[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Rules and Regulations]
[Pages 58280-58285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21877]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[OPP-2004-0249; FRL-7372-6]


Bacillus thuringiensis var. aizawai strain PS811 (Cry1F 
insecticidal protein); Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Bacillus thuringiensis var. aizawai 
strain PS811 (Cry1F insecticidal protein) and the genetic material 
necessary for its production in cotton when applied/used as a plant-
incorporated protectant. DowAgro Sciences, 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 an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus thuringiensis var. aizawai strain PS811 (Cry1F 
insecticidal protein) and the genetic material necessary for its 
production in cotton when used as a plant-incorporated protectant.

DATES: This regulation is effective September 30, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0249. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
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 either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South 
Bell St., 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.

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 potentially affected by this action if you are a person 
or company involved with agricultural biotechnology, that may develop 
and market plant-incorporated protectants. Potentially affected 
entities may include, but are not limited to:
     Seed companies (NAICS code 111)
     Pesticide manufacturers (NAICS code 32532)
     Establishments involved in research and development in the 
life sciences (NAICS code 54171)
     Colleges, universities, and professional schools (NAICS 
code 611310).
    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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A

[[Page 58281]]

frequently updated electronic version of 40 CFR part 174 is available 
at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of August 11, 2004 (69 FR 48870) (FRL-7673-
2), 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 3F6785) by DowAgro Sciences, LLC, 9330 Zionsville Road, 
Indianapolis, IN 46268-1054. The petition requested that 40 CFR part 
174 be amended by establishing a temporary exemption from the 
requirement of a tolerance for residues of Bacillus thuringiensis var. 
aizawai strain PS811 (Cry1F insecticidal protein) and the genetic 
material necessary for its production in cotton when used as a plant-
incorporated protectant.
    This notice included a summary of the petition prepared by the 
petitioner DowAgro Sciences, LLC. Comments were received by The 
National Cotton Council and cotton grower groups. All comments were in 
support of this tolerance exemption.
    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 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 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 to the Agency demonstrating the lack of 
mammalian toxicity at high levels of exposure to the pure Cry1F 
protein. These data demonstrate the safety of the Cry1F protein 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, 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 (Tier II and Tier III). The acute oral toxicity 
data submitted support the prediction that the Cry1F protein would be 
non-toxic to humans. Thus, 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.
    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 body weight (mL/kg bwt). 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 >5,050 
milligram (mg)/kg bwt of this microbially produced test material. The 
actual dose administered contained 576 mg Cry1F protein/kg bwt. At this 
dose, no LD50 was demonstrated as no toxicity was observed. 
Cry1F maize seeds contain 0.0017 to 0.0034 mg of Cry1F/gram of cotton 
kernel tissue. When proteins are toxic, they are known to act via acute 
mechanisms and at very low dose levels (Sjoblad, Roy D., et al., 
Toxicological Considerations for Protein Components of Biological 
Pesticide Products, Regulatory Toxicology and Pharmacology 15L, 3-9 
(1992). Therefore, since no effects were shown to be caused by the 
plant-pesticides, 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 databases. Finally, regarding 
toxicity to the immune system, the acute oral toxicity data submitted 
support the prediction that the Cry1F protein would be non-toxic to 
humans.
    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, and may be 
glycosylated and present at high concentrations in the food. Data has 
been submitted which demonstrates 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. This indicates that the protein is highly susceptible to 
digestion in the human digestive tract and that the potential for 
adverse health effects from chronic exposure is virtually nonexistent. 
Furthermore, studies submitted to EPA done in laboratory animals have 
not indicated any potential for allergic reactions to Bacillus 
thuringiensis or its components, including the 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 8 contiguous amino acids residues. Accordingly, the potential 
for the Cry1F protein to be a food allergen is minimal.

