[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Rules and Regulations]
[Page 27448-27452]
[DOCID:fr16my07-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0121; FRL-7713-1]

Pythium Oligandrum DV 74; Exemption from the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Pythium oligandrum DV 74 on food crops.
Biopreparaty Co. Ltd. submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Pythium
oligandrum DV 74.

DATES: This regulation is effective May 16, 2007. Objections and
requests for hearings must be received on or before July 16, 2007, 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-2005-EPA-0121. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

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

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

FOR FURTHER INFORMATION CONTACT: Tessa Milofsky, Biopesticides and
Pollution Prevention Division (7511P), 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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I 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 180 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-2005-EPA-0121 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 July 16, 2007.
    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-2005-EPA-0121, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

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

II. Background and Statutory Findings

    In the Federal Register of May 25, 2005 (70 FR 30105) (FRL-7713-1).
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 4F6877) by Biopreparaty, Co. Ltd. Tylisovska I, Prague 6,
Czech Republic. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement Pythium

oligandrum DV 74. This notice included a summary of the petition
prepared by the petitioner Biopreparaty Co. Ltd.
    One comment was received from a private citizen opposing the
``production or selling'' of Pythium oligandrum DV 74. The commentor
further stated that it was their wish that no exemptions be issued and
that no tolerances should be approved. The Agency understands the
commentor's concerns and recognizes that some individuals believe that
pesticides should be banned completely. However, under the existing
legal framework provided by section 408 of the FFDCA EPA is required to
establish pesticide tolerances or exemptions where persons seeking such
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute. The commentor has not provided the
Agency with a specific rationale or additional information pertaining
to the legal standards in FFDCA section 408 for opposing the
establishment of a tolerance exemption for Pythium oligandrum DV 74. In
the absence of any additional information of a factual nature, the
Agency can not effectively respond to the commentor's disagreement with
the Agency's decision.
    Another comment was received that supported the registration. The
commentator stated that ``Pythium oligandrum appears to be an unusually
effective (in its rapidity of action) and exceptionally safe (in terms
of mammalian toxicity) crop protection product.''
    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.

A. Acute Oral Toxicity and Pathogenicity (Master Record Identification
numbers 464107-02 and 464109-03; Data Request 152-30; OPPTS Harmonize
Guideline. 885.3050)

    A guideline acute oral toxicity study was carried out in 2001 using
mice. Ten mice (five males, five females) were given a total dose of
5,000 milligrams/kilogram (mg/kg) Pythium oligandrum DV 74 and no
adverse effects were seen in the mice which were observed for 14 days
after dosing. The test substance was rated Toxicity Category IV.

B. Acute Dermal Toxicity (Master Record Identification numbers 464109-
04, 464107-02; OPPTS Harmonize Guideline 870.1200)

    A guideline acute dermal toxicity study was conducted using rats.
The dermal LD50 for males, females, and combined was greater
than 5,000 mg/kg body wt. Pythium oligandrum DV 74 test substance was
rated Toxicity Category IV.

C. Acute Inhalation Toxicity (Master Record Identification number
464109-05; OPPTS Harmonize Guideline 870.1300)

    In a four-hour acute inhalation toxicity study using rats, a limit
dose (5 mg/L) of Pythium oligandrum DV 74 produced no mortality nor
adverse effects, and no gross abnormalities were seen at necropsy 14
days later. Although the MMD was 7.45 and [micro]m, approximately 68%
of the particles were < =3.75 [micro]m. The acute inhalation
LC50 for males, females, and combined was >5 mg/L for a 4
hour exposure. The test substance is Toxicity Category IV.

D. Acute Pulmonary Toxicity/Pathogenicity-Waiver Granted (Master Record
Identification number 464109-10; OPPTS Harmonize Guideline 885.3150)

    In a four-hour acute inhalation toxicity study using rats, a limit
dose (5 mg/L) of Pythium oligandrum DV 74 produced no mortality or
adverse effects, and no gross abnormalities were seen at necropsy 14
days later. Although the MMD was 7.45 [micro]m, approximately 68% of
the particles were < =3.75 [micro]m. The acute inhalation
LC50 for males, females, and combined was >5 mg/L for a 4
hour exposure. The test substance is classified as Toxicity Category
IV. Infectivity testing was waived for this study based on the results
of the growth temperature study which showed no growth on plant-based
growth media at or above 37[deg] C, and no growth at any temperature on
animal tissue-based growth media.

