Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, and the community, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life, others lives, and are continuing to save many others lives, like my grandmother. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Rules and Regulations]
[Pages 13501-13507]
[FR Doc No: 2013-04613]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152, 158 and 161

[EPA-HQ-OPP-2010-0427; FRL-9372-7]
RIN 2070-AJ26

Declaration of Prion as a Pest Under FIFRA; Related Amendments;
and Availability of Final Test Guidelines

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: With this final rule EPA declares a prion (i.e., proteinaceous
infectious particle) to be a ``pest'' under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and amends the regulations to
expressly include prion within the regulatory definition of pest. This
final rule also amends existing pesticide product performance data
requirements to clarify that efficacy data are required for pesticide
products with prion-related claims. In addition, EPA is announcing the
availability of final test guidelines on generating the product
performance data for prion-related pesticide products.

DATES: This final rule is effective April 29, 2013.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0427, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in the EPA West
Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPP Docket is<PHONE_NUMBER>. Please review the visitor instructions
and additional information about the docket available at http://www.epa.gov/dockets. In addition to being available in the docket, a
copy of the final test guidelines titled ``Product Performance Test
Guidelines, OCSPP 810.2700: Products with Prion-Related Claims'' is
available online at http://epa.gov/ocspp/pubs/frs/home/testmeth.htm.

FOR FURTHER INFORMATION CONTACT: Melba Morrow, Antimicrobials Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-2716; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you apply for or
own pesticide registrations. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document might apply to them. Potentially affected
entities may include, but are not limited to:
     Producers of pesticide products (NAICS code 32532).
     Producers of antimicrobial pesticides (NAICS code 32561).
     Veterinary testing laboratories (NAICS code 541940).
     Medical pathology laboratories (NAICS code 621511).
     Taxidermists, independent (NAICS code 711510).
     Surgeons (NAICS code 621111).
     Dental surgeons (NAICS code 621210).

B. What is the agency's authority for taking this action?

    This action is issued under the authority of sections 2 through 34
of FIFRA (7 U.S.C. 136-136y). In particular, the final rule is issued
pursuant to FIFRA section 25(a) (7 U.S.C. 136w(a)).

C. What action is the agency taking?

    EPA declares a prion (i.e., proteinaceous infectious particle) to
be a ``pest'' under FIFRA, and amends its regulations to expressly
include prion within the regulatory definition of pest. Since 2003, EPA
has considered a prion to be a pest under FIFRA, so a product intended
to reduce the infectivity of any prion on inanimate surfaces (i.e., a
``prion-related product'') is considered to be a pesticide and
regulated as such. Any company seeking to distribute or sell a
pesticide product regulated under FIFRA must, subject to some possible
exceptions, obtain a section 3 registration, section 24(c)
registration, or a section 18 emergency exemption before it can be
distributed or sold in the United States. This rule codifies the
Agency's current interpretation of FIFRA with respect to prions. The
amendment of the definition of ``pest'' in EPA's regulations, together
with the formal declaration under FIFRA section 25(c)(1) that a prion
is a pest, eliminates any confusion about the status of prion-related
products under FIFRA. Regulating prion-related products under FIFRA is
appropriate for protecting human health and the environment against
unreasonable adverse effects and ensuring that such products are
effective.
    EPA is also amending its product performance data requirements to
clarify that efficacy data are required for all products with prion-
related claims. The existing product performance data requirements
already require efficacy data to be submitted when the ``pesticide
product bears a claim to control pest microorganisms that pose a threat
to human health and whose presence cannot readily be observed by the
user including, but not limited to, microorganisms infectious to man in
any area of the inanimate environment * * * .'' Since this general
product performance data requirement applies to products with prion-
related claims, EPA is amending the regulation to specifically identify
the efficacy data that are required for products with prion-related
claims. In addition, EPA is announcing the availability of final test
guidelines concerning the generation of product performance data for
prion-related products.

D. What are the incremental costs and benefits of this action?

    This final rule will: (a) Codify the Agency's current
interpretation of FIFRA by adding ``prion'' to the list of pests in 40
CFR 152.5, and (b) amend the pesticide data requirement regulations to
clarify that efficacy data are required to support the registration of
all end-use products which bear label claims to reduce the infectivity
of prions. The qualitative benefits of this final rule relate to the
protection of human health and the environment by subjecting prion-
related products to regulation under FIFRA, including all data and
labeling requirements. The incremental costs of this rule are estimated
to range from $424,000 to $4.72 million per pesticide registration
action. See also Unit VI.A.

II. Background

A. What is a prion?

    Prions (proteinaceous infectious particles) may occur in the
central nervous system tissues of animals as an abnormal (misfolded),
infectious form of prion protein.
    Prion protein in its normal form, or conformation, can be
designated PrP\c\ (cellular isoform) while abnormal conformations of
prion proteins are generally called prions. Different types of prions
are commonly designated by the type of diseases they produce, such as
PrP\Sc\ (prions associated with scrapie) and PrP\BSE\ (prions
associated with bovine spongiform encephalopathy--mad cow disease).
    In the disease process, prions (such as PrP\sc\) recruit normal
prion proteins (PrP\c\) and convert them into prions (e.g., another
copy of PrP\Sc\). This recruitment and conversion process results in
the progressive accumulation of disease-producing prions. When this
process takes place in the brain, it causes disease that slowly
progresses from neuronal dysfunction and degeneration to death. These
neurodegenerative prion diseases are known collectively as
transmissible spongiform encephalopathies (TSE). TSEs include scrapie
disease in sheep, bovine spongiform encephalopathy (BSE) in cattle,
chronic wasting disease (CWD) in deer and elk, kuru and variant
Creutzfeld-Jakob Disease (vCJD) in humans, and similar diseases in
other animals. EPA and other agencies are concerned that animal-related
prions may spread to other animals (e.g., scrapie among sheep, CWD
among cervids) or to humans (e.g., BSE), and that human-related prions
may be passed to other humans (e.g., kuru or vCJD). These diseases are
always fatal in humans and animals alike, and there are no known
treatments or cures.

