Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic Material Necessary for Its Production in Corn in or on All Corn Commodities; Temporary Exemption From the Requirement of a Tolerance, 40431-40436 [E6-11249]
Download as PDF
<![CDATA[
rmajette on PROD1PC67 with RULES
Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Rules and Regulations
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
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
VerDate Aug<31>2005
15:22 Jul 14, 2006
Jkt 208001
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.
IX. 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: June 29, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PO 00000
Frm 00047
Fmt 4700
Sfmt 4700
40431
PART 174—[AMENDED]
1. The authority citation for part 174
continues to read as follows:
I
Authority: 7 U.S.C. 136-136y; 21 U.S.C.
346a and 371.
2. Section 174.453 is added to subpart
W to read as follows:
I
§ 174.453 Bacillus Thuringiensis
Cry1A.105 Protein and the Genetic Material
Necessary for Its Production in Corn.
Bacillus thuringiensis Cry1A.105
protein and the genetic material
necessary for its production in corn is
exempt from the requirement of a
tolerance when used as plantincorporated protectant in the food and
feed commodities of field corn, sweet
corn and popcorn. Genetic material
necessary for its production means the
genetic material which comprise genetic
material encoding the Cry1A.105
protein and its regulatory regions.
Regulatory regions are the genetic
material, such as promoters,
terminators, and enhancers, that control
the expression of the genetic material
encoding the Cry1A.105 protein. This
temporary exemption from the
requirement of a tolerance will permit
the use of the food commodities in this
paragraph when treated in accordance
with the provisions of the experimental
use permit 524–EUP–97 which is being
issued under 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 June 30, 2009; however, if the
experimental use permit is revoked, or
if any experience with or scientific data
on this pesticide indicate that the
tolerance is not safe, this temporary
exemption from the requirement of a
tolerance may be revoked at any time.
[FR Doc. E6–11245 Filed 7–14–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 174
[EPA–HQ–OPP–2006–0553; FRL–8076–6]
Bacillus Thuringiensis Cry2Ab2
Protein and the Genetic Material
Necessary for Its Production in Corn in
or on All Corn Commodities;
Temporary Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
temporary exemption from the
E:\FR\FM\17JYR1.SGM
17JYR1
40432
Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Rules and Regulations
requirement of a tolerance for residues
of the Bacillus Thuringiensis Cry2Ab2
protein and the genetic material
necessary for its production in corn on
field corn, sweet corn, and popcorn
when applied/used as a plantincorporated protectant. Monsanto
Company submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA), requesting the temporary/
tolerance exemption. This regulation
eliminates the need to establish a
maximum permissible level for residues
of Bacillus Thuringiensis Cry2Ab2
protein and the genetic material
necessary for its production in corn. The
temporary tolerance exemption will
expire on June 30, 2009.
This regulation is effective July
17, 2006. Objections and requests for
hearings must be received on or before
September 15, 2006, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0553. All documents in the
docket are listed in the index for the
docket. 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 Building),
2777 S. Crystal Drive, Arlington, VA.
The 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.
ADDRESSES:
rmajette on PROD1PC67 with RULES
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:
VerDate Aug<31>2005
15:22 Jul 14, 2006
Jkt 208001
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
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 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.
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–2006–0553 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before September 15, 2006.
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
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–2006–0553, 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 Building), 2777 S.
Crystal Drive, 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 telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of May 26,
2006 (Volume 71 FR 30400) (FRL–8066–
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
5G7005) by Monsanto Company, 800
North Lindbergh Blvd., St. Louis, MO
63167. The petition requested that 40
CFR part 174 be amended by
establishing a temporary exemption
from the requirement of a tolerance for
residues of Bacillus thuringiensis
Cry2Ab2 protein and the genetic
material necessary for its production in
corn. This notice included a summary of
the petition prepared by the petitioner
Monsanto Company. One comment was
received in response to the notice of
filing. The commenter objected to an
exemption from the requirement of a
tolerance, stated that she does not favor
genetically engineered corn, and stated
that such corn should be labeled. The
Agency understands the commenter’s
concerns and recognizes that some
individuals believe that genetically
modified crops and food should be
banned completely. Pursuant to its
authority under the FFDCA, EPA
conducted a comprehensive assessment
of the Cry2Ab2 protein and the genetic
material necessary for its production in
E:\FR\FM\17JYR1.SGM
17JYR1
Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Rules and Regulations
rmajette on PROD1PC67 with RULES
corn, including a review of acute oral
toxicity data on the Cry2Ab2 protein,
amino acid sequence comparisons to
known toxins and allergens, as well as
data demonstrating that the Cry2Ab2
protein is rapidly degraded by gastric
fluid in vitro, is not glycosylated, and is
present in low levels in corn tissue, and
has concluded that there is a reasonable
certainty that no harm will result from
dietary exposure to this protein as
expressed in genetically modified corn.
