[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Rules and Regulations]
[Page 15930-15937]
[DOCID:fr26mr08-24]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0107; FRL-8356-2]

Myclobutanil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of myclobutanil and its alcohol metabolite in or on artichoke, globe;
black sapote; canistel; cilantro, leaves; leafy greens, subgroup 4A,
except spinach; mamey sapote; mango; okra; papaya; sapodilla; star
apple; and fruiting vegetable group 8, except tomato. Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA). EPA is also deleting
several established myclobutanil tolerances that are no longer needed.

DATES: This regulation is effective March 26, 2008. Objections and
requests for hearings must be received on or before May 27, 2008, 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-2007-0107. 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: Barbara Madden, 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), 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 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 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 EPA's tolerance regulations at
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, 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-2007-0107 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 May 27, 2008.
    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-2007-0107, 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 Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 4, 2007 (72 FR 16352) (FRL-8119-
2), 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
3E6562 and 6E7138) by IR-4, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. These petitions requested that 40 CFR 180.443 be
amended by establishing tolerances for combined residues of the
fungicide myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-
triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-
hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile
(free and bound), in or on Black sapote, canistel, mamey sapote, mango,
papaya, sapodilla, and star apple at 3.0 parts per million (ppm) (PP
3E6562); and Fruiting vegetables, crop group 8, except tomato at 4.5
ppm; leafy vegetables, crop subgroup 4A, except spinach at 11.0 ppm;
globe artichoke at 0.9 ppm; cilantro at 11.0 ppm; and okra at 4.5 ppm
in (PP 6E7138). That notice referenced a summary of the petition
prepared by Dow Agrosciences LLC, 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
revised some of the commodity definitions and tolerance levels for
certain commodities. The reason for these changes is explained in Unit
IV.C.
    EPA is also deleting several established tolerances in Sec.
180.443(b) that are no longer needed. The tolerance deletions under
Sec.  180.443(b) are time-limited tolerances established under section
18 emergency exemptions. The time-limited tolerances for artichoke,
globe and pepper are superceded by the establishment of general
tolerances for myclobutanil and its alcohol metabolite under Sec.
180.443(a) as a result of this action. The time-limited tolerances for
sugar beet dried pulp, sugar molassess, refined sugar, roots, and tops
are being deleted since they have expired.

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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for combined residues of myclobutanil and its alcohol metabolite on
artichoke, globe at 0.90 ppm; canistel at 3.0 ppm; cilantro, leaves at
9.0 ppm; leafy greens, crop subgroup 4A, except spinach at 9.0 ppm;
mango at 3.0 ppm; okra at 4.0 ppm; papaya at 3.0 ppm; sapodilla at 3.0
ppm; sapote, black at 3.0 ppm; sapote, mamey at 3.0 ppm; star apple at
3.0 ppm; and vegetable, fruiting, group 8, except tomato at 4.0 ppm.
EPA's assessment of exposures and risks associated with establishing
the tolerance 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.
    Myclobutanil has low acute toxicity with the exception for ocular
irritation. In rat subchronic and chronic toxicity studies, the primary
target organs are liver and testes. Liver effects, following subchronic
exposure, include hypertrophy, hepatocellular necrosis and increased
liver weight. Chronic exposure to the rat also results in
hepatocellular vacuolization and additional testicular effects, which
include bilateral aspermatogenesis, increased incidences of hypospermia
and cellular debris in the epididymides and increased incidences of
arteritis/periarteritis in the testes. With the exception of testicular
effects, subchronic and chronic exposures in the mouse result in a
toxicity profile similar to the rat. The mouse, following chronic
exposure, has, in addition, increased Kupffer cell pigmentation,
periportal punctate vacuolation, and individual cell necrosis of the
liver. There is no evidence of carcinogenic potential in either the rat
or mouse. In the subchronic dog study, there are hepatocellular
hypertrophy, increased relative and absolute liver weight and increased
alkaline phosphatase. In the chronic dog study, liver toxicity is
similar with the addition of ``ballooned''