B. Regulatory History of Products With Prion-Related Claims

    On September 10, 2003, EPA determined that a prion should be
considered to be a ``pest'' under the FIFRA (7 U.S.C. 136 et seq.) and
that products intended to inactivate prions (i.e., ``prion-related
products'') should be regulated under FIFRA (Ref. 1).
    In the Federal Register issue of January 26, 2011 (76 FR 4602)
(FRL-8850-4), to eliminate any confusion about the status of prion-
related products under FIFRA, EPA issued a proposed rule that, when
finalized, would declare a prion a ``pest'' under FIFRA pursuant to the
authority of FIFRA section 25(c)(1), and amend EPA's regulations to
expressly include prion within the regulatory definition of pest. EPA
currently considers a prion to be a pest under FIFRA; in addition, a
product intended to reduce the infectivity of any prion on inanimate
surfaces (i.e., a ``prion-related product'') is considered to be a
pesticide and regulated as such. Subject to some exceptions, any
pesticide product must be registered or exempted under FIFRA sections
3, 24(c), or 18 before the product may be distributed or sold in the
United States.
    In the Federal Register issue of November 17, 2011 (76 FR 71294)
(FRL-8886-1), as a supplement to the proposed rule to declare a prion
(i.e., proteinaceous infectious particle) a ``pest'' under FIFRA, and
to amend its regulations to expressly include prion with the regulatory
definition of pest (January 26, 2011; 76 FR 4602), EPA proposed to
amend its product performance data requirements in 40 CFR parts 158 and
161 to clarify that efficacy data are required for all products with
prion-related claims. The existing product performance data
requirements already require efficacy data to be submitted when the
``pesticide product bears a claim to control pest microorganisms that
pose a threat to human health and whose presence cannot readily be
observed by the user including, but not limited to, microorganisms
infectious to man in any area of the inanimate environment * * * .''
Since this general product performance data requirement applies to
products with prion-related claims, EPA proposed to amend the
regulation to specifically identify the efficacy data required for
products with prion-related claims. In addition, EPA announced the
availability for public review and comment of draft test guidelines
concerning the generation of product performance data for prion-related
products.

C. Data Requirements for Pesticides

    First promulgated in 1984, EPA's pesticide data requirements
outline the kinds of data and related information typically needed to
register a pesticide. Since there is much variety in pesticide
chemistry, exposure and hazard, the requirements are designed to be
flexible. Test notes to the data requirements tables and other
information in the regulation explain the conditions under which data
are typically needed. Essentially, the data requirements identify the
questions that the applicant will need to answer regarding a pesticide
product before the Agency can consider it for registration.
    At this time, the data requirements for conventional, biochemical,
and microbial pesticides are codified in 40 CFR part 158, and data
requirements for antimicrobial pesticides are codified in 40 CFR part
161. In addition, part 158 contains general provisions concerning data
for the pesticides covered by the regulation (subpart A), instructions
on how to use the data tables in the regulation (subpart B), and a
series of data tables that identify data requirements tailored to
specific kinds of pesticides, i.e., conventional pesticides (subparts
D-O), biochemical pesticides (subpart U), microbial pesticides (subpart
V), and several reserved subparts as placeholders for future tailoring
of the data requirements that is underway to facilitate the utility of
the data tables for pesticide registrants, such as reserved subpart W
for antimicrobials.
    On October 26, 2007, EPA revised the structure of part 158 and the
data requirements for conventional pesticides (72 FR 60934), and
biochemical pesticides and microbial pesticides (72 FR 60988). In
conjunction with those revisions, EPA also transferred intact the
original 1984 pesticide data requirements that had been in part 158
into a new part 161, titled ``Data Requirements for Antimicrobial
Pesticides'' (72 FR 60251, October 24, 2007). In essence, part 161 is
intended to be transitional by preserving the existing data
requirements applicable to antimicrobial pesticides until a new final
regulation that tailors the data requirements for antimicrobial
pesticides is promulgated. On October 8, 2008 (73 FR 59382), EPA
proposed to establish data requirements specific to antimicrobial
pesticide chemicals in 40 CFR part 158, subpart W and to remove 40 CFR
part 161. To date, these proposed changes have not been promulgated.

D. Test Guidelines Used To Develop Data for Submission to EPA

    EPA's Office of Chemical Safety and Pollution Prevention (OCSPP)
has issued a series of harmonized test guidelines for use in the
testing of pesticides and toxic substances, and the development of test
data for submission to the Agency. The OCSPP test guidelines are
documents that specify methods that EPA recommends be used to generate
data that are submitted to EPA to support the registration of a
pesticide under FIFRA (7 U.S.C. 136 et seq.), setting of a tolerance or
tolerance exemption for pesticide residues under section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a), or
regulatory activities for other chemical substances under the Toxic
Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.). The OCSPP
harmonized test guidelines serve as a compendium of EPA-accepted
scientific methodologies and protocols for conducting the studies
routinely used for generating data on pesticides and industrial
chemicals regulated under FIFRA, FFDCA, and TSCA, and may also be
useful for voluntary testing purposes. The OCSPP harmonized test
guidelines can be accessed online at http://epa.gov/ocspp/pubs/frs/home/testmeth.htm.

III. Public Comments on the Proposed Rules

    All of the comments submitted to EPA on both of the proposed rules
are included in the docket for this rulemaking under docket ID number
EPA-HQ-OPP-2010-0427. EPA prepared two Response to Comment documents
that summarize the comments received and provide EPA's detailed
responses to all comments received. This unit discusses, in general
terms, the public comments and EPA's responses to those comments.