Thus, under the standard in FFDCA
section 408(b)(2), a tolerance exemption
is appropriate. The labeling of food is
under the jurisdiction of the Food and
Drug Administration (FDA).
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
VerDate Aug<31>2005
15:22 Jul 14, 2006
Jkt 208001
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.
Monsanto has submitted acute oral
toxicity data demonstrating the lack of
mammalian toxicity at high levels of
exposure to the pure Cry2Ab2 protein.
These data demonstrate the safety of the
product at a level well above maximum
possible exposure levels that are
reasonably anticipated in the crop.
Basing this conclusion on acute oral
toxicity data without requiring further
toxicity testing and residue data is
similar to the Agency position regarding
toxicity testing and the requirement of
residue data for the microbial Bacillus
thuringiensis products from which this
plant-incorporated protectant was
derived (See 40 CFR Sec.
158.740(b)(2)(i)). For microbial
products, further toxicity testing and
residue data are triggered by significant
adverse acute effects in studies such as
the mouse oral toxicity study, to verify
the observed adverse effects and clarify
the source of these effects (Tiers II and
III).
An acute oral toxicity study in mice
(MRID 44966602) indicated that
Cry2Ab2 is non-toxic to humans. Three
groups of ten male and ten female mice
were dosed by oral gavage with 30, 300,
or 1,000 milligrams/kilogram (mg/kg)
bodyweight of microbially-produced
Cry2Ab2 protein. Two negative control
groups were also included in the study:
Bovine serum albumin protein control,
and a vehicle control (purified water).
Two deaths occurred in control group
animals; both deaths were attributed to
gavage injury. All other mice survived
the study. Several animals in both the
control and test groups lost weight
during the study, and several
abnormalities were observed by gross
necropsy in several animals in both the
test and control groups. There were no
significant differences between the test
and control groups; therefore, the
Cry2Ab2 protein does not appear to
cause any significant adverse effects at
an exposure level of up to 1,000 mg/kg
bodyweight.
When proteins are toxic, they are
known to act via acute mechanisms and
at very low dose levels (Sjoblad, Roy D.,
et al., ‘‘Toxicological Considerations for
Protein Components of Biological
Pesticide Products,’’ Regulatory
Toxicology and Pharmacology 15, 3–9
(1992)). Therefore, since no acute effects
were shown to be caused by Cry2Ab2,
even at relatively high dose levels, the
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
40433
Cry2Ab2 protein is not considered toxic.
Further, amino acid sequence
comparisons showed no similarities
between the Cry2Ab2 protein and
known toxic proteins in protein
databases that would raise a safety
concern.
Since Cry2Ab2 is a protein, allergenic
potential was also considered.
Currently, no definitive tests for
determining the allergenic potential of
novel proteins exist. Therefore, EPA
uses a weight-of-evidence approach
where the following factors are
considered: Source of the trait; amino
acid sequence 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 heat, acid, and proteases,
may be glycosylated, and can be present
at high concentrations in the food.
1. Source of the trait. Bacillus
thuringiensis is not considered to be a
source of allergenic proteins.
2. Amino acid sequence. A
comparison of the amino acid sequence
of Cry2Ab2 with known allergens
showed no significant overall sequence
similarity or identity at the level of eight
contiguous amino acid residues.
