[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20923-20924]
[FR Doc No: 2013-08034]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0977]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and Adolescents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 8,
2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0312.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco To Protect Children and Adolescents--21 CFR Part 1140
(OMB Control Number 0910-0312)--Revision

    This is a request for an extension of OMB approval of the
information collection requirements contained in FDA's regulations for
cigarettes and smokeless tobacco containing nicotine. The regulations
that are codified at 21 CFR part 1140 (previously codified at 21 CFR
part 897) are authorized by section 102 of the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31). Section 102 of the Tobacco Control Act required FDA to publish a
final rule regarding cigarettes and smokeless tobacco identical in its
provisions to the regulation issued by FDA in 1996 (61 FR 44396, August
28, 1996), with certain specified exceptions--which included striking
subpart C (with Sec.  897.24) and Sec.  897.32(c) from the reissued
rule (section 102(a)(2)(B). The reissued final rule was published in
the Federal Register on March 19, 2010 (75 FR 13225).
    This collection includes reporting information requirements for
Sec.  1140.30, which directs persons to notify FDA if they intend to
use a form of advertising that is not addressed in the regulations.
Disclosure requirements for Sec.  1140.32 state that the advertising
must use black text on a white background, but that this particular
requirement does not apply to adult newspapers, magazines, periodicals,
or other publications. Recordkeeping requirements under Sec.  1140.32
indicate that competent and reliable survey evidence is required to
determine whether a particular publication is an ``adult'' publication.
    The requirements are as follows:
     Reporting--Sec.  1140.30 directs persons to notify FDA if
they intend to use a form of advertising that is not described in Sec.
1140.30(a)(1).
     Disclosure--Sec.  1140.32 requires firms to use black text
on white backgrounds in labeling and advertising.
     Recordkeeping--Sec.  1140.32 indicates that firms
advertising in ``adult'' magazines or publications may need survey
evidence demonstrating that the publication meets the criteria for an
``adult'' publication.
    For the disclosure and recordkeeping requirements under Sec.
1140.32, FDA has decided to use its discretionary enforcement and has
placed placeholders of 1 burden hour for disclosure and 1 burden hour
for reporting because FDA does not intend to enforce the requirements
for this section for the next 3 years.
    In the Federal Register of September 28, 2012 (77 FR 59622), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR Section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.30 (Scope of permissible forms of labeling and advertising)...             300                1              300                1              300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                           21 CFR Section                               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.32 (Format and content requirements for labeling and                         1                1                1                1                1
 advertising)......................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR Section                               Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.32............................................................               1                1                1                1                1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden hour estimates for this collection of information were
based on industry-prepared data and information regarding
pharmaceutical advertising and cigarette and smokeless tobacco product
advertising expenditures. The burden collection does not include
reporting burdens associated with providing established names on labels
and statements of intended use because section 102 of the Tobacco
Control Act required that these provisions be struck from the reissued
final rule (previously included in Sec. Sec.  897.24 and 897.32(c)).
    Section 1140.30 requires manufacturers, distributors, and retailers
to observe certain format and content requirements for labeling and
advertising, and requires manufacturers, distributors, and retailers to
notify FDA if they intend to use an advertising medium that is not
listed in the regulations. The concept of permitted advertising in
Sec.  1140.30 is sufficiently broad to encompass most forms of
advertising. FDA estimates that approximately 300 respondents will
submit an annual notice of alternative advertising, and the Agency has
estimated it should take 1 hour to provide such notice.
    For the recordkeeping and disclosure requirements, Sec.  1140.32
requires competent and reliable survey evidence to establish whether a
newspaper, magazine, periodical, or other publication qualifies as an
``adult'' publication. Section 1140.32 also requires the use of a black
text on a white background for labeling and advertising. The respondent
and hourly burden for recordkeeping and disclosure under this section
(2 burden hours total) reflect placeholders for the number of
manufacturers who would keep records under this section.
    During the next 3 years, FDA does not intend to enforce the
recordkeeping and disclosure requirements of Sec.  1140.32 and has
revised the burden to act as a placeholder in the event FDA exercises
its authority to enforce the requirements of this section in the
future.
    FDA estimates that the total time required for this collection of
information is 302 hours.

    Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08034 Filed 4-5-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 16, 2007 (Volume 72, Number 72)]
[Notices]
[Page 18972-18973]
[DOCID:fr16ap07-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 606-000]

Pacific Gas and Electric Company (PG&E); Notice of Authorization
for Continued Project Operation

April 10, 2007.
    On March 23, 2007, the Pacific Gas and Electric Company, licensee
for the Kilarc-Cow Creek Hydroelectric Project, filed a Proposed
License Surrender Application Schedule. The Kilarc-Cow Creek Project is
located on the Old Cow Creek and South Cow Creek in Shasta County,
California.
    The license for Project No. 606 was issued for a period ending
March 27, 2007. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA.
    Notice is hereby given that an annual license for Project No. 606
is issued to the Pacific Gas and Electric Company for a period
effective April 2, 2007 through March 31, 2008, or until the issuance
of a new license for the project or other disposition under the FPA,
whichever comes first. If issuance of a new license (or other
disposition) does not take place on or before March 31, 2008, notice is
hereby given that, pursuant to 18 CFR 16.18(c), an annual license under
section 15(a)(1) of the FPA is renewed automatically without further
order or notice by the

Commission, unless the Commission orders otherwise.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-7163 Filed 4-13-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Rules and Regulations]
[Pages 42654-42658]
[FR Doc No: 2012-17630]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0458; FRL-9354-8]

Trifloxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
trifloxystrobin in or on artichoke, globe. Bayer CropScience requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective July 20, 2012. Objections and
requests for hearings must be received on or before September 18, 2012,
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-2011-0458, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, 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: Dominic Schuler, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How can I 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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0458 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
September 18, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0458, 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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 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.htm.

    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 April 4, 2012 (77 FR 20334) (FRL-9340-
4), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1F7845)
by Bayer CropScience, 2 TW Alexander Dr., Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.555 be amended by
establishing tolerances for residues of the fungicide trifloxystrobin,
[benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-[[[[1-[3-
(trifluoromethyl)phenyl]ethylidene] amino]oxy]methyl]-methyl ester], in
or on artichoke, globe at 1.0 parts per million (ppm). That notice
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, which is available in the docket, http://www.regulations.gov.

    There were no comments received in response to the notice of
filing.

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 trifloxystrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with trifloxystrobin
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data 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.
    Trifloxystrobin exhibits very low toxicity following single oral,
dermal and inhalation exposures. It is a strong dermal sensitizer. In
repeated dose tests in rats, the liver is the target organ for
trifloxystrobin; toxicity is induced following oral and dermal exposure
for 28 days. There is no evidence of increased susceptibility following
prenatal exposure to rats and rabbits and postnatal exposures to rats.
Trifloxystrobin was determined not to be carcinogenic in mice or rats
following long-term dietary administration. Trifloxystrobin is positive
for mutagenicity in Chinese Hamster V79 cells, albeit at cytotoxic dose
levels. However, trifloxystrobin is negative in the remaining
mutagenicity studies. Specific information on the studies received and
the nature of the adverse effects caused by trifloxystrobin as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
the final rule published in the Federal Register of June 11, 2010 (75
FR 33190) (FRL-8829-2), and at http://www.regulations.gov in the
document ``Trifloxystrobin. Human Health Risk Assessment for a Section
3 Petition Proposing Increased Tolerances for Residues in/on Field,
Sweet and Pop Corn,'' pp. 17-21 in docket ID number EPA-HQ-OPP-2009-
0278.

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://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for trifloxystrobin used for human risk assessment is
discussed in Unit III.B. of the final rule published in the Federal
Register of June 11, 2010.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trifloxystrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing trifloxystrobin
tolerances in 40 CFR 180.555. EPA assessed dietary exposures from
trifloxystrobin 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. Such effects were identified
for trifloxystrobin. In estimating acute dietary exposure for females
13-49 years old, EPA conducted an analysis using the Dietary Exposure
Evaluation Model (DEEM\TM\ 7.81), which used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance
level residues. EPA assumed all commodities with established or
proposed tolerances were treated with trifloxystrobin.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues for all commodities with the exception of apples, oranges and
grapes. For these commodities EPA used anticipated residues from field
residue trials. EPA assumed all commodities with established or
proposed tolerances were treated with trifloxystrobin.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that trifloxystrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.

    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for trifloxystrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of trifloxystrobin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS), and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
trifloxystrobin plus its major degradation product, CGA-321113 for the
proposed artichoke, globe use are estimated to be 47.98 parts per
billion (ppb) and 47.31 ppb for surface water for acute and chronic
exposures, respectively. Modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
    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).
    Trifloxystrobin is currently registered for the following uses that
could result in residential exposures: Ornamentals and turfgrass. EPA
assessed residential exposure under the following exposure scenarios:
Adult post-application dermal exposure; and children's post-application
dermal and/or hand to mouth exposure. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.
    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 trifloxystrobin to share a common mechanism of
toxicity with any other substances, and trifloxystrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
trifloxystrobin 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://www.epa.gov/pesticides/cumulative.

