[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)]
[Rules and Regulations]
[Pages 16553-16555]
[FR Doc No: 2015-07104]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-1002; Directorate Identifier 2014-CE-033-AD;
Amendment 39-18127; AD 2015-06-09]
RIN 2120-AA64

Airworthiness Directives; Pacific Aerospace Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Pacific
Aerospace Limited (PAL) Model 750XL airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) issued by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as PAL Model 750XL airplanes manufactured with only one
attitude indicator. A second attitude indicator is required for flights
under instrument flight rules. We are issuing this AD to require
actions to address the unsafe condition on these products.

DATES: This AD is effective May 4, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of May 4, 2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
1002; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact Pacific
Aerospace Limited, Airport Road, Private Bag 3027, Hamilton 3240, New
Zealand; telephone: +64 7 843 6144; fax: +64 7 843 6134; email:
<EMAIL_ADDRESS>Internet: http://www.aerospace.co.nz/. You may
view this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
It is also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2014-1002.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to add an AD that would apply to Pacific Aerospace Limited
Model 750XL airplanes. The NPRM was published in the Federal Register
on December 8, 2014 (79 FR 72564). The NPRM proposed to correct an
unsafe condition for the specified products and was based on mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country. The MCAI states:

    This AD with effective date 10 November 2014 is prompted by a
recent determination that certain PAL750XL aircraft were
inadvertently manufactured with instrument panels with only one
Attitude Indicator (AI). A second AI is required for PAL750XL
operating under Instrument Flight Rules (IFR).

    The AD mandates the installation of either a second AI, or the
enablement of Reversionary Attitude mode in the Sandel Electronic
Horizontal Situation Indicator (EHSI), if fitted, when operating
under IFR.

The MCAI can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2014-1002-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 72564, December 8,
2014) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 72564, December 8, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 72564, December 8, 2014).

Relative Service Information Under 1 CFR part 51

    We reviewed Pacific Aerospace Limited Mandatory Service Bulletin
PACSB/XL/074, Issue 2, dated November 4, 2014. The service bulletin
describes procedures for installing a second attitude indicator or
enabling the reversionary mode on a Sandel SN3500 electronic horizontal
situation indicator (EHSI), if installed, whichever is applicable. This
service information is reasonably available; see ADDRESSES for ways to
access this service information.

Costs of Compliance

    We estimate that this AD will affect 17 products of U.S. registry.
We also estimate that it would take about 6 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts would cost about $3,500 per
product.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $68,170, or $4,010 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
1002; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2015-06-09 Pacific Aerospace Limited: Amendment 39-18127; Docket No.
FAA-2014-1002; Directorate Identifier 2014-CE-033-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 4, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pacific Aerospace Limited Model 750XL
airplanes, all serial numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 34: Navigation.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as Pacific
Aerospace Limited Model 750XL airplanes manufactured with instrument
panels with only one attitude indicator. A second attitude indicator
is required to operate under instrument flight rules (IFR). A
reversionary attitude indicator reduces the probability of a single
point failure, which could result in loss of control. We are issuing
this proposed AD to install a reversionary attitude indicator before
operating in IFR conditions.

(f) Actions and Compliance

    Unless already done, before the next flight requiring instrument
flight rules (IFR) after the effective date of this AD, install a
second attitude indicator into the right hand instrument panel or
enable the reversionary mode on a Sandel SN3500 electronic
horizontal situation indicator (EHSI), if installed, whichever is
applicable, following the ACCOMPLISHMENT INSTRUCTIONS in Pacific
Aerospace Limited Mandatory Service Bulletin PACSB/XL/074, Issue 2,
dated November 4, 2014.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, 901
Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-
4123; fax:<PHONE_NUMBER>; email:

<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI in Civil Aviation Authority (CAA) AD DCA/750XL/
17A, dated November 6, 2014, for related information. The MCAI can
be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-1002-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Pacific Aerospace Limited Mandatory Service Bulletin PACSB/
XL/074, Issue 2, dated November 4, 2014.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Pacific Aerospace Limited, Airport Road, Private Bag 3027, Hamilton
3240, New Zealand; telephone: +64 7 843 6144; fax: +64 7 843 6134;
email<EMAIL_ADDRESS>Internet: http://www.aerospace.co.nz/.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2014-1002.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on March 19, 2015.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-07104 Filed 3-27-15; 8:45 am]
 BILLING CODE 4910-13-P


RMBernero 09/ 29/ 2004 02: 45 PM To: Jeff Holmstead/ DC/ USEPA/ US@ EPA cc: Ray Clark/ DC/ USEPA/ US@ EPA, TJM3@ NRC. gov, KCrowley@ NAS. edu bcc:

Subject: EPA Standard for Yucca Mountain Jeff,

When you asked for comments at the September 20 meeting of the Board on Radioactive Waste Management, I gave you a vague comment that I wish to clarify. The attached note is offered as that clarification. Of course, I do not speak for the Board; this is my personal comment.

