Bacillus Thuringiensis VIP3A Insect Control Protein and the Genetic Material Necessary for its Production in cotton; Extension of a Temporary Exemption from the Requirement of a Tolerance, 24582-24586 [06-3852]
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Federal Register / Vol. 71, No. 80 / Wednesday, April 26, 2006 / Rules and Regulations
enforcement agencies. (ii) The Captain
of the Port will broadcast status updates
for this safety zone by Marine Safety
Radio Broadcast on VHF Marine Band
Radio Channel 22 (157.1 MHz and
through the means required under 5
U.S.C. 553.
Dated: April 17, 2006.
Patrick G. Gerrity,
Captain, U.S. Coast Guard, Captain of the
Port, Portland, OR.
[FR Doc. 06–3934 Filed 4–25–06; 8:45 am]
BILLING CODE 4910–15–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 21
RIN 2900–AL69
Reservists’ Education: Revision of
Eligibility Requirements for the
Montgomery GI Bill—Selected Reserve
Department of Veterans Affairs.
ACTION: Final rule; technical
amendment.
AGENCY:
The Department of Veterans
Affairs (VA) published a document in
the Federal Register on January 10,
2006 (71 FR 1496), revising eligibility
requirements for the Montgomery GI
Bill—Selected Reserve program. In that
document, we inadvertently removed
paragraphs (e)(2) through (e)(4) of
§ 21.7550 when we revised redesignated
paragraph (e)(1). This document
reinstates the dropped regulatory text of
those paragraphs.
DATES: Effective on January 10, 2006.
FOR FURTHER INFORMATION CONTACT:
Brandye R. Kidd, Management and
Program Analyst, Department of
Veterans Affairs (225C), 810 Vermont
Ave., NW., Washington, DC 20420, (202)
273–7420.
SUPPLEMENTARY INFORMATION: The
Department of Veterans Affairs (VA)
made revisions to 38 CFR 21.7550(e) in
order to update the regulations to reflect
the date that reservists would no longer
be eligible for benefits under the
Montgomery GI Bill—Selected Reserve
program. In making the necessary
adjustments to reflect the appropriate
time limits, paragraphs (e)(2)
through(e)(4) of § 21.7550 were
accidentally removed. A typographical
error occurred in the amendatory
instruction to the Office of Federal
Register editor. We instructed the editor
‘‘to revise redesignated paragraph (e)’’
when it was our intention only to revise
redesignated paragraph (e)(1).
Consequently, the revised regulatory
text of redesignated paragraph (e)(1)
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SUMMARY:
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replaced paragraphs (e)(2) through
(e)(4). This document reinstates the
regulatory text of paragraphs (e)(2)
through (e)(4) of § 21.7550.
List of Subjects in 38 CFR Part 21
Administrative practice and
procedure, Armed forces, Civil rights,
Claims, Colleges and universities,
Conflicts of interest, Defense
Department, Education, Employment,
Grant programs—education, Grant
programs—veterans, Health care, Loan
programs—education, Loan programs—
veterans, Manpower training programs,
Reporting and recordkeeping
requirements, Schools, Travel and
transportation expenses, Veterans,
Vocational education, Vocational
rehabilitation.
Approved: April 19, 2006.
Robert C. McFetridge,
Acting Assistant to the Secretary for
Regulation Policy and Management.
Accordingly, 38 CFR part 21, subpart
L, is amended as follows:
I
PART 21—VOCATIONAL
REHABILITATION AND EDUCATION
Forces and (after having involuntarily
ceased to be a member of the Selected
Reserve) is involuntarily separated from
the Armed Forces under adverse
conditions, as characterized by the
Secretary of the military department
concerned. The expiration of such a
reservist’s period of eligibility will be on
the date the reservist is involuntarily
separated under adverse conditions
from the Armed Forces.
*
*
*
*
*
[FR Doc. 06–3910 Filed 4–25–06; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 174 and 180
[EPA–HQ–OPP–2005–0282; FRL–7772–7]
Bacillus Thuringiensis VIP3A Insect
Control Protein and the Genetic
Material Necessary for its Production
in cotton; Extension of a Temporary
Exemption from the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
Subpart L—Educational Assistance for
Members of the Selected Reserve
1. The authority citation for part 21,
subpart L continues to read as follows:
I
Authority: 10 U.S.C. ch. 1606; 38 U.S.C.
501(a), 512, ch. 36, unless otherwise noted.
2. Amend § 21.7550 by adding
paragraphs (e)(2) through (e)(4) to read
as follows:
I
§ 21.7550
Ending dates of eligibility.
*
*
*
*
*
(e) * * *
(2) The conditions referred to in
paragraph (e)(1) of this section for
ceasing to be a member of the Selected
Reserve are:
(i) The deactivation of the reservist’s
unit of assignment; and
(ii) The reservist’s involuntarily
ceasing to be designated as a member of
the Selected Reserve pursuant to 10
U.S.C. 10143(a).