hepatocytes and increases in serum glutamic pyruvic transaminase (SGPT)
and gamma glutamyl transferase (GGT). Signs of toxicity observed in the
rat 28-day dermal studies are limited to dermal irritation. There is no
evidence of systemic toxicity in either study. There is no evidence of
increased susceptibility in either of the developmental toxicity
studies or the reproduction study. There is no concern for mutagenic
activity. Myclobutanil was determined to be not carcinogenic in two
acceptable animal studies.
    Specific information on the studies received and the nature of the
adverse effects caused by myclobutanil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of May 10, 2000 (65 FR 29963) (FRL-
6555-5) (http://www.epa.gov/fedrgstr/EPA-PEST/2000/May/Day-10/
p11571.htm).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from 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) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC 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
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 UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for myclobutanil used for
human risk assessment can be found at http://www.regulations.gov in
document Myclobutanil. Human-Health Risk Assessment for Proposed Use on
Section 3 Requests for Use on Snap Bean, Mint, Papaya, Gooseberry,
Currant, Caneberry, Bell and Non-Bell Pepper, Head and Leaf Lettuce,
and Artichoke at page 7 in docket ID number EPA-HQ-OPP-2007-0107.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to myclobutanil, EPA considered exposure under the petitioned-
for tolerances as well as all existing myclobutanil tolerances in 40
CFR 180.443. EPA assessed dietary exposures from myclobutanil 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. An acute dietary exposure
assessment was performed for females 13 to 49 years old. No acute
endpoint was identified for the general U.S. population or any other
population subgroup.
    In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As
to residue levels in food, EPA assumed all foods for which there are
tolerances were treated andcontain tolerance-level residues.
    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 USDA Pesticide
Data Program (PDP) monitoring data for apple juice, bananas (not
plantains) and milk. Tolerance level residues were used for all other
registered and proposed uses. Average percent cropped treated (PCT)
information was used for some commodities and 100 PCT information was
used for all other registered and proposed uses.
    iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, myclobutanil has been classified as ``Not likely to be
carcinogenic to humans.'' Consequently, a quantitative cancer exposure
and risk assessment is not appropriate for myclobutanil.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must 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. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of 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:
    a. 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.
    b. The exposure estimate does not underestimate exposure for any
significant subpopulation group.
    c. 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 FFDCA section
408(b)(2)(F), EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows: 40% apples (except
juice); 15% almonds; 25% apricots; 55% artichokes; 5% asparagus; 1%
green beans; 15% blackberries; 1% broccoli; 10% cantaloupes; 5%
cauliflower; 35% cherries; 1% cucumber; 25% grapes; 65% hops; 1% mint;
10% nectarines; 10% peaches; 10% plums; 15% pumpkins; 25 % raspberries;
1% soybeans; 10% squash; 35% strawberries; 1% sugar beets; 5% tomatoes;
and 5% watermelons.
    The Agency used projected percent crop treated (PPCT) information
for peppers estimating 46% of peppers are treated.
    EPA estimates PPCT for myclobutanil use on peppers 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 one with the greatest PCT) on that site
over the three most recent 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 a 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 USDA/NASS as the
source for raw PCT data because it is publicly available and does not
have to be calculated from available data sources. When a specific use
site is not surveyed by USDA/NASS, EPA uses proprietary data and
calculates the estimated PCT.
    This estimated PPCT, based on 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 or
a new 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 bears 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 pressures as indicated in
emergency exemption requests or other readily available information,
and whether the pathogenicity of the pest is prevalent in other states.
All information currently available has been considered for
myclobutanil, and it is the opinion of EPA that it is unlikely that
actual PCT for myclobutanil will exceed the estimated PPCT during the
next 5 years.
    The Agency believes that the three conditions listed in Unit
III.C.1.vi. have been met. With respect to Condition a, 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 b and c, 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 myclobutanil may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for myclobutanil 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 environmental
fate characteristics of myclobutanil. 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) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of myclobutanil for
acute exposures are estimated to be 120.1 parts per billion (ppb) for
surface water and 2.83 ppb for ground water. The estimated
environmental concentrations for chronic exposures are estimated to be
46.3 ppb for surface water and 2.83 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 120.1 ppb was used to
access the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 46.3 ppb was used to
access 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).
    Myclobutanil is currently registered for use on the following
residential non-dietary sites: turf, ornamentals, and home garden uses
on vegetables, fruit trees, nut trees, berries and mint. The risk
assessment was conducted using the following residential exposure
assumptions:
    For adults, there is potential for short-term dermal and inhalation
handler exposure, and short-term dermal post-application exposures from
the residential uses of myclobutanil, including ``pick your own''
orchards, home fruit and vegetable gardens, and treated turf. Since
myclobutanil is applied at 7- to 14-day intervals, only short-term
exposure is expected for the residential handler. For children/
toddlers, short-term dermal and non-dietary oral post-application
exposures may result from dermal contact with treated turf as well as
non-dietary ingestion/hand-to-mouth transfer of residues from turf
grass. Intermediate-term post-application exposures may result for
adults from dermal contact with treated fruits and vegetables at ``pick
your own'' gardens, treated home fruit and vegetable gardens and
treated turf. For toddlers, intermediate-term dermal and non-dietary
oral post-application exposures may result from dermal contact with
treated turf as well as non-dietary ingestion/hand-to-mouth transfer of
residues from turf grass. Based on the current use patterns, no chronic
residential exposures are expected.
    The current use patterns and labeling indicate that a variety of
application equipment could be used by the homeowner to apply
myclobutanil to ornamental plants, shrubs, fruit trees, home garden
vegetables and lawns. Therefore, the following scenarios were assessed:
    i. Aerosol spray can application to ornamentals and fruit trees;
    ii. Hose end sprayer application to ornamentals and fruit trees;
    iii. Low-pressure (LP) handwand application to ornamentals;
    iv. LP handwand application to vegetables;
    v. Ready to use (RTU) sprayer application to vegetables;
    vi. Hose end sprayer application to vegetables;
    vii. Hose end sprayer - mix your own - application to turf;
    viii. Hose end sprayer - ready to use - application to turf;
    ix. Belly grinder application to turf;
    x. Broadcast spreader application to turf.
    Unit exposure data were either taken from Pesticide Handler's
Exposure Database (PHED) study data or from the home garden and turf
application studies that were sponsored by the Outdoor Residential
Exposure Task Force (ORETF).
    Home garden post-application exposures can occur when home
gardeners perform tasks such as weeding, pruning or hand harvesting
following application of myclobutanil. In order to address these risks,
the post-application exposure to home gardens and orchard scenarios
were assessed based upon the Residential Standard

