[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