Document ID: EPA-HQ-OPP-2007-0346-0010
Agency: epa
Document Type: Rule
Title: Bacillus thuringiensis Cry2Ab2 protein; Exemption from the Requirement of a Tolerance
Posted Date: 2008-07-02T04:00Z

[Federal Register: July 2, 2008 (Volume 73, Number 128)]
[Rules and Regulations]               
[Page 37846-37850]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jy08-35]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-0346; FRL-8369-4]

 
Bacillus thuringiensis Cry2Ab2 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 Cry2Ab2 
protein in or on corn when used as 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(s) in 40 CFR 174.503 for the Bacillus thuringiensis 
Cry2Ab2 protein to establish a permanent exemption from the requirement 
of a tolerance for residues of the Bacillus thuringiensis Cry2Ab2 
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 Cry2Ab2 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 2, 2008. Objections and 
requests for hearings must be received on or before September 2, 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 affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 174 through the 
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of 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 2, 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.

[[Page 37847]]

II. Background and Statutory Findings

    In the Federal Register of August 1, 2007 (72 FR 42075-42077) (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 6F7143) 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 Cry2Ab2 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 Cry2Ab2 protein, including a review of acute oral 
toxicity data on Cry2Ab2 protein, amino acid sequence comparisons to 
known toxins and allergens, as well as data demonstrating that Cry2Ab2 
proteins are rapidly degraded by gastric fluid in vitro, are not 
glycosylated, and are present in 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 Cry1Ab2 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. In addition, 
instead of amending the existing temporary tolerance exemption in 40 
CFR 174.503 for the Bacillus thuringiensis Cry2Ab2 protein in corn by 
making it a permanent exemption, EPA instead is opting to amend the 
existing permanent tolerance exemption in 40 CFR 174.519 for the 
Bacillus thuringiensis Cry2Ab2 protein in cotton by adding to that 
provision the permanent tolerance exemption for Bacillus thuringiensis 
Cry2Ab2 protein in corn established by this final rule.
    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 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 Cry2Ab2 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 Cry2Ab2 expression values found in corn. 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 (Tiers II and III) and 
residue data are only triggered when significant adverse acute effects 
occur in toxicological studies, such as the acute oral toxicity study, 
to verify the observed adverse effects and clarify the source of these 
effects.
    An acute oral toxicity study in mice (Master Record Identification 
Number 44966602) indicated that Cry2Ab2 is non-toxic to humans. The 
Cry2Ab2 protein does not appear to cause any significant adverse 
effects at an exposure level of up to 1,000 milligrams/kilograms (mg/
kg) bodyweight.
    When proteins are toxic, they are known to act via acute mechanisms 
and at very low dose levels (Sjoblad, Roy D., et al., ``Toxicological 
Considerations for Protein Components of Biological Pesticide 
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)). 
Therefore, since no acute effects were shown to be caused by Cry2Ab2, 
even at relatively high dose levels, the Cry2Ab2 protein is not 
considered toxic. Further, amino acid sequence comparisons between the 
Cry2Ab2 protein and known toxic proteins in protein databases showed no 
similarities that would raise a safety concern. In addition, the 
Cry2Ab2 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 Cry2Ab2 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

[[Page 37848]]

there is a reasonable certainty no harm from toxicity will result from 
dietary exposure to residues of Cry2Ab2 in or on the identified corn 
commodities.
    Since Cry2Ab2 is a protein, allergenic potential was also 
considered. Currently, no definitive tests for determining the 
allergenic potential of novel proteins exist. Therefore, EPA uses a 
weight-of- evidence approach where the following factors are 
considered: Source of the trait; amino acid sequence 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 Cry2Ab2 follows:

