[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Rules and Regulations]
[Page 23640-23645]
[DOCID:fr20my09-14]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0275; FRL-8412-6]

Iodosulfuron-methyl-sodium; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
iodosulfuron-methyl-sodium in or on wheat, forage; wheat, grain; wheat,
hay; and wheat, straw. Bayer Cropscience requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 20, 2009. Objections and
requests for hearings must be received on or before July 20, 2009, 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-2009-0275. All documents in the
docket are listed in the docket index available at http://
www.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 (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Hope Johnson, 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 those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

    In addition to accessing electronically available documents 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0275 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 as required by 40 CFR part 178
on or before July 20, 2009.
    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 this copy, identified by docket ID number
EPA-HQ-OPP-2009-0275, 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 Facility'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 Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of July 9, 2008 (73 FR 39289) (FRL-8371-2),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1F6299)
by Bayer Cropscience, 2 Alexander Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.580 be amended by
establishing tolerances for residues of the herbicide iodosulfuron-
methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5 triazin-2-
yl) ureidosulfonyl] benzoate, sodium salt, in or on wheat, grain at
0.02 parts per million (ppm); wheat, forage at 0.06 ppm; wheat, straw
at 0.05 ppm; and wheat, hay at 0.05 ppm. That notice referenced a
summary of the petition prepared by Bayer Cropscience, the registrant,
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
concluded that 40 CFR 180.580 can be amended by establishing tolerances
for residues of the herbicide iodosulfuron-methyl sodium, methyl 4-
iodo-2-[3-(4-methoxy-6-methyl-1,3,5 triazin-2-yl) ureidosulfonyl]
benzoate, sodium salt, in or on wheat, grain at 0.02 ppm; wheat, straw
at 0.05 ppm; wheat, hay at 0.05ppm; and wheat, forage at 0.10 ppm

instead of the petitioned for 0.06 ppm for wheat, forage. The reason
for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for the petitioned-for
tolerances for residues of iodosulfuron-methyl-sodium on wheat, forage
at 0.06 ppm; wheat, grain at 0.02 ppm; wheat, hay at 0.05 ppm; and
wheat, straw at 0.05 ppm. EPA's assessment of exposures and risks
associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by iodosulfuron-methyl-sodium as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov in document Iodosulfuron-Methyl-Sodium;
Human-Health Risk Assessment for Proposed Section 3 New Use on Wheat,
page 37 in docket ID number EPA-HQ-OPP-2009-0275.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    Iodosulfuron-methyl-sodium was assessed in a complete battery of
subchronic (mice and rats), chronic (mice, rats, and dogs),
carcinogenicity (mice and rats), developmental (rat and rabbit) and
reproductive (rat) toxicity studies. In general high doses typically in
the range of greater than 300 mg/kg/day were required to cause systemic
toxicity characterized as decreases in body weight, body weight gain,
hepatotoxicity in mice and/or dogs and gross and histopathological
changes in the hematopoietic system in dogs. Developmental toxicity was
seen only at the limit dose in the rats, no developmental toxicity was
seen in the rabbit, and no reproductive toxicity was seen in the rat.
    Hematopoietic-related toxicity was only seen in female dogs in both
the subchronic and chronic toxicity studies. The hematopoietic system
involved in the production of blood includes primarily the bone marrow,
spleen, and lymph nodes. In both the subchronic and chronic studies,
microscopic pathology of the bone marrow and spleen were seen at
approximately (50 m/k/day; LOAEL). The NOAEL was 8 mg/kg/day.
    The toxicity profile of iodosulfuron-methyl-sodium indicates that
the dog to be the most sensitive species with the effects on the
hematopoietic system being the most sensitive endpoint. The NOAEL
(approximately 8 mg/kg/day) based on the most sensitive endpoint is
used for assessing risk to intermediate (oral, dermal and inhalation
routes) and chronic (oral, dermal and inhalation routes) durations
resulting from exposure to iodosulfuron-methyl-sodium.
    A summary of the toxicological endpoints for iodosulfuron-methyl-
sodium used for human risk assessment can be found at http://
www.regulations.gov in document Iodosulfuron-Methyl-Sodium; Human-
Health Risk Assessment for Proposed Section 3 New Use on Wheat, page 13
in docket ID number EPA-HQ-OPP-2009-0275.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to iodosulfuron-methyl-sodium, EPA considered exposure under
the petitioned-for tolerances as well as all existing iodosulfuron-
methyl-sodium tolerances in (40 CFR 180.580). EPA assessed dietary
exposures from iodosulfuron-methyl-sodium 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.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA),
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance
level residues and 100% crop treated