E. Acute Injection Tocity/Pathogenicity (Master Record Identification
numbers 465823-01, 467542-01,464109-10, and 469901-01; OPPTS Harmonize
Guideline 885.3200)

    An acute injection toxicity/pathogenicity study was conducted using
rats. Storage, stability data showed that after Batch No. 150405 was
stored for approximately 9 months, of 1.3x106 oospores/g
active ingredient 80.5% were viable after 120 hours incubation, giving
1.1x106 cfu/g - however, this study lists Batch No. 150405
as containing 107 granules/g, so viability would then be
only 11%. Based on the data submitted, Pythium oligandrum DV 74 does
not appear toxic nor pathogenic to rats when dosed at
2.9x104 oospores/animal - although no attempts to isolate
viable organisms prior to testing, or from test animals after
inoculation, were made. Therefore, infectivity cannot be assessed in
the study, initially rated not toxic nor pathogenic. In addition, there
were discrepancies with characterization of the test substance.
However, infectivity testing was waived for this study, based on the
results of the growth temperature study which showed no growth on
plant-based growth media at or above 37[deg] C, and no growth at any
temperature on animal tissue-based growth media.

F. Primary Dermal Irritation (Master Record Identification numbers
464605-02 and 464107-02; OPPTS Harmonize Guideline 870.2500)

    An acute dermal irritation study was conducted using rabbits. Very
slight erythema was noted on the skin of three rabbits one hour after
patch removal, with clearance on two rabbits by 24 hours and on one
rabbit by 48 hours. The primary irritation index was 0.3. Technical DV
74 was essentially nonirritating; the test substance was rated Toxicity
Category IV.

G. Acute Eye Irritation (Master Record Identification number 464109-
06;OPPTS Harmonize Guideline 870.2400)

    An acute eye irritation study was conducted using rabbits. No
corneal opacity nor iritis was observed during the study. Positive
conjunctival irritation (score 2) was noted on 2 rabbits 1 hour after
Pythium oligandrum DV 74 instillation with resolution by 48 hours. The
maximumaverage score was 6.7 at 24 hours after test material
instillation. The test substance is Toxicity Category III.

H. Skin sensitization-Waiver Granted (Master Record Identification
number 464109-10; OPPTS Harmonize Guideline 870.2600)

    A guideline acute dermal toxicity study was conducted using rats.
The dermal LD50 for males, females, and combined was greater
than 5,000 mg/kg body wt. Pythium oligandrum DV 74 and rated Toxicity
Category IV. An acute dermal irritation study was conducted using
rabbits. Very slight erythema was noted on 3/3 rabbits one hour after
patch removal, with clearance on two rabbits by 24 hours and on one
rabbit by 48 hours. The primary irritation index was 0.3. Technical DV
74 was essentially nonirritating and rated Toxicity Caterogy IV. In
addition, Pythium oligandrum occurs naturally in a variety of soil
types over a wide range of environmental conditions. Although
application of Pythium oligandrum DV 74 to seeds, foliage, or soil will
likely temporarily increase its concentration in the environment, the
population is expected to subside to normal levels, because the
organism does not thrive in the absence of sufficient nutrients. A
search of the public literature found no reports of Pythium oligandrum
having adverse effects in humans or other mammals. The only known
biological effects of Pythium oligandrum are parasitic effects on
fungal species and stimulation of resistance to parasitic infection in
plants. Neither the mechanism of the mycoparasitic action nor the
stimulation of plant resistance is associated with adverse effects in
mammals. Pythium oligandrum DV 74 is the active ingredient in various
over-the-counter products sold in Europe, including a mouthwash, a bath
additive and a skin cream. These products have been on the market in
parts of the EU since 1999 with no reported adverse effects. The lack
of any reported sensitization effects from repeated dermal exposure to
the consumer products suggests that Pythium oligandrum is not a dermal
sensitizer. To reduce exposure to this active ingredient from its
pesticide use, the agricultural use label requires that applicators and
handlers wear a long-sleeved shirt and long pants, waterproof gloves,
and shoes plus socks.

