[Federal Register: August 25, 2006 (Volume 71, Number 165)]
[Rules and Regulations]
[Page 50350-50354]
[DOCID:fr25au06-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0167; FRL-8088-8]

Quinoxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
quinoxyfen in or on commodities: lettuce, head and lettuce, leaf;
melon, subgroup 9A; pepper, bell and pepper, nonbell; and strawberry.
The Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 25, 2006. Objections and
requests for hearings must be received on or before October 24, 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-2006-0167. 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: Sidney Jackson, Registration Division
(7505P), 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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    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 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

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-2006-0167 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 October 24, 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-2006-0167, 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 April 21, 2006 (71 FR 20667) (FRL-8056-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
3E6755; 5E6969; and 5E6970) by the Interregional Research Project
4 (IR-4), 681 U.S. Highway 1 South, North Brunswick,
NJ 08902-3390. The petitions requested that 40 CFR 180.588 be amended
by establishing tolerances for residues of the fungicide quinoxyfen,
(5,7-dichloro-4-(4-fluorophenoxy) quinoline in or on the raw
agricultural commodities: eggplant at 1.0 parts per million (ppm) (PP
3E6755); peppers (bell and non-bell) at 1.0 ppm (PP 3E6755); melon
subgroup 9A at 0.1 ppm (PP 5E6969); lettuce, head and leaf at 17.0 ppm
(PP 5E6970); and strawberry at 0.8 ppm (PP 5E6970). That notice
included a summary of the petition prepared by Dow AgroSciences, the
registrant. There were no comments received in response to the notice
of filing.
    Upon completing review of the current quinoxyfen database, the
Agency concluded that the appropriate tolerance levels for quinoxyfen
residues in or on pending crops should be established as follow:
Lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon, subgroup 9A
at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and
strawberry at 0.90 ppm. The Agency concluded that there are
insufficient data to establish a tolerance for quinoxyfen residues in
or on eggplant, at this time.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires 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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of quinoxyfen on
lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon (subgroup 9A)
at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and
strawberry at 0.90 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the toxic effects caused by quinoxyfen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the Federal
Register of September 29, 2003 (68 FR 55858) (FRL-7318-2), under docket
ID number EPA-HQ-OPP-2003-0218, to which the reader may refer for
additional information.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The

Q* approach assumes that any amount of exposure will lead to some
degree of cancer risk, estimates risk in terms of the probability of
occurrence of additional cancer cases. More information can be found on
the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm
.

    A summary of the toxicological endpoints for quinoxyfen used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 29, 2003 (68 FR 55858)
(FRL-7318-2), under docket ID number EPA-HQ-OPP-2003-0218, to which the
reader may refer for additional information.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.588) for the residues of quinoxyfen, in or on a
variety of raw agricultural commodities. Permanent tolerances are
established for residues of quinoxyfen per se in/on cherry, sweet and
cherry, tart at 0.30 ppm; grape at 0.60 ppm; and dried hop cones at 3.0
ppm. In addition, time-limited tolerances are established under Section
18 emergency exemptions for residues of quinoxyfen per se in/on
pumpkin; squash, winter; and vegetables, curcubit, subgroup 9A. Risk
assessments were conducted by EPA to assess dietary exposures from
quinoxyfen in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
    There were no toxic effects attributable to a single dose.
Therefore, an endpoint of concern was not identified to quantitate
acute-dietary risk to the general population or to the subpopulation
females 13-50 years old. As a result, no acute risk is expected from
exposure to quinoxyfen.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), Version 2.03, which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity.
    The following assumptions were made for the chronic exposure
assessments: An unrefined, Tier 1 chronic dietary (food and water)
exposure assessment using tolerance-level residues and assuming 100%
crops treated for all proposed commodities, and default DEEM Version
7.76 processing factors for all commodities.
    iii. Cancer. Quinoxyfen is classified as ``not likely to be
carcinogenic to humans,'' based on the lack of evidence of
carcinogenicity in rat and mice studies. Therefore, an exposure
assessment for the purpose of evaluating cancer risk is not needed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for quinoxyfen in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of quinoxyfen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water.

    Typically EPA evaluates the potential for human exposure to
pesticides in drinking water through an assessment of available surface
water and ground water monitoring data and modeling. For quinoxyfen, no
monitoring data were available for use in this drinking water
assessment. Therefore, potential human exposures to quinoxyfen were
evaluated through modeling.
    The Agency used the FQPA Index Reservoir Screening Tool (FIRST) to
calculate the surface water Estimated Exposure Concentrations (EECs)
and the screening model SCI-GROW to calculate the groundwater EECs. The
Agency considered residues of quinoxyfen per se, plus a metabolite, 3-
OH quinoxyfen, in modeling studies. To do this, aerobic soil metabolism
and aerobic aquatic metabolism half-lives determined for the parent
compound in the guideline studies were recalculated using concentration
data for the parent compound plus 3-OH quinoxyfen when the latter
compound was present. Additionally, the Agency was restricted to the
use of soil adsorption coefficients determined only for the parent
compound; however, other available information from the guideline
studies indicates that 3-OH quinoxyfen has mobility in soil similar to
that of the parent compound. Because hydroxylation (the addition of the
3-OH) could increase its mobility relative to quinoxyfen, this
metabolite has the potential to reach drinking water sources in
significant quantities.
    For the surface water and groundwater assessments, EECs were
determined using a maximum annual application rate for cherries of 0.55
lb a.i./A (five applications of 0.114 lb a.i./A/application).
    Based on the FIRST and SCI-GROW models, the estimated environmental
concentrations (EECs) of quinoxyfen for chronic exposures are estimated
to be 0.84 ppb for surface water and 0.006 ppb for ground water. Model
estimates of drinking water concentrations were directly entered into
the dietary exposure model (DEEM-FCID).
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Quinoxyfen is not
registered for use on any sites that would result in residential
exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to quinoxyfen and any other
substances and quinoxyfen does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that quinoxyfen has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal

and postnatal toxicity and the completeness of the data base on
toxicity and exposure unless EPA determines based on reliable data that
a different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a MOE analysis or through using uncertainty
(safety) factors in calculating a dose level that poses no appreciable
risk to humans. In applying this provision, EPA either retains the
default value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
    2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility of rat and rabbit
fetuses to in utero exposure in developmental studies. There is
evidence of increased quantitative susceptibility (minimal decrease in
F1a pup weights) in the rat multi-generation reproduction study, but
the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the pup effects are minimal at
the LOAEL and only noted in the first-generation offspring; and (3) the
doses and endpoints selected for regulatory purposes would address the
concerns of the pup effects noted in the rat reproduction study.
Therefore, there are no residual uncertainties for prenatal/postnatal
toxicity in this study.
    3. Conclusion. There is a complete toxicity data base for
quinoxyfen and exposure data are complete or are estimated based on
data that reasonably account for potential exposures. There are no
residual uncertainties for prenatal/postnatal toxicity. No additional
safety factor is needed for data base uncertainties. No clinical sign
of neurotoxicity or neuropathology was seen in the data base, including
acute and subchronic neurotoxicity studies. A developmental
neurotoxicity study is not required. Therefore, EPA determined that the
10X SF to protect infants and children should be reduced to 1X.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An endpoint of concern was not identified to
quantitate acute-dietary risk to the general population or to the
subpopulation females 13-50 years old. As a result, no acute risk is
expected from exposure to quinoxyfen.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
quinoxyfen from (food + water) will utilize 1.3% of the cPAD for the
U.S. population, < 1% of the cPAD for infants < 1 year old), and 2.0% of
the cPAD for children (1 to 2 years old) the subpopulation at greatest
exposure. There are no residential uses for quinoxyfen that result in
chronic residential exposure to quinoxyfen.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Quinoxyfen is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Quinoxyfen is
not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Quinoxyfen has been
classified as ``not likely to be carcinogenic to humans.'' Therefore,
quinoxyfen is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to quinoxyfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A practical analytical method is available to monitor and enforce
the tolerances of quinoxyfen residues in crops. The analytical method
uses capillary gas chromatography and mass spectrometry detector (GC-
MSD) with limits of quantitation (LOQ) of approximately 0.01 ppm. The
method is adequate for collecting data and enforcing tolerances for
quinoxyfen residues in/on the subject crops. There are no livestock
feed items associated with these petitions, therefore, data collection
and tolerance enforcement methods for livestock commodities are not
required.

B. International Residue Limits

    There are no Mexican, Canadian or Codex maximum residue limits
(MRLs) established for quinoxyfen in/on crops considered in this
action. Therefore, no compatibility issues exist for these tolerances.

V. Conclusion

    Therefore, the tolerance is established for residues of quinoxyfen,
5,7-dichloro-4-(4-fluorophenoxy) quinoline in or on lettuce, head at
7.0 ppm and lettuce, leaf at 19 ppm; melon, subgroup 9A at 0.08 ppm;
pepper, bell at 0.35 ppm; pepper, nonbell at 1.7 ppm; and strawberry at
0.90 ppm.

VI. 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 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 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. 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 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.

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 16, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I 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 180.588 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:

Sec.  180.588  Quinoxyfen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
 Lettuce, head.......................................                7.0
Lettuce, leaf........................................                 19
Melon, subgroup 9A...................................               0.08
Pepper, bell.........................................               0.35
Pepper, nonbell......................................                1.7
Strawberry...........................................               0.90
------------------------------------------------------------------------

[FR Doc. E6-14065 Filed 8-24-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: April 7, 2010 (Volume 75, Number 66)]
[Notices]
[Page 17715-17716]
[DOCID:fr07ap10-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0048; FRL-8810-7]

Notice of Receipt of a Pesticide Petition Filed for Temporary
Tolerance Exemption for Residues of Prohydrojasmon on Red Apple
Varieties

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the Agency's receipt of an initial
filing of a petition requesting a temporary exemption from the
requirement of a tolerance for residues of pesticide chemicals in or on
various commodities. This temporary tolerance exemption is for the use
of prohydrojasmon (PDJ) on red apples varieties in the state of
California, Maryland, Michigan, New York, North Carolina, Oregon,
Pennsylvania, Virginia, Washington, and West Virginia. PDJ is intended
for use as a plant growth regulator.

DATES: Comments must be received on or before May 7, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0048 and the pesticide petition number (PP)
9G7656, 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 Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0048 and the pesticide petition number (PP) 9G7656. EPA's policy
is that all comments received will be included in the docket without
change and may be made available on-line at http://www.regulations.gov,
including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Do not submit information that you consider to be CBI or otherwise
protected through regulations.gov or e-mail. The regulations.gov
website is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either 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 hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Gina Casciano, 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. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have a typical or disproportionately high and adverse
human health impacts or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.

II. What Action is the Agency Taking?

    EPA is announcing receipt of a pesticide petition filed under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or modification of regulations
in 40 CFR part 174 or part 180 for residues of the pesticide chemical
prohydrojasmon (PDJ) in or on various food commodities. EPA has
determined that the pesticide petition described in this notice
contains data or information prescribed in FFDCA section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the
pesticide petition. Additional data may be needed before EPA can make a
final determination on this pesticide petition.
    In accordance with 40 CFR 180.7(f), a summary of the petition that
is the subject of this notice, prepared by the petitioner, is included
in a docket EPA has created for this rulemaking. The docket for this
petition is available on-line at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing a notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

Exemption from the Requirement of a Tolerance

    PP 9G7656. Fine Agrochemicals, Ltd., c/o SciReg, Inc., 12733
Director's Loop, Woodbridge, VA 22192, proposes establishment of a
temporary tolerance exemption for residues of the plant growth
regulator, prohydrojasmon (PDJ), in or on red apple varieties. The
petitioner believes no analytical method is needed because this is an
exemption from the requirement of a tolerance without any numerical
limitation.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: March 30, 2010.
 Keith A. Matthews,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

[FR Doc. 2010-7754 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S


## national lake temperature and air temperature models
## 5.31.2019

tempmod <- function(dat.merge) {
    require(mgcv)
    require(maps)
    require(mapproj)
    require(akima)

    # drop littoral duplicates
    dat.merge <- subset(dat.merge, sample.type == "MICX")

    dat.merge.sav <- dat.merge
    # select only variables that we need
    dat.merge <- dat.merge[, c("site.id.c", "doc.result",
                                "therm.sav",
                               "domean", "tempmean","tbot",
                                "do.hyp.fail", "do.hyp.pass",
                               "yday.x", "st.nla2012",
                               "year", "tmax",
                               "index.site.depth", "tmean.pt",
                               "elevation", "index.lat.dd",
                               "index.lon.dd", "tmin.pt")]

    ## calculated site mean values
    varlist <- c("index.site.depth", "tmean.pt", "elevation",
                 "index.lat.dd", "index.lon.dd", "tmin.pt")
    varlist2 <- c("Depth", "Temp", "Elev", "Lat", "Lon",
                  "TempMin")
    matout <- matrix(NA, ncol = length(varlist),
                     nrow = length(levels(dat.merge$site.id.c)))
    for (i in 1:length(varlist)) {
        matout[,i] <- as.vector(tapply(dat.merge[, varlist[i]],
                                       dat.merge$site.id.c, mean, na.rm = T))
    }
    dfmean <- data.frame(levels(dat.merge$site.id.c), matout)
    names(dfmean) <- c("site.id.c", varlist2)

    ## drop 2 missing temperatures
    incvec <- !is.na(dfmean$Temp)
    dfmean <- dfmean[incvec,]
    print(summary(dfmean))