information to complete the acute dietary exposure assessment. Drinking
water values were incorporated directly into the assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA, 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues and 100% crop treated information to complete the chronic
dietary exposure assessment. Drinking water values were incorporated
directly into the assessment.
    iii. Cancer. The Agency determined that iodosulfuron-methyl-sodium
was ``not likely to be a human carcinogen'' with regards to its
potential as a human carcinogen. This decision was based on the lack of
evidence for carcinogenicity in mice and rats. Iodosulfuron-methyl-
sodium was negative for mutagenicity in various assays. Furthermore,
registered sulfonyl urea compounds (structurally similar compounds)
have been found to be non-carcinogenic. Based on this weight-of-
evidence, an exposure assessment to evaluate cancer risk for
iodosulfuron-methyl-sodium was not necessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for iodosulfuron-methyl-sodium. Tolerance level residues and
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for iodosulfuron-methyl-sodium in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of iodosulfuron-methyl-sodium. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/oppefed1/models/
water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST),
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models,
the estimated drinking water concentrations (EDWCs) of iodosulfuron-
methyl-sodium for acute exposures are estimated to be 0.60 parts per
billion (ppb) for surface water and 0.00004 ppb for ground water. For
chronic exposures for non-cancer assessments are estimated to be 0.067
ppb for surface water and 0.00004 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 0.60 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.067 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Iodosulfuron-methyl-sodium is currently registered for the
following uses that could result in residential exposures: Ornamental
turf. EPA assessed residential exposure using the following
assumptions: As the ornamental turf use is labeled ``intended for
professional use,'' and therefore is not available for direct
residential use, a residential handler assessment was not conducted.
All applications for the turf use are to be performed by professional
(commercial) applicators. The ornamental turf product is intended for
use on ornamental turfgrass on golf courses, sports fields, commercial
lawns, cemeteries, parks, campsites, recreational areas, home lawns,
roadsides, school grounds and sodfarms. Based on this use pattern,
short and intermediate term risk was assessed.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found iodosulfuron-methyl-sodium to share a common
mechanism of toxicity with any other substances, and iodosulfuron-
methyl-sodium does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that iodosulfuron-methyl-sodium does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is qualitative
evidence of increased susceptibility based on the rat developmental
study where delayed ossification was observed in the fetuses of dams
that exhibited minimal maternal toxicity (salivation). Similarly, there
is qualitative and quantitative evidence of increased susceptibility
based on the multi-generation rat reproduction study where no parental
systemic effects were observed at the highest dose tested (HDT) and
offspring toxicity was observed at a lower dose. Susceptibility was not
observed in the developmental toxicity study in the rabbit.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for iodosulfuron-methyl-sodium is
complete, except for the requirements for an immunotoxicity, acute, and
subchronic neurotoxicity studies. The existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios and for
evaluation of the requirements under FQPA. EPA has determined that an
additional uncertainty factor is not required to account for potential
neurotoxicity or immunotoxicity. The reasons for this determination are
described as follows:
    a. The toxicity database for iodosulfuron-methyl-sodium is
complete, except for immunotoxicity testing. EPA began requiring
functional immunotoxicity testing of all food and non-food use
pesticides on December 26, 2007. Since this requirement went into
effect well after the tolerance petition was submitted, these studies
are not yet available for iodosulfuron-methyl-sodium.

    In the absence of specific immunotoxicity studies, EPA has
evaluated the available iodosulfuron-methyl-sodium toxicity data to
determine whether an additional database uncertainty factor is needed
to account for potential immunotoxicity. In the case of iodosulfuron-
methyl-sodium, the available data do not indicate a concern for
potential immunotoxicity. No treatment-related changes were seen in
hematology parameters, organ weights (thymus, spleen), gross necropsy
(enlarged lymph nodes) or histopathology (spleen, thymus, lymph nodes)
when tested up to and including the limit dose (1000 mg/kg/day) in mice
or rats. Marginal effects, manifested as histopathological changes in
the bone marrow and spleen, were seen in female dogs. Minimal to
moderate hyperplasia of the hematopoietic cells was seen in the one
female. No treatment-related changes were seen in male dogs. The
subcapsular congestion in the spleen is a common finding and is
probably related to the means of euthanasia since barbiturates can
cause the splenic musculature to relax and often leads to blood filled
spleens. Therefore, the lesions of the spleen are not evidence of
immunotoxicity. In the absence of corroborative changes in any
hematology parameters, weights of thymus, spleen and lymph nodes, or
histopathological changes in the thymus and lymph nodes in the dogs,
the changes observed are considered hematopoietic, not immunotoxic.
Therefore an additional uncertainty factor is not needed to account for
potential immunotoxicity.
    b. Acute and subchronic neurotoxicity testing is also required as a
result of changes made to pesticide data requirements in December 2007.
Although acute and subchronic neurotoxicity testing has not yet been
submitted, iodosulfuron-methyl-sodium does not belong to a class
chemical that would be expected to be neurotoxic. There is no evidence
of neurotoxicity in the data base in any species at any dose level. In
the 90-day dietary studies with mice and rats, there were no signs
indicative of neurotoxicity when tested at the limit dose (1000 mg/kg/
day). In both species, the LOAEL was based on decreases in body weight
and/or body weight gain. These findings indicate that the prospective
neurotoxicity studies will have to be tested at the Limit Dose and even
with the enhanced evaluation of neurotoxic parameters; these studies
will not yield a lower dose for risk assessment. Therefore, a database
uncertainty factor is not required.
     ii. While there is qualitative evidence of increased
susceptibility based on the rat developmental study, the developmental
toxicity manifested as delayed ossification (which are variations not
malformations) were seen only at the limit dose in the presence of
maternal toxicity, and with a clear NOAEL for the effect of concern.
Susceptibility was not observed in the developmental toxicity study in
the rabbit. Additionally no parental systemic effects were observed at
the limit dose and offspring toxicity was observed at a lower dose
(34.2 mg/kg/day; manifested as decreased pup viability on post-natal
day (PND) 0 and 4) in the multi-generation rat reproduction study. In
spite of the lack of parental toxicity, there was a well characterized
NOAEL/LOAEL for offspring toxicity; the developmental NOAEL is used for
the acute dietary risk assessment; and the NOAEL (7.3 mg/kg/day) used
for the chronic dietary risk assessment is approximately 47-fold lower
than the offspring NOAEL (346 mg/kg/day). Therefore, there is low
concern for increased susceptibility for iodosulfuron-methyl-sodium and
no additional uncertainty factor is needed.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to iodosulfuron-methyl-sodium in drinking water. EPA
used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by iodosulfuron-methyl-sodium.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to iodosulfuron-methyl-sodium will occupy <1.0 % of the aPAD for (all
infants (<1 year old)) the population group receiving the greatest
exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
iodosulfuron-methyl-sodium from food and water will utilize 3.1% of the
cPAD for (children 3-5 years old) the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
iodosulfuron-methyl-sodium is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Iodosulfuron-methyl-sodium is currently registered for use that
could result in short-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to iodosulfuron-
methyl-sodium.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate MOEs of
110,000 for children 3-5 years old and 420,000 for adults 20-49 years
old.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Iodosulfuron-methyl-sodium is currently registered for use that
could result in intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic exposure to
iodosulfuron-methyl-sodium through food and water with intermediate-
term exposures for iodosulfuron-methyl-sodium.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 21,000 for children 3-5 years old, and
84,000 for adults 20-49 years old.