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. There is no indication of
increased susceptibility of rat or rabbits to trifloxystrobin. In the
prenatal developmental study in rats, there was no developmental
toxicity at the limit dose. In the prenatal developmental study in
rabbits, developmental toxicity was seen at a dose that was higher than
the dose that caused maternal toxicity. In the 2-generation
reproduction study, there was no offspring toxicity at the highest dose
tested.
    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. That decision is based on the following
findings:
    i. The database is complete except for an immunotoxicity study and
an inhalation study. Although an immunotoxicity study is needed, the
entire trifloxystrobin toxicity database was examined and there was no
indication that this chemical directly targets the immune system. EPA
does not believe that conducting an immunotoxicity study will result in
a dose less than the points of departure already used in this risk
assessment and an additional database uncertainty factor (UF) for
potential immunotoxicity does not need to be applied. Regarding the
requirement for an inhalation toxicity study, the Agency has increased
its focus on the uncertainties associated with route-to-route
extrapolation (i.e., the use of oral toxicity studies for inhalation
risk assessment) and is presently requiring inhalation toxicity studies
more frequently. Although an inhalation toxicity study is now required
for trifloxystrobin based on OPP's current weight of the evidence (WOE)
approach, residential inhalation exposure is not anticipated;
therefore, there are no uncertainties with respect to residential
inhalation exposures to trifloxystrobin and no need to retain an
additional database uncertainty factor for this safety finding.
    ii. There is no indication that trifloxystrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. A waiver for a
subchronic neurotoxicity study has been granted. There is no evidence
of neurotoxicity in subchronic and chronic toxicity studies (rats,
dogs, mice), in developmental toxicity studies (rats, rabbits), or in a
reproductive toxicity study (rats). There is no concern for
neurotoxicity for trifloxystrobin based on the available database,
limited findings in an acute neurotoxicity study, and lack of
neurotoxicity in other fungicides of the strobilurin class.
    iii. There is no evidence that trifloxystrobin results in increased
susceptibility in in utero 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 acute dietary exposure assessment was unrefined, and the
chronic dietary exposure assessment was partially refined, assuming 100
PCT and tolerance-level residues for all commodities except for apples,
grapes, and oranges where the average field trial residues were used.
By using these screening-level assessments with minor refinement,
actual exposures/risks from residues in food will not be
underestimated. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
trifloxystrobin in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by trifloxystrobin.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to trifloxystrobin will occupy 1.9% of the aPAD for females 13-49 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
trifloxystrobin from food and water will utilize 64% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
trifloxystrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Trifloxystrobin is currently registered for uses that could result
in short-term residential exposure, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to trifloxystrobin. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of 1,100 for adults (dermal
residential + dietary food and drinking water exposures); 650 for
children 1-2 years (dermal residential + dietary food and drinking
water exposures); and 130 for children 1-2 years (incidental oral
residential + dietary food and drinking water exposures). Because EPA's
level of concern for trifloxystrobin is a MOE of 100 or less, these
MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Trifloxystrobin is not expected to pose an intermediate-term
risk based on a short soil half-life (approximately 2 days).
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, chemical name is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen
phosphorus detection (GC/NPD), Method AG-659A and liquid chromatography
with tandem mass spectrometry detection (LC/MS/MS), Method No. 200177)
is available to enforce the tolerance expression.
    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 a MRL for trifloxystrobin on
artichoke, globe. Therefore, international harmonization is not an
issue.

V. Conclusion

    Therefore, a tolerance is established for residues of
trifloxystrobin, [benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl)phenyl]ethylidene] amino]oxy]methyl]-methyl
ester], in or on artichoke, globe at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994). Since
tolerances and exemptions that are established on the basis of a
petition under 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 final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the

Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 11, 2012.
Lois Rossi,
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. Section 180.555 is amended by alphabetically adding ``Artichoke,
globe'' to the table in paragraph (a) to read as follows:

Sec.  180.555  Trifloxystrobin; tolerance for residues.

    (a) * * *

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

                                * * * * *
Artichoke, globe...........................................          1.0

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

* * * * *
[FR Doc. 2012-17630 Filed 7-19-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 17, 2008 (Volume 73, Number 117)]
[Rules and Regulations]
[Page 34184-34185]
[DOCID:fr17jn08-3]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use in Animal Feeds; Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Elanco Animal Health, A Division of Eli
Lilly & Co. The supplemental NADA provides for revision of an
effectiveness claim and pathogen nomenclature for a tylosin phosphate
and sulfamethazine Type A medicated article used to manufacture
medicated swine feeds.

