Bacillus thuringiensis VIP3A Protein and the Genetic Material Necessary for its Production; Temporary Exemption From the Requirement of a Tolerance, 21962-21966 [05-8530]
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Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Rules and Regulations
date of December 31, 2000, including
the Basis Statements and Appendix A.
I 3. In § 52.1031 Table 52.1031 is
amended by adding a new state citation
for Maine Chapter 127; ‘‘New Motor
Vehicle Emission Standards’’ to read as
follows:
§ 52.1031—EPA—approved
regulations.
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Maine
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TABLE 52.1031.—EPA-APPROVED RULES AND REGULATIONS
Date adopted by
State
State
Title/subject
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127 .........
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New Motor Vehicle
Emission Standards.
*
Date approved by
EPA
Federal Register
citation
*
*
April 28, 2005 .......
*
[Insert FR citiation
published date.
*
December 31,
2000.
*
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52.1020
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*
(c)(58) Low emission vehicle program, with no ZEV requirements. Program
achieves 90% of full LEV
benefits.
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*
*
Note.—1. The regulations are effective statewide unless stated otherwise in comments section.
[FR Doc. 05–8528 Filed 4–27–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0083; FRL–7706–7]
Bacillus thuringiensis VIP3A Protein
and the Genetic Material Necessary for
its Production; Temporary Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
extension of the temporary exemption
from the requirement of a tolerance for
residues of Bacillus thuringiensis VIP3A
protein and the genetic material
necessary for its production on cotton
when applied/used as a plantincorporated protectant. Syngenta Seeds
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 this extension. This
regulation eliminates the need to
establish a maximum permissible level
for residues of Bacillus thuringiensis
VIP3A protein and the genetic material
necessary for its production on cotton.
The temporary tolerance exemption will
expire on May 1, 2006.
DATES: This regulation is effective April
28, 2005. Objections and requests for
hearings must be received on or before
June 27, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a
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docket for this action under docket
identification (ID) number OPP–2005–
0083. All documents in the docket are
listed in the EDOCKET index at
https://www.epa.gov/edocket. Although
listed in the index, some information is
not publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Sharlene Matten, Biopesticides and
Pollution Prevention Division (7511C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 605–0514; e-mail address:
matten.sharlene@epa.gov.
SUPPLEMENTARY INFORMATION:
• Pesticide manufacturing (NAICS
code 32532)
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions. If
you have any questions regarding the
applicability of this action to a
particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
I. General Information
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET
(https://www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
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)
II. Background and Statutory Findings
On July 26, 2004, Syngenta Seeds,
3054 Cornwallis Road, Research
Triangle Park, NC 27709–2257
submitted a petition (PP 3G6547) 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 for Bacillus
thuringiensis VIP3A protein and the
genetic material necessary for its
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production in cotton found at 40 CFR
180.1247 be amended to include all
VIP3A events (VIP stands for vegetative
insecticidal protein). As it turns out,
however, this particular request was
unnecessary as the temporary tolerance
exemption found at 40 CFR 180.1247
already includes all VIP3A events. In a
subsequent letter dated July 29, 2004,
Syngenta Seeds also petitioned the
Agency to amend the temporary
tolerance exemption found at 40 CFR
180.1247 by extending it from May 1,
2005 to May 1, 2006.
On September 15, 2004, EPA
published a Notice in the Federal
Register (69 FR 55605; FRL–7675–1)
announcing the filing of the Syngenta
Seeds petition. This Notice of Filing,
however, was incorrect in two respects.
First, it reiterated in summary fashion
Syngenta Seeds request that the
temporary tolerance exemption found at
40 CFR 180.1247 be amended to include
all VIP3A events. As noted above, this
was unnecessary since that temporary
tolerance exemption already includes
all VIP3A events. Second, the Notice
failed to include Syngenta Seeds’
petition to extend the approved time
frame for the temporary exemption. In
the Federal Register of March 16, 2005
(70 FR 12879) (FRL–7703–3), EPA
published a Notice of Correction
clarifying that the pesticide petition,
3G6547 from Syngenta Seeds, as
summarized and presented in the
Agency’s September 15, 2004 Notice of
Filing, is solely a proposal to amend the
temporary tolerance exemption found at
40 CFR 180.1247 by extending it from
May 1, 2005 to May 1, 2006.