3. Prevalence in food. Expression
level analysis indicated that the protein
is present at relatively low levels in
corn: Approximately 2.3 µg/g in grain
on a dry weight basis. Thus, the
expression has been shown to be in the
parts per million range is much lower
than the amounts of allergen protein
found in commonly allergenic foods. In
those foods, allergens are major protein
components such as seed storage
globulin proteins in nuts and legumes,
meat associated proteins like
tropomyosin in fish and shellfish,
ovalbumin and ovomucoid in egg white
and lactalbumin and casein in milk. In
these cases, the allergens can be from
10% to 50% of the total protein found
whereas the plant-incorporated
protectant (PIP) that is the subject of this
tolerance determination is found in the
parts per million range.
4. Digestibility. The Cry2Ab2 protein
was digested within 15 seconds in
simulated gastric fluid containing
pepsin.
5. Glycosylation. Cry2Ab2 expressed
in corn was shown not to be
glycosylated.
6. Conclusion. Considering all of the
available information, EPA has
concluded that the potential for
Cry2Ab2 to be a food allergen is
minimal.
E:\FR\FM\17JYR1.SGM
17JYR1
40434
Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Rules and Regulations
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 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 protectants
chemical residue, and exposure from
non-occupational sources. Exposure via
the skin or inhalation is not likely since
the plant- incorporated protectant is
contained within plant cells, which
essentially eliminates these exposure
routes or reduces these exposure routes
to negligible. In addition, even if
exposure can occur through inhalation,
the potential for Cry2Ab2 to be an
allergen is low, as discussed above.
Although the allergenicity assessment
focuses on potential to be a food
allergen, the data also indicate a low
potential for Cry2Ab2 to be an
inhalation allergen. Exposure via
residential or lawn use to infants and
children is also not expected because
the use sites for the Cry2Ab2 protein is
agricultural. Oral exposure, at very low
levels, may occur from ingestion of
processed corn products and,
theoretically, drinking water. However,
oral toxicity testing showed no adverse
effects. Furthermore, the expression of
the Cry2Ab2 protein 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
amount of Cry2Ab2 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 Cry2Ab2 protein.
rmajette on PROD1PC67 with RULES
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
VerDate Aug<31>2005
15:22 Jul 14, 2006
Jkt 208001
considerations included the cumulative
effects on infants and children of such
residues and other substances with a
common mechanism of toxicity.
Because there is no indication of
mammalian toxicity from the plantincorporated protectant, we conclude
that there are no cumulative effects for
the Cry2Ab2 protein.
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
Cry2Ab2 protein includes the
characterization of the expressed
Cry2Ab2 protein in corn, as well as the
acute oral toxicity study, amino acid
sequence comparisons to known
allergens and toxins, and in vitro
digestibility of the protein. The results
of these studies were used to evaluate
human risk, and the validity,
completeness, and reliability of the
available data from the studies were also
considered.
Adequate information was submitted
to show that the Cry2Ab2 test material
derived from microbial culture was
biochemically and functionally
equivalent to the protein produced by
the plant-incorporated protectant
ingredient in corn. Microbially
produced protein was used in the safety
studies so that sufficient material for
testing was available.
The acute oral toxicity data submitted
support the prediction that the Cry2Ab2
protein would be non-toxic to humans.
As mentioned 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
treatment-related adverse effects were
shown to be caused by the Cry2Ab2
protein, even at relatively high dose
levels, the Cry2Ab2 protein is not
considered toxic. Basing this conclusion
on acute oral toxicity data without
requiring further toxicity testing and
residue data is similar to the Agency
position regarding toxicity and the
requirement of residue data for the
microbial Bacillus thuringiensis
products from which this plantincorporated protectant was derived
(See 40 CFR 158.740(b)(2)(i)). For
microbial products, further toxicity
testing and residue data are triggered
when significant adverse effects are seen
in studies such as the mouse oral
toxicity study. Further studies verify the
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
observed adverse effects and clarify the
source of these effects (Tiers II and III).
Residue chemistry data were not
required for a human health effects
assessment of the subject plantincorporated protectant ingredients
because of the lack of mammalian
toxicity. However, data submitted
demonstrated low levels of the
Cry1A.105 in corn tissues.
