
[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Rules and Regulations]               
[Page 23635-23639]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my09-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2009-0101; FRL-8417-3]

 
Bacillus thuringiensis Cry1A.105 protein; Time Limited Exemption 
from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an 18-month exemption from the 
requirement of a tolerance for residues of the Bacillus thuringiensis 
Cry1A.105 protein in or on the food and feed commodities cotton seed, 
cotton seed oil, cotton seed meal, cotton hay, cotton hulls, cotton 
forage and cotton gin byproducts when used as a plant-incorporated 
protectant. Monsanto Company submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting a time-limited 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus thuringiensis Cry1A.105 protein in or on the food 
and feed commodities cotton seed, cotton seed oil, cotton seed meal, 
cotton hay, cotton hulls, cotton forage and cotton gin byproducts. This 
tolerance exemption expires and is revoked on November 22, 2010.

DATES: This regulation is effective May 20, 2009. Objections and 
requests for hearings must be received on or before July 20, 2009, 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-2009-0101. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT:  Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-308-8263; e-mail address: greenway.denise@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

[[Page 23636]]

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 electronically available documents 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 e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0101 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before July 20, 2009.
    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-2009-0101, 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 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 4, 2009 (74 FR 9395) (FRL-8403-5), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
9F7521) by Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 
63167. The petition requested that 40 CFR part 174 be amended by 
establishing a time-limited exemption from the requirement of a 
tolerance for residues of the plant-incorporated protectant Bacillus 
thuringiensis Cry1A.105 protein, in or on the food and feed commodities 
cotton seed, cotton seed oil, cotton seed meal, cotton hay, cotton 
hulls, cotton forage and cotton gin byproducts. This notice included a 
summary of the petition prepared by the petitioner Monsanto Company. 
This petition was submitted to deal with a small amount--less than an 
acre--of an unauthorized, genetically-engineered cotton variety 
containing an unregistered plant-incorporated protectant--the Cry1A.105 
protein--that was inadvertently harvested along with 54 acres of a 
commercially-available, genetically engineered cotton variety. (http://
www.epa.gov/pesticides/biopesticides/pips/btcotton_statement.html). In 
response to EPA's notice announcing the filing of this petition, one 
comment was received from an anonymous person. The commenter said there 
should be zero toxic chemical residue left on any product and was 
especially concerned about cancer risk from this chemical residue. The 
commenter did not provide, however, any information in support of his/
her position or point out what assessment parameter needed closer 
examination for cancer risk. The Agency understands the commenter's 
concerns about the potential effects of this particular plant-
incorporated protectant to humans and the environment. Pursuant to its 
authority under the FFDCA, EPA conducted a comprehensive assessment of 
Cry1A.105 protein, including a review of the data submitted to justify 
the existing tolerance exemption for Cry1A.105 protein in corn (73 FR 
40756, FRL-8369-3) (40 CFR 174.502). The information for the corn 
tolerance exemption includes an acute oral toxicity test on Cry1A.105 
protein, as well as data demonstrating that Cry1A.105 protein is 
rapidly degraded by gastric fluid in vitro, is not glycosylated, does 
not have amino acid sequence similarities to known toxins or allergens, 
and is present at low levels in the tissues expressing the plant-
incorporated protectant. Since the Bacillus thuringiensis Cry1A.105 
protein expressed in cotton that is the subject of this action has only 
four amino acid differences compared to that expressed in corn, the 
Agency also examined data specific to the cotton-expressed Cry1A.105 
protein. This cotton-specific data was an amino acid sequence 
comparison to known toxins and allergens (MRID 477322-01). Based on the 
data from corn, which are also applicable for Cry1A.105 protein in 
cotton, as well as the cotton-specific data, the Agency has concluded 
that, for the 18-month time period for which this tolerance exemption 
is sought, there is a reasonable certainty that no harm will result 
from dietary exposure to residues of Bacillus thuringiensis Cry1A.105 
protein in or on the food and feed commodities cotton seed, cotton seed 
oil, cotton seed meal, cotton hay, cotton hulls, cotton forage and 
cotton gin byproducts when used as a plant-incorporated protectant. 
Thus, under the standard in FFDCA section 408(b)(2), a time-limited, 
18-month tolerance exemption is appropriate.
    Section 408(c)(2)(A)(i) of 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 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

[[Page 23637]]