A. Public Comments on the January 2011 Proposal

    In response to the January 2011 proposed rule, six parties
submitted comments--one in favor, four against, and one neutral. The
commenter in favor of the proposed rule expressed concern about the
threat posed to human health from prions and the need to use an
existing regulatory scheme to assure protection of public health. The
commenters disagreed with the proposed rule and cited a range of
reasons: Poor statutory analysis, use of regulatory authority to modify
the intent of Congress and to bypass the lawmaking processes, declaring
prions to be pests even though they are not

alive, and declaring a prion to be a pest could lead to further
declarations that other non-living materials are pests. EPA's responses
to these comments may be found in the document titled ``EPA, Office of
Pesticide Programs (OPP), Responses to Comments Received Concerning
`Declaration of Prion as a Pest Under FIFRA and Amendment of EPA's
Regulatory Definition of Pests to Include Prion.' '' (Ref. 2). Overall,
EPA was not persuaded by the negative comments to not issue the final
rule as proposed.

B. Public Comments on the November 2011 Supplemental Proposed Rule

    In response to the November 2011 supplemental proposed rule (76 FR
71294), two parties submitted comments--one in favor and one against
the proposed supplemental rule. The first commenter advocated that EPA
regulate all possible prion carriers that have any likelihood of being
transmitted to human beings, since the commenter stated that she lost
her mother to sporadic Creutzfeldt Jakob Disease. The second commenter
expressed opposition to the proposed supplemental rule, submitting the
exact same comments that he had submitted previously for the proposed
rule. EPA's responses to these comments may be found in the document
titled ``EPA, Office of Pesticide Programs (OPP), Responses to Comments
Received Concerning `Prions: Proposed Amendment to Clarify Product
Performance Data for Products With Prion-Related Claims and
Availability of Draft Test Guidelines' '' (Ref. 3). Overall, EPA was
not persuaded by the negative comment to not issue the changes to EPA's
existing regulations as proposed.

IV. The Final Rule

    EPA is finalizing the proposed changes as proposed. Specifically,
EPA has determined that under FIFRA a prion is considered to be a pest;
thus, pursuant to the authority of FIFRA section 25(c)(1), EPA is
declaring a prion to be a pest. For the same reasons, EPA is amending
the regulatory definition of ``pests'' in 40 CFR 152.5 to expressly
include ``prion.'' These actions make explicit the Agency's authority
to regulate products distributed or sold for the purpose of reducing
the infectivity of prions (i.e., prion-related products), other than
prions on or in living humans or other living animals and those on or
in processed food or processed animal feed, beverages, drugs (as
defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA
section 201(i)). Prion-related products are already regulated under
FIFRA and subject to all requirements and provisions of the Act based
on EPA's September 10, 2003 decision (Ref. 1) that prions share enough
characteristics of an ``other micro-organism'' or ``form of life'' (as
those terms are used in FIFRA) to fall within the scope of FIFRA
section 2(t) and 40 CFR 152.5(d). This rule ensures that the regulatory
definition reflects the Agency's authority to regulate prion-related
products. The primary impact of declaring that a prion is a pest and
including ``prion'' in the regulatory definition of ``pest'' is to
provide regulatory clarity that prion-related products must be
registered under FIFRA sections 3 or 24(c), or otherwise exempted
before such products may be distributed or sold in the United States.
    EPA is also amending its pesticide data requirement regulations to
clarify that efficacy data are required to support the registration of
all end-use products that are intended to be used on inanimate items
and/or environmental surfaces, and which bear label claims to reduce
the infectivity of prions. Specifically, EPA is amending the data
requirements for product performance testing that are currently found
in 40 CFR 158.400 and 40 CFR 161.640 by inserting an entry in the data
tables to more clearly specify that efficacy data are required for
prion-related products.
    Currently, EPA's regulations at 40 CFR 158.400(e)(1) and 40 CFR
161.640(b)(1) require efficacy data to be submitted when the
``pesticide product bears a claim to control pest microorganisms that
pose a threat to human health and whose presence cannot readily be
observed by the user including, but not limited to, microorganisms
infectious to man in any area of the inanimate environment * * * .''
Because a prion-related product bears a claim to reduce the infectivity
of prions (that poses a threat to human health), an applicant or
registrant is required by existing regulations to submit valid data
that demonstrate that its prion-related product is effective. As such,
today's amendment to the data requirements simply provides more
specificity for those who are considering whether to register a product
for use on inanimate items and/or environmental surfaces and make
claims that the product will reduce the infectivity of prions. In
summary, EPA is clearly specifying that efficacy data are required for
prion-related products by inserting a new entry in the data tables that
are currently found in 40 CFR 158.400 and 40 CFR 161.640.
    EPA is also announcing the availability of final test guidelines
that the Agency now includes in the OCSPP harmonized test guidelines
described in this Unit II.D., as part of the 810 Series of Product
Performance Test Guidelines. Specifically, the final guidelines address
product performance tests for products with prion-related claims and
are identified as ``Product Performance Test Guidelines; OCSPP
810.2700: Products with Prion-Related Claims'' (Ref. 4). The guidelines
for products with prion-related claims provide guidance concerning the
data and information needed to assess the efficacy of antimicrobial
pesticides intended to be used on inanimate items and/or environmental
surfaces, and which bear label claims to reduce the infectivity of
prions.
    On March 31 and April 1, 2009, EPA presented its draft test
guidelines to the FIFRA SAP for peer review (Ref. 5), along with a
``white paper'' summarizing the most relevant scientific studies and
publications related to the issue of whether a prion is a pest in
support of the separate proposed rule on that issue (Ref. 6). The SAP
provided comments on the draft guidance document on June 29, 2009 (Ref.
7). EPA has considered the SAP's recommendations and incorporated
changes, as appropriate (Ref. 8). In addition, the draft test
guidelines underwent interagency review in 2010.

