[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22252-22256]
[FR Doc No: 2010-9741]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0866; FRL-8801-6]

Cyromazine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
cyromazine in or on succulent beans at 2.0 parts per million (ppm).
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 28, 2010. Objections and
requests for hearings must be received on or before June 28, 2010, 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-2008-0866. 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: Barbara Madden, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-6463; 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.
    To access the OPPTS harmonized test guidelines referenced in this
document electronically please go to http://www.epa.gov/oppts and
select ``Test Methods & Guidelines'' on the left-side navigation menu.

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-2009-0866 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 June 28, 2010.
    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-2008-0866, 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 April 13, 2009 (74 FR 16866) (FRL-8396-
6), 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
8E7470) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR 180.414 be amended by establishing tolerances for residues
of the insecticide cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-
triamine) in or on bean, succulent at 2.0 parts per million (ppm). That
notice referenced a summary of the petition prepared by Syngenta, the
registrant, on behalf of IR-4 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.

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 cyromazine on bean, succulent at 2.0 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. Cyromazine is not an eye irritant or a dermal sensitizer but
is a mild skin irritant. The liver and bone marrow (hematological
system) are the primary targets for oral toxicity for cyromazine based
on a chronic dog study. Decrease in body weight and food consumption
are also common effects of cyromazine as observed in chronic dog, rat,
mouse, and rabbit studies. No dermal or systemic toxicity was seen at
the highest dose tested in two 21-day dermal toxicity studies in
rabbits. No neurotoxicity studies with cyromazine are available.
However, the cyromazine chemical class (triazine) does not generally
target the central or peripheral nervous system and available data show
no evidence of neurotoxic potential for cyromazine. There is no
evidence that cyromazine is teratogenic or that offspring are more
susceptible than adults based on developmental toxicity studies in rats
and rabbits. In the 2-generation reproduction study in rats no
reproductive effects were observed. Cyromazine was shown not to be
carcinogenic in mice or rats following long-term dietary administration
and is classified as ``not likely to be carcinogenic to humans.'' The
available mutagenicity data suggest that cyromazine does not have
genotoxic activity. Specific information on the studies received and
the nature of the adverse effects caused by cyromazine 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 docket ID number EPA-HQ-OPP-2009-0866,
pages 25-27 of the document titled ``Cyromazine Human Health Risk
Assessment for Proposed New Use of Cyromazine on Succulent Beans.''

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.
    A summary of the toxicological endpoints for cyromazine used for
human risk assessment can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2009-0866, page 15 of the document titled
``Cyromazine. Human Health Risk Assessment for Proposed New Use of
Cyromazine on Succulent Beans.''

