[Federal Register: March 31, 2004 (Volume 69, Number 62)]
[Rules and Regulations]
[Page 16806-16809]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr04-19]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0035; FRL-7350-8]
Time-Limited Exemption from Requirement of a Tolerance; Exemption
from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Bacillus thuringiensis VIP3A insect
control protein as expressed in event COT102 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 an 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 as expressed in event COT102
and the genetic material necessary for its production.
DATES: This regulation is effective March 31, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2004-0035,
must be received on or before June 1, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY
INFORMATION.
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 catergories and entities may include, but are not
limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2004-0035. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. You may access this Federal Register document
electronically through EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available on E-CFR Beta Site
Two at http://www.gpoaccess.gov/ecfr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of November 26, 2003 (68 FR 66422) (FRL-
7332-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a(e), as amended by FQPA (Public Law 104 -170), announcing
the filing of a pesticide tolerance petition (3F6756) by Syngenta
Seeds, Incorporated, P.O. Box 12257, 3054 Cornwallis Road, Research
Triangle Park, NC 27709-2257. This notice included a summary of the
petition prepared by the petitioner Syngenta Seeds, Incorporated.
Comments were received from grower groups, and the National Cotton
Council supporting this petition.
The petition requested that 40 CFR 180 be amended by establishing
an exemption from the requirement of a tolerance for residues of
Bacillus thuringiensis VIP3A Insect Control Protein as Expressed in
Event COT102 and the genetic material necessary for its production.
III. Risk Assessment
New 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 tolerance 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. Section 408 of the FFDCA (b)(2)(C)
requires 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.''
[[Page 16807]]
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.
IV. 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). 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 the vegetative-insecticidal
protein, even at relatively high does levels, vegetative-insecticidal
proteins are 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, 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 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.
V. 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.
VI. 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.
VII. 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.
[[Page 16808]]
VIII. 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.
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. EPA procedural regulations
which govern the submission of objections and requests for hearings
appear in 40 CFR part 178. Although the procedures in those regulations
require some modification to reflect the amendments made to the FFDCA
by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0035 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 1,
2004.
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 (1900C),
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 Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2004-0035, 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 Unit I.B.1. 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 a time-limited 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
[[Page 16809]]
(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. This time-limited exemption from the requirement of a
tolerance expires May 1, 2005.
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: March 18, 2004.
James Jones,
Director, 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:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1247 is added to subpart D 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, 2005.
[FR Doc. 04-6931 Filed 3-30-04; 8:45 am]
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