Bacillus Thuringiensis Vip3Aa20 Protein and the Genetic Material Necessary for its Production in Corn; Extension of Temporary Exemption From the Requirement of a Tolerance, 68525-68529 [E7-23308]
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Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations
K. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as amended 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 Congress and the
Comptroller General of the United
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States before publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). This final
rule is effective on January 4, 2008.
L. Statutory Authority
The statutory authority for this action
comes from section 213 of the Clean Air
Act as amended (42 U.S.C. 7547). This
action is a rulemaking subject to the
provisions of Clean Air Act section
307(d). See 42 U.S.C. 7607(d).
List of Subjects in 40 CFR Part 94
Environmental protection,
Administrative practice and procedure,
Air pollution control, Confidential
business information, Imports,
Penalties, Reporting and recordkeeping
requirements, Vessels, Warranties.
Dated: November 29, 2007.
Stephen L. Johnson,
Administrator.
For the reasons set out in the
preamble, title 40, chapter I of the Code
of Federal Regulations is amended as
follows:
I
PART 94—CONTROL OF AIR
POLLUTION FROM MARINE
COMPRESSION—IGNITION
EMISSIONS
1. The authority citation for part 94
continues to read as follows:
I
Authority: 42 U.S.C. 7401–7671q.
2. Section 94.8 is amended by revising
paragraph (a)(2)(ii) to read as follows:
I
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§ 94.8
Exhaust emission standards.
(a) * * *
(2) * * *
(ii) EPA has not finalized Tier 2
standards for Category 3 engines. EPA
will promulgate final Tier 2 standards
for Category 3 engines on or before
December 17, 2009.
*
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[FR Doc. E7–23557 Filed 12–4–07; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 174
[EPA–HQ–OPP–2007–0574; FRL–8340–5]
Bacillus Thuringiensis Vip3Aa20
Protein and the Genetic Material
Necessary for its Production in Corn;
Extension of Temporary Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation extends the
temporary exemption from the
requirement of a tolerance for residues
of Bacillus thuringiensis Vip3Aa20
protein in corn when applied or used as
a plant-incorporated protectant.
Syngenta Seeds, Inc., submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA), requesting that the
temporary tolerance exemption be
extended. This regulation eliminates the
need to establish a maximum
permissible level for residues of the
Bacillus thuringiensis Vip3Aa20 protein
in corn when applied or used as a plantincorporated protectant on field corn,
sweet corn, and popcorn. The temporary
tolerance exemption expires on October
31, 2009.
DATES: This regulation is effective
December 5, 2007. Objections and
requests for hearings must be received
on or before February 4, 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–2007–0574. To access the
electronic docket, go to https://
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.
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Publicly available docket materials are
available in the electronic docket at
https://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:
Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
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. 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 https://
www.regulations.gov, you may access
this ‘‘Federal Register’’ document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 174
through the Government Printing
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Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
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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–2007–0574 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 February 4, 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–2007–0574, by one of
the following methods.
• Federal eRulemaking Portal: https://
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 8,
2007 (72 FR 44521) (FRL–8139–7), 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 petition (PP 7F7212) by
Syngenta Seeds, Inc., 3054 Cornwallis
Rd., P.O. Box 12257, Research Triangle
Park, NC 27709. The petition requested
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that 40 CFR 174.458 (now 40 CFR
174.528, see the Federal Register issue
of April 25, 2007 (72 FR 20431) (FRL–
7742–2) be amended such that the
temporary tolerance exemption for
Bacillus thuringiensis Vip3Aa20 protein
and the genetic material necessary for
its production in corn when applied/
used as a plant-incorporated protectant
on field corn, sweet corn, and popcorn
expires on October 31, 2009.
This notice included a summary of
the petition prepared by Syngenta
Seeds, Inc., the registrant. There were
no comments received in response to
the notice of filing.
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(c)(2)(B) of
FFDCA, EPA has reviewed the available
scientific data and other relevant
information in support of this action
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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.
