[Federal Register: July 17, 2006 (Volume 71, Number 136)]
[Rules and Regulations]
[Page 40427-40431]
[DOCID:fr17jy06-12]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0554; FRL-8076-5]

Bacillus Thuringiensis Cry1A.105 Protein and the Genetic Material
Necessary for Its Production in Corn in or on All Corn Commodities;
Temporary Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of the Bacillus Thuringiensis
Cry1A.105 protein 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. Monsanto Company 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 the
temporary/tolerance exemption. This regulation eliminates the need to
establish a maximum permissible level for residues of Bacillus
Thuringiensis Cry1A.105 protein and the genetic material necessary for
its production in corn. The temporary tolerance exemption will expire
on June 30, 2009.

DATES: This regulation is effective July 17, 2006. Objections and
requests for hearings must be received on or before September 15, 2006,
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-2006-0554. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket 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 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. 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-2006-0554 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 September 15, 2006.
    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-2006-0554, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of May 26, 2006 (71 FR 30401) (FRL-8066-5),
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 5G6940) by Monsanto Company, 800 North Lindbergh Blvd.,
St. Louis, MO 63167. The petition requested that 40 CFR part 174 be
amended by establishing a temporary exemption from the requirement of a
tolerance for residues of Bacillus thuringiensis Cry1A.105 protein and
the genetic material necessary for its production in corn. This notice
included a summary of the petition prepared by the petitioner Monsanto
Company. One comment was received in response to the notice of filing.
The commenter objected to an exemption from the requirement of a
tolerance, stated that she does not favor genetically engineered corn,
and stated that such corn should be labeled. The commentor also
expressed concern about the mechanics of submitting comments via the
http://www.regulations.gov site for the notice of filing. The Agency

understands the commenter's concerns and recognizes that some
individuals believe that genetically modified crops and food should be
banned completely. Pursuant to its authority under the FFDCA, EPA
conducted a comprehensive assessment of the Cry1A.105 protein and the
genetic material necessary for its production in corn, including a
review of acute oral toxicity data on the Cry1A.105 protein, amino acid
sequence comparisons to known toxins and allergens, as well as data
demonstrating that the Cry1A.105 protein is rapidly degraded by gastric
fluid in vitro, is not glycosylated, and is present in low levels in
corn tissue, and as concluded that there is a reasonable certainty that
no harm will result from dietary exposure to this protein as expressed
in genetically modified corn. Thus, under the standard in FFDCA section
408(b)(2), a tolerance exemption is appropriate. The labeling of food
is under the jurisdiction of the Food and Drug Administration (FDA).
When commenting on notices of filing, commentors should either choose
``Notices'' or ``All Document Types'' in the Document Type box.
    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.
    Monsanto has submitted acute oral toxicity data demonstrating the
lack of mammalian toxicity at high levels of exposure to the pure
Cry1A.105 protein. These data demonstrate the safety of the product at
a level well above maximum possible exposure levels that are reasonably
anticipated in the crop. Basing this conclusion on acute oral toxicity
data without requiring further toxicity testing and residue data is
similar to the Agency position regarding toxicity testing and the
requirement of residue data for the microbial Bacillus thuringiensis
products from which this plant-incorporated protectant was derived (See
40 CFR Sec. 158.740(b)(2)(i)). For microbial products, further toxicity
testing and residue data are triggered by significant adverse acute
effects in studies such as the mouse oral toxicity study, to verify the
observed adverse effects and clarify the source of these effects (Tiers
II and III).
    An acute oral toxicity study in mice (MRID 46694603) indicated that
Cry1A.105 is non-toxic to humans. Cry1A.105 produced from microbial
culture was dosed by gavage as two doses separated by 4 hours (< plus-
minus>20 minutes) to 10 females and 10 males (2,072 milligrams/kilogram
(mg/kg) body weight). Two control groups were also included in the
study: A bovine serum albumin protein control, and a vehicle control.
One male in the test protein group was moribund and sacrificed on day 1
due to a mechanical dosing error; this death was not attributed to the
test material. All other mice survived the study. There were no
significant differences in body weight or body weight change among the
three groups during the study, and no treatment-related gross
pathological findings were observed. The oral LD50 for males, females,
and combined mice was greater than 2,072 mg/kg.
    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 acute effects were shown to be caused by Cry1A.105,
even at relatively high dose levels, the Cry1A.105 protein is not
considered toxic. Further, amino acid sequence comparisons showed no
similarities between the Cry1A.105 and known toxic proteins in protein
databases that would raise a safety concern.
    Since Cry1A.105 is a protein, allergenic potential was also
considered. Currently, no definitive tests for determining the
allergenic potential of novel proteins exist. Therefore, EPA uses a
weight-of-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
(SGF) and glycosylation. Current scientific knowledge suggests that
common food allergens tend to be resistant to degradation by heat,
acid, and proteases, may be glycosylated, and can be present at high
concentrations in the food.
    1. Source of the trait. Bacillus thuringiensis is not considered to
be a source of allergenic proteins.
    2. Amino acid sequence. A comparison of the amino acid sequence of
Cry1A.105 with known allergens showed no overall sequence similarity or
identity at the level of eight contiguous amino acid residues.
    3. Prevalence in food. Expression level analysis indicated that the
protein is present at relatively low levels in corn: Approximately 3
[mu]g/g in grain on a dry weight basis. Thus, the expression has been
shown to be in the parts per million range is much lower than the
amounts of allergen protein found in commonly allergenic foods. In
those foods, allergens are major protein components such as seed
storage globulin proteins in nuts and legumes, meat associated proteins
like tropomyosin in fish and shellfish, ovalbumin and ovomucoid in egg
white and lactalbumin and casein in milk. In these cases, the allergens
can be from 10% to 50% of the total protein found whereas the plant-
incorporated protectant (PIP) that is the subject of this tolerance
determination is found in the parts per million range.
    4. Digestibility. The Cry1A.105 protein was digested within 30
seconds in simulated gastric fluid containing pepsin.
    5. Glycosylation. Cry1A.105 expressed in corn was shown to have not
to be glycosylated
    6. Conclusion. Considering all of the available information, EPA
has concluded that the potential for Cry1A.105 to be a food allergen is
minimal.