    ## model for minimum air temperature
    ## fill in missing TempMin with GAM
    dftemp <- na.omit(dfmean[, c("Lat", "Lon", "Elev", "TempMin")])
    modmintemp <- gam(TempMin ~ s(Lat, Lon, k = 100) + Elev, data = dftemp)
    print(summary(modmintemp))

    predout <- predict(modmintemp, dfmean[, c("Lat", "Lon", "Elev")])
    dfmean$TempMin.old <- dfmean$TempMin
    dfmean$TempMin <- predout

    save(modmintemp, file = "modmintemp.rda")

    ## model for mean air temperature as function of location and elevation
    ## this model can be used with the parameters b[1] and b[2]
    ## from the model to predict the first day of stratification for
    ## an arbitrary location
    modairtemp <- gam(Temp ~ s(Lat, Lon, k = 30) + Elev, data = dfmean)
    print(summary(modairtemp))
    predout <- predict(modairtemp)
    save(modairtemp, file = "modairtemp.rda")

    dat.merge<-merge(dat.merge, dfmean, by = "site.id.c")
    incvec <- !is.na(dat.merge$tmax) & ! is.na(dat.merge$yday.x) &
        ! is.na(dat.merge$Lat) & ! is.na(dat.merge$Elev) &
            ! is.na(dat.merge$Temp)
    dat.merge <- dat.merge[incvec,]

    ## two outliers in lake temperature excluded
    incvec <- dat.merge$tmax < 5
    dat.merge <- dat.merge[!incvec,]
    incvec <- dat.merge$tmax >  35
    dat.merge <- dat.merge[!incvec,]

    ## model for maximum lake temperature as a function of location,
    ## elevation, and day of the year
    mod2 <- gam(tmax ~ s(yday.x, k =7) + s(Lat, Lon, k = 30) + Elev,
                data = dat.merge)
    print(summary(mod2))

    new.data <- dat.merge
    new.data$Elev <- mean(new.data$Elev)
    new.data$yday.x <- mean(new.data$yday.x)
    predout <- predict(mod2, new.data)

    save(mod2, file = "tempmod.rda")

    ## show map of location effect
    png(width = 5, height = 3, pointsize = 8, units = "in",
        file = "laketempmap.png", res = 600)
    par(mar = c(1,1,1,1))
    map("state", proj = "albers", par = c(30,40), col = "grey")
    pout <- mapproject(dat.merge$Lon, dat.merge$Lat, proj = "")
    contour(interp(pout$x, pout$y, predout, duplicate = "mean"),add = T)
    dev.off()

    ## plot two other predictors
    png(width = 6, height = 2.5, pointsize = 8, units = "in",
        res = 600, file ="temppreds.png")
    par(mar = c(4,4,1,1), mfrow = c(1,2), mgp = c(2.3,1,0), bty = "l")
    xnew <- seq(min(dat.merge$yday.x), max(dat.merge$yday.x), length = 100)
    new.data <- data.frame(yday.x = xnew)
    new.data$Elev <- mean(dat.merge$Elev)
    new.data$Lat <- mean(dat.merge$Lat)
    new.data$Lon <- mean(dat.merge$Lon)
    predout <- predict(mod2, new.data, se.fit = T)
    up <- predout$fit + 2*predout$se.fit
    dn <- predout$fit - 2*predout$se.fit
    plot(xnew, predout$fit, ylim = range(c(up, dn)),
         type = "n", xlab = "Day of year", ylab = "Lake temperature")
    polygon(c(xnew, rev(xnew)), c(up, rev(dn)), col = "grey",
            border = NA)
    lines(xnew, predout$fit)

    xnew <- seq(min(dat.merge$Elev), max(dat.merge$Elev), length = 100)
    new.data <- data.frame(Elev = xnew)
    new.data$yday.x <- mean(dat.merge$yday.x)
    new.data$Lat <- mean(dat.merge$Lat)
    new.data$Lon <- mean(dat.merge$Lon)
    predout <- predict(mod2, new.data, se.fit = T)
    up <- predout$fit + 2*predout$se.fit
    dn <- predout$fit - 2*predout$se.fit
    plot(xnew, predout$fit, ylim = range(c(up, dn)),
         type = "n", xlab = "Elevation (m)", ylab = "Lake temperature")
    polygon(c(xnew, rev(xnew)), c(up, rev(dn)), col = "grey",
            border = NA)
    lines(xnew, predout$fit)
    dev.off()

    return()

}

tempmod(dat.merge.all)


 MEMORANDUM
June 23, 2011
TO:  Air Docket
FROM:  Nancy Ketcham-Colwill
SUBJECT:  Meeting Summary
On December 10, 2010, EPA representatives met with representatives of the oil and ethanol industries and gasoline marketers at the request of several of those representatives to explore the possibility of conducting an E15 workshop to address various issues in potentially bringing E15 to market.   EPA representatives sought feedback on whether and when it would be useful to conduct such a workshop and the importance of active and good faith participation by stakeholders for such a workshop to be successful.  Representatives of the different industries described their varying perspectives on introducing E15 into commerce   However, there was general agreement that, to the extent E15 enters the market, a number of important infrastructure, liability and consumer education issues must be addressed to avoid misfueling and other potential problems, and that a workshop or work group might be useful for addressing those issues at some point.
Attendees:
Margo Oge, EPA
Karl Simon, EPA
Paul Argyropoulous, EPA
Nancy Ketcham-Colwill, EPA
Bob Greco, API
Greg Scott, NPRA
John Eichberger, NACS
Bob Dinneen, RFA
Tom Buis, Growth Energy
Mark Morgan, PMAA
Timothy Columbus, SIGMA
Brandon Wright, PMAA


Responsible Official may not require the applicant to gather data or
perform analyses that unnecessarily duplicate either existing data or
the results of existing analyses available to EPA.  The Responsible
Official must limit the request for environmental information to that
necessary for the environmental review.

 (d) If, prior to completion of the environmental review for a project,
the Responsible Official receives notification from the applicant under
section 6.301(e) of this that would result in significant impacts or
would limit alternatives, the Responsible Official must notify the
applicant promptly that EPA will take appropriate action to ensure that
the objectives and procedures of NEPA are achieved (see 40 CFR
1506.1(b)).  Such actions may include withholding grant funds or denial
of permits.

(e) The Responsible Official must begin the NEPA review as soon as
possible after receiving the applicant’s EID or draft EA.  The
Responsible Official must independently evaluate the information
submitted and be responsible for its accuracy (see 40 CFR 1506.5).

 (f) At the request of an applicant and at the discretion of the
Responsible Official, an applicant may prepare an EA or EIS and
supporting documents or enter into a third-party contract pursuant to
section 6.303 of this part.

(g)The Responsible Official must have reviewed and taken responsibility
for the completed NEPA documents before rendering a final decision on
the proposed action.

§6.303	Third-party agreements.