Data have been submitted
demonstrating a lack of mammalian
toxicity at high levels of exposure to the
pure (microbially expressed) Vip3Aa20
protein. These data demonstrate the
safety of Vip3Aa20 at well above
maximum possible exposure levels that
are reasonably anticipated in the crops.
This 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, the need for Tier II and III
toxicity testing and residue data to
verify the observed effects and clarify
the source of these effects is triggered
only by significant acute effects in
studies such as the mouse oral toxicity
study.
In order to clarify the discussion that
follows in the remainder of this final
rule, it is necessary to distinguish the
various Vip3A designations that are
used. Vip3Aa20 is the designation
applicable to Vip3A protein expressed
in corn. Vip3Aa19 is the designation
applicable to Vip3A protein expressed
in cotton. Because the Agency has
determined that both Vip3Aa19 and
Vip3Aa20 are functionally equivalent,
the Agency in amending this temporary
tolerance exemption for Vip3Aa20
expressed in corn has relied on data and
analysis specifically developed for
Vip3Aa20, as well as on data and
analysis specifically developed for
Vip3Aa19. A separate temporary
exemption from the requirement of
tolerance already has been established
for Vip3Aa19 as expressed in cotton (72
FR 40754; 40 CFR 174.501).
An acute oral toxicity study was
submitted for the Vip3Aa19 protein.
Male and female mice (16 of each) were
dosed with 3,675 milligrams/kilograms
bodyweight (mg/kg bwt) of Vip3Aa19
protein. All mice survived the study,
gained weight, had no test materialrelated clinical signs, and had no test
material-related findings at necropsy.
This acute oral toxicity data also
supports the prediction that the
Vip3Aa20 protein would be non-toxic to
humans.
When proteins are toxic, they are
known to act via acute mechanisms and
at very low-dose levels (Sjoblad, Roy D.,
et al. 1992). Therefore, since no effects
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were shown to be caused by the plantincorporated protectants, even at
relatively high-dose levels, the
Vip3Aa20 protein is not considered
toxic. Amino acid sequence
comparisons showed no similarity
between the Vip3Aa20 protein and
known toxic proteins available in public
protein data bases. According to the
Codex Alimintarius guidelines, the
assessment of potential toxicity also
includes stability to heat Food and
Agriculture Organization of the United
Nations/World Health Organization
Standards Programme, 2001. A heat
lability study demonstrated that
Vip3Aa19 is inactivated against fall
army worm, when heated to 55 °C for
30 minutes.
Since Vip3Aa20 is a protein,
allergenic sensitivities were considered.
Currently, no definitive tests exist for
determining the allergenic potential of
novel proteins. 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, and glycosylation. Current
scientific knowledge suggests that
common food allergens tend to be
resistant to degradation acid and
proteases; may be glycosylated; and
present at high concentrations in the
food.
Data have been submitted that
demonstrate that the Vip3A from
recombinant maize (LPPACHA–0199)
and E. coli (VIP3A-0100) proteins are
rapidly degraded by gastric fluid in
vitro. (VIP3A–0100 refers to a
microbially expressed Vip3A that has
been shown to be the equivalent of the
plant-expressed Vip3A protein.) In a
solution of simulated gastric fluid
(containing pepsin) and either 80
microLiter (µL) of LPPACHA–0199 or
320 µL of VIP3A–0100 test protein, both
were shown to be susceptible to pepsin
degradation. These data support the
conclusion that Vip3A proteins
expressed in transgenic plants will be
readily digested as a conventional
dietary protein under typical
mammalian gastric conditions. Further
data demonstrate that Vip3Aa20 is not
glycoslylated and a comparison of
amino acid sequences of known
allergens uncovered no evidence of any
homology with Vip3Aa20, even at the
level of 8 contiguous amino acid
residues. Preliminary data of the
quantification of Vip3Aa20 protein in
various maize tissues were also
submitted. This data demonstrated that
mean Vip3Aa20 concentrations in corn
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kernels ranged from circa (ca). 24.6–40.3
microgram (µg) Vip3Aa20/gram (g) dry
weight, representing ca. 0.003% of the
total protein in grain (assuming that
corn grain contains 10% total protein by
weight). Therefore, Vip3Aa20 is present
in low levels in corn tissue and the
protein expression is much lower than
the amounts of allergen protein found in
commonly allergenic foods. In those
foods, the allergens can be 10 to 50% of
the total protein found.