(3) The provisions of paragraphs (e)(1)
and (e)(2) of this section do not apply
if the reservist ceases to be a member of
the Selected Reserve under adverse
conditions, as characterized by the
Secretary of the military department
concerned. The expiration of such a
reservist’s period of eligibility will be on
the date the reservist ceases, under
adverse conditions, to be a member of
the Selected Reserve.
(4) A reservist’s period of eligibility
will expire if he or she is a member of
a reserve component of the Armed
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SUMMARY: This regulation establishes a
temporary exemption from the
requirement of a tolerance for residues
of the Bacillus Thuringiensis VIP3A
Insect Control Protein in cotton when
applied or used as a plant incorporated
protectant. Syngenta Seeds, Inc.
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA),
requesting an extension to the existing
temporary exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of Bacillus Thuringiensis
VIP3A Insect Control Protein. The
temporary tolerance exemption will
expire on May 1, 2007. This regulation
also removes 40 CFR 180.1247 Bacillus
Thuringiensis VIP3A Insect Control
Protein and establishes 40 CFR 174.452
Bacillus Thuringiensis VIP3A Insect
Control Protein under Part 174—
Procedures and Requirements for Plantincorporated protectants.
DATES: This regulation is effective April
26, 2006. Objections and requests for
hearings must be received on or before
June 26, 2006.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit IX. of the SUPPLEMENTARY
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Federal Register / Vol. 71, No. 80 / Wednesday, April 26, 2006 / Rules and Regulations
INFORMATION.
EPA has established a
docket for this action under Docket
identification (ID) number EPA–HQ–
OPP–2005–0282. All documents in the
docket are listed on the regulations.gov
website. EDOCKET, EPA’s electronic
public docket and comment system was
replaced on November 25, 2005, by an
enhanced federal-wide electronic docket
management and comment system
located at https://www.regulations.gov/.
Follow the on-line instructions.
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.
• Important Note: OPP will be
moving to a new location the first week
of May 2006. As a result, from Friday,
April 28 to Friday, May 5, 2006, the
OPP Regulatory Public Docket will NOT
be accepting any deliveries at the
Crystal Mall #2 address and this facility
will be closed to the public. Beginning
on May 8, 2006, the OPP Regulatory
Public Docket will reopen at 8:30 a.m.
and deliveries will be accepted in Rm.
S–4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA 22202. The mail code for
the mailing address will change to
(7502P), but will otherwise remain the
same. The OPP Regulatory Public
Docket telephone number and hours of
operation will remain the same after the
move.
FOR FURTHER INFORMATION CONTACT:
Leonard Cole, Biopesticides and
Pollution Prevention Division (7511C),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5412; e-mail address:
cole.leonard@epa.gov.
SUPPLEMENTARY INFORMATION:
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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:
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• 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 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
In the Federal Register of November
30, 2005 (70 FR 71842) (FRL–7743–1),
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 3G6547)
by Syngenta Seeds, Inc., P.O. Box
12257, 3054 Cornwallis Road, Research
Triangle Park, NC 27709–2257. The
petition requested that 40 CFR part 180
be amended by extending an existing
temporary exemption from the
requirement of a tolerance for residues
of Bacillus Thuringiensis VIP3A Insect
Control Protein. This notice included a
summary of the petition prepared by the
petitioner Syngenta Seeds, Inc. There
were no comments received in response
to the notice of filing.
This regulation also removes 40 CFR
180.1247 and establishes 40 CFR
174.452 Bacillus Thuringiensis VIP3A
Insect Control Protein under Part 174—
Procedures and Requirements for Plantincorporated protectants, because EPA
is gradually moving the plantincorporated protectant exemptions
from part 180 to part 174.
Section 408(c)(2)(A)(i) of the FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
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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.
In the initial petition requesting the
establishment of a temporary exemption
from the requirement of a tolerance,
data were 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
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Federal Register / Vol. 71, No. 80 / Wednesday, April 26, 2006 / Rules and Regulations
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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
at 5,050 milligrams/kilogram/body
weight (mg/kg/bwt). 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 vegetativeinsecticidal protein, even at relatively
high does levels, it is not considered
toxic.
Since VIP3A is a protein, allergenic
sensitivities were considered. The
amino acid sequence of VIP3A is not
homologous to that of any known or
putative allergens described in public
data bases. 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,
32 parts per million (ppm). This
conclusion is based on the presence of
proteins of the appropriate molecular
weight and immunoreactivity (by SDSPAGE and western blot), and
quantitation by Enzyme Linked
Immunosorbent Assay (ELISA).
Therefore, it is conceivable that small
quantities of VIP3A protein 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
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
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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
protein, it is reasonable to conclude that
there are no cumulative effects for this
vegetative-insecticidal protein.