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 protectants 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. In addition, even if
exposure can occur through inhalation, the potential for Cry1A.105 to
be an allergen is low, as discussed above. Although the allergenicity
assessment focuses on potential to be a food allergen, the data also
indicate a low potential for Cry1A.105 to be an inhalation allergen.
Exposure via residential or lawn use to infants and children is also
not expected because the use sites for the Cry1A.105 protein is
agricultural. Oral exposure, at very low levels, may occur from
ingestion of processed corn products and, theoretically, drinking
water. However oral toxicity testing showed no adverse effects.
Furthermore, the expression of the Cry1A.105 protein in corn kernels
has been shown to be in the parts per million range, which makes the
expected dietary exposure several orders of magnitude lower than the
amount of Cry1A.105 shown to have no toxicity. Therefore, even if
negligible aggregate exposure should occur, the Agency concludes that
such exposure would result in no harm due to the lack of mammalian
toxicity and low potential for allergenicity demonstrated for the
Cry1A.105 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 from the plant-incorporated protectant, we conclude
that there are no cumulative effects for the Cry1A.105 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 Cry1A.105 protein includes the characterization of the expressed
Cry1A.105 protein in corn, as well as the acute oral toxicity study,
amino acid sequence comparisons to known allergens and toxins, and in
vitro digestibility of the protein. The results of these studies were
used to evaluate human risk, and the validity, completeness, and
reliability of the available data from the studies were also
considered.
    Adequate information was submitted to show that the Cry1A.105 test
material derived from microbial culture was biochemically and
functionally equivalent to the protein produced by the plant-
incorporated protectant ingredient in corn. Microbially produced
protein was used in the safety studies so that sufficient material for
testing was available.
    The acute oral toxicity data submitted support the prediction that
the Cry1A.105 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 treatment-related adverse effects were shown to be caused by
the Cry1A.105 protein, even at relatively high dose levels, the
Cry1A.105 protein is not considered toxic. Basing this conclusion on
acute oral toxicity data without requiring further toxicity testing and
residue data 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 when
significant adverse effects are seen in studies such as the mouse oral
toxicity study. Further studies verify the observed adverse effects and
clarify the source of these effects (Tiers II and III).
    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 the Cry1A.105 in corn tissues.
    Since Cry1A.105 is a protein, potential allergenicity is also
considered as part of the toxicity assessment. Considering all of the
available information (1) Cry1A.105 originates from a non-allergenic
source; (2) Cry1A.105 has no sequence similarities with known
allergens; (3) Cry1A.105 is not glycosylated; (4) Cry1A.105 will only
be present at low levels in food; and (5) Cry1A.105 is rapidly digested
in simulated gastric fluid; EPA has concluded that the potential for
Cry1A.105 to be a food allergen is minimal.
    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 Cry1A.105 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 ingredient include the nucleic acids
(DNA, RNA) that encode these proteins and regulatory regions. The
genetic material (DNA, RNA), necessary for the production of the
Cry1A.105 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 for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database 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 finds that there is no toxicity for the Cry1A.105 protein and
the genetic material necessary for its production. Thus, there are no
threshold effects of concern and, as a result, the provision requiring
an additional margin of safety does not apply. Further, the
considerations 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 from
aggregate exposure to the U.S. population, including infants and
children, to the Cry1A.105 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 a
source that is not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of this plant-incorporated protectant at this time.

B. Analytical Method(s)

    A short description of an enzyme-linked immunosorbent assay for the
detection and quantification of Cry1A.105 in corn tissue has been
submitted.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the plant-incorporated
protectant Bacillus thuringiensis Cry1A.105 protein and the genetic
material necessary for its production in corn.

VIII. Statutory and Executive Order Reviews

    This final rule establishes an 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.

IX. 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: June 29, 2006.
James Jones,
Director, 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 174.453 is added to subpart W to read as follows:

Sec.  174.453  Bacillus Thuringiensis Cry1A.105 Protein and the Genetic
Material Necessary for Its Production in Corn.