I. Pathogenicity and Infectivity (Master Record Identification numbers
469901-01 and 02)

    Pythium oligandrum DV 74 is primarily a fungal hyperparasite that
exhibits limited growth on plant-based media and no growth on animal
tissue-based media. In addition, its growth tapers off as temperature
approaches normal human body temperature of 37[deg] C and there is no
growth at or above this temperature. Therefore, infectivity testing is
not possible. This information supports waivers for infectivity testing
in the acute oral, acute dermal, acute inhalation, and injection
exposure studies.

J. Subchronic, Chronic Toxicity and Oncogenicity

    Based on the data generated in accordance with Tier I data
requirements (40 CFR 158.740(c)), Tier II tests (Guidelines 152B-40
through 152B-49), which include acute oral, acute inhalation,
subchronic oral, acute intraperitoneal/intracerebral, primary dermal,
primary eye, immune response, teratogenicity, virulence enhancement,
and mammalian mutagenicity were not required. Tier III tests
(Guidelines 152-50 through 53), which include chronic testing,
oncogenicity testing, mutagenicity, and teratogenicity were also not
required.

K. Effects on the Endocrine System

    EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients)
``humans that is similar to an effect produced by a naturally-occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Pythium oligandrum is not a known endocrine disruptor nor
is it related to any class of known endocrine disruptors. Consequently,
endocrine-related concerns did not adversely impact the Agency's safety
finding for Pythium oligandrum.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    Due to the proposed use of Pythium oligandrum on food crops, fungal
residues may be present on agricultural commodities. However,
negligible to no risk is expected for the general population, including
infants and children, because Pythium oligandrum demonstrated no
pathogenicity nor acute oral toxicity at the maximum doses tested.
    1. Food. Due to the proposed use of Pythium oligandrum on food
crops, fungal residues may be present on agricultural commodities.
However, negligible to no risk is expected for the general population,
including infants and children, because Pythium oligandrum demonstrated
no pathogenicity or oral toxicity at the maximum doses tested.
    2. Drinking water exposure. Pythium oligandrum does not thrive in
aquatic environments and there are no aquatic use sites for the
pesticide. Accordingly, application of this pesticide to approved use
sites is not expected to increase drinking water exposure to Pythium
oligandrum. Furthermore, any Pythium oligandrum that might be consumed
through drinking water would pose negligible to the general population,
including infants and children, due to the pesticide's low toxicity
classification.

B. Other Non-Occupational Exposure

    Pythium oligandrum will be applied to agricultural fields, turf and
professional landscapes, and in home gardens. Although some
applications may be made near residential areas, no harm would be
expected to result from exposure to Pythium oligandrum due to its low
toxicity classification.
    1.Dermal exposure. Dermal exposure is limited by use of the
required PPE and REI in occupational settings, and residential users
are advised to avoid

skin contact and to wash any exposed skin or clothing.
    2. Inhalation exposure. The greatest likelihood of inhalation
exposure would occur in an occupational setting, among mixers/loaders
and applicators. However, as demonstrated in the acute pulmonary
toxicity/pathogenicity test, Pythium oligandrum is not infective,
pathogenic, or toxic to mammals. Despite the benign nature of the
active ingredient, the agency requires that all workers exposed to
microbial pesticides must wear a dust/mist filtering respirator. As
such, the risks anticipated for inhalation exposure are minimal.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effect of exposure to Pythium oligandrum and to
other substances that have a common mechanism of toxicity. These
considerations include the possible cumulative effects of such residues
on infants and children. As demonstrated in Unit III.A., Pythium
oligandrum is not toxic or pathogenic to mammals, and only minimally
irritating to eyes. Consequently, no cumulative effects from the
residues of this product with other related microbial pesticides are
anticipated.