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) of FFDCA, 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) of FFDCA, 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 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 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.
    Mammalian toxicity and allergenicity assessment. Monsanto Company 
previously submitted, and the Agency previously evaluated, acute oral 
toxicity data that demonstrate the lack of mammalian toxicity at high 
levels of exposure to the pure Cry1A.105 protein. Since the study was 
done with pure Cry1A.105 protein, this study can be used to address the 
toxicity of the Cry1A.105 protein not only in corn, but also in cotton. 
These data demonstrate the safety of the protein at a level well above 
maximum possible exposure levels that are reasonably anticipated in 
cotton using submitted Cry1A.105 expression values for corn and other 
similar Cry proteins expressed in cotton. 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 residue data requirement for the microbial Bacillus 
thuringiensis products from which this plant-incorporated protectant 
was derived (See 40 CFR 158.2130). 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 those 
effects (Tiers II and III).
    The acute oral toxicity study in mice used for the corn tolerance 
determination (MRID 466946-03) indicated that pure Cry1A.105 protein is 
non-toxic to humans. The oral LD50 for mice was greater than 
2,072 milligrams/kilogram of bodyweight (mg/kg bw). This dose level is 
above 2,000 mg/kg, which is above the limit dose (i.e., the highest 
dose used in acute toxicity testing).
    When proteins are toxic, they are known to act via acute mechanisms 
and at very low dose levels (Sjoblad, R.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 Cry1A.105, 
even at relatively high dose levels, the Cry1A.105 protein is not 
considered toxic. Further, amino acid sequence comparisons between the 
Cry1A.105 protein and known toxic proteins in protein databases showed 
no similarities that would raise a safety concern. In addition, the 
Cry1A.105 protein was shown to be substantially degraded by heat when 
examined by immunoassay. This instability to heat would also lessen the 
potential dietary exposure to intact Cry1A.105 protein in cooked or 
processed foods. These biochemical features along with the lack of 
adverse results in the acute oral toxicity test support the conclusion 
that, for the 18-month time period for which this tolerance exemption 
is sought, there is a reasonable certainty no harm from toxicity will 
result from dietary exposure to residues of Cry1A.105 protein in or on 
the identified cotton commodities.
    Since Cry1A.105 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 comparison with known 
allergens; and biochemical properties of the protein, including in 
vitro digestibility in simulated gastric fluid (SGF) and glycosylation. 
This approach is consistent with the approach outlined in the Annex to 
the Codex Alimentarius ``Guideline for the Conduct of Food Safety 
Assessment of Foods Derived from Recombinant-DNA Plants.'' The 
allergenicity assessment for corn is equally applicable for the 
Cry1A.105 protein as expressed in cotton since it is based on 
characteristics of the protein itself regardless of the plant 
expressing it. The allergenicity assessment for Cry1A.105 protein in 
cotton follows:
    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 
Cry1A.105 with known allergens showed no overall sequence similarity 
(35% identity over 80 amino acids) or identity at the level of eight 
contiguous amino acid residues, indicating a lack of potential linear 
epitopes found in known food allergens.
    3. Digestibility. The Cry1A.105 protein was digested within 30 
seconds in simulated gastric fluid containing pepsin. The rapid 
degradation of Cry1A.105 in the gastric environment suggests little 
possible exposure to intact protein in the intestinal lumen where 
sensitization to food allergens occurs.
    4. Glycosylation. Cry1A.105 expressed in corn was shown not to be 
glycosylated and no glycosylation motifs were present in the cotton 
variant Cry1A.105.
    5. Conclusion. Considering all of the available information, EPA 
has concluded that the potential for Cry1A.105 to be a food allergen is 
minimal.
    The information on the safety of pure Cry1A.105 protein is more 
than adequate to address possible exposures to Cry1A.105 protein in or 
on cotton crops.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of 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).

A. Dietary Exposure

    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

[[Page 23638]]

other related substances. These considerations include dietary exposure 
under the tolerance exemption and all other tolerances or exemptions in 
effect for residues of the plant-incorporated protectant, 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 Cry1A.105 to 
be an allergen is low, as discussed in Unit III above. Although the 
allergenicity assessment focuses on the potential to be a food 
allergen, the data (comparing amino acid sequence similarity to 
allergens, including aeroallergens) also indicate a low potential for 
Cry1A.105 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 Cry1A.105 protein are agricultural. Oral exposure, at 
very low levels, may occur from ingestion of processed cotton products 
and, theoretically, drinking water. However, oral toxicity testing 
showed no adverse effects.
    Food. The data submitted and cited regarding potential health 
effects for the Cry1A.105 protein includes information on the pure 
protein and the Cry1A.105 protein expressed in cotton, as well as the 
acute oral toxicity study, amino acid sequence comparisons to known 
allergens and toxins, and in vitro digestibility of the pure Cry1A.105 
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 Cry1A.105 test 
material derived from microbial culture was biochemically and 
functionally equivalent to the protein produced by the plant-
incorporated protectant in the plant. Microbially produced Cry1A.105 
protein was used in the studies so that sufficient material for testing 
was available.
    The acute oral toxicity data submitted support the prediction that 
the Cry1A.105 protein would be non-toxic to humans. As mentioned above 
in Unit III, when proteins are toxic, they are known to act via acute 
mechanisms and at very low dose levels (Sjoblad, R.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 Cry1A.105 protein, even at relatively high dose levels 
(e.g., 2,072 mg/kg body weight), the Cry1A.105 protein is not 
considered toxic. (See Unit III above for a fuller discussion of the 
basis for this conclusion.)
    Residue chemistry data were not required for a human health effects 
assessment of the subject plant-incorporated protectant because of the 
lack of mammalian toxicity. Nonetheless, data submitted demonstrated 
low levels of the Cry1A.105 protein in corn tissues (5-7 ppm in grain, 
20-570 ppm in forage or leaf tissue) and in cotton seed for similar Cry 
proteins (2-45 ppm in cotton seed), indicating a low potential for 
dietary exposure.
    Since Cry1A.105 is a protein, potential allergenicity is also 
considered as part of the toxicity assessment. Considering that 
Cry1A.105 protein (1) originates from a non-allergenic source, (2) has 
no sequence similarities with known allergens, (3) is not glycosylated 
in corn and the cotton variant does not have glycosylation motifs, and 
(4) is rapidly digested in simulated gastric fluid, EPA has concluded 
that the potential for Cry1A.105 protein to be a food allergen is 
minimal.
    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 
Cry1A.105 protein has been exempted from the requirement of a tolerance 
under 40 CFR 174.507--Nucleic acids that are part of a plant-
incorporated protectant; exemption from the requirement of a tolerance.

