Document ID: EPA-HQ-OPP-2006-0174-0001
Agency: epa
Document Type: Rule
Title: Modified Cry3A Protein and the Genetic Material for Its Production in Corn; Extension of a Temporary Exemption from the Requirement of a Tolerance
Posted Date: 2006-03-15T15:35:21Z

[Federal Register: March 15, 2006 (Volume 71, Number 50)]
[Rules and Regulations]               
[Page 13269-13274]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr06-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0174; FRL-7766-6]

 
Modified Cry3A Protein and the Genetic Material for Its 
Production in Corn; Extension of a Temporary Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends an existing 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 this extension of the existing temporary 
tolerance exemption. This regulation eliminates the need to establish a 
maximum permissible level for residues of modified Cry3A protein 
(mCry3A) and the genetic material necessary for its production in corn. 
The temporary tolerance exemption as extended will expire on October 
15, 2007.

DATES: This regulation is effective March 15, 2006. Objections and 
requests for hearings must be received on or before May 15, 2006.

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 EPA-HQ-OPP-2006-0174. All documents in the 
docket are listed on the http://www.regulations.gov Web site. (EDOCKET, 

EPA's electronic public docket system was replaced on November 25, 
2005, by an enhanced federal-wide eletronic management and comment 
system located at http//http://www.regulations.gov/. Follow the on-line 

instructions.) 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 S. 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).

[[Page 13270]]

     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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 174 

is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of January 25, 2006 (71 FR 4140) (FRL-7757-
6), 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 East 
Cornwallis Road, Research Triangle Park, NC 27709-2257. The petition 
requested that 40 CFR part 174 be amended by extending by 1 year 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 on field corn, sweet 
corn, and popcorn when applied/used as a plant-incorporated protectant 
(40 CFR 174.456). 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. The commentor objected to 
an exemption from the requirement of a tolerance, stated that she does 
not favor genetically engineered corn, and objected to the lack of long 
term tests. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that genetically modified 
crops and food should be banned completely. Regarding the commenter's 
concern regarding a lack of long term tests; 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 the plant-incorporated protectants, even at relatively high 
dose levels, the mCry3A protein is not considered toxic. Pursuant to 
its authority under the FFDCA, EPA conducted a comprehensive assessment 
of the modified Cry3A protein and the genetic material necessary for 
its production in corn, including a review of acute oral toxicity data 
on the mCry3A protein, amino acid sequence comparisons to known toxins 
and allergens, as well as data demonstrating that the mCry3A protein is 
rapidly degraded by gastric fluid in vitro, is not glycosylated, is 
inactivated when heated to 95 [deg]C for 30 minutes, 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.
    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

[[Page 13271]]

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 oncentrations 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 muL 6 N HCl, and 2.7 mg/mL pepsin) resulting in 10 pepsin 
activity units/ mug protein (complies with year 2000 U.S. 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 eight contiguous amino acids residues. Further, data 
demonstrate that mCry3A is not glycosylated, 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 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 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/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 
thesource 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

[[Page 13272]]

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 
theproduction 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, 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. 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 EPA-HQ-OPP-2006-0174 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 May 15, 
2006.
    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 EPA-HQ-OPP-2006-0174, to: 
Public Information and Records Integrity Branch, Information Technology 
and Resources Management 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

[[Page 13273]]

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 
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.

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 2, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, 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 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 temporarily 
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

[[Page 13274]]

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, 2007; 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. 06-2431 Filed 3-14-06; 8:45 am]

BILLING CODE 6560-50-S