V. FIFRA Mandated Reviews

    In accordance with FIFRA section 25(a) and (d), on August 2, 2012,
EPA submitted a draft of this final rule to the Secretary of the
Senate, the Clerk of the House of Representatives, the Committee on
Agriculture in the House of Representatives, the Committee on
Agriculture, Nutrition, and Forestry in the United States Senate, the
United States Department of Agriculture (USDA), and the FIFRA
Scientific Advisory Panel (SAP). In accordance with FIFRA section
21(b), EPA also submitted a draft of this final rule to the Secretary
of Health and Human Services (HHS). The HHS and SAP waived review of
this final rule. USDA submitted comments on September 5, 2012, to which
EPA responded on December 3, 2012 (see docket noted in ADDRESSES
above).

VI. Statutory and Executive Order Reviews

    This action amends existing regulations to include prion as a pest
and to add more specificity regarding an existing efficacy data
requirement for products intending to make prion-related claims. It
does not otherwise amend or impose any other requirements. This rule
does not

otherwise involve any significant policy or legal issues, but does
impact existing costs.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and was
not therefore submitted to the Office of Management and Budget (OMB)
for review under Executive Orders 12866 and 13563 (76 FR 3821, January
21, 2011).
    EPA prepared an economic analysis of the potential costs associated
with this action, titled ``Economic Analysis of the Notice of Proposed
Rulemaking Concerning the Status of Prion as a Pest under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).'' The Economic
Analysis (EA) presents the Agency's assessment of the potential costs
and benefits expected to result from this rule. In terms of benefits,
the rule will ensure that EPA can protect human health and the
environment by subjecting prion-related products to regulation under
FIFRA, including all data and labeling requirements. In terms of costs,
using pre-2003 costs as the baseline, the incremental costs of this
rule per registration action range from $424,000 to $4.72 million (Ref.
9).
    The EA presents the costs of various types of registrations under
this rule and presents expected incremental costs for three product
registration types. The three types of registration actions which are
possible under this rule are the registration of: (1) A new active
ingredient, (2) a new use product, or (3) amendment of an existing
registration to add a new use.
    The EA estimates that three firms might seek registrations for
major new use products in the first year. If all uses are high exposure
(e.g., indirect food uses) for a new active ingredient, the maximum
potential total cost to industry in the first year would be
approximately $7.05 million, and costs per firm would be approximately
$2.35 million. Given the uncertainty that characterizes the market for
prion-related products at this time, the Agency did not speculate
further on the expected number of registrations in subsequent years.
However, registrations that occur after the initial major new use
product registrations would probably be major new use amendments. Data
requirements would entail only product-specific efficacy data for major
new use amendments at a cost of approximately $431,000 per registration
action. Approximately 80% of the firms in the pesticide manufacturing
industry are small firms with revenues of $22 million, on average. A
cost of $7.05 million suggests that the incremental cost per firm of
$2.35 million would equal nearly 11% of annual revenues. However, after
the initial three registrations, a major new use amendment at a cost of
$431,000 would represent fewer than 2% of average annual revenues.
    The EA identifies three categories of persons who could be affected
by the rule--pesticide registrants, users of prion-related products,
and researchers. The registration-related requirements under FIFRA,
however, are imposed on the entity that registers the prion-related
product. Users of prion-related products and researchers are affected
indirectly. The EA summarizes potential qualitative impacts of
regulating prion-related products that were expressed by product users
to EPA during its outreach efforts to these users.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new significant information
collection burden that would require additional review or approval by
OMB under the PRA, 44 U.S.C. 3501 et seq. The information collection
activities contained in the regulation are already approved under
information collection instruments related to:
    1. The submission of data to EPA to establish a tolerance or an
exemption from the requirement to have a tolerance currently approved
under OMB Control No. 2070-0024 (EPA ICR No. 0597).
    2. The activities associated with the application for a new or
amended registration of a pesticide currently approved under OMB
Control No. 2070-0060 (EPA ICR No. 0277).
    3. The activities associated with the application for an
experimental use permit currently approved under OMB Control No. 2070-
0040 (EPA ICR No. 0276).
    4. Activities associated with the generation of data in response to
a Data-Call-In currently approved under OMB Control No. 2070-0174 (EPA
ICR No. 2288).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for certain
EPA regulations in 40 CFR are listed in 40 CFR part 9 and in the
Federal Register, as appropriate.

C. Regulatory Flexibility Act (RFA)

    The RFA, 5 U.S.C. 601 et seq., generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act, 5 U.S.C. 551-553, or any other statute unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities.
    Small entities include small businesses, small organizations, and
small governmental jurisdictions. For purposes of assessing the impacts
of this rule on small entities, small entity is defined as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201. A small business
that manufactures pesticides and other agricultural chemicals as
defined by NAICS code 325320 has 500 or fewer employees based on the
SBA standards.
    2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000; or
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The
amendments do not change existing impacts. Although no small entities
have been identified that are directly affected by these amendments,
any such impacts are likely to be minimal. In general, EPA strives to
minimize potential adverse impacts on small entities when developing
regulations to achieve the environmental and human health protection
goals of the statute and the Agency.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for
Federal agencies to assess the effects of their regulatory actions on
State, local, and tribal governments and the private sector. This rule
does not contain a Federal mandate that may result in expenditures of
$100 million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. Thus, this rule is not
subject to the requirements of UMRA sections 202 or 205. This rule is
also not subject to the requirements of UMRA section 203, because it
contains no regulatory requirements that might significantly or
uniquely affect small governments. These amendments are unlikely to
affect State, local, and tribal governments at

all, and are likely to affect the private sector only trivially.

