[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Rules and Regulations]
[Pages 23073-23077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10663]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0147; FRL-7302-4]


Bacillus thuringiensis Cry1F Protein in Cotton; 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 
Cry1F protein in cotton when applied/used as a plant-incorporated 
protectant. Mycogen Seeds, c/o Dow AgroSciences LLC, 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 Cry1F protein in cotton. The 
temporary tolerance exemption will expire on May 1, 2004.

DATES: This regulation is effective April 30, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0147, 
must be received by EPA on or before June 30, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5412; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0147. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This 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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the Federal Register 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml --00/Title --40/40cfr180 --00.html, 
a beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of October 9, 2002 (67 FR 62971) (FRL-7196-
2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide tolerance petition (PP 2G6494) by Mycogen Seeds, c/o Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. 
This notice included a summary of the petition prepared by the 
petitioner Mycogen Seeds, c/o Dow AgroSciences LLC. Comments were 
received in response to the notice of filing. These comments were from 
grower groups, state agencies, and academia. All comments were in 
support of the registration of Dow AgroSciences' stacked gene plant-
incorporated protectant.
    The petition requested that 40 CFR part 180 be amended by 
establishing a temporary exemption from the requirement of a tolerance 
for residues of Bacillus thuringiensis Cry1F protein and the genetic 
material necessary for its production in cotton.
    New 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. Section 408(b)(2)(C) of the FFDCA 
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

[[Page 23074]]

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 were submitted, reviewed, and determined acceptable for 
product characterization of Cry1F expressed in cotton (construct 
pAGM281). Adequate product characterization data also were submitted to 
demonstrate that the Cry1F protein expressed in or on cotton and Cry1F 
protein expressed in or on corn were the same protein (Ref. 2). The 
registrant requested that the data submitted for corn (construct PHI 
8999) be used to support the acute oral toxicity, in vitro 
digestibility, and heat stability studies for Cry1F protein expressed 
in or on cotton based on the substantial similarity to Cry1F protein 
expressed in corn which is already exempt from the requirement of a 
tolerance (40 CFR 180.1217). EPA reviewed the product characterization 
data for both Cry1F expressed in or on cotton and corn and determined 
that the Cry1F proteins are the same. Therefore, EPA has concluded that 
the data which supported the tolerance exemption for Cry1F and its 
genetic material necessary for its production in corn can also support 
Cry1F and its genetic material necessary for its production in or on 
cotton.
    Adequate data also was submitted to demonstrate that the Cry1F test 
material derived from microbial cultures was biochemically and, 
functionally similar to the protein produced by the plant-incorporated 
protectant expressed in cotton (Ref. 2). Production of microbially-
produced protein was chosen in order to obtain sufficient material for 
testing and because a diet of only cotton seed would not provide an 
adequate diet for test animals. The FIFRA Scientific Advisory Panel has 
supported this approach. See Mammalian Toxicity Assessment Guidelines 
for Protein Plant Pesticides (SAP Report No. 2000-03B, September 28, 
2000) at http://www.epa.gov/scipoly/sap/2000/June/finbtmamtox.pdf. 
Given that the Cry1F protein produced in corn and cotton have been 
determined to be the same protein, EPA has determined that the acute 
oral toxicity (MRID numbers 446911-01 and 450201-18), heat stability 
(MRID numbers 452748-01 and 449717-01), and in vitro digestibility 
(MRID number 447149-03) studies which support 40 CFR 180.1217 also 