Therefore, the potential for the
Vip3Aa20 protein to be a food allergen
is minimal. As noted in grams/kilogram
(gm/kg), toxic proteins typically act as
acute toxins with low-dose levels.
Therefore, since no effects were shown
to be caused by this plant-incorporated
protectant, even at relatively high-dose
levels, the Vip3Aa20 protein is not
considered toxic.
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 nonoccupational 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 protectant
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. The amino acid homology
assessment revealed no similarities to
known aeroallergens, indicating that
Vip3A has a low potential to be an
inhalation allergen. It has been
demonstrated that there is no evidence
of occupationally related respiratory
symptoms, based on a health survey on
migrant workers after exposure to
Bacillus thuringiensis pesticides
(Berstein et al. 1999), which provides
further evidence of the negligible
respiratory risks of Bacillus
thuringiensis plant-incorporated
protectants. Exposure via residential or
lawn use to infants and children is also
not expected because the use sites for
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the Vip3Aa20 protein are all agricultural
for control of insects. Oral exposure, at
very low levels may occur from
ingestion of processed corn products
and, theoretically, drinking water.
However, oral toxicity testing done at
a dose in excess of 3 grams/kilogram
showed no adverse effects. Furthermore,
the expected dietary exposure from both
cotton and corn are several orders of
magnitude lower than the amounts of
Vip3Aa20 protein shown to have no
toxicity. Therefore, even if negligible
aggregate exposure should occur, the
Agency concludes that such exposure
would present no harm due to the lack
of mammalian toxicity and the rapid
digestibility demonstrated for the
Vip3Aa20 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 include 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, the Agency
concludes that there are no cumulative
effects arising from Vip3Aa20 protein
residues in corn.
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
Vip3Aa20 protein include the
characterization of the expressed
Vip3Aa20 protein in corn, as well as the
acute oral toxicity, heat stability, 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 Vip3A protein test
material derived from microbial cultures
(designated VIP3A–0100) was
biochemically and functionally similar
to the Vip3Aa20 protein expressed in
corn. Microbially produced protein was
chosen in order to obtain sufficient
material for testing.
The acute oral toxicity data submitted
support the prediction that the
Vip3Aa20 protein 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-
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dose levels (Sjoblad, Roy D., et al. 1992).
Since no effects were shown to be
caused by Vip3Aa20 protein, even at
relatively high-dose levels (3,675 mg
Vip3Aa19/kg bwt), the Vip3Aa20
protein is not considered toxic. This 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. Moreover, Vip3Aa20 showed
no sequence similarity to any known
toxin.
Protein residue chemistry data for
Vip3Aa20 were not required for a
human health effects assessment of the
subject plant-incorporated protectant
ingredients because of the lack of
mammalian toxicity. However,
preliminary data (that were submitted
with administrative materials for an
Experimental Use Permit (EUP)
application for corn expressing the
Vip3Aa20 protein) demonstrated low
levels of Vip3Aa20 in corn tissues with
less than 40 µg Vip3Aa20 protein/g dry
weight in kernels and less than 75 µg
Vip3Aa20 protein/g dry weight of whole
corn plant.
Since Vip3Aa20 is a protein, its
potential allergenicity is also considered
as part of the toxicity assessment.
Information considered as part of the
allergenicity assessment included data
demonstrating that the Vip3Aa20
protein came from a Bacillus
thuringiensis which is not a known
allergenic source, showed no sequence
similarity to known allergens, was
readily degraded by pepsin, and was not
glycosylated when expressed in the
plant. Therefore, there is a reasonable
certainty that the Vip3Aa20 protein will
not be an allergen.
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
Vip3Aa20 protein, as well as the
minimal potential to be a food allergen,
demonstrate the safety of Vip3Aa20 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
Vip3Aa20 protein already are exempted
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from the requirement of a tolerance
under a blanket exemption for all
nucleic acids (40 CFR 174.507).
