[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:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    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 LD<INF>50</INF> 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 LD<INF>50</INF> 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 <greek-d>--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 <a href="/cdn-cgi/l/email-protection#d4a0bbb9a4bfbdbaa7fabebdb994b1a4b5fab3bba2"><span class="__cf_email__" data-cfemail="1662797b667d7f7865387c7f7b5673667738717960">[email protected]</span></a>, 
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: <a href="/cdn-cgi/l/email-protection#553a252578313a363e3021153025347b323a23"><span class="__cf_email__" data-cfemail="9cf3ececb1f8f3fff7f9e8dcf9ecfdb2fbf3ea">[email protected]</span></a>. 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]
BILLING CODE 6560-50-S


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