[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Rules and Regulations]
[Page 55254-55260]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se05-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[OPP-2005-0211; FRL-7735-4]
Bacillus Thuringiensis Cry34Ab1 and Cry35Ab1 Proteins and the
Genetic Material Necessary for Their Production in Corn; 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 Cry34Ab1 and
Cry35Ab1 proteins and the genetic material necessary for their
production in corn on corn, field; corn, sweet; and corn, pop when
applied/used as a plant-incorporated protectant. Mycogen Seeds c/o Dow
AgroSciences LLC 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
[[Page 55255]]
need to establish a maximum permissible level for residues of Bacillus
thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material
necessary for their production in corn.
DATES: This regulation is effective September 21, 2005. Objections and
requests for hearings must be received on or before November 21, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0211. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8715; e-mail address: mendelsohn.mike@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit I. 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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 174
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of August 31, 2004 (69 FR 53060) (FRL-7369-
7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 3F6785) by Mycogen Seeds c/o Dow AgroSciences LLC, 9330
Zionsville Road, Indianapolis, IN 46268. The petition requested that a
temporary exemption from the requirement of a tolerance be established
for residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins
and the genetic material necessary for their production in corn. This
notice included a summary of the petition prepared by the petitioner
Mycogen Seeds c/o Dow AgroSciences LLC. One comment was received from a
private citizen who opposed issuance of a final rule. She expressed
concern regarding Dow's record, genetically modified corn, the impact
that killing rootworm would have on the environment, and that the
notice of filing mentioned ``studies'' without giving a specific
number. The Agency understands and recognizes that some individuals
believe that genetically modified crops and food should be banned
completely. Corn rootworms are a significant agricultural pest and are
extensively treated in the United States. Pursuant to its authority
under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA has
conducted a comprehensive assessment of the Cry34Ab1 and Cry35Ab1
proteins and the genetic material necessary for their production in
corn. EPA has concluded that there is a reasonable certainty that no
harm will result from dietary exposure to these proteins as expressed
in genetically modified corn. Specific studies were listed in the
administrative material provided in the docket.
Section 408(c)(2)(A)(i) of the 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 the 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), 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), 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 the 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 the 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.
[[Page 55256]]
Acute oral toxicity data have been submitted demonstrating the lack
of mammalian toxicity at high levels of exposure to the pure Cry34Ab1
and Cry35Ab1 proteins separately and combined. These data demonstrate
the safety of the products at levels well above maximum possible
exposure levels that are reasonably anticipated in the crops. 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 these plant-
incorporated protectants were derived (See 40 CFR 158.740(b)(2)(i)).
For microbial products, further toxicity testing and residue data are
triggered by significant acute effects in studies such as the mouse
oral toxicity study, to verify the observed effects and clarify the
source of these effects (Tiers II and III).
Three acute oral toxicity studies on Cry34Ab1 and Cry35Ab1 in mice
were submitted, which indicated that these proteins are non-toxic to
humans.
In an oral toxicity study of Cry34Ab1 alone, Cry34Ab1 produced from
microbial culture was administered to five male mice (5,000 milligrams/
kilogram (mg/kg) body weight) by oral gavage as a 20% mixture in a 0.5%
aqueous methylcellulose vehicle. All animals survived the 2-week study.
No clinical signs were noted for any animals during the study. An
initial weight loss was observed in three mice at test days 1 and 2,
but they gained weight for the remainder of the study. The two other
animals gained weight throughout the study. No treatment-related gross
pathologic changes were observed during the study. Under the conditions
of this study, the acute oral LD50 for the test substance in
male CD-1 mice is greater than 5,000 mg/kg. Since the test substance
contained Cry34Ab1 at 54% purity, the acute oral LD50 for
the pure Cry34Ab1 protein is greater than 2,700 mg/kg.
In an oral toxicity study of Cry35Ab1 alone, Cry35Ab1 produced from
microbial culture was administered to five male mice (5,000 mg/kg body
weight) by oral gavage as a 20% mixture in a 0.5% aqueous
methylcellulose vehicle. All animals survived the 2-week study. No
clinical signs were noted for any animal during the study. An initial
weight loss was observed in two mice at test days 1 and 2, but they
gained weight for the remainder of the study. One animal had
fluctuating body weight. The other two animals gained weight throughout
the study. No treatment-related gross pathologic changes were observed
during the study. Under the conditions of this study, the acute oral
LD50 for the test substance in male CD-1 mice is greater
than 5,000 mg/kg. Since the test substance contained Cry35Ab1 at 37%
purity, the acute oral LD50 for the pure Cry35Ab1 protein is
greater than 1,850 mg/kg.