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyromazine, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyromazine tolerances in 40 CFR
180.414. EPA assessed dietary exposures from cyromazine in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
cyromazine; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. A chronic dietary risk assessments was
conducted for cyromazine using the Dietary Exposure Evaluation Model
(DEEM-FCID, Version 2.03), which uses food consumption data from the
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from
1994-1996 and 1998. As to residue levels in food, tolerance level
residues and 100% crop treated assumptions were used. DEEM default and
empirical processing factors were used to modify the tolerance values.
    iii. Cancer. Based on the absence of evidence of carcinogenicity in
two adequate rodent carcinogenicity studies, EPA has classified
cyromazine as ``not likely to be carcinogenic to humans.'' Therefore, a
quantitative exposure assessment to evaluate cancer risk is
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for cyromazine. Tolerance level residues and/or 100%
crop treated 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 cyromazine in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyromazine. 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 cyromazine for chronic exposures for
non-cancer assessments are estimated to be 15.8 parts per billion (ppb)
for surface water and 1.1 ppb for ground water. Modeled estimates of
drinking water concentrations were directly entered into the dietary
exposure model. For chronic dietary risk assessment, the water
concentration of value 15.8 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). Cyromazine is not
registered for any specific use patterns that would result in
residential exposure.
    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.''
    Cyromazine contains a symmetrical triazine substructure like the
herbicides simazine and atrazine, but atrazine and simazine are
chlorotriazines, and the toxicity of these chemicals is associated with
the presence of a chlorine substituent on the triazine ring. Cyromazine
is not a chlorotriazine. The chlorotriazines have a much different
toxicological profile than does cyromazine which does not have a
chlorine substituent on the triazine ring. EPA has not found cyromazine
to share a common mechanism of toxicity with any other substances, and
cyromazine does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that cyromazine 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 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. Based on the available data,
there is no quantitative and qualitative evidence of increased
susceptibility observed following in utero cyromazine exposure to rats
and rabbits or following prenatal/postnatal exposure in the 2-
generation reproduction study. The database is considered adequate for
selection of study endpoints and determination of a dose/response to
characterize the potential prenatal or postnatal toxicity of cyromazine
to infants and children. No increase in susceptibility was seen in
developmental toxicity studies in rat and rabbit or reproductive
toxicity studies in the rat. Toxicity to offspring was observed at dose
levels the same or greater than those causing maternal or parental
toxicity. Based on the results of developmental and reproductive
toxicity studies, there is not a concern for increased qualitative and/
or quantitative susceptibility following in utero exposure to
cyromazine.
    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 cyromazine is complete except for
acute and subchronic neurotoxicity studies and immunotoxicity testing.
Recent changes to 40 CFR part 158 make these studies (OPPTS Guideline
870.7800) required for pesticide registration; however, the available
data for cyromazine do not show potential for neurotoxicity or
immunotoxicity. Although specific neurotoxicity studies have not yet
been submitted, there is no evidence of neurotoxicity in any study in
the toxicity database for cyromazine. In the absence of specific
immunotoxicity studies, EPA has evaluated the available cyromazine
toxicity database to determine whether an additional database
uncertainty factor is needed to account for potential immunotoxicity.
No evidence of immunotoxicity was found. Due to the lack of evidence of
immunotoxicity for cyromazine, EPA does not believe that conducting
immunotoxicity testing will result in a NOAEL less than the cRfD NOAEL
of 1.5 mg/kg bw/day already established for cyromazine. Consequently,
the EPA believes the existing data are sufficient for endpoint
selection for exposure/risk assessment scenarios and for evaluation of
the requirements under the FQPA, and an additional database uncertainty
factor does not need to be applied.
    ii. There is no indication that cyromazine 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 cyromazine 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 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 cyromazine in drinking water.

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. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyromazine is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyromazine from food and water will utilize 85% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for cyromazine.
    3. Short- and intermediate term risk. Short- and intermediate-term
aggregate exposure takes into account short-term and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Cyromazine is not
registered for any use patterns that would result in residential
exposure. Therefore, the short-term and intermediate-term aggregate
risk is the sum of the risk from exposure to cyromazine through food
and water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Cyromazine is
classified as a ``Group E'' chemical (negative for carcinogenicity in
humans). This classification is based on the lack of evidence of
carcinogenicity in mice and rats. EPA does not expect cyromazine 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 cyromazine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Methods AG-408 [high-performance liquid chromatography/ultraviolet
(HPLC/UV)] and AG-417A [gas-liquid chromatography/nitrogen-phosphorus
detector (GLC/NPD)] are the tolerance enforcement methods for
cyromazine as published in the Pesticide Analytical Manual (PAM), Vol.
II. These methods combined and with minor modifications comprise Method
AG-621. The residue data submitted in support of this petition were
generated using Methods AG-408 and AG-621. Method AG-621 has been
adequately validated for use for the determination of residues of
cyromazine in/on bulb vegetables, leafy Brassica vegetables, and turnip
greens. Method AG-408 is adequate for enforcement of the proposed
tolerance for residues of cyromazine.

B. International Residue Limits

    There are currently no established Codex maximum residue limits
(MRLs) for residues of cyromazine on succulent beans.

V. Conclusion

    Therefore, tolerances are established for residues of cyromazine,
N-cyclopropyl-1,3,5-triazine-2,4,6-triamine, in or on bean, succulent
at 2.0 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: March 26, 2010.
Lois Rossi,
Director, Registration DivisionOffice 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 180.414 is amended by alphabetically adding the following
commodity to the table in paragraph (a)(1) to read as follows:

Sec. 180.414  Cyromazine; tolerances for residues

    (a)* * * (1)* * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Bean, succulent................................                      2.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-9741 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: September 9, 2010 (Volume 75, Number 174)]
[Notices]
[Page 54889-54890]
[DOCID:fr09se10-75]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0451]

