[Federal Register: March 15, 2006 (Volume 71, Number 50)]
[Rules and Regulations]
[Page 13269-13274]
[DOCID:fr15mr06-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0174; FRL-7766-6]

Modified Cry3A Protein and the Genetic Material for Its
Production in Corn; 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 extends an existing temporary exemption from
the requirement of a tolerance for residues of the Bacillus
thuringiensis modified Cry3A protein (mCry3A) and the genetic material
necessary for its production in corn on field corn, sweet corn, and
popcorn when applied/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 this extension of the existing temporary
tolerance exemption. This regulation eliminates the need to establish a
maximum permissible level for residues of modified Cry3A protein
(mCry3A) and the genetic material necessary for its production in corn.
The temporary tolerance exemption as extended will expire on October
15, 2007.

DATES: This regulation is effective March 15, 2006. Objections and
requests for hearings must be received on or before May 15, 2006.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2006-0174. All documents in the
docket are listed on the http://www.regulations.gov Web site. (EDOCKET,

EPA's electronic public docket system was replaced on November 25,
2005, by an enhanced federal-wide eletronic management and comment
system located at http//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.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511C), 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 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 174

is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of January 25, 2006 (71 FR 4140) (FRL-7757-
6), 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 4G6808) by Syngenta Seeds, Inc., P.O. Box 12257, 3054 East
Cornwallis Road, Research Triangle Park, NC 27709-2257. The petition
requested that 40 CFR part 174 be amended by extending by 1 year a
temporary exemption from the requirement of a tolerance for residues of
Bacillus thuringiensis modified Cry3A protein (mCry3A) and the genetic
material necessary for its production in corn on field corn, sweet
corn, and popcorn when applied/used as a plant-incorporated protectant
(40 CFR 174.456). This notice included a summary of the petition
prepared by the petitioner Syngenta Seeds, Inc.. One comment was
received in response to the notice of filing. The commentor objected to
an exemption from the requirement of a tolerance, stated that she does
not favor genetically engineered corn, and objected to the lack of long
term tests. The Agency understands the commenter's concerns and
recognizes that some individuals believe that genetically modified
crops and food should be banned completely. Regarding the commenter's
concern regarding a lack of long term tests; when proteins are toxic,
they are known to act via acute mechanisms and at very low dose levels
(Sjoblad, Roy D., et al. ``Toxicological Considerations for Protein
Components of Biological Pesticide Products,'' Regulatory Toxicology
and Pharmacology 15, 3-9 (1992)). Since no effects were shown to be
caused by the plant-incorporated protectants, even at relatively high
dose levels, the mCry3A protein is not considered toxic. Pursuant to
its authority under the FFDCA, EPA conducted a comprehensive assessment
of the modified Cry3A protein and the genetic material necessary for
its production in corn, including a review of acute oral toxicity data
on the mCry3A protein, amino acid sequence comparisons to known toxins
and allergens, as well as data demonstrating that the mCry3A protein is
rapidly degraded by gastric fluid in vitro, is not glycosylated, is
inactivated when heated to 95 [deg]C for 30 minutes, and is present in
low levels in corn tissue, and has concluded that there is a reasonable
certainty that no harm will result from dietary exposure to this
protein as expressed in genetically modified corn.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information. '' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue....''
Additionally, section 408(b)(2)(D) of the FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
    Data have been submitted demonstrating the lack of mammalian
toxicity at high levels of exposure to the pure mCry3A protein. These
data demonstrate the safety of the products at levels 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,
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).
     An acute oral toxicity study was submitted for the mCry3A protein.
The acute oral toxicity data submitted support the prediction that the
mCry3A protein would be non-toxic to humans. Male and female mice (5 of
each) were dosed with 2,377 milligrams/kilograms bodyweight (mg/kg bwt)
of mCry3A protein. With the exception of one female in the test group
that was euthanized on day 2 (due to adverse clinical signs consistent
with a dosing injury), all other mice survived the study, gained
weight, had no test material-related clinical signs, and had no test
material-related findings at necropsy.
     When proteins are toxic, they are known to act via acute
mechanisms and at very low dose levels (Sjoblad, Roy D., et al.
``Toxicological Considerations for Protein Components of Biological
Pesticide Products,'' Regulatory Toxicology and Pharmacology 15, 3-9
(1992)).Therefore, since no effects were