Since Cry2Ab2 is a protein, potential
allergenicity is also considered as part
of the toxicity assessment. Considering
all of the available information (1)
Cry2Ab2 originates from a nonallergenic source; (2) Cry2Ab2 has no
sequence similarities with known
allergens; (3) Cry2Ab2 is not
glycosylated; (4) Cry2Ab2 will only be
present at low levels in food; and (5)
Cry2Ab2 is rapidly digested in
simulated gastric fluid; EPA has
concluded that the potential for
Cry2Ab2 to be a food allergen is
minimal.
Neither available information
concerning the dietary consumption
patterns of consumers (and major
identifiable subgroups of consumers
including infants and children) nor
safety factors that are generally
recognized as appropriate for the use of
animal experimentation data were
evaluated. The lack of mammalian
toxicity at high levels of exposure to the
Cry2Ab2 protein, as well as the minimal
potential to be a food allergen,
demonstrate the safety of the product at
levels well above possible maximum
exposure levels anticipated in the crop.
The genetic material necessary for the
production of the plant-incorporated
protectant active ingredient include the
nucleic acids (DNA, RNA) that encode
these proteins and regulatory regions.
The genetic material (DNA, RNA),
necessary for the production of the
Cry2Ab2 protein has been exempted
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
E:\FR\FM\17JYR1.SGM
17JYR1
Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Rules and Regulations
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 finds
no toxicity for the Cry2Ab2 protein and
the genetic material necessary for its
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 considerations of consumption
patterns, special susceptibility, and
cumulative effects do not apply.
C. Overall Safety Conclusion
There is a reasonable certainty that no
harm will result from aggregate
exposure to the U.S. population,
including infants and children, to the
Cry2Ab2 protein and the genetic
material necessary for its production.
This includes all anticipated dietary
exposures and all other exposures for
which there is reliable information. The
Agency has arrived at this conclusion
because, as discussed above, no toxicity
to mammals has been observed, nor any
indication of allergenicity potential for
the plant-incorporated protectant.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredient is a
protein, derived from a source that is
not known to exert an influence on the
endocrine system. Therefore, the
Agency is not requiring information on
the endocrine effects of this plantincorporated protectant at this time.
B. Analytical Method(s)
A short description of an enzymelinked immunosorbent assay for the
detection and quantification of Cry2Ab2
in corn tissue has been submitted, and
a commercially available qualitative
immunochromatographic test strip was
shown to detect the Cry2Ab2 protein in
corn tissues.
rmajette on PROD1PC67 with RULES
C. Codex Maximum Residue Level
No Codex maximum residue level
exists for the plant-incorporated
protectant Bacillus thuringiensis
Cry2Ab2 protein and the genetic
material necessary for its production in
corn.
VIII. 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,
VerDate Aug<31>2005
15:22 Jul 14, 2006
Jkt 208001
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
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
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
40435
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.
IX. 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.
E:\FR\FM\17JYR1.SGM
17JYR1
40436
Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Rules and Regulations
Dated: June 29, 2006.
James Jones,
Director Office of Pesticide Programs.
2006–2008 Specifications
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Therefore, 40 CFR chapter I is
amended as follows:
I
50 CFR Part 648
PART 174—[AMENDED]
1. The authority citation for part 174
continues to read as follows:
I
Authority: 7 U.S.C. 136–136y; 21 U.S.C.
346a and 371.
2. Section 174.454 is added to subpart
W to read as follows:
I
§ 174.454 Bacillus Thuringiensis Cry2Ab2
Protein and the Genetic Material Necessary
for Its Production in Corn.
Bacillus thuringiensis Cry2Ab2
protein and the genetic material
necessary for its production in corn is
exempt from the requirement of a
tolerance when used as plantincorporated protectant in the food and
feed commodities of field corn, sweet
corn and popcorn. Genetic material
necessary for its production means the
genetic material which comprise genetic
material encoding the Cry2Ab2 protein
and its regulatory regions. Regulatory
regions are the genetic material, such as
promoters, terminators, and enhancers,
that control the expression of the
genetic material encoding the Cry2Ab2
protein. This temporary exemption from
the requirement of a tolerance will
permit the use of the food commodities
in this paragraph when treated in
accordance with the provisions of the
experimental use permit 524–EUP–97
which is being issued under 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 June 30, 2009; however, if the
experimental use permit is revoked, or
if any experience with or scientific data
on this pesticide indicate that the
tolerance is not safe, this temporary
exemption from the requirement of a
tolerance may be revoked at any time.