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

    There is a reasonable certainty that no harm to the U.S.
population, including infants and children, will result from aggregate
exposure to residues of Pythium oligandrum due to its use as a
microbial pest control agent. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. As discussed in UnitIII.A., Pythium oligandrum is not
toxic or pathogenic to mammals, and only minimally irritating in an eye
exposure study. Accordingly, exempting Pythium oligandrum from the
requirement of a tolerance is considered safe and poses no significant
risks.
    FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional tenfold margin of exposure (safety) for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and
exposure, unless EPA determines that a different margin of exposure
(safety) will be safe for infants and children. Margins of exposure
(safety), which often are referred to as uncertainty factors, are
incorporated into EPA risk assessment either directly or through the
use of a margin of exposure analysis or by using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk.
Actual exposures to adults and children through diet are expected to be
several orders of magnitude less than the doses used in the toxicity
and pathogenicity tests referenced in Unit III. Thus, the Agency has
determined that an additional margin of safety for infants and children
is unnecessary.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally-occurring estrogen, or other such endocrine effects as the
Administrator may designate.'' Pythium oligandrum is not a known
endocrine disruptor nor is it related to any class of known endocrine
disruptors. Consequently, endocrine-related concerns did not adversely
impact the Agency's safety finding for Pythium oligandrum.

B. Analytical Method(s)

    The acute oral toxicity and pathogenicity findings discussed in
Unit III demonstrate that the active ingredient does not pose a dietary
risk. Nevertheless, the Agency has concluded that for the analysis of
the pesticide itself, microbiological and biochemical methods exist and
are acceptable forthe enforcement purposes for product identity of
Pythium oligandrum DV 74. Other appropriate methods are required for
quality control to assure that product characterization, the control of
human pathogens, and other unintentional metabolites or ingredients are
within regulatory limits, and to ascertain storage stability and
viability of the pesticidal active ingredient.

C. Codex Maximum Residue Level

    There is no established Codex maximum residue level for residues of
Pythium oligandrum DV 74.

VIII. Conclusions

    The results of the studies discussed are sufficient to comply with
the requirements of FQPA. They support an exemption from the
requirement of tolerance for residues of Pythium oligandrum DV 74, on
treated food of food commodities. In addition, the Agency is of the
opinion that, if the microbial active ingredient is used as allowed,
aggregate and cumulative exposures are not likely to pose any undue
hazard to the U.S. population of adult, children, and infant humans.
Therefore, an exemption from the requirement of tolerance is granted in
response to pesticide petition 4F6877.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination

with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not
apply to this rule. In addition, This rule does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 4, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1275 is added to subpart D to read as follows:

Sec.  180.1275  Pythium; Exception from the requirement of a tolerance.

    An exemption from the requirement of tolerance is established on
all food/feed commodities, for residues of pythium oligandrum DV 74
when the pesticide is used on food crops.
[FR Doc. E7-9298 Filed 5-15-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: March 30, 2010 (Volume 75, Number 60)]
[Rules and Regulations]
[Page 15609-15610]
[DOCID:fr30mr10-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 61

[Docket No. FAA-2007-29015; Amdt. No. 61-125A]
RIN 2120-AJ10

Certification of Aircraft and Airmen for the Operation of Light-
Sport Aircraft; Modifications to Rules for Sport Pilots and Flight
Instructors With a Sport Pilot Rating; Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting a final rule published on February 1,
2010. In that rule, the FAA amended its regulations for sport pilots
and flight instructors with a sport pilot rating to address airman
certification and operational issues that have arisen since regulations
for the certification of aircraft and airmen for the operation of
light-sport aircraft were implemented in 2004. This document corrects
errors in the codified text of that document.