Draft Guidance for Industry on Suicidality: Prospective
Assessment of Occurrence in Clinical Trials; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Suicidality:
Prospective Assessment of Occurrence in Clinical Trials.'' The purpose
of this guidance is to assist sponsors in prospectively assessing the
occurrence of treatment-emergent suicidality in clinical trials of drug
and biological products. Specifically, this guidance addresses FDA's
current thinking regarding the importance of suicidality assessment in
psychiatric and nonpsychiatric drug trials and the general principles
for how best to accomplish this assessment during drug development.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 8, 2010.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Thomas Laughren, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4114, Silver Spring, MD 20993-0002, 301-
796-2260.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Suicidality: Prospective Assessment of Occurrence in
Clinical Trials.'' The purpose of this guidance is to assist sponsors
in prospectively assessing the occurrence of treatment-emergent
suicidality in clinical trials of drug and biological products.
Specifically, this guidance addresses FDA's current thinking regarding
the importance of suicidality assessment in psychiatric and
nonpsychiatric drug trials and the general principles for how best to
accomplish this assessment during drug development.
    The principles discussed in this guidance for the prospective
assessment of suicidality involve actively querying patients about the
occurrence of suicidal thinking and behavior, rather than relying on
patients to report such occurrences spontaneously, followed by
retrospective classification of events into appropriate categories.
This guidance recommends a specific suicidality assessment instrument
that can be used to conduct such prospective assessments and offers
guidance on the use of alternative instruments. This guidance does not
address the complex analytic issues involved in the analysis of the
suicidality data that will be derived from prospective assessments of
suicidality; these issues will be addressed in separate guidances.
    Comments are welcome regarding the recommended approach of carrying
out prospective suicidality assessments in all clinical trials for all
drugs that are pharmacologically similar to isotretinoin and other
tretinoins, beta blockers (especially those entering the brain),
reserpine, drugs for smoking cessation, and drugs for weight loss for
which possible signals of risk for suicidality have already been
identified.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
prospective assessment of suicidality occurrence in clinical trials. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: September 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22404 Filed 9-8-10; 8:45 am]
BILLING CODE 4160-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 Office of Air Quality and Planning Standards
                           109 T.W. Alexander Drive
                               Durham, NC 27709

                                   OFFICE OF
                               AIR AND RADIATION

MEMORANDUM

SUBJECT:	Data files used in the analysis of "Potential for Excess Local Deposition of Mercury in Areas near U.S. EGUs" for MATS docket EPA-HQ-OAR-2009-0234

FROM:	Halil Cakir
		Air Quality Analysis Division
		Office of Air Quality and Planning Standards

TO:		Docket EPA-HQ-OAR-2009-0234

DATE:		December 12, 2011

The purpose of this memorandum is to transmit data files which were used in the GIS analysis of excess local mercury deposition supporting the appropriate and necessary finding for the Mercury and Air Toxics Standard.  This analysis is described in the "Technical Support Document: Potential for Excess Local Deposition of Mercury in Areas near U.S. EGUs", which is available in the docket.

The disc accompanying this memo contains the following information:

   a) ArcGIS 10 ArcMap document (Hot Spot Analysis.mxd) that saves map layouts, features, symbology, spatial extent of the maps, and relative path names.
   b)  the CMAQ-modeled Hg excess deposition files for the 2005 and 2016 scenarios
   c) the spatial averages of the U.S. EGU-attributable deposition (obtained by subtracting estimated mercury deposition with U.S. EGU Hg emissions zeroed out from baseline mercury deposition from all sources including U.S. EGU Hg emissions) across the grid cells with centers falling inside the 50 km and 500 km buffers.

Attachments


55826 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations nor an environmental impact statement is required. This rule does not meet the definition of `` rule'' in 5 U. S. C. 804( 3)( A) because it is a rule of `` particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U. S. C. 801   808.

List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds.

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

PART 558   NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS  1. The authority citation for 21 CFR part 558 continues to read as follows:

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

§ 558.355 [ Amended]

 2. Section 558.355 Monensin is amended in paragraph ( f)( 1)( xiv)( b) after `` 046573'' by adding `` and 053389''.

Dated: September 11, 2003. Linda Tollefson, Deputy Director, Center for Veterinary Medicine. [ FR Doc. 03   24436 Filed 9   26   03; 8: 45 am]

BILLING CODE 4160   01   S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 26, 161, 164, and 165 [ USCG   2003   14757]

RIN 1625   AA67 Automatic Identification System; Vessel Carriage Requirement AGENCY: Coast Guard, DHS. ACTION: Policy statement.