Finally, in an oral toxicity of Cry34Ab1 and Cry35Ab1 combined, a
mixture of the microbially produced Cry34Ab1 and Cry35Ab1 proteins
(5,000 mg test material, containing 482 mg pure Cry34Ab1 and 1,520 mg
pure Cry35Ab1 (corresponding to an equimolar ratio), per kg body
weight) was administered by oral gavage to five female and five male
mice as a 20% mixture in 0.5% aqueous methylcellulose. All animals
survived the 2-week study. One female mouse exhibited protruding or
bulging eyes on days 6 and 7, but this resolved thereafter. This
observation was not attributed to the treatment as it was an isolated
observation (i.e., no other animals exhibited this). No other clinical
signs were noted for any animals during the study. An initial weight
loss was observed in two mice at test days 1 and 2, but both gained
weight for the remainder of the study. All other animals gained weight
throughout the study. No treatment related gross pathologic changes
were noted. Under the conditions of the study, the acute oral
LD50 of the test material in male and female CD-1 mice is
greater than 5,000 mg/kg body weight, corresponding to 2,000 mg/kg of
an equimolar ratio of the pure proteins.
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 effects were shown to be caused by the plant-
incorporated protectants, even at relatively high dose levels, the
Cry34Ab1 and Cry35Ab1 proteins are not considered toxic. Further, amino
acid sequence comparisons showed no similarity between the Cry34Ab1 and
Cry35Ab1 proteins to known toxic proteins available in public protein
data bases.
Since Cry34Ab1 and Cry35Ab1 are proteins, allergenic potential was
also considered. Currently, no definitive tests for determining the
allergenic potential of novel proteins exist. Therefore, EPA uses a
weight-of-the-evidence approach where the following factors are
considered: Source of the trait; amino acid sequence similarity with
known allergens; prevalence in food; and biochemical properties of the
protein, including in vitro digestibility in simulated gastric fluid
(SGF) and glycosylation. Current scientific knowledge suggests that
common food allergens tend to be resistant to degradation by acid and
proteases; may be glycosylated, and can be present at high
concentrations in the food. In the past, EPA has also considered heat
stability in assessing allergenicity potential; however, the FIFRA
Scientific Advisory Panel at a March 1-2, 2005 meeting stated that heat
stability based on a bioactivity assay is of minimal to no value in
predicting the allergenicity potential of novel proteins, and EPA
agrees. Therefore, EPA did not consider heat stability of these
proteins in its weight-of-evidence approach.
1. Source of the trait. Bacillus thuringiensis is not considered to
be a source of allergenic proteins.
2. Amino acid sequence. A comparison of amino acid sequences of
Cry34Ab1 and Cry35Ab1 with known allergens showed no overall sequence
similarities or homology at the level of eight contiguous amino acid
residues.
3. Prevalence in food. Expression level analysis indicated that the
proteins are present at relatively low levels in corn; on a dry weight
basis, Cry34Ab1 is present at a concentration of approximately 50
nanograms/milligram (ng/mg) in grain from Event 59122-7, and Cry35Ab1
is present at a concentration of approximately 1 ng/mg in grain from
Event 59122-7. Thus, expression of the Cry34Ab1 and Cry35Ab1 proteins
in corn kernels has been shown to be in the parts per million range.
4. Digestibility. Two in vitro digestibility studies were conducted
to determine the stability of the Cry34Ab1 and Cry35Ab1 proteins in
simulated gastric fluid (i.e., an acid environment containing pepsin;
SGF). In the first in vitro digestibility study, the proteins were
incubated in SGF (pepsin concentration: 3.2 milligrams/milliliter (mg/
mL); pH 1.2; 37[deg] C) with a pepsin to protein substrate ratio of
approximately 20:1, molecule/molecule (mol/mol) (equivalent to 60:1, w/
w for Cry34Ab1 and 17:1, w/w for Cry35Ab1). Samples taken at 1, 5, 7,
15, 20, 30, and 60 minutes were analyzed by sodium dodecyl sulfate
polyacrylamide gel electrophoresis (SDS-PAGE) and western blot.
Cry35Ab1 was no longer visible at the 5-minute time-point using both
SDS-PAGE stained with Coomassie Brilliant Blue and western blot
detection. Cry34Ab1 was visible on the stained gel for the 15-minute
sample,
[[Page 55257]]
but not in later sample time points. In the western blot analysis,
Cry34Ab1 was visible in the 20-minute sample, but not in later sample
time points. In conclusion, this first study showed that Cry34Ab1 was
digested within 30 minutes and Cry35Ab1 was digested within 5 minutes
in SGF under the conditions of the study.
