Document ID: EPA-HQ-OPP-2006-0783-0004
Agency: epa
Document Type: Rule
Title: Bacillus thuringiensis Vip3Aa20 Protein and the Genetic Material Necessary for its Production in Corn; Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2007-04-04T04:00Z

[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Rules and Regulations]               
[Page 16277-16281]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap07-10]                         

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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.

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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 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 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 plant-incorporated 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.

[[Page 16278]]

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 plant-incorporated 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 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 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 (FAO/WHO Standards Programme, 2001). A heat 
lability study demonstrated that Vip3Aa19 is inactivated against Fall 
Armyworms (FAW), 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 
(SGF), and glycosylation. Current scientific knowledge suggests that 
common food allergens tend to be resistant to degradation acids and

[[Page 16279]]

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 ([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 approximately 24.6 - 40.3 micrograms 
([micro]g) 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 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 Bt pesticides (Berstein et al. 1999), which provides 
further evidence of the negligible respiratory risks of Bt 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 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 [micro]g Vip3Aa20 protein/gram dry 
weight in kernels and less than 75 [micro]g 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

[[Page 16280]]

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 plant-incorporated 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

[[Page 16281]]

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.

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

0
2. Section 174.458 is added to subpart W to read as follows:

Sec.  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