Operating Procedures (SOP) 3.0 for Garden Plants and SOP 4.0 for Trees.
    Two dislodgeable foliar residue (DFR) studies on grapes in
California were used to assess the home garden exposures. The studies
were performed using airblast sprayers while the proposed home garden
applications would be made with LP handwand or hose end sprayers. Based
upon experience with other fungicides, however, it is anticipated that
DFRs resulting from handwand applications would be similar to DFRs from
airblast applications. The initial DFR was assumed to be 23% of the
application rate.
    ``Pick your own'' exposures can occur at commercially operated
``pick your own'' strawberry farms and orchards where myclobutanil has
been applied. To address these risks, post-application exposure for
pick your own strawberries and tree fruit were assessed based upon the
Residential SOP 15.0 for ``pick your own'' strawberries. The DFR data
that were used for the home gardener post-application risks were also
used to assess ``pick your own'' exposures. The exposure estimates used
for pick your own exposures are considered conservative because that
scenario is based upon a screening-level transfer coefficient (TC) and
a dermal absorption factor of 50%.
    The following exposure scenarios were assessed for residential
post-application risks:
     Toddlers playing on treated turf;
     Adults performing yard work on treated turf;
     Adults playing golf on treated turf.
    A total radioactive residue (TTR) study was used to assess the turf
exposures. The field portion of this study was in North Carolina and
California. The initial TTR for dermal exposures was assumed to be 2.4%
of the application rate and was based upon an average of the days after
treatment (DAT) of 0 and DAT of 3 for the California site. The maximum
application rate for turf of 0.62 to 0.68 lb active ingredient/Acre was
use to assess the turf exposures.
    Additional information on residential exposure assumptions can be
found at http://www.regulations.gov in the document ``Myclobutanil.
Human-Health Risk Assessment for Proposed Use on Section 3 Requests for
Use on Snap Bean, Mint, Papaya, Gooseberry, Currant, Caneberry, Bell
and Non-Bell Pepper, Head and Leaf Lettuce, and Artichoke,'' in docket
ID number EPA-HQ-OPP-2007-0107.
    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.''
    Myclobutanil is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events, including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at http://www.epa.gov/pesticides/
cumulative.
    Myclobutanil is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazole alanine and triazole acetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including myclobutanil, EPA conducted a
human health risk assessment for exposure to 1,2,4-triazole, triazole
alanine, and triazole acetic acid resulting from the use of all current
and pending uses of any triazole-derived fungicide. The risk assessment
is a highly conservative, screening-level evaluation in terms of
hazards associated with common metabolites (e.g., use of a maximum
combination of uncertainty factors) and potential dietary and non-
dietary exposures (i.e., high end estimates of both dietary and non-
dietary exposures). In addition, the Agency retained the additional 10X
FQPA safety factor for the protection of infants and children. The
assessment includes evaluations of risks for various subgroups,
including those comprised of infants and children. The Agency's
complete risk assessment is found in the propiconazole reregistration
docket at http://www.regulations.gov (Docket ID EPA-HQ-OPP-2005-0497).
Additional information regarding the uses proposed for myclobutanil in
this action can also be found at http://www.regulations.gov in the
following documents: 1,2,4 Triazole Revised Chronic and Acute Aggregate
Dietary Exposure Assessments to Include for New Uses of Myclobutanil on
Snap Bean, Mint, Papaya, Gooseberry, Currant, Caneberry, Bell and Non-
Bell Pepper, Head and Leaf Lettuce, and Artichoke, and Triazole Alanine
and Triazole Acetic Acid Revised Chronic and Acute Aggregate Dietary
Exposure Assessments for New Uses of Myclobutanil on Snap Bean, Mint,
Papaya, Gooseberry, Currant, Caneberry, Bell and Non-Bell Pepper, Head
and Leaf Lettuce, and Artichoke in docket ID number EPA-HQ-OPP-2007-
0107.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') 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. This additional
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no indication of
quantitative or qualitative increased susceptibility in rats or rabbits
from in utero and/or postnatal exposure to myclobutanil. In the rat
developmental toxicity study, maternal toxicity, which included rough
hair coat and salivation, alopecia, desquamation and red exudate around
mouth occurs at the same dose level as increases in incidences of 14th
rudimentary and 7th cervical ribs in the fetuses. The maternal and
developmental toxicity NOAELs in the rat developmental toxicity study
were

