[Federal Register: December 6, 2007 (Volume 72, Number 234)]
[Rules and Regulations]
[Page 68744-68748]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de07-2]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2007-0575; FRL-8340-4]
Bacillus Thuringiensis Vip3Aa19 Protein in Cotton; Extension of a
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 the Bacillus thuringiensis
Vip3Aa19 protein in cotton when applied or used as a plant-incorporated
protectant (PIP). Syngenta Seeds, Inc., submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA), requesting the
temporary tolerance exemption be extended. This regulation eliminates
the need to establish a maximum permissible level for residues of
Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used
as a PIP on cotton. The temporary tolerance exemption expires on May 1,
2009.
DATES: This regulation is effective December 6, 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-2007-0575. 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
[[Page 68745]]
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: Alan Reynolds, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 605-0515; e-mail
address: reynolds.alan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 174 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0575 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-2007-0575, 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 FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F7216) by Syngenta Seeds, Inc., 3054 Cornwallis Rd., P.O.
Box 12257, Research Triangle Park, NC 27709. The petition requested
that 40 CFR 174.501 be amended such that the temporary exemption from
the requirement of a tolerance for residues of Bacillus thuringiensis
Vip3Aa19 insect control protein (vector pCOT1) when applied or used as
a PIP on cotton expires on May 1, 2009. This notice included a summary
of the petition prepared by the petitioner, Syngenta Seeds, Inc. There
were no comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' Additionally, section 408(b)(2)(D) of FFDCA requires that
the Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major
[[Page 68746]]
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) Vip3Aa19
protein. These data demonstrate the safety of Vip3Aa19 at levels well
above maximum possible exposure levels that are reasonably anticipated
in the crops. This is similar to the Agency position regarding toxicity
and the requirement of residue data for the microbial Bacillus
thuringiensis products from which this PIP was derived (See 40 CFR
158.740(b)(2)(i)). For microbial products, the need for Tier II and III
toxicity testing and residue data to verify the observed effects and
clarify the source of these effects is triggered only by significant
acute effects in studies such as the mouse oral toxicity study.
In previously submitted Vip3A studies and applications, the
designation VIP3A or Vip3A was used to describe the Vip PIP protein
and/or test material. In the final rule, it is necessary to distinguish
the various Vip3A designations based on the Crickmore Bacillus
thuringiensis Vip3A nomenclature (see http://www.lifesci.sussex.ac.uk/Home/Neil_Crickmore/Bt
). The original Vip3A toxin as expressed in
COT102 is now known as Vip3Aa19 toxin according to the Crickmore
nomenclature designation. A temporary exemption from the requirement of
tolerance already has been established for the Bacillus thuringiensis
Vip3Aa19 protein in cotton (See the Federal Register issue of July 25,
2007 (72 FR 40752) (FRL-8134-3); 40 CFR 174.501 that expires May 1,
2008.
An acute oral toxicity study was submitted for the Vip3Aa19
protein. Male and female mice (16 of each) were dosed with 3,675
milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All
mice survived the study, gained weight, had no test material-related
clinical signs, and had no test material-related findings at necropsy.
This acute oral toxicity data supports the prediction that the Vip3Aa19
protein would be non-toxic to humans.
When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Sjoblad, Roy D., et al. 1992). Therefore,
since no effects were shown to be caused by the PIP, even at relatively
high-dose levels, the Vip3Aa19 protein is not considered toxic. Amino
acid sequence comparisons showed no similarity between the Vip3Aa19
protein and known toxic proteins available in public protein data
bases. According to the Codex Alimintarius Commission (Codex)
guidelines, the assessment of potential toxicity also includes
stability to heat (Joint Food and Agriculture Organization of the
United Nations/World Health Organization (FAO/WHO) Food Standard
Programme, Codex Alimentarius Commission, 2003\1\). A heat lability
study demonstrated that Vip3Aa19 is inactivated against fall armyworm
when heated to 55 [deg]C for 30 minutes.
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\1\ Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex
Alimentarius Commission, Twenty-Fifth Session, Rome, Italy 30 June-5
July, 2003. Appendix III, Guideline for the conduct of food safety
assessment of foods derived from recombinant-DNA plants and Appendix
IV, Annex on the assessment of possible allergenicity. Rome, Codex
Alimentarius Commission, 2003, p.p 47-60.