E. Executive Order 13132: Federalism

    This rule does not have federalism implications because it will not
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,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
State and local governments are rarely pesticide applicants or
registrants, so these amendments are not expected to affect these
governments. Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action will
not have substantial direct effects on Indian Tribes, will not
significantly or uniquely affect the communities of Indian Tribal
governments, and does not involve or impose any requirements that
affect Indian Tribes. Tribal governments are rarely pesticide
applicants or registrants, so these amendments are not expected to
affect these governments. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045, because it does not
establish an environmental standard intended to mitigate health or
safety risks, nor is it an ``economically significant regulatory
action'' as defined in Executive Order 12866.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use
voluntary consensus standards in its regulatory activities unless to do
so would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. NTTAA directs EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable voluntary consensus standards. This action does not involve
any technical standards. Therefore, EPA did not consider the use of any
voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations, because it generally
increases the level of protection provided to human health or the
environment and thereby not adversely affect any population. This rule
does not entail special considerations of environmental justice related
issues.

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 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

VIII. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket (under docket ID number EPA-HQ-
OPP-2010-0427) includes these documents and other information
considered by EPA, including documents that are referenced within the
documents that are included in the docket, even if the referenced
document is not physically located in the docket. For assistance in
locating these other documents, please consult the contact person
listed under FOR FURTHER INFORMATION CONTACT.

    1. U.S. Environmental Protection Agency. 2004. Considerations of
Prions as a Pest under FIFRA. Memorandum to the Record from Susan B.
Hazen, Principal Deputy Assistant Administrator, Office of
Prevention, Pesticides, and Toxic Substances. April 29, 2004.
    2. U.S. Environmental Protection Agency. 2012. EPA, Office of
Pesticide Programs (OPP), Responses to Comments Received Concerning
``Declaration of Prion as a Pest Under FIFRA and Amendment of EPA's
Regulatory Definition of Pests to Include Prion.''
    3. U.S. Environmental Protection Agency. 2012. EPA, Office of
Pesticide Programs (OPP), Responses to Comments Received Concerning
``Prions: Proposed Amendment to Clarify Product Performance Data for
Products With Prion-Related Claims and Availability of Draft Test
Guidelines.''
    4. U.S. Environmental Protection Agency. 2012. Product
Performance Test Guidelines, OCSPP 810.2700: ``Products with Prion-
Related Claims.'' Final December 2012.
    5. U.S. Environmental Protection Agency. 2009. Product
Performance Test Guidelines, Series 810, Draft OCSPP No. 810.XXXX,
titled ``Products with Prion-Related Claims.'' Draft dated February
23, 2009.
    6. U.S. Environmental Protection Agency. 2009. Scientific
Information Concerning the Issue of Whether Prions Are a ``Pest''
under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). Draft dated December 17, 2008.
    7. U.S. Environmental Protection Agency. 2009. Transmittal of
Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held
March 31-April 1, 2009, on ``Scientific Issues Associated with
Designating a Prion as a `Pest' under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test
Methods.'' Memorandum from Myrta R. Christian, Designated Federal
Official, FIFRA Scientific Advisory Panel, Office of Science
Coordination and Policy, to Debbie Edwards, Ph.D., Director, Office
of Pesticide Programs.

June 29, 2009. See http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html.
    8. U.S. Environmental Protection Agency. 2010. EPA Responses to
Comments by the FIFRA Scientific Advisory Panel Concerning
``Scientific Information Concerning the Issue of Whether Prions Are
a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).'' February 17, 2010.
    9. U.S. Environmental Protection Agency. 2010. Economic Analysis
of the Notice of Proposed Rulemaking Concerning the Status of Prion
as a Pest under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).

List of Subjects in 40 CFR Parts 152, 158 and 161

    Environmental protection, Administrative practice and procedures,
Agricultural commodities, Chemical testing, Pesticides and pests,
Reporting and recordkeeping requirements, Test guidelines.

    Dated: February 21, 2013.
Bob Perciasepe,
Acting Administrator.
    Therefore, 40 CFR chapter I is amended as follows:

PART 152--[AMENDED]

0
1. The authority citation for part 152 continues to read as follows:

    Authority:  7 U.S.C. 136-136y; subpart U is also issued under 31
U.S.C. 9701.

0
2. In Sec.  152.5, revise paragraph (d) to read as follows:

Sec.  152.5  Pests.

* * * * *
    (d) Any fungus, bacterium, virus, prion, or other microorganism,
except for those on or in living man or other living animals and those
on or in processed food or processed animal feed, beverages, drugs (as
defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA
section 201(i)).

PART 158--[AMENDED]

0
3. The authority citation for part 158 continues to read as follows:

    Authority:  7 U.S.C. 136-136y, 21 U.S.C. 346a.

0
4. In Sec.  158.400(d), amend the table under the category ``Efficacy
of antimicrobial agents'' by adding a new entry at the end of the
category to read as follows:

Sec.  158.400  Product performance data requirements table.

* * * * *

                                                                                Table--Product Performance Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use pattern                                                                                Test substance to support
                                    --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   Guideline      Data requirement                 Terrestrial                               Aquatic                               Greenhouse                                                                                Test note No.
     number                         ------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor                MP                 EP
                                          Food crop         Non-food crop           Food              Non-food            Food crop         Non-food crop                              outdoor
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                                * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
810.2700.......  Products with       NR................  NR................  NR................  NR................  NR................  NR................  NR................  NR................  R.................  NR...............  EP...............  1
                  prion-related
                  claims.

                                                                                * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

PART 161--[AMENDED]

0
5. The authority citation for part 161 continues to read as follows:

    Authority: 7 U.S.C. 136-136y, 21 U.S.C. 346a.

0
6. In Sec.  161.640, revise the section heading and in paragraph (a)
amend the table by adding under the category ``Efficacy of
antimicrobial agents'' a new entry at the end of the category to read
as follows:

Sec.  161.640  Product performance data requirements table.

