[Federal Register: March 21, 2007 (Volume 72, Number 54)]
[Rules and Regulations]
[Page 13168-13174]
[DOCID:fr21mr07-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0579; FRL-8114-4]

Spinosad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and amends tolerances for residues
of spinosad in or on certain commodities. The Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 21, 2007. Objections and
requests for hearings must be received on or before May 21, 2007, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0579. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0579 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before May 21, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0579, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday,

excluding legal holidays). Special arrangements should be made for
deliveries of boxed information. The Docket telephone number is (703)
305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 14, 2006 (71 FR 40105) (FRL-8077-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
6E7068 and 3E6802) by the IR-4, 500 College Rd. East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.495 be
amended by establishing a tolerance for residues of the insecticide
spinosad, in or on hops at 22 parts per million (ppm) (under PP 6E7068)
and amaranth, grain, stover at 10 ppm; cattle, meat at 2 ppm; sheep,
meat at 2 ppm; goat, meat at 2 ppm; horse, meat at 2 ppm; poultry, meat
at 0.1 ppm; cattle, fat at 50 ppm; sheep, fat at 50 ppm; goat, fat at
50 ppm; horse, fat at 50 ppm; poultry, fat at 1.3 ppm; milk at 7.0 ppm;
milk, fat at 85 ppm; and egg at 0.3 ppm (under PP 3E6802).
    Additionally, existing tolerances for meat byproducts which are
currently based on residues in liver will be amended to establish
separate liver tolerances and lower the meat byproducts tolerances
which will now be based on residues in the kidney as follows: Cattle,
meat byproducts, except liver at 5 ppm; sheep, meat byproducts, except
liver at 5 ppm; goat, meat byproducts, except liver at 5 ppm; horse,
meat byproducts, except liver at 5 ppm; poultry meat byproducts
tolerance raised from 0.03 ppm and set at 0.1 ppm; cattle, liver at 10
ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and horse, liver at
10 ppm (under PP 3E6802). That notice referenced a summary of the
petition prepared by Dow AgroScience, the registrant, that is available
in the docket for this rulemaking. There were no comments received in
response to the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm and http://

://

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for residues of spinosad in or on
hop, dried cones at 22 ppm; amaranth, grain, stover at 10 ppm; cattle,
meat at 2.0 ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm; horse,
meat at 2.0 ppm; poultry, meat at 0.10 ppm; cattle, fat at 50 ppm;
sheep, fat at 50 ppm; goat, fat at 50 ppm; horse, fat at 50 ppm;
poultry, fat at 1.30 ppm; milk at 7.0 ppm; milk, fat at 85 ppm; and egg
at 0.30 ppm. Additionally, existing tolerances for meat byproducts
which are based on residues in liver will be amended to establish
separate liver tolerances and lower the meat byproducts tolerances
which will now be based on residues in the kidney as follows: Cattle,
meat byproducts, except liver at 5.0 ppm; sheep, meat byproducts,
except liver at 5.0 ppm; goat, meat byproducts, except liver at 5.0
ppm; horse, meat byproducts, except liver at 5.0 ppm; poultry meat
byproducts tolerance raised from 0.03 ppm and set at 0.10 ppm; cattle,
liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and
horse, liver at 10 ppm. EPA's assessment of exposures and risks
associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by spinosad 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 Federal
Register of September 27, 2002 (67 FR 60923) (FRL-7199-5).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the lowest
dose at which the LOAEL is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for spinosad used for
human risk assessment can be found at http://www.regulations.gov in the