Bob Bernero September 29, 2004 Note to: Jeffrey Holmstead, Asst. Adm. For Air and Radiation, EPA From: Robert M. Bernero, USNRC, ret'd Subject: Options for 40CFR Part 197 Consideration of peak dose You appeared in an open meeting of the Board on Radioactive Waste Management on September 20, 2004. You asked for input in your exploration of options for dealing with the recent Court ruling that 40CFR Part 1 failed to consider the peak dose occurring at Yucca Mountain. I spoke to you as an individual, not as a memb of the Board, and urged you to choose an option that considered the peak dose. I regret that my comment wa so vague that it was probably of no use to you. I left on travel right from the Board meeting. I have now returned, and after studying my copy of the Final Notice promulgating 40CFR Part 197, I would like to offer you a more specific version of my comment.

For my comment I refer to Section II. G. 1. g. How Far Into the Future Is It Reasonable To Project Disposal System Performance?, ( pages 57 65 in the plain printed version of the Final Notice), and to 40CFR Part 197.3 In the third paragraph of this section of the Final Notice ( p. 58), EPA notes:

" We require DOE to include the results and bases of the additional analyses [ calculation of peak dose] the EIS for Yucca Mountain as an indicator of the future performance of the disposal system. The rul does not, however, require that DOE meet a specific dose limit after 10,000 years. We have concerns regarding the uncertainties associated with such projections, and whether long term projections can be considered meaningful; however, existing assessment results indicate that the peak dose may occur beyond 10,000 years ( see Chapter 7, Section 7.3, of the BID). Such results may, therefore, give a mor complete description of the repository of repository behavior. We acknowledge, however, that these results, because of the inherent uncertainties associated with such long term projections, are not likely be of the quality necessary to support regulatory decisions based upon a quantitative analysis and thus need to be considered cautiously. In any case, these very long term projections will provide more complete information on disposal system performance."

The last sentence of the preceding passage implies that the " more complete information on disposal system performance" would be available for the NRC and DOE to evaluate in the repository licensing process. That licensing evaluation should determine whether the repository, even if it satisfies the terms of compliance, pos a long term threat to public protection. For example, careful consideration during the licensing review might reveal that the engineered features of the repository alone assure compliance with the standard, but weaknesse in the geologic barriers indicate that releases after failure of the engineered features would pose a grave publi health risk after the compliance period. Calculation of the peak dose in the time after the compliance period might not be of the quality to support a regulatory decision such as required by 40CFR Part 197.20, "  reasonable expectation that  the exposed individual receives no more than  150 microsieverts ( 15 millirem) from releases from the undisturbed Yucca Mountain disposal system." Recall that this dose and ris is a strict standard for compliance; it sets this strict standard, the same as for presently permitted practices, for compliance time longer than recorded human history. The NAS recommended " that compliance assessment conducted for the time when the greatest risk occurs, within the limits imposed by the long term stability of th geologic environment." It appears that the NAS Report, and the Court ruling, would apply the same strict, reasonable expectation, compliance standard out to hundreds of thousands of years without distinction regarding the different uncertainties with the 10,000 year projection, and with the 1,000,000 year projection.

The EPA has recognized the differences in the cited passage above, and noted that the long term decisions should be considered cautiously. I suggest that EPA modify its rule, 40CFR Part 197, to require an additiona regulatory decision for the post compliance period. As presently worded, Part 197.35 simply requires that DO calculate the peak dose after 10,000 years and states; " No regulatory standard applies to the results of this analysis ". I suggest that Part 197.35 be amended to apply a regulatory standard, applied in a less certain w than in Part 197.20. The revised rule should require these long term projections to be evaluated carefully in t repository licensing process to assess the peak dose, the timing of peak dose and the expectation of geologic stability. If the peak dose projections fall within the 10,000 year compliance terms, then they are evidently acceptable, and consistent with compliance. If the peak dose projections exceed the 10,000 year compliance terms, then the factors that influence the time and the degree to which the terms are exceeded should be evaluated to determine whether disposal system design changes or even site abandonment are warranted. I believe that this second level of regulatory decision should be required by EPA and carried out in the NRC licensing process, just as multiple barrier and defense in depth concepts are carried out.