B. Infants and Children Risk
Conclusions
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, 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 data base, 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 Vip3Aa20 protein and
the genetic material necessary for its
production in corn. Because there are no
threshold effects of concern, the Agency
has determined that the additional
tenfold margin of safety is not necessary
to protect infants and children. 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 to the U.S. population,
including infants and children, from
aggregate exposure to residues of the
Vip3Aa20 protein and the genetic
material necessary for its production in
corn, when it is applied/used in
accordance with good agricultural
practices on field corn, sweet corn, and
popcorn. 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 previously
discussed, no toxicity to mammals has
been observed, nor has there been any
indication of allergenicity potential for
this plant-incorporated protectant.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredient is a
protein, 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 plantincorporated protectant at this time.
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B. Analytical Method(s)
A method for extraction and Enzyme
Linked Immunosorbent (ELISA)
Analysis of Vip3Aa20 protein in corn
has been submitted and is under review
by the Agency.
C. Codex Maximum Residue Level
No Codex maximum residue levels
exist for the plant-incorporated
protectant Bacillus thuringiensis
Vip3Aa20 protein and the genetic
material necessary for its production in
corn.
VIII. Statutory and Executive Order
Reviews
This final rule extends the exemption
from the requirement of a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866, 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) 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
E:\FR\FM\05DER1.SGM
05DER1
Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations
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 6, 2000) do not apply
to this rule. In addition, This 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).
IX. 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,
Corn, Pesticides and pests, Reporting
and recordkeeping requirements.
Dated: November 19, 2007,
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 174—[AMENDED]
1. The authority citation for part 174
continues to read as follows:
sroberts on PROD1PC70 with RULES
I
Authority: 7 U.S.C. 136–136y; 21 U.S.C.
346a and 371.
2. Section 174.528 is revised to read
as follows:
I
VerDate Aug<31>2005
17:07 Dec 04, 2007
Jkt 214001
§ 174.528 Bacillus thuringiensis Vip3Aa20
protein in corn; temporary exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis
Vip3Aa20 protein in corn are
temporarily exempt from the
requirement of a tolerance when used as
a plant-incorporated protectant in the
food and feed commodities; corn, field;
corn, sweet; and corn, pop. This
temporary exemption from the
requirement of tolerance will permit the
use of the food commodities in this
section when treated in accordance with
the provisions of the experimental use
permit 67979–EUP–6, which is being
amended and extended in accordance
with the provisions of the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended (7 U.S.C. 136).
This temporary exemption from the
requirement of a tolerance expires and
is revoked October 31, 2009; however, if
the experimental use permit is revoked,
or if any experience with or scientific
data on this pesticide indicate that the
temporary tolerance exemption is not
safe, this temporary exemption from the
requirement of a tolerance may be
revoked at any time.
[FR Doc. E7–23308 Filed 12–4–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0195; FRL–8342–2]
Ethalfluralin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of ethalfluralin
in or on dill, dried leaves; dill, fresh
leaves; mustard, seed; potato; and
rapeseed, seed. It also removes the
current tolerance for residues of
ethalfluralin on canola seed since
residues on canola are covered by the
rapeseed tolerance, thus making the
canola tolerance unnecessary.
Interregional Research Project Number 4
(IR–4) requested the new tolerances and
removal of the canola tolerance under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
December 5, 2007. Objections and
requests for hearings must be received
on or before February 4, 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).
PO 00000
Frm 00059
Fmt 4700
Sfmt 4700
68529
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0195. To access the
electronic docket, go to https://
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
https://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:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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 those engaged in the
following activities:
• Crop production (NAICS code
111), e.g., agricultural workers;
greenhouse, nursery, and floriculture
workers; farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
E:\FR\FM\05DER1.SGM
05DER1
]]>Agencies
[Federal Register Volume 72, Number 233 (Wednesday, December 5, 2007)]
[Rules and Regulations]
[Pages 68525-68529]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23308]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2007-0574; FRL-8340-5]
Bacillus Thuringiensis Vip3Aa20 Protein and the Genetic Material
Necessary for its Production in Corn; Extension of Temporary Exemption
From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation extends the temporary exemption from the
requirement of a tolerance for residues of Bacillus thuringiensis
Vip3Aa20 protein in corn when applied or used as a plant-incorporated
protectant. Syngenta Seeds, Inc., submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA), requesting that the temporary
tolerance exemption be extended. This regulation eliminates the need to
establish a maximum permissible level for residues of the Bacillus
thuringiensis Vip3Aa20 protein in corn when applied or used as a plant-
incorporated protectant on field corn, sweet corn, and popcorn. The
temporary tolerance exemption expires on October 31, 2009.