93.8 mg/kg/day. EPA concludes that there is no evidence qualitative
susceptibility in rat developmental toxicity study since the fetal
variations (14th rudimentary ribs and 7th cervical ribs) are normal
occurance control animals that occurred in the presence of severe
maternal toxicity (red exudate around mouth and salivation). In the
rabbit developmental toxicity study there is reduced body weight and
body weight gain during the dosing period, clinical signs of toxicity
such as bloody urine and bloody urogenital or anal area and a possible
increase in abortions (blood and/or aborted material in the cage pan)
in the does at the same dose level as developmental toxicity manifested
as increased resorptions, decreased litter size and decreased viability
index. The maternal and developmental toxicity NOAELs in the rabbit
developmental toxicity study were 93.8 mg/kg/day. EPA concludes that
there is no evidence qualitative susceptibility in rabbit developmental
toxicity study since the fetal effects (resorptions, decreased litter
size and viability) occurred in the presence of equally severe maternal
toxicity (abortions, bloody urine and bloody urogenital or anal
area).The maternal NOAEL in the 2-generation reproduction study was 50
ppm (2.5 mg/kg/day) based on hepatocellular hypertrophy and increased
liver weight seen at 200 ppm (10 mg/kg/day; LOAEL). The offspring
toxicity NOAEL was 200 ppm (10 mg/kg/day) based on decreased pup body
weight gain during lactation seen at 1,000 ppm (50 mg/kg/day; LOAEL).
The reproductive toxicity NOAEL was 200 ppm (10 mg/kg/day) based on
increased incidences in the number of still born pups and atrophy of
the testes, epididymides and prostate observed at 1,000 ppm (50 mg/kg/
day; LOAEL). EPA concludes that there is no evidence on increased
susceptibility (qualitative or quantitative) in the 2-generation
reproduction study in rats because the offspring and reproductive
toxicity were observed at a higher dose than the dose that caused
maternal toxicity.
    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 toxicity database for myclobutanil is complete.
    ii. There is no indication that myclobutanil is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that myclobutanil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessment (females 13 to 49
years old only) utilizes existing and proposed tolerance level residues
and 100 PCT information for all commodities. The chronic dietary food
exposure assessment utilizes existing and proposed tolerance level
residues; USDA Pesticide Data Program (PDP) monitoring data for apple
juice, bananas (not plantains) and milk; average PCT data for some
commodities and 100 PCT information for all other commodities. The
dietary drinking water assessment utilizes water concentration values
generated by model and associated modeling parameters, which are
designed to provide conservative, health protective, high-end estimates
of water concentrations which will not likely be exceeded. Finally, the
residential handler assessment is based upon the residential standard
operating procedures (SOPs) and utilized unit exposure data from the
Outdoor Residential Exposure Task Force (ORETF) and the Pesticide
Handler's Exposure Database (PHED). The residential post-application
assessment is based upon chemical-specific turf transferable residue
(TTR) data and DFR data. The chemical-specific study data as well as
the surrogate study data used are reliable and also are not expected to
underestimate risk to adults as well as to children. In a few cases
where chemical-specific data were not available, the SOPs were used
alone. The residential SOPs are based upon reasonable ``worst-case''
assumptions and are not expected to underestimate risk. These
assessments of exposure are not likely to underestimate the exposure to
myclobutanil.