DATES: The final rule and this correction will become effective April
2, 2010.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this rule, contact Larry L. Buchanan, Light-Sport Aviation Branch, AFS-
610, Regulatory Support Division, Flight Standards Service, Federal
Aviation Administration, 6500 South MacArthur Blvd., Oklahoma City, OK
73169; telephone<PHONE_NUMBER>; Mailing address: Light-Sport Aviation
Branch, AFS-610, P.O. Box 25082, Oklahoma City, OK 73125.
    For legal questions concerning this rule, contact Paul G. Greer,
Regulations Division, AGC-200, Federal Aviation Administration, 800
Independence Ave., SW., Washington, DC 20591; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On February 1, 2010, the FAA published a final rule entitled,
``Certification of Aircraft and Airmen for the Operation of Light-Sport
Aircraft; Modifications to Rules for Sport Pilots and Flight
Instructors With a Sport Pilot Rating'' (75 FR 5204).
    In that final rule, the FAA revised Sec.  61.327. Paragraph (a)
introductory text of Sec.  61.327 referenced endorsement requirements
for a sport pilot operating ``a light-sport aircraft that has a
VH less than or equal to 87 knots CAS.'' Paragraph (b)
introductory text of Sec.  61.327 referenced endorsement requirements
for persons operating ``a light-sport aircraft that has a VH
greater than 87 knots CAS.'' In the revision to Sec.  61.315(c)(14)(i)
and (c)(14)(ii), however, references to those paragraphs of Sec.
61.327 were incorrectly cited.
    Additionally, the FAA revised Sec.  61.327 to require a sport pilot
who seeks to operate a light-sport aircraft that has a VH
less than or equal to 87 knots CAS to receive and log training in an
aircraft that has a VH less than or equal to 87 knots CAS.
In the preamble to the final rule, the FAA noted that it ``does not
believe that receiving training in an airplane with a VH
greater than 87 knots CAS will adequately prepare a sport pilot to
operate a low-speed, high-drag airplane with a VH less than
or equal to 87 knots CAS without additional training.'' The agency did
not intend to require specific endorsements for other categories and
classes of aircraft, such as powered parachutes and weight-shift-
control aircraft that typically have a VH that does not
exceed 87 knots CAS. Accordingly the FAA is correcting Sec.  61.327(a)
and (c) to reflect the agency's intent and is making conforming
corrections in Sec. Sec.  61.315(c)(14), 61.415(f), and 61.423
(a)(2)(iii)(C).
    Sections 61.319 and 61.323 were revised to eliminate the
requirement that persons exercising sport pilot privileges have an
aircraft make-and-model endorsement to operate an aircraft within a
specific set of aircraft. The FAA therefore also should have included a
conforming amendment to Sec.  61.317 Is my sport pilot certificate
issued with aircraft category and class ratings? to remove reference to
the words ``make and model.''
    Lastly, Sec. Sec.  61.315(c)(14)(ii) and 61.327(c) contained
provisions that permit a sport pilot to operate an aircraft with a
VH less than or equal to 87 knots CAS if that person has
logged flight time

as pilot in command of an aircraft with a VH less than or
equal to 87 knots CAS prior to March 3, 2010. The FAA is correcting
this date to read ``April 2, 2010,'' to correspond with the effective
date of the final rule.

Corrections

    In final rule FR Doc. 2010-2056, beginning on page 5204 in the
Federal Register of February 1, 2010, make the following corrections:

0
1. On page 5222, in the first column, revise Sec.  61.315(c)(14) to
read as follows:

Sec.  61.315  What are the privileges and limits of my sport pilot
certificate?

* * * * *
    (c) * * *
    (14) If the aircraft:
    (i) Has a VH greater than 87 knots CAS, unless you have
met the requirements of Sec.  61.327(b).
    (ii) Has a VH less than or equal to 87 knots CAS, unless
you have met the requirements of Sec.  61.327(a) or have logged flight
time as pilot in command of an airplane with a VH less than
or equal to 87 knots CAS before April 2, 2010.
* * * * *

0
2. On page 5222, in the first column, add amendment 15A to read as
follows:

Sec.  61.317  [Amended]

0
15A. Amend Sec.  61.317 by removing the words ``logbook endorsement for
the category, class, and make and model of aircraft'' from the last
sentence and adding in their place the words ``logbook endorsement for
the category and class of aircraft''.