    Bacillus thuringiensis Cry1A.105 protein and the genetic material
necessary for its production in corn is 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 Cry1A.105 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 Cry1A.105 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 524-EUP-97 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 June 30, 2009;
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. E6-11245 Filed 7-14-06; 8:45 am]

BILLING CODE 6560-50-S


Sulfur Compounds from Oilfield Steam Generators - Kern
                                  12/17/1992
                                 not submitted
                                      N/A
                                      N/A

                                     4407
In-situ Combustion Well Vents
                                   5/19/1994
                                   5/19/1994
                                   5/19/1994
                                  60 FR 12121
                                   (3/6/95)

                                     4408
Glycol Dehydration Systems
                                  12/19/2002
                                  12/19/2002
                                  12/19/2002
                                  68 FR 51187
                                   (8/26/03)

                                     4409
Components at Light Crude Oil or Gases at Light Crude Oil and Gas Production
                                   4/20/2005
                                   4/20/2005
                                   4/20/2005
                                  71 FR 14653
                                   (3/23/06)

                                     4451
Valves, Pressure Relief Valves, Flanges, Threaded Connections and Process Drains at Petroleum Refineries and Chemical Plants
                                   4/20/2005
                                   4/20/2005
                                   4/20/2005
                                  71 FR 14652
                                   (3/23/06)

                                     4452
Pump and Compressor Seals at Petroleum Refiners
                                   4/20/2005
                                   4/20/2005
                                   4/20/2005
                                  71 FR 14653
                                   (3/23/06)

                                     4453
Refinery Vacuum Producing Devices or Systems
                                  12/19/1992
                                  12/19/1992
                                      N/A
                                   73 FR 48
                                   (1/02/08)
                                   withdrawn

                                     4454
Refinery Process Turnaround
                                  12/19/1992
                                  12/19/1992
                                      N/A
                                   73 FR 48
                                   (1/02/08)
                                   withdrawn

                                     4455
Components at Refineries
                                   4/20/2005
                                   4/20/2005
                                   4/20/2005
                                  71 FR 14652
                                   (3/23/06)

                                     4501
Alternate Compliance for BARCT
                                   6/17/1999
                                   6/17/1999
                                      N/A
                                   no action

                                     4550
Conservation Management Practices
                                   8/19/2004
                                   8/19/2004
                                   8/19/2004
                                  71 FR 7683
                                   (2/14/06)

                                     4565
Biosolids, Animal Manure, and Poultry Litter Operations
                                   3/15/2007
                                   3/15/2007
                                NPR: 3/15/2007
                             76 FR 56706 (9/14/11)
Control strategy measures
                                     4566
Organic Waste
                                   8/18/2011
                                      N/A
                                      N/A
                                      N/A
Control strategy measure
                                     4570
Confined Animal Facilities
                                  10/21/2010
                                  10/21/2010
                                NPR: 10/21/2010
                                   6/18/2009
                             76 FR 56706 (9/14/11)
                                  75 FR 2079
                                   (1/14/10)
Control strategy measures
                                     4601
Architectural Coatings
                                  12/17/2009
                                  12/17/2009
                                  12/17/2009
                                  10/31/2001
                          NPR: 76 FR 35167 (6/16/11)
                                   69 FR 34
                                   (1/02/04)
Control strategy measure
                                     4602
Motor Vehicle and Mobile Equipment Coating Operations
                                   9/17/2009
                                   9/17/2009
                                   9/17/2009
                                  12/20/2001
                           NPR: 76 FR 3214 (6/3/11)
                                  67 FR 42999
                                   (6/26/02)

                                     4603
Surface Coating of Metal Parts and Products
                                   9/17/2010
                                   9/17/2010
                                   9/17/2010
                                  10/16/2008
                           NPR: 76 FR 3214 (6/3/11)
                             75 FR 4612 (1/19/10)

                                     4604
Can and Coil Coating Operations
                                   9/20/2007
                                   9/20/2007
                                   9/20/2007
                             75 FR 4612 (1/19/10)

                                     4605
Aerospace Assembly and Component Coating
                                   6/16/2011
                                   6/16/2011
                                 NPR: 6/16/11
                                   9/20/2007
                            NPR: 76 56134 (9-12-11)
                             75 FR 3996 (1/26/10)

                                     4606
Wood Products Coating Operations
                                  10/16/2008
                                  10/16/2008
                                  10/16/2008
                            74 FR 52894 (10/15/09)

                                     4607
Graphic Arts
                                  12/18/2008
                                  12/18/2008
                                  12/18/2008
                            74 FR 52894 (10/15/09)
Control strategy measure
                                     4610
Glass Coating Operations
                                   4/17/2003
                                   4/17/2003
                                   4/17/2003
                            69 FR 60962 (10/14/04)

                                     4612
Motor Vehicle and Mobile Equipment Coating Operations  -  Phase 2
                                  10/21/2010
                                  10/21/2010
                                   9/20/2007
                             75 FR 4612 (1/19/10)

                                     4621
Gasoline Transfer into Stationary Storage Containers
                                  12/20/2007
                                  12/20/2007
                                  12/20/2007
                            74 FR 56120 (10/30/09)

                                     4622
Gasoline Transfer into Motor Vehicles
                                  12/20/2007
                                  12/20/2007
                                  12/20/2007
                            74 FR 56120 (10/30/09)

