```

[Federal Register Volume 66, Number 92 (Friday, May 11, 2001)]
[Rules and Regulations]
[Pages 24061-24066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11917]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301123; FRL-6781-6]
RIN 2070-AB78

Bacillus Thuringiensis Cry3Bb1 and Cry2Ab2 Protein and the 
Genetic Material Necessary for its Production in Corn and Cotton; 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a time-limited exemption from the 
requirement of a tolerance for residues of the plant-pesticides 
Bacillus thuringiensis Cry3Bb1 protein and the genetic material 
necessary for its production in corn on field corn, sweet corn, and 
popcorn and the plant-pesticides Bacillus thuringiensis Cry2Ab2 protein 
and the genetic material necessary for its production in corn on field 
corn, sweet corn, popcorn, or in cotton on cotton seed, cotton oil, 
cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin 
byproducts when applied/used as a plant-pesticide. Monsanto Company 
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. This exemption from 
the requirement of a tolerance will expire on May 1, 2004.

DATES: This regulation is effective May 11, 2001. Objections and 
requests for hearings, identified by docket control number [OPP-
301123], must be received by EPA, on or before July 10, 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-301123 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

[[Page 24062]]

Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: 
(703) 308-8715; and e-mail address: [email protected].

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
           Categories                 NAICS codes         potentially
                                                      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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301123. 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 October 10, 1997 (62 FR 52998) (FRL-
5748-5), 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 7F4888, 
by Monsanto Company, 700 Chesterfield Parkway, North, St. Louis, MO 
63198. This notice included a summary of the petition prepared by the 
petitioner Monsanto Company. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180 be amended by establishing 
an exemption from the requirement of a tolerance for residues of the 
plant pesticides consisting of Bacillus thuringiensis Cry1, Cry2, and 
Cry3 classes of proteins and the genetic material necessary for the 
production of these proteins in or on all raw agricultural commodities. 
In August and November of 1999, Monsanto amended their petition to 
narrow its scope to the following Cry proteins: Cry1Ab, Cry1Ac, Cry2Aa, 
Cry2Ab, Cry3Aa, and Cry3Bb in or on all plant raw agricultural 
commodities. While this final rule is limited to particular Cry3Bb in 
or on corn and Cry2Ab proteins in or on corn and cotton (Cry3Bb1 and 
Cry2Ab2), the Agency may at future dates issue final rules for the 
other specified Cry protein plant-pesticides on particular plant 
agricultural commodities.

III. Risk Assessment

    Pursuant to section 408(c)(2)(A)(i) of the FFDCA, EPA may establish 
or 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 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 Cry3Bb1 and Cry2Ab2 
proteins. 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

[[Page 24063]]

(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).
    Two acute oral studies were submitted for Cry3Bb1 proteins. These 
studies were done with two variants of the Cry3Bb1 protein engineered 
with either four or five internal amino acid sequence changes to 
enhance activity against the corn rootworm. The acute oral toxicity 
data submitted support the prediction that the Cry3Bb1 protein would be 
non-toxic to humans. Male and female mice (10 of each) were dosed with 
36, 396, or 3,780 milligrams/kilograms bodyweight (mg/kg bwt) of 
Cry3Bb1 protein for one variant. The mice were dosed with 38.7, 419, or 
2,980 mg/kg bwt of Cry3Bb1 protein for the other variant. In one study, 
two animals in the high dose group died within a day of dosing. These 
animals both had signs of trauma probably due to dose administration 
(i.e., lung perforation or severe discoloration of lung, stomach, brain 
and small intestine). No clinical signs were observed in the surviving 
animals and body weight gains were recorded throughout the 14-day study 
for the remaining animals. Gross necropsies performed at the end of the 
study indicated no findings of toxicity attributed to exposure to the 
test substance in either study. No other mortality or clinical signs 
attributed to the test substance were noted during either study.
    The acute oral toxicity data submitted support the prediction that 
the Cry2Ab2 protein would be non-toxic to humans. Male and female mice 
(10 of each) were dosed with 67, 359, and 1,450 mg/kg bwt of Cry2Ab2 
protein. Outward clinical signs were observed and body weights recorded 
throughout the 14-day study. Gross necropsies performed at the end of 
the study indicated no findings of toxicity attributed to exposure to 
the test substance. No mortality or clinical signs attributed to the 
test substance were noted during the study. 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 Cry3Bb1 and Cry2Ab2 proteins are not considered toxic. 
Further, amino acid sequence comparisons showed no similarity between 
Cry3Bb1 and Cry2Ab2 proteins to known toxic proteins available in 
public protein data bases.
    Since Cry3Bb1 and Cry2Ab2 are proteins, 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 have been submitted that demonstrate that the Cry3Bb1 protein 
is rapidly degraded by gastric fluid in vitro. In a solution of 
simulated gastric fluid (pH 1.2 - U.S. Pharmacopeia), complete 
degradation of detectable Cry3Bb1 protein occurred within 30 seconds. 
Insect bioassay data indicated that the protein loss insecticidal 
activity within 2 minutes of incubation in SGF. Incubation in simulated 
intestinal fluid resulted in a~59 kDa protein digestion product. A 
comparison of amino acid sequences of known allergens uncovered no 
evidence of any homology with Cry3Bb1, even at the level of 8 
contiguous amino acids residues.
