[Federal Register Volume 85, Number 100 (Friday, May 22, 2020)]
[Notices]
[Page 31192]
[FR Doc No: 2020-11065]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1371]

Request for Nominations on the Tobacco Products Scientific
Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for a nonvoting representative of the interests of the
tobacco growers to serve on the Tobacco Products Scientific Advisory
Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to
include the views of women and men, members of all racial and ethnic
groups, and individuals with and without disabilities on its advisory
committees and, therefore encourages nominations of appropriately
qualified candidates from these groups. A nominee may either be self-
nominated or nominated by an organization. In addition, FDA is
requesting that any industry organizations interested in participating
in the selection of a nonvoting representative of the interests of the
tobacco growers industry to serve on the TPSAC, notify FDA in writing.
Nominations will be accepted for either the representative to serve on
TPSAC or for the selection group effective with this notice.

DATES: Nomination materials for prospective candidates should be sent
to FDA by June 22, 2020. Concurrently, any industry organization
interested in participating in the selection of an appropriate
nonvoting member to represent the interests of the tobacco growers
industry must send a letter stating that interest to the FDA by June
22, 2020 (see sections I and II of this document for further details).

ADDRESSES: All nominations for nonvoting representatives of the
interests of the tobacco growers industry may be submitted
electronically by accessing the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and
Management Staff, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993-0002.
    All statements of interest from industry organizations interested
in participating in the selection process of nonvoting representatives
of the interests of the tobacco growers industry nomination should be
sent to Janice O'Connor (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Janice O'Connor, Office of Science,
Center for Tobacco Products, Food and Drug Administration, Center for
Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373
(choose Option 5), email<EMAIL_ADDRESS>    Information about becoming a member of an FDA advisory committee
can also be obtained by visiting FDA's website at: http://www.fda.gov/AdvisoryCommittees/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a
nonvoting representative of the interests of the tobacco growers
industry on the TPSAC.

I. General Description of the Committee Duties

    The TPSAC advises the Commissioner of Food and Drugs (the
Commissioner) or designee in discharging responsibilities related to
the regulation of tobacco products. The TPSAC reviews and evaluates
safety, dependence, or health issues relating to tobacco products and
provides appropriate advice, information, and recommendations to the
Commissioner.

II. Nomination Procedure

    Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting representative of the
interests of the tobacco growers industry. Nominations must include a
current r[eacute]sum[eacute] or curriculum vitae for each nominee,
including current business address and/or home address, telephone
number, and email address if available. Nominations must specify the
advisory committee for which the nominee is recommended. Nominations
must also acknowledge that the nominee is aware of the nomination
unless self-nominated. The nomination should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this document (see DATES). FDA will forward
all nominations to the organizations expressing interest in
participating in the selection process. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process.)

III. Selection Procedure

    The Agency is also seeking names of organizations to participate in
the selection of the nonvoting representative of the interests of the
tobacco growers industry. Any industry organization interested in
participating in the selection of an appropriate nonvoting member to
represent growers industry interests should send a letter stating that
interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT)
within 30 days of publication of this document (see DATES). Within the
subsequent 30 days, FDA will send a letter to each organization that
has expressed an interest in participating in the selection group,
attaching a complete list of all organizations participating in
selection; and a list of all nonvoting nominees along with their
current r[eacute]sum[eacute]s. The letter will also state that it is
the responsibility of the interested organizations on the selection
group to confer with one another and to select a candidate and an
alternative as backup, within 60 days after the receipt of the FDA
letter, to serve as the nonvoting member to represent growers industry
interests for the TPSAC. The interested organizations are not bound by
the list of nominees in selecting a candidate. However, if no
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent growers industry interests.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: May 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11065 Filed 5-21-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Notices]
[Pages 27384-27385]
[FR Doc No: 2019-12423]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Exchange Act Rule 3a71-3, SEC File No. 270-655, OMB Control No.
3235-0717

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 3a71-3 (17 CFR 240.3a71-
3) under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).
The Commission plans to submit this existing collection of information
to the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 3a71-3 is adopted and in effect, but the compliance date for
Rule 3a71-3 has not yet passed. The representations contemplated by
Rule 3a71-3 will be relied upon by counterparties to determine whether
such transaction is a ``transaction conducted through a foreign
branch'' of a counterparty, as defined in Rule 3a71-3(a)(3)(i), as well
as to verify whether a security-based swap counterparty is a ``U.S.
person.'' Counterparties to security-based swap transactions may
voluntarily give such representations to one another to reduce
operational costs and allow each party to ascertain whether such
transaction is subject to certain Title VII requirements. Because any
representations provided to counterparties under Rule 3a71-3 will
constitute voluntary third-party disclosures, the Commission will not
typically receive these disclosures.
    The Commission believes that the representations contemplated by
Rule 3a71-3 will, in most cases, be made through amendments to the
parties' existing trading documentation (e.g., the schedule to a master
agreement). The Commission believes that, because trading relationship
documentation is established between two counterparties, whether a
counterparty is able to represent that it is entering into a
``transaction conducted through a foreign branch'' or that it does not
meet the criteria of the ``U.S. person'' definition will not change on
a transaction-by-transaction basis and, therefore, such representations
will generally be made in the schedule to a master agreement, rather
than in individual confirmations. Because these representations relate
to new regulatory requirements, the Commission anticipates that
counterparties may elect to develop and incorporate these
representations in trading documentation soon after the effective date
of the Commission's security-based swap regulations, rather than
incorporating specific language on a transactional basis. The
Commission believes that counterparties will be able to adopt, where
appropriate, standardized language across all of their security-based
swap trading relationships. The Commission believes that this
standardized language may be developed by individual respondents or
through a combination of trade associations and industry working
groups.
    a. Representations regarding a ``transaction conducted through a
foreign branch''
    Pursuant to Rule 3a71-3, parties to security-based swaps are
permitted to rely on certain representations from their counterparties
when determining whether a transaction falls within the definition of a
``transaction conducted through a foreign branch.'' The Commission
staff estimates that a total of 50 entities will incur burdens under
this collection of information, whether solely in connection with the
business conduct requirements or also in connection with the
application of the de minimis exception. These estimates are based on
our understanding of the over-the-counter (``OTC'') derivatives
markets, including the size of the market, the number of counterparties
that are active in the market, and how market participants currently
structure security-based swap transactions.
    The Commission estimates the one-time third-party disclosure burden
associated with developing representations under this collection of
information will be, for each U.S. bank counterparty that will make
such representations, no more than five hours, and up to $2,000 for the
services of outside professionals, for an estimate of approximately 250
hours \1\ or 83.33 hours \2\ per year when annualized over three years,
across all security-based swap counterparties that will make such
representations.\3\ This estimate assumes little or no reliance on
standardized disclosure language.
---------------------------------------------------------------------------

