

[Federal Register: April 26, 2006 (Volume 71, Number 80)]
[Rules and Regulations]               
[Page 24582-24586]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap06-9]                         

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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.

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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 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 http://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 (http://www.epa.gov/edocket/), you may 

access this Federal Register document electronically through the 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 at E-CFR Beta Site Two at http://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].

0
2. Section 180.1247 is Removed.
[FR Doc. 06-3852 Filed 4-25-06; 8:45 am]

BILLING CODE 6560-50-S