following indices:
    1. Docket ID number EPA-HQ-OPP-2006-0579, entitled Application of
Spinosad to Hops and as a Mosquito Larvicide. Human Health Risk
Assessment, dated August 2, 2006.
    2. Docket ID number EPA-HQ-OPP-2005-0510, entitled PPs 3E6699,
3E6780, and 4E6811. Application of Spinosad to Mint; Banana; Plantain;
Peanut; Bulb Vegetables; Legume Vegetables; Forage, Fodder, and Straw
of Cereal Grains (crop group 16); Grass Forage, Fodder, and Hay (crop
group 17); and Nongrass Animal Feeds (crop group 18) and Application of
Spinosad for Control of Fruit Flies. HED Risk Assessment, dated
September 15, 2005.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.495) for the residues of spinosad, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from spinosad 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.
    The Agency did not select a dose and endpoint for an acute dietary
risk assessment due to the lack of toxicological effects of concern
attributable to a single exposure (dose) in studies available in the
database including oral developmental toxicity studies in rats and
rabbits. In the acute neurotoxicity study, the NOAEL was 2,000
milligrams/kilograms/day (mg/kg/day), highest dose tested. An acute
dietary exposure assessment is not required.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEM-FCID\TM\) version 2.03
(acute and cancer endpoints were not identified), which incorporates
food consumption data as reported by respondents in the U.S. Department
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII), and accumulated exposure to the
chemical for each commodity. The chronic dietary analyses assumed
average/projected percent crop treated (PPCT) estimates; projected
percent head treated resulting from the dermal and premise treatments
to ruminants, average field trial residues, and experimentally
determined processing factors; and anticipated livestock residues. The
chronic analysis assumed tolerance level residues for all crop,
poultry, and egg commodities and anticipated residues for ruminant and
milk commodities.
    iii. Cancer. Spinosad has been classified as not likely to be
carcinogenic in humans based on the results of a carcinogenicity study
in mice and the combined chronic toxicity and carcinogenicity study in
rats. Therefore, a quantitative cancer exposure assessment was not
performed.
    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 chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to FFDCA section 408(f)(1) require 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. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. For the
present action, EPA will issue such data call-ins for information
relating to anticipated residues as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data
call-ins will be required to be submitted no later than 5 years from
the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
    The Agency used PCT information as follows: Almond 5%; apple 30%;
apricot 10%; avocado 5%; broccoli 40%; brussel sprout 15%; cabbage 30%;
cantaloupes 10%; cauliflower 45%; celery 50%; cherry 25%; citrus 5%,
excluding lemon, tangerine, and orange; collards 25%; corn, sweet 1%;
cotton 5%; cucumber 20%; eggplant 15%; green, mustard 15%; green,
turnip 5%; kale 30%; lemon 10%; lettuce 50%; nectarine 30%; orange 10%;
peach 5%; pear 10%; pepper 35%; potato 5%; prune and plum 10%; spinach
30%; squash 10%; strawberry 35%; tangerine 10%; tomato 20%; and
watermelon 5%.
    Exposure analysis also incorporated projected percent ruminant head
treated resulting from the registered dermal and premise use (dairy
cattle 23% and beef cattle 31%, actual data are not available despite
this being a registered use) and projected PCT for alfalfa of 1%.
    EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, State, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five except for those situations in which the
average PCT is less than one. In those cases assumed not less than 1%,
is used as the average and 2.5% is used the maximum. EPA uses a maximum
PCT for acute dietary risk analysis. The maximum PCT figure is the
single maximum value reported overall from available Federal, State,
and private market survey data on the existing use, across all years,
and rounded up to the nearest multiple of five. In most cases, EPA uses
available data from USDA/National Agricultural Statistics Service
(USDA/NASS), Proprietary Market Surveys, and the National Center for
Food and Agriculture Policy (NCFAP) for the most recent 6 years.
    EPA estimates PPCT for a new pesticide Use for use in chronic
dietary risk assessment by assuming that the PCT during the pesticide's
initial 5 years of use on a specific use site will not exceed the
average PCT of the dominant pesticide (i.e., the market leader
pesticide with the greatest PCT) on that site over the three most
recent pesticide usage surveys. Comparisons are only made among
pesticides of the same pesticide types (i.e., the dominant insecticide
on the use site is selected for comparison with the new insecticide).
The PCTs included in the average may be each for the same pesticide or
for different pesticides since the same or different pesticides may
dominate for each year selected. Typically, EPA uses data from the
USDA/NASS as the source for the PCT data because they are publicly
available. When a specific use site is not surveyed by USDA/NASS, EPA
uses other data which may include proprietary data.
    The estimated PPCT, equivalent to the average PCT of the market
leader is appropriate for use in the chronic dietary risk assessment.
This method of estimating a PPCT for a new use of a registered
pesticide produces a high-end estimate that is unlikely, in most cases,
to be exceeded during the initial 5 years of actual use.
    The predominant factors that bear on whether the estimated PPCT
could be exceeded are whether the new pesticide use is more efficacious
or controls a broader spectrum of pests than the dominant pesticides,
whether there are

concerns with pest pressure as indicated in emergency exemption
requests or other readily available information, and/or other factors
based on analysis of additional information. All information readily
available has been considered for spinosad on dairy cattle, beef cattle
and alfalfa, and it is the opinion of the Agency that it is unlikely
that actual PCTs for spinosad on these sites will exceed the
corresponding estimated PPCTs during the next 5 years. For cattle, the
estimated PPCTs likely would not be exceeded because spinosad generally
is more expensive than the leading alternative insecticides although it
has efficacy on the same order for the targeted pests. For alfalfa, its
estimated PPCT likely also would not be exceeded because it is
considerably more expensive than the leading alternative, and
treatments for the targeted pest, armyworms, have been relatively small
on average over the past 8 years.
    The Agency believes that the three conditions listed in Unit
III.C.1.iv. have been met. With respect to Condition 1, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions 2 and 3, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which spinosad may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for spinosad in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of spinosad. 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.