Because Cry34Ab1 appeared to be somewhat resistant to SGF in the
study described above that used the time-to-disappearance endpoint, Dow
submitted a second study on the in vitro digestibility of Cry34Ab1 in
SGF using a kinetic approach. The digestion was performed under the
same conditions as the previous study except that reaction mixtures
were shaken during incubation, and samples were analyzed at 1, 2, 3, 5,
7.5, 10, 15, and 20 minutes. The previous study on pepsin digestibility
of Cry34Ab1 and Cry35Ab1, as well as other pepsin digestibility studies
used in allergenicity assessments, focused on the time required for the
protein to become undetectable, and therefore, the results are
dependent on the detection limit of the analytical method used. In this
second study, Dow determined the rate of pepsin digestion of Cry34Ab1
by measuring the relative amounts of Cry34Ab1 at each of the time
points based on SDS-PAGE densitometry estimates. Under the conditions
of the study, the rate of decay fit a first-order model (with respect
to Cry34Ab1 concentration), and Dow estimated the DT50
(half-life) and DT90 (time until 90% decay) to be 1.9
minutes and 6.2 minutes, respectively. In this experiment, Cry34Ab1 was
visible on gels and blots in 15-minute time point samples but not in
20-minute time point samples.
Because the digestibility of Cry34Ab1 was assessed using a
different method (i.e., the kinetic approach) rather than the typical
end-point method that has been used previously, comparison studies
using the kinetic approach to assess the digestibility of known
allergens and non-allergens were submitted to validate the method and
allow comparison of the digestibility of Cry34Ab1 with known allergens
and non-allergens. In the comparison study where the conditions used
were the same as those used in the kinetic study on the digestibility
of Cry34Ab1, two allergens and two non-allergens were shown to digest
similarly to Cry34Ab1. From these studies and published studies, EPA
concludes that Cry35Ab1 is rapidly digested and Cry34Ab1 is digested at
a moderate rate in SGF; Cry34Ab1 appears to digest slower than
previously registered proteins and many other proteins that are not
considered allergens but faster than most previously tested allergens.
On March 1-2, 2005, EPA held a FIFRA Scientific Advisory Panel
(SAP) meeting, http://www.epa.gov/oscpmont/sap/#march, to address the
scientific issues that arose during the human health safety assessment
of Cry34Ab1 and Cry35Ab1. EPA asked the SAP to comment on EPA's
allergenicity assessment of Cry34Ab1. The SAP agreed with EPA's
preliminary assessment that the allergenicity potential of Cry34Ab1 is
low. However, the Panel based its conclusion in part on statements made
by Dow that Cry34Ab1 and Cry35Ab1 do not aggregate in solution. The
Panel was concerned that if the proteins were to aggregate, protease
binding sites could be masked, and the rate of digestion could be
slower than was observed for the individual proteins. Therefore, EPA
asked Dow to submit data supporting the claim that Cry34Ab1 and
Cry35Ab1 do not associate with one another in solution.
To support the digestibility studies on the individual proteins,
Dow submitted a study using size exclusion chromatography, which
demonstrated that Cry34Ab1 and Cry35Ab1 do not associate with one
another in solution under acidic conditions.
5. Glycosylation. Cry34Ab1 and Cry35Ab1 expressed in corn were
shown not to be glycosylated.
6. Conclusion. Considering all of the available information: (1)
Cry34Ab1 and Cry35Ab1 originate from a non-allergenic source;(2)
Cry34Ab1 and Cry35Ab1 have no overall sequence similarities or homology
at the level of eight contiguous amino acid residues with known
allergens; (3) Cry34Ab1 and Cry35Ab1 will only be present at low levels
in food; (4) Cry35Ab1 is rapidly digested in SGF, and Cry34Ab1 is
digested at a moderate rate in SGF; and (5) Cry34Ab1 and Cry35Ab1 are
not glycoslyated when expressed in maize. EPA has concluded that the
potential for the Cry34Ab1 and Cry35Ab1 proteins to be food allergens
is minimal. The FIFRA SAP that met on March 1-2, 2005, agreed with this
conclusion regarding the allergenicity potential of Cry34Ab1. There
were no triggers to raise concern about the allergenicity of Cry35Ab1,
so the SAP was not asked to comment specifically on Cry35Ab1. As noted
above, toxic proteins typically act as acute toxins with low dose
levels. Therefore, since no effects were shown to be caused by the
plant-incorporated protectants, even at relatively high dose levels,
the Cry34Ab1 and Cry35Ab1 proteins are not considered toxic.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the 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 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 protectants are contained
within plant cells, which essentially eliminates these exposure routes
or reduces these exposure routes to negligible. Exposure via
residential or lawn use to infants and children is also not expected
because the use sites for the Cry34Ab1 and Cry35Ab1 proteins are all
agricultural for control of insects. Oral exposure, at very low levels,
may occur from ingestion of processed corn products and, potentially,
drinking water. However, oral toxicity testing showed no adverse
effects. Furthermore, the expression of the Cry34Ab1 and Cry35Ab1
proteins in corn kernels has been shown to be in the parts per million
range, which makes the expected dietary exposure several orders of
magnitude lower than the amounts of Cry34Ab1 and Cry35Ab1 proteins
shown to have no toxicity. Therefore, even if negligible aggregate
exposure should occur, the Agency concludes that such exposure would
result in no harm due to the lack of mammalian toxicity and low
potential for allergenicity demonstrated for the Cry34Ab1 and Cry35Ab1
proteins.