    \1\ 50 (total number of entities) * 5 hours = 250 hours.
    \2\ 250 hours (total hours to develop representations) / 3 years
= 83.33 hours.
    \3\ See Business Conduct Adopting Release at 30096.
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    The Commission expects that the majority of the burden associated
with the new disclosure requirements will be experienced during the
first year as language is developed and trading documentation is
amended. After the new representations are developed and incorporated
into trading documentation, the Commission continues to believe that
the ongoing third-party disclosure burden associated with this
requirement will be 10 hours per U.S. bank counterparty for verifying
representations with existing counterparties, for a total of
approximately 500 hours \4\ across all applicable U.S. bank
counterparties.\5\
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    \4\ 50 (total number of entities) * 10 hours = 500 hours.
    \5\ The Commission staff estimates that this burden will consist
of 10 hours of in-house counsel time for each security-based swap
market participant that will make such representations. See Business
Conduct Adopting Release, at 30097, note 1581.
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    The Commission believes that some of the entities that will have to
comply with Rule 3a71-3 will seek outside counsel to help them develop
new representations contemplated by Rule 3a71-3. For PRA purposes, the
Commission assumes that all 50 respondents will seek outside counsel
for the first year only and will, on average, consult with outside
counsel for a cost of up to $2,000. The Commission also assumes that
none of the 50 respondents will seek outside legal services for year
two or year three. Thus, the Commission expects the cost over the
three-year period will be $100,000 \6\ or $33,333 \7\ per year when
annualized over three years, across all security-based swap
counterparties that will make such representations. The

Commission expects the total labor cost per respondent will be
approximately $666.67 \8\ when annualized over three years.
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    \6\ 50 (estimated number of entities) * $2,000 (cost of outside
counsel) = $100,000.
    \7\ $100,000 (total cost to seek outside counsel over three
years) / 3 years = $33,333.33.
    \8\ $33,333 (total labor cost to seek outside counsel per year)
/ 50 (estimated number of entities that will seek outside counsel to
help them develop new representations contemplated by Rule 3a71-
3(a)(3)(ii)) = $666.67.
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    b. Representations regarding U.S.-person status
    Pursuant to Rule 3a71-3(a)(4)(iv), persons may rely on
representations from a counterparty that the counterparty does not
satisfy the criteria defining U.S. person set forth in Rule 3a71-
3(a)(4)(i), unless such person knows or has reason to know that the
representation is not accurate. Commission staff has estimated, based
on its understanding of OTC derivatives markets, including the
domiciles of counterparties that are active in the market, that up to
2,400 entities will provide representations that they do not meet the
criteria necessary to be U.S. persons.
    As with representations regarding whether a transaction is
conducted through a foreign branch, the Commission estimates the
maximum total third-party disclosure burden associated with developing
new representations will be, for each counterparty that will make such
representations, no more than five hours and up to $2,000 for the
services of outside professionals, for a maximum of approximately
12,000 hours or 4,000 hours per year when annualized over three years,
across all security-based swap counterparties that will make such
representations. This estimate assumes little or no reliance on
standardized disclosure language.
    The Commission expects that the majority of the burden associated
with the new disclosure requirements will be experienced during the
first year as language is developed and trading documentation is
amended. After the new representations are developed and incorporated
into trading documentation, the Commission believes that the annual
third-party disclosure burden associated with this requirement will be
no more than approximately 10 hours per counterparty for verifying
representations with existing counterparties and onboarding new
counterparties, for a maximum of approximately 24,000 hours \9\ across
all applicable security-based swap counterparties.
---------------------------------------------------------------------------

    \9\ 2,400 (total number of entities) * 10 hours = 24,000 hours
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    The Commission believes that some of the entities that will have to
comply with Rule 3a71-3 will seek outside counsel to help them develop
new representations contemplated by Rule 3a71-3. For PRA purposes, the
Commission assumes that all 2,400 respondents will seek outside legal
for the first year only and will, on average, consult with outside
counsel for a cost of up to $2,000. The Commission also assumes that
none of the 2,400 respondents will seek outside legal services for year
two or year three. Thus, the Commission expects the cost over the
three-year period will be $4,800,000 \10\ or $1,600,000 \11\ per year
when annualized over three years, across all security-based swap
counterparties that will make such representations. The Commission
expects the total labor cost per respondent will be approximately
$666.67 \12\ when annualized over three years.
---------------------------------------------------------------------------

    \10\ 2,400 (total number of entities) * $2,000 = $4,800,000.
    \11\ $4,800,000 (total cost over three years) / 3 years =
$1,600,000.
    \12\ $1,600,000 (total labor cost to seek outside counsel per
year) / 2,400 (estimated number of entities that will seek outside
counsel to help them develop new representations contemplated by
Rule 3a71-3(4)(iv)) = $666.67.
---------------------------------------------------------------------------

    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Candace Kenner, 100 F Street NE, Washington, DC 20549, or send an
email to<EMAIL_ADDRESS>
    Dated: June 7, 2019.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-12423 Filed 6-11-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: March 20, 2009 (Volume 74, Number 53)]
[Notices]
[Page 11992-11993]
[DOCID:fr20mr09-118]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket No. NHTSA-2009-0052]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Request for public comment on proposed collection of
information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under the procedures established by the Paperwork
Reduction Act of 1995, before seeking OMB approval, Federal agencies
must solicit public comment on proposed collections of information,
including extensions and reinstatements of previously approved
collections. This document describes one collection of information for
which NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before May 19, 2009.

ADDRESSES: Direct all written comments to: U.S. Department of
Transportation, Docket Management Facility, West Building, 1200 New
Jersey Ave, SE., Room W12-140, Washington, DC 20590. You may also
submit comments electronically at http://www.regulations.gov. All
comments should refer to the docket no. NHTSA-2009-0052.

FOR FURTHER INFORMATION CONTACT: Ms. Eunyoung Lim, Contracting
Officer's Technical Representative, Office of Behavioral Safety
Research (NTI-131), National Highway Traffic Safety Administration,
1200 New Jersey Ave, SE., Washington, DC 20590. Phone number: 202-366-
2755. Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulations (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (i) 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) 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) How to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
    In compliance with these requirements, NHTSA asks public comment on
the following proposed collection of information:

National Survey of Speeding Attitudes and Behavior: 2010

    Type of Request--New information collection requirement.
    OMB Clearance Number--None.
    Form Number--This collection of information uses no standard forms.
    Requested Expiration Date of Approval--June 30, 2012.
    Summary of the Collection of Information--NHTSA proposes to

conduct a National Survey of Speeding Attitudes and Behavior by
telephone among a national probability sample of 6,000 drivers, age 16
and older. Participation by respondents would be voluntary. Survey
topics would include the extent to which drivers speed, attitudes and
perceptions about speeding, reasons and motivations for speeding, and
knowledge and attitudes towards countermeasure strategies to deter
speeding.
    In conducting the proposed survey, the interviewers would use
computer-assisted telephone interviewing to reduce interview length and
minimize recording errors. A Spanish-language translation and bilingual
interviewers would be used to minimize language barriers to
participation. Interviews will be conducted with respondents using
landline phones and with respondents using cell phones. The proposed
survey would be anonymous; the survey would not collect any personal
information that would allow anyone to identify respondents.
    Description of the Need for the Information and Proposed Use of the
Information--The National Highway Traffic Safety Administration's
(NHTSA) mission is to save lives, prevent injuries, and reduce
healthcare and other economic costs associated with motor vehicle
crashes. Over thirty percent of all fatal crashes are estimated to be
speed-related crashes, defined as racing, exceeding the speed limit, or
driving too fast for conditions. Speed-related crashes resulted in
13,040 lives lost in 2007 and an estimated cost of $40.4 billion in
2000. In order to plan and evaluate programs intended to reduce speed-
related crashes, NHTSA periodically conducts telephone surveys to
update its knowledge and understanding of the public's attitudes and
behaviors with respect to speeding issues.
    NHTSA has conducted two previous administrations of the National
Survey of Speeding Attitudes and Behavior--once in 1997 and again in
2002. In the 2010 survey, NHTSA intends to examine the extent to which
drivers speed, who the speeders are, when and why drivers speed, and
what countermeasures are most acceptable and effective in reducing
speeding. Furthermore, NHTSA plans to assess whether or not self-
reported behaviors, attitudes, and perceptions regarding speeding and
associated countermeasure strategies have changed over time, since the
administration of the 1997 and 2002 national surveys. The findings from
this proposed collection of information will assist NHTSA in designing,
targeting, and implementing programs intended to reduce speed on the
roadways and to provide data to States, localities, and law enforcement
agencies that will aid in their efforts to reduce speed-related crashes
and injuries.
    Description of the Likely Respondents (Including Estimated Number,
and Proposed Frequency of Response to the Collection of Information)--
Under this proposed effort, the Contractor would conduct telephone
interviews averaging approximately 20 minutes in length with 6,000
randomly selected members of the general driving public, age 16 and
older. The respondent sample would be selected from all 50 States and
the District of Columbia. Interviews would be conducted with randomly
selected persons with residential phones or cell phones. Businesses are
ineligible for the sample and would not be interviewed. No more than
one respondent would be selected per household. Each member of the
sample would complete one interview.
    Prior to the administration of the survey, a total of 15 pretest
interviews, averaging 20 minutes in length would be administered to
test the computer programming of the questionnaire, and to determine if
any final adjustments to the questionnaire are needed. Following any
revisions carried out as a result of the pretest, the Contractor would
begin the main survey administration.
    Estimate of the Total Annual Reporting and Recordkeeping Burden
Resulting From the Collection of Information--NHTSA estimates that
respondents will spend an average of 20 minutes each to complete the
survey, for a total of 2005 hours for the 15 pretest respondents and
6000 survey respondents. The respondents would not incur any reporting
cost from the information collection. The respondents also would not
incur any recordkeeping burden or recordkeeping cost from the
information collection.

    Authority: 44 U.S.C. Section 3506(c)(2)(A)

Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. E9-6116 Filed 3-19-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Rules and Regulations]
[Pages 59239-59240]
[FR Doc No: 2013-23381]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0320]
RIN 1625-AA00

Safety Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Navy Pier Southeast Safety
Zone in Chicago Harbor during specified periods from October 26, 2013
through January 1, 2014. This action is necessary and intended to
ensure safety of life on the navigable waters of the United States
immediately prior to, during, and immediately after fireworks events.
Enforcement of this safety zone will establish restrictions upon, and
control movement of, vessels in a specified area immediately prior to,
during, and immediately after various fireworks events. During the
enforcement period, no person or vessel may enter the safety zone
without permission of the Captain of the Port, Lake Michigan.

DATES: The regulations in 33 CFR 165.931 will be enforced at specified
times between 9:15 p.m. on October 26, 2013 through 12:30 a.m. on
January 1, 2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email MST1 Joseph McCollum, Prevention Department, Coast Guard
Sector Lake Michigan, Milwaukee, WI at<PHONE_NUMBER>, email
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety
Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL listed in 33 CFR
165.931 for the following events:

Navy Pier Fireworks with times and dates as follows:
    October 26, 2013 from 9:15 p.m. through 9:45 p.m.;
    November 23, 2013 from 8:45 p.m. through 9:25 p.m.;
    December 31, 2013 from 6:45 p.m. through 7:25 p.m.;
    December 31, 2013 at 11:45 p.m. through January 1, 2014 at 12:30
a.m.

    This safety zone encompasses the waters of Lake Michigan within
Chicago Harbor bounded by coordinates beginning at 41[deg]53'26.5'' N,
087[deg]35'26.5'' W; then south to 41[deg]53'7.6'' N, 087[deg]35'26.3''
W; then west to 41[deg]53'7.6'' N, 087[deg]36'23.2'' W; then north to
41[deg]53'26.5'' N, 087[deg]36'24.6'' W; then east back to the point of
origin (NAD 83). All vessels must obtain permission from the Captain of
the Port, Lake Michigan, or his on-scene representative to enter, move
within or exit the safety zone. Vessels and persons granted permission
to enter the safety zone shall obey all lawful orders or directions of
the Captain of the Port, Lake Michigan, or his on-scene representative.
    This notice is issued under authority of 33 CFR 165.931 and 5
U.S.C. 552 (a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with advance
notification of these enforcement periods via broadcast Notice to
Mariners or Local Notice to Mariners. If the Captain of the Port, Lake
Michigan, determines that the safety zone need not be enforced for the
full duration stated in this notice, he may use a Broadcast Notice to
Mariners to grant general permission to enter the safety zone. The
Captain of the Port, Lake Michigan, or his on-scene representative may
be contacted via VHF Channel 16.

    Dated: September 13, 2013.
M.W. Sibley,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2013-23381 Filed 9-25-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Rules and Regulations]
[Pages 21941-21946]
[FR Doc No: 2017-09592]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0013; FRL-9959-91]

Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
flonicamid in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation revokes
the established tolerance for vegetable, fruiting, group 8-10 that is
superseded by this action. Interregional Research Project Number 4 (IR-
4) and ISK Biosciences Corporation requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 11, 2017. Objections and
requests for hearings must be received on or before July 10, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0013, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton 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.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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 applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0013 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 10, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0013, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02); August 12, 2016 (81 FR 53379) (FRL-9949-53) and December 9, 2016
(81 FR 89036) (FRL-9953-69), EPA issued documents pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of
pesticide petitions (PPs) by IR-4 (PP 5E8428); and ISK Biosciences (PP
5F8416 and 6F8443), respectively. These petitions request that 40 CFR
180.613 be amended by establishing tolerances for residues of the
insecticide flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on several commodities as follows.
Pesticide petition 5E8428 submitted by IR-4 Project Headquarters,
Rutgers, The State University of New Jersey, 500 College Road East,
Suite 201 W., Princeton, NJ 08540 requests to increase the existing
tolerance on Vegetables, fruiting, group 8-10 from 0.4 ppm to 1.50 ppm.
Pesticide petitions 5F8416 and 6F8443 submitted by ISK Biosciences
Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077 request
tolerances on tea at 40 ppm and fruit, citrus group 10-10 at 1.5 ppm,
respectively. All supporting documents for this final rule, which
bundles the three above-referenced petitions for purposes of this final
rule, are found in docket ID EPA-HQ-OPP-2016-0013.
    Summaries of the petitions prepared by IR4 and the registrant, ISK
Biosciences Corporation, are available in the following dockets at
http://www.regulations.gov: PP 5E8428 in