    Typically, EPA evaluates the potential for human exposure to
pesticides in drinking water through an assessment of available surface
water and ground water monitoring data and modeling. For spinosad, no
monitoring data were available for use in this drinking water
assessment. Therefore, potential human exposures to spinosad were
evaluated through modeling. Estimated exposure concentrations (EECs) in
surface water were calculated using Pesticide Root Zone Model/Exposure
Analyses Modeling System (PRZM/EXAMS). Ground water concentrations were
modeled using Screening Concentration in Ground Water (SCI-GROW)
(version 2.3). Drinking water residues were then incorporated into the
DEEM-FCID\TM\ into the food categories ``water, direct, all sources''
and ``water, indirect, all sources.''
    Available environmental fate data indicate that the spinosad
transformation products maintain the basic ring structure of spinosad
and that combined spinosad and its transformation products are stable.
Therefore, the Agency concluded that a total residue method should be
used when estimating spinsad residues in water, and that spinosad and
its transformation products are stable under the aqueous photolysis,
aerobic soil metabolism, and anaerobic aquatic metabolism conditions.
    Based on modeling results from surface water FQPA Index Reservoir
Screening Tool (FIRST) and ground water SCI-GROW drinking water
concentrations from application of spinosad to turf (4 x 0.4 pound
active ingredient/acre (lb ai/acre); re-entry interval (RTI) = 7 days;
highest registered/proposed rate excluding the mosquito larvicide use):
The EECs of spinosad for acute exposures are 34.5 parts per billion
(ppb), 10.5 ppb for chronic exposures, and 1.1 ppb for ground water.
The dietary exposure assessment assumed a water concentration of 10.5
ppb for all water sources (direct and indirect). Modeled estimates of
drinking water concentrations were directly entered into the dietary
exposure model (DEEM-FCID\TM\).
    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).
    Spinosad is currently registered for use on numerous crops with
tolerances for combined residues of spinosad ranging from 0.01 to 200
ppm, as well as residential, non-dietary sites including turf and
ornamentals to control a variety of worms, moths, flies, beetles,
midges, thrips, leafminers, and fire ants. Granular (homeowner) and EC
(commercial applicators) formulations are registered. No dermal
endpoints were identified and based on the granular formulation and
low-vapor pressure for spinosad, residential handler/applicator and
post-application dermal/inhalation exposure assessments were not
conducted. The Agency concluded that there is a potential for toddler
short-term, non-dietary, oral exposures (hand-to-mouth, object-to-
mouth, ingestion of granulars, and soil ingestion). Since EPA did not
identify an acute dietary endpoint, episodic ingestion of granulars was
not assessed.
    The Agency notes that the registered fruit fly bait application
scenario permits application to non-crop vegetation and this use may
result in residential exposures. Based on the application rates (fruit
fly bait--0.0003 lb ai/acre and turf/ornamental--0.41 lbs ai/acre), EPA
concludes that residential exposure resulting from the fruit fly
application will be insignificant when compared to the exposure
resulting from the turf/ornamental application. Therefore, quantitative
analysis of the residential exposure resulting from the fruit fly bait
application was not performed.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to spinosad and any other
substances and spinosad does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that spinosad has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by

EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rat and rabbit fetuses to in utero and/or
postnatal exposure to spinosad.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicological database for spinosad is complete for FQPA
assessment.
    ii. There is no evidence of increased susceptibility of rat or
rabbit fetuses following in utero exposure in the developmental studies
with spinosad, and there is no evidence of increased susceptibility of
young rats in the reproduction study with spinosad.
    iii. There are no residual uncertainties identified in the exposure
databases; the dietary food exposure assessment (chronic only; no acute
endpoint was identified) is refined using anticipated residues
calculated from field trial data and available PCT information.
    iv. EPA has indicated that the dietary drinking water exposure is
based on conservative modeling estimates.
    v. EPA Residential Standard Operational Procedures (SOPs) were used
to assess post-application exposure to children as well as incidental
oral exposure of toddlers, so these assessments do not underestimate
the exposure and risks posed by spinosad.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability
of additional cancer cases given aggregate exposure. Short-,
intermediate-, and long-term risks are evaluated by comparing aggregate
exposure to the LOC to ensure that the MOE called for by the product of
all applicable uncertainty/safety factors is not exceeded.
    1. Acute risk. As there were no toxic effects attributable to a
single dose, an endpoint of concern was not identified for the general
population or to the subpopulation females 13-50 years old. No acute
risk is expected from exposure to spinosad.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to spinosad
from food and water will utilize 37% of the cPAD for the U.S.
population, 32% of the cPAD for all infants less than a year old, and
86% of the cPAD for children 1-2 years old. Based on the use pattern,
chronic residential exposure to residues of spinosad is not expected.
Therefore, EPA does not expect the aggregate exposure to exceed 100% of
the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Spinosad is currently registered for uses (turf and ornamental
application) that could result in short-term residential exposures
(incidental oral exposures to toddlers). This incidental oral exposure
is combined with chronic dietary (food and water) exposure for
determination of aggregate short-term exposure. The Agency uses chronic
dietary exposure when conducting short-term aggregate assessments as it
has been determined this will more accurately reflect exposure from
food than will acute exposure.
    Upon analyses of all available data, resulting aggregate MOEs are
greater than or equal to 160. Therefore, the Agency concludes that
short-term aggregate exposure to spinosad from food and residential
uses is below the LOC.
    4. Aggregate cancer risk for U.S. population. Spinosad has been
classified as ``not likely to be carcinogenic in humans'' based on the
results of a carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in rats. Therefore, spinosad is not
expected to pose a cancer risk to humans.
    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, and to infants and children from aggregate
exposure to spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There is a practical method; liquid chromatography mass
spectroscopy-accelerated climate prediction initiative (LCMS-ACPI) for
detecting and measuring levels of spinosad in or on food with a limit
of detection (0.002 ppm) that allows monitoring of food with residues
at or above the level set for these tolerances. The method has
undergone successful EPA laboratory validation.
    Adequate enforcement methodology using high pressure liquid
chromatography with ultraviolet detector (HPLC/UV) is available to
enforce the tolerances in plants. Adequate livestock methods are
available for tolerance enforcement. Method RES 94094 (GRM 95.03) is an
HPLC/UV method suitable for determination of spinosad residues in
ruminant commodities. Method GRM 95.03 has undergone successful
independent laboratory validation (ILV) and EPA laboratory validation,
and has been forwarded to the Food and Drug Administration (FDA) for
inclusion in PAM Volume II. Method GRM 95.15 is another HPLC/UV method
suitable for determination of spinosad residues in poultry commodities.
This method has been forwarded to FDA for inclusion in PAM Volume II.
Method RES 95114, an immunoassay method for determination of spinosad
residues in ruminant commodities, underwent a successful ILV and EPA
laboratory validation. It has been submitted to FDA for inclusion in
PAM Volume II. The methods may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) have
been established for residues of spinosad on the raw agricultural
commodities associated with this action.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad.
Spinosad is a fermentation product of Saccharopolyspora spinosa. The
product consist of two selected active ingredients: Spinosyn A (Factor
A: CAS 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-
L-manno-pyranosyl)oxy]-13-[[5(dimethylamino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione; and Spinosyn D (Factor D; CAS 131929-63-0) or 2-[(6-
deoxy-2,3,4-tri-O-methyl-[alpha]L-manno-pyranosyl)oxy]-13-[[5(dimethyl-
amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on hop, dried cones
at 22 ppm and amaranth, grain, stover at 10 ppm; cattle, meat at 2.0
ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm; horse, meat at 2.0
ppm; poultry, meat at 0.10 ppm; cattle, fat at 50 ppm; sheep, fat at 50
ppm; goat, fat at 50 ppm; horse, fat at 50 ppm; poultry, fat at 1.3
ppm; milk at 7.0 ppm; milk, fat at 85 ppm; egg at 0.30 ppm; cattle,
meat byproducts, except liver at 5.0 ppm; sheep, meat byproducts,
except liver at 5.0 ppm; goat, meat byproducts, except liver at 5.0
ppm; horse, meat byproducts, except liver at 5.0 ppm; poultry meat
byproducts tolerance raised from 0.03 ppm and set at 0.10 ppm; cattle,
liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and
horse, liver at 10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to petitions 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 due to its lack of
significance, this final rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This action does not alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this final rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This final rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this final rule.