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79907-79908]
[FR Doc No: 2015-32316]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4644]

Draft Guidance for Industry on Advancement of Emerging Technology
Applications To Modernize the Pharmaceutical Manufacturing Base; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Advancement of Emerging Technology Applications to Modernize the
Pharmaceutical Manufacturing Base.'' This guidance provides
recommendations to pharmaceutical companies interested in participating
in a program involving the submission of chemistry, manufacturing, and
controls (CMC) information containing emerging manufacturing
technology. The program is open to companies that intend the technology
to be submitted as part of an investigational new drug application
(IND), or an original or supplemental new drug application (NDA),
abbreviated new drug application (ANDA), or biologics license
application (BLA) reviewed by the Center for Drug Evaluation and
Research (CDER), where that technology meets certain criteria described
in the guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 22, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential,

if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-4644 for ``Advancement of Emerging Technology Applications
to Modernize the Pharmaceutical Manufacturing Base.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sau L. Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 4144, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or for
further information or to submit requests to participate in the
program, please use<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Advancement of Emerging Technology Applications to Modernize
the Pharmaceutical Manufacturing Base.'' The Office of Pharmaceutical
Quality and Office of Compliance, CDER, are committed to supporting and
enabling the modernization of pharmaceutical manufacturing as part of
the Agency's mission to protect and promote the public health. While
the implementation of emerging technology is critical to modernizing
pharmaceutical manufacturing and improving quality, FDA also recognizes
that innovative approaches to manufacturing may represent challenges to
industry and regulators. By the very nature of an approach being
innovative, a limited knowledge and experiential base about the
technology may exist. Pharmaceutical companies may have concerns that
using such technologies could result in delays while FDA reviewers
familiarize themselves with the new technologies and determine how they
fit within existing regulatory approaches. Through CDER's Emerging
Technology Team, FDA intends to encourage the adoption of innovative
approaches to pharmaceutical manufacturing by leveraging existing
resources within the Agency to facilitate the regulatory review of
submissions to the Agency involving manufacturing technologies likely
to improve product safety, identity, strength, quality, and purity.
    The draft guidance provides recommendations to pharmaceutical
companies interested in participating in a program involving the
submission of CMC information containing emerging manufacturing
technology to FDA. Acceptance of a request to participate in this CDER
program will depend on the applicant's proposed plan for submission of
an IND or original or supplemental ANDA, BLA, or NDA, based on certain
criteria described in the guidance. To be considered for inclusion in
the program, the proposal should be for an innovative or novel product,
manufacturing process, and/or testing technology that is subject to CMC
review, and for which the Agency has limited review or inspection
experience.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on Advancement of
Emerging Technology Applications to Modernize the Pharmaceutical
Manufacturing Base. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The information to be included in a meeting request for a
product submitted in an IND, BLA, or NDA is approved under OMB control
number 0910-0429 (Guidance for Industry on Formal Meetings Between the
FDA and Sponsors or Applicants). Information to be included in a
meeting request for a product submitted in an ANDA is approved under
OMB control number 0910-0797 (Guidance on Controlled Correspondence
Related to Generic Drug Development). The submission of INDs under 21
CFR 312.23 is approved under OMB control number 0910-0014; the
submission of BLAs under 21 CFR 601.2 and 601.12 is approved under OMB
control number 0910-0338; and the submission of NDAs and ANDAs under 21
CFR 314.50, 314.70, 314.71, 314.94, and 314.97 are approved under OMB
control number 0910-0001.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32316 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P


Pesticide Registration ( PR) Notice 2003 3 NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND REGISTRANTS OF PESTICIDE PRODUCTS ATTENTION: Persons Interested in Pesticide Policy Development and Persons Responsible for Registration of Pesticide Products SUBJECT: Procedural Guidance for EPA's Office of Pesticide Programs Procedures Concerning the Development, Modification, and Implementation of Policy Guidance Documents EPA's Office of Pesticide Programs ( OPP) will use the following procedures for developing, modifying, and implementing its pesticide program policy guidance documents. These procedures have two goals. The first is to facilitate public participation in the development, modification, and implementation of OPP policy guidance documents; the second is to clarify that while such documents are non binding policy statements and not legally binding rules, they nonetheless play an important role in helping to ensure a consistent starting point for OPP decision making.