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 UFs. 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 UFs is
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure for females 13 to 49 years old (no acute
endpoint was identified for the general U.S. population or any other
population subgroup), the acute dietary exposure from food and water to
myclobutanil will occupy 4% of the aPAD for females 13 to 49 years old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
myclobutanil from food and water will utilize 30% of the cPAD for
children 1 to 2 years old, the subpopulation group with greatest
exposure. Based on the use pattern, chronic residential exposure to
residues of myclobutanil is not expected.
    3. Short-term risk and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Myclobutanil is currently registered for uses that could result in
short-term and intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic food and
water and short-term exposures for myclobutanil. As discussed in Unit
III.C.3., short-term and intermediate-term exposures were assessed for
adults and for children/toddlers. A NOAEL (10 mg/kg/day) from a 2-
generation reproduction toxicity study in rats was used for assessing
short-term and intermediate-term dermal, inhalation and incidental oral
exposures; therefore, the short-term and intermediate-term aggregate
risk estimates from the post-application exposure scenarios are the
same for the general U.S. population and children/toddlers.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food,
water, and residential exposures aggregated result in aggregate MOEs
ranging from 110 to 990: 110 for post-application exposures for adults
for ``pick your own fruit'' operations; 120 for post-application
exposures for adults to turf, heavy yard work; 130 post-application
exposures for children playing on the lawn; 170 for adult handlers; 280
for adult post application exposures to home gardens; and 980 for adult
post applications exposures while playing golf.
    4. Aggregate cancer risk for U.S. population. The Agency has
classified myclobutanil as not likely to be a

human carcinogen. Myclobutanil was determined to be not carcinogenic in
two acceptable animal studies. Myclobutanil is not expected to pose a
cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to myclobutanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detector (GC/NPD) for myclobutanil and gas chromatography/
electron-capture detection (GC/ECD) for the alcohol metabolite) is
available to enforce the tolerance expression. The methods 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 currently no established Codex, Canadian, or Mexican MRLs
for myclobutanil.