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: March 5, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. The table in paragraph (a) of Sec.  180.495 is amended by:
0
i. Alphabetically adding amaranth, grain, stover; cattle, liver; goat,
liver; hop, dried cones; horse, liver; and sheep, liver.
0
ii. Revising the remainder of the entries listed.
    The additions and revisions to the table in paragraph (a) read as
follows:

Sec.  180.495  Spinosad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
                                * * * * *
Amaranth, grain, stover...........                 10               None
                                * * * * *
Cattle, fat.......................                 50               None
Cattle, liver.....................                 10               None
Cattle, meat......................                2.0               None
Cattle, meat byproducts, except                   5.0               None
 liver............................
                                * * * * *
Egg...............................               0.30               None
                                * * * * *
Goat, fat.........................                 50               None
Goat, liver.......................                 10               None
Goat, meat........................                2.0               None
Goat, meat byproducts, except                     5.0               None
 liver............................
                                * * * * *
Hop, dried cones..................                 22               None
Horse, fat........................                 50               None
Horse, liver......................                 10               None
Horse, meat.......................                2.0               None
Horse, meat byproducts, except                    5.0               None
 liver............................
                                * * * * *
Milk..............................                7.0               None
Milk, fat.........................                 85               None
                                * * * * *
Poultry, fat......................                1.3               None
Poultry, meat.....................               0.10               None
Poultry, meat byproducts..........               0.10               None
                                * * * * *
Sheep, fat........................                 50               None
Sheep, liver......................                 10               None
Sheep, meat.......................                2.0               None
Sheep, meat byproducts, except                    5.0               None
 liver............................
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-4760 Filed 3-20-07; 8:45 am]