    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence for carcinogenicity in mice and rats, iodosulfuron-methyl-
sodium is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to iodosulfuron-methyl-sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography using mass
spectrometric detection (LC/MS/MS) and by high performance liquid
chromatography with ultra violet detection (HPLC/UV)) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex MRLs for residues of iodosulfuron-methyl-sodium,
and no Mexican MRLs have been established. Canadian MRLs have been
established for certain residues of iodosulfuron-methyl-sodium;
however, no MRLs have been established for wheat commodities at this
time.

C. Revisions to Petitioned-For Tolerances

    Review of available field trial data indicate that the proposed
tolerance for wheat, forage (0.06 ppm) is too low; a tolerance of 0.10
ppm is appropriate based on the maximum residue limit (MRL) observed
in/on forage.

V. Conclusion

    Therefore, tolerances are established for residues of iodosulfuron-
methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5 triazin-2-
yl) ureidosulfonyl] benzoate, sodium salt, in or on wheat, forage at
0.10 ppm; wheat, grain at 0.02 parts per million (ppm); wheat, hay at
0.05 ppm; and wheat, straw at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under 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.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 11, 2009.
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. Section 180.580 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.580  Iodosulfuron-methyl-sodium; tolerances for residues.

    (a) * * *

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

                              * * * * * * *
Wheat, forage........................................               0.10
Wheat, grain.........................................               0.02
Wheat, hay...........................................               0.05

Wheat, straw.........................................               0.05
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-11633 Filed 5-19-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Rules and Regulations]
[Pages 42600-42603]
[FR Doc No: 2018-18150]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2018-0002; Internal Agency Docket No. FEMA-8543]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Adrienne L. Sheldon, PE, CFM, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 400 C

Street SW, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.
    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq., Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community    cancellation of    Current effective map   Date certain  Federal
      State and location             No.        sale of flood             date             assistance no longer
                                                 insurance in                              available  in SFHAs
                                                  community
----------------------------------------------------------------------------------------------------------------
           Region II

New Jersey:
    Brigantine, City of,              345286  May 15, 1970,      August 28, 2018.......  August 28, 2018.
     Atlantic County.                          Emerg; June 18,
                                               1971, Reg;
                                               August 28, 2018,
                                               Susp.
    Buena, Borough of,                340004  January 17, 1975,  ......do..............   Do.
     Atlantic County.                          Emerg; March 4,
                                               1983, Reg;
                                               August 28, 2018,
                                               Susp.
    Hamilton, Township of,            340009  November 26,       ......do..............   Do.
     Atlantic County.                          1971, Emerg;
                                               March 15, 1977,
                                               Reg; August 28,
                                               2018, Susp.
    Hammonton, Town of,               340010  July 7, 1975,      ......do..............   Do.
     Atlantic County.                          Emerg; January
                                               6, 1982, Reg;
                                               August 28, 2018,
                                               Susp.
    Linwood, City of, Atlantic        340011  March 27, 1974,    ......do..............   Do.
     County.                                   Emerg; January
                                               19, 1983, Reg;
                                               August 28, 2018,
                                               Susp.
    Longport, Borough of,             345302  July 10, 1970,     ......do..............   Do.
     Atlantic County.                          Emerg; June 18,
                                               1971, Reg;
                                               August 28, 2018,
                                               Susp.
    Margate City, City of,            345304  July 10, 1970,     ......do..............   Do.
     Atlantic County.                          Emerg; June 19,
                                               1971, Reg;
                                               August 28, 2018,
                                               Susp.