support this exemption from the requirement of a tolerance. Although 
Cry1F expression level data were required for an environmental fate and 
effects assessment, residue chemistry data were not required for a 
human health effects assessment of the subject plant-incorporated 
protectant ingredients because of the lack of mammalian toxicity.
    Data were submitted and reviewed which demonstrate the lack of 
mammalian toxicity at high levels of exposure to the pure Cry1F protein 
(Ref. 3). These data adequately demonstrate the safety of the Cry1F 
protein at levels well above maximum possible exposure levels that are 
reasonably anticipated in the cotton crops (Ref. 2). 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, further toxicity testing and residue data are 
triggered by significant acute effects in studies such as the mouse 
oral toxicity study, to verify the observed effects and clarify the 
source of these effects (Tiers II and III). Refer to the Bacillus 
thuringiensis Plant-Incorporated Protectants Reassessment Biopesticide 
Regulatory Action Document (BRAD) dated October 15, 2001 (Ref. 3).
    The acute oral toxicity data (MRID numbers 446911-01 and 450201-18) 
submitted support the prediction that the Cry1F protein is non-toxic to 
humans. Male and female mice (5 of each) were dosed with 15% (w/v) of 
the test substance, which consisted of Bacillus thuringiensis var. 
aizawai Cry1F protein at a net concentration of 11.4%. Two doses were 
administered approximately an hour apart to achieve the dose totaling 
33.7 milliliter/kilogram (mL/kg) body weight. Outward clinical signs 
and body weights were observed and recorded throughout the 14-day 
study. Gross necropsies performed at the end of the study indicated no 
findings of toxicity. No mortality or clinical signs were noted during 
the study. A lethal dose (LD)50 was estimated at greater 
than 5,050 mg/kg body weight of this microbially produced test 
material. The actual dose administered contained 576 mg Cry1F protein/
kg body weight. At this dose, no LD50 was demonstrated as no 
toxicity was observed. Cry1F cotton seeds contain 0.0017 to 0.0034 mg 
of Cry1F/gram of cotton tissue which is a much lower level than the 
highest no observable effect level.
    When proteins are toxic, they are known to act via acute mechanisms 
and at very low dose levels (Ref. 1). Therefore, since no effects were 
shown to be caused by the plant-incorporated protectant, even at 
relatively high dose levels, the Cry1F protein is not considered toxic. 
Further, amino acid sequence comparisons showed no similarity between 
Cry1F protein to known toxic proteins available in public protein data 
bases.
    Since Cry1F is a protein, allergenic sensitivities were considered. 
Current scientific knowledge suggests that common food allergens tend 
to be resistant to degradation by heat, acid, and proteases may be 
glycosylated and present at high concentrations in the food (Ref. 3). 
Data were submitted and reviewed, and these data demonstrate that the 
Cry1F protein is rapidly degraded by gastric fluid in vitro and is non-
glycosylated. In a solution of Cry1F:pepsin at a molar ratio of 1:100, 
complete degradation of Cry1F to amino acids and small peptides 
occurred in 5 minutes. A heat lability study demonstrated the loss of 
bioactivity of Cry1F protein to neonate tobacco budworm larvae after 30 
minutes at 75 [deg]C. Studies submitted to EPA using laboratory animals 
have not indicated any potential for allergic reactions to Bacillus 
thuringiensis or its components, including the delta-endotoxin of the 
crystal protein. Additionally, a comparison of amino acid sequences of 
known allergens uncovered no evidence of any homology with Cry1F, even 
at the level of eight contiguous amino acids residues. The potential 
for the Cry1F protein to be a food allergen is minimal (Ref. 2).
    Regarding toxicity to the immune system, the acute oral toxicity 
data submitted support the prediction that the Cry1F proteins are non-
toxic to humans. When proteins are toxic, they are known to act via 
acute mechanisms and at very low dose levels (Ref. 1). Therefore, since 
no effects were shown to be caused by the plant-incorporated 
protectant, even at relatively high dose levels, the Cry1F protein is 
not considered toxic.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information