[FR Doc. E6–11249 Filed 7–14–06; 8:45 am]
rmajette on PROD1PC67 with RULES
BILLING CODE 6560–50–S
[Docket No. 060418103–6181–02; I.D.
040706F]
RIN 0648–AT59
Fisheries of the Northeastern United
States; Final 2006–2008 Specifications
for the Spiny Dogfish Fishery
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule.
AGENCY:
SUMMARY: NMFS announces final
specifications for the 2006–2008 fishing
years, which is May 1, 2006, through
April 30, 2009. NMFS is also
establishing possession limits for
dogfish at 600 lb (272 kg) for both quota
periods 1 and 2 of the fishery.
DATES: The regulatory change at 50 CFR
648.235 that sets the dogfish possession
limits at 600 lb (272 kg) is effective
August 16, 2006. The specifications are
effective August 16, 2006, through April
30, 2009.
ADDRESSES: Copies of supporting
documents used by the Joint Spiny
Dogfish Committee and the Spiny
Dogfish Monitoring Committee
(Monitoring Committee); the
Environmental Assessment, Regulatory
Impact Review, Initial Regulatory
Flexibility Analysis (EA/RIR/IRFA); and
the Essential Fish Habitat Assessment
(EFHA) are available from Daniel
Furlong, Executive Director, MidAtlantic Fishery Management Council
(MAFMC), Federal Building, Room
2115, 300 South Street, Dover, DE
19904. The EA, RIR, IRFA and EFHA are
accessible via the Internet at http:/
www.nero.gov.
FOR FURTHER INFORMATION CONTACT:
Eric
Jay Dolin, Fishery Policy Analyst,
(978)281–9259, fax (978)281–9135.
SUPPLEMENTARY INFORMATION:
Background
A proposed rule for this action was
published in the Federal Register on
May 8, 2006 (71 FR 26726), with public
comment accepted through May 23,
2006. The final specifications are
unchanged from those that were
proposed. A complete discussion of the
development of the specifications
appears in the preamble to the proposed
rule and is not repeated here.
VerDate Aug<31>2005
15:22 Jul 14, 2006
Jkt 208001
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
The commercial spiny dogfish quota
for the 2006–2008 fishing years is 4
million lb (1.81 million kg) annually, to
be divided into two semi-annual periods
as follows: 2,316,000 lb (1.05 million kg)
for quota period 1 (May 1 - Oct. 31); and
1,684,000 lb (763,849 kg) for quota
period 2 (Nov. 1 – April 30). The
possession limits are 600 lb (272 kg) for
quota periods 1 and 2, to discourage a
directed fishery.
Comments and Responses
There were 1,099 comments
submitted on the proposed measures, by
4 organizations and 1,095 individuals.
Comment 1: Three organizations and
1,081 individuals argued that NMFS
should have followed the Monitoring
Committee’s recommendation, setting
the quota at 2 million lb (907 mt) and
the possession limits at 600 lb (272 kg)
and 300 lb (136 kg), respectively. These
commenters argued that the Monitoring
Committee’s recommendation
represented the best available scientific
information.
