Document ID: EPA-HQ-OPP-2006-0784-0001
Agency: epa
Document Type: Rule
Title: Bacillus Thuringiensis Modified Cry3A Protein and the Genetic Material Necessary for Its Production in Corn; Exemption from the Requirement of a Tolerance
Posted Date: 2006-11-01T13:55:05Z

[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Rules and Regulations]               
[Page 64128-64132]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no06-8]                         

[[Page 64128]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0784; FRL-8096-4]

 
Bacillus Thuringiensis Modified Cry3A 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 permanent 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 an exemption from the requirement of a tolerance. 
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.

DATES: This regulation is effective November 1, 2006. Objections and 
requests for hearings must be received on or before January 2, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0784. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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 in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The 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 (7511P), 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.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    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. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0784 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 January 2, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0784, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of October 27, 2004 (69 FR 62688) (FRL-
7370-1), 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 4F6838) 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 
permanent exemption from the requirement of a tolerance for residues of 
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. One comment was 
received in response to the notice of filing from the National Corn 
Growers Association.

[[Page 64129]]

They supported the petition and requested EPA to quickly issue the 
final rule.
    On March 14-15, 2006, EPA held a FIFRA Scientific Advisory Panel 
(SAP) meeting, at http://www.epa.gov/scipoly/sap/meetings/2006/index.htm#march
 to address the scientific issues that arose during the 

risk assessment of mCry3A. EPA asked the SAP to comment on the 
equivalence of the mCry3A proteins from corn event MIR604 and from 
recombinant E. coli - specifically the presence of two forms in the 
bacterial-produced mCry3A protein and the differences in bioactivity in 
the WCRM bioassay. The majority of the Panel concluded that the two 
forms of the mCry3A are of relatively comparable biological activity 
for the purposes of the human health assessments based on the amino 
acid sequence identity, lack of glycosylation, and general stability.
    EPA also asked the SAP to comment on EPA's conclusions regarding 
the lack of mammalian toxicity and allergenicity of the mCry3A protein-
specifically the impact of the less potent mCry3A form on the results 
of the acute oral toxicity tests and the usefulness of in vitro 
digestibility studies and amino acid sequence homology analysis as part 
of the risk assessment. Overall, the Panel was more concerned with the 
quality of data, i.e. inadequately described methods and poor 
reproduction of data images. The Panel specifically noted that the 
amino acid sequence analysis to known toxins and allergens were missing 
the following data: Specification of which version of NCBI database was 
utilized; descriptions of parameters utilized; and dates accessed for 
the BLAST search. EPA recognizes that these are important parameters to 
include in a description of an amino acid analysis and is requiring 
submission of additional information by Syngenta Seeds, Inc. in order 
to confirm the method used. However, EPA maintains that the conclusions 
of the amino acid sequence analysis are still valid for the purpose of 
the risk assessment. EPA reached this decision based on the following: 
(1) Lack of mammalian toxicity of mCry3A protein as shown by the acute 
oral mouse study; (2) mCry3A protein is rapidly digested in SGF; (3) 
mCry3A protein originates from a non-allergenic source; (4) lack of 
sequence identity of mCry3A protein with eight contiguous amino acids 
or more than 35% identity over 80 amino acids with known toxins or 
allergens; and (5) mCry3A protein is not glycosylated when expressed in 
corn.
    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 mCry3A protein alone. 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 and known 
toxic proteins available in public protein data bases. According to the 
Codex Alimintarius guidelines, the assessment of potential toxicity 
also includes stability to heat (FAO/WHO Standards Programme, 2001). 
Further data demonstrate that mCry3A is inactivated against Western 
corn rootworm, when heated to 95 [deg]C for 30 minutes.
    Since mCry3A is a protein, allergenic sensitivities were 
considered. Current scientific knowledge suggests that common food 
allergens tend to be resistant to degradation by 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 milligrams/milliliter (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/
microgram ([mu]g) protein (complies with year 2000 U.S. Pharmacopoeia 
recommendations),

[[Page 64130]]

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 
eight contiguous amino acids residues. Further, data demonstrate that 
mCry3A is not glycosylated, and is present in low levels in corn 
tissue. Therefore, the potential for the mCry3A protein to be a food 
allergen 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 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 grams/kilogram (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 present reasonable 
certainty of 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/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). Moreover, mCry3A showed no 
sequence similarity to any known toxin and was inactivated by heat 
against Western corn rootworm. No further toxicity testing and residue 
data were required because for microbial products, further toxicity 
testing and residue data requirements 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).
    Modified Cry3A 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 [mu]g mCry3A protein/gram dry weight in 
kernals and less than 30 [mu]g 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, 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).

[[Page 64131]]

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, also referred to as 
margins of exposure (MOEs), 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 MOE 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 production. Thus, 
there are no threshold effects of concern to infants and children when 
the mCry3A protein is used as a plant-incorporated protectant. 
Accordingly, the Agency concludes that the additional MOE is not 
necessary to protect infants and children, and that not adding any 
additional MOE will be safe for infants and children.

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. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption from 
the requirement of a 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 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.

IX. 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

[[Page 64132]]

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: September 29, 2006.
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: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 174.456 is revised 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.
[FR Doc. E6-18223 Filed 10-31-06; 8:45 am]

BILLING CODE 6560-50-S