(a) If an EA or EIS is to be prepared for an action subject to subparts
A through C of this part, the Responsible Official and the applicant may
enter into an agreement whereby the applicant engages and pays for the
services of a third-party contractor to prepare an EA or EIS and any
associated documents for consideration by EPA.  In such cases, the
Responsible Official must approve the qualifications of the third-party
contractor.  The third-party contractor must be selected on the basis of
ability and absence of any conflict of interest.  Consistent with 40 CFR
1506.5(c), in consultation with the applicant, the Responsible Official
shall select the contractor.  The Responsible Official must provide
guidance to the applicant and contractor regarding the information to be
developed, including the project’s scope, and guide and participate in
the collection, analysis, and presentation of the information.  The
Responsible Official has sole authority for final approval of and EA or
EIS.

(1) The applicant must engage and pay for the services of a contractor
to prepare the EA or EIS and any associated documents without using EPA
financial assistance (including required match);

(2) The Responsible Official, in consultation with the applicant, must
ensure that the contractor is qualified to prepare an EA or EIS, and
that the substantive terms of the contract specify the information to be
developed, and the procedures for gathering, analyzing and presenting
the information;

(3) The Responsible Official must prepare a disclosure statement for the
applicant to include in the contract specifying that the contractor has
no financial or other interest in the outcome of the project (see 40 CFR
1506.5(c)).

(4) The Responsible Official will ensure that the EA or EIS and any
associated documents contain analyses and conclusions that adequately
assess the relevant environmental issues.

(b) In order to make a decision on the action, the Responsible Official
must independently evaluate the information submitted in the EA or EIS
and any associated documents, and issue an EA or draft and final EIS.
After review of, and appropriate changes to, the EA or EIS submitted by
the applicant, the Responsible Official may accept it as EPA’s
document.  The Responsible Official is responsible for the scope,
accuracy, and contents of the EA or EIS and any associated documents
(see 40 CFR 1506.5).

(c) A third-party agreement may not be initiated unless both the
applicant and the Responsible Official agree to its creation and terms.

(d) The terms of the contract between the applicant and the third-party
contractor must ensure that the contractor does not have recourse to EPA
for financial or other claims arising under the contract, and that the
Responsible Official, or other EPA designee, may give technical advice
to the contractor.

Subpart D – Assessing the Environmental Effects Abroad of EPA Actions

Authority:  42 U.S.C. 4321, note, E.O. 12114, 44 FR 1979, 3 CFR, 1979
Comp., p. 356.

§6.400	Purpose and policy.

(a) Purpose.  On January 4, 1979, the President signed Executive Order
12114 entitled "Environmental Effects Abroad of Major Federal Actions."
The purpose of this Executive Order is to enable responsible Federal
officials in carrying out or approving major Federal actions which
affect foreign nations or the global commons to be informed of pertinent
environmental considerations and to consider fully the environmental
impacts of the actions undertaken.  While based on independent
authority, this Order furthers the purpose of the National Environmental
Policy Act (NEPA) (42 U.S.C. 4321 et seq.) and the Marine Protection,
Research, and Sanctuaries Act (MPRSA) (33 U.S.C. 1401 et seq.).  It
should be noted, however, that in fulfilling its responsibilities under
Executive Order 12114, EPA shall be guided by CEQ regulations only to
the extent that they are made expressly applicable by this subpart.  The
procedures set forth below reflect EPA’s duties and responsibilities
as required under the Executive Order and satisfy the requirement for
issuance of procedures under section 2-1 of the Executive Order.

(b) Policy.  It shall be the policy of this Agency to carry out the
purpose and requirements of the Executive Order to the fullest extent
possible.  EPA, within the realm of its expertise, shall work with the
Department of State and the Council on Environmental Quality to provide
information to other Federal agencies and foreign nations to heighten
awareness of and interest in the environment.  EPA shall further
cooperate to the extent possible with Federal agencies to lend special
expertise and assistance in the preparation of required environmental
documents under the Executive Order.  EPA shall perform environmental
reviews of activities significantly affecting the global commons and
foreign nations as required under Executive Order 12114 and as set forth
under these procedures.

§6.401	Applicability.

(a) Administrative actions requiring environmental review.  The
environmental review requirements apply to the activities of EPA as
follows:

(1) Major research or demonstration projects which affect the global
commons or a foreign nation.

(2) Ocean dumping activities carried out under section 102 of the MPRSA
which affect the related environment.

(3) Major permitting or licensing by EPA of facilities which affect the
global commons or the environment of a foreign nation.  This may include
such actions as the issuance by EPA of hazardous waste treatment,
storage, or disposal facility permits pursuant to section 3005 of the
Resource Conservation and Recovery Act (42 U.S.C. 6925), NPDES permits
pursuant to section 402 of the Clean Water Act (33 U.S.C. 1342), and
prevention of significant deterioration approvals pursuant to Part C of
the Clean Air Act (42 U.S.C. 7470 et seq.)

(4) Wastewater Treatment Construction Grants Program under section 201
of the Clean Water Act when activities addressed in the facility plan
would have environmental effects abroad.

(5) Other EPA activities as determined by OFA and OIA (see §6.406(c)).

(b) [Reserved].

§6.402	Definitions.

As used in this subpart, environment means the natural and physical
environment and excludes social, economic and other environments; global
commons is that area (land, air, water) outside the jurisdiction of any
nation; and responsible official is either the EPA Assistant
Administrator or Regional Administrator as appropriate for the
particular EPA program.  Also, an action significantly affects the
environment if it does significant harm to the environment even though
on balance the action may be beneficial to the environment.  To the
extent applicable, the responsible official shall address the
considerations set forth in the CEQ regulations under 40 CFR 1508.27 in
determining significant effect.

§6.403	Environmental review and assessment requirements.

(a) Research and demonstration projects.  The appropriate Assistant
Administrator is responsible for performing the necessary degree of
environmental review on research and demonstration projects undertaken
by EPA.  If the research or demonstration project affects the
environment of the global commons, the applicant shall prepare an
environmental analysis.  This will assist the responsible official in
determining whether an EIS is necessary.  If it is determined that the
action significantly affects the environment of the global commons, then
an EIS shall be prepared.  If the undertaking significantly affects a
foreign nation EPA shall prepare a unilateral, bilateral or multilateral
environmental study.  EPA shall afford the affected foreign nation or
international body or organization an opportunity to participate in this
study.  This environmental study shall discuss the need for the action,
analyze the environmental impact of the various alternatives considered
and list the agencies and other parties consulted.

(b) Ocean dumping activities.

(1) The Assistant Administrator for Water shall ensure the preparation
of appropriate environmental documents relating to ocean dumping
activities in the global commons under section 102 of the MPRSA.  For
ocean dumping site designations prescribed pursuant to section 102(c) of
the MPRSA and 40 CFR part 228, and for the establishment or revision of
criteria under section 102(a) of the MPRSA, EPA shall prepare
appropriate environmental documents consistent with EPA’s Notice of
Policy and Procedures for Voluntary Preparation of National
Environmental Policy Act (NEPA) Documents dated October 29, 1998 (see 63
FR 58045).

