[Federal Register Volume 66, Number 109 (Wednesday, June 6, 2001)]
[Rules and Regulations]
[Pages 30321-30325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13837]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301130; FRL-6783-3]
RIN 2070-AB78
Bacillus thuringiensis Cry1F Protein and the Genetic Material
Necessary for its Production in Corn; Exemption from the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited exemption from the
requirement of a tolerance for residues of the plant-pesticides
Bacillus thuringiensis Cry1F protein and the genetic material necessary
for its production in corn on field corn, sweet corn, and popcorn when
applied/used as a plant-pesticide. Mycogen Seeds c/o Dow AgroSciences
LLC submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996,
requesting an exemption from the requirement of a tolerance.
DATES: This regulation is effective June 6, 2001. Objections and
requests for hearings, identified by docket control number OPP-301130,
must be received by EPA, on or before August 6, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, electronically, or in person. Please follow the detailed
instructions for each method as provided in Unit IX. of the
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your
objections and hearing requests must identify docket control number
OPP-301130 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Mike Mendelsohn, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8715; and e-mail
address: mendelsohn.mike @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:
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Examples of Potentially
Categories NAICS Affected Entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
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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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to 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_180/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301130. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 2, 2000 (65 FR 11311) (FRL-6494-
3), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as amended by the
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the
filing of a pesticide tolerance petition, petition number 0F6078, 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. There were no comments received in response to the notice of
filing.
The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of the plant pesticide Bacillus thuringiensis Cry1F protein
and the genetic material necessary for its production in plants in or
on all food commodities. While this final rule is limited to Cry1F in
or on corn, the Agency may at future dates issue final rules for Cry1F
protein plant-pesticides on plant agricultural commodities in addition
to corn.
III. Risk Assessment
Pursuant to section 408(c)(2)(A)(i) of the FFDCA, EPA may establish
of leave in effect 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 tolerance exemption is ``safe.'' With
respect to an exemption for a pesticide chemical residue, section
408(c)(2)(A)(ii) 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
[[Page 30322]]
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance or tolerance exemption 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) requires that the
Agency consider ``available information'' concerning, inter alia, 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.
IV. Toxicological Profile
Pursuant to section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
Data have been submitted demonstrating the lack of mammalian
toxicity at high levels of exposure to the pure Cry1F protein. These
data demonstrate the safety of the products 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-pesticide 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).
The acute oral toxicity data submitted support the prediction that
the Cry1F protein would be 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 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. An LD50 was estimated at >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 maize seeds contain 0.0017 to 0.0034 mg of Cry1F/gram
of corn 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.
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.
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. 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.
The potential for the Cry1F protein to be a food allergen is
minimal.
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. 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 15, 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.
V. Aggregate Exposures
Pursuant to FFDCA section 408(b)(2)(D)(vi), EPA considers available
information concerning aggregate 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-pesticide chemical residue, and exposure from non-
occupational sources. Exposure via the skin or inhalation is not likely
since the plant-pesticide 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 corn products and, potentially, drinking water.
However a lack of mammalian toxicity and the digestibility of the
plant-pesticides 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.
VI. 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
[[Page 30323]]
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-pesticides, we conclude that there are no cumulative effects for
the Cry1F protein.
VII. Determination of Safety for U.S. Population, Infants and
Children
A. Toxicity and Allergenicity Conclusions
The data submitted and cited regarding potential health effects for
the 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.
Adequate information was submitted to show that the Cry1F test
material derived from microbial cultures was biochemically and,
functionally similar to the protein produced by the plant-pesticide
ingredients in corn. 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. 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 15,'' 3-9 (1992)). 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-pesticide 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-pesticide ingredients because of the lack of mammalian toxicity.
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-
pesticides active ingredients are the nucleic acids (DNA, RNA) which
comprise (1) genetic material encoding these proteins and (2) 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) 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 pre- and post-natal
toxicity and the completeness of the database 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 the genetic material necessary for its production. 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
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 the genetic material necessary for
its production. 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-
pesticides.
VIII. 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-pesticides at this time.
B. Analytical Method
A validated method for extraction and direct enzyme linked
immunosorbent assay analysis of Cry1F in corn grain has been submitted
and found acceptable by the Agency.
C. Codex Maximum Residue Level
No Codex maximum residue levels exists for the plant-pesticides
Bacillus thuringiensis Cry1F protein and the genetic material necessary
for its production in corn.
IX. 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 that 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
[[Page 30324]]
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
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 control number OPP-301130 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 August 6,
2001.
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 (1900),
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW., Washington, DC 20460. You may also deliver your request to
the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St.,
SW., Washington, DC 20460. 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) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.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.2. Mail your
copies, identified by docket number OPP-301130, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
X. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) 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). 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
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 other 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 FFDCA
section 408(d), such as the tolerance 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
[[Page 30325]]
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 FFDCA section 408(n)(4).
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. Submission to Congress and the Comptroller General
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: May 18, 2001.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180 --[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.1217 is added to subpart D to read as follows:
Sec. 180.1217 Bacillus thuringiensis Cry1F Protein and the Genetic
Material Necessary for its Production in Corn; exemption from the
requirement of a tolerance.
Bacillus thuringiensis Cry1F protein and the genetic material
necessary for its production in corn are exempt from the requirement of
a tolerance when used as plant-pesticides in the food and feed
commodities of field corn, sweet corn and popcorn. ``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 promoters, terminators, and enhancers, that control the
expression of the genetic material encoding the Cry1F protein.
[FR Doc. 01-13837 Filed 6-5-01; 8:45 am]
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