Response: The Council’s analysis
concluded that the U.S. commercial
spiny dogfish landings are controlled
more by the possession limits than the
overall quota. Maintaining the limits of
600 lb (272 kg) for both quota periods
does not erode the control over landings
and would allow for a limited level of
retention of spiny dogfish caught
incidentally while fishing for other
species. Standardizing the possession
limits for both quota periods will
address a perceived inequity that has
been identified by some vessel
operators, without creating an incentive
for directed fishing. Discouraging
directed fishing through this modest
possession limit and an incidental catch
quota will provide protection for mature
female spiny dogfish, the portion of the
stock that has traditionally been targeted
by the directed fishery, and the stock
component that is most in need of
protection and rebuilding. These
measures would also be consistent with
the measures being implemented under
the Atlantic States Marine Fishieries
Commission’s (ASMFC) Interstate
Fishery Management Plan in state
waters, at least for FY 2006. This would
have the benefit of establishing
consistent management measures in
Federal and state jurisdictions, and
would simplify monitoring and
enforcement. As demonstrated in
previous years, when measures differed
in state and Federal waters, the benefits
of a more restrictive quota in Federal
waters would likely be slight because
fishing would continue in state waters
E:\FR\FM\17JYR1.SGM
17JYR1
]]>Agencies
[Federal Register Volume 71, Number 136 (Monday, July 17, 2006)]
[Rules and Regulations]
[Pages 40431-40436]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11249]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2006-0553; FRL-8076-6]
Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic Material
Necessary for Its Production in Corn in or on All Corn Commodities;
Temporary Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a temporary exemption from the
[[Page 40432]]
requirement of a tolerance for residues of the Bacillus Thuringiensis
Cry2Ab2 protein and the genetic material necessary for its production
in corn on field corn, sweet corn, and popcorn when applied/used as a
plant-incorporated protectant. Monsanto Company submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of 1996 (FQPA), requesting the
temporary/tolerance exemption. This regulation eliminates the need to
establish a maximum permissible level for residues of Bacillus
Thuringiensis Cry2Ab2 protein and the genetic material necessary for
its production in corn. The temporary tolerance exemption will expire
on June 30, 2009.
DATES: This regulation is effective July 17, 2006. Objections and
requests for hearings must be received on or before September 15, 2006,
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-2006-0553. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The 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 (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 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 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. 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-2006-0553 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before September 15, 2006.
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-2006-0553, 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of May 26, 2006 (Volume 71 FR 30400) (FRL-
8066-7), 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 5G7005) by Monsanto Company, 800 North Lindbergh
Blvd., St. Louis, MO 63167. The petition requested that 40 CFR part 174
be amended by establishing a temporary exemption from the requirement
of a tolerance for residues of Bacillus thuringiensis Cry2Ab2 protein
and the genetic material necessary for its production in corn. This
notice included a summary of the petition prepared by the petitioner
Monsanto Company. One comment was received in response to the notice of
filing. The commenter objected to an exemption from the requirement of
a tolerance, stated that she does not favor genetically engineered
corn, and stated that such corn should be labeled. The Agency
understands the commenter's concerns and recognizes that some
individuals believe that genetically modified crops and food should be
banned completely. Pursuant to its authority under the FFDCA, EPA
conducted a comprehensive assessment of the Cry2Ab2 protein and the
genetic material necessary for its production in
[[Page 40433]]
corn, including a review of acute oral toxicity data on the Cry2Ab2
protein, amino acid sequence comparisons to known toxins and allergens,
as well as data demonstrating that the Cry2Ab2 protein is rapidly
degraded by gastric fluid in vitro, is not glycosylated, and is present
in low levels in corn tissue, and has concluded that there is a
reasonable certainty that no harm will result from dietary exposure to
this protein as expressed in genetically modified corn. Thus, under the
standard in FFDCA section 408(b)(2), a tolerance exemption is
appropriate. The labeling of food is under the jurisdiction of the Food
and Drug Administration (FDA).
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.
Monsanto has submitted acute oral toxicity data demonstrating the
lack of mammalian toxicity at high levels of exposure to the pure
Cry2Ab2 protein. These data demonstrate the safety of the product at a
level well above maximum possible exposure levels that are reasonably
anticipated in the crop. Basing this conclusion on acute oral toxicity
data without requiring further toxicity testing and residue data is
similar to the Agency position regarding toxicity testing and the
requirement of residue data for the microbial Bacillus thuringiensis
products from which this plant-incorporated protectant was derived (See
40 CFR Sec. 158.740(b)(2)(i)). For microbial products, further toxicity
testing and residue data are triggered by significant adverse acute
effects in studies such as the mouse oral toxicity study, to verify the
observed adverse effects and clarify the source of these effects (Tiers
II and III).
An acute oral toxicity study in mice (MRID 44966602) indicated that
Cry2Ab2 is non-toxic to humans. Three groups of ten male and ten female
mice were dosed by oral gavage with 30, 300, or 1,000 milligrams/
kilogram (mg/kg) bodyweight of microbially-produced Cry2Ab2 protein.
Two negative control groups were also included in the study: Bovine
serum albumin protein control, and a vehicle control (purified water).