    (a) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                General use patterns                                                                                Test substance
                                                  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Kind of data  required          (b) Notes                   Terrestrial                             Aquatic                             Greenhouse                                                                                Guideline
                                                  ------------------------------------------------------------------------------------------------------------------      Forestry      Domestic outdoor       Indoor        Data to support   Data to support    reference No.
                                                       Food crop        Non-food crop           Food             Non-food          Food crop        Non-food crop                                                                  MP                EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Efficacy of antimicrobial agents

                                                                                * * * * * * *
Products with prion-related     *................  .................  .................  .................  .................  .................  .................  .................  R...............  ................  EP *............  810.2700........
 claims.

                                                                                * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-04613 Filed 2-27-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Proposed Rules]
[Pages 31514-31515]
[FR Doc No: 2022-11081]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 260, 261, 262, 263, 264, 265, 267, 271 and 761

[EPA-HQ-OLEM-2021-0609; FRL-7308-03-OLEM]

Integrating e-Manifest With Hazardous Waste Exports and Other
Manifest-Related Reports, PCB Amendments and Technical Corrections;
Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is extending the
comment period for the proposed rule entitled ``Integrating e-Manifest
with Hazardous Waste Exports and Other Manifest-related Reports, PCB
Amendments and Technical Corrections.'' EPA published the proposed rule
in the Federal Register on April 1, 2022 (87 FR 19290), and the public
comment period was scheduled to end on May 31, 2022. However, EPA has
received at least one request for additional time to develop and submit
comments on the proposal. In response to the request for additional
time, EPA is extending the comment period for an additional 61 days,
through August 1, 2022.

DATES: Comments must be received on or before August 1, 2022.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OLEM-2021-0609, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov
(our preferred method). Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information or other information whose
disclosure is restricted by statute.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, OLEM Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460.
     Hand Delivery or Courier (by scheduled appointment only):
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004. The Docket Center's hours of
operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal
Holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document. Out
of an abundance of caution for members of the public and our staff, the
EPA Docket Center and Reading Room are open to the public by
appointment only to reduce the risk of transmitting COVID-19. Our
Docket Center staff also continues to provide remote customer service
via email, phone, and webform. Hand deliveries and couriers may be
received by scheduled appointment only. For further information on EPA
Docket Center services and the current status, please visit us online
at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For further information on this
document, contact Bryan Groce, Program Implementation and Information
Division, Office of Resource Conservation and Recovery,<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Summary

    On April 1, 2022 (87 FR 19290), EPA published in the Federal
Register a proposal to amend certain aspects of the hazardous waste
manifest regulations under the Resource Conservation and Recovery Act
(RCRA), specifically concerning the e-Manifest system to: (1)
Incorporate hazardous waste export manifests into the e-Manifest
system; (2) expand the required international shipment data elements on
the manifest form; (3) revise aspects of the manifest form to improve
compliance with import and export consents and tracking requirements
and to allow for greater precision in waste data reported on the
manifest; (4) incorporate three manifest-related reports (i.e.,
discrepancy, exception, and unmanifested waste reports); (5) provide
discussion regarding potential future integration of the e-Manifest
system with Biennial Reporting requirements; (6) make conforming
changes to the polychlorinated biphenyl (PCB) manifest regulations
under the Toxic Substances Control Act (TSCA); and (6) make other
technical corrections to

remove obsolete requirements, correct typographical errors, establish
definitions, and/or improve alignment with the e-Manifest program.
    The comment period for the proposed rule was scheduled to end on
May 31, 2022. Since publication, EPA has received at least one request
to extend that comment period to allow for additional time to develop
comments on the proposed rule. After considering this request for
additional time, EPA has decided to extend the comment period for an
additional 61 days, through August 1, 2022.

II. Public Participation

    Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2021-
0609, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit to
EPA's docket at https://www.regulations.gov any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

List of Subjects

40 CFR Part 260

    Environmental protection, Exports, Hazardous materials
transportation, Hazardous waste, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.

40 CFR Part 261

    Environmental Protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.

40 CFR Part 262

    Environmental protection, Electronic reporting requirements,
Exports, Hazardous materials transportation, Hazardous waste, Imports,
Labeling, Packaging and containers, Reporting and recordkeeping
requirements.

40 CFR Part 263

    Environmental protection, Electronic reporting requirements,
Exports, Hazardous materials transportation, Hazardous waste, Imports.

40 CFR Part 264

    Environmental protection, Electronic reporting requirements,
Hazardous waste, Imports, Packaging and containers, Reporting and
recordkeeping requirements, Security measures.

40 CFR Part 265

    Environmental protection, Electronic reporting requirements,
Hazardous waste, Imports, Packaging and containers, Reporting and
recordkeeping requirements.

40 CFR Part 267

    Standards for Owners and Operators of Hazardous Waste Facilities
Operating Under a Standardized Permit.

40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Electronic reporting requirements,
Hazardous materials transportation, Hazardous waste, Reporting and
recordkeeping requirements.

40 CFR Part 761

    Environmental protection, Manifest, Polychlorinated biphenyls.

    Dated: May 18, 2022.
Carolyn Hoskinson,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2022-11081 Filed 5-23-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Proposed Rules]
[Pages 12954-12957]
[FR Doc No: 2015-05032]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0247; Directorate Identifier 2014-NM-178-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 777-200 and -300 series airplanes
equipped with Rolls-Royce Trent 800 series engines. This proposed AD
was prompted by a report of multiple cases of heat damage to the strut
aft fairing heat shield primary seal, as well as heat and wear damage
to the heat shield insulation blankets. This proposed AD would require
repetitive inspections for heat damage to the strut aft fairing lower
spar web structure (a flammable fluid zone barrier and fire wall) and
heat shield primary seal, and heat and wear damage to heat shield
insulation blankets; and related investigative and corrective actions
if necessary. This proposed AD would also provide optional terminating
action for the repetitive inspections. We are proposing this AD to
detect and correct heat damage to the strut aft fairing lower spar web
structure and heat shield primary seal, as well as heat and wear damage
to the heat shield insulation blankets, which could lead to through-
cracks in the aft fairing web structure and heating of the aft fairing
web structure, and consequent uncontrolled fire in the aft fairing,
fuel tank ignition or possible departure of the engine, and subsequent
loss of the airplane.