                                     4623
Storage of Organic Liquids
                                   5/19/2005
                                   5/19/2005
                                   5/19/2005
                             70 FR 53937 (9/13/05)
Control strategy measure
                                     4624
Transfer of Organic Liquids
                                  12/20/2007
                                  12/20/2007
                                  12/20/2007
                            74 FR 52894 (10/15/09)
Control strategy measure
                                     4625
Wastewater Separators
                                  12/17/1992
                                  12/17/1992
                                  12/17/1992
                             76 FR 39777 (7/7/11)

                                     4641
Cutback, Slow Cure, and Emulsified Asphalt Paving and Maintenance Operations
                                  12/17/1992
                                  12/17/1992
                                  12/17/1992
                             75 FR 10691 (3/9/10)

                                     4642
Solid Waste Disposal Site
                                   4/16/1998
                                   4/16/1998
                                   4/16/1998
                             66 FR 38939 (7/26/01)

                                     4651
Soil Decontamination Operations
                                   9/20/2007
                                   9/20/2007
                                   9/20/2007
                            74 FR 56120 (10/30/09)

                                     4652
Coatings and Ink Manufacturing
                                  12/17/1992
                                 not submitted
                                      N/A
                                      N/A
No sources
                                     4653
Adhesives
                                   9/16/2010
                                   9/16/2010
                                   9/20/2007
                            74 FR 52894 (10/15/09)
Control strategy measures
                                     4661
Organic Solvents
                                   9/20/2007
                                   9/20/2007
                                   9/20/2007
                            75 FR 24406 (5/5/2010)
Control strategy measure
                                     4662
Organic Solvent Degreasing Operations
                                   9/20/2007
                                   9/20/2007
                                   9/20/2007
                             74 FR 37948 (7/30/09)
Control strategy measure
                                     4663
Organic Solvent Cleaning, Storage, and Disposal
                                   9/20/2007
                                   9/20/2007
                                   9/20/2007
                             74 FR 37948 (7/30/09)
Control strategy measure
                                     4672
Petroleum Solvent Dry Cleaning Operations
                                  12/17/1992
                                  12/17/1992
                                  12/17/1992
                                  75 FR 10691
                                   (3/9/10)

                                     4681
Rubber Tire Manufacturing
                                  12/16/1993
                                  12/16/1993
                                  12/16/1993
                                  63 FR 43881
                                   (8/17/98)

                                     4682
Polystyrene, Polyethylene, and Polypropylene Products Manufacturing
                                   9/20/2007
                                   9/20/2007
                                   9/20/2007
                          NPR: 76 FR 41745 (7/15/11)
Control strategy measure
                                     4684
Polyester Resin Operations
                                   8/18/2011
                                   6/16/2011
                                 NPR: 8/18/11
                                   9/20/2007
                          NPR: 76 FR 56132 (9/12/11)
                                  75 FR 3996
                                   (1/26/10)

                                 4691 (461.02)
Vegetable Oil Processing Operations
                                  12/17/1992
                                  12/17/1992
                                  12/17/1992
                                  59 FR 2535
                                   (1/18/94)

                                     4692
Commercial Charbroiling
                                   9/17/2009
                                   9/17/2009
                                   9/17/2009
                                   3/21/2002
                          NPR: 76 FR 38340 (6/30/11)
                             68 FR 33005 (6/03/03)

                                     4693
Bakery Ovens
                                   5/16/2002
                                   5/16/2002
                                   5/16/2002
                                  69 FR 22441
                                   (4/26/04)

                                     4694
Wine Fermentation and Storage Tanks
                                   8/18/2011
                                  12/15/2005
                                  12/15/2005
                                   no action
Control strategy measure
                                     4695
Brandy and Wine Aging
                                   9/17/2009
                                   9/17/2009
                                   9/17/2009
                             76 FR 470761 (8/4/11)
Control strategy measure
                                     4701
I/C Engines - Phase 1
                                   8/21/2003
                                   8/21/2003
                                   8/21/2003
                             69 FR 28061 (5/18/04)

                                     4702
I/C Engines - Phase 2
                                   8/18/2011
                                   1/18/2007
                                   1/18/2007
                             73 FR 1819 (1/10/08)
Control strategy measure
                                     4703
Stationary Gas Turbines
                                   9/20/2007
                                   9/20/2007
                                   9/20/2007
                                  74 FR 53888
                                  (10/21/09)
Control strategy measure
                                     4801
Sulfur Compounds
                                  12/17/1992
                                  12/17/1992
                                  12/17/1992
                                   no action

                                     4802
Sulfuric Acid Mist
                                  12/17/1992
                                  12/17/1992
                                  12/17/1992
                             64 FR 30396 (6/08/99)

                                     4901
Wood Burning Fireplaces and Wood Burning Heaters
                                  10/16/2008
                                  10/16/2008
                                  10/16/2008
                            74 FR 57907 (11/10/09)

                                     4902
Residential Water Heaters
                                   3/19/2009
                                   3/19/2009
                                   3/19/2009
                             75 FR 24408 (5/5/10)
Control strategy measure
                                     4905
Natural Gas-fired, fan-type, residential central furnaces
                                  10/20/2005
                                  10/20/2005
                                  10/20/2005
                             72 FR 29886 (5/30/07)