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Since Vip3Aa19 is a protein, allergenic sensitivities were
considered. Currently, no definitive tests exist for determining the
allergenic potential of novel proteins. Therefore, EPA uses a weight-
of-the-evidence approach where the following factors are considered:
source of the trait; amino acid sequence similarity with known
allergens; prevalence in food; and biochemical properties of the
protein, including in vitro digestibility in simulated gastric fluid
(SGF), and glycosylation. This approach was described by the Codex
guidelines for the conduct of food safety assessment of food derived
from recombinant-DNA plants including the assessment of possible
allergenicity in 2003 (Joint FAO/WHO Food Standard Programme, Codex
Alimentarius Commission, 2003\1\).
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 SGF (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 Vip3Aa19 is not glycoslylated
and a comparison of amino acid sequences of known allergens uncovered
no evidence of any homology with Vip3Aa19, even at the level of eight
contiguous amino acid residues. These data demonstrated that mean
Vip3Aa19 concentration in cotton seed ranged from (circa). 2.51 to 3.23
micrograms ([micro]g) Vip3A/g dry weight. Vip3Aa19 was not detected in
cotton fiber or nectar. Analysis of the refined oil and de-fatted meal
by Enzyme-Linked Immunosorbent Assay (ELISA) detected Vip3Aa19 protein
in COT102 meal, but not in oil. Therefore, based on the data provided
for the specific Vip3Aa19 protein, one can conclude that the Vip3Aa19
protein is present in low levels in cotton seed and not detected in
cotton fiber.
Therefore, the potential for the Vip3Aa19 protein to be a food
allergen is minimal. As noted in Unit III., toxic proteins typically
act as acute toxins with low dose levels. Therefore, since no effects
were shown to be caused by this PIP, even at relatively high-dose
levels, the Vip3Aa19 protein is not considered toxic.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other 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 PIP chemical residue, and exposure from non-occupational
sources. Exposure via the skin or inhalation is not likely since the
PIP is contained within plant cells, which essentially eliminates these
exposure routes or reduces these exposure routes to negligible. The
amino acid homology assessment revealed no similarities to known
aeroallergens, indicating that 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 PIPs.
Exposure via residential or lawn use to infants and children is also
not expected because the use sites for the Vip3Aa19 protein are all
agricultural for control of insects. Oral exposure, at very low levels
may
[[Page 68747]]
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 (gm/kg) showed no adverse effects. Furthermore, the expected
dietary exposure from cotton is several orders of magnitude lower than
the amounts of Vip3Aa19 protein shown to have no toxicity. Therefore,
even if negligible aggregate exposure should occur, the Agency
concludes that such exposure would present no harm due to the lack of
mammalian toxicity and the rapid digestibility demonstrated for the
Vip3Aa19 proteins.
V. Cumulative Effects
Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations include the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity, the
Agency concludes that there are no cumulative effects arising from
Vip3Aa19 protein residues in cotton.
VI. Determination of Safety for U.S. Population, Infants and Children
A. Toxicity and Allergenicity Conclusions
The data submitted and cited regarding potential health effects for
the Vip3Aa19 protein include the characterization of the expressed
Vip3Aa19 protein in cotton, as well as the acute oral toxicity, heat
stability, and in vitro digestibility of the proteins. The results of
these studies were determined applicable to evaluate human risk, and
the validity, completeness, and reliability of the available data from
the studies were considered.
Adequate information was submitted to show that the Vip3A protein
test material derived from microbial cultures (designated VIP3A-0100)
was biochemically and functionally similar to the Vip3Aa19 protein
expressed in cotton. Microbially produced protein was chosen in order
to obtain sufficient material for testing.
The acute oral toxicity data submitted supports the prediction that
the Vip3Aa19 protein would be non-toxic to humans. As mentioned in Unit
III., when proteins are toxic, they are known to act via acute
mechanisms and at very low-dose levels (Sjoblad, Roy D., et al. 1992).