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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. Thus, there are no threshold
effects of concern, and as a result, the
provision requiring an additional MOS
does not apply. 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. Conclusions
The Agency concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to the plant incorporated
protectant, Bacillus thuringiensis VIP3A
protein and genetic material necessary
for its production in cotton, when used
in accordance with label directions as a
plant incorporated protectant.
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Federal Register / Vol. 71, No. 80 / Wednesday, April 26, 2006 / Rules and Regulations
IX. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to the
FFDCA by the FQPA, EPA will continue
to use those procedures, with
appropriate adjustments, until the
necessary modifications can be made.
The new section 408(g) of the FFDCA
provides essentially the same process
for persons to ‘‘object’’ to a regulation
for an exemption from the requirement
of a tolerance issued by EPA under new
section 408(d) of the FFDCA, as was
provided in the old sections 408 and
409 of the FFDCA. However, the period
for filing objections is now 60 days,
rather than 30 days.
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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
EPA–HQ–OPP–2005–0282 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 26, 2006.
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 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,
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DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit IX.A.1., 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
EPA–HQ–OPP–2005–0282, to: Public
Information and Records Integrity
Branch, Information Technology and
Resources Management Division
(7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. In person or by courier,
bring a copy to the location of the PIRIB
described in ADDRESSES. You may also
send an electronic copy of your request
via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and
avoid the use of special characters and
any form of encryption. Copies of
electronic objections and hearing
requests will also be accepted on disks
in WordPerfect 6.1/8.0 or ASCII file
format. Do not include any CBI in your
electronic copy. You may also submit an
electronic copy of your request at many
Federal Depository Libraries.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
X. Statutory and Executive Order
Reviews
This final rule establishes an
extension to an existing 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
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24585
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. The
Agency hereby certifies that this rule
will not have significant negative
economic impact on a substantial
number of small entities. 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,
entitledFederalism (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
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26APR1
24586
Federal Register / Vol. 71, No. 80 / Wednesday, April 26, 2006 / Rules and Regulations
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.
hsrobinson on PROD1PC68 with RULES
XI. 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).
and pests, Reporting and recordkeeping
requirements.
ENVIRONMENTAL PROTECTION
AGENCY
Dated: April 14, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
40 CFR Part 180
Therefore, 40 CFR chapter I is
amended as follows:
Benzaldehyde, Captafol,
Hexaconazole, Paraformaldehyde,
Sodium dimethyldithiocarbamate, and
Tetradifon; Tolerance Actions
PART 174—[AMENDED]
AGENCY:
I
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 174.452 is added to subpart
W to read as follows:
I
§ 174.452 Bacillus thuringiensis VIP3A
protein and the genetic material necessary
for its production; temporary exemption
from the requirement of a tolerance.
Bacillus thuringiensis VIP3A protein
and the genetic material necessary for
its production is temporarily exempt
from the requirement of a tolerance
when used as a vegetative-insecticidal
protein in 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
temporary exemption from the
requirement of a tolerance expires May
1, 2007.
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
§ 180.1247
I
[Removed].
2. Section 180.1247 is Removed.
[FR Doc. 06–3852 Filed 4–25–06; 8:45 am]
BILLING CODE 6560–50–S
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
VerDate Aug<31>2005
14:58 Apr 25, 2006
Jkt 208001
[EPA–HQ–OPP–2005–0322; FRL–8065–1]
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is revoking specific
tolerances and tolerance exemptions for
residues of the insecticides
paraformaldehyde and tetradifon;
fungicides captafol, hexaconazole, and
sodium dimethyldithiocarbamate; and
bee repellent benzaldehyde. EPA
canceled food use registrations or
deleted food uses from registrations
following requests for voluntary
cancellation or use deletion by the
registrants, or non-payment of
registration maintenance fees. Also,
stakeholders have withdrawn their
support for import tolerances for
captafol and hexaconazole. The
regulatory actions in this document
contribute toward the Agency’s
tolerance reassessment requirements of
the Federal Food, Drug, and Cosmetic
Act (FFDCA) section 408(q), as amended
by the Food Quality Protection Act
(FQPA) of 1996. By law, EPA is required
by August 2006 to reassess the
tolerances in existence on August 2,
1996. The regulatory actions in this
document pertain to the revocation of
39 tolerances and tolerance exemptions
of which 38 count as tolerance
reassessments toward the August, 2006
review deadline.
DATES: This regulation is effective April
26, 2006. Objections and requests for
hearings must be received on or before
June 26, 2006.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit IV. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number EPA–HQ–
OPP–2005–0322. All documents in the
docket are listed on the
www.regulations.gov website.
