[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:
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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.
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Therefore, 40 CFR chapter I is amended as follows:
PART 174--[AMENDed]
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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]
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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