Document ID: EPA-HQ-OPP-2006-0553-0001
Agency: epa
Document Type: Rule
Title: Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic Material Necessary for Its Production in Corn in or on All Corn Commodities; Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2006-07-17T13:00:11Z

[Federal Register: July 17, 2006 (Volume 71, Number 136)]
[Rules and Regulations]               
[Page 40431-40436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy06-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0553; FRL-8076-6]

 
Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic Material 
Necessary for Its Production in Corn in or on All Corn Commodities; 
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

[[Page 40432]]

requirement of a tolerance for residues of the Bacillus Thuringiensis 
Cry2Ab2 protein 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. Monsanto Company 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 Cry2Ab2 protein and the genetic material necessary for 
its production in corn. The temporary tolerance exemption will expire 
on June 30, 2009.

DATES: This regulation is effective July 17, 2006. Objections and 
requests for hearings must be received on or before September 15, 2006, 
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-2006-0553. 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), 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.

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 174 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-2006-0553 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 September 15, 2006.
    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-2006-0553, 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 May 26, 2006 (Volume 71 FR 30400) (FRL-
8066-7), 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 5G7005) by Monsanto Company, 800 North Lindbergh 
Blvd., St. Louis, MO 63167. 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 Cry2Ab2 protein 
and the genetic material necessary for its production in corn. This 
notice included a summary of the petition prepared by the petitioner 
Monsanto Company. One comment was received in response to the notice of 
filing. The commenter objected to an exemption from the requirement of 
a tolerance, stated that she does not favor genetically engineered 
corn, and stated that such corn should be labeled. The Agency 
understands the commenter's concerns and recognizes that some 
individuals believe that genetically modified crops and food should be 
banned completely. Pursuant to its authority under the FFDCA, EPA 
conducted a comprehensive assessment of the Cry2Ab2 protein and the 
genetic material necessary for its production in

[[Page 40433]]

corn, including a review of acute oral toxicity data on the Cry2Ab2 
protein, amino acid sequence comparisons to known toxins and allergens, 
as well as data demonstrating that the Cry2Ab2 protein is rapidly 
degraded by gastric fluid in vitro, is not glycosylated, and is present 
in low levels in corn tissue, and has concluded that there is a 
reasonable certainty that no harm will result from dietary exposure to 
this protein as expressed in genetically modified corn. Thus, under the 
standard in FFDCA section 408(b)(2), a tolerance exemption is 
appropriate. The labeling of food is under the jurisdiction of the Food 
and Drug Administration (FDA).
    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.
    Monsanto has submitted acute oral toxicity data demonstrating the 
lack of mammalian toxicity at high levels of exposure to the pure 
Cry2Ab2 protein. These data demonstrate the safety of the product at a 
level well above maximum possible exposure levels that are reasonably 
anticipated in the crop. Basing this conclusion on acute oral toxicity 
data without requiring further toxicity testing and residue data is 
similar to the Agency position regarding toxicity testing and the 
requirement of residue data for the microbial Bacillus thuringiensis 
products from which this plant-incorporated protectant was derived (See 
40 CFR Sec. 158.740(b)(2)(i)). For microbial products, further toxicity 
testing and residue data are triggered by significant adverse acute 
effects in studies such as the mouse oral toxicity study, to verify the 
observed adverse effects and clarify the source of these effects (Tiers 
II and III).
    An acute oral toxicity study in mice (MRID 44966602) indicated that 
Cry2Ab2 is non-toxic to humans. Three groups of ten male and ten female 
mice were dosed by oral gavage with 30, 300, or 1,000 milligrams/
kilogram (mg/kg) bodyweight of microbially-produced Cry2Ab2 protein. 
Two negative control groups were also included in the study: Bovine 
serum albumin protein control, and a vehicle control (purified water). 
Two deaths occurred in control group animals; both deaths were 
attributed to gavage injury. All other mice survived the study. Several 
animals in both the control and test groups lost weight during the 
study, and several abnormalities were observed by gross necropsy in 
several animals in both the test and control groups. There were no 
significant differences between the test and control groups; therefore, 
the Cry2Ab2 protein does not appear to cause any significant adverse 
effects at an exposure level of up to 1,000 mg/kg bodyweight.
    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 acute effects were shown to be caused by Cry2Ab2, 
even at relatively high dose levels, the Cry2Ab2 protein is not 
considered toxic. Further, amino acid sequence comparisons showed no 
similarities between the Cry2Ab2 protein and known toxic proteins in 
protein databases that would raise a safety concern.
    Since Cry2Ab2 is a protein, allergenic potential was also 
considered. Currently, no definitive tests for determining the 
allergenic potential of novel proteins exist. Therefore, EPA uses a 
weight-of-evidence approach where the following factors are considered: 
Source of the trait; amino acid sequence similarity with known 
allergens; prevalence in food; and biochemical properties of the 
protein, including in vitro digestibility in simulated gastric fluid 
(SGF) and glycosylation. Current scientific knowledge suggests that 
common food allergens tend to be resistant to degradation by heat, 
acid, and proteases, may be glycosylated, and can be present at high 
concentrations in the food.
    1. Source of the trait. Bacillus thuringiensis is not considered to 
be a source of allergenic proteins.
    2. Amino acid sequence. A comparison of the amino acid sequence of 
Cry2Ab2 with known allergens showed no significant overall sequence 
similarity or identity at the level of eight contiguous amino acid 
residues.
    3. Prevalence in food. Expression level analysis indicated that the 
protein is present at relatively low levels in corn: Approximately 2.3 
[mu]g/g in grain on a dry weight basis. Thus, the expression has been 
shown to be in the parts per million range is much lower than the 
amounts of allergen protein found in commonly allergenic foods. In 
those foods, allergens are major protein components such as seed 
storage globulin proteins in nuts and legumes, meat associated proteins 
like tropomyosin in fish and shellfish, ovalbumin and ovomucoid in egg 
white and lactalbumin and casein in milk. In these cases, the allergens 
can be from 10% to 50% of the total protein found whereas the plant-
incorporated protectant (PIP) that is the subject of this tolerance 
determination is found in the parts per million range.
    4. Digestibility. The Cry2Ab2 protein was digested within 15 
seconds in simulated gastric fluid containing pepsin.
    5. Glycosylation. Cry2Ab2 expressed in corn was shown not to be 
glycosylated.
    6. Conclusion. Considering all of the available information, EPA 
has concluded that the potential for Cry2Ab2 to be a food allergen is 
minimal.

