[Federal Register: December 5, 2007 (Volume 72, Number 233)]
[Rules and Regulations]
[Page 68525-68529]
[DOCID:fr05de07-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-0574; FRL-8340-5]

Bacillus Thuringiensis Vip3Aa20 Protein and the Genetic Material
Necessary for its Production in Corn; Extension of Temporary Exemption
From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends the temporary exemption from the
requirement of a tolerance for residues of Bacillus thuringiensis
Vip3Aa20 protein in corn 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 that the temporary
tolerance exemption be extended. This regulation eliminates the need to
establish a maximum permissible level for residues of the Bacillus
thuringiensis Vip3Aa20 protein in corn when applied or used as a plant-
incorporated protectant on field corn, sweet corn, and popcorn. The
temporary tolerance exemption expires on October 31, 2009.

DATES: This regulation is effective December 5, 2007. Objections and
requests for hearings must be received on or before February 4, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0574. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 174 through the
Government Printing

Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0574 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 February 4, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0574, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of August 8, 2007 (72 FR 44521) (FRL-8139-
7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7212) by Syngenta Seeds, Inc., 3054 Cornwallis Rd., P.O. Box 12257,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
174.458 (now 40 CFR 174.528, see the Federal Register issue of April
25, 2007 (72 FR 20431) (FRL-7742-2) be amended such that the temporary
tolerance exemption for Bacillus thuringiensis Vip3Aa20 protein and the
genetic material necessary for its production in corn when applied/used
as a plant-incorporated protectant on field corn, sweet corn, and
popcorn expires on October 31, 2009.
    This notice included a summary of the petition prepared by Syngenta
Seeds, Inc., the registrant. There were no comments received in
response to the notice of filing.
    Section 408(c)(2)(A)(i) of 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 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) of FFDCA, 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) of FFDCA, 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 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(c)(2)(B) of 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 a lack of mammalian toxicity
at high levels of exposure to the pure (microbially expressed) Vip3Aa20
protein. These data demonstrate the safety of Vip3Aa20 at well above
maximum possible exposure levels that are reasonably anticipated in the
crops. This is similar to the Agency position regarding toxicity and
the requirement of residue data for the microbial Bacillus
thuringiensis products from which this plant-incorporated protectant
was derived (see 40 CFR 158.740(b)(2)(i)). For microbial products, the
need for Tier II and III toxicity testing and residue data to verify
the observed effects and clarify the source of these effects is
triggered only by significant acute effects in studies such as the
mouse oral toxicity study.
    In order to clarify the discussion that follows in the remainder of
this final rule, it is necessary to distinguish the various Vip3A
designations that are used. Vip3Aa20 is the designation applicable to
Vip3A protein expressed in corn. Vip3Aa19 is the designation applicable
to Vip3A protein expressed in cotton. Because the Agency has determined
that both Vip3Aa19 and Vip3Aa20 are functionally equivalent, the Agency
in amending this temporary tolerance exemption for Vip3Aa20 expressed
in corn has relied on data and analysis specifically developed for
Vip3Aa20, as well as on data and analysis specifically developed for
Vip3Aa19. A separate temporary exemption from the requirement of
tolerance already has been established for Vip3Aa19 as expressed in
cotton (72 FR 40754; 40 CFR 174.501).
    An acute oral toxicity study was submitted for the Vip3Aa19
protein. Male and female mice (16 of each) were dosed with 3,675
milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All
mice survived the study, gained weight, had no test material-related
clinical signs, and had no test material-related findings at necropsy.
This acute oral toxicity data also supports the prediction that the
Vip3Aa20 protein would be non-toxic to humans.
    When proteins are toxic, they are known to act via acute mechanisms
and at very low-dose levels (Sjoblad, Roy D., et al. 1992). Therefore,
since no effects