For several years OPP has provided an opportunity for the public to comment on proposed and/ or draft policy guidance documents and related substantive revisions. This practice reflects OPP's general preference for public and stakeholder participation in the development of most significant policy approaches. OPP believes that routinely providing an opportunity for public review and comment has not only helped stakeholders interact with OPP more effectively but also has improved the quality of the resulting policy guidance documents. Accordingly, OPP believes that it makes sense to adopt procedural guidelines for its staff indicating when providing an opportunity for public comment on draft policy guidance may be most valuable and should be used, and when doing so might provide little added value and merely delay the issuance or implementation of a policy or policy refinement.

OPP believes that procedural guidance on policy development and refinement should also help policy writers develop useful guidance documents that do not cross the line between nonbinding policy statements and legally binding regulations. EPA, as well as other federal agencies, have increasingly faced litigation claiming that policy documents are, in effect, thinly disguised regulations and that they are invalid for failure to comply with the procedural requirements of the Administrative Procedures Act ( APA) ( 5 U. S. C. § 553). See, e. g., General Electric, Co. v. EPA, 290 F. 3d 377, 384 ( D. C. Cir. 2002); Appalachian Power Co. v. EPA, 208 F. 3d 1015, 1023 ( D. C. Cir. 2000). The challenge is to provide guidance to staff to help insure consistent agency decisionmaking while at the same time not constraining agency discretion or appearing to discourage affected parties from seeking alternatives to agency policy approaches. Accordingly, this policy guidance document provides procedural guidance for OPP's drafters of policy guidance documents that will help them balance the sometimes conflicting objectives of consistency and flexibility.

I. EFFECT OF THIS PROCEDURAL GUIDANCE DOCUMENT This document sets forth procedures on developing policy guidance documents. In addition, it explains how staff should use policy guidance documents in agency decision making. These procedures are not binding on EPA and any affected party may urge EPA to follow a different approach to policy development.

II. GENERAL STATEMENT OF OPP'S POLICY UNDERLYING THESE PROCEDURES OPP thinks that public involvement in the development of all types of policy guidance documents is useful. Therefore, OPP's general practice should be to provide notice and an opportunity for public comment as early as practicable and appropriate in the development of all significant new pesticide policy guidance documents ( defined below) or significant modifications to such policy guidance documents. Non significant policy guidance documents ( defined below) should be available to the public and a procedure should be described by which affected parties can communicate their views on such documents to OPP.

All policy guidance documents should clearly explain that, while they are intended to aid consistent decision making by OPP, they are not binding either on OPP or on affected parties. In other words, policy guidance documents define a framework and starting point for OPP decisionmaking but each regulatory action considered by OPP presents the opportunity to reassess both the policy itself and its application to the particular circumstances.

III. DEFINITIONS " Policy guidance document"   A policy guidance document describes OPP policies of general applicability for the benefit of OPP staff, the regulated community, advocacy groups, and the general public. Policy guidance documents generally include the term " policy" or " guidance" in their titles. Policy guidance documents generally would not include pesticide specific peer reviews or registration, reregistration, or tolerance decision documents ( including orders issued under FIFRA section 3( c)( 2)( B), whether issued to a registrant of an individual pesticide or multiple registrants of a group of pesticides), internal OPP administrative procedures, reports, speeches, press materials, or letters or other correspondence with individuals, organizations, or companies. This document describes two subgroups of policy guidance documents: " significant policy guidance documents" and " non significant policy guidance documents."

" Significant policy guidance document"   The judgment that a policy guidance document is significant should take into account, among other things, the following factors: ( 1) the potential impact of the policy on regulated entities and on the public health and the environment and whether some stakeholders are likely to regard the impact as significant; ( 2) whether the policy involves the initial implementation of statutory or regulatory changes; ( 3) the complexity of the science or technical issues involved; ( 4) the policy's potential for creating controversy; and ( 5) the potential breadth of applicability of the document. For example, each of these factors suggests that OPP's policy implementing the FQPA provision for an additional safety factor to protect infants and children would qualify as significant. OPP believes that its guidelines for performing pesticide testing would also be significant in most instances. Further, many Pesticide Registration Notices would meet these criteria for significance.