shown to be caused by the plant-incorporated protectants, even at
relatively high dose levels, the mCry3A protein is not considered
toxic. Further, amino acid sequence comparisons showed no similarity
between the mCry3A protein to known toxic proteins available in public
protein data bases.
     Since mCry3A 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 oncentrations in
the food.
     Data have been submitted that demonstrate that the mCry3A protein
is rapidly degraded by gastric fluid in vitro. In a solution of
simulated gastric fluid 1 milligrams/milliliter (mg/mL) mCry3A test
protein mixed with simulated gastric fluid (pH 1.2, containing 2 mg/mL
NaCl, 14 muL 6 N HCl, and 2.7 mg/mL pepsin) resulting in 10 pepsin
activity units/ mug protein (complies with year 2000 U.S. Pharmacopoeia
recommendations), complete degradation of detectable mCry3A protein
occurred within 2 minutes. A comparison of amino acid sequences of
known allergens uncovered no evidence of any homology with mCry3A, even
at the level of eight contiguous amino acids residues. Further, data
demonstrate that mCry3A is not glycosylated, is inactivated when heated
to 95 [deg]C for 30 minutes, and is present in low levels in corn
tissue. Therefore, the potential for the mCry3A protein to be a food
allergens is minimal. As noted above, toxic proteins typically act as
acute toxins with low dose levels. Therefore, since no effects were
shown to be caused by the plant-incorporated protectant, even at
relatively high dose levels, the mCry3A protein is not considered
toxic.

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).
    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. Exposure via residential
or lawn use to infants and children is also not expected because the
use sites for the mCry3A protein are all agricultural for control of
insects. Oral exposure, at very low levels, may occur from ingestion of
processed corn products and, potentially, drinking water. However, oral
toxicity testing done at a dose in excess of 2 grams/kilogram (gm/kg)
showed no adverse effects. Furthermore, the expression of the modified
Cry3A protein in corn kernals has been shown to be in the parts per
million range, which makes the expected dietary exposure several orders
of magnitude lower than the amounts of mCry3A protein shown to have no
toxicity. Therefore, even if negligible aggregate exposure should
occur, the Agency concludes that such exposure would prevent no harm
due to the lack of mammalian toxicity and the rapid digestibility
demonstrated for the mCry3A protein.

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,
resulting from the plant-incorporated protectant, we conclude that
there are no cumulative effects for the mCry3A protein.

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 mCry3A protein include the characterization of the expressed
mCry3A protein in corn, as well as the acute oral toxicity, 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 mCry3A protein
test material derived from microbial cultures was biochemically and
functionally similar to the protein produced by the plant-incorporated
protectant ingredients in corn. Production of microbially produced
protein was chosen in order to obtain sufficient material for testing.
     The acute oral toxicity data submitted supports the prediction
that the mCry3A 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.
``Toxicological Considerations for Protein Components of Biological
Pesticide Products,'' Regulatory Toxicology and Pharmacology 15, 3-9
(1992)). Since no effects were shown to be caused by mCry3A protein,
even at relatively high dose levels (2,377 mg/kg bwt), the mCry3A
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. (See 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
thesource of these effects (Tiers II and III).
     MCry3A protein residue chemistry data were not required for a
human health effects assessment of the subject plant-incorporated
protectant ingredients because of the lack of mammalian toxicity.
However, data submitted demonstrated low levels of mCry3A in corn
tissues with less than 2 micrograms mCry3A protein/gram dry weight in
kernals and less than 30 micrograms mCry3A protein/gram dry weight of
whole corn plant.
     Since modified Cry3A is a protein, its potential allergenicity is
also considered as part of the toxicity assessment. Data considered as
part of the allergenicity assessment include that the modified Cry3A
protein came from Bacillus thuringiensis which is not a known
allergenic source, showed no sequence similarity to known allergens,
was readily degraded by pepsin, was inactivated by heat and was not
glycosylated when expressed in the plant. Therefore, there is a
reasonable certainty that modified Cry3A 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 mCry3A protein, as well as the minimal potential to be
a food allergen demonstrate the safety of the product 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
theproduction of mCry3A protein has been exempted under the blanket
exemption for all nucleic acids (40 CFR 174.475).