were shown to be caused by the plant-incorporated protectants, even at
relatively high-dose levels, the Vip3Aa20 protein is not considered
toxic. Amino acid sequence comparisons showed no similarity between the
Vip3Aa20 protein and known toxic proteins available in public protein
data bases. According to the Codex Alimintarius guidelines, the
assessment of potential toxicity also includes stability to heat Food
and Agriculture Organization of the United Nations/World Health
Organization Standards Programme, 2001. A heat lability study
demonstrated that Vip3Aa19 is inactivated against fall army worm, when
heated to 55 [deg]C for 30 minutes.
    Since Vip3Aa20 is a protein, allergenic sensitivities were
considered. Currently, no definitive tests exist for determining the
allergenic potential of novel proteins. Therefore, EPA uses a weight of
the evidence approach where the following factors are considered:
source of the trait; amino acid sequence similarity with known
allergens; prevalence in food; and biochemical properties of the
protein, including in vitro digestibility in simulated gastric fluid,
and glycosylation. Current scientific knowledge suggests that common
food allergens tend to be resistant to degradation acid and proteases;
may be glycosylated; and present at high concentrations in the food.
    Data have been submitted that demonstrate that the Vip3A from
recombinant maize (LPPACHA-0199) and E. coli (VIP3A-0100) proteins are
rapidly degraded by gastric fluid in vitro. (VIP3A-0100 refers to a
microbially expressed Vip3A that has been shown to be the equivalent of
the plant-expressed Vip3A protein.) In a solution of simulated gastric
fluid (containing pepsin) and either 80 microLiter ([micro]L) of
LPPACHA-0199 or 320 [micro]L of VIP3A-0100 test protein, both were
shown to be susceptible to pepsin degradation. These data support the
conclusion that Vip3A proteins expressed in transgenic plants will be
readily digested as a conventional dietary protein under typical
mammalian gastric conditions. Further data demonstrate that Vip3Aa20 is
not glycoslylated and a comparison of amino acid sequences of known
allergens uncovered no evidence of any homology with Vip3Aa20, even at
the level of 8 contiguous amino acid residues. Preliminary data of the
quantification of Vip3Aa20 protein in various maize tissues were also
submitted. This data demonstrated that mean Vip3Aa20 concentrations in
corn kernels ranged from circa (ca). 24.6-40.3 microgram ([micro]g)
Vip3Aa20/gram (g) dry weight, representing ca. 0.003% of the total
protein in grain (assuming that corn grain contains 10% total protein
by weight). Therefore, Vip3Aa20 is present in low levels in corn tissue
and the protein expression is much lower than the amounts of allergen
protein found in commonly allergenic foods. In those foods, the
allergens can be 10 to 50% of the total protein found.
    Therefore, the potential for the Vip3Aa20 protein to be a food
allergen is minimal. As noted in grams/kilogram (gm/kg), toxic proteins
typically act as acute toxins with low-dose levels. Therefore, since no
effects were shown to be caused by this plant-incorporated protectant,
even at relatively high-dose levels, the Vip3Aa20 protein is not
considered toxic.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
    The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for the plant-incorporated protectant chemical residue, and exposure
from non-occupational sources. Exposure via the skin or inhalation is
not likely since the plant-incorporated protectant is contained within
plant cells, which essentially eliminates these exposure routes or
reduces these exposure routes to negligible. The amino acid homology
assessment revealed no similarities to known aeroallergens, indicating
that Vip3A has a low potential to be an inhalation allergen. It has
been demonstrated that there is no evidence of occupationally related
respiratory symptoms, based on a health survey on migrant workers after
exposure to Bacillus thuringiensis pesticides (Berstein et al. 1999),
which provides further evidence of the negligible respiratory risks of
Bacillus thuringiensis plant-incorporated protectants. Exposure via
residential or lawn use to infants and children is also not expected
because the use sites for the Vip3Aa20 protein are all agricultural for
control of insects. Oral exposure, at very low levels may occur from
ingestion of processed corn products and, theoretically, drinking
water.
    However, oral toxicity testing done at a dose in excess of 3 grams/
kilogram showed no adverse effects. Furthermore, the expected dietary
exposure from both cotton and corn are several orders of magnitude
lower than the amounts of Vip3Aa20 protein shown to have no toxicity.
Therefore, even if negligible aggregate exposure should occur, the
Agency concludes that such exposure would present no harm due to the
lack of mammalian toxicity and the rapid digestibility demonstrated for
the Vip3Aa20 proteins.

