Document ID: EPA-HQ-OPP-2007-0574-0003
Agency: epa
Document Type: Rule
Title: Bacillus Thuringiensis Vip3Aa20 Protein and the Genetic Material Necessary for its Production in Corn; Extension of Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2007-12-05T05:00Z

[Federal Register: December 5, 2007 (Volume 72, Number 233)]
[Rules and Regulations]               
[Page 68525-68529]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de07-18]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-0574; FRL-8340-5]

 
Bacillus Thuringiensis Vip3Aa20 Protein and the Genetic Material 
Necessary for its Production in Corn; Extension of Temporary Exemption 
From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends the temporary exemption from the 
requirement of a tolerance for residues of Bacillus thuringiensis 
Vip3Aa20 protein in corn when applied or used as a plant-incorporated 
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 that the temporary 
tolerance exemption be extended. This regulation eliminates the need to 
establish a maximum permissible level for residues of the Bacillus 
thuringiensis Vip3Aa20 protein in corn when applied or used as a plant-
incorporated protectant on field corn, sweet corn, and popcorn. The 
temporary tolerance exemption expires on October 31, 2009.

DATES: This regulation is effective December 5, 2007. Objections and 
requests for hearings must be received on or before February 4, 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-2007-0574. 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 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: Mike Mendelsohn, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8715; e-mail 
address: mendelsohn.mike@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

[[Page 68526]]

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-2007-0574 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 February 4, 2008.
    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-2007-0574, 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 August 8, 2007 (72 FR 44521) (FRL-8139-
7), 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 petition (PP 
7F7212) by Syngenta Seeds, Inc., 3054 Cornwallis Rd., P.O. Box 12257, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
174.458 (now 40 CFR 174.528, see the Federal Register issue of April 
25, 2007 (72 FR 20431) (FRL-7742-2) be amended such that the temporary 
tolerance exemption for Bacillus thuringiensis Vip3Aa20 protein and the 
genetic material necessary for its production in corn when applied/used 
as a plant-incorporated protectant on field corn, sweet corn, and 
popcorn expires on October 31, 2009.
    This notice included a summary of the petition prepared by Syngenta 
Seeds, Inc., the registrant. 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(c)(2)(B) 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.
    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 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 amending 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 (72 FR 40754; 40 CFR 174.501).
    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 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

[[Page 68527]]

were shown to be caused by the plant-incorporated 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 Food 
and Agriculture Organization of the United Nations/World Health 
Organization Standards Programme, 2001. A heat lability study 
demonstrated that Vip3Aa19 is inactivated against fall army worm, when 
heated to 55 [deg]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, 
and glycosylation. Current scientific knowledge suggests that common 
food allergens tend to be resistant to degradation acid and 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 microLiter ([micro]L) of 
LPPACHA-0199 or 320 [micro]L 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 circa (ca). 24.6-40.3 microgram ([micro]g) 
Vip3Aa20/gram (g) dry weight, representing ca. 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 in grams/kilogram (gm/kg), 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 FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational 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 Bacillus thuringiensis pesticides (Berstein et al. 1999), 
which provides further evidence of the negligible respiratory risks of 
Bacillus thuringiensis plant-incorporated 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 grams/
kilogram 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 support 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-

[[Page 68528]]

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. 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 (EUP) application for corn 
expressing the Vip3Aa20 protein) demonstrated low levels of Vip3Aa20 in 
corn tissues with less than 40 [micro]g Vip3Aa20 protein/g dry weight 
in kernels and less than 75 [mu]g Vip3Aa20 protein/g 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 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 174.507).

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 
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/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 plant-incorporated protectant at this time.

B. Analytical Method(s)

    A method for extraction and Enzyme Linked Immunosorbent (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 extends the 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 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

[[Page 68529]]

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, 
Corn, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: November 19, 2007,
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
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.

0
2. Section 174.528 is revised to read as follows:

Sec.  174.528  Bacillus thuringiensis Vip3Aa20 protein 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; corn, 
field; corn, sweet; and corn, pop. 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 67979-EUP-6, which is being amended and 
extended 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 October 31, 2009; 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. E7-23308 Filed 12-4-07; 8:45 am]

BILLING CODE 6560-50-S