[[Page 58282]]

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    The Agency has considered available information on the aggregate 
exposure levels of consumers (and major identifiable subgroups of 
consumers) to the pesticide chemical residue and to other related 
substances. These considerations include dietary exposure under the 
tolerance exemption and all other tolerances or exemptions in effect 
for the plant-incorporated 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 or reduces these exposure 
routes to negligible. Oral exposure, at very low levels, may occur from 
ingestion of processed cotton products and, potentially, drinking 
water. However, such exposures are unlikely to be problematic because 
of the demonstrated lack of mammalian toxicity and the digestibility of 
the Cry1F protein. Also, the protein is not likely to be present in 
drinking water because the protein is deployed in minute quantities 
within the plant, and studies demonstrate that Cry1F protein is rapidly 
degraded in soil. Finally, 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.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, 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.'' These considerations 
include the possible cumulative effects of such residues on infants and 
children.
    Common modes of toxicity are not relevant to a consideration of 
cumulative exposure to the Bacillus thuringiensis Cry1F insect control 
protein. The product has demonstrated low mammalian toxicity and Bt 
insecticidal crystal proteins are known to bind to specific receptors 
in the insect gut, such that biological effects do not appear to be 
cumulative with any other known compounds.
    Thus, the Agency does not expect any cumulative or incremental 
effects from exposure to residues of the Cry1F protein and the genetic 
material necessary for its production in cotton when applied/used as a 
plant-incorporated protectant as directed on the label and in 
accordance with good agricultural practices.

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

    There is a reasonable certainty that no harm to the U.S. 
population, including infants and children, will result from aggregate 
exposure to residues of the Cry1F protein and the genetic material 
necessary for its production in cotton due to its use as a plant-
incorporated protectant. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for 
the Cry1F protein include the characterization of the expressed Cry1F 
protein in cotton, as well as the acute oral toxicity, heat stability, 
and in vitro digestibility of the protein. 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 has been submitted to show that 
the Cry1F test material derived from microbial cultures was 
biochemically and functionally similar to the protein produced by the 
plant-incorporated protectant ingredients in cotton. Production of 
microbially produced protein was chosen in order to obtain sufficient 
material for testing. The acute oral toxicity data submitted supports 
the prediction that the Cry1F protein would be non-toxic to humans.
    Both (1) available information concerning the dietary consumption 
patterns of consumers (and major identifiable subgroups of consumers, 
including infants and children); and (2) 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 were not 
evaluated. 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.
    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. Regulatory regions are the genetic material, such 
as promoters, terminators, and enhancers, that control the expression 
of the genetic material encoding the proteins. DNA and RNA are common 
to all forms of plant and animal life and the Agency knows of no 
instance where these nucleic acids have been associated with toxic 
effects related to their consumption as a component of food. These 
ubiquitous nucleic acids, as they appear in the subject active 
ingredient, have been adequately characterized by the applicant. 
Therefore, no mammalian toxicity is anticipated from dietary exposure 
to the genetic material necessary for the production of the subject 
active plant pesticidal ingredients.

 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) provides that EPA shall apply 
an additional tenfold margin of exposure (safety) for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure, unless EPA determines that a different margin of exposure 
(safety) will be safe for infants and children. Margins of exposure 
(safety) are incorporated into EPA risk assessments either by (1) using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans, or (2) using a margin of exposure analysis.
    In this instance, due to the anticipated agricultural use pattern 
for the product, non-dietary exposure to infants and children is not 
anticipated. Moreover, because all available information concerning the 
Cry1F protein and the genetic material necessary for its production 
demonstrates low to no