" Non significant policy guidance document"   Any policy guidance document that is not " significant" is considered a " non significant policy guidance document." Examples of documents which generally would not qualify as significant include Standard Operating Procedures for EPA review of studies, or memoranda by any of OPP's internal peer review committees, unless they contain significant new policy guidance. Additionally, Pesticide Registration Notices that simply convey information, such as where to send application materials, would also be considered nonsignificant policy guidance.

IV. PROCEDURES FOR SIGNIFICANT POLICY GUIDANCE DOCUMENTS A. Procedures For significant policy guidance documents or significant modifications of such policy documents, notice of a draft policy and a comment opportunity should be provided in a manner likely to insure it comes to the attention of interested stakeholders. At a minimum, this should include a clear notice on the Agency's website ( e. g., OPP's or the Science Advisory Panel's ( SAP) website) and the publication of a notice in the Federal Register. In some cases, it may also be appropriate to provide individual notice to affected parties. When OPP or the SAP announces the opportunity to comment on a significant policy guidance document in the Federal Register, it will also follow applicable procedures for establishing and maintaining a public docket ( including procedures for ensuring that confidential business information is not inadvertently released), utilizing EPA's online docket and comment system, EDOCKET at http:// www. epa. gov/ edocket. The period for public comment should be long enough to allow meaningful comment, taking into account any needs of OPP to act quickly.

B. Timing of Comment Opportunity To the extent practical and appropriate, a notice and comment opportunity for a significant policy guidance document should be provided prior to the issuance of the document for implementation. Frequently, however, policy positions are first implemented in individual pesticide registration or tolerance decisions, and only after accumulating experience through a case by case approach does OPP draft a policy guidance document for general applicability. Where such policy guidance documents principally systemize and extend the policies developed through earlier case by case decisions, the concept of preimplementation notice and comment must be adapted to recognize the facts of the situation. When a policy guidance document makes a significant break with prior OPP practice, preimplementation notice and comment is more appropriate; however, it is still important to take into account such factors as any need for OPP to act quickly to protect the public health and the environment or other goals of importance. If pre implementation notice and comment is not provided, a prompt post implementation notice and comment period should be held.

C. Response to Comment When OPP provides a comment opportunity on a significant policy guidance document, a document responding to all significant comments should generally be prepared. This document should generally be made available in the same time frame as when the policy guidance document is issued and should be in a form that shows how EPA evaluated public comments. To ensure easy and direct public access, this document will be placed in the public docket established for the draft policy guidance document. In circumstances where commenters voice a significant disagreement with a draft policy guidance document, release of a response to comments document prior to revision of the draft policy guidance document should be considered if such further interaction with stakeholders might substantially aid implementation of the guidance document.

V. PROCEDURES FOR NON SIGNIFICANT POLICY GUIDANCE DOCUMENTS A. Procedures. Policy guidance documents that OPP does not regard as significant should be made available to the public on OPP's website if they are of public interest. Documents likely to fall into this category are certain OPP Standard Operating Procedures and minor modifications to significant policy guidance documents. As part of placing the document on the website, the document should identify a contact person within OPP and the public docket established in EDOCKET to which comments on the document may be sent.

B. Timing. Placement of such policy guidance documents on the website should occur as soon as practical after the document is issued. Staff should plan time, before posting the documents on the EPA website, to review the document for the presence of trade secret and Confidential Business Information ( CBI) and for the preparation of the document to comply with requirements for accessibility by people with disabilities ( 29 U. S. C § 794d).

C. Response to Comments. Non frivolous, substantive comments received on nonsignificant policy guidance documents placed on OPP's website should be acknowledged and addressed appropriately, either individually or by preparing a generic response document. Comments received and OPP's responses will be placed in the public docket.

VI. PROCEDURES TO CLARIFY THE NON BINDING NATURE OF POLICY GUIDANCE DOCUMENTS Policy guidance documents do not bind either outside parties ( regulated entities, advocacy groups, or the public) or OPP. Under general principles of administrative law, a document of general applicability including binding requirements is not a policy but a regulation, and thus must comply with the statutory requirements for promulgating regulations, i. e., the APA or other applicable statutory authority.

Every OPP policy guidance document should clearly state that it is not binding on the public or OPP, and that OPP decision makers and staff should not treat any policy guidance document as if it were a legally binding rule. Each policy guidance document should also explain that OPP staff should remain open to consideration of alternative approaches, and that affected parties remain free to assert that the policy should not apply B in whole or in part B to a given situation, or to urge a totally different policy approach on OPP. A model statement is included in the Appendix.