Docket: EPA-HQ-OPP-2016-0013; PP 5F8416 in Docket: EPA-HQ-OPP-2011-
0985; and PP 6F8443 in EPA-HQ-OPP-2015-0561. Comments were received on
the notices of filings. EPA's responses to the comments are discussed
in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance level for certain crops and corrected commodity
definitions to be consistent with current EPA policies. The reasons for
these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flonicamid, including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flonicamid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database and considered
its validity, completeness, and reliability as well as the relationship
of the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Flonicamid and its metabolites of concern, TFNA, TFNA-AM, TFNG,
TFNG-AM, and TFNA-OH, demonstrated low toxicity in acute oral toxicity
studies. Fonicamid showed no systemic toxicity in a 28-day dermal study
at the limit dose.
    Feeding studies in rats and dogs show the kidney and liver are the
target organs for flonicamid toxicity. In repeat-dose subchronic and
chronic oral toxicity studies, the consistently observed adverse effect
in rats and mice were kidney toxicity (i.e., hyaline deposition and
nephritis); in dogs, vomiting and increased percentage of reticulocytes
(an indicator for potential anemia).
    There is no evidence that flonicamid results in increased
susceptibility (qualitative or quantitative) in utero in rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study. In the rat prenatal developmental
toxicity study, maternal toxicity consisted of kidney toxicity (i.e.,
nephritis) in the absence of developmental toxicity at the highest-dose
tested (HDT); in the rabbit, maternal toxicity consisted of decreased
food consumption in the absence of developmental toxicity at the HDT.
In the rat reproduction and fertility effects study, parental toxicity
(i.e., kidney hyaline deposition and luteinizing hormone level
increases) occurred at doses much lower than doses causing offspring
effects (i.e., decreased body weight and delayed sexual maturation).
    There are no concerns for flonicamid neurotoxicity. In the acute
neurotoxicity study in rats, signs of toxicity such as decreased motor
activity, tremors, impaired gait, and impaired respiration were
observed at lethal dose levels (1000 mg/kg). In the subchronic
neurotoxicity study, decreased body weight, food consumption, foot
splay, and motor activity were observed in males at doses greater than
67 mg/kg/day, and in females at 722 mg/kg/day. In the immunotoxicity
study in mice, there were no indications of increased immunotoxic
potential in the T-cell dependent antibody response (TDAR) assay at the
limit dose.
    Mutagenicity studies were negative for flonicamid and its
metabolites of concern. Treatment-related lung tumors were observed in
CD-1 mice. This tumor type, however, is associated with species and
strain sensitivity and is not directly correlated with cancer risks in
humans. Nasal cavity tumors in male Wistar rats were linked to incisor
inflammation. Nasolacrimal duct tumor findings for females were
confounded by the lack of a dose-response, and the biological
significance of these tumors is questionable. The determination of
carcinogenicity potential for flonicamid was based on the weight of the
evidence approach and resulted in the classification of ``suggestive
evidence of carcinogenicity, but not sufficient to assess human
carcinogenic potential.'' The Agency determined that quantification of
risk using a non-linear approach (i.e., using a chronic reference dose
(cRfD)) adequately accounts for all chronic toxicity, including
carcinogenicity that could result from exposure to flonicamid.
    Specific information on the studies received and the nature of the
adverse effects caused by flonicamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Subject: Flonicamid. Human Health
Risk Assessment for New Uses on Legume Vegetables, Subgroups 6A, 6B,
and 6C; Add Directions for use on Greenhouse Grown Peppers and Increase
the Tolerance for Residues on Fruiting Vegetables, Group 8-10; New Use
on Citrus Fruits, Group 10-10; and a Tolerance without U.S.
Registration for residues in/on Dried Tea'' at page 28 in docket ID
number EPA-HQ-OPP-2016-0013.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://

www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-
human-health-risk-pesticides.
    A summary of the toxicological endpoints for flonicamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of November 14, 2012 (77 FR 67771)
(FRL-9368-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flonicamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing flonicamid tolerances in 40 CFR
180.613. EPA assessed dietary exposures from flonicamid in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for flonicamid; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model--Food
Commodity Intake Database (DEEM-FCIDTM), Version 3.16, which
incorporates 2003-2008 food consumption information from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA used an unrefined chronic dietary
assessment conducted assuming 100 percent crop treated (PCT) estimates,
tolerance-level residues for all commodities, and empirical or Dietary
Exposure Evaluation Model--Food Commodity Intake Database (DEEM-
FCID\TM\) default processing factors. The processing factor was set to
1.0 for potato granules/flakes, tomato paste and tomato puree; for all
other processed commodities DEEM default processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to flonicamid. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flonicamid. Tolerance level residues and/or 100%
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water.
    The Agency used screening level water exposure models in the
dietary exposure analysis and risk assessment for flonicamid in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of flonicamid.
Further information regarding EPA drinking water models used in
pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The drinking water assessment was conducted using both a parent
only exposure, and a total toxic residue approach, which considers the
parent compound and its major degradates of concern. Total toxic
residues include 4-trifluoromethylnicotinic acid (TFNA), 4-
trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-
trifluoromethylnicotinic acid (TFNA-OH), N-(4-
trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-
trifluoromethylnicotinoyl)glycinamide (TFNG-AM).
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the
estimated drinking water concentrations (EDWCs) of flonicamid for
chronic exposures for non-cancer assessments are estimated to be 0.94
parts per billion (ppb) for surface water and 9.92 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 9.92 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Flonicamid is not
registered for any specific use patterns that would result in
residential exposure.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found flonicamid to share a common mechanism of
toxicity with any other substances, and flonicamid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flonicamid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for flonicamid includes prenatal developmental
toxicity studies in rats and rabbits and a multigeneration reproduction
toxicity study in rats. There is no evidence that flonicamid results in
increased susceptibility (qualitative or quantitative) in utero in rats
or rabbits in the prenatal developmental studies or in young rats in
the multi-generation reproduction study. No developmental effects were
seen in rabbits. In the multi-generation reproduction study,
developmental delays in the offspring (decreased body weights, delayed
sexual maturation) were seen only in the presence of parental toxicity
(kidney and blood effects). Also, there are clear NOAELs and LOAELs for
all effects. The degree of concern for prenatal and/or post-natal
susceptibility is, therefore, low due to the lack of evidence of
qualitative and quantitative susceptibility.