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 include 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, the
Agency concludes that there are no cumulative effects arising from
Vip3Aa20 protein residues in corn.

VI. Determination of Safety for U.S. Population, Infants and Children

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for
the Vip3Aa20 protein include the characterization of the expressed
Vip3Aa20 protein in corn, as well as the acute oral toxicity, heat
stability, and in vitro digestibility of the proteins. The results of
these studies were determined applicable to evaluate human risk, and
the validity, completeness, and reliability of the available data from
the studies were considered.
    Adequate information was submitted to show that the Vip3A protein
test material derived from microbial cultures (designated VIP3A-0100)
was biochemically and functionally similar to the Vip3Aa20 protein
expressed in corn. Microbially produced protein was chosen in order to
obtain sufficient material for testing.
    The acute oral toxicity data submitted support the prediction that
the Vip3Aa20 protein would be non-toxic to humans. As mentioned above,
when proteins are toxic, they are known to act via acute mechanisms and
at very low-

dose levels (Sjoblad, Roy D., et al. 1992). Since no effects were shown
to be caused by Vip3Aa20 protein, even at relatively high-dose levels
(3,675 mg Vip3Aa19/kg bwt), the Vip3Aa20 protein is not considered
toxic. This is similar to the Agency position regarding toxicity and
the requirement of residue data for the microbial Bacillus
thuringiensis products from which this plant-incorporated protectant
was derived. Moreover, Vip3Aa20 showed no sequence similarity to any
known toxin.
    Protein residue chemistry data for Vip3Aa20 were not required for a
human health effects assessment of the subject plant-incorporated
protectant ingredients because of the lack of mammalian toxicity.
However, preliminary data (that were submitted with administrative
materials for an Experimental Use Permit (EUP) application for corn
expressing the Vip3Aa20 protein) demonstrated low levels of Vip3Aa20 in
corn tissues with less than 40 [micro]g Vip3Aa20 protein/g dry weight
in kernels and less than 75 [mu]g Vip3Aa20 protein/g dry weight of
whole corn plant.
    Since Vip3Aa20 is a protein, its potential allergenicity is also
considered as part of the toxicity assessment. Information considered
as part of the allergenicity assessment included data demonstrating
that the Vip3Aa20 protein came from a Bacillus thuringiensis which is
not a known allergenic source, showed no sequence similarity to known
allergens, was readily degraded by pepsin, and was not glycosylated
when expressed in the plant. Therefore, there is a reasonable certainty
that the Vip3Aa20 protein will not be an allergen.
    Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children), nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the Vip3Aa20 protein, as well as the minimal potential to
be a food allergen, demonstrate the safety of Vip3Aa20 at levels well
above possible maximum exposure levels anticipated in the crop.
    The genetic material necessary for the production of the plant-
incorporated protectant active ingredients are the nucleic acids (DNA,
RNA) which comprise genetic material encoding these proteins and their
regulatory regions. The genetic material (DNA, RNA) necessary for the
production of Vip3Aa20 protein already are exempted from the
requirement of a tolerance under a blanket exemption for all nucleic
acids (40 CFR 174.507).

B. Infants and Children Risk Conclusions

    Section 408(b)(2)(C) of FFDCA 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 will be safe for infants
and children.
    In this instance, based on all the available information, the
Agency concludes that there is a finding of no toxicity for the
Vip3Aa20 protein and the genetic material necessary for its production
in corn. Because there are no threshold effects of concern, the Agency
has determined that the additional tenfold margin of safety is not
necessary to protect infants and children. Further, the provisions of
consumption patterns, special susceptibility, and cumulative effects do
not apply.