DATES: We must receive comments on this proposed AD by April 27, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at

the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the Internet at https://www.regulations.gov by searching and locating Docket No. FAA-2015-0247.

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-2015-
0247; 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 this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kevin Nguyen, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6501; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2015-0247;
Directorate Identifier 2014-NM-178-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received a report of multiple cases of heat damage to the
strut aft fairing heat shield primary seals, as well as heat and wear
damage to the heat shield insulation blankets. Improper design of the
strut aft fairing #1 heat shield (a titanium pan casting) and #1 heat
shield insulation blanket allows hot turbulent gas from the exhaust
nozzle to wear and cause degradation of the front face of the #1
insulation blankets and flow into the heat shield cavity, the space or
cavity between the heat shields and insulation blankets, and the strut
aft fairing lower spar web structure. Continuous exposure to hot
turbulent gas further damages the primary seal and #1 insulation
blanket, increases the temperature in the heat shield cavity, and can
damage all insulation blankets and lower web structure.
    The insulation blankets are attached underneath the lower spar web
structure and are intended to protect the web from hot exhaust gas. The
insulation blankets were not originally designed to withstand
additional hot gas exposure, and consequently are unable to adequately
protect the lower web structure. The strut aft fairing lower spar web
structure is made of aluminum and designed to be a flammable fluid zone
barrier and firewall, as part of the aft fairing fire protection
system.
    Insufficient thermal protection and continuous exposure to hot
gases and elevated temperatures can degrade the lower spar web
structure material property. The heat-damaged web structures could
become annealed and cracked from fatigue, compromising the firewall and
allowing flammable fluids to leak onto the high-temperature heat
shield, initiate a fire, and cause an uncontained fire in the aft
fairing, potentially leading to fire in the wing tank. An uncontained
fire in the aft fairing can weaken the diagonal brace and lower wing
skin, which are primary structural elements that carry and support
engine loads. This condition, if not corrected, could result in
through-cracks in the aft fairing web structure and heating of the aft
fairing web structure, and consequent uncontrolled fire in the aft
fairing, fuel tank ignition or possible departure of the engine.

Related Service Information Under 1 CFR Part 51

    We reviewed the following service information:
     Boeing Service Bulletin 777-54A0031, Revision 1, dated May
9, 2014.
     Boeing Service Bulletin 777-54-0030, dated May 27, 2014.
    The service information describes procedures for repetitive
inspections for heat damage to the strut aft fairing lower spar web
structure (a flammable fluid zone barrier and fire wall) and heat
shield primary seal, and heat and wear damage to heat shield insulation
blankets; and related investigative and corrective actions. For
information on the procedures and compliance times, see this service
information. This service information is reasonably available; see
ADDRESSES for ways to access this service information.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously.
    The phrase ``related investigative actions'' is used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that (1) are related to the primary actions, and (2) further
investigate the nature of any condition found. Related investigative
actions in an AD could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.

Costs of Compliance

    We estimate that this proposed AD affects 57 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost     Cost per  product        operators
----------------------------------------------------------------------------------------------------------------
Inspections......................  40 work-hours x $85            $0   $3,400 per            $193,800 per
                                    per hour = $3,400                   inspection cycle.     inspection cycle.
                                    per inspection
                                    cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of airplanes that might need
these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Heat shield primary seal replacement..........  10 work-hours x $85 per hour =            $1,940          $2,790
                                                 $850.
Cracked or damaged parts replacement..........  110 work-hours x $85 per hour =           52,992          62,342
                                                 $9,350.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    (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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2015-0247; Directorate Identifier
2014-NM-178-AD.

(a) Comments Due Date

    We must receive comments by April 27, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200 and -300
series airplanes equipped with Rolls-Royce Trent 800 series engines,
certificated in any category, as identified in Boeing Service
Bulletin 777-54A0031, Revision 1, dated May 9, 2014.

(d) Subject

    Air Transport Association (ATA) of America Code 54, Nacelles/
Pylons.

(e) Unsafe Condition

    This AD was prompted by reports of heat damage to the strut aft
fairing heat shield primary seal, as well as heat and wear damage to
the heat shield insulation blankets. We are issuing this AD to
detect and correct heat damage to the strut aft fairing lower spar
web structure (a flammable fluid zone barrier and fire wall) and
heat shield primary seal, as well as heat and wear damage to the
heat shield insulation blankets, which could lead to through-cracks
in the aft fairing web structure and heating of the aft fairing web
structure, and consequent uncontrolled fire in the aft fairing, fuel
tank ignition or possible departure of the engine.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Service Bulletin 777-54A0031, Revision 1,
dated May 9, 2014, except as required by paragraph (i) of this AD:
Do the inspections specified in paragraphs (g)(1), (g)(2), and
(g)(3) of this AD, and do all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 777-54A0031, Revision 1,
dated May 9, 2014. Do all applicable related investigative and
corrective actions before further flight. Repeat the inspections
specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Service Bulletin 777-54A0031, Revision 1, dated May 9, 2014.
    (1) Do a detailed inspection for cracks and heat damage of the
aft fairing lower spar upper surface.
    (2) Do a conductivity inspection for heat damage of the aft
fairing lower spar upper surface.
    (3) Do a detailed inspection for wear of the heat shield primary
seal.