The National Cotton Council and a
private citizen each submitted
comments in response to the September
15, 2004 Notice. That same private
citizen also submitted similar comments
in response to the March 16, 2005
Notice. In addition, a second private
citizen submitted comments in response
to the March 16, 2005 Notice. The
National Cotton Council supported
issuance of the temporary tolerance. The
first private citizen, however, objected
to the issuance of the temporary
tolerance based on unspecified
environmental and human health
effects. The second private citizen
objected to the issuance of the
temporary tolerance based on possible
environmental and health effects of
programmed cell death. The Agency
understands the commenters’ concerns.
Pursuant to its authority under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), EPA has conducted an
assessment of the VIP3A insect control
proteins and the genetic material
necessary for their production in cotton.
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EPA has concluded that there is a
reasonable certainty that no harm will
result from dietary exposure to this
protein as expressed in cotton.
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.
Data have been submitted
demonstrating the lack of mammalian
toxicity at high levels of exposure to the
pure VIP3A proteins. This is similar to
the Agency position regarding toxicity
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of Bacillus thuringiensis products from
which this vegetative-insecticidal
protein is derived. The requirement for
residue data for the derivative protein is
consistent with residue data
requirements in 40 CFR 158.740(b)(2)(i).
For microbial products, further toxicity
testing and residue data are triggered by
significant acute effects in studies such
as the mouse oral toxicity study, to
verify the observed effects and clarify
the source of these effects (Tiers II and
III). The acute oral toxicity data
submitted support the prediction that
the VIP3A protein would be non-toxic
to humans. Male and female mice (11 of
each) were dosed with the test material
5,050 milligrams/kilogram/body weight
(mg/kg/bwt) (3,675 mg of pure VIP3A
protein per kg body weight). Outward
clinical signs were observed and body
weights recorded throughout the 14–day
study. No mortality or clinical signs
attributed to the test substance were
noted during the study. When proteins
are toxic, they are known to act via
acute mechanisms and at very low doses
(Sjoblad, R.D., J.T. McClintock and R.
Engler (1992)). Therefore, since no
effects were shown to be caused by this
vegetative-insecticidal protein, even at
relatively high does levels, it is not
considered toxic. The amino acid
sequence of VIP3A is not homologous to
that of any known or putative allergens
described in public data bases. Since
VIP3A is a protein, allergenic
sensitivities were considered. Current
scientific knowledge suggests that
common food allergens tend to be
resistant to degradation by heat, acid,
and proteases, and may be glycosylated
and present at high concentrations in
the food. Data have been submitted that
demonstrate that the VIP3A protein
appears to be present in multiple
commercial formulations of Bt microbial
insecticides at concentrations estimated
to be ca. 0.4 to 32 parts per million
(ppm). This conclusion is based on the
presence of proteins of the appropriate
molecular weight and immunoreactivity
(by SDS-PAGE and western blot), and
quantitation by ELISA. Therefore, it is
conceivable that small quantities of
VIP3A protein already are present in the
food supply because VIP3A (or a very
similar protein, based on size and
immunoreactivity) appears to be present
in currently registered insecticide
products used on food crops, including
fresh market produce. These
commercial Bt products are all exempt
from food and feed tolerances.
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of the FFDCA directs EPA
to consider available information
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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).
A. Dietary Exposure
The Agency has considered available
information on the aggregate exposure
levels of consumers (and major
identifiable subgroups of consumers) to
the pesticide chemical residue and to
other related substances. These
considerations include dietary exposure
under the tolerance exemption and all
other tolerances or exemptions in effect
for the vegetative-insecticidal protein
chemical residue, and exposure from
non-occupational sources.