[[Page 40434]]

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 protectants 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. In addition, even if 
exposure can occur through inhalation, the potential for Cry2Ab2 to be 
an allergen is low, as discussed above. Although the allergenicity 
assessment focuses on potential to be a food allergen, the data also 
indicate a low potential for Cry2Ab2 to be an inhalation allergen. 
Exposure via residential or lawn use to infants and children is also 
not expected because the use sites for the Cry2Ab2 protein is 
agricultural. Oral exposure, at very low levels, may occur from 
ingestion of processed corn products and, theoretically, drinking 
water. However, oral toxicity testing showed no adverse effects. 
Furthermore, the expression of the Cry2Ab2 protein in corn kernels has 
been shown to be in the parts per million range, which makes the 
expected dietary exposure several orders of magnitude lower than the 
amount of Cry2Ab2 shown to have no toxicity. Therefore, even if 
negligible aggregate exposure should occur, the Agency concludes that 
such exposure would result in no harm due to the lack of mammalian 
toxicity and low potential for allergenicity demonstrated for the 
Cry2Ab2 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 from the 
plant-incorporated protectant, we conclude that there are no cumulative 
effects for the Cry2Ab2 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 Cry2Ab2 protein includes the characterization of the expressed 
Cry2Ab2 protein in corn, as well as the acute oral toxicity study, 
amino acid sequence comparisons to known allergens and toxins, and in 
vitro digestibility of the protein. The results of these studies were 
used to evaluate human risk, and the validity, completeness, and 
reliability of the available data from the studies were also 
considered.
    Adequate information was submitted to show that the Cry2Ab2 test 
material derived from microbial culture was biochemically and 
functionally equivalent to the protein produced by the plant-
incorporated protectant ingredient in corn. Microbially produced 
protein was used in the safety studies so that sufficient material for 
testing was available.
    The acute oral toxicity data submitted support the prediction that 
the Cry2Ab2 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 treatment-related adverse effects were shown to be caused by 
the Cry2Ab2 protein, even at relatively high dose levels, the Cry2Ab2 
protein is not considered toxic. Basing this conclusion on acute oral 
toxicity data without requiring further toxicity testing and residue 
data 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 when significant adverse effects 
are seen in studies such as the mouse oral toxicity study. Further 
studies verify the observed adverse effects and clarify the source of 
these effects (Tiers II and III).
    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 the Cry1A.105 in corn tissues.
    Since Cry2Ab2 is a protein, potential allergenicity is also 
considered as part of the toxicity assessment. Considering all of the 
available information (1) Cry2Ab2 originates from a non-allergenic 
source; (2) Cry2Ab2 has no sequence similarities with known allergens; 
(3) Cry2Ab2 is not glycosylated; (4) Cry2Ab2 will only be present at 
low levels in food; and (5) Cry2Ab2 is rapidly digested in simulated 
gastric fluid; EPA has concluded that the potential for Cry2Ab2 to be a 
food allergen is minimal.
    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 Cry2Ab2 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 ingredient include the nucleic acids 
(DNA, RNA) that encode these proteins and regulatory regions. The 
genetic material (DNA, RNA), necessary for the production of the 
Cry2Ab2 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 database unless

[[Page 40435]]

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 finds no toxicity for the Cry2Ab2 protein and the genetic 
material necessary for its production. Thus, there are no threshold 
effects of concern and, as a result, the provision requiring an 
additional margin of safety does not apply. Further, the considerations 
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 Cry2Ab2 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 a 
source that is not known to exert an influence on the endocrine system. 
Therefore, the Agency is not requiring information on the endocrine 
effects of this plant-incorporated protectant at this time.

B. Analytical Method(s)

    A short description of an enzyme-linked immunosorbent assay for the 
detection and quantification of Cry2Ab2 in corn tissue has been 
submitted, and a commercially available qualitative 
immunochromatographic test strip was shown to detect the Cry2Ab2 
protein in corn tissues.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the plant-incorporated 
protectant Bacillus thuringiensis Cry2Ab2 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 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 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 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 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.

[[Page 40436]]

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

0
2. Section 174.454 is added to subpart W to read as follows:

Sec.  174.454  Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic 
Material Necessary for Its Production in Corn.

    Bacillus thuringiensis Cry2Ab2 protein 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 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 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 524-EUP-97 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 June 30, 2009; 
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. E6-11249 Filed 7-14-06; 8:45 am]

BILLING CODE 6560-50-S