    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X, except where assessing risks from
inhalation exposure as discussed below. Those decisions are based on
the following findings:
    i. The toxicity database for flonicamid is essentially complete,
except for an outstanding subchronic 28-day inhalation study. In the
absence of a subchronic inhalation study, EPA has retained a 10X FQPA
SF to assess risks from inhalation exposure, although at present,
residential inhalation exposure is not expected from existing or
pending uses of flonicamid.
    ii. There is no evidence that flonicamid is a neurotoxic chemical.
As discussed in Unit III.A., EPA has concluded that the clinical signs
observed from available acute and subchronic neurotoxicity studies were
not the result of a neurotoxic mechanism. Therefore, there is no need
for a developmental neurotoxicity study or additional UFs to account
for neurotoxicity.
    iii. There is no evidence that flonicamid results in increased
susceptibility in utero in rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was based on
100 PCT, tolerance-level residues and where applicable, default
processing factors. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
flonicamid in drinking water. These assessments will not underestimate
the exposure and risks posed by flonicamid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
flonicamid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flonicamid from food and water will utilize 59% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. There are no residential uses for flonicamid.
    3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Flonicamid is not
registered for any use patterns that would result in short- and
intermediate-term residential exposures.
    4. Aggregate cancer risk for U.S. population. Based on the
information referenced in Unit III.A., EPA has concluded that the cPAD
is protective of possible cancer effects from flonicamid, and as
evidenced in Unit III.E.2, aggregate exposure to flonicamid is below
the cPAD.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (FMC Method No. P-3561M, a liquid
chromatography with tandem mass spectrometry (LC/MS/MS) method) is
available to enforce the tolerance expression for flonicamid and its
metabolites in or on plant commodities.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established MRLs for flonicamid.

C. Response to Comments

    1. Anonymous comments: One comment each on petitions, 5E8428 and
5F8416, was received. Both comments claim that flonicamid is a ``toxic
pesticide'' and residues at any level in food commodities including tea
(leaves) should not be allowed and requested that EPA deny setting
tolerances for the petition-for new uses of flonicamid. One comment
stated that the proposed flonicamid use would add to about 25,000 toxic
chemicals currently in the environment and combine to create even more
toxic chemical residues in food and drinking water further increasing
harmful effects to humans and environment.
    Agency response: The Agency understands the commenters' concerns
and recognizes that some individuals believe that pesticides should be
banned completely. However, under the existing legal framework provided
by FFDCA section 408, EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute.
    When new or amended tolerances are requested for the presence of
the residues of a pesticide and its toxicologically significant
metabolite(s) in food or feed, the Agency, as is required by FFDCA
section 408, estimates the risk of the potential exposure to these
residues by performing an aggregate risk assessment. Such a risk
assessment integrates the individual assessments that are conducted for
food, drinking water, and residential exposures. Additionally, the
Agency, as is further required by FFDCA Section 408, considers
available information concerning what are termed the cumulative
toxicological effects of the residues of that pesticide and of other
substances having a common mechanism of toxicity with it. The Agency
has concluded after this assessment that there is a reasonable
certainty that no harm will result from

exposure to the residues of interest. Therefore, the proposed
tolerance(s) are found to be acceptable.
    2. Comment: A comment on petition 6F8443 stressed the importance of
the Agency's use of concise and reliable analytical methods to identify
and quantify chemical residues of flonicamid and various fungicides in
order to draw accurate and definitive scientific conclusions regarding
their effects on the environment.
    Agency response: An available, accurate and concise EPA approved
analytical method is a prerequisite for EPA pesticide registration and
critical to the Agency's ability to identify, monitor and enforce
pesticides residues, including metabolites and degradates of concern,
that may exist in trace amounts in plants, animals and the environment.
Unit IV.A. of this document identifies the specific analytical method
used by the Agency in enforcing appropriate flonicamid use as well as
how additional information can be obtained on the method.

D. Revisions to Petitioned-For Tolerances

    Although the petitioner requested that the vegetable, fruiting
group 8-10 tolerances be increased from 0.4 ppm to 1.5 ppm, data
submitted did not support an increase in tolerances for the entire
subgroup. The submitted data (which examined residues on greenhouse
peppers only) only support an increase for the commodities in subgroup
8-10B. Therefore, EPA is maintaining the existing tolerance level for
crops in subgroup 8-10A and revising the tolerance level for crops in
subgroup 8-10B. Using the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures and available field
trial data (average) residues, EPA is establishing a tolerance for
Pepper/Eggplant subgroup 8-10B at 3.0 ppm, instead of at 1.5 ppm as
requested.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid,
N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its
metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on Fruit, citrus, group 10-10 at 1.5
ppm; Pepper/Eggplant, subgroup 8-10B at 3.0 ppm; Tea at 40 ppm; and
Tomato subgroup 8-10A at 0.4 ppm. In addition, EPA is revoking the
existing tolerance for Vegetable, fruiting, group 8-10 because it is
superseded by the new tolerances for subgroups 8-10A and 8-10B.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 21, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.613:
0
i. Remove ``Vegetable, fruiting, group 8-10'' from the table in
paragraph (a).
0
ii. Add alphabetically the following commodities to the table in
paragraph (a): ``Fruit, citrus, group 10-10''; ``Pepper/Eggplant,
subgroup 8-10B''; and ``Tomato subgroup 8-10A''.
0
iii. Add ``Tea'' to the table in paragraph (a) and add footnote 1.
    The additions to the table in paragraph (a) read as follows:

Sec.  180.613   Flonicamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Fruit, citrus, group 10-10..................................         1.5

                                * * * * *
Pepper/Eggplant, subgroup 8-10B.............................         3.0

                                * * * * *
 Tea\1\.....................................................          40

                                * * * * *
Tomato subgroup 8-10A.......................................         0.4

                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for tea as of May 11, 2017.

* * * * *
[FR Doc. 2017-09592 Filed 5-10-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56814-56816]
[FR Doc No: 2014-22515]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1286]

Collaborative Approaches for Medical Device and Healthcare
Cybersecurity; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Collaborative Approaches for Medical Device
and Healthcare Cybersecurity''. FDA, in collaboration with other
stakeholders within the Department of Health and Human Services (HHS)
and the Department of Homeland Security (DHS), seeks broad input from
the Healthcare and Public Health (HPH) Sector on medical device and
healthcare cybersecurity. The vision for this public workshop is to
catalyze collaboration among all HPH stakeholders. Participants will
identify barriers to promoting cooperation; discuss innovative
strategies to address challenges that may jeopardize critical
infrastructure; and enable proactive development of analytical tools,
processes, and best practices by the stakeholder community in order to
strengthen medical device cybersecurity.
    Dates and Times: The public workshop will be held on October 21 and
22, 2014, from 9 a.m. to 5 p.m.
    Location: The public workshop will be held at the National
Intellectual Property Rights Coordination Center Auditorium, 2451
Crystal Dr., suite 200, Arlington, VA 22202. Entrance for the public
workshop participants is through the main doors which face Crystal
Drive. Upon arrival at the facility, participants should visit the
registration table to check in. For parking, participants may choose
from a number of pay garages, including one directly beneath the
facility.
    Contact Person: Suzanne Schwartz, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:
301-847-8510, email<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 4 p.m., October 14, 2014. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be provided beginning at 8:30 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
no later than October 15, 2014.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Suzanne Schwartz to register (see
Contact Person). Registrants will receive confirmation after they have
been accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 4 p.m., October 14, 2014. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after October 16, 2014. Most updated browsers will
support the Webcast.
    Comments: FDA is holding this public workshop to obtain information
on medical device cybersecurity. In order to permit the widest possible
opportunity to obtain public comment,