1. Food. Oral exposure, at very low
levels, may occur from ingestion of
processed cotton seed by products.
However, a lack of mammalian toxicity
and the digestibility of the vegetativeinsecticidal protein have been
demonstrated. The use sites of the
VIP3A proteins are all agricultural for
control of insects.
2. Drinking water exposure. Oral
exposure, at very low levels, may occur
from drinking water. However, a lack of
mammalian toxicity and the
digestibility of the vegetativeinsecticidal protein have been
demonstrated. The use sites for the
VIP3A proteins are all agricultural for
control of insects.
B. Other Non-Occupational Exposure
1. Dermal exposure. Exposure via the
skin is not likely since the vegetativeinsecticidal protein is contained within
plant cells, which essentially eliminates
this exposure route or reduces these
exposure routes to negligible.
2. Inhalation exposure. Exposure via
inhalation is not likely since the
vegetative-insecticidal protein is
contained within plant cells, which
essentially eliminates this exposure
route or reduces this exposure route to
negligible.
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 to the VIP3A
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protein, it is reasonable to conclude that
there are no cumulative effects for this
vegetative-insecticidal protein.
VI. Determination of Safety for U.S.
Population, Infants, and Children
FFDCA section 408(b)(2)(C) provides
that EPA shall assess the available
information about consumption patterns
among infants and children, special
susceptibility of infants and children to
pesticide chemical residues and the
cumulative effects on infants and
children of the residues and other
substances with a common mechanism
of toxicity. In addition, FFDCA section
408(B)(2)(C) also provides that EPA
shall apply an additional tenfold margin
of safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the data base unless
EPA determines that a different margin
of safety (MOS) will be safe for infants
and children. In this instance, based on
the available data, the Agency
concludes that there is a finding of no
toxicity for VIP3A proteins and the
genetic material necessary for their
production. In the absence of any
threshold effects of concern, the Agency
has determined that the additional
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.
VII. Other Considerations
A. Endocrine Disruptors
The safety data submitted show no
adverse effects in mammals, even at
very high dose levels, and support the
prediction that the VIP3A protein would
be non-toxic to humans. Therefore no
effects on the immune or endocrine
systems are expected.
B. Analytical Method(s)
Validated methods for extraction and
direct ELISA analysis of VIP3A in
cotton seed have been submitted and
found acceptable by the Agency.
C. Codex Maximum Residue Level
No Codex maximum residue levels
exist for the vegetative-insecticidal
protein Bacillus thuringiensis VIP3A
protein and genetic material necessary
for its production in cotton.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
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for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to the
FFDCA by the FQPA, EPA will continue
to use those procedures, with
appropriate adjustments, until the
necessary modifications can be made.
The new section 408(g) of the FFDCA
provides essentially the same process
for persons to ‘‘object’’ to a regulation
for an exemption from the requirement
of a tolerance issued by EPA under new
section 408(d), as was provided in the
old sections 408 and 409 of the FFDCA.
However, the period for filing objections
is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP –2005 –0083 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 June 27, 2005.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issues(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
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with the Hearing Clerk as described in
Unit VIII.A., you should also send a
copy of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
OPP–2005–0083, to: Public Information
and Records Integrity Branch,
Information Resources and Services
Division (7502C), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001. In person
or by courier, bring a copy to the
location of the PIRIB described in
ADDRESSES. You may also send an
electronic copy of your request via email to: opp-docket@epa.gov. Please use
an ASCII file format and avoid the use
of special characters and any form of
encryption. Copies of electronic
objections and hearing requests will also
be accepted on disks in WordPerfect
6.1/8.0 or ASCII file format. Do not
include any CBI in your electronic copy.
You may also submit an electronic copy
of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
IX. Statutory and Executive Order
Reviews
This final rule establishes an
extension of the temporary 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
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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’’
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as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
X. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 21, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1247 is revised to read
as follows:
I
§ 180.1247 Bacillus thuringiensis VIP3A
protein and the genetic material necessary
for its production in cotton is exempt from
the requirement of a tolerance.