Since no effects were shown to be caused by Vip3Aa19 protein, even at
relatively high dose levels (3,675 mg Vip3Aa19/kg bwt), the Vip3Aa19
protein is not considered toxic. This is similar to the Agency position
regarding toxicity and the requirement of residue data for the
microbial Bacillus thuringiensis products from which this PIP was
derived. (See 40 CFR 158.740(b)(2)(i)). Moreover, Vip3Aa19 showed no
sequence similarity to any known toxin.
Protein residue chemistry data for Vip3Aa19 were not required for a
human health effects assessment of the subject PIP ingredients because
of the lack of mammalian toxicity. Expression data demonstrated that
mean Vip3Aa19 concentrations in cotton seed ranged from approximately
2.51 to 3.23 [micro]g Vip3Aa19/g dry weight. Vip3Aa19 was not detected
in cotton fiber or nectar. Analysis of the refined oil and de-fatted
meal by ELISA detected Vip3Aa19 protein in COT102 meal, but not in oil.
Therefore, Vip3Aa19 is present in low levels in cotton seed and not
detectable in cotton fiber.
Since Vip3Aa19 is a protein, its potential allergenicity is also
considered as part of the toxicity assessment. Information considered
as part of the allergenicity assessment included data demonstrating
that the Vip3Aa19 protein came from a Bacillus thuringiensis which is
not a known allergenic source, showed no sequence similarity to known
allergens, was readily degraded by pepsin, and was not glycosylated
when expressed in the plant. Therefore, there is a reasonable certainty
that the Vip3Aa19 protein will not be an allergen.
Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children), nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the Vip3Aa19 protein, as well as the minimal potential to
be a food allergen, demonstrate the safety of Vip3Aa19 at levels well
above possible maximum exposure levels anticipated in the crop.
The genetic material necessary for the production of the PIP active
ingredients are the nucleic acids Deoxyribonucleic acid, Ribonucleic
acid (DNA, RNA) which comprise genetic material encoding these proteins
and their regulatory regions. The genetic material DNA, RNA necessary
for the production of Vip3Aa19 protein already are exempted from the
requirement of a tolerance under a blanket exemption for all nucleic
acids (40 CFR 174.507).
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
Vip3Aa19 protein and the genetic material necessary for its production
in cotton. Because there are no threshold effects of concern, the
Agency has determined that the additional tenfold margin of safety is
not necessary to protect infants and children. Further, the provisions
of consumption patterns, special susceptibility, and cumulative effects
do not apply.
C. Overall Safety Conclusion
There is a reasonable certainty that no harm will result to the
U.S. population, including infants and children, from aggregate
exposure to residues of the Vip3Aa19 protein and the genetic material
necessary for its production in cotton, when it is applied or used in
accordance with good agricultural practices. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. The Agency has arrived at this conclusion
because, as previously discussed, no toxicity to mammals has been
observed, nor has there been any indication of allergenicity potential
for this PIP.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredient is a protein, derived from sources
that are not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of the PIP at this time.
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B. Analytical Method(s)
A method for extraction and ELISA analysis of the Vip3Aa19 protein
in cotton has been submitted and is under review by the Agency. For the
temporary tolerance exemption, the ELISA method described with the
expression data is sufficient.
C. Codex Maximum Residue Level
No Codex maximum residue levels exist for the PIP Bacillus
thuringiensis Vip3Aa19 protein and the genetic material necessary for
its production in cotton.
VIII. Statutory and Executive Order Reviews
This final rule extends the temporary 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 do not require the issuance
of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 174
Environmental protection, Administrative practice and procedure,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: November 27, 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 174.501 is revised to read as follows:
Sec. 174.501 Bacillus thuringiensis Vip3Aa19 protein in cotton;
temporary exemption from the requirement of a tolerance.
Residues of Bacillus thuringiensis Vip3Aa19 protein in cotton are
temporarily exempt from the requirement of a tolerance when used as a
plant-incorporated protectant in the food and feed commodities of
cotton; vegetative-insecticidal protein in cotton, undelinted seed,
cotton, oil, cotton meal, cotton hay, cotton hulls, cotton forage, and
cotton, gin byproducts. This temporary exemption from the requirement
of tolerance will permit the use of the food commodities in this
section when treated in accordance with the provisions of the
experimental use permit 67979-EUP-7, which is being 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
May 1, 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. E7-23660 Filed 12-5-07; 8:45 am]
BILLING CODE 6560-50-S