DATES: This rule is effective June 17, 2008.

FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 41-275 that provides for use of TYLAN 40 SULFA-G
(tylosin phosphate and sulfamethazine) Elliptical Pellets, a Type A
medicated article. The

supplement provides for revision of an effectiveness claim and pathogen
nomenclature. The supplemental NADA is approved as of May 8, 2008, and
the regulations in 21 CFR 558.630 are amended to reflect the approval.
    Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. Revise Sec.  558.630 to read as follows:

Sec.  558.630  Tylosin and sulfamethazine.

    (a) Specifications. Type A medicated articles containing equal
amounts of tylosin phosphate and sulfamethazine, available in
concentrations of 4, 5, 10, 20, or 40 grams each, per pound.
    (b) Approvals. See sponsor numbers in Sec.  510.600(c) of this
chapter for use as in paragraph (e) of this section.
    (1) No. 000986: 10 or 40 grams per pound each for use as in
paragraph (e)(2)(i) of this section.
    (2) No. 021930: 2 grams per pound each for use as in paragraph
(e)(2)(i) of this section.
    (3) No. 051311: 40 grams per pound each for use as in paragraph
(e)(2)(ii) of this section.
    (4) No. 017139: 4, 10, or 20 grams per pound each for use as in
paragraph (e)(2)(ii) of this section.
    (5) Nos. 000986, 010439, 016968, 021930, 024174, 030841, 034936,
035098, 046573, 046987, and 051359: 5, 10, 20, or 40 grams per pound
each for use as in paragraph (e)(2)(ii) of this section.
    (6) No. 000986: 40 grams per pound each for use as in paragraph
(e)(2)(iii) of this section.
    (c) Special considerations. Labeling shall bear the statement: ``Do
not use in medicated feeds containing in excess of 2% bentonite.''
    (d) Related tolerances. See Sec. Sec.  556.670 and 556.740 of this
chapter.
    (e) Conditions of use. It is used in feed for swine as follows:
    (1) Amount per ton. 100 grams tylosin and 100 grams sulfamethazine.
    (2) Indications for use-(i) Maintaining weight gains and feed
efficiency in the presence of atrophic rhinitis; lowering the incidence
and severity of Bordetella bronchiseptica rhinitis; prevention of swine
dysentery (vibrionic); control of swine pneumonias caused by bacterial
pathogens (Pasteurella multocida and/or Corynebacterium pyogenes); for
reducing the incidence of cervical lymphadenitis (jowl abscesses)
caused by Group E Streptococci. Only the sulfamethazine portion of this
combination is active in controlling jowl abscesses.
    (ii) Maintaining weight gains and feed efficiency in the presence
of atrophic rhinitis; lowering the incidence and severity of Bordetella
bronchiseptica rhinitis; prevention of swine dysentery (vibrionic);
control of swine pneumonias caused by bacterial pathogens (Pasteurella
multocida and/or Corynebacterium pyogenes).
    (iii) For maintaining weight gains and feed efficiency in the
presence of atrophic rhinitis; lowering the incidence and severity of
Bordetella bronchiseptica rhinitis; prevention of swine dysentery
associated with Brachyspira hyodysenteriae; and control of swine
pneumonias caused by bacterial pathogens (Pasteurella multocida and/or
Arcanobacterium pyogenes).
    (3) Limitations. Withdraw 15 days before swine are slaughtered.

    Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13606 Filed 6-16-08; 8:45 am]

BILLING CODE 4160-01-S


Summary of some provisions in EPA's formaldhyde regulations that deviate from the CARM ATCM:

1. Testing Requirements for Hardwood Plywood -- Frequency and Sampling:  In addition to several provisions that are identical to those in the CARB ATCM, EPA is proposing the following quality control testing frequency provision for hardwood plywood producers that make less than 100,000 square feet of a product:
             If weekly production of hardwood plywood at the panel producer is 100,000 square feet or less, at least one test per 100,000 square feet for each product type produced; or, if less than 100,000 square feet of a particular product type in a single production run is produced, one quality control test of that product type per production run or lot produced.  (§ 770.18(b)(2)(iii)(D)).

2. Testing Requirements -- Demonstration of Equivalence of Test Methods: EPA is proposing to allow flexibility in sampling and removing the requirement of testing products with multiple emission ranges. ((§ 770.18(d)). Also, EPA is proposing to have third-party certifiers determine whether test methods are adequately correlated or equivalent to the large chamber test method.