Bacillus thuringiensis VIP3A protein
and the genetic material necessary for
its production in cotton is exempt from
the requirement of a tolerance when
used as a vegetative-insecticidal protein
in the food and feed commodities,
cotton seed, cotton oil, cotton meal,
cotton hay, cotton hulls, cotton forage,
and cotton gin byproducts. Genetic
material necessary for its production
means the genetic material which
comprise genetic encoding the VIP3A
protein and its regulatory regions.
Regulatory regions are the genetic
material, such as promoters,
terminators, and enhancers, that control
expression of the genetic material
encoding the VIP3A protein. This timelimited exemption from the requirement
of a tolerance expires May 1, 2006.
[FR Doc. 05–8530 Filed 4–27–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[FRL–7905–2]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List
Environmental Protection
Agency.
ACTION: Deletion of the Syosset Landfill
Superfund Site from the National
Priorities List.
SUMMARY: The Environmental Protection
Agency (EPA) Region 2 Office
announces the deletion of the Syosset
Landfill Superfund Site, in the Town of
Oyster Bay, Nassau County, New York
from the National Priorities List (NPL).
The NPL is appendix B to the National
Oil and Hazardous Substances Pollution
Contingency Plan (NCP), 40 CFR part
300, which EPA promulgated pursuant
to section 105 of the Comprehensive
Environmental Response,
Compensation, and Liability Act of 1980
(CERCLA), as amended. EPA and the
State of New York, through the
Department of Environmental
Conservation (NYSDEC), have
determined that responsible parties or
other persons have implemented all
appropriate response actions required.
In addition, EPA and the NYSDEC have
15:55 Apr 27, 2005
Jkt 205001
EFFECTIVE DATE:
FOR FURTHER INFORMATION CONTACT:
Sherrel D. Henry, Remedial Project
Manager, U.S. Environmental Protection
Agency, Region 2, 290 Broadway, 20th
Floor, New York, New York 10007–
1866, (212) 637–4273.
The site to
be deleted from the NPL is: Syosset
Landfill Superfund Site, Town of Oyster
Bay, Nassau County, New York.
A Notice of Intent to Delete for this
site was published in the Federal
Register on February 15, 2005 (70 FR
7708). The closing date for comments on
the Notice of Intent to Delete was March
17, 2005. No comments were received.
The EPA maintains the NPL as the list
of those sites that appear to present a
significant risk to public health or the
environment. Sites on the NPL can have
remedial actions financed by the
Hazardous Substances Response Fund.
As described in § 300.425(e)(3) of the
NCP, any site or portion thereof deleted
from the NPL remains eligible for Fundfinanced remedial actions in the
unlikely event that conditions at the site
warrant such action in the future.
Deletion of a site from the NPL does not
affect responsible party liability or
impede agency efforts to recover costs
associated with response efforts.
SUPPLEMENTARY INFORMATION:
Environmental protection, Air
pollution controls, Chemicals,
Hazardous substances, Hazardous
waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
Dated: April 19, 2005.
George Pavlou,
Acting Regional Administrator, Region 2.
For the reasons set out in the preamble,
40 CFR part 300, is amended as follows:
I
PART 300—[AMENDED]
1. The authority citation for part 300
continues to read as follows:
I
Authority: 42 U.S.C. 9601–9657; 33 U.S.C.
1321(c)(2); E.O. 12777, 56 FR 54757, 3 CFR,
1991 Comp., p. 351; E.O. 12580, 52 FR 2923,
3 CFR, 1987 Comp., p. 193.
Appendix B—[Amended]
2. Table 1 of Appendix B to part 300
is amended by removing the entry
‘‘Syosset Landfill’’ found in the list of
I
PO 00000
Frm 00046
sites in NY State along with the city/
county name ‘‘Oyster Bay.’’