C. Overall Safety Conclusion

    There is a reasonable certainty that no harm will result to the
U.S. population, including infants and children, from aggregate
exposure to residues of the Vip3Aa20 protein and the genetic material
necessary for its production in corn, when it is applied/used in
accordance with good agricultural practices on field corn, sweet corn,
and popcorn. This includes all anticipated dietary exposures and all
other exposures for which there is reliable information. The Agency has
arrived at this conclusion because, as previously discussed, no
toxicity to mammals has been observed, nor has there been any
indication of allergenicity potential for this plant-incorporated
protectant.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from sources
that are not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of the plant-incorporated protectant at this time.

B. Analytical Method(s)

    A method for extraction and Enzyme Linked Immunosorbent (ELISA)
Analysis of Vip3Aa20 protein in corn has been submitted and is under
review by the Agency.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exist for the plant-incorporated
protectant Bacillus thuringiensis Vip3Aa20 protein and the genetic
material necessary for its production in corn.

VIII. Statutory and Executive Order Reviews

    This final rule extends the exemption from the requirement of a
tolerance under section 408(d) of 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, 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) or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national

government and the States or tribal governments, or on the distribution
of power and responsibilities among the various levels of government or
between the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not 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).
    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).

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Corn, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: November 19, 2007,
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 174.528 is revised to read as follows:

Sec.  174.528  Bacillus thuringiensis Vip3Aa20 protein in corn;
temporary exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Vip3Aa20 protein in corn are
temporarily exempt from the requirement of a tolerance when used as a
plant-incorporated protectant in the food and feed commodities; corn,
field; corn, sweet; and corn, pop. This temporary exemption from the
requirement of tolerance will permit the use of the food commodities in
this section when treated in accordance with the provisions of the
experimental use permit 67979-EUP-6, which is being amended and
extended in accordance with the provisions of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This
temporary exemption from the requirement of a tolerance expires and is
revoked October 31, 2009; however, if the experimental use permit is
revoked, or if any experience with or scientific data on this pesticide
indicate that the temporary tolerance exemption is not safe, this
temporary exemption from the requirement of a tolerance may be revoked
at any time.
[FR Doc. E7-23308 Filed 12-4-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Page 78740]
[FR Doc No: 2022-27784]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96517; File No. SR-CboeBZX-2022-035]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change To
List and Trade Shares of the VanEck Bitcoin Trust Under BZX Rule
14.11(e)(4), Commodity-Based Trust Shares

December 16, 2022.
    On June 24, 2022, Cboe BZX Exchange, Inc. (``BZX'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the VanEck Bitcoin Trust under BZX Rule 14.11(e)(4),
Commodity-Based Trust Shares. The proposed rule change was published
for comment in the Federal Register on July 13, 2022.\3\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 95218 (July 7,
2022), 87 FR 41755.
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    On August 24, 2022, pursuant to Section 19(b)(2) of the Act,\4\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ On October 4, 2022, the Commission instituted proceedings
under Section 19(b)(2)(B) of the Act \6\ to determine whether to
approve or disapprove the proposed rule change.\7\ The Commission has
received no comments on the proposed rule change.
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    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 95596, 87 FR 53038
(Aug. 30, 2022).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 95978, 87 FR 61418
(Oct. 11, 2022).
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    Section 19(b)(2) of the Act \8\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing of the proposed rule change.
The Commission may extend the period for issuing an order approving or
disapproving the proposed rule change, however, by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination. The proposed rule
change was published for comment in the Federal Register on July 13,
2022.\9\ The 180th day after publication of the proposed rule change is
January 9, 2023. The Commission is extending the time period for
approving or disapproving the proposed rule change for an additional 60
days.
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    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See supra note 3 and accompanying text.
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    The Commission finds that it is appropriate to designate a longer
period within which to issue an order approving or disapproving the
proposed rule change so that it has sufficient time to consider the
proposed rule change and the issues raised therein. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\10\ designates
March 10, 2023, as the date by which the Commission shall either
approve or disapprove the proposed rule change (File No. SR-CboeBZX-
2022-035).
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(57).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-27784 Filed 12-21-22; 8:45 am]
BILLING CODE 8011-01-P