    Weymouth, Township of,            340536  August 13, 1975,   ......do..............   Do.
     Atlantic County.                          Emerg; August
                                               10, 1979, Reg;
                                               August 28, 2018,
                                               Susp.
           Region IV

North Carolina:
    Belville, Town of,                370545  September 15,      ......do..............   Do.
     Brunswick County.                         2003, Emerg;
                                               June 2, 2006,
                                               Reg; August 28,
                                               2018, Susp.
    Holden Beach, Town of,            375352  March 19, 1971,    ......do..............   Do.
     Brunswick County.                         Emerg; May 26,
                                               1972, Reg;
                                               August 28, 2018,
                                               Susp.
    Navassa, Town of,                 370593  May 19, 2005,      ......do..............   Do.
     Brunswick County.                         Emerg; June 2,
                                               2006, Reg;
                                               August 28, 2018,
                                               Susp.
    Shallotte, Town of,               370388  July 1, 1975,      ......do..............   Do.
     Brunswick County.                         Emerg; January
                                               3, 1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Varnamtown, Town of,              370648  N/A, Emerg; May    ......do..............   Do.
     Brunswick County.                         30, 2001, Reg;
                                               August 28, 2018,
                                               Susp.
           Region V

Michigan:
    Acme, Township of, Grand          260749  March 3, 1986,     August 28, 2018.......  August 28, 2018.
     Traverse County.                          Emerg; December
                                               18, 1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Bingham, Township of,             260772  August 29, 1986,   ......do..............   Do.
     Leelanau County.                          Emerg; September
                                               18, 1987, Reg;
                                               August 28, 2018,
                                               Susp.
    Cleveland, Township of,           260302  July 18, 1974,     ......do..............   Do.
     Leelanau County.                          Emerg; September
                                               1, 1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Elmwood, Township of,             260113  July 2, 1975,      ......do..............   Do.
     Leelanau County.                          Emerg; February
                                               2, 1983, Reg;
                                               August 28, 2018,
                                               Susp.
    Empire, Township of,              260765  June 16, 1986,     ......do..............   Do.
     Leelanau County.                          Emerg; September
                                               4, 1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Empire, Village of,               260605  April 8, 1975,     ......do..............   Do.
     Leelanau County.                          Emerg; November
                                               15, 1985, Reg;
                                               August 28, 2018,
                                               Susp.
    Garfield, Charter Township        260753  April 25, 1986,    ......do..............   Do.
     of, Grand Traverse County.                Emerg; December
                                               18, 1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Glen Arbor, Township of,          260604  March 7, 1975,     ......do..............   Do.
     Leelanau County.                          Emerg; September
                                               1, 1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Leelanau, Township of,            260114  June 5, 1975,      ......do..............   Do.
     Leelanau County.                          Emerg; April 2,
                                               1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Leland, Township of,              260760  May 5, 1986,       ......do..............   Do.
     Leelanau County.                          Emerg; March 18,
                                               1987, Reg;
                                               August 28, 2018,
                                               Susp.
    Northport, Village of,            260580  July 24, 1975,     ......do..............   Do.
     Leelanau County.                          Emerg; March 2,
                                               1989, Reg;
                                               August 28, 2018,
                                               Susp.
    Paradise, Township of,            260830  December 20,       ......do..............   Do.
     Grand Traverse County.                    1990, Emerg; May
                                               4, 1992, Reg;
                                               August 28, 2018,
                                               Susp.
    Peninsula, Township of,           260747  March 3, 1986,     ......do..............   Do.
     Grand Traverse County.                    Emerg; December
                                               18, 1986, Reg;
                                               August 28, 2018,
                                               Susp.
    Suttons Bay, Township of,         260770  July 21, 1986,     ......do..............   Do.
     Leelanau County.                          Emerg; April 3,
                                               1987, Reg;
                                               August 28, 2018,
                                               Susp.
    Suttons Bay, Village of,          260283  September 17,      August 28, 2018.......  August 28, 2018.
     Leelanau County.                          1973, Emerg;
                                               June 1, 1977,
                                               Reg; August 28,
                                               2018, Susp.
    Traverse City, City of,           260082  August 8, 1975,    ......do..............   Do.
     Grand Traverse and                        Emerg; December
     Leelanau Counties.                        15, 1982, Reg;
                                               August 28, 2018,
                                               Susp.
    Union, Township of, Grand         260805  April 23, 1987,    ......do..............   Do.
     Traverse County.                          Emerg; September
                                               30, 1988, Reg;
                                               August 28, 2018,
                                               Susp.
    Whitewater, Township of,          260794  January 29, 1987,  ......do..............   Do.
     Grand Traverse County.                    Emerg; September
                                               30, 1988, Reg;
                                               August 28, 2018,
                                               Susp.
           Region VI

Texas:
    Brown County,                     480717  June 6, 1990,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; March 1,
                                               1991, Reg;
                                               August 28, 2018,
                                               Susp.
    Brownwood, City of, Brown         480087  June 20, 1975,     ......do..............   Do.
     County.                                   Emerg; April 15,
                                               1981, Reg;
                                               August 28, 2018,
                                               Susp.
    Early, City of, Brown             480088  January 12, 1982,  August 28, 2018.......  August 28, 2018.
     County.                                   Emerg; July 1,
                                               1987, Reg;
                                               August 28, 2018,
                                               Susp.
----------------------------------------------------------------------------------------------------------------
Code for reading third column: Emerg. -- Emergency; Reg. -- Regular; Susp -- Suspension.
*-do- =Ditto.