[FR Doc. 05–8527 Filed 4–27–05; 8:45 am]
BILLING CODE 6560–50–P
April 28, 2005.
List of Subjects in 40 CFR Part 300
AGENCY:
VerDate jul<14>2003
determined that the remedial measures
taken at the Syosset Landfill Site protect
public health, welfare, and the
environment.
Fmt 4700
Sfmt 4700
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
RIN 1018–AU10
Endangered and Threatened Wildlife
and Plants; Amendment of Lower St.
Johns River Manatee Refuge in Florida
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
SUMMARY: The Fish and Wildlife Service
is amending a portion of the Lower St.
Johns River Manatee Refuge area in
Duval County, Florida, to provide for
both improved public safety and
increased manatee protection through
improved marking and enforcement of
the manatee protection area.
Specifically, that portion of this
manatee protection area which lies
downstream of the Hart Bridge to
Reddie Point will be modified to allow
watercraft to travel up to 25 miles per
hour (mph) in a broader portion of the
St. Johns River to include areas adjacent
to but outside of the navigation channel.
Watercraft traveling near the banks of
the river will be required to travel at
slow speed much as they do now. The
primary exception will be around
Exchange Island where the coverage of
the existing State and local slow-speed
zones will be expanded. However, in
the main portion of the river, watercraft
will be allowed to travel at speeds up to
25 mph. The manatee protection area
will also be expanded approximately
one mile further downstream, to the
extent it was originally proposed (68 FR
16602; April 4, 2003), in order to be
consistent with existing State and local
governmental manatee protection
measures and thereby facilitate
compliance. This modification is
supported by State and local
government and parties to the March 18,
2003, Stipulated Order which resulted
in the initial rulemaking for this
manatee protection area.
The current configuration of the
manatee protection area is not
supported by the State of Florida or
Duval County. While the Service is
committed to enforcing these current
protection measures, State and local
government would normally provide a
substantial portion of the enforcement
E:\FR\FM\28APR1.SGM
28APR1
]]>Agencies
[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Rules and Regulations]
[Pages 21962-21966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8530]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0083; FRL-7706-7]
Bacillus thuringiensis VIP3A Protein and the Genetic Material
Necessary for its Production; Temporary Exemption From the Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an extension of the temporary
exemption from the requirement of a tolerance for residues of Bacillus
thuringiensis VIP3A protein and the genetic material necessary for its
production on cotton when applied/used as a plant-incorporated
protectant. Syngenta Seeds 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 this extension. This
regulation eliminates the need to establish a maximum permissible level
for residues of Bacillus thuringiensis VIP3A protein and the genetic
material necessary for its production on cotton. The temporary
tolerance exemption will expire on May 1, 2006.
DATES: This regulation is effective April 28, 2005. Objections and
requests for hearings must be received on or before June 27, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2005-0083. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket.
Although listed in the index, some information is not publicly
available, i.e., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT: Sharlene Matten, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 605-0514; e-mail
address: matten.sharlene@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
On July 26, 2004, Syngenta Seeds, 3054 Cornwallis Road, Research
Triangle Park, NC 27709-2257 submitted a petition (PP 3G6547) 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 for Bacillus thuringiensis VIP3A protein
and the genetic material necessary for its
[[Page 21963]]
production in cotton found at 40 CFR 180.1247 be amended to include all
VIP3A events (VIP stands for vegetative insecticidal protein). As it
turns out, however, this particular request was unnecessary as the
temporary tolerance exemption found at 40 CFR 180.1247 already includes
all VIP3A events. In a subsequent letter dated July 29, 2004, Syngenta
Seeds also petitioned the Agency to amend the temporary tolerance
exemption found at 40 CFR 180.1247 by extending it from May 1, 2005 to
May 1, 2006.