Two deaths occurred in control group animals; both deaths were
attributed to gavage injury. All other mice survived the study. Several
animals in both the control and test groups lost weight during the
study, and several abnormalities were observed by gross necropsy in
several animals in both the test and control groups. There were no
significant differences between the test and control groups; therefore,
the Cry2Ab2 protein does not appear to cause any significant adverse
effects at an exposure level of up to 1,000 mg/kg bodyweight.
When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Sjoblad, Roy D., et al., ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Therefore, since no acute effects were shown to be caused by Cry2Ab2,
even at relatively high dose levels, the Cry2Ab2 protein is not
considered toxic. Further, amino acid sequence comparisons showed no
similarities between the Cry2Ab2 protein and known toxic proteins in
protein databases that would raise a safety concern.
Since Cry2Ab2 is a protein, allergenic potential was also
considered. Currently, no definitive tests for determining the
allergenic potential of novel proteins exist. Therefore, EPA uses a
weight-of-evidence approach where the following factors are considered:
Source of the trait; amino acid sequence 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 heat,
acid, and proteases, may be glycosylated, and can be present at high
concentrations in the food.
1. Source of the trait. Bacillus thuringiensis is not considered to
be a source of allergenic proteins.
2. Amino acid sequence. A comparison of the amino acid sequence of
Cry2Ab2 with known allergens showed no significant overall sequence
similarity or identity at the level of eight contiguous amino acid
residues.
3. Prevalence in food. Expression level analysis indicated that the
protein is present at relatively low levels in corn: Approximately 2.3
[mu]g/g in grain on a dry weight basis. Thus, the expression has been
shown to be in the parts per million range is much lower than the
amounts of allergen protein found in commonly allergenic foods. In
those foods, allergens are major protein components such as seed
storage globulin proteins in nuts and legumes, meat associated proteins
like tropomyosin in fish and shellfish, ovalbumin and ovomucoid in egg
white and lactalbumin and casein in milk. In these cases, the allergens
can be from 10% to 50% of the total protein found whereas the plant-
incorporated protectant (PIP) that is the subject of this tolerance
determination is found in the parts per million range.
4. Digestibility. The Cry2Ab2 protein was digested within 15
seconds in simulated gastric fluid containing pepsin.
5. Glycosylation. Cry2Ab2 expressed in corn was shown not to be
glycosylated.
6. Conclusion. Considering all of the available information, EPA
has concluded that the potential for Cry2Ab2 to be a food allergen is
minimal.
[[Page 40434]]
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 protectant is contained within
plant cells, which essentially eliminates these exposure routes or
reduces these exposure routes to negligible. In addition, even if
exposure can occur through inhalation, the potential for Cry2Ab2 to be
an allergen is low, as discussed above. Although the allergenicity
assessment focuses on potential to be a food allergen, the data also
indicate a low potential for Cry2Ab2 to be an inhalation allergen.
Exposure via residential or lawn use to infants and children is also
not expected because the use sites for the Cry2Ab2 protein is
agricultural. Oral exposure, at very low levels, may occur from
ingestion of processed corn products and, theoretically, drinking
water. However, oral toxicity testing showed no adverse effects.
Furthermore, the expression of the Cry2Ab2 protein 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
amount of Cry2Ab2 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
Cry2Ab2 protein.
V. Cumulative Effects
Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations included the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity from the
plant-incorporated protectant, we conclude that there are no cumulative
effects for the Cry2Ab2 protein.
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 Cry2Ab2 protein includes the characterization of the expressed
Cry2Ab2 protein in corn, as well as the acute oral toxicity study,
amino acid sequence comparisons to known allergens and toxins, and in
vitro digestibility of the protein. The results of these studies were
used to evaluate human risk, and the validity, completeness, and
reliability of the available data from the studies were also
considered.
Adequate information was submitted to show that the Cry2Ab2 test
material derived from microbial culture was biochemically and
functionally equivalent to the protein produced by the plant-
incorporated protectant ingredient in corn. Microbially produced
protein was used in the safety studies so that sufficient material for
testing was available.