B. Infants and Children Risk Conclusions

     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, also referred to as
margins of exposure (MOEs), 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 MOE 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 mCry3A
protein and the genetic material necessary for their production. Thus,
there are no threshold effects of concern to infants and children when
the mCry3A protein is used as a plant-incorporated protectant.
Accordingly, the Agency concludes that the additional MOE is not
necessary to protect infants and children, and that not adding any
additional MOE will be safe for infants and children.

C. Overall Safety Conclusion

     There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to the mCry3A protein and the genetic material necessary for
its production. 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 discussed
above, no toxicity to mammals has been observed, nor any indication of
allergenicity potential for the 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 ELISA analysis of mCry3A protein in
corn has been submitted and found acceptable by the Agency.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exist for the plant-incorporated
protectant Bacillus thuringiensis mCry3A protein and the genetic
material necessary for its production in corn.

VIII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d),
as was provided in the old sections 408 and 409 of the FFDCA. However,
the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2006-0174 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 May 15,
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(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is<PHONE_NUMBER>.
    2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VIII.A.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by docket ID number EPA-HQ-OPP-2006-0174, 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<EMAIL_ADDRESS>
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an

electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

IX. Statutory and Executive Order Reviews

    This final rule establishes a temporary exemption from the
tolerance requirement under section 408(d) of the FFDCA in response to
a petition submitted to the Agency. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

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

    Dated: March 2, 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 174.456 is revised to read as follows:

Sec.  174.456  Bacillus thuringiensis modified Cry3A protein (mCry3A)
and the genetic material necessary for its production in corn.

    Bacillus thuringiensis modified Cry3A protein (mCry3A) and the
genetic material necessary for its production in corn is temporarily
exempt from the requirement of a tolerance when used as plant-
incorporated protectant in the food and feed commodities of field corn,
sweet corn and popcorn. Genetic material necessary for its production
means the genetic material which comprise genetic material encoding the
mCry3A protein and its regulatory regions. Regulatory regions are the
genetic material, such as promoters, terminators, and enhancers, that
control the expression of the genetic material encoding the mCry3A
protein. This temporary exemption from the requirement of a tolerance
will permit

the use of the food commodities in this paragraph when treated in
accordance with the provisions of the experimental use permit 67979-
EUP-4 which is being issued under 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 15, 2007; however, if the experimental use permit is revoked,
or if any experience with or scientific data on this pesticide indicate
that the tolerance is not safe, this temporary exemption from the
requirement of a tolerance may be revoked at any time.

[FR Doc. 06-2431 Filed 3-14-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 39049-39051]
[FR Doc No: 2019-16977]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2019-0105]

Senior Executive Service Performance Review Boards Membership

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Notice of Performance Review Board (PRB) Appointments.

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SUMMARY: DOT published the names of the persons selected to serve on
Departmental PRBs as required by 5 U.S.C. 4314(c)(4).

FOR FURTHER INFORMATION CONTACT: Lisa M. Williams, Director,
Departmental Office of Human Resource Management<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The persons named below may be selected to
serve on one or more Departmental PRBs.

    Issued in Washington, DC, on August 2, 2019.
Keith E. Washington,
Deputy Assistant Secretary for Administration.