On September 15, 2004, EPA published a Notice in the Federal
Register (69 FR 55605; FRL-7675-1) announcing the filing of the
Syngenta Seeds petition. This Notice of Filing, however, was incorrect
in two respects. First, it reiterated in summary fashion Syngenta Seeds
request that the temporary tolerance exemption found at 40 CFR 180.1247
be amended to include all VIP3A events. As noted above, this was
unnecessary since that temporary tolerance exemption already includes
all VIP3A events. Second, the Notice failed to include Syngenta Seeds'
petition to extend the approved time frame for the temporary exemption.
In the Federal Register of March 16, 2005 (70 FR 12879) (FRL-7703-3),
EPA published a Notice of Correction clarifying that the pesticide
petition, 3G6547 from Syngenta Seeds, as summarized and presented in
the Agency's September 15, 2004 Notice of Filing, is solely a proposal
to amend the temporary tolerance exemption found at 40 CFR 180.1247 by
extending it from May 1, 2005 to May 1, 2006.
The National Cotton Council and a private citizen each submitted
comments in response to the September 15, 2004 Notice. That same
private citizen also submitted similar comments in response to the
March 16, 2005 Notice. In addition, a second private citizen submitted
comments in response to the March 16, 2005 Notice. The National Cotton
Council supported issuance of the temporary tolerance. The first
private citizen, however, objected to the issuance of the temporary
tolerance based on unspecified environmental and human health effects.
The second private citizen objected to the issuance of the temporary
tolerance based on possible environmental and health effects of
programmed cell death. The Agency understands the commenters' concerns.
Pursuant to its authority under the Federal Food, Drug, and Cosmetic
Act (FFDCA), EPA has conducted an assessment of the VIP3A insect
control proteins and the genetic material necessary for their
production in cotton. EPA has concluded that there is a reasonable
certainty that no harm will result from dietary exposure to this
protein as expressed in cotton.
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.
Data have been submitted demonstrating the lack of mammalian
toxicity at high levels of exposure to the pure VIP3A proteins. This is
similar to the Agency position regarding toxicity of Bacillus
thuringiensis products from which this vegetative-insecticidal protein
is derived. The requirement for residue data for the derivative protein
is consistent with residue data requirements in 40 CFR
158.740(b)(2)(i). For microbial products, further toxicity testing and
residue data are triggered by significant acute effects in studies such
as the mouse oral toxicity study, to verify the observed effects and
clarify the source of these effects (Tiers II and III). The acute oral
toxicity data submitted support the prediction that the VIP3A protein
would be non-toxic to humans. Male and female mice (11 of each) were
dosed with the test material 5,050 milligrams/kilogram/body weight (mg/
kg/bwt) (3,675 mg of pure VIP3A protein per kg body weight). Outward
clinical signs were observed and body weights recorded throughout the
14-day study. No mortality or clinical signs attributed to the test
substance were noted during the study. When proteins are toxic, they
are known to act via acute mechanisms and at very low doses (Sjoblad,
R.D., J.T. McClintock and R. Engler (1992)). Therefore, since no
effects were shown to be caused by this vegetative-insecticidal
protein, even at relatively high does levels, it is not considered
toxic. The amino acid sequence of VIP3A is not homologous to that of
any known or putative allergens described in public data bases. Since
VIP3A is a protein, allergenic sensitivities were considered. Current
scientific knowledge suggests that common food allergens tend to be
resistant to degradation by heat, acid, and proteases, and may be
glycosylated and present at high concentrations in the food. Data have
been submitted that demonstrate that the VIP3A protein appears to be
present in multiple commercial formulations of Bt microbial
insecticides at concentrations estimated to be ca. 0.4 to 32 parts per
million (ppm). This conclusion is based on the presence of proteins of
the appropriate molecular weight and immunoreactivity (by SDS-PAGE and
western blot), and quantitation by ELISA. Therefore, it is conceivable
that small quantities of VIP3A protein already are present in the food
supply because VIP3A (or a very similar protein, based on size and
immunoreactivity) appears to be present in currently registered
insecticide products used on food crops, including fresh market
produce. These commercial Bt products are all exempt from food and feed
tolerances.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information
[[Page 21964]]
concerning exposures from the pesticide residue in food and all other
non-occupational exposures, including drinking water from ground water
or surface water and exposure through pesticide use in gardens, lawns,
or buildings (residential and other indoor uses).