SUMMARY: The Coast Guard is announcing its policy and intent to establish one uniform compliance date for U. S. domestic vessels subject to Automatic Identification System carriage regulations while transiting a Vessel Traffic Service ( VTS) area. On July 1, 2003, the Coast Guard published a temporary interim rule that established 3 different compliance dates, depending on particular VTS areas. This policy statement aligns these dates with the deadline date of the Maritime Transportation Security Act of 2002. DATES: This policy is effective on September 29, 2003.

FOR FURTHER INFORMATION CONTACT: If you have questions on this Policy Statement, contact Mr. Jorge Arroyo, U. S. Coast Guard Office of Vessel Traffic Management ( G   MWV), by telephone 202   267   6277, toll free telephone 1   800   842   8740 ext. 7   6277, or electronic mail JArroyo@ comdt. uscg. mil.

SUPPLEMENTARY INFORMATION:

Background On July 1, 2003, we published a temporary interim rule with request for comments and notice of public meeting titled `` Automatic Identification System; Vessel Carriage Requirement'' in the Federal Register ( 68 FR 39353). This temporary interim rule was one of a series of temporary interim rules on maritime security published in the July 1, 2003, issue of the Federal Register. On July 16, 2003, we published a document correcting typographical errors and omissions in that rule ( 68 FR 41913). The temporary interim rule established an Automatic Identification System ( AIS) compliance date that varies depending upon VTS area. They are as follows: ( 1) For VTS St. Marys River, not later than December 31, 2003; ( 2) For VTS Berwick Bay, VMRS Los Angeles/ Long Beach, VTS Lower Mississippi River, VTS Port Arthur and VTS Prince William Sound, not later than July 1, 2004; and ( 3) For VTS Houston Galveston, VTS New York, VTS Puget Sound, and VTS San Francisco, not later than December 31, 2004. These deadline dates were established to coincide with anticipated AIScapability at each of these respective ports via our Ports and Waterways Safety System ( PAWSS) upgrades. PAWSS is an effort to establish a national transportation system that collects, processes, and disseminates information on the marine operating environment and maritime vessel traffic in major U. S. ports and waterways. Work continues on schedule in our PAWSS process; however, we recognize that having differing deadline dates has caused unwarranted confusion and may place certain vessels at a disadvantage of reaping market benefits. Therefore, the Coast Guard will amend its temporary interim rule, by a forthcoming final rule, that will adopt December 31, 2004, as the compliance date for all VTS users, not on international voyage, that are subject to the provisions of 33 CFR 164.46( b). Policy Statement Until the Coast Guard publishes its final rule regarding AIS carriage requirements, the following policy applies: The Coast Guard will not enforce the deadline dates as stated in 33 CFR 164.46( c)( 1) through ( 4).

How Long Will This Policy Remain in Effect? This policy will remain in effect until publication of the final rule regarding AIS carriage [ USCG 2003   14757], that we anticipate publishing prior to October 25, 2003. In the final rule we intend to adopt December 31, 2004, as the deadline date for domestic AIS carriage for those vessels denoted in 33 CFR 164.46( b).

Dated: September, 22 2003. T. H. Gilmour, Rear Admiral, Coast Guard, Assistant Commandant for Marine Safety, Security and Environmental Protection. [ FR Doc. 03   24571 Filed 9   26   03; 8: 45 am]

BILLING CODE 4910   15   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0303; FRL   7327   3]

Dimethomorph; Pesticide Tolerances AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of dimethomorph in or on brassica, leafy greens, subgroup 5B; taro, corm; taro, leaves; and vegetable, fruiting, group 8. EPA is also deleting certain dimethomorph tolerances that are no longer needed as a result of this action. Interregional Research Project Number 4 ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective September 29, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0303, must be received on or before November 28, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55827 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   3194; e mail address: brothers. shaja@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