    Dated: August 9, 2018.
Katherine B. Fox,
Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration--FEMA Resilience, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2018-18150 Filed 8-22-18; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24122-24124]
[FR Doc No: 2018-11132]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1558]

Food and Drug Administration's Evaluation of Approaches To
Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is evaluating its
current thinking regarding the design of studies intended to generate
data to support substantial evidence of effectiveness for
investigational new animal drugs intended for the prevention of
heartworm disease in dogs. We are specifically requesting public input
on possible alternative approaches for evaluating such products or
information to assist in the potential development of alternative
recommended study designs.

DATES: Submit either electronic or written comments on the proposed
method by August 22, 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 August 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 22, 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-2018-N-1558 for ``FDA's Evaluation of Approaches to Demonstrate
Effectiveness of Heartworm Preventatives for Dogs.'' 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.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to 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.
    Submit written requests for single copies of the proposed method to
the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. Persons with access to the internet may
obtain the draft guidance at either https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052417.pdf or https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: FDA is evaluating its current thinking
regarding the design of studies intended to generate data to support
substantial evidence of effectiveness for investigational new animal
drugs intended for the prevention of heartworm disease in dogs.
    An application for a new animal drug shall include ``evidence to
establish safety and effectiveness'' (21 CFR 514.1(b)(8)).
Additionally, ``an application may be refused unless it includes
substantial evidence of the effectiveness of the new animal drug as
defined in 514.4 [21 CFR 514.4]'' (21 CFR 514.1(b)(8)(ii)). Regarding
studies, under 21 CFR 514.4(b)(3)(i) substantial evidence of the
effectiveness of a new animal drug for each intended use and associated
conditions of use shall consist of a sufficient number of current
adequate and well-controlled studies of sufficient quality and
persuasiveness to permit qualified experts:
     To determine that the parameters selected for measurement
and the measured responses reliably reflect the effectiveness of the
new animal drug;
     To determine that the results obtained are likely to be
repeatable, and that valid inferences can be drawn to the target animal
population [(independent substantiation and inferential value)]; and
     To conclude that the new animal drug is effective for the
intended use at the dose or dose range and associated conditions of use
prescribed, recommended, or suggested in the proposed labeling.
    The current recommended approach to demonstrating substantial
evidence of effectiveness of an investigational new animal drug
intended for the prevention of heartworm disease is for sponsors to
conduct two laboratory dose confirmation studies and one multi-site
field safety and effectiveness study under the principles of Good
Clinical Practice (GCP) as described in Guidance for Industry #85,
``Good Clinical Practice (VICH GL9).'' \1\ The laboratory dose
confirmation studies are experimentally-induced infection studies, each
conducted at different laboratory facilities, led by independent
investigators and using recent isolates of Dirofilaria immitis from two
separate United States geographic locations. The field effectiveness
study is a multi-site study conducted with investigators in various
geographical regions of the continental United States with endemic
heartworm disease that evaluates the use of the investigational new
animal drug in client-owned animals.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052417.pdf.
---------------------------------------------------------------------------

    Both study types have strengths and limitations. Strengths of the
laboratory studies includes the use of a negative control group, which
provides direct evidence of the effect of the new animal drug and that
results are not due to the impact of other treatments or external
influences on disease transmission and progression. In addition,
laboratory studies allow for appropriate classification of exposure due
to contemporaneous experimental infection of the same number of
infectious D. immitis larvae to control and investigational new animal
drug-administered groups and the appropriate classification of outcome
due to performance of an adult worm count post mortem. The worm count
allows for qualitative and quantitative evaluation of outcome by
determining the presence of adult worms as well as the determination of
the individual worm burden in each dog. One significant limitation of
the laboratory studies is the evaluation of only two isolates. Although
each isolate should be from a different geographic area in the United
States, under laboratory conditions the isolates may not accurately
represent the current diversity of D. immitis in the United States and
may not account for variable susceptibility in the isolates in the
field. From a substantial evidence of effectiveness standpoint, this
condition limits the inferential value of the two studies because the
use of the laboratory isolates may over- or under-represent the
relative susceptibility of other isolates in the field to the
investigational new animal drug. Additionally, the small number of
animals used in the study limits confidence in the interpretation of
effectiveness results.
    The strength of the field study is that the study evaluates the
investigational new animal drug under actual conditions of use and with
the current

