Bacillus thuringiensis Modified Cry3A Protein (mCry3A) and the Genetic Material Necessary for its Production in Corn; Temporary Exemption From the Requirement of a Tolerance, 17323-17327 [05-6499]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 65 (Wednesday, April 6, 2005)]
[Rules and Regulations]
[Pages 17323-17327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6499]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[OPP-2005-0073; FRL-7704-4]


Bacillus thuringiensis Modified Cry3A Protein (mCry3A) and the 
Genetic Material Necessary for its Production in Corn; Temporary 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the Bacillus thuringiensis 
modified Cry3A protein (mCry3A) and the genetic material necessary for 
its production in corn on field corn, sweet corn, and popcorn when 
applied/used as a plant-incorporated protectant. Syngenta Seeds, Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA), requesting the temporary/tolerance exemption. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus thuringiensis modified Cry3A protein (mCry3A) and 
the genetic material necessary for its production in corn. The 
temporary tolerance exemption will expire on October 15, 2006.

DATES: This regulation is effective April 6, 2005. Objections and 
requests for hearings must be received on or before June 6, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0073. All documents in the docket 
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8715; e-mail 
address: mendelsohn.mike@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 17324]]

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 174 
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of August 31, 2004 (69 FR 53064) (FRL-7369-
8), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 4G6808) by Syngenta Seeds, Inc., P.O. Box 12257, 3054 
Cornwallis Road, Research Triangle Park, NC 27709-2257. The petition 
requested that 40 CFR part 174 be amended by establishing a temporary 
exemption from the requirement of a tolerance for residues of Bacillus 
thuringiensis modified Cry3A protein (mCry3A) and the genetic material 
necessary for its production in corn. This notice included a summary of 
the petition prepared by the petitioner Syngenta Seeds, Inc. The 
National Corn Growers Association submitted the only comment that was 
received in response to the notice of filing. They supported the 
establishment of a tolerance exemption based on benefits to farmers and 
the environment. Under the Federal, Food, Drug, and Cosmetic Act, EPA 
must make a finding that there is a reasonable certainty of no harm 
from the granting of the proposed temporary tolerance exemption. EPA is 
making such a finding and herein sets forth the bases for this finding.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which require EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue. . . .'' 
Additionally, section 408(b)(2)(D) of the FFDCA requires that the 
Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues'' and ``other substances 
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness and 
reliability and the relationship of this information to human risk. EPA 
has also considered available information concerning the variability of 
the sensitivities of major identifiable subgroups of consumers, 
including infants and children.
    Data have been submitted demonstrating the lack of mammalian 
toxicity at high levels of exposure to the pure mCry3A 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-incorporated protectant 
was derived (See 40 CFR 158.740(b)(2)(i)). For microbial products, 
further toxicity testing and residue data are triggered by significant 
acute effects in studies such as the mouse oral toxicity study, to 
verify the observed effects and clarify the source of these effects 
(Tiers II and III).
    An acute oral toxicity study was submitted for the mCry3A protein. 
The acute oral toxicity data submitted support the prediction that the 
mCry3A protein would be non-toxic to humans. Male and female mice (5 of 
each) were dosed with 2,377 milligrams/kilograms bodyweight (mg/kg bwt) 
of mCry3A protein. With the exception of one female in the test group 
that was euthanized on day 2 (due to adverse clinical signs consistent 
with a dosing injury), all other mice survived the study, gained 
weight, had no test material-related clinical signs, and had no test 
material-related findings at necropsy.
    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-
incorporated protectants, even at relatively high dose levels, the 
mCry3A protein is not considered toxic. Further, amino acid sequence 
comparisons showed no similarity between the mCry3A protein to known 
toxic proteins available in public protein data bases.
    Since mCry3A 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 have been submitted that demonstrate that the mCry3A protein 
is rapidly degraded by gastric fluid in vitro. In a solution of 
simulated gastric fluid 1 mg/mL mCry3A test protein mixed with 
simulated gastric fluid (pH 1.2, containing 2 mg/mL NaCl, 14 [mu]L 6 N 
HCl, and 2.7 mg/mL pepsin) resulting in 10 pepsin activity units/ [mu]g 
protein (complies with 2000 US Pharmacopoeia recommendations), complete 
degradation of detectable mCry3A protein occurred within 2 minutes. A 
comparison of amino acid sequences of known allergens uncovered no 
evidence of any homology with mCry3A, even at the level of 8 contiguous 
amino acids residues. Further data demonstrate that mCry3A is not 
glycoslylated, is inactivated when heated to 95 [deg]C for 30 minutes, 
and is present in low levels in corn tissue. Therefore, the potential 
for the mCry3A protein to be a food allergens is minimal. As noted 
above, toxic proteins typically act as acute toxins with low dose 
levels. Therefore, since no effects were shown to be caused by the 
plant-incorporated protectant, even at relatively high dose levels, the 
mCry3A protein is not considered toxic.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide

[[Page 17325]]

residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    The Agency has considered available information on the aggregate 
exposure levels of consumers (and major identifiable subgroups of 
consumers) to the pesticide chemical residue and to other related 
substances. These considerations include dietary exposure under the 
tolerance exemption and all other tolerances or exemptions in effect 
for the plant-incorporated protectant chemical residue, and exposure 
from non-occupational sources. Exposure via the skin or inhalation is 
not likely since the plant-incorporated protectant is contained within 
plant cells, which essentially eliminates these exposure routes or 
reduces these exposure routes to negligible. Exposure via residential 
or lawn use to infants and children is also not expected because the 
use sites for the mCry3A protein are all agricultural for control of 
insects. Oral exposure, at very low levels, may occur from ingestion of 
processed corn products and, potentially, drinking water. However, oral 
toxicity testing done at a dose in excess of 2 gm/kg showed no adverse 
effects. Furthermore, the expression of the modified Cry3A protein in 
corn kernals has been shown to be in the parts per million range, which 
makes the expected dietary exposure several orders of magnitude lower 
than the amounts of mCry3A protein shown to have no toxicity. 
Therefore, even if negligible aggregate exposure should occur, the 
Agency concludes that such exposure would prevent no harm due to the 
lack of mammalian toxicity and the rapid digestibility demonstrated for 
the mCry3A protein.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered 
available information on the cumulative effects of such residues and 
other substances that have a common mechanism of toxicity. These 
considerations included the cumulative effects on infants and children 
of such residues and other substances with a common mechanism of 
toxicity. Because there is no indication of mammalian toxicity, 
resulting from the plant-incorporated protectant, we conclude that 
there are no cumulative effects for the mCry3A protein.

VI. 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 mCry3A protein include the characterization of the expressed mCry3A 
protein in corn, 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 mCry3A protein 
test material derived from microbial cultures was biochemically and, 
functionally similar to the protein produced by the plant-incorporated 
protectant 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 mCry3A protein would be non-toxic to humans. As mentioned above, 
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 mCry3A protein, even at 
relatively high dose levels (2,377 mg mCry3A/kg bwt), the mCry3A 
protein is not considered toxic. This is similar to the Agency position 
regarding toxicity and the requirement of residue data for the 
microbial Bacillus thuringiensis products from which this plant-
incorporated protectant was derived. (See 40 CFR 158.740(b)(2)(i)). For 
microbial products, further toxicity testing and residue data are 
triggered by significant acute effects in studies such as the mouse 
oral toxicity study to verify the observed effects and clarify the 
source of these effects (Tiers II and III).
    MCry3A protein residue chemistry data were not required for a human 
health effects assessment of the subject plant-incorporated protectant 
ingredients because of the lack of mammalian toxicity. However, data 
submitted demonstrated low levels of mCry3A in corn tissues with less 
than 2 micrograms mCry3A protein/gram dry weight in kernals and less 
than 30 micrograms mCry3A protein/gram dry weight of whole corn plant.
    Since modified Cry3A is a protein, its potential allergenicity is 
also considered as part of the toxicity assessment. Data considered as 
part of the allergenicity assessment include that the modified Cry3A 
protein came from Bacillus thuringiensis which is not a known 
allergenic source, showed no sequence similarity to known allergens, 
was readily degraded by pepsin, was inactivated by heat and was not 
glycosylated when expressed in the plant. Therefore, there is a 
reasonable certainty that modified Cry3A protein will not be an 
allergen.
    Neither available information concerning the dietary consumption 
patterns of consumers (and major identifiable subgroups of consumers 
including infants and children); nor safety factors that are generally 
recognized as appropriate for the use of animal experimentation data 
were evaluated. The lack of mammalian toxicity at high levels of 
exposure to the mCry3A protein, as well as the minimal potential to be 
a food allergen 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-
incorporated protectant active ingredients are the nucleic acids (DNA, 
RNA) which comprise genetic material encoding these proteins and their 
regulatory regions. The genetic material (DNA, RNA), necessary for the 
production of mCry3A protein has been exempted under the blanket 
exemption for all nucleic acids (40 CFR 174.475).

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 mCry3A 
protein and the genetic material necessary for their

[[Page 17326]]

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 mCry3A 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, nor any indication of 
allergenicity potential for the plant-incorporated protectant.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, 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 the plant-incorporated protectant at this time.

B. Analytical Method(s)

    A method for extraction and ELISA analysis of mCry3A protein in 
corn has been submitted and found acceptable by the Agency.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exist for the plant-incorporated 
protectant Bacillus thuringiensis mCry3A protein and the genetic 
material necessary for its production in corn.

VIII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d), 
as was provided in the old sections 408 and 409 of the FFDCA. However, 
the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0073 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 [insert 
date 60 days after date of publication in the Federal Register].
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2005-0073, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IX. Statutory and Executive Order Reviews

    This final rule establishes a temporary exemption from the 
requirement of a tolerance requirement under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in

[[Page 17327]]

Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994); or OMB review or any Agency action under Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the temporary 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government''. This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: March 23, 2005.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.


0
2. Section 174.456 is added to subpart W to read as follows:


Sec.  174.456  Bacillus thuringiensis Modified Cry3A Protein (mCry3A) 
and the Genetic Material Necessary for its Production in Corn.

    Bacillus thuringiensis modified Cry3A protein (mCry3A) and the 
genetic material necessary for its production in corn is exempt from 
the requirement of a tolerance when used as plant-incorporated 
protectant 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 mCry3A 
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 mCry3A protein. 
This temporary exemption from the requirement of a tolerance will 
permit the use of the food commodities in this paragraph when treated 
in accordance with the provisions of the experimental use permit 67979-
EUP-4 which is being issued under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary 
exemption from the requirement of a tolerance expires and is revoked 
October 15, 2006; however, if the experimental use permit is revoked, 
or if any experience with or scientific data on this pesticide indicate 
that the tolerance is not safe, this temporary exemption from the 
requirement of a tolerance may be revoked at any time.
[FR Doc. 05-6499 Filed 4-5-05; 8:45 am]
BILLING CODE 6560-50-S