(2) For individual permits issued by EPA under section 102(b) an
environmental assessment shall be made by EPA.  Pursuant to 40 CFR part
221, the permit applicant shall submit with the application an
environmental analysis which includes a discussion of the need for the
action, an outline of alternatives, and an analysis of the environmental
impact of the proposed action and alternatives consistent with the EPA
criteria established under section 102(a) of MPRSA.  The information
submitted under 40 CFR part 221 shall be sufficient to satisfy the
environmental assessment requirement.

(c) EPA permitting and licensing activities.  The appropriate Regional
Administrator is responsible for conducting concise environmental
reviews with regard to permits issued under section 3005 of the Resource
Conservation and Recovery Act (RCRA permits), section 402 of the Clean
Water Act (NPDES permits), and section 165 of the Clean Air Act (PSD
permits), for such actions undertaken by EPA which affect the global
commons or foreign nations.  The information submitted by applicants for
such permits or approvals under the applicable consolidated permit
regulations (40 CFR parts 122 and 124) and Prevention of Significant
Deterioration (PSD) regulations (40 CFR part 52) shall satisfy the
environmental document requirement under Section 2-4(b) of Executive
Order 12114.  Compliance with applicable requirements in part 124 of the
consolidated permit regulations (40 CFR part 124) shall be sufficient to
satisfy the requirements to conduct a concise environmental review for
permits subject to this paragraph.

(d) Wastewater treatment facility planning.  40 CFR part 6, subparts A
through C, detail the environmental review process for the facilities
planning process under the wastewater treatment works construction
grants program.  For the purpose of these regulations, the facility plan
shall also include a concise environmental review of those activities
that would have environmental effects abroad.  This shall apply only to
the Step 1 grants awarded after January 14, 1981, but on or before
December 29, 1981, and facilities plans developed after December 29,
1981.  Where water quality impacts identified in a facility plan are the
subject of water quality agreements with Canada or Mexico, nothing in
these regulations shall impose on the facility planning process
coordination and consultation requirements in addition to those required
by such agreements.

(e) Review by other Federal agencies and other appropriate officials.
The responsible officials shall consult with other Federal agencies with
relevant expertise during the preparation of the environmental document.
 As soon as feasible after preparation of the environmental document,
the responsible official shall make the document available to the
Council on Environmental Quality, Department of State, and other
appropriate officials.  The responsible official with assistance from
OIA shall work with the Department of State to establish procedures for
communicating with and making documents available to foreign nations and
international organizations.

§6.404	Lead or cooperating agency.

(a) Lead Agency.  Section 3-3 of Executive Order 12114 requires the
creation of a lead agency whenever an action involves more than one
Federal agency.  In implementing section 3-3, EPA shall, to the fullest
extent possible, follow the guidance for the selection of a lead agency
contained in 40 CFR 1501.5 of the CEQ regulations.

(b) Cooperating Agency.  Under Section 2-4(d) of the Executive Order,
Federal agencies with special expertise are encouraged to provide
appropriate resources to the agency preparing environmental documents in
order to avoid duplication of resources.  In working with a lead agency,
EPA shall to the fullest extent possible serve as a cooperating agency
in accordance with 40 CFR 1501.6.  When other program commitments
preclude the degree of involvement requested by the lead agency, the
responsible EPA official shall so inform the lead agency in writing.

§6.405	Exemptions and considerations.

Under section 2-5 (b) and (c) of the Executive Order, Federal agencies
may provide for modifications in the contents, timing and availability
of documents or exemptions from certain requirements for the
environmental review and assessment.  The responsible official, in
consultation with the Director, Office of Federal Activities (OFA), and
the Assistant Administrator, Office of International Affairs (OIA), may
approve modifications for situations described in section 2-5(b).  The
responsible official, in consultation with the Director, OFA and
Assistant Administrator, OIA, shall obtain exemptions from the
Administrator for situations described in section 2-5(c).  The
Department of State and the Council on Environmental Quality shall be
consulted as soon as possible on the utilization of such exemptions.

§6.406	Implementation.

(a) Oversight.  OFA is responsible for overseeing the implementation of
these procedures and shall consult with OIA wherever appropriate.  OIA
shall be utilized for making formal contacts with the Department of
State.  OFA shall assist the responsible officials in carrying out their
responsibilities under these procedures.

(b) Information exchange.  OFA with the aid of OIA, shall assist the
Department of State and the Council on Environmental Quality in
developing the informational exchange on environmental review activities
with foreign nations.

(c) Unidentified activities.  The responsible official shall consult
with OFA and OIA to establish the type of environmental review or
document appropriate for any new EPA activities or requirements imposed
upon EPA by statute, international agreement or other agreements.

( PAGE  36

 PAGE

 PAGE   105


[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Rules and Regulations]
[Pages 48646-48650]
[FR Doc No: 2020-17089]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 29

[Docket No. FAA-2020-0756; Special Conditions No. 29-050-SC]

Special Conditions: Leonardo S.p.A. (Leonardo) Model AW189,
Search and Rescue (SAR) Automatic Flight Control System (AFCS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Leonardo Model
AW189 helicopters. This model of helicopter, as modified by Leonardo,
will have the novel or unusual design feature associated with
installing an optional SAR AFCS. The applicable airworthiness standards
do not contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to show a level of
safety equivalent to that established by the existing airworthiness
standards.

DATES: The effective date of these special conditions is August 27,
2020. The FAA must receive your comments by September 11, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0756
using any of the following methods:
    [ballot] Federal eRegulations Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
    [ballot] Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
    [ballot] Hand Delivery of Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m., and 5 p.m.,
Monday through Friday, except Federal holidays.
    [ballot] Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://regulations.gov, including any personal information
the commenter provides. Using the search function of the docket
website, anyone can find and read the electronic form of all comments
received into any FAA docket, including the name of the individual
sending the comment (or signing the comment for an association,
business, labor union, etc.). DOT's complete Privacy Act Statement can
be found in the Federal Register published on April 11, 2000 (65 FR
19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington,

DC, between 9 a.m., and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: FAA, Mr. Mitchell Soth (AIR-713),
Regulations and Policy Section, AIR-681, Rotorcraft Standards Branch,
Policy & Innovation Division, Aircraft Certification Service, 10101
Hillwood Parkway, Fort Worth, Texas 76177; telephone<PHONE_NUMBER>;
facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Reason for No Prior Notice and Comment Before Adoption

    The FAA has determined, in accordance with 5 U.S. Code 553(b)(3)(B)
and 553(d)(3), that notice and opportunity for prior public comment
hereon are unnecessary because substantially identical special
conditions have been previously subject to the public comment process
in several prior instances such that the FAA is satisfied that new
comments are unlikely. For the same reason, the FAA finds that good
cause exists for adopting these special conditions upon issuance. The
FAA is requesting comments to allow interested persons to submit views
that may not have been submitted in response to the prior opportunities
for comment.

