[Federal Register: April 30, 2003 (Volume 68, Number 83)]
[Rules and Regulations]
[Page 23073-23077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap03-11]
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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: cole.leonard@epa.gov.
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 tompkins.jim@epa.gov,
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: 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).
[[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.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
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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