DATES: This regulation is effective December 5, 2007. Objections and
requests for hearings must be received on or before February 4, 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-2007-0574. To access the
electronic docket, go to https://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 https://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: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
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. 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 https://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 174 through the
Government Printing
[[Page 68526]]
Office's pilot e-CFR site at https://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-2007-0574 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 February 4, 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-2007-0574, by one of the following methods.
Federal eRulemaking Portal: https://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 8, 2007 (72 FR 44521) (FRL-8139-
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 petition (PP
7F7212) by Syngenta Seeds, Inc., 3054 Cornwallis Rd., P.O. Box 12257,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
174.458 (now 40 CFR 174.528, see the Federal Register issue of April
25, 2007 (72 FR 20431) (FRL-7742-2) be amended such that the temporary
tolerance exemption for Bacillus thuringiensis Vip3Aa20 protein and the
genetic material necessary for its production in corn when applied/used
as a plant-incorporated protectant on field corn, sweet corn, and
popcorn expires on October 31, 2009.
This notice included a summary of the petition prepared by Syngenta
Seeds, Inc., the registrant. There were no comments received in
response to the notice of filing.
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(c)(2)(B) 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.
Data have been submitted demonstrating a lack of mammalian toxicity
at high levels of exposure to the pure (microbially expressed) Vip3Aa20
protein. These data demonstrate the safety of Vip3Aa20 at well above
maximum possible exposure levels that are reasonably anticipated in the
crops. This 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, the
need for Tier II and III toxicity testing and residue data to verify
the observed effects and clarify the source of these effects is
triggered only by significant acute effects in studies such as the
mouse oral toxicity study.
In order to clarify the discussion that follows in the remainder of
this final rule, it is necessary to distinguish the various Vip3A
designations that are used. Vip3Aa20 is the designation applicable to
Vip3A protein expressed in corn. Vip3Aa19 is the designation applicable
to Vip3A protein expressed in cotton. Because the Agency has determined
that both Vip3Aa19 and Vip3Aa20 are functionally equivalent, the Agency
in amending this temporary tolerance exemption for Vip3Aa20 expressed
in corn has relied on data and analysis specifically developed for
Vip3Aa20, as well as on data and analysis specifically developed for
Vip3Aa19. A separate temporary exemption from the requirement of
tolerance already has been established for Vip3Aa19 as expressed in
cotton (72 FR 40754; 40 CFR 174.501).
An acute oral toxicity study was submitted for the Vip3Aa19
protein. Male and female mice (16 of each) were dosed with 3,675
milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All
mice survived the study, gained weight, had no test material-related
clinical signs, and had no test material-related findings at necropsy.
This acute oral toxicity data also supports the prediction that the
Vip3Aa20 protein would be non-toxic to humans.
When proteins are toxic, they are known to act via acute mechanisms
and at very low-dose levels (Sjoblad, Roy D., et al. 1992). Therefore,
since no effects
[[Page 68527]]
were shown to be caused by the plant-incorporated protectants, even at
relatively high-dose levels, the Vip3Aa20 protein is not considered
toxic. Amino acid sequence comparisons showed no similarity between the
Vip3Aa20 protein and known toxic proteins available in public protein
data bases. According to the Codex Alimintarius guidelines, the
assessment of potential toxicity also includes stability to heat Food
and Agriculture Organization of the United Nations/World Health
Organization Standards Programme, 2001. A heat lability study
demonstrated that Vip3Aa19 is inactivated against fall army worm, when
heated to 55 [deg]C for 30 minutes.