Sec.  61.327  [Corrected]

0
3. On page 5222, in the first column, amend Sec.  61.327 by:
0
a. Amending paragraph (a) introductory text by removing the words
``light-sport aircraft that has'' and adding in their place the words
``light-sport aircraft that is an airplane with''.
0
b. Amending paragraph (a)(1) by removing the word ``aircraft'' and
adding in its place the word ``airplane''.
0
c. Amending paragraph (a)(2) by removing the words ``light-sport
aircraft'' and adding in their place the words ``light-sport aircraft
that is an airplane''.
0
d. Amending paragraph (c) by removing the word ``aircraft'' and adding
in its place the word ``airplane'' and by removing the date ``March 3,
2010'' and adding in its place the date ``April 2, 2010''.

Sec.  61.415  [Corrected]

0
4. On page 5222, in the second column, in Sec.  61.415(f), remove the
words ``light-sport aircraft'' and add in their place the words
``light-sport aircraft that is an airplane''.

Sec.  61.423  [Corrected]

0
5. On page 5222, in the third column, in Sec.  61.423(a)(2)(iii)(C),
remove the words ``light-sport aircraft'' and add in their place the
words ``light-sport aircraft that is an airplane''.

    Issued in Washington, DC, on March 25, 2010.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. 2010-7039 Filed 3-29-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Notices]
[Page 36132]
[FR Doc No: 2021-14589]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-2272-000]

Golden Hills Wind Farm, 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
Golden Hills Wind Farm, 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 July 21, 2021.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: July 1, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-14589 Filed 7-7-21; 8:45 am]
BILLING CODE 6717-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on September 18, 2006

July 21, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-135274-19479

________________________________________________________________________
________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application  of BRENDAN AIRWAYS, LLC d/b/a USA 3000 AIRLINES (USA 3000)
filed 68/22/06 for:

XX  Renewal of exemption for two years under 49 U.S.C. 40109 to provide
the following serviceRenewal of exemption for two years under 49 U.S.C.
40109 to provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between Philadelphia, Pennsylvania, and Bermuda.

Applicant rep:   Pierre Murphy<PHONE_NUMBER>     DOT Analyst:  Linda
L. LundellThuy H. Cooper<PHONE_NUMBER>5423

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken:   July 21, 2004  September
18, 2006, through July 21, 2006   September 18, 2008.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX   The authority granted is consistent with the aviation agreement
between the United States and the United Kingdom.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX  Holder’s certificate of public convenience and necessity

		XX  Standard Exemption Conditions (attached)

________________________________________________________________________
________________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at: http://dms.dot.gov//reports/reports_aviation.aspU.S. Carrier
Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004


[Federal Register: August 11, 2009 (Volume 74, Number 153)]
[Notices]
[Page 40178-40179]
[DOCID:fr11au09-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. OR09-20-000]

BP West Coast Products LLC, Complainant v. Calnev Pipe Line,
L.L.C., Respondent; Notice of Complaint

August 4, 2009.
    Take notice that on July 31, 2009, pursuant to Rule 206 of the
Rules of Practice and Procedure of the Federal Energy Regulatory
Commission (Commission), 18 CFR 385.206, section 343.2 of the
Procedural Rules Applicable to Oil Pipeline Proceedings, 18 CFR 343.2,
sections 1(5), 8, 9, 13, 15, and 16 of the Interstate Commerce Act, 49
U.S.C. App. 1(5), 8, 9, 13, 15, and 16 (1988) and section 1803 of the
Energy Policy Act of 1992, BP West Coast

Products LLC (Complainant) filed a formal complaint against Calnev Pipe
Line, L.L.C (Respondent) challenging the justness and reasonableness of
all of the Respondent's rates in effect on July 31, 2009, as reflected
in its FERC Tariff Nos. 26 and 27.
    The Complainant certifies that copies of the complaint were served
on both counsel for the Respondent and contacts listed on the
Commission's list of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests, must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 20, 2009.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-19134 Filed 8-10-09; 8:45 am]

BILLING CODE 6717-01-P