0
1. Source of the trait. Bacillus thuringiensis is not considered to be 
a source of allergenic proteins.
    2. Amino acid sequence. A comparison of the amino acid sequence of 
Cry2Ab2 with known allergens showed no significant overall sequence 
similarity (using the CODEX similarity standard of 35% amino acid 
similarity in any 80 amino acid window) or identity at the level of 
eight contiguous amino acid residues, indicting a lack of potential 
linear epitopes found in known food allergens.
    3. Digestibility. The Cry2Ab2 protein was digested within 15 
seconds in simulated gastric fluid containing pepsin. The rapid 
degradation of Cry2Ab2 in the gastric environment suggests little 
possible exposure to intact protein in the intestinal lumen, where 
sensitization to food allergens occurs.
    4. Glycosylation. Cry2Ab2 expressed in corn was shown not to be 
glycosylated.
    5. Conclusion. Considering all of the available information, EPA 
has concluded that the potential for Cry2Ab2 to be a food allergen is 
minimal. The information on the safety of pure Cry2Ab2 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 residues of the plant-incorporated protectant, and exposure from 
non-occupational sources. Although the allergenicity assessment focuses 
on its potential to be a food allergen, the data (comparing amino acid 
sequence similarity to allergens, including aeroallergens) also 
indicate a low potential for Cry2Ab2 to be an inhalation allergen. 
Exposure via residential or lawn use to infants and children is also 
not expected because the use sites for the Cry2Ab2 protein are 
agricultural. Oral exposure, at very low levels, may occur from 
ingestion of processed corn products and, theoretically, drinking 
water. However, oral toxicity testing done at dose levels several 
orders of magnitude above the plant expression level showed no adverse 
effects.
    Food. The data submitted and cited regarding potential health 
effects for the Cry2Ab2 protein includes the characterization of the 
expressed Cry2Ab2 protein in corn, as well as the acute oral toxicity 
study, amino acid sequence comparisons to known allergens and toxins, 
and the in vitro digestibility of the protein. The results of these 
studies were used to evaluate human risk, and the validity, 
completeness, and reliability of the available data from the studies 
were also considered.
    Adequate information was submitted to show that the Cry2Ab2 test 
material derived from microbial culture was biochemically and 
functionally equivalent to the protein in the plant. Microbially 
produced protein was used in the safety studies so that sufficient 
material for testing was available.
    The acute oral toxicity data submitted support the prediction that 
the Cry2Ab2 protein would be non-toxic to humans. As mentioned 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 Cry2Ab2 protein even at high dose levels (e.g., 1,450 mg/
kg bodyweight), the Cry2Ab2 protein is not considered toxic. Basing 
this conclusion on acute oral toxicity data without requiring further 
toxicity testing and residue data is similar to the Agency's 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 only 
triggered when significant adverse effects are seen in toxicological 
studies, such as the acute oral toxicity study. Further studies verify 
the observed adverse effects and clarify the source of those effects.
    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 Cry2Ab2 protein in corn tissues (1-3 ppm in grain, 
20-90 ppm in forage or leaf tissue), indicating a low potential for 
dietary exposure.
    Since Cry2Ab2 is a protein, potential allergenicity is also 
considered as part of the toxicity assessment. Considering all of the 
available information:
    1. Cry2Ab2 originates from a non-allergenic source;
    2. Cry2Ab2 has no sequence similarities with known allergens;
    3. Cry2Ab2 is not glycosylated; and
    4. Cry2Ab2 is rapidly digested in simulated gastric fluid; EPA has 
concluded that the potential for Cry2Ab2 to be a food allergen is 
minimal.
    Neither available information concerning the dietary consumption 
patterns of consumers (and major identifiable subgroups of consumers, 
including infants and children) nor safety factors that are generally 
recognized as appropriate for the use of animal experimentation data 
were evaluated. The lack of mammalian toxicity at high levels of 
exposure to the Cry2Ab2 protein, as well as the minimal potential to be 
a food allergen, demonstrate the safety of the product at levels well 
above possible maximum exposure levels anticipated in the crop.
    The genetic material necessary for the production of the plant-
incorporated protectant active ingredient include the nucleic acids 
(DNA, RNA) that encode these proteins and regulatory regions. The 
genetic material (DNA, RNA) necessary for the production of the Cry2Ab2 
protein has been exempted

[[Page 37849]]

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 Cry2Ab2 to be 
an allergen is minimal as discussed in Unit.III.

V. Cumulative Effects

    Pursuant to section 408(b)(2)(D)(v) of FFDCA, EPA has considered 
available information on the cumulative effects of such residues and 
other substances that have a common mechanism of toxicity. These 
considerations included the cumulative effects on infants and children 
of such residues and other substances with a common mechanism of 
toxicity. Because there is no indication of mammalian toxicity from the 
plant-incorporated protectant, we conclude that there are no cumulative 
effects for the Cry2Ab2 protein.

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

    Section 408(b)(2)(C) of FFDCA 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, section 408(b)(2)(C) of FFDCA 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 Cry2Ab2 
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.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from a 
source that is not known to exert an influence on the endocrine system. 
Therefore, the Agency is not requiring information on the endocrine 
effects of this plant-incorporated protectant at this time.

B. Analytical Methods

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

C. Codex Maximum Residue Level

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

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 Cry2Ab2 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 above, no toxicity to mammals has been 
observed, nor 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, 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

[[Page 37850]]

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

Sec.  174.503  [Removed]

0
2. Section 174.503 is removed.
0
3. Section 174.519 is revised to read as follows:

Sec.  174.519  Bacillus thuringiensis Cry2Ab2 protein in corn and 
cotton; exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ab2 protein in or on corn or 
cotton are exempt from the requirement of a tolerance when used as a 
plant-incorporated protectant in the food and feed commodities of corn; 
corn, field; corn, sweet; corn, pop; and cotton seed, cotton oil, 
cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin 
byproducts.
[FR Doc. E8-14794 Filed 7-1-08; 8:45 am]

BILLING CODE 6560-50-S