the safety of Vip3Aa20 at 

levels well above possible maximum 

exposure levels anticipated in the crop. 

The genetic material necessary for the 

production of the plant-incorporated 

protectant 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 

Vip3Aa20 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 

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 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 Vip3Aa20 protein and 

the genetic material necessary for its 

production in corn. 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 

Vip3Aa20 protein and the genetic 

material necessary for its production in 

corn, when it is applied or/used in 

accordance with good agricultural 

practices on field corn, sweet corn, and 

popcorn. 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 plant-incorporated protectant. 

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 plantincorporated protectant at this time. 

B. Analytical Method 

A method for extraction and enzyme 

linked immunosorbent assay (ELISA) 

analysis of Vip3Aa20 protein in corn 

has been submitted and is under review 

by the Agency. 

C. Codex Maximum Residue Level 

No Codex maximum residue levels 

exist for the plant-incorporated 

protectant Bacillus thuringiensis 

Vip3Aa20 protein and the genetic 

material necessary for its production in 

corn. 

VIII. 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 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 exemption 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 


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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: March 23, 2007. 

James Jones, 

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

■ 2. Section 174.458 is added to subpart 

W to read as follows: 

§ 174.458 Bacillus thuringiensis Vip3Aa20 

protein and the genetic material necessary 

for its production in corn; temporary 

exemption from the requirement of a 

tolerance. 

Residues of Bacillus thuringiensis 

Vip3Aa20 protein in corn are 

temporarily exempt from the 

requirement of a tolerance when used as 

a plant-incorporated protectant in the 

food and feed commodities of corn; 

corn, field; corn, sweet; corn, pop. This 

temporary exemption from the 

requirement of tolerance will permit the 

use of the food commodities in this 

paragraph when treated in accordance 

with the provisions of the experimental 

use permit 67979–EUP–6, 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 March 31, 2008; however, if 

the experimental use permit 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. E7–6256 Filed 4–3–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0731; FRL–8120–4] 

Diphenylamine; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of diphenylamine 

in or on pear. Interregional Research 

Project Number 4 (IR-4) requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

4, 2007. Objections and requests for 

hearings must be received on or before 

June 4, 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-HQOPP-2006-0731. 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 

web site 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 

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 

telephone number is (703) 305-5805. 

FOR FURTHER INFORMATION CONTACT: 

Shaja R. Brothers, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 

(703) 308-3194; e-mail address: 

brothers.shaja@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), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 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 EPA’s tolerance 

regulations at 40 CFR part 180 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 the FFDCA, 

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 


cprice-sewell on PROD1PC61 with RULES