BILLING CODE 6560-50-S


Enclosure
1
County
Designation
Recommendation
Adams
Attainment/
unclassifiable
Allen
Attainment
Bartholomew
Attainment/
unclassifiable
Benton
Attainment/
unclassifiable
Blackford
Attainment/
unclassifiable
Boone
Attainment/
unclassifiable
Brown
Attainment/
unclassifiable
Carroll
Attainment/
unclassifiable
Cass
Attainment/
unclassifiable
Clark
Nonattainment
Clay
Attainment/
unclassifiable
Clinton
Attainment/
unclassifiable
Crawford
Attainment/
unclassifiable
Daviess
Attainment/
unclassifiable
Dearborn
Attainment/
unclassifiable
Decatur
Attainment/
unclassifiable
DeKalb
Attainment/
unclassifiable
Delaware
Attainment
Dubois
Nonattainment
Elkhart
Nonattainment
Fayette
Attainment/
unclassifiable
Floyd
Attainment
Fountain
Attainment/
unclassifiable
Franklin
Attainment/
unclassifiable
Fulton
Attainment/
unclassifiable
Gibson
Attainment/
unclassifiable
Grant
Attainment/
unclassifiable
Greene
Attainment/
unclassifiable
Hamilton
Attainment/
unclassifiable
Hancock
Attainment/
unclassifiable
Harrison
Attainment/
unclassifiable
Hendricks
Attainment/
unclassifiable
Henry
Attainment
Howard
Attainment
Huntington
Attainment/
unclassifiable
Jackson
Attainment/
unclassifiable
Jasper
Attainment/
unclassifiable
Jay
Attainment/
unclassifiable
Jefferson
Attainment/
unclassifiable
Jennings
Attainment/
unclassifiable
Johnson
Attainment/
unclassifiable
Knox
Attainment/
unclassifiable
Kosciusko
Attainment/
unclassifiable
LaGrange
Attainment/
unclassifiable
Lake
Nonattainment
LaPorte
Attainment
Enclosure
1
County
Designation
Recommendation
Lawrence
Attainment/
unclassifiable
Madison
Attainment
Marion
Nonattainment
Marshall
Attainment/
unclassifiable
Martin
Attainment/
unclassifiable
Miami
Attainment/
unclassifiable
Monroe
Attainment/
unclassifiable
Montgomery
Attainment/
unclassifiable
Morgan
Attainment/
unclassifiable
Newton
Attainment/
unclassifiable
Noble
Attainment/
unclassifiable
Ohio
Attainment/
unclassifiable
Orange
Attainment/
unclassifiable
Owen
Attainment/
unclassifiable
Parke
Attainment/
unclassifiable
Perry
Attainment/
unclassifiable
Pike
Attainment/
unclassifiable
Porter
Attainment
Posey
Attainment/
unclassifiable
Pulaski
Attainment/
unclassifiable
Putnam
Attainment/
unclassifiable
Randolph
Attainment/
unclassifiable
Ripley
Attainment/
unclassifiable
Rush
Attainment/
unclassifiable
St.
Joseph
Attainment
Scott
Attainment/
unclassifiable
Shelby
Attainment/
unclassifiable
Spencer
Attainment
Starke
Attainment/
unclassifiable
Steuben
Attainment/
unclassifiable
Sullivan
Attainment/
unclassifiable
Switzerland
Attainment/
unclassifiable
Tippecanoe
Attainment/
Unclassifiable
Tipton
Attainment/
unclassifiable
Union
Attainment/
unclassifiable
Vanderburgh
Nonattainment
Vermillion
Attainment/
unclassifiable
Vigo
Attainment
Wabash
Attainment/
unclassifiable
Warren
Attainment/
unclassifiable
Warrick
Attainment
Washington
Attainment/
unclassifiable
Wayne
Attainment/
unclassifiable
Wells
Attainment/
unclassifiable
White
Attainment/
unclassifiable
Whitley
Attainment/
unclassifiable


[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Page 9422]
[FR Doc No: 2010-4195]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Tobacco Products Scientific Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Tobacco Products Scientific Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 30 and 31, 2010,
from 8:30 a.m. to 5 p.m.
    Location: National Transportation Safety Board (NTSB) Conference
Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (at Metro's
L'Enfant Plaza station; parking is limited and public transportation is
recommended.)
    Contact Person: Cristi Stark, Office of Science, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On March 30, 2010, the Tobacco Products Scientific Advisory
Committee will cover the following two topics: (Topic 1) Receive
presentations on the background and overview of the FDA Center for
Tobacco Products, the Family Smoking Prevention and Tobacco Control Act
(the Tobacco Control Act), and the Tobacco Products Scientific Advisory
Committee; and (Topic 2) receive presentations on and discuss the
published literature on menthol as it relates to the demographics of
users, preferential use by persons initiating tobacco use, the health
effects of menthol in cigarettes, the effects of menthol on addiction
and cessation, marketing and consumer perceptions about menthol
cigarettes, the sensory qualities of menthol cigarettes, and the
effects of menthol on how cigarettes are smoked. On March 31, 2010, the
Committee will continue the presentations and discussions of topic 2;
and also receive preliminary information about topics planned for
discussion at future meetings, including an action plan designed to
ensure the enforcement of restrictions required by the Tobacco Control
Act on the advertising and promotion of menthol and other cigarettes to
youth, and the establishment of a list of harmful and potentially
harmful tobacco product constituents, including smoke constituents.
These discussions are preliminary to the preparation of the Tobacco
Products Scientific Advisory Committee's required report to the
Secretary of Health and Human Services regarding the impact of use of
menthol in cigarettes on the public's health. A second meeting of the
Tobacco Products Scientific Advisory Committee, focusing on tobacco
industry research and documents related to menthol and cigarettes, is
planned for summer 2010.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written subissions may be made to the contact person on or before March
22, 2010. Oral presentations from the public will be scheduled between
approximately 9:30 a.m. and 10:30 a.m. on March 31, 2010. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before March 12, 2010. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by March 15, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Cristi Stark at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 24, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-4195 Filed 3-1-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70179-70180]
[FR Doc No: 2014-27816]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2003-0013: FRL 9919-78-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Title IV of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002: Drinking Water
Security and Safety

