Document ID: EPA-HQ-OPP-2007-1204-0004
Agency: epa
Document Type: Rule
Title: Bacillus thuringiensis Modified Cry1Ab 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 40760-40764]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy08-19]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-1204; FRL-8371-6]

 
Bacillus thuringiensis Modified Cry1Ab 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 modified 
Cry1Ab protein as identified under OECD Unique Identifier SYN-IR67B-1 
when used as a plant-incorporated protectant in the food and feed 
commodities of cotton; cotton, undelinted seed; cotton, refined oil; 
cotton, meal; cotton, hay; cotton, hulls; cotton, forage; and cotton, 
gin byproducts. Syngenta Seeds, Inc. submitted a petition to EPA under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act of 1996 (FQPA), requesting an exemption 
from the requirement of a tolerance. This regulation eliminates the 
need to establish a maximum permissible level for residues of Bacillus 
thuringiensis modified Cry1Ab protein as identified under OECD Unique 
Identifier SYN-IR67B-1 when used as a plant-incorporated protectant in 
cotton.

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-2007-1204. 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: Alan Reynolds, Biopesticides and

[[Page 40761]]

Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 605-0515; e-mail address: reynolds.alan@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-2007-1204 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-2007-1204, 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 January 30, 2008 (73 FR 5563) (FRL-8348-
4), 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 7F7290) by Syngenta Seeds, Inc., P.O. Box 12257, 3054 E. 
Cornwallis Road, Research Triangle Park, NC 27709. The petition 
requested that 40 CFR part 174 be amended by establishing an exemption 
from the requirement of a tolerance for residues of Bacillus 
thuringiensis modified Cry1Ab protein containing an additional 26 amino 
acid sequence (``Geiser Motif'') in all crops and agricultural 
commodities. A summary of the petition prepared by the petitioner, 
Syngenta Seeds, Inc., was posted on www.regulations.gov in the docket 
for this action (EPA-HQ-OPP-2007-1204). After review, the Agency 
determined that the appropriate designation for the protein is Bacillus 
thuringiensis modified Cry1Ab protein as identified under OECD Unique 
Identifier SYN-IR67B-1 (hereafter referred to as modified Cry1Ab). 
There was one comment received in response to the notice of filing. The 
commenter objected to the petition, pesticide residues on food crops, 
and the widespread use of Bacillus thuringiensis (Bt). The Agency 
understands the commenter's concerns regarding tolerances of pesticide 
residues on food. Pursuant to its authority under the FFDCA, EPA 
conducted a comprehensive assessment of modified Cry1Ab protein, 
including a review of acute oral toxicity data on modified Cry1Ab 
protein, amino acid sequence comparisons to known toxins and allergens, 
as well as data demonstrating that modified Cry1Ab protein is rapidly 
degraded by gastric fluid in vitro, is not glycosylated, and is present 
in low levels in plant tissues. Based on these data, the Agency has 
concluded that there is a reasonable certainty that no harm will result 
from dietary exposure to this protein as expressed in plant-
incorporated protectants. 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 petitioner Syngenta Seeds, Inc. 
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 such 
residues in those commodities in which it will be used as a plant-
incorporated protectant - in this case, the food and feed commodities 
of cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal; 
cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts. 
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

[[Page 40762]]

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

    Syngenta Seeds, Inc. has submitted acute oral toxicity data 
demonstrating the lack of mammalian toxicity at high levels of exposure 
to the pure modified Cry1Ab protein as identified under the 
Organisation for Economic Co-operation and Development (OECD) Unique 
Identifier SYN-IR67B-1 (hereafter referred to as modified Cry1Ab). The 
modified Cry1Ab protein contains a 26 amino acid sequence that is found 
at the C-terminus of the pro-toxin portion of the modified Cry1Ab 
protein. This sequence naturally occurs in Cry1Ab protein expressed in 
microbial Bacillus thuringiensis (Bt). The pro-toxin containing the 
additional 26 amino acid sequence is enzymatically cleaved in the 
insect gut to produce active Cry1Ab. These toxicity data demonstrate 
the safety of the product at a level well above maximum possible 
exposure levels that are reasonably anticipated in the crop. Basing 
this conclusion on acute oral toxicity data without requiring further 
toxicity testing and residue data is similar to the Agency position 
regarding toxicity testing and the requirement of residue data for the 
microbial Bacillus thuringiensis products from which this plant-
incorporated protectant was derived (See 40 CFR 158.2140). For 
microbial products, further toxicity testing (Tiers II and III) and 
residue data are triggered by significant adverse acute effects in 
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 indicated that modified Cry1Ab 
is non-toxic to humans. Groups of five male and five female mice were 
given 0 or 1,830 mg/kg bodyweight microbially-produced modified Cry1Ab 
by oral gavage as a single dose. There were no effects on clinical 
condition, body weight, food consumption, clinical pathology, organ 
weight, or macroscopic or microscopic pathology that were attributed to 
the test substance.
    When proteins are toxic, they are known to act via acute mechanisms 
and at very low dose levels (Ref. 1). Therefore, since no acute effects 
were shown to be caused by modified Cry1Ab, even at relatively high 
dose levels, the modified Cry1Ab protein is not considered toxic.
    Since modified Cry1Ab 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 modified Cry1Ab 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 
modified Cry1Ab with known allergens showed no significant sequence 
identity over 80 amino acids or identity at the level of 8 contiguous 
amino acid residues.
    3. Digestibility. Modified Cry1Ab was rapidly digested in simulated 
gastric fluid containing pepsin.
    4. Glycosylation. Modified Cry1Ab expressed in cotton was shown not 
to be glycosylated.
    5. Conclusion. Considering all of the available information, EPA 
has concluded that the potential for modified Cry1Ab to be a food 
allergen is minimal.
    Although modified Cry1Ab was only shown not to be glycosylated in 
cotton, it is unlikely to be glycosylated in any other crops because in 
order for a protein to be glycoslyated, it needs to contain specific 
recognition sites for the enzymes involved in glycosylation, and the 
mechanisms of protein glycosylation are similar in different plants 
(Ref. 2).