The acute oral toxicity data submitted support the prediction that
the Cry2Ab2 protein would be non-toxic to humans. As mentioned 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 treatment-related adverse effects were shown to be caused by
the Cry2Ab2 protein, even at relatively high dose levels, the Cry2Ab2
protein is not considered toxic. Basing this conclusion on acute oral
toxicity data without requiring further toxicity testing and residue
data is similar to the Agency position regarding toxicity and the
requirement of residue data for the microbial Bacillus thuringiensis
products from which this plant-incorporated protectant was derived (See
40 CFR 158.740(b)(2)(i)). For microbial products, further toxicity
testing and residue data are triggered when significant adverse effects
are seen in studies such as the mouse oral toxicity study. Further
studies verify the observed adverse effects and clarify the source of
these effects (Tiers II and III).
Residue chemistry data were not required for a human health effects
assessment of the subject plant-incorporated protectant ingredients
because of the lack of mammalian toxicity. However, data submitted
demonstrated low levels of the Cry1A.105 in corn tissues.
Since Cry2Ab2 is a protein, potential allergenicity is also
considered as part of the toxicity assessment. Considering all of the
available information (1) Cry2Ab2 originates from a non-allergenic
source; (2) Cry2Ab2 has no sequence similarities with known allergens;
(3) Cry2Ab2 is not glycosylated; (4) Cry2Ab2 will only be present at
low levels in food; and (5) Cry2Ab2 is rapidly digested in simulated
gastric fluid; EPA has concluded that the potential for Cry2Ab2 to be a
food allergen is minimal.
Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children) nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the Cry2Ab2 protein, as well as the minimal potential to be
a food allergen, demonstrate the safety of the product at levels well
above possible maximum exposure levels anticipated in the crop.
The genetic material necessary for the production of the plant-
incorporated protectant active ingredient include the nucleic acids
(DNA, RNA) that encode these proteins and regulatory regions. The
genetic material (DNA, RNA), necessary for the production of the
Cry2Ab2 protein has been exempted 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
[[Page 40435]]
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 finds no toxicity for the Cry2Ab2 protein and the genetic
material necessary for its 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 considerations
of consumption patterns, special susceptibility, and cumulative effects
do not apply.
C. Overall Safety Conclusion
There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to the Cry2Ab2 protein and the genetic material necessary for
its production. This includes all anticipated dietary exposures and all
other exposures for which there is reliable information. The Agency has
arrived at this conclusion because, as discussed above, no toxicity to
mammals has been observed, nor any indication of allergenicity
potential for the plant-incorporated protectant.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredient is a protein, derived from a
source that is not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of this plant-incorporated protectant at this time.
B. Analytical Method(s)
A short description of an enzyme-linked immunosorbent assay for the
detection and quantification of Cry2Ab2 in corn tissue has been
submitted, and a commercially available qualitative
immunochromatographic test strip was shown to detect the Cry2Ab2
protein in corn tissues.
C. Codex Maximum Residue Level
No Codex maximum residue level exists for the plant-incorporated
protectant Bacillus thuringiensis Cry2Ab2 protein and the genetic
material necessary for its production in corn.
VIII. 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 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.
IX. 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.
[[Page 40436]]
Dated: June 29, 2006.
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 174.454 is added to subpart W to read as follows:
Sec. 174.454 Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic
Material Necessary for Its Production in Corn.
Bacillus thuringiensis Cry2Ab2 protein and the genetic material
necessary for its production in corn is exempt from the requirement of
a tolerance when used as plant-incorporated protectant in the food and
feed commodities of field corn, sweet corn and popcorn. Genetic
material necessary for its production means the genetic material which
comprise genetic material encoding the Cry2Ab2 protein and its
regulatory regions. Regulatory regions are the genetic material, such
as promoters, terminators, and enhancers, that control the expression
of the genetic material encoding the Cry2Ab2 protein. This temporary
exemption from the requirement of a tolerance will permit the use of
the food commodities in this paragraph when treated in accordance with
the provisions of the experimental use permit 524-EUP-97 which is being
issued under 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 June 30, 2009;
however, if the experimental use permit is revoked, or if any
experience with or scientific data on this pesticide indicate that the
tolerance is not safe, this temporary exemption from the requirement of
a tolerance may be revoked at any time.
[FR Doc. E6-11249 Filed 7-14-06; 8:45 am]
BILLING CODE 6560-50-S