C. Explanation of Tolerance Revisions

    Based upon review of the data supporting the petitions, EPA revised
the tolerance levels based on analyses of the residue field trial data
using the Agency's Tolerance Spreadsheet in accordance with the
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial
Data Standard Operating Procedure (SOP) as follows: (1) PP 3E6562 from
3.0 ppm to 4.0 ppm for canistel; mango; papaya; sapodilla; sapote,
black; sapote, mamey; and star apple; (2) PP 6E7138 from 4.5 ppm to 4.0
ppm for fruiting vegetables, crop group 8, except tomato and okra; from
11 ppm to 9.0 ppm for leafy vegetables, crop subgroup 4A, except
spinach and cilantro; and from 0.9 ppm to 0.90 ppm for globe artichoke.

V. Conclusion

    Therefore, tolerances are established for combined residues of
myclobutanil and its alcohol metabolite on artichoke, globe at 0.90
ppm; canistel at 3.0 ppm; cilantro, leaves at 9.0 ppm; leafy greens,
crop subgroup 4A, except spinach at 9.0 ppm; mango at 3.0 ppm; okra at
4.0 ppm; papaya at 3.0 ppm; sapodilla at 3.0 ppm; sapote, black at 3.0
ppm; sapote, mamey at 3.0 ppm; star apple at 3.0 ppm; and vegetable,
fruiting, group 8, except tomato at 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866, this 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) 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 6, 2000) do not apply to this rule. In addition, This
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: March 13, 2008.
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 180.443 is amended by removing from the table in paragraph
(b) the entries for artichoke, globe; beet, sugar, dried pulp; beet,
sugar, molasses; beet, sugar, refined sugar; beet, sugar, roots; beet,
sugar, tops; and pepper and by alphabetically adding commodities to the
table in paragraph (a) to read as follows:

180.443  Myclobutanil; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Artichoke, globe........................................            0.90
                                * * * * *
Canistel................................................             3.0

                                * * * * *
Cilantro, leaves........................................             9.0
                                * * * * *
Leafy greens, subgroup 4A, except spinach...............             9.0
Mango...................................................             3.0
                                * * * * *
Okra....................................................             4.0
Papaya..................................................             3.0
                                * * * * *
Sapodilla...............................................             3.0
Sapote, black...........................................             3.0
Sapote, mamey...........................................             3.0
                                * * * * *
Star apple..............................................             3.0
                                * * * * *
Vegetable, fruiting, group 8, except tomato.............             4.0
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-6205 Filed 3-25-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Rules and Regulations]
[Page 26606]
[FR Doc No: 2011-11269]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0311]

Drawbridge Operation Regulation; Neches River, Beaumont, TX

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
KCS vertical lift span bridge across the Neches River, mile 19.5, at
Beaumont, Texas. The deviation is necessary to replace four haul cables
on the bridge. This deviation allows the bridge to remain closed to
navigation for 72 consecutive hours.