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).
    The Agency has considered available information on the aggregate 
exposure levels of consumers (and major identifiable subgroups of 
consumers) to the pesticide chemical residue (i.e., the modified Cry1Ab 
protein) and to other related substances. These considerations include 
dietary exposure under the tolerance exemption and all other exposures 
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 modified 
Cry1Ab to be an allergen is low, as discussed above. Although the 
allergenicity assessment focuses on potential to be a food allergen, 
the data also indicate a low potential for modified Cry1Ab 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 
modified Cry1Ab protein is agricultural. Dietary exposure may occur 
from ingestion of processed cotton products but is expected to be very 
low because the already low expression levels in the seed would be 
reduced further by the heat and pressure used for processing. Also, 
dietary exposure may theoretically occur

[[Page 40763]]

through exposure in drinking water because plant stubble may release 
modified Cry1Ab protein into ground water upon decay. This protein 
would not be expected to survive in the soil due to microbial 
degradation, adherence to soil components and removal upon exposure to 
drinking water treatment procedures. In addition, oral toxicity testing 
showed no adverse effects.

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, there is no common mechanism of toxicity 
for this protein; therefore, section 408(b)(2)(D)(v) does not apply.

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

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for 
the modified Cry1Ab protein includes the characterization of the 
expressed modified Cry1Ab protein in cotton, as well as the acute oral 
toxicity study, amino acid sequence comparisons to known allergens, 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 modified Cry1Ab 
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 modified Cry1Ab protein is non-toxic to humans. As mentioned above, 
when proteins are toxic, they are known to act via acute mechanisms and 
at very low dose levels (Ref. 1). Since no treatment-related adverse 
effects were shown to be caused by the Cry1Ab protein, even at 
relatively high dose levels, the modified Cry1Ab protein is not 
considered toxic. Basing this conclusion on acute oral toxicity data 
without requiring further toxicity testing and residue data is similar 
to the Agency position regarding toxicity and the requirement of 
residue data for the microbial Bacillus thuringiensis products from 
which this plant-incorporated protectant was derived (See 40 CFR 
158.2140). 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.
    Residue chemistry data were not required for a human health effects 
assessment of the subject plant-incorporated protectant ingredients 
because of the lack of mammalian toxicity. However, data submitted 
demonstrated low levels of the modified Cry1Ab protein in cotton 
tissues.
    Since Cry1Ab is a protein, potential allergenicity is also 
considered as part of the toxicity assessment. Considering all of the 
available information (1) modified Cry1Ab originates from a non-
allergenic source; (2) modified Cry1Ab has no sequence similarities 
with known allergens; (3) modified Cry1Ab is not glycosylated; and (4) 
modified Cry1Ab is rapidly digested in simulated gastric fluid; EPA has 
concluded that the potential for modified Cry1Ab to be an 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 modified Cry1Ab protein, as well as the minimal 
potential to be an allergen, demonstrate the safety of the product at 
levels well above possible maximum exposure levels anticipated.
    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 
modified Cry1Ab 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.

B. Infants and Children Risk Conclusions

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues and the cumulative effects on infants and children of 
the residues and other substances with a common mechanism of toxicity. 
In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database unless 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 
modified Cry1Ab protein. Thus, there are no threshold effects of 
concern and, as a result, the provision requiring an additional margin 
of safety does not apply. Further, the considerations of consumption 
patterns, special susceptibility, and cumulative effects do not apply.

C. Overall Safety Conclusion

    There is a reasonable certainty that no harm will result from 
aggregate exposure to the U.S. population, including infants and 
children, to the modified Cry1Ab protein and the genetic material 
necessary for its production. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion because, as 
discussed above, no toxicity to mammals has been observed, nor any 
indication of allergenicity potential for the plant-incorporated 
protectant.

VII. Other Considerations

A. Endocrine Disruptors

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

B. Analytical Method(s)

    A lateral flow enzyme-linked immunosorbent assay (ELISA) protocol 
has been provided to the Agency for detecting modified Cry1Ab in 
cotton.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the plant-incorporated 
protectant Bacillus thuringiensis modified Cry1Ab protein.

VIII. References

    1. Sjoblad, Roy D., et al., ``Toxicological Considerations for

[[Page 40764]]

Protein Components of Biological Pesticide Products,'' Regulatory 
Toxicology and Pharmacology 15, 3-9 (1992).
    2. Lerouge, P., Cabanes-Macheteau, M., Rayon, C., Fichette-
Lain[egrave], A-C., Gomord, V., and Faye, L., ``N-Glycoprotein 
biosynthesis in plants: recent developments and future trends,'' Plant 
Molecular Biology 38: 31-48 (1998).

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, 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 26, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

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

0
2. Section 174.529 is added to subpart W to read as follows:

Sec.  174.529  Bacillus thuringiensis modified Cry1Ab protein as 
identified under OECD Unique Identifier SYN-IR67B-1 in cotton; 
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis modified Cry1Ab protein as 
identified under OECD Unique Identifier SYN-IR67B-1 are exempt from the 
requirement of a tolerance when used as a plant-incorporated protectant 
in cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal; 
cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts.
[FR Doc. E8-16277 Filed 7-15-08; 8:45 am]

BILLING CODE 6560-50-S