[[Page 23075]]

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 the product characterization data showing 
expression levels of Cry1F protein in cotton seed 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 protectants' 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. Oral exposure, at very low levels, 
may occur from ingestion of processed cottonseed oils and, potentially, 
drinking water. However, a lack of mammalian toxicity and the 
digestibility of the plant-incorporated protectants have been 
demonstrated. The use sites for the Cry1F protein are all agricultural 
for control of insects. Therefore, exposure via residential or lawn use 
to infants and children is not expected. Even if negligible exposure 
should occur, the Agency concludes that such exposure would present no 
risk due to the lack of toxicity demonstrated for the Cry1F protein. 
Refer to the Bacillus thuringiensis Reassessment BRAD dated October 15, 
2001.

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 included 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 to these 
plant-incorporated protectants, EPA concludes that there are no 
cumulative effects for the Cry1F protein.

VI. Determination of Safety for U.S. Population, Infants and Children

A. Toxicity and Allergenicity Conclusions

    The product characterization data are acceptable for Cry1F protein 
expressed in cotton. The Agency was able to determine that the Cry1F 
protein expressed in cotton was the same protein as the Cry1F expressed 
in corn which is covered by an existing tolerance exemption (40 CFR 
180.1217). Also the Cry1F protein produced by microbial culture was 
biochemically and functionally similar to the protein produced by the 
plant-incorporated protectant in cotton. Therefore, the Agency was able 
to bridge mammalian toxicity data from a previous submission for Cry1F 
protein expressed in corn to cover the mammalian toxicity studies 
required for Cry1F protein expressed in cotton. These studies are the 
acute oral toxicity (MRID numbers 446911-01 and 450201-18), heat 
stability, amino acid homology (MRID numbers 452749-01 and 449717-01) 
and in vitro digestibility (MRID number 447149-03) studies.
    The data submitted and cited regarding potential health effects for 
the Cry1F protein include the characterization of the expressed Cry1F 
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.
    The acute oral toxicity data submitted supports the prediction that 
the Cry1F 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 (Ref. 1). Since no effects were shown to be caused by Cry1F 
protein, even at relatively high dose levels (>5,050 mg test substance/
kg body weight; 576 mg Cry1F/kg body weight), the Cry1F 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). For microbial products, 
further toxicity testing and residue data are triggered by significant 
acute effects in studies such as the mouse oral toxicity study to 
verify the observed effects and clarify the source of these effects 
(Tiers II and III).
    Although Cry1F expression level data were required for an 
environmental fate and effects assessment, residue chemistry data were 
not required for a human health effects assessment of the subject 
plant-incorporated protectant ingredients because of the lack of 
mammalian toxicity.
    Both: available information concerning the dietary consumption 
patterns of consumers (and major identifiable subgroups of consumers 
including infants and children); and safety factors which, in the 
opinion of experts qualified by scientific training and experience to 
evaluate the safety of food additives, are generally recognized as 
appropriate for the use of animal experimentation data. The lack of 
mammalian toxicity at high levels of exposure to the Cry1F protein 
demonstrates the safety of the product at levels well above possible 
maximum exposure levels anticipated in the crop. Refer to the Bacillus 
thuringiensis Reassessment BRAD dated October 15, 2001. Its 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 
Cry1F protein in cotton has been exempted under the blanket exemption 
for all nucleic acids (40 CFR 174.175).

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 Cry1F 
protein and its genetic material necessary for its production in or on 
cotton. Thus, there are no threshold effects of concern and, as a 
result, the provision requiring an additional margin of safety does not 
apply. Further, the provisions of consumption patterns, special

[[Page 23076]]

susceptibility, and cumulative effects do not apply.

C. Overall Safety Conclusion

    There is a reasonable certainty that no harm will result from 
aggregate exposure to the U.S. population, including infants and 
children, to the Cry1F protein and its genetic material necessary for 
its production in or on cotton. 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 
discussed above, no toxicity to mammals has been observed for the 
plant-incorporated protectants.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredients are proteins, 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 these plant-protectants at this time.

B. Analytical Method

    A method for extraction and direct enzyme linked immunosorbent 
assay analysis of Cry1F in cotton has been submitted (MRID number 
458084-23). This method is adequate to support a temporary tolerance 
exemption.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exists for the plant-incorporated 
protectants Bacillus thuringiensis Cry1F protein and its genetic 
material necessary for its production in or on cotton.

VIII. Objections and Hearing Requests

    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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d), 
as was provided in the old sections 408 and 409 of the FFDCA. However, 
the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0147 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 30, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.1. Mail 
your copies, identified by docket ID number OPP-2003-0147, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

[[Page 23077]]

IX. References

    1. Sjoblad, Roy D., et al. ``Toxicological Considerations for 
Protein Components of Biological Pesticide Products,'' Regulatory 
Toxicology and Pharmacology 15L, 3-9 (1992).
    2. U.S. EPA. Memorandum, S.R. Matten, Ph.D. to L. Cole. March 26, 
2003.
    3. U.S. EPA. Bacillus thuringiensis Plant-Incorporated Protectants 
Reassessment BRAD. October 15, 2001.

X. Statutory and Executive Order Reviews

    This final rule establishes a temporary exemption from the 
requirement of a tolerance under section 408(d) of the 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 due to its lack of 
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the temporary 
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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

XI. Congressional Review Act

     The Congressional Review Act, 5 U.S.C. 801 et seq., as added by 
the Small Business Regulatory Enforcement Fairness Act of 1996, 
generally provides that before a rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, 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 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: April 11, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

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

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1227 is added to subpart D to read as follows:


Sec.  180.1227  Bacillus thuringiensis Cry1F protein and its genetic 
material necessary for its production in or on cotton; temporary 
exemption from the requirement of a tolerance.

    Bacillus thuringiensis Cry1F protein and its genetic material 
necessary for its production in cotton are exempt from the requirement 
of a tolerance when used as a plant-incorporated protectant in the food 
and feed commodity of cotton. This temporary tolerance exemption 
expires on May 1, 2004.

[FR Doc. 03-10663 Filed 4-29-03; 8:45 am]
BILLING CODE 6560-50-S