VII. PROCEDURES TO AID IN CONSISTENT DECISION MAKING UNDER POLICY GUIDANCE DOCUMENTS Each policy guidance document should also emphasize the importance of consistent application of policy guidance documents by OPP staff. Nonetheless, because policy guidance documents are not binding, they should also note that a decision cannot be justified simply by citing to the policy guidance document but must also contain the rationale for the decision.

Further, the policy guidance document should specifically highlight the importance of explaining the rationale for any departure from existing policy guidance documents. Although OPP policy guidance documents are non binding, they reflect the current thinking of OPP, and therefore OPP staff are expected to apply them consistently unless there is a good reason for adopting an alternative approach. If OPP staff believe an alternative approach is warranted, that approach and rationale should be presented to OPP decision makers. Any decision by OPP to vary from a policy guidance document should explicitly state how it varies from existing guidance and provide a written explanation for the variation. A model statement explaining these points is included in the Appendix.

After release of a policy guidance document, decisions made with regard to the policy guidance document should be periodically examined to determine if the policy guidance document has, in fact, aided in consistent decision making. This evaluation process may be helpful in deciding whether the policy guidance document should be retained, revised, or eliminated. Appendix   Model Language to Include in OPP Policy Guidance Documents Non binding Nature of This Policy Guidance Document This document describes a current policy position of OPP, but it is not a legally binding regulation. It binds no one   not the regulated community, not advocacy groups, not the public, and not OPP. In any decision before OPP, any stakeholder may urge OPP to: ( 1) conclude that this policy guidance document is inapplicable; ( 2) consider factors other than those described in this policy guidance document; ( 3) make an exception to the policy guidance document as written; or ( 4) amend or abandon the policy in its entirety. Even if no such arguments are made to OPP, OPP may decide on its own initiative that the circumstances warrant the Agency to act at variance from this policy guidance document. Thus affected parties should not assume that carefully following this policy guidance document will guarantee a specific decision or action by OPP. If OPP does decide to vary from this policy guidance document, OPP would explicitly state how it varies from the policy and provide a written explanation for this variance in the context of that decision.

Consistent Application of This Policy Guidance Document Although OPP's policy guidance documents, including this one, are non binding, they reflect the current thinking of OPP, and therefore OPP staff are expected to use them as guides for decision making unless there is a good reason for adopting an alternative approach. Accordingly, this policy guidance documents should serve as a reference and starting point for OPP staff for analyzing the issues as they arise in individual pesticide matters. Importantly, it should be remembered, however, that this policy guidance document does not provide authority for reaching specific results B each individual decision must be based on sound factual, scientific, and legal conclusions. Further, if OPP staff believe, based upon their own analysis or upon comments of any stakeholder, that an alternative decision making approach to the one outlined in this policy guidance document is warranted, that approach would be presented to OPP decision makers for their consideration. Any decision by OPP to vary from this policy guidance document should be accompanied by a written explanation provided in the context of that decision specifically addressing the reason for the variance.


Construction and Development Spatial Data Processing Results

QA/Verification compiled database table

June 26, 2009

Table   SEQ Table \* ARABIC  1 . Final QA tracking of data layers for urban masking processing

	STATSGO Related Factors	Checked Version of QA evaluated layers in compilation is correct

1	K factor	MM 6/25/09

2	Hydrologic Group	MM 6/25/09, Fractions adjusted to 100%

3	Slope	MM 6/25/09

4	Soil Fraction (% clay/sand/silt)	MM 6/25/09, Fractions adjusted to 100%

5	R Factor	MM 6/25/09

	Precipitation

	6	PRISM Annual Average Precipitation (in) 	MM 6/26/09

	Development

	7	Annual Development Rate	MM 6/25/09(9 year average rate 590,357acres/yr)

Updated Counts in Final DB Table

Notes on Construction and Development Compiled database

Number of ERF1.2 watersheds: 61,214

Number of ERF1.2 watersheds crossing at least 2 state boundaries: 4,253

Number of unique State/ERF1.2 watersheds: 65,573

Number of unique State/ERF1.2 watersheds with land use change data: 42,629

Number of unique State/ERF1.2 watersheds with zero land use change data from USGS watershed analysis: 71