3. NAF/ULEF Provisions and Provisions for Reduced Quality Control Testing for MDF and Particleboard: EPA is not proposing to require panel producers to apply to EPA for the TPC exemption or reduced testing. EPA is proposing that the panel producer apply to an accredited TPC for a TPC exemption/reduced testing and send a copy of the application to EPA. Under the proposal, TPCs would be responsible for reviewing applications from panel producers, approving an application within 90 days of receipt if it demonstrates that the requirements under TSCA Title VI are met, notifying EPA of all approvals within 5 days of the approval, and forwarding copies of all approved applications to EPA within 30 days of receipt. (§ 770.7(c)(2)(iii)).

4. Hardwood Plywood and Laminated Products: Under the proposal, hardwood plywood includes laminated products, except "hardwood plywood does not include laminated products that are made by attaching a wood or woody grass veneer with a no-added formaldehyde-based resin to a core that has been manufactured in compliance with this subpart and that is either certified in accordance with § 770.15, manufactured with no-added formaldehyde-based resins under § 770.17, or manufactured with ultra low-emitting formaldehyde-based resins under § 770.18(d)." (§ 770.3)

5. The Definition of Laminated Products: EPA is proposing a broader definition of laminated products which would include some products that are considered HWPW under the CARB ATCM. EPA is proposing to define "Laminated product" to mean "a product in which a wood or woody grass veneer is affixed to a particleboard platform, a medium-density fiberboard platform, or a veneer core platform. A laminated product is a component part used in the construction or assembly of a finished good." (§ 770.3)

5. Engineered Veneer: EPA is not proposing to exempt engineered veneer from the statutory definition of hardwood plywood.

6. Record Retention Period: EPA is proposing a 3 year record retention period for all record keeping requirements in the regulations.

7. Stockpiling: TSCA Title VI directs EPA to base the stockpiling provisions on a "manufactured-by date," as opposed to a "sell-by date." So products can be sold at any point before or after the program takes effect provided they were manufactured before the designated date of manufacture.  Under the proposal "stockpiling" is defined as "manufacturing or purchasing composite wood products, whether in the form of panels or incorporated into finished goods, between July 7, 2010 and [date 180 days after publication of the final rule in the Federal Register] at an average rate at least 20% greater than the average rate of manufacture or purchase during the 2009 calendar year for the purpose of circumventing the emission standards and other requirements of this subpart." (§ 770.3; § 770.12)

8. Labeling: EPA's proposal would require labels to have a statement that the product is TSCA Title VI compliant in addition to the information the CARB ATCM requires to appear on labels. (§ 770.45).

9. Definition of "Hardboard": EPA proposes to define "hardboard" as "a panel composed of cellulosic fibers made by dry or wet forming and hot pressing of a fiber mat, either without resins, or with a phenolic resin (e.g., a phenol-formaldehyde resin) or a resin system in which there is no added formaldehyde as part of the resin cross-linking structure, as determined under one of the following ANSI standards: ANSI A135.4 (Basic Hardboard), ANSI A135.5 (Prefinished Hardboard Paneling), or ANSI A135.6 (Hardboard Siding)." (§ 770.3) Under this proposed definition, products made with urea formaldehyde resin, would not be considered "hardboard."

10. Non-Complying Lots: The EPA proposal states that, "[n]on-complying lots are not certified composite wood products and they may not be sold, supplied or offered for sale in the United States except in accordance with this section." (§ 770.22) The proposal would require panel producers to hold on to lots selected for sampling until passing test results are received.  (§ 770.20(b)(3)&(c)(2)(iv)).

11. Import Certification Requirements: Under TSCA Title VI importers must comply with the import certification requirements found at 19 CFR §§ 12.118 through 12.127 or as later promulgated. (§ 770.30(c)).

12. Accreditation Bodies (ABs): EPA is proposing to recognize certain product and laboratory ABs to accredit TPCs to provide TSCA Title VI certifications.  (§ 770.7(a) &(b)).

13. Third-Party Certifiers: EPA is proposing that TPCs must be accredited by an EPA recognized product and laboratory AB. In addition, TPCs that not are located domestically will need to designate an agent within the United States. (§ 770.7(c)).

      14. Recordkeeping: EPA's proposal provides that importers, fabricators, and laminated product producers must obtain and keep the following records: (1) Records identifying the panel producer and the date the composite wood products were produced; (2) Records identifying the date the composite wood products were purchased; (3) Bills of lading or invoices that include a written affirmation from the supplier that the composite wood products are compliant with this subpart. (§ 770.30). Distributors and retailers would only be required to retain invoices and bills of lading and copies of labels used. (§ 770.40 (e)).
15. Length of TPC Accreditation/Approval: EPA is proposing that TPCs are approved/accredited for 3 years, subject to renewals. (§ 770.7(c)).