FDA is soliciting either electronic or written comments on all aspects
of the public workshop topics, regardless of attendance at the public
workshop. The deadline for submitting comments related to this public
workshop is November 24, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
questions as outlined in section III of this document, please identify
the question number you are addressing. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    In February 2013, the President issued Executive Order 13636,
``Improving Critical Infrastructure Cybersecurity,'' recognizing that
resilient infrastructure is essential to preserving national security,
economic stability, and public health and safety in the United States
(Ref. 1). Executive Order 13636 states that cyber threats to national
security are among the most serious, so stakeholders must enhance the
cybersecurity and resilience of critical infrastructure. This includes
the HPH Sector. Furthermore, Presidential Policy Directive (P.P.D.) 21
tasks Federal Government entities to strengthen the security and
resilience of critical infrastructure against physical and cyber
threats such that these efforts reduce vulnerabilities, minimize
consequences, and identify and disrupt threats (Ref. 2). Moreover,
P.P.D. 21 encourages all public and private owners and operators to
share responsibility in achieving these outcomes. By convening this
public meeting, FDA and its workshop partners strive to engage all
stakeholders in HPH. These stakeholders include, but are not limited
to: medical device manufacturers; healthcare facilities and personnel
(e.g., healthcare providers, biomedical engineers, IT system
administrators); professional and trade organizations (including
medical device cybersecurity consortia); patient groups; insurance
providers; cybersecurity researchers; local, State, and Federal
Governments; and information security firms.
    Executive Order 13636 and P.P.D. 21 together serve as a call to
action for promoting the cybersecurity of the Nation's critical
infrastructure. The National Institute of Standards and Technology
(NIST) developed the ``Framework for Improving Critical Infrastructure
Cybersecurity'' (``Framework'') with collective input from government
agencies and the private sector to address Executive Order 13636's call
for a voluntary, risk-based approach, harnessing a set of industry
standards and best practices to manage cybersecurity risks (Ref. 3).
P.P.D. 21 identifies critical sectors within the United States and
charges each with adapting and implementing the Framework. HHS, as lead
for the HPH Sector, seeks to adapt the Framework across its workspace.
Developing a common lexicon is critical to this public-private
collaboration to address and manage medical device cybersecurity risks.
This workshop is an integral step towards the HPH Sector's collective
understanding of the Framework and how it might be adapted to address
the unique medical device cybersecurity needs and challenges within the
sector.
    If exploited, cyber vulnerabilities may result in medical device
malfunction, disruption of healthcare services including treatment
interventions, inappropriate access to patient information, or
compromised electronic health record data integrity. Such outcomes
could have a profound impact on patient care and safety. As devices
become more connected and interoperable, the threat potential
increases. Now, rather than impacting a single device or single system,
multiple devices or an entire hospital network may be compromised.
Addressing medical device cybersecurity requires recognizing
interoperability and interconnectivity. Therefore, enhancing security
and resilience entails designing healthcare systems for seamless
integration. Such integration will foster innovative and interoperable
medical devices that protect and improve patient health and safety.
    Advancing medical device cybersecurity measures within the HPH
Sector relies upon a `whole of community' approach that will require
acceptance of a `shared ownership and shared responsibility' model. The
objectives of such a model are twofold: (1) To seek solutions that
incentivize businesses to adopt best practices and industry standards
to be included in product design and systems architecture, and (2) to
foster stakeholder collaboration such that emerging threat and
vulnerability information is readily shared. This effort requires
breaking down barriers and building trust between stakeholders.
Ultimately, this effort will facilitate a forum to implement HPH cyber
vulnerability and threat management.

II. Topics for Discussion at the Public Workshop

    The public workshop sessions will incorporate the following general
themes:
     Envisioning a collaborative environment for information
sharing and developing a shared risk-assessment framework using a
common lexicon;
     Overcoming barriers (perceived and real) to create a
community of `shared ownership and shared responsibility' within the
HPH Sector to increase medical device cybersecurity;
     Gaining situational awareness of the current cyber threats
to the HPH Sector, especially to medical devices;
     Identifying cybersecurity gaps and challenges, especially
end-of-life support for legacy devices and interconnectivity of medical
devices;
     Adapting and implementing the Framework to support
management of cybersecurity risks involving medical devices;
     Developing tools and standards to build a comprehensive
cybersecurity program to meet the unique needs of the sector's critical
infrastructure, including medical devices;
     Leveraging the technical subject matter expertise of the
cybersecurity researcher community working with HPH stakeholders to
identify, assess, and mitigate vulnerabilities; and
     Building potential solutions: Exploring collaborative
models to gather diverse experts and establish medical

device security benchmarks which are continuously validated.

III. Questions for Consideration

    FDA also requests HPH Sector stakeholders to provide perspective on
the following:
    1. Are stakeholders aware of the ``Framework for Improving Critical
Infrastructure Cybersecurity''? If so, how might we adapt/translate the
Framework to meet the medical device cybersecurity needs of the HPH
Sector?
    2. How can we establish partnerships within the HPH Sector to
quickly identify, analyze, communicate, and mitigate cyber threats and
medical device security vulnerabilities?
    3. How might the stakeholder community create incentives to
encourage sharing information about medical device cyber threats and
vulnerabilities?
    4. What lessons learned, case studies, and best practices (from
within and external to the sector) might incentivize innovation in
medical device cybersecurity for the HPH Sector? What are the
cybersecurity gaps from each stakeholder's perspective: Knowledge,
leadership, process, technology, risk management, or others? and,
    5. How do HPH stakeholders strike the balance between the need to
share health information and the need to restrict access to it?
    The deadline for submitting answers to these questions for
consideration and any other additional comments on the proposed
workshop topics is October 7, 2014.

IV. References

1. Executive Order 13636, ``Improving Critical Infrastructure
Cybersecurity,'' Feb. 19, 2013, available at http://www.gpo.gov/fdsys/pkg/FR-2013-02-19/pdf/2013-03915.pdf.
2. Presidential Policy Directive 21, ``Critical Infrastructure
Security and Resilience,'' Feb. 12, 2013, available at http://www.whitehouse.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil.
3. National Institute of Standards and Technology (NIST),
``Framework for Improving Critical Infrastructure Cybersecurity,''
version 1, Feb. 12, 2014, available at http://www.nist.gov/cyberframework/upload/cybersecurity-framework-021214-final.pdf.