    Data have been submitted that demonstrate that the Cry2Ab2 delta-
endotoxin is rapidly degraded by gastric fluid in vitro. In a solution 
of simulated gastric fluid (pH 1.2 - U.S. Pharmacopeia), complete 
degradation of detectable Cry2Ab2 protein occurred within 15 seconds. 
Incubation in simulated intestinal fluid resulted in a ~50 kDa protein 
digestion product. A comparison of amino acid sequences of known 
allergens uncovered no evidence of any homology with Cry2Ab2, even at 
the level of 8 contiguous amino acids residues.
    The potential for the Cry3Bb1 and Cry2Ab2 proteins to be food 
allergens is minimal. Regarding toxicity to the immune system, the 
acute oral toxicity data submitted support the prediction that the 
Cry3Bb1 and Cry2Ab2 proteins 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 Cry3Bb1 and 
Cry2Ab2 proteins are 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 Cry3Bb1 
and Cry2Ab2 proteins 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 Cry3Bb1 and Cry2Ab2 proteins.

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 
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 Cry3Bb1 and Cry2Ab2 proteins.

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 Cry3Bb1 and Cry2Ab2 proteins include the characterization of the 
expressed Cry3Bb1 protein in corn and the

[[Page 24064]]

expressed Cry2Ab2 protein in corn and cotton, as well as the acute oral 
toxicity, 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 Cry3Bb1 test 
material derived from microbial cultures was biochemically and, 
functionally similar to the protein produced by the plant-pesticide 
ingredients in corn. Adequate information was submitted to show that 
the Cry2Ab2 test material derived from microbial cultures was 
biochemically and, functionally similar to the protein produced by the 
plant-pesticide ingredients in corn and cotton. Production of 
microbially produced protein was chosen in order to obtain sufficient 
material for testing.
    The acute oral toxicity data submitted supports the prediction that 
the Cry3Bb1 and Cry2Ab2 proteins 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 Cry3Bb1 and Cry2Ab2 
proteins, even at relatively high dose levels (3,780 mg Cry3Bb1/kg bwt 
and 1,450 mg/kg bwt of Cry2Ab2 protein), the Cry3Bb1 and Cry2Ab2 
proteins are 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).
    Cry3Bb1 and Cry2Ab2 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 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 were not 
evaluated. The lack of mammalian toxicity at high levels of exposure to 
the Cry3Bb1 and Cry2Ab2 proteins demonstrate 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 genetic material encoding these proteins and their regulatory 
regions. ``Regulatory regions'' are the genetic material, such as 
promoters, terminators, and enhancers, that control the expression of 
the genetic material encoding the proteins. DNA and RNA are common to 
all forms of plant and animal life and the Agency knows of no instance 
where these nucleic acids have been associated with toxic effects 
related to their consumption as a component of food. These ubiquitous 
nucleic acids, as they appear in the subject active ingredient, have 
been adequately characterized by the applicant. Therefore, no mammalian 
toxicity is anticipated from dietary exposure to the genetic material 
necessary for the production of the subject active plant pesticidal 
ingredients.

B. Infants and Children Risk Conclusions

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues and the cumulative effects on infants and children of 
the residues and other substances with a common mechanism of toxicity. 
In addition, FFDCA section 408(B)(2)(C) 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 Cry3Bb1 
and Cry2Ab2 proteins and the genetic material necessary for their 
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 Cry3Bb1 and Cry2Ab2 proteins and the genetic material 
necessary for their 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(s)

    Validated methods for extraction and direct ELISA analysis of 
Cry3Bb1 in corn grain, Cry2Ab2 in corn grain, and Cry2Ab2 in cotton 
seed have been submitted and found acceptable by the Agency.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exists for the plant-
pesticidesBacillus thuringiensis Cry3Bb1 protein and the genetic 
material necessary for its production in corn and Bacillus 
thuringiensis Cry2Ab2 protein and the genetic material necessary for 
its production in corn or cotton.

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 
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.

[[Page 24065]]

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-301123 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 July 10, 
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-301123, 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 a tolerance 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 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 FFDCA section 408(d), such as the tolerance 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

[[Page 24066]]

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 theFederal 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 27, 2001.
Anne E. Lindsay,
Acting 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 180.1214 is added to subpart D to read as follows:

Sec. 180.1214  Bacillus thuringiensis Cry3Bb1 protein and the genetic 
material necessary for its production in corn; exemption from the 
requirement of a tolerance.

    Bacillus thuringiensis Cry3Bb1 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 Cry3Bb1 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 Cry3Bb1 protein.This exemption from 
the requirement of a tolerance will expire on May 1, 2004.
    3. Section 180.1215 is added to subpart D to read as follows:

Sec. 180.1215  Bacillus thuringiensis Cry2Ab2 protein and the genetic 
material necessary for its production in corn or cotton; exemption from 
the requirement of a tolerance.

    Bacillus thuringiensis Cry2Ab2 protein and the genetic material 
necessary for its production in corn or cotton are exempt from the 
requirement of a tolerance when used as plant-pesticides in the food 
and feed commodities of field corn, sweet corn, popcorn, cotton seed, 
cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and 
cotton gin byproducts. Genetic material necessary for its production 
means the genetic material which comprise genetic material encoding the 
Cry2Ab2 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 Cry2Ab2 
protein. This exemption from the requirement of a tolerance will expire 
on May 1, 2004.

[FR Doc. 01-11917 Filed 5-10-01; 8:45 am]
BILLING CODE 6560-50-S
```