enzootic status and genetic factors affecting the disease in each
location, thereby providing better inferential value than the
laboratory study. Limitations of the field study are that the exposure
to infective D. immitis larvae is assumed, but uncertain, and, in cases
of dogs with positive antigen tests, the actual timing of the exposure
is unknown. Additionally, the relatively short duration of the field
study in relationship to the heartworm life cycle and testing
limitations may not adequately evaluate the entire dosing period of the
investigational new animal drug. Assurance that individual dogs were
exposed to D. immitis larvae during the critical first few months of
the study is lacking, which complicates interpretation of a negative
antigen test at the end of the study. If the study is started during a
time of low transmission, such as in winter, exposure is even more
uncertain. Because of the delay in the ability to detect an adult
heartworm infection, it is impossible to tell with certainty if
infections detected between 4 and 8 months after study initiation were
pre-existing infections or due to lack of effectiveness of the
preventative. Obtaining false negative and false positive antigen test
results are possible and, because worm counts are not performed, the
false results may result in the misclassification of outcome for
individual dogs.
    In recognition of the limitations of the current recommended
laboratory and field effectiveness studies for heartworm preventatives
for use in dogs, we are interested in evaluating alternative approaches
to these study designs that would mitigate the limitations of such
studies while ensuring that the studies generate data to support
substantial evidence of effectiveness as defined in 21 CFR 514.4.
    Currently, there are gaps in knowledge and understanding that
prevent us from fully evaluating alternative approaches to meeting the
substantial evidence of effectiveness standard. To address these gaps,
we are seeking public comment regarding the following questions:
    Population level effectiveness endpoint. The design and evaluation
of effectiveness studies rely on an understanding of the appropriate
outcome measure. In seeking to design alternative study approaches, we
would like to determine a population level effectiveness endpoint that
could be used to design future studies. Currently we do not have a
defined level of performance that heartworm preventatives are expected
to meet when applied to the entire United States canine population.
Determining a population level endpoint would allow us to explore the
suitability and feasibility of alternative study designs for the
evaluation of effectiveness for heartworm preventatives. Factors that
may contribute to a heartworm preventative's effectiveness include the
inherent potency of the drug, differences in heartworm susceptibility,
and owner compliance.
    1. Assuming that a product was administered according to labeled
directions, what would be an acceptable rate of failure of an approved
heartworm preventative in the overall United States canine population
to which it is administered?
    2. What would be the maximum acceptable rate of failure in a high-
risk population?
    3. Alternatively, if you do not have a numerical estimate, what
recommendations do you have for determining what an acceptable rate of
failure should be?
    Exposure to infective D. immitis larvae. For humane reasons, field
studies are not conducted with a negative control group that would
reflect the study population's level of exposure to heartworm
infection. Therefore, it is necessary to have other measures to ensure
that the level of exposure to infective D. immitis larvae experienced
in the study is sufficient to adequately test the effectiveness of the
investigational new animal drug. Please provide comment on other
methods that could reliably be used to ensure adequate exposure of dogs
enrolled in a field study. Consider the following points:
    4. Can available tests be used to determine an individual dog's
exposure to infective larvae? What are the sensitivity and specificity
of those tests in this application? How would the level of sensitivity
and specificity of these tests impact the reliable assessment of rate
of failure in the population?
    5. Does the use of a heartworm preventative, even if only partially
effective, have an impact on the results of these tests?
    6. Could methods that consider a wider area (as opposed to an
individual animal) such as mosquito testing, forecasting, or modeling
be reliably used to determine the likely exposure to infective larvae
of dogs at a specific study site? What information would be needed to
create the methods or to verify the validity of the methods? What are
the limitations to such an approach?
    Outcome Assessment. Accurate assessment of the outcome endpoint
(heartworm infection) is essential for field studies where necropsy
worm counts will not be performed.
    7. What are the most reliable ways of properly classifying the
outcome in a non-terminal study?
    8. Are there critical pieces of information supporting substantial
evidence of effectiveness that can only be gained from a well-
controlled laboratory study? Are there elements that could be added to
a field study that would partially address those data gaps?
    Other.
    9. Are there laboratory study designs other than the traditional
dose confirmation study that provide additional information or include
a model that is more representative of real world exposure? For
example, the use of live mosquitoes to induce infection rather than the
mechanical injection of larvae.
    10. How might differences in the route of administration, dosing
frequency, or pharmacokinetic factors impact effectiveness? How might
studies be designed to incorporate these factors? For example, a drug
that demonstrates an early peak, with minimal to no drug levels in the
dog for the remainder of the dosing interval versus a product with
continuous drug levels in the dog for the entire dosing interval?

    Dated: May 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11132 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P


January 31, 2003 Greg H. Guinther Senior Advisor Ethyl Corporation Ethyl Petroleum Additives, Inc. P. O. Box 2158 Richmond, VA 23218 2158 Dear Mr. Guinther,

On January 10, 2003, you submitted to Joe Sopata of my staff a request for an amendment to the study protocol entitled, " Fleet Testing and Vehicle Service Protocol for Ethyl Corporation's Alternative Tier 2 Emission Characterization Program". As you know, the MMT Alternative Tier 2 Health Effects Testing Requirements require Agency approval of amendments to a previously approved protocol. This study protocol was approved by the Agency on December 19, 2002.