    Dated: September 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22515 Filed 9-22-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 3081-3083]
[FR Doc No: 2013-00696]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Federal Motor Vehicle Motor Theft
Prevention Standard; Toyota

AGENCY: National Highway Traffic Safety Administration, Department Of
Transportation (DOT).

ACTION: Grant of petition for exemption.

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

SUMMARY: This document grants in full Toyota Motor North America,
Inc.'s (Toyota) petition for an exemption of the RAV4 vehicle line in
accordance with 49 CFR part 543, Exemption from the Theft Prevention
Standard. This petition is granted because the agency has determined
that the antitheft device to be placed on the line as standard
equipment is likely to be as effective in reducing and deterring motor
vehicle theft as compliance with the parts-marking requirements of the
Theft Prevention Standard (49 CFR Part 541).

DATES: The exemption granted by this notice is effective beginning with
the 2014 model year (MY).

FOR FURTHER INFORMATION CONTACT: Ms. Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Standards, NHTSA, W43-
439, 1200 New Jersey Avenue SE., Washington, DC 20590. Ms. Ballard's
phone number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated October 16, 2012, Toyota
requested an exemption from the parts-marking requirements of the theft
prevention standard (49 CFR part 541) for the RAV4 vehicle line
beginning with MY 2014. The petition requested an exemption from parts-
marking pursuant to 49 CFR part 543, Exemption from Vehicle Theft
Prevention Standard, based on the installation of an antitheft device
as standard equipment for the entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant an
exemption for one vehicle line per model year. In its petition, Toyota
provided a detailed description and diagram of the identity, design,
and location of the components of the antitheft device for the RAV4
vehicle line. Toyota stated that the MY 2014 RAV4 vehicle line will
offer two entry systems but both will have an engine immobilizer device
as standard equipment. Specifically, Toyota stated that the RAV4
vehicle line will offer a ``smart key'' system (keyless entry and push
button start) and a ``conventional key'' entry system. Key components
of the ``smart key'' system will include an engine immobilizer,
certification electronic control unit (ECU), engine switch, steering
lock ECU, security indicator, door control receiver, electrical key and
an electronic control module (ECM). The conventional key components
consist of a transponder key ECU assembly, transponder key coil,
security indicator, ignition key and an ECM. Toyota will not offer an
audible and visual alarm for the RAV4 vehicle line. Toyota's submission
is considered a complete petition as required by 49 CFR 543.7 in that
it meets the general requirements contained in 543.5 and the specific
content requirements of 543.6.
    On the RAV4 vehicle line, the ``smart key'' system allows the
driver to press the ``ON'' button located on the instrument panel to
start the vehicle. Once the driver pushes the ``ON'' button, the
certification ECU verifies the electrical key, and the certification
ECU and steering lock ECU receive confirmation of the valid key,
allowing the ECM to start the engine. With the conventional key system,
once the key is inserted into the key cylinder, the transponder chip in
the key sends the key ID codes to the transponder key ECU assembly to
verify the code. Once the code is verified, the immobilizer will allow
the ECM to start the engine.
    Toyota stated that with the smart key system, the immobilizer is
activated when the power button is pushed from the ``ON'' status to any
other ignition status and the certification ECU performs the
calculation of the immobilizer then the immobilizer signals the ECM.
For the ``conventional key'' system, activation of the immobilizer
occurs when the ignition

key is turned from the ``ON'' status to any other position and/or the
key is removed. Toyota also stated that the devices' security indicator
will provide the immobilizer status for the RAV4 vehicle line. When the
immobilizer is activated, the indicator flashes continuously. When the
immobilizer is not activated, the indicator is turned off. The device
is deactivated when the doors are unlocked and the device recognizes
the key code from the smart key system. Deactivation of the
conventional key system occurs when the doors are unlocked and the key
is turned to the ``ON'' position.
    Toyota also stated that there will be position switches installed
in the vehicle to protect the hood and doors. Specifically, the
position switches in the hood will trigger the antitheft device when
they sense inappropriate opening of the hood. The position switches in
the doors will trigger the antitheft device when they sense opening of
the doors is being attempted without the use of a key, wireless switch
or smart entry system.
    In addressing the specific content requirements of 543.6, Toyota
provided information on the reliability and durability of its proposed
device. To ensure reliability and durability of the device, Toyota
conducted tests based on its own specified standards. Toyota provided a
detailed list of the tests conducted (i.e., high and low temperature,
strength, impact, vibration, electro-magnetic interference, etc.).
Toyota stated that it believes that its device is reliable and durable
because it complied with its own specific design standards and that the
device is installed in other vehicle lines for which the agency has
granted a parts-marking exemption. As an additional measure of
reliability and durability, Toyota stated that its vehicle key
cylinders are covered with casting cases to prevent the key cylinder
from easily being broken. Toyota further stated that there are so many
key cylinder combinations and key plates for its gutter keys that it
would be very difficult to unlock the doors without using a valid key.
    To provide comparison, Toyota referenced NHTSA-published theft rate
data for the RAV4 vehicle line for several years before and after it
was equipped with a standard antitheft device with an immobilizer.
Toyota stated that the average theft rate for the RAV4 for MY 2009 is
0.66 thefts per thousand vehicles produced as compared to 0.86 per
1,000 vehicles, the average theft rate for the RAV 4 for model years
(MYs) 2005-2008. Toyota further stated that the antitheft device which
is already installed as standard equipment beginning with MY 2009 RAV4
will continue to be installed on the MY 2014 RAV4 vehicle line. Toyota
also compared its proposed device with other devices NHTSA has
determined to be as effective in reducing and deterring motor vehicle
theft as would compliance with the parts-marking requirements (i.e.,
Toyota Prius and Prius v, Toyota Camry and Corolla, Lexus LS and GS
vehicle lines). The Toyota Camry, Corolla, Lexus LS and GS vehicle
lines have all been granted parts-marking exemptions by the agency. The
theft rates for the Toyota Camry, Corolla, Lexus LS, GS and Prius
vehicle lines using an average of three model years' data (2008-2010)
are 1.8107, 1.7399, 0.9468, 0.4915 and 0.3756 respectively. Therefore,
Toyota has concluded that the antitheft device proposed for its RAV4
vehicle line is no less effective than those devices in the lines for
which NHTSA has already granted full exemption from the parts-marking
requirements. Toyota believes that installing the immobilizer as
standard equipment reduces the theft rate and expects the RAV4 to
experience comparable effectiveness, ultimately being more effective
than parts-marking labels.
    Based on the evidence submitted by Toyota, the agency believes that
the antitheft device for the RAV4 vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard
(49 CFR part 541).
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7 (b), the agency grants
a petition for exemption from the parts-marking requirements of Part
541, either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of Part 541. The agency
finds that Toyota has provided adequate reasons for its belief that the
antitheft device for the Toyota RAV4 vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard
(49 CFR part 541). This conclusion is based on the information Toyota
provided about its device.
    The agency concludes that the device will provide four of the five
types of performance listed in Sec.  543.6(a)(3): promoting activation;
preventing defeat or circumvention of the device by unauthorized
persons; preventing operation of the vehicle by unauthorized entrants;
and ensuring the reliability and durability of the device.
    For the foregoing reasons, the agency hereby grants in full
Toyota's petition for exemption for the Toyota RAV4 vehicle line from
the parts-marking requirements of 49 CFR Part 541. The agency notes
that 49 CFR part 541, appendix A-1, identifies those lines that are
exempted from the Theft Prevention Standard for a given model year. 49
CFR 543.7(f) contains publication requirements incident to the
disposition of all Part 543 petitions. Advanced listing, including the
release of future product nameplates, the beginning model year for
which the petition is granted and a general description of the
antitheft device is necessary in order to notify law enforcement
agencies of new vehicle lines exempted from the parts marking
requirements of the Theft Prevention Standard.
    If Toyota decides not to use the exemption for this line, it must
formally notify the agency. If such a decision is made, the line must
be fully marked according to the requirements under 49 CFR 541.5 and
541.6 (marking of major component parts and replacement parts).
    NHTSA notes that if Toyota wishes in the future to modify the
device on which this exemption is based, the company may have to submit
a petition to modify the exemption. Section 543.7(d) states that a Part
543 exemption applies only to vehicles that belong to a line exempted
under this part and equipped with the antitheft device on which the
line's exemption is based. Further, Sec.  543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that Sec.
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend in drafting Part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if the
manufacturer contemplates making any changes, the effects of which
might be characterized as de minimis, it should consult the agency
before preparing and submitting a petition to modify.