[[Page 58283]]

mammalian toxicity, a lack of allergenic potential, and a high degree 
of digestability, dietary exposure is anticipated to be at very low 
levels and, even then, is not anticipated to pose any harm to infants 
and children. Thus, the Agency concludes that the toxicity and exposure 
data are sufficiently complete to adequately address the potential for 
additional sensitivity of infants and children to residues of the Cry1F 
protein and the genetic material necessary for its production in 
cotton, and that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to residues of 
the Cry1F protein and the genetic material necessary for its production 
in cotton. Accordingly, the Agency has determined that the additional 
margin of safety is not necessary to protect infants and children, and 
that not adding any additional margin of safety will be safe for 
infants and children.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under FFDCA section 408(p), as amended by FQPA, to 
develop a screening process to determine whether pesticide chemicals 
(and any other substance that may have an effect that is cumulative to 
an effect of a pesticide chemical) ``may have an effect in humans that 
is similar to an effect produced by a naturally occurring estrogen, or 
other such effects as the Administrator may designate.'' Following the 
recommendations of its Endocrine Disruptor Screening and Advisory 
Committee (EDSTAC), EPA determined that there was no scientific basis 
for including, as part of the program, the androgen-and thyroid hormone 
systems, in addition to the estrogen hormone systems. EPA also adopted 
EDSTAC's recommendation that the Program include evaluations of 
potential effects in wildlife. For pesticide chemicals, EPA will use 
FIFRA and, to the extent that effects in wildlife may help determine 
whether a substance may have an effect in humans, FFDCA authority to 
require the wildlife evaluations. As the science develops and resources 
allow, screening of additional hormone systems may be added to the 
Endocrine Disruptor Screening Program (EDSP). When the appropriate 
screening and/or testing protocols being considered under the Agency's 
EDSP have been determined, Cry1F proteins may be subjected to 
additional screening and/or testing to better characterize any effects 
related to endocrine disruption.
    To date, however, and based on the weight of available data, the 
Agency has no information to suggest that the Cry1F protein and the 
material necessary for its production in cotton has an effect on the 
endocrine system. The Cry1F pesticidal active ingredient is a protein, 
derived from sources that are not known and not expected to exert an 
influence on the endocrine system. Similarly, given the rapid 
digestibility of the Cry1F insecticidal crystal protein, no chronic 
effects are expected. Accordingly, there is no impact via endocrine-
related effects on the Agency's safety finding as set forth in this 
final rule for the Cry1F protein and the genetic material necessary for 
its production in cotton when applied/used as a plant-incorporated 
protectant. Therefore, the Agency is not requiring information on the 
endocrine effects of this plant-incorporated protectant at this time.

B. Analytical Method(s)

    A validated method for extraction and direct enzyme linked 
immunosorbent assay analysis of Cry1F in cotton meal, cotton seed oil, 
and cotton by products has been submitted and found acceptable by the 
Agency.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exists for the plant-incorporated 
protectant Bacillus thuringiensis Cry1F protein and the genetic 
material necessary for its production in 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) 
of the FFDCA, 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-2004-0249 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 November 
29, 2004.
    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 (1900L), 
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 Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. 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 (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A.1., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2004-0249, 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 ADDRESSES. You may also send an electronic copy of 
your request via e-

[[Page 58284]]

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).

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement 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 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.

X. 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 174

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests, Plant-incorporated protectant, Reporting and 
recordkeeping requirements.

    Dated: September 23, 2004.
James Jones,
Director, Office of Pesticides 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. 321(q), 346a and 371.

0
2. Section 174.455 is added to subpart W to read as follows:


Sec.  174.455  Bacillus thuringiensis Cry1F protein and the genetic 
material necessary for its production in cotton; exemption from the 
requirement of a tolerance.

    Bacillus thuringiensis Cry1F protein and the genetic material 
necessary for its production in cotton are exempt from the requirement 
of a tolerance when used as a plant-incorporated protectant in food and 
feed commodities of cotton. ``Genetic material necessary for its 
production'' means the genetic material which comprise: Genetic 
material encoding the Cry1F protein and its regulatory regions. 
``Regulatory regions'' are the genetic material, such as

[[Page 58285]]

promoters, terminators, and enhancers, that control the expression of 
the genetic material encoding the Cry1F protein.
[FR Doc. 04-21877 Filed 9-29-04; 8:45 am]
BILLING CODE 6560-50-S