With this amendment, Ethyl is proposing several changes to the modified Standard Mileage Accumulation ( SMA) vehicle driving cycle, which was specified in the May 11, 2000, MMT notification letter to Ethyl to be used for mileage accumulation in the emission characterization study. According to your letter, the requested changes to cruise speeds, number of stops, time per stop, and acceleration rates will allow Ethyl's contractor, Southwest Research Institute ( SwRI), to operate the test vehicles on public roads in a legal and safe manner.

The SMA cycle, which was originally proposed by EPA for the mileage accumulation requirements and which ultimately became the modified SMA through negotiations with Ethyl, was designed to be conducted on test tracks, not on public roads. We believe the 80 mph speeds and wide open throttle ( WOT) accelerations simulate real world driving and are requirements that should be maintained. Moreover, by following the modified SMA on a test track, Ethyl and SwRI will ensure that the test vehicles are driven over the prescribed mileage accumulation period in the exact manner specified in the requirements, thus reducing the variability associated with driving on public roads. Therefore, EPA is not approving your request for this amendment.  2

If you have any questions, please contact Joe Sopata of my staff at ( 202) 564 9034.

Sincerely,

/ s/

Suzanne Rudzinski Director Transportation and Regional Programs Division cc: Monica Alvarez, ORD/ OSP Tim Backstrom, OGC Kevin Fast, Hunton & Williams


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Notices]
[Page 5846-5847]
[DOCID:fr04fe10-101]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Supplemental Notice of Intent To Prepare an Environmental
Assessment and Request for Public Scoping Comments for the Air Tour
Management Plan Program at Death Valley National Park

AGENCY: Federal Aviation Administration (FAA).

ACTION: Supplemental notice of intent to prepare an Environmental
Assessment and to request Public Scoping comments.

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

SUMMARY: The FAA, with National Park Service (NPS) as a cooperating
agency, has initiated development of an Air Tour Management Plan (ATMP)
for Death Valley National Park (DEVA), pursuant to the National Parks
Air Tour Management Act of 2000 (Pub. L. 106-181) and its implementing
regulations (14 CFR Part 136, Subpart B, National Parks Air Tour
Management). The objective of the ATMP is to develop acceptable and
effective measures to mitigate or prevent the significant adverse
impacts, if any, of commercial air tour operations upon the natural
resources, cultural resources, and visitor experiences of a national
park unit and any tribal lands within or abutting the park. It should
be noted that the ATMP has no authorization over other non-air-tour
operations such as military and general aviation operations. In
compliance with the National Environmental Policy Act of 1969 (NEPA)
and FAA Order 1050.1E, an Environmental Assessment is being prepared.
This supplemental notice of intent, revises the Federal Register notice
published on January 19, 2010 (Vol. 75, No. 11, 2922-2923) which had an
incorrect link to the FAA web site containing the meeting minutes for
the kickoff meeting and the public scoping document mentioned below.
This supplemental notice also extends the date by which scoping
comments must be submitted (see DATES).
    The ATMP will be prepared using an Aviation Rulemaking Committee
(ARC) process, as authorized under 49 U.S.C. 106. The purpose of using
the ARC process is to provide early advice, information, and
recommendations from interested stakeholders to the FAA and NPS,
regarding environmental and other issues to consider in the development
of an ATMP. The DEVA ARC is composed of various representatives
including air tour operators, federal, local and regional agencies,
environmental organizations, local businesses, and the Timbisha
Shoshone tribe. It is chaired by the Superintendent of Death Valley
National Park.
    In June 2009, the ARC held a two-day kickoff meeting at DEVA;
minutes may be found at: http://www.faa.gov/about/office_org/
headquarters_offices/arc/programs/air_tour_management_plan/park_
specific_plans/Death_Valley.cfm
    The purpose of the kickoff meeting was for stakeholders to have the
opportunity to provide advice, information, and recommendations to the
FAA and NPS regarding environmental and other issues to consider in the
development of an ATMP. Materials presented at the meeting included
information on: park resources; the acoustical environment at DEVA;
military operations over DEVA and the surrounding areas; current and
historical air tour operations; and, a map of current air tour flight
paths. Comments were received from members of the ARC regarding
sensitive park resources, tribal concerns, changes in tourism patterns,
and air tour operations. After a generalized map of current air tour
flight paths was presented, ARC members made suggestions regarding
options for an air tour flight track that would consolidate flight
paths and modify elevations and flight locations. ARC members'
recommendations attempted to address the concerns raised at the
meeting. Refer to the Public Scoping Document (mentioned below) to see
how these suggestions are incorporated into an air tour route.
    Based on input received at the meeting, the FAA and NPS have
decided to proceed with ATMP development at DEVA via the ARC process.
The FAA is now inviting the public, agencies, and other interested
parties to provide comments, suggestions, and input on the scope of
issues and the identification of significant issues regarding
commercial air tours and their potential impacts on natural, cultural,
and historical resources. Input is also welcome on other areas to be
addressed in the environmental process, such as past, present, and
future actions (which, when considered with ATMP alternatives, may
result in potentially significant cumulative impacts), and potential
ATMP alternatives.