(EDOCKET, EPA’s electronic public
docket and comment system was
replaced on November 25, 2005, by an
enhanced Federal-wide electronic
docket management and comment
system located at https://
www.regulations.gov/. Follow the online
instructions.) Although listed in the
E:\FR\FM\26APR1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 80 (Wednesday, April 26, 2006)]
[Rules and Regulations]
[Pages 24582-24586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3852]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 174 and 180
[EPA-HQ-OPP-2005-0282; FRL-7772-7]
Bacillus Thuringiensis VIP3A Insect Control Protein and the
Genetic Material Necessary for its Production in cotton; Extension of a
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
requirement of a tolerance for residues of the Bacillus Thuringiensis
VIP3A Insect Control Protein in cotton when applied or used as a plant
incorporated protectant. Syngenta Seeds, Inc. submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of 1996 (FQPA), requesting an
extension to the existing temporary exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Bacillus Thuringiensis VIP3A Insect
Control Protein. The temporary tolerance exemption will expire on May
1, 2007. This regulation also removes 40 CFR 180.1247 Bacillus
Thuringiensis VIP3A Insect Control Protein and establishes 40 CFR
174.452 Bacillus Thuringiensis VIP3A Insect Control Protein under Part
174--Procedures and Requirements for Plant-incorporated protectants.
DATES: This regulation is effective April 26, 2006. Objections and
requests for hearings must be received on or before June 26, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY
[[Page 24583]]
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0282. All documents in the
docket are listed on the regulations.gov website. EDOCKET, EPA's
electronic public docket and comment system was replaced on November
25, 2005, by an enhanced federal-wide electronic docket management and
comment system located at https://www.regulations.gov/. Follow the on-
line instructions. 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.
Important Note: OPP will be moving to a new location the
first week of May 2006. As a result, from Friday, April 28 to Friday,
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall 2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
OPP Regulatory Public Docket telephone number and hours of operation
will remain the same after the move.
FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5412; e-mail address: cole.leonard@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 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
In the Federal Register of November 30, 2005 (70 FR 71842) (FRL-
7743-1), 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 3G6547) by Syngenta Seeds, Inc., P.O. Box 12257,
3054 Cornwallis Road, Research Triangle Park, NC 27709-2257. The
petition requested that 40 CFR part 180 be amended by extending an
existing temporary exemption from the requirement of a tolerance for
residues of Bacillus Thuringiensis VIP3A Insect Control Protein. This
notice included a summary of the petition prepared by the petitioner
Syngenta Seeds, Inc. There were no comments received in response to the
notice of filing.
This regulation also removes 40 CFR 180.1247 and establishes 40 CFR
174.452 Bacillus Thuringiensis VIP3A Insect Control Protein under Part
174--Procedures and Requirements for Plant-incorporated protectants,
because EPA is gradually moving the plant-incorporated protectant
exemptions from part 180 to part 174.
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.
In the initial petition requesting the establishment of a temporary
exemption from the requirement of a tolerance, data were 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
[[Page 24584]]
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 at 5,050 milligrams/kilogram/body weight (mg/kg/bwt).
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.
Since VIP3A is a protein, allergenic sensitivities were considered.
The amino acid sequence of VIP3A is not homologous to that of any known
or putative allergens described in public data bases. 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, 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 Enzyme Linked Immunosorbent Assay
(ELISA). Therefore, it is conceivable that small quantities of VIP3A
protein 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 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. Thus, there are no
threshold effects of concern, and as a result, the provision requiring
an additional MOS does not apply. 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. Conclusions
The Agency concludes that there is a reasonable certainty that no
harm will result to the U.S. population, including infants and
children, from aggregate exposure to the plant incorporated protectant,
Bacillus thuringiensis VIP3A protein and genetic material necessary for
its production in cotton, when used in accordance with label directions
as a plant incorporated protectant.
[[Page 24585]]
IX. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2005-0282 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 26,
2006.
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 on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A.1.,
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 EPA-HQ-OPP-2005-0282, to:
Public Information and Records Integrity Branch, Information Technology
and Resources Management Division (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
X. Statutory and Executive Order Reviews
This final rule establishes an extension to an existing 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. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. 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, entitledFederalism
(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
[[Page 24586]]
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.
XI. 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 14, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 174--[AMENDED]
0
1. The authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.
0
2. Section 174.452 is added to subpart W to read as follows:
Sec. 174.452 Bacillus thuringiensis VIP3A protein and the genetic
material necessary for its production; temporary exemption from the
requirement of a tolerance.
Bacillus thuringiensis VIP3A protein and the genetic material
necessary for its production is temporarily exempt from the requirement
of a tolerance when used as a vegetative-insecticidal protein in 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 temporary exemption from the requirement of a tolerance
expires May 1, 2007.
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
Sec. 180.1247 [Removed].
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2. Section 180.1247 is Removed.
[FR Doc. 06-3852 Filed 4-25-06; 8:45 am]
BILLING CODE 6560-50-S