Department of Transportation

Federal Highway Administration

ALONZI, ACHILLE
ARNOLD, ROBERT E
BAKER, SHANA V
BEZIO, BRIAN R
BIONDI, EMILY CHRISTINE
BRIGGS, VALERIE ANNETTE
CHRISTIAN, JAMES C
COLLINS, BERNETTA L.
CRONIN, BRIAN P
EVANS, MONIQUE REDWINE
EVERETT, THOMAS D
FINFROCK, ARLAN E JR
FLEURY, NICOLLE M
FOUCH, BRIAN J
FURST, ANTHONY T
GATTI, JONATHAN D
GRIFFITH, MICHAEL S
HARTMANN, JOSEPH L
HESS, TIMOTHY G.
HUGHES, CAITLIN GWYNNE
KALLA, HARI
KEHRLI, MARK R
KNOPP, MARTIN C
KRISHNAMOORTI, MALATHI
LEONARD, KENNETH
LEWIS, DAVID A
LILLIE, MARK STEVEN
LUCERO, AMY C
MAMMANO, VINCENT P
MARQUIS, RICHARD J
OSBORN, PETER W
PETTY, KENNETH II
RICHARDSON, CHRISTOPHER S
RICHTER, CHERYL ALLEN
RICO, IRENE

RIDGEWAY, MARY F
ROHLF, JOHN G
SCHAFTLEIN, SHARI M
SCHMIDT, ROBERT T
SHEPHERD, GLORIA MORGAN
SIGEL, BETHANY RENEE
STEPHANOS, PETER J
SUAREZ, RICARDO
TURNER, DERRELL E
WALKER, CHERYL J
WINTER, DAVID R
WRIGHT, LESLIE JANICE
ZIMMERMAN, MARY BETH

Federal Motor Carrier Safety Administration

COLLINS, ANNE L
DELORENZO, JOSEPH P
FROMM, CHARLES J
HANSON, ALAN ROSS
HERNANDEZ, SCOTT
HORAN, CHARLES A III
JONES, DARIN G
KEANE, THOMAS P
MILLER, ROBERT WILLIAM
MINOR, LARRY W
MULLEN, JAMES ANTHONY
REGAL, GERALDINE K
RIDDLE, KENNETH H.
RUBAN, DARRELL L
SCHREIBMAN, JACK L
VAN STEENBURG, JOHN W

Federal Railroad Administration

ALEXY, JOHN KARL
ALLAHYAR, MARYAM
HAYWARD-WILLIAMS, CAROLYN
JORTLAND, BRETT ANDREW
KENDALL, QUINTIN C
LESTINGI, MICHAEL W.
LONG, MICHAEL T
NISSENBAUM, PAUL
PENNINGTON, REBECCA A
RENNERT, JAMIE P.
REYES-ALICEA, REBECCA
RIGGS, TAMELA LYNN

Federal Transit Administration

AHMAD, MOKHTEE
ALLEN, REGINALD E
BRENNAN, JOHN J III
BROOKINS, KELLEY
BUCHANAN, HENRIKA J.
DALTON-KUMINS, SELENE FAE
GARCIA CREWS, THERESA
GEHRKE, LINDA M
GOODMAN, STEPHEN C
NIFOSI, DANA C.
PATRICK, ROBERT C
TAYLOR, YVETTE G
TELLIS, RAYMOND S
TERWILLIGER, CINDY E
TUCCILLO, ROBERT J
VALDES, VINCENT
WELBES, MATTHEW J
WILLIAMS, KIMBERLY JANE

Maritime Administration

BALLARD, JOHN R
BALZANO, RICHARD A
BRAND, LAUREN K
BROHL, HELEN A
BUONO, JOACHIM
BURNETT, DOUGLAS R
DAVIS, DELIA P
DUNLAP, SUSAN LYNN
FISHER, ANTHONY JR
KUMAR, SHASHI N
MC MAHON, CHRISTOPHER J
MOSCHKIN, LYDIA
PIXA, RAND R.
TOKARSKI, KEVIN M