Since Vip3Aa20 is a protein, allergenic sensitivities were
considered. Currently, no definitive tests exist for determining the
allergenic potential of novel proteins. 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,
and glycosylation. Current scientific knowledge suggests that common
food allergens tend to be resistant to degradation acid and proteases;
may be glycosylated; and present at high concentrations in the food.
Data have been submitted that demonstrate that the Vip3A from
recombinant maize (LPPACHA-0199) and E. coli (VIP3A-0100) proteins are
rapidly degraded by gastric fluid in vitro. (VIP3A-0100 refers to a
microbially expressed Vip3A that has been shown to be the equivalent of
the plant-expressed Vip3A protein.) In a solution of simulated gastric
fluid (containing pepsin) and either 80 microLiter ([micro]L) of
LPPACHA-0199 or 320 [micro]L of VIP3A-0100 test protein, both were
shown to be susceptible to pepsin degradation. These data support the
conclusion that Vip3A proteins expressed in transgenic plants will be
readily digested as a conventional dietary protein under typical
mammalian gastric conditions. Further data demonstrate that Vip3Aa20 is
not glycoslylated and a comparison of amino acid sequences of known
allergens uncovered no evidence of any homology with Vip3Aa20, even at
the level of 8 contiguous amino acid residues. Preliminary data of the
quantification of Vip3Aa20 protein in various maize tissues were also
submitted. This data demonstrated that mean Vip3Aa20 concentrations in
corn kernels ranged from circa (ca). 24.6-40.3 microgram ([micro]g)
Vip3Aa20/gram (g) dry weight, representing ca. 0.003% of the total
protein in grain (assuming that corn grain contains 10% total protein
by weight). Therefore, Vip3Aa20 is present in low levels in corn tissue
and the protein expression is much lower than the amounts of allergen
protein found in commonly allergenic foods. In those foods, the
allergens can be 10 to 50% of the total protein found.
Therefore, the potential for the Vip3Aa20 protein to be a food
allergen is minimal. As noted in grams/kilogram (gm/kg), toxic proteins
typically act as acute toxins with low-dose levels. Therefore, since no
effects were shown to be caused by this plant-incorporated protectant,
even at relatively high-dose levels, the Vip3Aa20 protein is not
considered toxic.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue 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 protectant 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. The amino acid homology
assessment revealed no similarities to known aeroallergens, indicating
that Vip3A has a low potential to be an inhalation allergen. It has
been demonstrated that there is no evidence of occupationally related
respiratory symptoms, based on a health survey on migrant workers after
exposure to Bacillus thuringiensis pesticides (Berstein et al. 1999),
which provides further evidence of the negligible respiratory risks of
Bacillus thuringiensis plant-incorporated protectants. Exposure via
residential or lawn use to infants and children is also not expected
because the use sites for the Vip3Aa20 protein are all agricultural for
control of insects. Oral exposure, at very low levels may occur from
ingestion of processed corn products and, theoretically, drinking
water.
However, oral toxicity testing done at a dose in excess of 3 grams/
kilogram showed no adverse effects. Furthermore, the expected dietary
exposure from both cotton and corn are several orders of magnitude
lower than the amounts of Vip3Aa20 protein shown to have no toxicity.
Therefore, even if negligible aggregate exposure should occur, the
Agency concludes that such exposure would present no harm due to the
lack of mammalian toxicity and the rapid digestibility demonstrated for
the Vip3Aa20 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 include 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, the
Agency concludes that there are no cumulative effects arising from
Vip3Aa20 protein residues in corn.
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 Vip3Aa20 protein include the characterization of the expressed
Vip3Aa20 protein in corn, as well as the acute oral toxicity, heat
stability, 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 Vip3A protein
test material derived from microbial cultures (designated VIP3A-0100)
was biochemically and functionally similar to the Vip3Aa20 protein
expressed in corn. Microbially produced protein was chosen in order to
obtain sufficient material for testing.