    Authority:  49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: January 9, 2013.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2013-00696 Filed 1-14-13; 8:45 am]
BILLING CODE 4910-59-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [insert name and telephone number with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

[Dow AgroSciences L.L.C.]

[IN-11012]

	EPA has received a pesticide petition (IN-11012) from [Dow AgroSciences], [9330 Zionsville Road, Indianapolis, IN 46268] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

	2. to establish an exemption from the requirement of a tolerance for

	[nicotinamide (CAS 98-92-0) when used as an inert ingredient as a corrosion inhibitor at up to 5% within a pesticidal product].  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

 [Because an exemption from the requirement of a tolerance is requested, no field residue studies are required.]

B. Toxicological Profile

	1. Acute toxicity.  [Nicotinamide has low acute toxicity in lab animals with oral LD50 values >2200 mg/kg body weight (bw) and dermal LD50 values >2000 mg/kg bw.]

	2. Genotoxicty. [Nicotinamide was negative in the Ames assay, the in vitro chromosomal aberration assay, and the in vivo mouse micronucleus assay.]

	3. Reproductive and developmental toxicity. [In a rat developmental toxicity assay, no teratogenic effects were observed at doses up to the high dose of 1000 mg/kg/day.  Fetotoxicity (decreased fetal weight) was observed only at the maternally toxic dose of 1000 mg/kg/dy.]

	4. Subchronic toxicity. [In a 28-day oral toxicity study in rats, the NOAEL was considered to be 215 mg/kg bw/day based on spleen effects in females at 1000 mg/kg bw/day.  Rabbits and guinea pigs fed nicotinamide at 2% in the diet showed no adverse effects.  Side effects such as headaches, nausea, vomiting, itching, and insomnia are reported in humans consuming therapeutic doses of greater than 6 g/day.]

	5. Chronic toxicity. [There was no increase in tumor incidence in Swiss mice fed 1% nicotinamide in the diet (~2600 mg/kg bw/day for females and ~3300 mg/kg bw/day for males).]

	6. Animal metabolism. [Nicotinamide is a vitamin required for lipid metabolism, tissue respiration, and glycogenolysis.  It is rapidly absorbed and incorporated into the body as NAD or is excreted in the urine, primarily as N-methyl-nicotinamide or N-methyl-2-pyridone-5-carboxamide.]

	7. Metabolite toxicology. [No specific information was identified on toxicity of nicotinamide metabolites.  However, nicotinamide is a normal part of the human diet.  It is rapidly metabolized, and metabolite toxicity would be represented in the effects observed following human or animal ingestion.  Overall, metabolite toxicity is considered to be low.]

	8. Endocrine disruption. [Nicotinamide does not belong to a class of chemicals known or suspected to have adverse effects on the estrogen receptor or endocrine system.]

C. Aggregate Exposure

	1. Dietary exposure. [Nicotinamide is a natural part of the human diet and may be consumed as a dietary supplement.  A recommended daily allowance (RDA) for niacin has been established at not less than 16 mg/day for an adult male.  An upper limit (UL) was set for niacin at 35 mg/day based on flushing, a very sensitive effect associated with nicotinic acid, but not nicotinamide exposures.  Therefore, a UL for nicotinamide could theoretically be established based on the next most sensitive effect (ocular effects) at 1 g/day for adults.]

	i. Food. [An assessment based on the general results of the EPA screening-level dietary exposure model I-DEEM is provided.  I-DEEM is based on a screening level dietary assessment of 57 of the most "significant" active ingredients used as surrogates for inerts within the Dietary Exposure Evaluation Model software with food Commodity Intake Database (DEEM-FCID, Version 3.16).  Exposures were compared to the RDA and UL for nicotinamide mentioned above.  All exposures were below the RDA and less than 0.5% of the UL.]

	ii. Drinking water. [Drinking water estimates have been included in the I-DEEM model and are included in the conclusion of a passing dietary risk assessment as discussed above.]

	2. Non-dietary exposure. [No uses of nicotinamide in pesticidal products for non-crop uses are indicated in publically available databases.  Non-dietary consumer exposures to nicotinamide are possible due to its use in personal care products such as cleansers and lotions.  There is a history of safe human use of such products and as such, no quantitative risk assessment has been conducted.  Furthermore, as dietary exposures are well below established limits and levels regularly safely consumed as dietary supplements, a reasonable certainty of no harm can be concluded for aggregate exposures based on a history of safe use.  The use of nicotinamide in pesticidal products is not expected to appreciably change human exposures.]

D. Cumulative Effects

	[Unlike for pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, for nicotinamide EPA has not made a common mechanism of toxicity finding.  Consideration of a common mode of toxicity is not appropriate given that there is no information available that indicates potential toxic effects, if any, would be cumulative with any other compounds.]

E. Safety Determination

	1. U.S. population. [A reasonable certainty of no harm has been established for the general population for the proposed use of nicotinamide as an inert ingredient in pesticide formulations.  This use is not expected to appreciably increase current exposures from other exposure sources.]

	2. Infants and children. [The available information does not indicate any qualitative or quantitative evidence of increased susceptibility to infants and children for nicotinamide.  Assessment of the various child subpopulations is included in the I-DEEM analysis and for all subpopulations, exposures are below the RDA and UL for nicotinamide and are not expected to significantly alter current exposure levels.  A reasonable certainty of no harm has been established for children as well.]

F. International Tolerances

	[No international tolerances have been established for nicotinamide.]