National Highway Traffic Safety Administration

AIZCORBE, CHRISTINA G
BLINCOE, LAWRENCE J
DANIELSON, JACK H.
DOHERTY, JANE H
DONALDSON, K JOHN
GIUSEPPE, JEFFREY M
HATIPOGLU, CEM
HINES, DAVID M
JOHNSON, TIM J
KING, HEIDI R
KOLLY, JOSEPH M
KROHMER, JON R
MARSHALL, JOHN W
MATHEKE, OTTO G III
MORRISON, JONATHAN C
PARKER, CYNTHIA D
PFISTER, JAMIE DURHAM
POSTEN, RAYMOND R
RIDELLA, STEPHEN A
RITTER, ROBERT G
RUSHTON, SEAN G
SPRAGUE, MARY G.
WOOD, STEPHEN P

Pipeline and Hazardous Materials Safety Administration

BORENER, SHERRY S
CURRY, KIM Y
DAUGHERTY, LINDA
FARLEY, AUDREY L.
MAYBERRY, ALAN K
MCMILLAN, HOWARD W
PEARCE, DRUE
PERRIELLO, TAMI L
QUADE, WILLIAM A III
ROBERTI, PAUL
SCHOONOVER, WILLIAM S
TAHAMTANI, MASSOUD
TSAGANOS, VASILIKI B

Saint Lawrence Seaway Development Corporation

LAVIGNE, THOMAS A
MCINERNEY, MARIANNE
MIDDLEBROOK, CRAIG H

Office of the Secretary

ABRAHAM, JULIE
ALBRIGHT, JACK G
AUDET, ANNE H
AUGUSTINE, JOHN E
AYLWARD, ANNE D
BALDWIN, KRISTEN K.
BEDELL, ANTHONY R.
BOHNERT, ROGER V
CALLENDER, DUANE A
CARLSON, TERENCE W
CHAVEZ, RICHARD M.
CHULUMOVICH, MADELINE M
COGGINS, COLLEEN P
CONNORS, SUSAN M
CONRAD, JESSICA MARIE
COTE, GREGORY D
COTE, RYAN ERNEST
DEBONO, DAN PATRICK
FARAJIAN, MORTEZA
FLEMING, GREGG G
FULTON, THOMAS FINCH
FUNK, JENNIFER S
FURCHTGOTT--ROTH, DIANA EL
GAUTREAUX, CATHY FOSTER
GEIER, PAUL M
GENERO, LAURA
HEDBERG, BRIAN J
HERLIHY, THOMAS W
HOLDEN, STEPHEN H.
HOMAN, TODD M
HORN, DONALD H
HU, PATRICIA S.
HURDLE, LANA T
INMAN, JAMES TODD
JACKSON, RONALD A
JAMES, CHARLES E.
JEFFERSON, DAPHNE Y
JOYNER, GREGORY GILBERT
KALETA, JUDITH S
KNOUSE, RUTH D.
KRAMER, JOHN E JR
LAWRENCE, CHRISTINE A
LEFEVRE, MARIA S.
LOHRENZ, MAURA C
MACECEVIC, LISA J
MARCHESE, APRIL LYNN
MARTIN, HAROLD W III
MCCARTNEY, ERIN P
MCKENNA, WILLIAM
MCMASTER, SEAN K B
MEDINA, YVONNE R.
MILLER, JANNINE MARIE
MORGAN, DANIEL S.
MORRIS, WILLIS A.
MOSS, JONATHAN P.
O'BERRY, DONNA
ORNDORFF, ANDREW R
OWENS, JAMES C JR
PAIEWONSKY, LUISA M
PETROSINOWOOLVERTON, MARI
POPKIN, STEPHEN M
POST, ANDREW CHARLES
REINKE, ANNE CHETTLE
SCHMITT, ROLF R
SHORT, DAVID E
SIMPSON, JOAN
SMITH, LOREN A. JR
SMITH, WILLIE H
SOLOMON, GERALD L
STURGES, MATHEW MICHAEL
SZAKAL, KEITH J
SZATMARY, RONALD ALLEN JR
TIMOTHY, DARREN P
WASHINGTON, KEITH E
WILLIAMS, LISA M