                                     8011
Fugitive Dust General Requirements
                                   8/19/2004
                                   8/19/2004
                                   8/19/2004
                             71 FR 8461 (2/17/06)

                                     8021
Construction, Demolition, Excavation, Extraction, and other Earthmoving Activities
                                   8/19/2004
                                   8/19/2004
                                   8/19/2004
                             71 FR 8461 (2/17/06)

                                     8031
Bulk Materials
                                   8/19/2004
                                   8/19/2004
                                   8/19/2004
                             71 FR 8461 (2/17/06)

                                     8041
Carryout and Trackout
                                   8/19/2004
                                   8/19/2004
                                   8/19/2004
                             71 FR 8461 (2/17/06)

                                     8051
Open Areas
                                   8/19/2004
                                   8/19/2004
                                   8/19/2004
                             71 FR 8461 (2/17/06)

                                     8061
Paved and Unpaved Roads
                                   8/19/2004
                                   8/19/2004
                                   8/19/2004
                             71 FR 8461 (2/17/06)

                                     8071
Unpaved Vehicle/ Equipment Traffic Areas
                                   9/16/2004
                                   9/16/2004
                                   9/16/2004
                             71 FR 8461 (2/17/06)

                                     8081
Agricultural Sources
                                   9/16/2004
                                   9/16/2004
                                   9/16/2004
                             71 FR 8461 (2/17/06)

                                     9310
School Bus
                                   9/21/2006
                                   9/21/2006
                                   9/21/2006
                             75 FR 10420 (3/8/10)

                                     9410
Employer Based Trip Reduction
                                  12/17/2009
                                  12/17/2009
                                      N/A
                                   no action
Control strategy measure. Submitted May 17, 2010 (complete June 8, 2010)
                                     9510
Indirect Source Review
                                  12/15/2005
                                  12/15/2005
                                   12/15/2005
                             76 FR 26609 (5/9/11)


[Federal Register: July 22, 2008 (Volume 73, Number 141)]
[Rules and Regulations]
[Page 42526-42529]
[DOCID:fr22jy08-7]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0215]
RIN 1625-AA00

Safety Zones: Festival of Sail San Francisco, San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard will establish temporary safety zones in
support of the scheduled Festival of Sail Events from July 23, 2008,
through July 27, 2008. The safety zones will include a parade and two
mock cannon battles referred to as location ``alpha'' and location
``bravo''. The temporary safety zones are necessary to provide for the
safety of spectators, participating vessels and crews.

DATES: This rule is effective for the Festival of Sail--Parade of Ships
from 11:59 a.m. through 4 p.m. on July 23, 2008; for the mock cannon
battle location ``alpha'' from 2 p.m. through 4:30 p.m. on July 25,
2008, and July 26, 2008; and for the mock cannon battle location
``bravo'' from 2 p.m. through

4:30 p.m. on July 24, 2008, and July 27, 2008.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0215 and are available online at http://
www.regulations.gov. This material is also available for inspection or
copying at two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays and Coast Guard
Sector San Francisco, 1 Yerba Buena Island, San Francisco, California,
94130 between 8 a.m. and 4 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Lieutenant Junior Grade Sheral Richardson, U.S.
Coast Guard Sector San Francisco, at<PHONE_NUMBER>. If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On June 13, 2008, we published a notice of proposed rulemaking
(NPRM) entitled ``Safety Zones: Festival of Sail San Francisco, San
Francisco, CA'' in the Federal Register (73 FR 115). We received no
letters commenting on the proposed rule. No public meeting was
requested, and none was held.

Background and Purpose

    The American Sail Training Association, in coordination with the
local sponsor, Festival of Sail San Francisco, is sponsoring the 2008
Festival of Sail Event. This event is a part of the Tall Ships[supreg]
Challenge race series transiting the Pacific Ocean along the west coast
of North America. Between the races, the participating vessels will
visit several ports, including San Francisco. Vessels will be docked
along the waterfront offering the public the opportunity to tour
vessels, sail and learn. There are many activities on the water
scheduled to take place; such as mock cannon battles and the parade.
Safety zones will be established along with the issuance of marine
event permits for this event. The temporary safety zones are necessary
to provide for the safety of the crews, spectators, and participants of
the Festival of Sail and are also necessary to protect other vessels
and users of waterway.

Discussion of Comments and Changes

    No comments were received about the event taking place. This
document reflects the information published in the original NPRM.