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) has submitted
an information collection request (ICR), ``Title IV of the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002:
Drinking Water Security and Safety'' (EPA ICR No. 2103.05, OMB Control
No. 2040-0253) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). This is a proposed extension of the ICR, which is
currently approved through November 30, 2014. Public comments were
previously requested via the Federal Register on July 16, 2014, during
a 60-day comment period. This notice allows for an additional 30 days
for public comments. A fuller description of the ICR is provided in
this request, including its estimated burden and cost to the public. An
Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Additional comments may be submitted on or before December 26,
2014.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OW-2003-0013, to (1) EPA online using www.regulations.gov (our
preferred method), or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Karen Edwards, Water Security
Division, Office of Ground Water and Drinking Water, Mailcode: 4608T,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-0055; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Section 1433 of the Safe Drinking Water Act, as amended
by the Bioterrorism Act, requires each community water system serving a
population of more than 3,300 people to conduct a vulnerability
assessment of its water system and to prepare or revise an emergency
response plan that incorporates the results of the vulnerability
assessment. These requirements are mandatory under the statute. EPA
will continue to use the information collected under this ICR to
determine whether community water systems have conducted vulnerability
assessments and prepared or revised emergency response plans in
compliance with Section 1433. EPA is required to protect all
vulnerability assessments and all information derived from them from
disclosure to unauthorized parties and has established an Information
Protection Protocol describing how that will be accomplished.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are community water systems serving more than 3,300
persons.
    Respondent's obligation to respond: Mandatory (Section 1433 of the
Safe Drinking Water Act, as amended by the Bioterrorism Act).

    Estimated number of respondents: 80 (total).
    Frequency of response: Once.
    Total estimated burden: 8,994 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $803,501 (per year), includes $337 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is no increase of hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. The cost increase is an adjustment to the respondent
burden estimates to account for inflation.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2014-27816 Filed 11-24-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 24, 2009 (Volume 74, Number 55)]
[Rules and Regulations]
[Page 12247-12249]
[DOCID:fr24mr09-9]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1327; Directorate Identifier 2008-NM-161-AD;
Amendment 39-15859; AD 2009-06-22]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A318, A319, A320, and A321
Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing

airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    An A320 aircraft experienced an event where it was not possible
to open the reinforced cockpit door, even after power had been
removed from the aircraft. Investigation has identified that the
cockpit door latch/striker assembly may have overheated, causing
permanent internal damage prior to being electrically isolated by
the internal thermal fuse. This condition, in case of a rapid
decompression in the cockpit, would prevent the necessary unlocking/
opening of the door, which may lead to failure of the airplane
structure.

* * * * *
We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective April 28, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 28,
2009.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2141; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on December 23, 2008
(73 FR 78670). That NPRM proposed to correct an unsafe condition for
the specified products. The MCAI states:

    An A320 aircraft experienced an event where it was not possible
to open the reinforced cockpit door, even after power had been
removed from the aircraft. Investigation has identified that the
cockpit door latch/striker assembly may have overheated, causing
permanent internal damage prior to being electrically isolated by
the internal thermal fuse. This condition, in case of a rapid
decompression in the cockpit, would prevent the necessary unlocking/
opening of the door, which may lead to failure of the airplane
structure.
    To prevent this, an improved strike package/door bolting system,
including a Polymer Positive Temperature Coefficient (PPTC) element
(overheat protection) was introduced by Airbus Modification 35219 in
production and modification 35218 (Service Bulletin A320-25-1444)
in-service. The PPTC is a resettable thermistor and is installed on
the frame of the electrically-operated cockpit door latch/striker
assembly.
    The in-service implementation of this modification was
originally managed by an Airbus campaign but the rate of
installation by operators has not met the expected timescales,
making mandatory action necessary to address this.
    For the reasons described above, this AD requires the
installation of improved cockpit door latch/striker assemblies.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 620 products of U.S. registry.
We also estimate that it will take 6 work-hours per product to comply
with the basic requirements of this AD. The average labor rate is $80
per work-hour. Required parts will cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of this AD to the U.S. operators to be
$297,600, or $480 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http: http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2009-09-22 Airbus: Amendment 39-15859. Docket No. FAA-2008-1327;
Directorate Identifier 2008-NM-161-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective April
28, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A318-111, -112, -121, and -
122; A319-111, -112, -113, -114, -115, -131, -132, and -133; A320-
111, -211, -212, -214, -231, -232, -233; and A321-111, -112, -131, -
211, -212, -213, -231, and -232 series airplanes; certificated in
any category; equipped with a cockpit door latch/striker assembly
having part number AR4714-1 or AR4714-3.