WOMACK, KEVIN C.
WORKIE, BLANE A
ZIFF, LAURA M

[FR Doc. 2019-16977 Filed 8-7-19; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7324-7326]
[FR Doc No: 2020-02460]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0002; Internal Agency Docket No. FEMA-B-2010]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA

Map Service Center at https://msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                                             Chief executive officer  of                                    Online location of letter  of                             Community
         State and county           Location and case No.             community               Community map  repository              map revision             Date of modification       No.
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Arizona:
    Pima..........................  City of Tucson (19-09- The Honorable Jonathan          Planning and Development        https://msc.fema.gov/portal/     Apr. 21, 2020..........       040076
                                     1100P).                Rothschild, Mayor, City of      Services, Public Works          advanceSearch.
                                                            Tucson, 255 West Alameda        Building, 201 North Stone
                                                            Street, Tucson, AZ 85701.       Avenue, Tucson, AZ 85701.
    Pima..........................  Unincorporated Areas   The Honorable Richard           Pima County Flood Control       https://msc.fema.gov/portal/     Apr. 20, 2020..........       040073
                                     of Pima County (19-    El[iacute]as, Chairman, Board   District, 201 North Stone       advanceSearch.
                                     09-1762P).             of Supervisors, Pima County,    Avenue, 9th Floor, Tucson, AZ
                                                            130 West Congress Street,       85701.
                                                            11th Floor, Tucson, AZ 85701.
    Pima..........................  Unincorporated Areas   The Honorable Richard           Pima County Flood Control       https://msc.fema.gov/portal/     Apr. 24, 2020..........       040073
                                     of Pima County (19-    El[iacute]as, Chairman, Board   District, 201 North Stone       advanceSearch.
                                     09-2213P).             of Supervisors, Pima County,    Avenue, 9th Floor, Tucson, AZ
                                                            130 West Congress Street,       85701.
                                                            11th Floor, Tucson, AZ 85701.
California:
    San Luis Obispo...............  City of Morro Bay (18- The Honorable John Headding,    City Hall, 595 Harbor Street,   https://msc.fema.gov/portal/     Apr. 21, 2020..........       060307
                                     09-0960P).             Mayor, City of Morro Bay, 595   Morro Bay, CA 93442.            advanceSearch.
                                                            Harbor Street, Morro Bay, CA
                                                            93442.
    Shasta........................  City of Redding (19-   The Honorable Julie Winter,     Permit Center Division, 777     https://msc.fema.gov/portal/     Apr. 9, 2020...........       060360
                                     09-0032P).             Mayor, City of Redding, 777     Cypress Avenue, 1st Floor,      advanceSearch.
                                                            Cypress Avenue, 3rd Floor,      Redding, CA 96001.
                                                            Redding, CA 96001.
    Shasta........................  Unincorporated Areas   The Honorable Leonard Moty,     Shasta County, Public Works     https://msc.fema.gov/portal/     Apr. 9, 2020...........       060358
                                     of Shasta County (19-  Chairman, Board of              Department, 1855 Placer         advanceSearch.
                                     09-0032P).             Supervisors, Shasta County,     Street, Redding, CA 96001.
                                                            1450 Court Street, Suite
                                                            308B, Redding, CA 96001.
Florida: St. Johns................  Unincorporated Areas   The Honorable Jeb S. Smith,     St. Johns County Permit         https://msc.fema.gov/portal/     May 5, 2020............       125147
                                     of St. Johns County    Chair, St. Johns County Board   Center, 4040 Lewis Speedway,    advanceSearch.
                                     (19-04-5378P).         of Commissioners, 500 San       St. Augustine, FL 32084.
                                                            Sebastian View, St.
                                                            Augustine, FL 32084.
Illinois:
    Will..........................  Unincorporated Areas   The Honorable Lawrence M.       Land Use Department, 58 East    https://msc.fema.gov/portal/     Apr. 24, 2020..........       170695
                                     of Will County (19-    Walsh, County Executive, Will   Clinton Street, Suite 100,      advanceSearch.
                                     05-4930P).             County, Will County Office      Joliet, IL 60432.
                                                            Building, 302 North Chicago
                                                            Street, Joliet, IL 60432.