Discussion of Rule

    The Coast Guard will establish a moving safety zone extending 100
yards around each vessel participating in the Festival of Sail--Parade
of Ships as each vessel transits through San Francisco Bay. The safety
zones surrounding the participant vessels will be enforced on July 23,
2008. The parade route is as follows, it will commence at the Golden
Gate Bridge, extend east to Alcatraz Island and then south to Pier 40,
and will be bounded by a line connecting the following points:
37[deg]48'40'' N and 122[deg]28'38'' W, 37[deg]49'10'' N and
122[deg]28'41'' W, 37[deg]49'31'' N and 122[deg]25'18'' W,
37[deg]49'06'' N and 122[deg]24'08'' W, 37[deg]47'53'' N and
122[deg]22'42'' W, 37[deg]46'54'' N, 122[deg]23'09'' W.
    The Coast Guard will establish a temporary safety zone for the mock
cannon battles taking place west of Alcatraz Island. This location will
be called location ``alpha''. The safety zone will be bounded by a line
connecting the following points: 37[deg]49'18'' N and 122[deg]25'40''
W, 37[deg]49'24'' N and 122[deg]25'18'' W, 37[deg]49'45'' N and
122[deg]25'42'' W, and lastly 37[deg]49'37'' N and 122[deg]26'05'' W;
and will include all navigable waters from the surface to the seafloor.
This safety zone will be in effect on July 25, 2008, and July 26, 2008.
    The Coast Guard will establish a temporary safety zone for the mock
cannon battles taking place west of Treasure Island in Anchorage 7.
This location will be called location ``bravo''. The safety zone will
be bounded by a line connecting the following points: 37[deg]48'55'' N
and 122[deg]23'03'' W, 37[deg]49'07'' N and 122[deg]22'32'' W,
37[deg]49'28'' N and 122[deg]22'53'' W and lastly 37[deg]49'18'' N and
122[deg]23'28'' W; and will include all navigable waters from the
surface to the seafloor. This safety zone will be in effect on July 24,
2008, and July 27, 2008.
    These safety zones are necessary to provide for the safety of the
crews, spectators, and participants of the Festival of Sail. Persons
and vessels would be prohibited from entering into, transiting through,
or anchoring within these safety zones unless authorized by the Captain
of the Port, or his designated representative.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of

their discretionary regulatory actions. In particular, the Act
addresses actions that may result in the expenditure by a State, local,
or tribal government, in the aggregate, or by the private sector of
$100,000,000 or more in any one year. Though this rule will not result
in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is not likely to
have a significant effect on the human environment. A preliminary
``Environmental Analysis Check List'' supporting this preliminary
determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

0
For the reasons discussed in the preamble, the Coast Guard proposes to
amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add temporary Sec.  165.T11-025 to read as follows:

Sec.  165.T11-025  Safety Zones; Festival of Sail, San Francisco, CA.

    (a) Location. These temporary safety zones are established for the
Festival of Sail Events taking place in the following locations:
    (1) For the Festival of Sail--Parade of Ships the moving safety
zone extends 100 yards around each vessel participating in the Parade
of Ships as each vessel transits through San Francisco Bay to its
respective mooring site.
    (2) For the mock cannon battles, the safety zone for location
``alpha'' will take place west of Alcatraz Island. The safety zone will
be bounded by a line connecting the following points: 37[deg]49'18'' N
and 122[deg]25'40'' W, 37[deg]49'24'' N and 122[deg]25'18'' W,
37[deg]49'45'' N and 122[deg]25'42'' W, and lastly 37[deg]49'37'' N and
122[deg]26'05'' W; and will include all navigable waters from the
surface to the seafloor.
    (3) For the mock cannon battles, the safety zone for location
``bravo'' will take place west of Treasure Island in Anchorage 7. The
safety zone will be bounded by a line connecting the following points:
37[deg]48'55'' N and 122[deg]23'03'' W, 37[deg]49'07'' N and
122[deg]22'32'' W, 37[deg]49'28'' N and 122[deg]22'53'' W and lastly
37[deg]49'18'' N and 122[deg]23'28'' W; and will include all navigable
waters from the surface to the seafloor.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port San Francisco (COTP) in the enforcement of the
safety zones.
    (c) Regulations. (1) Under the general regulations in Sec.  165.23,
entry into, transiting, or anchoring within these safety zones is
prohibited unless authorized by the COTP or the COTP's designated
representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or the COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP or the COTP's designated representative. Persons and
vessels may request permission to enter the safety zone on VHF-16 or
the 24-

hour Command Center via telephone at<PHONE_NUMBER>.
    (d) Effective period. This section is effective for the Festival of
Sail-Parade of Ships from 11:59 a.m. through 4 p.m. on July 23, 2008;
for the mock cannon battle location ``alpha'' from 2 p.m. through 4:30
p.m. on July 25, 2008, and July 26, 2008; and for the mock cannon
battle location ``bravo'' from 2 p.m. through 4:30 p.m. on July 24,
2008, and July 27, 2008.

    Dated: July 9, 2008.
P.M. Gugg,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
 [FR Doc. E8-16674 Filed 7-22-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18222-18223]
[FR Doc No: 2020-06758]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-1385-000]

Bluestone Farm Solar, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Bluestone Farm Solar, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 15, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies

of the intervention or protest to the Federal Energy Regulatory
Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 26, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-06758 Filed 3-31-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Rules and Regulations]
[Pages 30833-30836]
[FR Doc No: 2018-13932]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31200; Amdt. No. 3806]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective July 2, 2018. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of July 2, 2018.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC, 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Procedures Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and Takeoff Minimums and ODPs with their applicable effective
dates. This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on June 15, 2018.
John S. Duncan,
Executive Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [AMENDED]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date           State              City                 Airport          FDC No.      FDC date                     Subject .
--------------------------------------------------------------------------------------------------------------------------------------------------------
19-Jul-18............  IA             Newton..............  Newton Muni-Earl           7/1792       6/5/18  VOR RWY 14, Amdt 9A.
                                                             Johnson Field.