The acute oral toxicity data submitted support the prediction that
the Vip3Aa20 protein 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-
[[Page 68528]]
dose levels (Sjoblad, Roy D., et al. 1992). Since no effects were shown
to be caused by Vip3Aa20 protein, even at relatively high-dose levels
(3,675 mg Vip3Aa19/kg bwt), the Vip3Aa20 protein is not considered
toxic. This 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. Moreover, Vip3Aa20 showed no sequence similarity to any
known toxin.
Protein residue chemistry data for Vip3Aa20 were not required for a
human health effects assessment of the subject plant-incorporated
protectant ingredients because of the lack of mammalian toxicity.
However, preliminary data (that were submitted with administrative
materials for an Experimental Use Permit (EUP) application for corn
expressing the Vip3Aa20 protein) demonstrated low levels of Vip3Aa20 in
corn tissues with less than 40 [micro]g Vip3Aa20 protein/g dry weight
in kernels and less than 75 [mu]g Vip3Aa20 protein/g dry weight of
whole corn plant.
Since Vip3Aa20 is a protein, its potential allergenicity is also
considered as part of the toxicity assessment. Information considered
as part of the allergenicity assessment included data demonstrating
that the Vip3Aa20 protein came from a Bacillus thuringiensis which is
not a known allergenic source, showed no sequence similarity to known
allergens, was readily degraded by pepsin, and was not glycosylated
when expressed in the plant. Therefore, there is a reasonable certainty
that the Vip3Aa20 protein will not be an allergen.
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 Vip3Aa20 protein, as well as the minimal potential to
be a food allergen, demonstrate the safety of Vip3Aa20 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 Vip3Aa20 protein already are exempted from the
requirement of a tolerance under a blanket exemption for all nucleic
acids (40 CFR 174.507).
B. Infants and Children Risk Conclusions
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, 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 data base, 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
Vip3Aa20 protein and the genetic material necessary for its production
in corn. Because there are no threshold effects of concern, the Agency
has determined that the additional tenfold margin of safety is not
necessary to protect infants and children. 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 to the
U.S. population, including infants and children, from aggregate
exposure to residues of the Vip3Aa20 protein and the genetic material
necessary for its production in corn, when it is applied/used in
accordance with good agricultural practices on field corn, sweet corn,
and popcorn. 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 previously discussed, no
toxicity to mammals has been observed, nor has there been any
indication of allergenicity potential for this plant-incorporated
protectant.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredient is a protein, 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 protectant at this time.
B. Analytical Method(s)
A method for extraction and Enzyme Linked Immunosorbent (ELISA)
Analysis of Vip3Aa20 protein in corn has been submitted and is under
review by the Agency.
C. Codex Maximum Residue Level
No Codex maximum residue levels exist for the plant-incorporated
protectant Bacillus thuringiensis Vip3Aa20 protein and the genetic
material necessary for its production in corn.
VIII. Statutory and Executive Order Reviews
This final rule extends the exemption from the requirement of a
tolerance under section 408(d) of FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866, 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) 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
[[Page 68529]]
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 6, 2000) do not apply to this rule. In addition, This
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).
IX. 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,
Corn, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: November 19, 2007,
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 174--[AMENDED]
0
1. The authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.
0
2. Section 174.528 is revised to read as follows:
Sec. 174.528 Bacillus thuringiensis Vip3Aa20 protein in corn;
temporary exemption from the requirement of a tolerance.
Residues of Bacillus thuringiensis Vip3Aa20 protein in corn are
temporarily exempt from the requirement of a tolerance when used as a
plant-incorporated protectant in the food and feed commodities; corn,
field; corn, sweet; and corn, pop. This temporary exemption from the
requirement of tolerance will permit the use of the food commodities in
this section when treated in accordance with the provisions of the
experimental use permit 67979-EUP-6, which is being amended and
extended in accordance with the provisions of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This
temporary exemption from the requirement of a tolerance expires and is
revoked October 31, 2009; however, if the experimental use permit is
revoked, or if any experience with or scientific data on this pesticide
indicate that the temporary tolerance exemption is not safe, this
temporary exemption from the requirement of a tolerance may be revoked
at any time.
[FR Doc. E7-23308 Filed 12-4-07; 8:45 am]
BILLING CODE 6560-50-S