Subject

    (d) Air Transport Association (ATA) of America Code 25:
Equipment/furnishings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    An A320 aircraft experienced an event where it was not possible
to open the reinforced cockpit door, even after power had been
removed from the aircraft. Investigation has identified that the
cockpit door latch/striker assembly may have overheated, causing
permanent internal damage prior to being electrically isolated by
the internal thermal fuse. This condition, in case of a rapid
decompression in the cockpit, would prevent the necessary unlocking/
opening of the door, which may lead to failure of the airplane
structure.
    To prevent this, an improved strike package/door bolting system,
including a Polymer Positive Temperature Coefficient (PPTC) element
(overheat protection) was introduced by Airbus Modification 35219 in
production and modification 35218 (Service Bulletin A320-25-1444)
in-service. The PPTC is a resettable thermistor and is installed on
the frame of the electrically-operated cockpit door latch/striker
assembly.
    The in-service implementation of this modification was
originally managed by an Airbus campaign but the rate of
installation by operators has not met the expected timescales,
making mandatory action necessary to address this.
    For the reasons described above, this AD requires the
installation of improved cockpit door latch/striker assemblies.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 8 months after the effective date of this AD: Replace
all cockpit door latch/striker assemblies having part number AR4714-
1 or AR4714-3 with modified units in accordance with Airbus Service
Bulletin A320-25-1444, Revision 02, dated August 1, 2006 (Airbus
Modification 35218).
    (2) Previous accomplishment of the replacement before the
effective date of this AD in accordance with Airbus Service Bulletin
A320-25-1444, dated April 29, 2005; or Revision 01, dated July 19,
2005; meets the requirements of paragraph (f)(1) of this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Tim
Dulin, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2008-0151, dated August 5, 2008; and Airbus Service
Bulletin A320-25-1444, Revision 02, dated August 1, 2006; for
related information.

Material Incorporated by Reference

    (i) You must use Airbus Service Bulletin A320-25-1444, Revision
02, dated August 1, 2006 to do the actions required by this AD,
unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; e-mail<EMAIL_ADDRESS>Internet
http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on March 12, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-5959 Filed 3-23-09; 8:45 am]

BILLING CODE 4910-13-P


(3) Nothing in this section shall relieve any service company
subject thereto from compliance with requirements as to record-
retention that may be prescribed by any other regulatory agency.
    (b) Accounting requirements.--(1) General. Unless otherwise
exempted or granted a waiver by Commission rule or order pursuant to
Sec. Sec.  366.3 and 366.4, beginning January 1, 2007, every service
company that is not a special-purpose company (e.g., a fuel supply
company or a construction company) shall maintain and make available to
the Commission such books, accounts, memoranda, and other records as
the Commission prescribes in parts 101 and 201 of this chapter, in
sufficient detail to permit examination, audit, and verification, as
necessary and appropriate for the protection of utility customers with
respect to jurisdictional rates. Every such service company shall
maintain and make available such books, accounts, memoranda, and other
records in such manner as are prescribed in parts 101 and 201 of this
chapter, and shall keep no other records with respect to the same
subject matter except:
    (i) Records other than accounts;
    (ii) Records required by federal or state law;
    (iii) Subaccounts or supporting accounts which are not inconsistent
with the accounts required either by the Uniform System of Accounts in
parts 101 and 201 of this chapter; and
    (iv) Such other accounts as may be authorized by the Commission.
    (2) Transition period. Until December 31, 2006, service companies
in holding company systems registered under the Public Utility Holding
Company Act of 1935 (15 U.S.C. 79a et seq.), as described in paragraph
(b)(1) of this section, may follow either the Commission's Uniform
System of Accounts in parts 101 and 201 of this chapter or the
Securities and Exchange Commission's Uniform System of Accounts in 17
CFR part 256.
    (3) Nothing in this section shall relieve any service company
subject thereto from compliance with requirements as to accounting that
may be prescribed by any other regulatory agency.

Sec.  366.23  FERC Form No. 60, annual report of service companies, and
FERC-61, narrative description of service company functions.

    (a) General.--(1) FERC Form No. 60. Unless otherwise exempted or
granted a waiver by Commission rule or order pursuant to Sec. Sec.
366.3 and 366.4, every service company in a holding company system that
is not a special-purpose company (e.g., a fuel supply company or a
construction company) shall file with the Commission by May 1, 2006 and
by May 1 each year thereafter, a report, FERC Form No. 60, for the
prior calendar year. Every such report shall be submitted on the FERC
Form No. 60 then in effect and shall be prepared in accordance with the
instructions incorporated in such form.
    (2) FERC-61. Unless otherwise exempted or granted a waiver by
Commission rule or order pursuant to Sec. Sec.  366.3 and 366.4, every
service company in a holding company system, including a special-
purpose company (e.g., a fuel supply company or a construction
company), that does not file a FERC Form No. 60 shall instead file with
the Commission by May 1, 2007 and by May 1 each year thereafter, a
narrative description, FERC-61, of the service company's functions
during the prior calendar year. In complying with this section, a
holding company may make a single filing on behalf of all such service
company subsidiaries.
    (3) For good cause shown, the Commission may extend the time within
which any such report or narrative description required to be filed
pursuant to paragraphs (a)(1) or (2) of this section is to be filed or
waive the requirements applicable to any such report or narrative
description. The authority to act on motions for extensions of time to
file any such reports or to waive the requirements applicable to any
such reports or narrative descriptions, including granting or denying
such motions, in whole or in part, is delegated to the Chief Accountant
or the Chief Accountant's designee.
    (b) Transition period.--Service companies in holding company
systems

exempted from the requirements of the Public Utility Holding Company
Act of 1935 (15 U.S.C. 79a et seq.) need not file an annual report,
FERC Form No. 60, for calendar years 2005 and 2006, after which they
must comply with the provisions of this section.

