Document ID: EPA-HQ-OPP-2007-0346-0014
Agency: epa
Document Type: Rule
Title: Bacillus thuringiensis Cry 1A.105 protein; Exemption from the Requirement of a Tolerance
Posted Date: 2008-07-16T04:00Z

[Federal Register: July 16, 2008 (Volume 73, Number 137)]
[Rules and Regulations]               
[Page 40756-40760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy08-18]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-0346; FRL-8369-3]

 
 Bacillus thuringiensis Cry 1A.105 protein; Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Bacillus thuringiensis Cry 1A.105 
protein in or on corn when used as a plant-incorporated protectant in 
the food and feed commodities of corn; corn, field; corn, sweet; and 
corn, pop. 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 to amend the existing 
temporary tolerance in 40 CFR 174.502 for the Bacillus thuringiensis 
Cry 1A.105 protein to establish a permanent exemption from the 
requirement of a tolerance for residues of the Bacillus thuringiensis 
Cry 1A.105 protein in or on all food commodities when used as a plant-
incorporated protectant in all food commodities. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of the Bacillus thuringiensis Cry 1A.105 insecticidal protein 
in or on the food and feed commodities of corn; corn, field; corn, 
sweet; and corn, pop.

DATES: This regulation is effective July 16, 2008. Objections and 
requests for hearings must be received on or before September 15, 2008, 
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-2007-0346. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Susanne Cerrelli, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8077; e-mail address: cerrelli.susanne@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

[[Page 40757]]

affected by this action. Other types of entities not listed in this 
unit could also be affected. The North American Industrial 
Classification System (NAICS) codes have been provided to assist you 
and others in determining whether this action might apply to certain 
entities. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

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

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by 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-2007-0346 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, 2008.
    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-2007-0346, 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'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 August 1, 2007 (72 FR 42075) (FRL-8129-
8), 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 6F7142) by Monsanto Company, 800 North Lindbergh Blvd. St. 
Louis, MO 63167. The petition requested that 40 CFR part 174 be amended 
by establishing an exemption from the requirement of a tolerance for 
residues of the Bacillus thuringiensis Cry 1A.105 protein in or on all 
food commodities when used as plant-incorporated protectant in all food 
commodities. This notice included a summary of the petition prepared by 
the petitioner Monsanto Company. One commenter objected to the 
petition, expressing concerns about Monsanto obtaining an exemption 
from tolerance and potential harmful effects. The Agency understands 
the commenter's concerns about 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 Cry 1A.105 protein, including a review of acute oral 
toxicity data on Cry 1A.105 protein, amino acid sequence comparisons to 
known toxins and allergens, as well as data demonstrating that Cry 
1A.105 protein is rapidly degraded by gastric fluid in vitro, is not 
glycosylated, and is present at low levels in the tissues expressing 
the plant-incorporated protectant. Based on these data, the Agency has 
concluded that there is a reasonable certainty that no harm will result 
from dietary exposure to residues of Cry1A.105 protein in the food and 
feed commodities of corn; corn, field; corn, sweet; and corn, pop, when 
used as a plant-incorporated protectant. Thus, under the standard in 
FFDCA section 408(b)(2), a tolerance exemption is appropriate. In 
taking this action, EPA, pursuant to its authority under section 
408(d)(4)(A)(i) of the FFDCA, is issuing a final regulation that varies 
from the regulation sought by Monsanto in its petition. Specifically, 
instead of issuing a tolerance exemption that covers residues of the 
subject plant-incorporated protectant in all food commodities, EPA is 
issuing a tolerance exemption that covers residues of the subject 
plant-incorporated protectant in those commodities in which it will be 
used as a plant-incorporated protectant-- in this case, the food and 
feed commodities of corn; corn, field; corn, sweet; and corn, pop. In 
this way, the tolerance exemption is coextensive with the registered 
uses for this particular plant-incorporated protectant.
    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 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

[[Page 40758]]

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 has 
submitted acute oral toxicity data demonstrating the lack of mammalian 
toxicity at high levels of exposure to the pure Cry1A.105 protein. 
These data demonstrate the safety of the product at a level well above 
maximum possible exposure levels that are reasonably anticipated in 
corn using submitted Cry1A.105 expression values. 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 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 these effects (Tiers II & III).
    An acute oral toxicity study in mice (MRID 46694603) indicated that 
Cry1A.105 is non-toxic to humans. The oral LD50 for mice was 
greater than 2,072 milligrams/kiligrams (mg/kg) bodyweight. 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, 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 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 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 there is a reasonable certainty no harm from toxicity will result 
from dietary exposure to residues of Cry1A.105 in or on the identified 
corn 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 Cry1A.105 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.
    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 provides 
adequate justification to address possible exposures in all corn 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 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 Cry1A.105 to 
be an allergen is low, as discussed in unit III. Although the 
allergenicity assessment focuses on 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 corn 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 the characterization of the 
expressed Cry1A.105 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 Cry1A.105 test 
material derived from microbial culture was biochemically and 
functionally equivalent to the protein produced by the plant-
incorporated protectant ingredient in the plant. Microbially produced 
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

[[Page 40759]]

to humans. As mentioned in this unit, 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 Cry1A.105 protein, even at 
relatively high dose levels (e.g., 2072 mg/kg body weight), the 
Cry1A.105 protein is not considered toxic. Basing this conclusion on 
acute oral toxicity data without requiring further toxicity testing or 
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 acute 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 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), 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 all of the 
available information:
    1. Cry1A.105 originates from a non-allergenic source;
    2. Cry1A.105 has no sequence similarities with known allergens;
     3. Cry1A.105 is not glycosylated; and
    4. Cry1A.105 is rapidly digested in simulated gastric fluid; EPA 
has concluded that the potential for Cry1A.105 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 to 
be an allergen is minimal, as discussed in this unit. Although the 
allergenicity assessment focuses on 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

    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 EPA determines 
that a different margin of safety will be safe for infants and 
children. In this instance, based on all the available information, the 
Agency concludes that there is a finding of no toxicity for the 
Cry1A.105 protein. Thus, there are no threshold effects of concern and, 
as a result, the provision requiring an additional tenfold margin of 
safety does not apply. Further, the considerations of consumption 
patterns, special susceptibility, and cumulative effects do not apply.
    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.

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 the plant-incorporated protectant at this time.

B. Analytical Method

    A standard operating procedure for an enzyme-linked immunosorbent 
assay for the detection and quantification of Cry1A.105 in corn tissue 
has been submitted.

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 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 corn; corn, field; corn, sweet; and corn, pop. 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 in this unit, 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 exemption 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,

[[Page 40760]]

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: June 10, 2008.
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: 21 U.S.C. 321(q), 346a and 371.

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

Sec.  174.502  Bacillus thuringiensis Cry 1A.105 protein in corn; 
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry 1A.105 protein in or on the 
food and feed commodities of corn; corn, field; corn, sweet; and corn, 
pop, are exempt from the requirement of a tolerance when the Bacillus 
thuringiensis Cry 1A.105 protein is used as a plant-incorporated 
protectant in those food and feed corn commodities.
[FR Doc. E8-15836 Filed 7-15-08; 8:45 am]

BILLING CODE 6560-50-S