------------------------------------------------------------------------
        Special conditions No.            Company and helicopter model
------------------------------------------------------------------------
No. 29-041-SC \1\.....................  Bell Helicopter Textron Inc.
                                         Model 412EP Helicopter.
No. 29-022-SC \2\.....................  Eurocopter France Model EC225LP
                                         Helicopter.
No. 29-027-SC \3\.....................  Agusta S.p.A. Model AW139 and
                                         AB139 Helicopter.
No. 29-023-SC \4\.....................  Sikorsky Aircraft Corporation
                                         Model S-92A Helicopter.
------------------------------------------------------------------------
\1\ 82 FR 24458, May 30, 2017.
\2\ 77 FR 60883, October 5, 2012.
\3\ 77 FR 44110, July 27, 2012.
\4\ 75 FR 77524, December 13, 2010.

Comments Invited

    While the FAA did not precede these special conditions with a
notice of proposed special conditions, the FAA invites interested
people to take part in this rulemaking by sending written comments,
data, or views. The most helpful comments reference a specific portion
of the special conditions, explain the reason for any recommended
change, and include supporting data. The FAA will consider all comments
received by the closing date for comments. The FAA will consider
comments filed late if it is possible to do so without incurring
expense or delay. The FAA may change these special conditions based on
the comments received.

Background

    On October 18, 2019, Leonardo applied for a change to Type
Certificate (TC) No. R00004RD to install an optional SAR AFCS in the
Model AW189 helicopter. The Model AW189 is a transport category
helicopter certificated for Category A operations. This helicopter is
also certificated for instrument flight under the requirements of
Appendix B of 14 CFR part 29, Amendment 29-51. It is powered by two
General Electric CT7-2E1 engines and is capable of carrying a maximum
of 19 passengers and 2 crew members.
    Leonardo proposes that the Model AW189 include the use of a novel
and unusual design feature, which is a SAR AFCS. The use of dedicated
AFCS upper modes, in which a fully coupled autopilot provides
operational SAR profiles, is needed for SAR operations conducted over
water in offshore areas clear of obstructions. The SAR modes enable the
helicopter pilot to fly fully coupled maneuvers, to include predefined
search patterns during cruise flight, and to transition from cruise
flight to a stabilized hover and departure (transition from hover to
cruise flight). The SAR AFCS also includes an auxiliary crew control
that allows another crewmember (such as a hoist operator) to have
limited authority to control the helicopter's longitudinal and lateral
position during hover operations.
    Flight operations conducted over water at night may have an
extremely limited visual horizon with little visual reference to the
surface even when conducted under Visual Meteorological Conditions.
Consequently, the certification requirements for SAR modes must meet
Appendix B to 14 CFR part 29. While Appendix B to 14 CFR part 29
prescribes airworthiness criteria for instrument flight, it does not
consider operations below instrument flight minimum speed
(VMINI), whereas the SAR modes allow for coupled operations
at low speed, all-azimuth flight to zero airspeed (hover).
    The regulations as currently promulgated did not envision
instrument flight below the Appendix B envelope, including hover using
AFCS modes. This necessitates the development of a special condition to
address the gap in 14 CFR part 29 regulations and the lack of adequate
airworthiness standards for AFCS SAR mode certification to include
flight characteristics, performance, and installed equipment and
systems.

Type Certification Basis

    Under 14 CFR 21.101, Leonardo must show the AW189 model helicopter,
as changed, continues to meet either the applicable provisions of the
regulations incorporated by reference in TC No. R00004RD or the
applicable regulations in effect on the date of application for the
change, depending on the significance of the change as defined by 14
CFR 21.101. The regulations incorporated by reference in the TC are
commonly referred to as the ``original type certification basis.'' The
regulations incorporated by reference in R00004RD are as follows: 14
CFR 21.29 and Part 29, Amendments 29-1 through 29-52 (dated March 30,
2010). 14 CFR 36, Appendix H, Amendment 36-1 through Amendment 36-29
(dated March 11, 2013). Special Condition No. 29-034-SC, 30 Minute All
Engines Operating (AEO) Power Rating: 14 CFR 29.1049, 29.1305, 29.1521.
    Equivalent Level of Safety Findings (ELOS) issued against:
    (a) 14 CFR 29.807(c) Passenger emergency exits (documented in ELOS
Memo TC4265RD-R-C-01).
    (b) 14 CFR 29.813(c) Passenger access to each emergency exit
(documented in ELOS Memo TC4265RD-R-C-02).
    (c) 14 CFR 29.807 (d)(2) & (d)(3) Ditching emergency exits for
passengers (documented in ELOS Memo TC4265RD-R-C-04).
    (d) 14 CFR 29.815 Main aisle width (documented in ELOS Memo
TC4265RD-R-C-05).
    (e) 14 CFR 29.1545(b) Airspeed indicator (documented in ELOS Memo
TC4265RD-R-F-01).
    (f) 14 CFR 29.1305 and Sec.  29.1549 Power Index (documented in
ELOS Memo TC4265RD-R-F-03).

Regulatory Basis for Special Conditions

    The Administrator has determined that the applicable airworthiness
regulations (that is, 14 CFR part 29) do not contain adequate or
appropriate safety standards for the Leonardo Model AW189 helicopter
because of a novel or unusual design feature. Therefore, special
conditions are prescribed under the provisions of 14 CFR 21.16.
    The FAA issues special conditions, as defined in Sec.  11.19, under
Sec.  11.38, and they become part of the type certification basis under
Sec.  21.101.
    Special conditions are initially applicable to the model for which
they are issued. Should the TC for that model be amended later to
include any other model that incorporates the same novel or unusual
design feature, or should any other model already included on the same
TC be modified to incorporate the

same novel or unusual design feature, these special conditions would
also apply to the other model under Sec.  21.101.

Novel or Unusual Design Features

    The Leonardo Model AW189 helicopters will incorporate the following
novel or unusual design features:
    The SAR system is composed of a navigation computer with SAR modes,
an AFCS that provides coupled SAR functions, hoist operator control, a
hover speed reference system, and two radio altimeters. The AFCS
coupled SAR functions include:
    (a) Hover hold at selected height above the surface.
    (b) Ground speed hold.
    (c) Transition down and hover to a waypoint under guidance from the
navigation computer.
    (d) SAR pattern, transition down, and hover near a target over
which the helicopter has flown.
    (e) Transition up, climb, and capture a cruise height.
    (f) Capture and track SAR search patterns generated by the
navigation computer.
    (g) Monitor the preselected hover height with an automatic increase
in collective if the aircraft height drops below the safe minimum
height.
    These SAR modes are intended to be used over large bodies of water
in areas clear of obstructions. Further, the use of the modes that
transition down from cruise to hover will include operation at
airspeeds below VMINI.
    The SAR system only entails navigation, flight control, and coupled
AFCS operation of the helicopter. The system does not include the
additional equipment that may be required for over water flight or
external loads to meet other operational requirements.