[FR Doc. 06-4042 Filed 5-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38149-38151]
[FR Doc No: 2018-16616]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1093]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Additive Petitions and Investigational Food
Additive Exemptions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information,

including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of our regulations regarding Food Additive Petitions and
Investigational Food Additive Exemptions.

DATES: Submit either electronic or written comments on the collection
of information by October 2, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 2, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-1093 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Additive Petitions and
Investigational Food Additive Exemptions.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Food Additive Petitions and Investigational Food Additive Exemptions--
21 CFR 570.17, 571.1, and 571.6

OMB Control Number 0910-0546--Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by

regulation for investigational use. Section 409(b) of the FD&C Act (21
U.S.C. 348(b)) specifies the information that must be submitted by a
petitioner to establish the safety of a food additive and to secure the
issuance of a regulation permitting its use.
    To implement the provisions of Sec.  409 of the FD&C Act, we issued
procedural regulations under 21 CFR part 571. These procedural
regulations are designed to specify more thoroughly the information
that must be submitted to meet the requirement set down in broader
terms by the FD&C Act. The regulations add no substantive requirements
to those indicated in the FD&C Act, but attempt to explain these
requirements and provide a standard format for submission to speed
processing of the petition. Labeling requirements for food additives
intended for animal consumption are also set forth in various
regulations contained in 21 CFR parts 501, 573, and 579. The labeling
regulations are considered by FDA to be cross-referenced to Sec.
571.1, which is the subject of this same OMB clearance for food
additive petitions.
    With regard to the investigational use of food additives, Sec.
409(j) of the FD&C Act (Sec.  409(j)) (21 U.S.C. 348(j)) provides that
any food additive, or any food bearing or containing such an additive,
may be exempted from the requirements of this section if intended
solely for investigational use by qualified experts. Investigational
use of a food additive is typically to address the safety and/or
intended physical or technical effect of the additive.
    To implement the provisions of Sec.  409(j), we issued regulations
under 21 CFR 570.17. These regulations are designed to specify more
thoroughly the information that must be submitted to meet the
requirement set down in broad terms by the FD&C Act. Labeling
requirements for investigational food additives are also set forth in
various regulations contained in 21 CFR 501. The labeling regulations
are considered by FDA to be cross-referenced to Sec.  570.17, which is
the subject of this same OMB clearance for investigational food
additive files.
    The information collected is necessary to protect the public
health. We use the information submitted by food manufacturers or food
additive manufacturers to ascertain whether the data establish the
identity of the substance, justify its intended effect in/on the food,
and establish that its intended use in/on food is safe.
    Description of Respondents: Respondents to this collection of
information are food manufacturers or food additive manufacturers.
    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
----------------------------------------------------------------------------------------------------------------
Food Additive Petitions:
    571.1(c) Moderate Category..              12               1              12           3,000          36,000
    571.1(c) Complex Category...              12               1              12          10,000         120,000
    571.6 Amendment of Petition.               2               1               2           1,300           2,600
Investigational Food Additive
 Files:
    570.17 Moderate Category....               4               1               4           1,500           6,000
    570.17 Complex Category.....               5               1               5           5,000          25,000
                                 -------------------------------------------------------------------------------
        Total Hours.............  ..............  ..............  ..............  ..............         189,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimate of the total annual responses on submissions
received during fiscal years 2016 and 2017. We base our estimate of the
hours per response upon our experience with the petition and filing
processes.
    Sec.  571.1(c) Moderate Category: For a food additive petition
without complex chemistry, manufacturing, efficacy or safety issues,
the estimated time requirement per petition is approximately 3,000
hours. We estimate that, annually, 12 respondents will each submit 1
such petition, for a total of 36,000 hours.
    Sec.  571.1(c) Complex Category: For a food additive petition with
complex chemistry, manufacturing, efficacy and/or safety issues, the
estimated time requirement per petition is approximately 10,000 hours.
We estimate that, annually, 12 respondents will each submit 1 such
petition, for a total of 120,000 hours.
    Sec.  571.6: For a food additive petition amendment, the estimated
time requirement per petition is approximately 1,300 hours. We estimate
that, annually, two respondents will each submit one such amendment,
for a total of 2,600 hours.
    Sec.  570.17 Moderate Category: For an investigational food
additive file without complex chemistry, manufacturing, efficacy, or
safety issues, the estimated time requirement per file is approximately
1,500 hours. We estimate that, annually, four respondents will each
submit one such file, for a total of 6,000 hours.
    Sec.  570.17 Complex Category: For an investigational food additive
file with complex chemistry, manufacturing, efficacy, and/or safety
issues, the estimated time requirement per file is approximately 5,000
hours. We estimate that, annually, five respondents will each submit
one such file, for a total of 25,000 hours.
    The burden for this information collected has not changed since the
last OMB approval.

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16616 Filed 8-2-18; 8:45 am]
 BILLING CODE 4164-01-P