(h) Optional Terminating Action

    The concurrent accomplishment of the actions specified in
paragraphs (h)(1) and (h)(2) of this AD terminates the requirements
of paragraph (g) of this AD.
    (1) Replacement of all heat shield insulation blankets (rub
strips, heat shield pan casting, Velcro strips, aft fairing web
drain sump, drain screen, and drain tubes, as applicable) in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 777-54-0030, dated May 27, 2014.
    (2) A one-time detailed inspection for cracks and heat damage of
the aft fairing lower spar upper surface, conductivity inspection
for heat damage of the aft fairing lower spar upper surface, and
detailed inspection for wear of heat shield primary seal, and all
applicable related investigative and corrective actions, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 777-54A0031, Revision 1, dated May 9, 2014, provided all
applicable

related investigative and corrective actions are done before further
flight.

(i) Exception to Service Information Specifications

    Where Boeing Service Bulletin 777-54A0031, Revision 1, dated May
9, 2014, specifies a compliance time ``After the Original Issue Date
of this Service Bulletin,'' this AD requires compliance within the
specified compliance time after the effective date of this AD.

(j) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraphs (g)(1), (g)(2), (g)(3) and (h)(2) of this AD, if those
actions were performed before the effective date of this AD using
Boeing Alert Service Bulletin 777-54A0031, dated June 7, 2013.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (l)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(l) Related Information

    (1) For more information about this AD, contact Kevin Nguyen,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton,
WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 19, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-05032 Filed 3-11-15; 8:45 am]
 BILLING CODE 4910-13-P


Note to the Docket – 25 October 2006

Two phone conversations on SNAP MVAC proposal

1.  Dave Cappert, National Institute for Automotive Service Excellence
(ASE); 13 October 2006

	Dave reviewed the proposal and didn’t see any servicing issues that
would impact ASE certified technicians.  ASE awaits the follow-up rule
that will cover 609 issues.

ASE's mission is to improve the quality of vehicle repair and service
through the testing and certification of repair and service
professionals.  Their certified technicians represent independent,
dealership and chain store A/C service technicians.

2.  Doug Greenhouse, National Automobile Dealers Association (NADA); 23
October 2006

	Doug indicated there should be more language on why retrofits are not
allowed.  He also said additional training on flammability or high
pressure should not be required since service technicians already deal
with those issues.

NADA represents new car and truck dealers, both domestic and
international.


[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8306-8307]
[FR Doc No: 2015-03153]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2014-0925, FRL-9922-93-OSWER]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Requirements for Generators, Transporters, and Waste
Management Facilities Under the RCRA Hazardous Waste Manifest System

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), Requirements for
Generators, Transporters, and Waste Management Facilities Under the
RCRA Hazardous Waste Manifest System (EPA ICR No. 0801.20, OMB Control
No. 2050-0039) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. This is a proposed extension of the ICR, which is
currently approved through May 31, 2015. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before April 20, 2015.

ADDRESSES: Submit your comments, referencing by Docket ID No. EPA-HQ-
RCRA-2014-0925, online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Bryan Groce, Office of Resource
Conservation and Recovery, Materials Recovery and Waste Management
Division, (5304P), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information the EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: This ICR covers recordkeeping and reporting activities
for the hazardous waste manifest paper system, under the Resource
Conservation and Recovery Act (RCRA). EPA's authority to require use of
a manifest system stems primarily from

RCRA 3002(a)(5) (also RCRA Sections 3003(a)(3) and 3004.) Regulations
are found in 40 CFR part 262 (registrant organizations and generators),
part 263 (transporters), and parts 264 and 265 (TSDFs). The manifest
lists the wastes that are being shipped and the treatment, storage, or
disposal facility (TSDF) to which the wastes are bound. Generators,
transporters, and TSDFs handling hazardous waste are required to
complete the data requirements for manifests and other reports
primarily to: (1) Track each shipment of hazardous waste from the
generator to a designated facility; (2) provide information
requirements sufficient to allow the use of a manifest in lieu of a
Department of Transportation (DOT) shipping paper or bill of lading,
thereby reducing the duplication of paperwork to the regulated
community; (3) provide information to transporters and waste management
facility workers on the hazardous nature of the waste; (4) inform
emergency response teams of the waste's hazard in the event of an
accident, spill, or leak; and (5) ensure that shipments of hazardous
waste are managed properly and delivered to their designated
facilities.
    On February 7, 2014, EPA published the electronic manifest (e-
Manifest) Final Rule. The final rule established new manifest
requirements that authorized the use of electronic manifests (or e-
Manifests) as a means to track off-site shipments of hazardous waste
from a generator's site to the site of the receipt and disposition of
the hazardous waste. EPA is taking action now to establish the national
e-Manifest system, but unknown variables (e.g., funding contingencies
for e-Manifest system development) could delay the actual deployment of
the system. Therefore, until EPA announces that the e-Manifest system
is available for use in a subsequent Federal Register document, all
respondents under the information collection requirements covered in
this ICR (i.e., hazardous waste generators, transporters, and
treatment, storage, and disposal facilities (TSDFs)) must continue to
comply with the current paper-based manifest system and use the
existing paper manifests forms for the off-site transportation of
hazardous waste shipments. The EPA anticipates that the initial system
will become available for use no later than spring 2018.
    Form Numbers: Form 8700-22 and 8700-22A.
    Respondents/affected entities: Business or other for-profit.
    Respondent's obligation to respond: mandatory (RCRA 3002(a)(5)).
    Estimated number of respondents: 161,720.
    Frequency of response: each shipment.
    Total estimated burden: 3,473,577 hours. Burden is defined at 5 CFR
1320.03(b).
    Total estimated cost: $105,622,281, which includes $974,463
annualized labor costs and $2,092,291 annualized capital or O&M costs.
    Changes in Estimates: The burden hours are likely to stay
substantially the same.

    Dated: February 5, 2015.
Barnes Johnson,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2015-03153 Filed 2-13-15; 8:45 am]
BILLING CODE 6560-50-P