DATES: This deviation is effective from 7 a.m. on Monday, May 23, 2011
to 7 a.m. on Thursday, May 26, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0311 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0252 in the
``Keyword'' box and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail David Frank, Bridge Administration Branch, Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Kansas City Southern Railroad has
requested a temporary deviation from the operating schedule of the
vertical lift span bridge across the Neches River at mile 19.5 in
Beaumont, Texas. The vertical clearance of the bridge in the closed-to-
navigation position is 13 feet above Mean High Water and 140 feet above
Mean High Water in the open-to-navigation position.
    In accordance with 33 CFR 117.971, the vertical lift span of the
bridge is automated and normally not manned but will open on signal for
the passage of vessels. This deviation allows the vertical lift span of
the bridge to remain closed to navigation from 7 a.m. on Monday, May
23, 2011 through 7 a.m. on Thursday, May 26, 2011.
    The closure is necessary in order to replace four haul cables on
the bridge that allow the bridge to be raised. This maintenance is
essential for the continued operation of the bridge. Notices will be
published in the Eighth Coast Guard District Local Notice to Mariners
and will be broadcast via the Coast Guard Broadcast Notice to Mariners
System.
    Navigation on the waterway consists of commercial and recreational
fishing vessels, small to medium crew boats, and small tugs with and
without tows. No alternate routes are available for the passage of
vessels; however, the closure was coordinated with waterway interests
who have indicated that they will be able to adjust their operations
around the proposed work schedule. Small vessels may pass under the
bridge while in the closed-to-navigation position provided caution is
exercised.
    Due to prior experience and coordination with waterway users, it
has been determined that this closure will not have a significant
effect on vessels that use the waterway.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 26, 2011.
David M. Frank,
Bridge Administrator.
[FR Doc. 2011-11269 Filed 5-6-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 12, 2010 (Volume 75, Number 196)]
[Notices]
[Page 62531]
[DOCID:fr12oc10-66]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 485-063]

Georgia Power Company; Notice of Meeting and Environmental Site
Review

October 4, 2010.
    On October 14, 2010, Commission staff, together with
representatives of Georgia Power Company (the applicant), will hold a
meeting and an Environmental Site Review for the Bartletts Ferry
Project. The purpose of the one-day meeting and site review is to
orient Commission staff who are in new roles in the Bartletts Ferry
relicensing proceeding to project facilities and the approved study
plans.
    The meeting for the Bartletts Ferry Project will begin at 9 a.m.
EST (8 a.m. Central) at the Bartletts Ferry Clubhouse, 61 Lee Road 335,
Salem, AL 36874. The boat tour of Lake Harding will begin at 12:30 p.m.
EST (11:30 a.m. Central). All interested individuals, organizations,
agencies, and Indian tribes are invited to attend the meeting and/or
boat tour. All participants are responsible for their own
transportation to the meeting location and throughout the day (except
boat tour), as may be necessary. Anyone with questions about the
meeting and boat tour, as well as to make the necessary arrangements to
get to the Bartletts Ferry Clubhouse and reserve space for the boat
tour, should contact Mr. George Martin of Georgia Power Company at
(404) 506-1357, or Ms. Courtenay O'Mara of Southern Company Generation
at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25515 Filed 10-8-10; 8:45 am]
BILLING CODE 6717-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     WASHINGTON, D.C.  20460

                  OFFICE OF

PREVENTION, PESTICIDES AND

         TOXIC SUBSTANCES

February 26, 2007

MEMORANDUM

SUBJECT:	Aldicarb (List A Case 0140, Chemical ID No. 098301).  HED
Response to Comments Received During the Public Comment Period.  DP
Barcode No. D336284.

FROM:	Felecia Fort, Chemist

		Linda Taylor, Ph.D, Toxicologist

		Jeff Dawson, Chemist

Reregistration Branch 1

Health Effects Division (7509C)

THRU:	Michael Metzger, Branch Chief

Reregistration Branch 1

Health Effects Division (7509C)

TO:		Sherrie Kinard, Chemical Review Manager

Special Review Branch

Special Review and Reregistration Division (7508W)

Comments were received from the registrant, Bayer CropScience  (BSC) and
the Natural Resources Defense Council (NRDC) following a 60-day public
comment period for aldicarb.  The comments received pertain to the
Environmental Protection Agency's HED Revised Human Health Risk
Assessment for the Reregistration Eligibility Decision Document (RED)
[DP Barcode No. D331540] dated November 1, 2006.

All of the comments received by both BSC and NRDC have been previously
addressed in the HED Response to Comments document dated November 1,
2006 titled “Aldicarb (List A Case 0140, Chemical ID No. 098301).  HED
Response to Comments Received During the Public Comment Period.  DP
Barcode No. D331538.”  The HED Human Health Risk Assessment will not,
therefore, be revised to reflect any of the comments received during
this public comment period.  Both parties should refer to the above
mentioned response to comments document and/or to the HED Revised Human
Health Risk Assessment for more information.

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