Discussion

    The following is a summary of the final special conditions:
    (a) In addition to the requirements of 14 CFR part 29 for Category
A and Appendix B Helicopter Instrument Flight (IFR), the SAR Helicopter
and AFCS must:
    (1) Be safe and controllable in flight for all three axes at
airspeeds from VMINI to hover,
    (2) have adequate dynamic stability, and
    (3) provide an automatic transition sequencing from the approved
Appendix B IFR envelope without unintended flight below a safe minimum
height and return to the Appendix B envelope.
    (4) Deliver adequate one engine inoperative (OEI) performance.
    (5) Operate safely in the requested flight envelope, which
includes:
    (i) Sea States where the wave height is 2.5m (8.2 feet) and
    (ii) a headwind of 25 knots, 17 knots from all other azimuths.
    (6) Contain relevant limitations and procedures, including
operations in salt spray environments.
    (b) The design and system architecture of the SAR helicopter must:
    (1) Include a ground mapping radar.
    (2) Incorporate a system to limit engine power demand such that
engine limits are not exceeded.
    (3) Provide the following to each pilot:
    (i) A selectable Go-Around Mode and minimum safe height,
    (ii) aircraft height above the surface,
    (iii) heading and pilot-selected heading information,
    (iv) aircraft and pilot selected ground speeds when used by the
AFCS, and
    (v) wind speed and direction.
    (4) Include a system that monitors flight guidance deviations,
failures, mode changes and alerts the flight crew.
    (5) Provide to the SAR Hoist operator a control which includes a
flight control with limited authority, which
    (i) is designed, located and safely controllable for that operator
without interfering with the safe operation of the helicopter, and
    (ii) can be safely overridden by the pilot or copilot.
    (6) Ensure the AFCS design is reliable in relation to the effects
of its failures and operating environment.

Applicability

    These special conditions apply to the Leonardo Model AW189
helicopter. Should Leonardo apply at a later date for an amendment to
the TC to include another model incorporating the same novel or unusual
design feature, these special conditions would apply to that model as
well.

Conclusion

    This action affects only certain novel or unusual design features
on the Leonardo Model AW189 helicopter. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 29

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Leonardo Model AW189 helicopter
when the optional Search and Rescue (SAR) Automatic Flight Control
System (AFCS) is installed:
    In addition to the part 29 certification requirements for Category
A and helicopter instrument flight for Appendix B, the following
additional requirements must be met for certification of the SAR AFCS:
    (a) SAR Flight Modes. The coupled SAR flight modes must provide:
    (1) Safe and controlled flight in the three axes at all airspeeds
(lateral position and speed, longitudinal position and speed, and
height and vertical speed) from the previous VMINI to a
hover (within the maximum demonstrated wind envelope).
    (2) Automatic transition to the helicopter instrument flight
(Appendix B) envelope as part of the normal SAR mode sequencing.
    (3) A pilot-selectable Go-Around mode that safely interrupts any
other coupled mode and automatically transitions the helicopter to the
instrument flight (Appendix B) envelope.
    (4) A means to prevent unintended flight below a safe minimum
height. Pilot-commanded descent below the safe minimum height is
acceptable, provided the alerting requirements in paragraph (b)(8)(i)
of these Special Conditions alert the pilot of this descent below safe
minimum height.
    (b) SAR Mode System Architecture. To support the integrity of the
SAR modes, the following system architecture is required:
    (1) Ground mapping radar function that presents real-time
information to the pilots.
    (2) A system for limiting the engine power demanded by the AFCS
when any of the automatic piloting modes are engaged, so full authority
digital engine control power limitations, such as torque and
temperature, are not exceeded.
    (3) A system providing the aircraft height above the surface and
final pilot-selected height at a location on the instrument panel in a
position acceptable to the FAA that will make it plainly visible to and
usable by any pilot at their station.
    (4) A system providing the aircraft heading and the pilot-selected
heading at a location on the instrument panel in a position acceptable
to the FAA that will make it plainly visible to and usable by any pilot
at their station.
    (5) A system providing the aircraft longitudinal and lateral ground
speeds and the pilot-selected longitudinal and