19-Jul-18............  GA             Washington..........  Washington-Wilkes          7/2604       6/7/18  RNAV (GPS) RWY 31, Amdt 1A.
                                                             County.
19-Jul-18............  TX             Alice...............  Alice Intl..........       7/6033       6/5/18  VOR RWY 31, Amdt 13D.
19-Jul-18............  TX             Alice...............  Alice Intl..........       7/6034       6/5/18  VOR-A, Amdt 15B.
19-Jul-18............  IA             Ames................  Ames Muni...........       8/0696      6/11/18  RNAV (GPS) RWY 19, Amdt 1.
19-Jul-18............  NE             Kearney.............  Kearney Rgnl........       8/0910      5/29/18  RNAV (GPS) RWY 13, Orig-A.
19-Jul-18............  KS             Burlington..........  Coffey County.......       8/0936       6/5/18  NDB RWY 36, Amdt 2.
19-Jul-18............  KS             Burlington..........  Coffey County.......       8/0937       6/5/18  RNAV (GPS) RWY 18, Orig-A.
19-Jul-18............  PA             Beaver Falls........  Beaver County.......       8/0984      5/29/18  RNAV (GPS) RWY 10, Orig-B.
19-Jul-18............  PA             Beaver Falls........  Beaver County.......       8/0985      5/29/18  RNAV (GPS) RWY 28, Orig-B.
19-Jul-18............  PA             Beaver Falls........  Beaver County.......       8/0986      5/29/18  VOR RWY 28, Amdt 10B.
19-Jul-18............  MA             Stow................  Minute Man Air Field       8/1764      6/11/18  VOR/DME RWY 21, Amdt 3D.
19-Jul-18............  MA             Stow................  Minute Man Air Field       8/1767      6/11/18  RNAV (GPS) RWY 21, Orig-A.
19-Jul-18............  TX             Llano...............  Llano Muni..........       8/1773      5/29/18  VOR-A, Amdt 4.
19-Jul-18............  TX             Llano...............  Llano Muni..........       8/1774      5/29/18  RNAV (GPS) RWY 17, Orig.
19-Jul-18............  TX             Llano...............  Llano Muni..........       8/1775      5/29/18  RNAV (GPS) RWY 35, Orig.
19-Jul-18............  MN             Rochester...........  Rochester Intl......       8/2046      5/29/18  RADAR-1, Amdt 8.
19-Jul-18............  CA             Bakersfield.........  Meadows Field.......       8/2899      5/29/18  ILS OR LOC RWY 30R, Amdt 31.
19-Jul-18............  CA             Bakersfield.........  Meadows Field.......       8/2901      5/29/18  RNAV (GPS) RWY 30R, Amdt 2A.
19-Jul-18............  WI             East Troy...........  East Troy Muni......       8/3005      5/29/18  VOR/DME-A, Amdt 1B.
19-Jul-18............  WI             East Troy...........  East Troy Muni......       8/3009      5/29/18  RNAV (GPS) RWY 8, Orig-B.
19-Jul-18............  WI             East Troy...........  East Troy Muni......       8/3013      5/29/18  RNAV (GPS) RWY 26, Orig-B.
19-Jul-18............  AK             Kake................  Kake................       8/3041       6/5/18  RNAV (GPS) RWY 11, Orig.
19-Jul-18............  AK             Kake................  Kake................       8/3043       6/5/18  NDB/DME RWY 11, Amdt 1.
19-Jul-18............  AL             Jackson.............  Jackson Muni........       8/3051       6/7/18  RNAV (GPS) RWY 1, Orig.
19-Jul-18............  MN             Longville...........  Longville Muni......       8/3119       6/5/18  RNAV (GPS) RWY 31, Orig.
19-Jul-18............  OH             Phillipsburg........  Phillipsburg........       8/3327       6/1/18  VOR OR GPS RWY 21, Amdt 3A.
19-Jul-18............  OH             Phillipsburg........  Phillipsburg........       8/3329       6/1/18  Takeoff Minimums and Obstacle DP, Amdt 1.
19-Jul-18............  TN             Camden..............  Benton County.......       8/3588       6/7/18  RNAV (GPS) RWY 22, Orig-C.
19-Jul-18............  MT             Laurel..............  Laurel Muni.........       8/5735      5/21/18  RNAV (GPS) RWY 4, Amdt 1B.
19-Jul-18............  MT             Laurel..............  Laurel Muni.........       8/5737      5/21/18  RNAV (GPS) RWY 22, Amdt 1B.
19-Jul-18............  MT             Laurel..............  Laurel Muni.........       8/5739      5/21/18  VOR RWY 22, Amdt 2A.
19-Jul-18............  IL             Bloomington/Normal..  Central IL Rgnl Arpt       8/6132       6/1/18  ILS OR LOC RWY 29, Amdt 11A.
                                                             at Bloomington-
                                                             Normal.
19-Jul-18............  IL             Decatur.............  Decatur.............       8/6136       6/1/18  ILS OR LOC RWY 6, Amdt 13F.
19-Jul-18............  AR             Monticello..........  Monticello Muni/           8/6939       6/5/18  RNAV (GPS) RWY 3, Amdt 1B.
                                                             Ellis Field.
19-Jul-18............  LA             Many................  Hart................       8/7523       6/6/18  RNAV (GPS) RWY 12, Orig.