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,
resulting from the
[[Page 55258]]
plant-incorporated protectants, we conclude that there are no
cumulative effects for the Cry34Ab1 and Cry35Ab1 proteins.
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 Cry34Ab1 and Cry35Ab1 proteins include the characterization of the
expressed Cry34Ab1 and Cry35Ab1 proteins in corn, as well as the acute
oral toxicity, and in vitro digestibility of the proteins. The results
of these studies were determined applicable to evaluate human risk, and
the validity, completeness, and reliability of the available data from
the studies were considered.
Adequate information was submitted to show that the Cry34Ab1 and
Cry35Ab1 proteins test material derived from microbial cultures was
biochemically and, functionally similar to the protein produced by the
plant-incorporated protectant ingredients in corn. Production of
microbially produced protein was chosen in order to obtain sufficient
material for testing.
The acute oral toxicity data submitted support the prediction that
the Cry34Ab1 and Cry35Ab1 proteins would be 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 (Sjoblad, Roy D., et al.
``Toxicological Considerations for Protein Components of Biological
Pesticide Products,'' Regulatory Toxicology and Pharmacology 15, 3-9
(1992)). Since no effects were shown to be caused by the Cry34Ab1 and
Cry35Ab1 proteins, even at relatively high dose levels, the Cry34Ab1
and Cry35Ab1 proteins are 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 these plant-incorporated protectants
were derived. (See 40 CFR 158.740(b)(2)(i)). For microbial products,
further toxicity testing and residue data are triggered by significant
acute effects in studies such as the mouse oral toxicity study to
verify the observed effects and clarify the source of these effects
(Tiers II and III).
Cry34Ab1 and Cry35Ab1 proteins 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
Cry34Ab1 and Cry35Ab1 proteins in corn tissues.
Since Cry34Ab1 and Cry35Ab1 are proteins, their potential
allergenicity is also considered as part of the toxicity assessment.
Considering all of the available information (1) Cry34Ab1 and Cry35Ab1
originate from a non-allergenic source; (2) Cry34Ab1 and Cry35Ab1 have
no overall sequence similarities or homology at the level of eight
contiguous amino acid residues with known allergens; (3) Cry34Ab1 and
Cry35Ab1 are not glycoslyated when expressed in maize; (4) Cry34Ab1 and
Cry35Ab1 will only be present at low levels in food; and (5) Cry35Ab1
is rapidly digested in SGF, and Cry34Ab1 is digested at a moderate rate
in SGF; EPA has concluded that the potential for the Cry34Ab1 and
Cry35Ab1 proteins to be food allergens is minimal. The FIFRA Scientific
Advisory Panel (SAP) that met on March 1-2, 2005 agreed with this
conclusion regarding the allergenicity potential of Cry34Ab1. There
were no triggers to raise concern about the allergenicity of Cry35Ab1,
so the SAP was not asked to comment specifically on Cry35Ab1.
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 Cry34Ab1 and Cry35Ab1 proteins, 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 ingredients are the nucleic acids (DNA,
RNA) which comprise genetic material encoding these proteins and their
regulatory regions. The genetic material (DNA, RNA), necessary for the
production of the Cry34Ab1 and Cry35Ab1 proteins have been exempted
under the blanket exemption for all nucleic acids (40 CFR 174.475).
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
Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for
their production. 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 provisions 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 Cry34Ab1 and Cry35Ab1 proteins and the genetic
material necessary for their 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 protectants.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredients are proteins, derived from
sources that are 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 protectants at this time.
B. Analytical Method(s)
Validated enzyme-linked immunosorbent assays for the detection and
quantification of Cry34Ab1 and Cry35Ab1 in corn tissue have been
submitted and found acceptable by the Agency.
[[Page 55259]]
C. Codex Maximum Residue Level
No Codex maximum residue levels exist for the plant-incorporated
protectants Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and
the genetic material necessary for its production in corn.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the 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. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0211 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 November
21, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0211 , to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the 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 rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this 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). 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., or 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). 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);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the exemption 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to
[[Page 55260]]
include regulations that have ``substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: August 29, 2005.
James Jones,
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 174.457 is added to subpart W to read as follows:
Sec. 174.457 Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins
and the genetic material necessary for their production in corn;
exemption from the requirement of a tolerance.
Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the
genetic material necessary for their production in corn are exempted
from the requirement of a tolerance when used as plant-incorporated
protectants in the food and feed commodities of corn; corn, field;
corn, sweet; and corn, pop.
[FR Doc. 05-18582 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S