B. Other Non-Occupational Exposure

     Dermal and inhalation exposure. 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 Cry1A.105 protein to be an allergen is minimal, as discussed above 
in Unit III. Although the allergenicity assessment focuses on the 
potential to be a food allergen, the data also indicate a low potential 
for Cry1A.105 to be an inhalation allergen.

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 Cry1A.105 protein.

VI. Determination of Safety for U.S. Population, Infants and Children

    FDCA 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 EPA determines 
that a different margin of safety will be safe for infants and 
children.
    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 Cry1A.105 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.
    Based on all the available information, the Agency finds that there 
is no toxicity associated with the Cry1A.105 protein. Thus, there are 
no threshold effects of concern and, as a result, the Agency has 
concluded that the additional tenfold margin of safety for infants and 
children is unnecessary in this instance. Further, the considerations 
of consumption patterns, special susceptibility, and cumulative effects 
do not apply.

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

[[Page 23639]]

the endocrine effects of the plant-incorporated protectant at this 
time.

B. Analytical Method(s)

    A Polymerase Chain Reaction (PCR) method for the detection and (in 
the context of a tolerance exemption) measurement of the Bacillus 
thuringiensis Cry1A.105 protein in cotton has been submitted (MRID 
477497-01).

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the plant-incorporated 
protectant Bacillus thuringiensis Cry1A.105 protein.

VIII. Conclusions

    There is a reasonable certainty that, during the 18-month time 
period during which this tolerance exemption will be effective, no harm 
will result from aggregate exposure to the U.S. population, including 
infants and children, to residues of the Cry1A.105 protein in or on all 
food and feed commodities of cotton seed, cotton seed oil, cotton seed 
meal, cotton hay, cotton hulls, cotton forage and cotton gin byproducts 
when the Cry1A.105 protein is used as a plant-incorporated protectant 
in such food and feed commodities of cotton in accordance with good 
agricultural practices. 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 is there any indication of 
allergenicity potential for the plant-incorporated protectant.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: May 13, 2009.
W. Michael McDavit,
Acting 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: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 174.502 is revised to read as follows:


Sec.  174.502  Bacillus thuringiensis Cry1A.105 protein; exemption from 
the requirement of a tolerance.

    (a) Residues of Bacillus thuringiensis Cry1A.105 protein in or on 
the food and feed commodities of corn; corn, field, flour; corn, field, 
forage; corn, field, grain; corn, field, grits; corn, field, meal; 
corn, field, refined oil; corn, field, stover; corn, sweet, forage; 
corn, sweet, kernel plus cob with husk removed; corn, sweet, stover; 
corn, pop, grain and corn, pop, stover are exempt from the requirement 
of a tolerance when the Bacillus thuringiensis Cry1A.105 protein is 
used as a plant-incorporated protectant in these food and feed corn 
commodities.
    (b) A time-limited exemption from the requirement of a tolerance is 
established for residues of Bacillus thuringiensis Cry1A.105 protein in 
or on the food and feed commodities of cotton; cotton, forage; cotton, 
gin byproducts; cotton, hay; cotton, hulls; cotton, meal; cotton, 
refined oil; and cotton, undelinted seed when the Bacillus 
thuringiensis Cry1A.105 protein is used as a plant-incorporated 
protectant in these food and feed cotton commodities. The exemption 
from the requirement of a tolerance expires and is revoked on November 
22, 2010.

[FR Doc. E9-11759 Filed 5-19-09; 8:45 am]

BILLING CODE 6560-50-S