DATES: By this notice, the FAA is requesting comments on the scope of
the environmental assessment for the ATMP at Death Valley National
Park. Comments must be submitted by March 8, 2010.

FOR FURTHER INFORMATION CONTACT: Keith Lusk--Mailing address: P.O. Box

92007, Los Angeles, California 90009-2007. Telephone:<PHONE_NUMBER>.
Street address: 15000 Aviation Boulevard, Lawndale, California 90261.
E-mail<EMAIL_ADDRESS>    Written comments on the scope of the Environmental Assessment
should be submitted electronically via the electronic public comment
form on the NPS Planning, Environment and Public Comment System at:
http://parkplanning.nps.gov/projectHome.cfm?parkId=297&projectId=27781,
or sent to the mailing address or e-mail address above.

SUPPLEMENTARY INFORMATION: A Public Scoping Document that describes the
project in greater detail is available at:
     The NPS Planning, Environment and Public Comment System
at: http://parkplanning.nps.gov/
projectHome.cfm?parkId=297&projectId=27781
     http://www.faa.gov/about/office_org/headquarters_
offices/arc/programs/air_tour_management_plan/park_specific_plans/
Death_Valley.cfm
     The following locations within Death Valley National Park:
Furnace Creek Visitor Center & Museum, Stovepipe Wells Ranger Station,
Scotty's Castle
     Shoshone Museum, Shoshone, CA.
     Eastern Sierra Interagency Center, Highway 395 and Highway
136, Lone Pine, CA.
     Beatty Library District, 400 North 4th Street, Beatty, NV.
     Inyo County Free Library: 168 North Edwards Street,
Independence, CA; 210 Academy Street and 110 North Main Street in
Bishop, CA.
     Pahrump Community Library: 701 East Street, Pahrump, NV.
     Amargosa Valley Library: 829 East Farm Road, Amargosa
Valley, NV.
    Notice Regarding FOIA: Individuals may request that their name and/
or address be withheld from public disclosure. If you wish to do this,
you must state this prominently at the beginning of your comment.
Commentators using the Web site can make such a request by checking the
box ``keep my contact information private.'' Such requests will be
honored to the extent allowable by law, but you should be aware that
pursuant to the Freedom of Information Act, your name and address may
be disclosed. We will make all submissions from organizations,
businesses, and from individuals identifying themselves as
representatives or officials of organizations or businesses available
for public inspection in their entirety.

    Issued in Hawthorne, CA, on January 27, 2010.
Keith Lusk,
Program Manager, Special Programs Staff, Western-Pacific Region.
[FR Doc. 2010-2466 Filed 2-3-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39849-39851]
[FR Doc No: 2022-14269]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002; Internal Agency Docket No. FEMA-B-2247]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to

seek general information and comment regarding the preliminary FIRM,
and where applicable, the FIS report that the Federal Emergency
Management Agency (FEMA) has provided to the affected communities. The
FIRM and FIS report are the basis of the floodplain management measures
that the community is required either to adopt or to show evidence of
having in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before October 3, 2022.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2247, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           Calhoun County, Mississippi and Incorporated Areas
        Project: 19-04-0009S Preliminary Date: September 29, 2021
------------------------------------------------------------------------
City of Bruce..........................  City Hall, 100 Public Square,
                                          Bruce, MS 38915.
City of Calhoun City...................  City Hall, 102 South Monroe
                                          Street, Calhoun City, MS
                                          38916.
Town of Derma..........................  Town Hall, 120 South Main
                                          Street, Derma, MS 38839.
Town of Pittsboro......................  City Hall, 103 East Main
                                          Street, Pittsboro, MS 38951.
Unincorporated Areas of Calhoun County.  Calhoun County Courthouse, 103
                                          West Main Street, Pittsboro,
                                          MS 38951.
Village of Big Creek...................  City Hall, 101 West Main
                                          Street, Big Creek, MS 38914.
------------------------------------------------------------------------
           Carroll County, Mississippi and Incorporated Areas
        Project: 19-04-0009S Preliminary Date: September 29, 2021
------------------------------------------------------------------------
Unincorporated Areas of Carroll County.  Carroll County Courthouse, 600
                                          Lexington Street, Carrollton,
                                          MS 38917.
------------------------------------------------------------------------
           Grenada County, Mississippi and Incorporated Areas
        Project: 19-04-0009S Preliminary Date: September 29, 2021
------------------------------------------------------------------------
City of Grenada........................  City Hall, 108 South Main
                                          Street, Grenada, MS 38901.
Unincorporated Areas of Grenada County.  Grenada County Chancery Clerk,
                                          59 Green Street, Suite 1,
                                          Grenada, MS 38901.
------------------------------------------------------------------------

          Montgomery County, Mississippi and Incorporated Areas
        Project: 19-04-0009S Preliminary Date: September 29, 2021
------------------------------------------------------------------------
Unincorporated Areas of Montgomery       Montgomery County Courthouse,
 County.                                  614 Summit Street, Winona, MS
                                          38967.
------------------------------------------------------------------------

[FR Doc. 2022-14269 Filed 7-1-22; 8:45 am]
BILLING CODE 9110-12-P