lateral ground speeds when used by the AFCS in the flight envelope
where airspeed indications become unreliable. This information must be
presented at a location on the instrument panel in a position
acceptable to the FAA that is plainly visible to and usable by any
pilot at their station.
    (6) A system providing wind speed and wind direction when automatic
piloting modes are engaged or transitioning from one mode to another.
    (7) A system that monitors for flight guidance deviations and
failures and contains an alerting function that provides the flight
crew with enough information to take appropriate corrective action.
    (8) The alerting system must provide visual or aural alerts, or
both, to the flight crew under any of the below conditions:
    (i) When the stored or pilot-selected safe minimum height is
reached.
    (ii) When a SAR mode system malfunction occurs.
    (iii) When the AFCS changes modes automatically from one SAR mode
to another. For normal transitions from one SAR mode to another, a
single visual or aural alert may suffice. For a SAR mode malfunction or
a mode having a time-critical component, the flight crew alerting
system must activate early enough to allow the flight crew to take
timely and appropriate action. The alerting system means must be
designed to alert the flight crew in order to minimize crew errors that
could create an additional hazard.
    (9) The SAR system hoist operator control is considered a flight
control with limited authority and must comply with the following:
    (i) The hoist operator control must be designed and located to
provide for convenient operation and to prevent confusion and
inadvertent operation.
    (ii) The helicopter must be safely controllable by the hoist
operator control throughout the range of that control.
    (iii) The hoist operator control may not interfere with the safe
operation of the helicopter.
    (iv) Pilot and copilot flight controls must be able to smoothly
override the limited control authority of the hoist operator control,
without exceptional piloting skill, alertness, or strength, and without
the danger of exceeding any other limitation because of the override.
    (10) The reliability of the AFCS must be related to the effects of
its failure. The occurrence of any failure condition that would prevent
continued safe flight and landing must be extremely improbable. For any
failure condition of the AFCS which is not shown to be extremely
improbable:
    (i) The helicopter must be safely controllable and capable of
continued safe flight without exceptional piloting skill, alertness, or
strength. Additional unrelated probable failures affecting the control
system must be evaluated.
    (ii) The AFCS must be designed so that it cannot create a hazardous
deviation in the flight path or produce hazardous loads on the
helicopter during normal operation or in the event of a malfunction or
failure, assuming corrective action begins within an appropriate period
of time. Where multiple systems are installed, subsequent malfunction
conditions must be evaluated in sequence unless their occurrence is
shown to be improbable.
    (11) A functional hazard assessment and a system safety assessment
must address the failure conditions associated with SAR operations.
    (i) For SAR catastrophic failure conditions, changes may be
required to the following:
    (A) System architecture.
    (B) Software and complex electronic hardware design assurance
levels.
    (C) High Intensity Radiated Fields (HIRF) test levels.
    (D) Instructions for continued airworthiness.
    (ii) The assessments must consider all the systems required for SAR
operations to include the AFCS, all associated AFCS sensors (for
example, radio altimeter), and primary flight displays. Electrical and
electronic systems with SAR catastrophic failure conditions (for
example, AFCS) must comply with the Sec.  29.1317(a)(4) HIRF
requirements.
    (c) SAR Mode Performance Requirements.
    (1) Demonstrate the SAR modes for the requested flight envelope,
including the following minimum sea-state and wind conditions:
    (i) Sea State: Wave height of 2.5 meters (8.2 feet), considering
both short and long swells.
    (ii) Wind: 25 knots headwind; 17 knots for all other azimuths.
    (2) The selected hover height and hover velocity must be captured
(to include the transition from one captured mode to another captured
mode) accurately and smoothly and not exhibit any significant overshoot
or oscillation.
    (3) The minimum use height (MUH) for the SAR modes must be no more
than the maximum loss of height following any single failure or any
combination of failures not shown to be extremely improbable, plus an
additional margin of 15 feet above the surface. MUH is the minimum
height at which any SAR AFCS mode may be engaged.
    (4) The SAR mode system must be usable up to the maximum certified
gross weight of the aircraft or to the lower of the following weights:
    (i) Maximum emergency flotation weight.
    (ii) Maximum hover Out-of-Ground Effect (OGE) weight.
    (iii) Maximum demonstrated weight.
    (d) Flight Characteristics.
    (1) The basic aircraft must meet all of the part 29 airworthiness
criteria for helicopter instrument flight (Appendix B).
    (2) For SAR mode coupled flight below VMINI, at the
maximum demonstrated winds, the helicopter must be able to maintain any
required flight condition and make a smooth transition from any flight
condition to any other flight condition without requiring exceptional
piloting skill, alertness, or strength, and without exceeding the limit
load factor. This requirement also includes aircraft control through
the hoist operator's control.
    (3) For coupled flight below the previously established
VMINI, the following stability requirements replace the
stability requirements of paragraph IV, V, and VI of Appendix B to part
29:
    (i) Static Longitudinal Stability: The requirements of paragraph IV
of Appendix B are not applicable.
    (ii) Static Lateral-Directional Stability: The requirements of
paragraph V of Appendix B are not applicable.
    (iii) Dynamic Stability: The requirements of paragraph VI of
Appendix B are replaced with the following two paragraphs:
    (A) Any oscillation must be damped and any aperiodic response must
not double in amplitude in less than 10 seconds. This requirement must
also be met with degraded upper mode(s) of the AFCS. An ``upper mode''
is a mode that utilizes a fully coupled autopilot to provide an
operational SAR profile.
    (B) After any upset, the AFCS must return the aircraft to the last
commanded position within 10 seconds or less.
    (4) With any of the upper modes of the AFCS engaged, the pilot must
be able to manually recover the aircraft and transition to the normal
(Appendix B) IFR flight profile envelope without exceptional skill,
alertness, or strength.
    (e) One-Engine Inoperative (OEI) Performance Information.
    (1) The following performance information must be provided in the
Rotorcraft Flight Manual Supplement (RFMS):
    (i) OEI performance information and emergency procedures, providing
the

maximum weight that will provide a minimum clearance of 15 feet above
the surface, following failure of the critical engine in a hover. The
maximum weight must be presented as a function of the hover height for
the temperature and pressure altitude range requested for
certification. The effects of wind must be reflected in the hover
performance information.
    (ii) Hover OGE performance with the critical engine inoperative for
OEI continuous and time-limited power ratings for those weights,
altitudes, and temperatures for which certification is requested.

    Note: These OEI performance requirements do not replace
performance requirements that may be needed to comply with the
airworthiness or operational standards (14 CFR 29.865 or 14 CFR part
133) for external loads or human external cargo.

    (f) RFMS.
    (1) Limitations necessary for safe operation of the SAR system to
include:
    (i) Minimum crew requirements. No fewer than two pilots, except for
approved external load operations that will also require a hoist
operator.
    (ii) Maximum SAR weight as determined by the lower of the SAR Mode
performance requirement of paragraph (c)(4) of these Special Conditions
or the aircraft performance information provided by paragraph (e) of
these Special Conditions.
    (iii) Maximum demonstrated sea state conditions for ditching
compliance.
    (iv) Engagement criteria for each of the SAR modes to include MUH
(as determined in subparagraph (c)(3)) of these Special Conditions.
    (v) Normal and emergency procedures for operation of the SAR system
(including operation of the hoist operator control), with AFCS failure
modes, AFCS degraded modes, and engine failures.
    (2) Performance information:
    (i) OEI performance and height-loss.
    (ii) Hover OGE performance information, utilizing OEI continuous
and time-limited power ratings.
    (iii) The maximum wind envelope demonstrated in flight test.
    (iv) Information and advisory information concerning operations in
a heavy salt spray environment, including any airframe or power effects
as a result of salt encrustation.
    (g) Flight Demonstration.
    (1) Before approval of the SAR system, an acceptable flight
demonstration of all the coupled SAR modes is required.
    (2) The AFCS must provide fail-safe operations during coupled
maneuvers. The demonstration of fail-safe operations must include a
pilot workload assessment associated with manually flying the aircraft
to an altitude greater than 200 feet above the surface and an airspeed
of at least the best rate of climb airspeed (Vy).
    (3) For any failure condition of the SAR system not shown to be
extremely improbable, the pilot must be able to make a smooth
transition from one flight mode to another without exceptional piloting
skill, alertness, or strength.
    (4) Failure conditions that are not shown to be extremely
improbable must be demonstrated by analysis, ground testing, or flight
testing. For failures demonstrated in flight, the following normal
pilot recovery times are acceptable:
    (i) Transition modes (Cruise-to-Hover/Hover-to-Cruise) and Hover
modes: Normal pilot recognition plus 1 second.
    (ii) Cruise modes: Normal pilot recognition plus 3 seconds.
    (5) All AFCS malfunctions must include evaluation at the low-speed
and high-power flight conditions typical of SAR operations.
Additionally, AFCS hard-over, slow-over, and oscillatory malfunctions,
particularly in yaw, require evaluation. AFCS malfunction testing must
include a single or a combination of failures (such as, erroneous data
from and loss of the radio altimeter, attitude, heading, and altitude
sensors) that are not shown to be extremely improbable.
    (6) The flight demonstration must include the following
environmental conditions:
    (i) Swell into the wind.
    (ii) Swell and wind from different directions.
    (iii) Cross swell.
    (iv) Swell of different lengths (short and long swell).
    (7) The flight demonstration must also evaluate OEI procedures from
hover while hoisting an external load.

    Issued in Fort Worth, Texas, on July 31, 2020.
Jorge Castillo,
Manager, Rotorcraft Standards Branch, AIR-680 Policy & Innovation
Division, Aircraft Certification Service.
[FR Doc. 2020-17089 Filed 8-10-20; 8:45 am]
BILLING CODE 4910-13-P