A. Dietary Exposure
The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for the vegetative-insecticidal protein chemical residue, and exposure
from non-occupational sources.
1. Food. Oral exposure, at very low levels, may occur from
ingestion of processed cotton seed by products. However, a lack of
mammalian toxicity and the digestibility of the vegetative-insecticidal
protein have been demonstrated. The use sites of the VIP3A proteins are
all agricultural for control of insects.
2. Drinking water exposure. Oral exposure, at very low levels, may
occur from drinking water. However, a lack of mammalian toxicity and
the digestibility of the vegetative-insecticidal protein have been
demonstrated. The use sites for the VIP3A proteins are all agricultural
for control of insects.
B. Other Non-Occupational Exposure
1. Dermal exposure. Exposure via the skin is not likely since the
vegetative-insecticidal protein is contained within plant cells, which
essentially eliminates this exposure route or reduces these exposure
routes to negligible.
2. Inhalation exposure. Exposure via inhalation is not likely since
the vegetative-insecticidal protein is contained within plant cells,
which essentially eliminates this exposure route or reduces this
exposure route to negligible.
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 to the
VIP3A protein, it is reasonable to conclude that there are no
cumulative effects for this vegetative-insecticidal protein.
VI. Determination of Safety for U.S. Population, Infants, and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with a common mechanism of toxicity.
In addition, FFDCA section 408(B)(2)(C) also provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA determines
that a different margin of safety (MOS) will be safe for infants and
children. In this instance, based on the available data, the Agency
concludes that there is a finding of no toxicity for VIP3A proteins and
the genetic material necessary for their production. In the absence of
any threshold effects of concern, the Agency has determined that the
additional 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.
VII. Other Considerations
A. Endocrine Disruptors
The safety data submitted show no adverse effects in mammals, even
at very high dose levels, and support the prediction that the VIP3A
protein would be non-toxic to humans. Therefore no effects on the
immune or endocrine systems are expected.
B. Analytical Method(s)
Validated methods for extraction and direct ELISA analysis of VIP3A
in cotton seed have been submitted and found acceptable by the Agency.
C. Codex Maximum Residue Level
No Codex maximum residue levels exist for the vegetative-
insecticidal protein Bacillus thuringiensis VIP3A protein and genetic
material necessary for its production in cotton.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d),
as was provided in the old sections 408 and 409 of the FFDCA. However,
the period for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP -2005 -0083 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 June 27,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request
[[Page 21965]]
with the Hearing Clerk as described in Unit VIII.A., you should also
send a copy of your request to the PIRIB for its inclusion in the
official record that is described in ADDRESSES. Mail your copies,
identified by docket ID number OPP-2005-0083, to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IX. Statutory and Executive Order Reviews
This final rule establishes an extension of the temporary 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.
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 21, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
[[Page 21966]]
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.1247 is revised to read as follows:
Sec. 180.1247 Bacillus thuringiensis VIP3A protein and the genetic
material necessary for its production in cotton is exempt from the
requirement of a tolerance.
Bacillus thuringiensis VIP3A protein and the genetic material
necessary for its production in cotton is exempt from the requirement
of a tolerance when used as a vegetative-insecticidal protein in the
food and feed commodities, cotton seed, cotton oil, cotton meal, cotton
hay, cotton hulls, cotton forage, and cotton gin byproducts. Genetic
material necessary for its production means the genetic material which
comprise genetic encoding the VIP3A protein and its regulatory regions.
Regulatory regions are the genetic material, such as promoters,
terminators, and enhancers, that control expression of the genetic
material encoding the VIP3A protein. This time-limited exemption from
the requirement of a tolerance expires May 1, 2006.
[FR Doc. 05-8530 Filed 4-27-05; 8:45 am]
BILLING CODE 6560-50-S