19-Jul-18............  LA             Many................  Hart................       8/7526       6/5/18  RNAV (GPS) RWY 30, Orig.
19-Jul-18............  MA             Fitchburg...........  Fitchburg Muni......       8/7537       6/7/18  RNAV (GPS) RWY 20, Orig-C.
19-Jul-18............  WV             Lewisburg...........  Greenbrier Valley...       8/7828       6/7/18  Takeoff Minimums and Obstacle DP, Amdt 4.
19-Jul-18............  NC             Reidsville..........  Rockingham County NC       8/7839       6/7/18  RNAV (GPS) RWY 13, Orig.
                                                             Shiloh.
19-Jul-18............  NC             Reidsville..........  Rockingham County NC       8/7840       6/7/18  RNAV (GPS) RWY 31, Orig-A.
                                                             Shiloh.
19-Jul-18............  NC             Reidsville..........  Rockingham County NC       8/7842       6/7/18  NDB RWY 31, Amdt 5A.
                                                             Shiloh.
19-Jul-18............  NC             Reidsville..........  Rockingham County NC       8/7843       6/7/18  VOR/DME-A, Amdt 9A.
                                                             Shiloh.
19-Jul-18............  TX             Houston.............  Ellington...........       8/7904       6/5/18  ILS OR LOC RWY 22, Amdt 3G.
19-Jul-18............  AL             Hartselle...........  Hartselle-Morgan           8/7959       6/7/18  RNAV (GPS) RWY 18, Amdt 1.
                                                             County Regional.
19-Jul-18............  AL             Hartselle...........  Hartselle-Morgan           8/7960       6/7/18  RNAV (GPS) RWY 36, Amdt 1.
                                                             County Regional.
19-Jul-18............  FL             St Augustine........  Northeast Florida          8/8029       6/7/18  RNAV (GPS) RWY 13, Orig-D.
                                                             Rgnl.
19-Jul-18............  FL             St Augustine........  Northeast Florida          8/8031       6/7/18  VOR RWY 13, Orig-D.
                                                             Rgnl.
19-Jul-18............  ND             Lakota..............  Lakota Muni.........       8/8043       6/5/18  RNAV (GPS) RWY 33, Orig.
19-Jul-18............  OK             Ketchum.............  South Grand Lake           8/8672       6/5/18  RNAV (GPS) RWY 36, Orig.
                                                             Rgnl.
19-Jul-18............  OK             Ketchum.............  South Grand Lake           8/8673       6/5/18  RNAV (GPS) RWY 18, Orig.
                                                             Rgnl.
19-Jul-18............  AL             Ozark...............  Blackwell Field.....       8/8783       6/7/18  Takeoff Minimums and Obstacle DP, Amdt 2.
19-Jul-18............  AL             Ozark...............  Blackwell Field.....       8/8796       6/7/18  RNAV (GPS) RWY 13, Orig-A.
19-Jul-18............  AL             Ozark...............  Blackwell Field.....       8/8798       6/7/18  RNAV (GPS) RWY 31, Orig-A.
19-Jul-18............  AL             Ozark...............  Blackwell Field.....       8/8803       6/7/18  VOR RWY 31, Amdt 7A.
19-Jul-18............  MI             Bay City............  James Clements Muni.       8/8880       6/7/18  Takeoff Minimums and Obstacle DP, Amdt 6.
19-Jul-18............  MI             Bay City............  James Clements Muni.       8/8882       6/7/18  RNAV (GPS) RWY 18, Orig-B.
19-Jul-18............  MI             Bay City............  James Clements Muni.       8/8883       6/7/18  VOR-A, Amdt 12A.
19-Jul-18............  MO             Aurora..............  Jerry Sumners Sr           8/9567       6/5/18  RNAV (GPS) RWY 18, Orig-A.
                                                             Aurora Muni.
19-Jul-18............  MO             Aurora..............  Jerry Sumners Sr           8/9575       6/5/18  VOR/DME-A, Amdt 4.
                                                             Aurora Muni.
19-Jul-18............  AZ             Grand Canyon........  Valle...............       8/9769      5/29/18  GPS RWY 01, Orig-B.

19-Jul-18............  AZ             Grand Canyon........  Valle...............       8/9770      5/29/18  VOR/DME RWY 19, Orig.
19-Jul-18............  AZ             Grand Canyon........  Valle...............       8/9773      5/29/18  GPS RWY 19, Orig-A.
19-Jul-18............  MA             Worcester...........  Worcester Rgnl......       8/9807      5/29/18  ILS OR LOC RWY 11, Amdt 25.
19-Jul-18............  AL             Dothan..............  Dothan Rgnl.........       8/9937       6/7/18  RNAV (GPS) RWY 14, Amdt 2A.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-13932 Filed 6-29-18; 8:45 am]
 BILLING CODE 4910-13-P