    Will..........................  Village of Mokena (19- The Honorable Frank Fleischer,  Village Hall, 11004 Carpenter   https://msc.fema.gov/portal/     Apr. 24, 2020..........       170705
                                     05-4930P).             Village President, Village of   Street, Mokena, IL 60448.       advanceSearch.
                                                            Mokena, 11004 Carpenter
                                                            Street, Mokena, IL 60448.
Indiana:
    Hancock.......................  Unincorporated Areas   Mr. John Jessup, Commissioner,  Hancock County Government       https://msc.fema.gov/portal/     Apr. 24, 2020..........       180419
                                     of Hancock County      Hancock County, 111 South       Building, 111 South American    advanceSearch.
                                     (19-05-3686P).         American Legion Place, Suite    Legion Place, Greenfield, IN
                                                            219 Greenfield, IN 46140.       46140.
    Marion........................  City of Lawrence (19-  The Honorable Steve Collier     City Hall, 9001 East 59th       https://msc.fema.gov/portal/     Apr. 24, 2020..........       180160
                                     05-3686P).             Mayor, City of Lawrence, 9001   Street, Lawrence, IN 46216.     advanceSearch.
                                                            East 59th Street, Lawrence,
                                                            IN 46216.
Kansas: Leavenworth...............  Unincorporated Areas   The Honorable Doug Smith,       City Hall, 100 North 5th        https://msc.fema.gov/portal/     May 8, 2020............       200186
                                     of Leavenworth         Chairman, Board of              Street, Leavenworth, KS         advanceSearch.
                                     County (19-07-         Leavenworth County              66048.
                                     1449P).                Commissioners, County
                                                            Courthouse, 300 Walnut
                                                            Street, Suite 225,
                                                            Leavenworth, KS 66048.
Nevada: Washoe....................  City of Reno (19-09-   The Honorable Hillary Schieve,  City Hall, 1 East 1st Street,   https://msc.fema.gov/portal/     Apr. 15, 2020..........       320020
                                     0890P).                Mayor, City of Reno, P.O. Box   Reno, NV 89501.                 advanceSearch.
                                                            1900, Reno, NV 89505.
New York: Onondaga................  Town of Camillus (19-  Ms. Mary Ann Coogan             Town Hall, 4600 West Genesee    https://msc.fema.gov/portal/     Jun. 19, 2020..........       360570
                                     02-0665P).             Supervisor, Town of Camillus,   Street, Syracuse, NY 13219.     advanceSearch.
                                                            4600 West Genesee Street,
                                                            Syracuse, NY 13219.
Texas:
    Tarrant.......................  City of Fort Worth     The Honorable Betsy Price,      Department of Transportation    https://msc.fema.gov/portal/     May 1, 2020............       480596
                                     (19-06-1628P).         Mayor, City of Fort Worth,      and Public Works, 200 Texas     advanceSearch.
                                                            200 Texas Street, Fort Worth,   Street, Fort Worth, TX 76102.
                                                            TX 76102.
    Tarrant.......................  City of Fort Worth     The Honorable Betsy Price,      Department of Transportation    https://msc.fema.gov/portal/     Apr. 17, 2020..........       480596
                                     (19-06-4087P).         Mayor, City of Fort Worth,      and Public Works, 200 Texas     advanceSearch.
                                                            200 Texas Street, Fort Worth,   Street, Fort Worth, TX 76102.
                                                            TX 76102.
Washington: King..................  City of Auburn (19-10- The Honorable Nancy Backus,     City Hall, 25 West Main         https://msc.fema.gov/portal/     Apr. 17, 2020..........       530073
                                     0993P).                Mayor, City of Auburn, 25       Street, Auburn, WA 98001.       advanceSearch.
                                                            West Main Street, Auburn, WA
                                                            98001.
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[FR Doc. 2020-02460 Filed 2-6-20; 8:45 am]
 BILLING CODE 9110-12-P