[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Rules and Regulations]
[Page 58280-58285]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se04-11]
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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: cole.leonard@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 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: opp-docket@epa.gov. 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