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

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0303. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of August 20, 2003 ( 68 FR 50138) ( FRL   7321   7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of pesticide petitions ( PP 2E6483 and 3E6558) by IR 4, 681 US Highway # 1 South, New Brunswick, NJ 08902   3390. That notice included a summary of the petitions prepared by BASF Corporation, the registrant. The petitions requested that 40 CFR 180.493 be amended by establishing tolerances for residues of the fungicide, dimethomorph,( E, Z) 4[ 3( 4 chlorophenyl) 3( 3,4 dimethoxyphenyl) 1 oxo 2 propenyl] morpholine in or on the following commodities: Brassica, leafy greens, subgroup 5B at 20.0 part per million ( ppm); taro, corm at 0.5 ppm; taro, leaves at 6.0 ppm; and vegetable, fruiting, group 8 at 2.0 ppm. The tolerance petition for vegetable, fruiting, group 8 was subsequently amended to propose the tolerance at 1.5 ppm. EPA is also deleting tolerances for tomato, fruit at 0.5 ppm, and tomato, paste at 1.0 ppm established under section 180.493 ( a). These commodities will be covered by the tolerance for vegetable, fruiting, group 8 at 1.5 ppm. There were no comments received on these petitions. Section 408( b)( 2)( A)( i) of the 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 the 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 the 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 rasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL   5754   7).

III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for tolerances for residues of dimethomorph on brassica, leafy greens, subgroup 5B at 20.0 ppm; taro, corm at 0.5 ppm; taro, leaves at 6.0 ppm; and vegetable, fruiting, group 8 at 1.5 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow.

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. The nature of the toxic effects caused by dimethomorph are discussed in the Federal Register of September 27, 2002 ( 67 FR 60916) ( FRL   7199   2).

B. Toxicological Endpoints The dose at which no adverse effects are observed ( the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55828 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factors ( SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer= point of departure/ exposures) is calculated. A summary of the toxicological endpoints for dimethomorph used for human risk assessment is shown is shown in Table 1 of this unit:

TABLE 1.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR DIMETHOMORPH FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF Special FQPA SF* and Endpoint for Risk Assessment Study and Toxicological Effects Acute dietary females 13 50 years of age Not applicable Not applicable No endpoint attributable to a single dose was identified.

Acute dietary general population including infants and children Not applicable Not applicable No endpoint attributable to a single dose was identified Chronic dietary all populations NOAEL= 11 mg/ kg/ day UF = 100 Chronic RfD = 0.1 mg/ kg/ day Special FQPA SF = 1 cPAD = chronic RfD/ Special FQPA SF = 0.1 mg/ kg/ day Carcinogenicity study in the rat LOAEL = 46.3 mg/ kg/ day based on decreased body weight and statistically significant increases in liver lesions in female rats Short term dermal ( 1 to 7 days) Oral study NOAEL= 60 mg/ kg/ day ( dermal absorption factor = 5 %) LOC for MOE = 100 Developmental toxicity study in the rat LOAEL = 160 mg/ kg/ day based on decreased body weight, decreased body weight gain, and decreased food consumption Intermediate term dermal ( 1 week to several months) Oral study NOAEL= 15 mg/ kg/ day ( dermal absorption factor = 5 % LOC for MOE = 100 Subchronic feeding study in dogs LOAEL = 43 mg/ kg/ day based on decreased absolute and relative prostate weight and possible threshold liver effects Long term dermal ( several months to lifetime) Not applicable Not applicable The current use pattern does not indicate a concern for long term exposure risk Short term inhalation ( 1 to 7 days) Oral study NOAEL= 60 mg/ kg/ day ( inhalation absorption factor = 100 %) LOC for MOE = 100 Developmental toxicity study in the rat LOAEL = 160 mg/ kg/ day based on decreased body weight, decreased body weight gain, and decreased food consumption Intermediate term nhalation ( 1 week to several months) Oral study NOAEL= 15 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 Subchronic feeding study in dogs LOAEL = 43 mg/ kg/ day based on decreased absolute and relative prostate weight and possible threshold liver effects Long term inhalation ( several months to lifetime) Not applicable Not applicable The current use pattern does not indicate a concern for long term exposure risk VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55829 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations TABLE 1.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR DIMETHOMORPH FOR USE IN HUMAN RISK ASSESSMENT   Continued Exposure Scenario Dose Used in Risk Assessment UF Special FQPA SF* and Endpoint for Risk Assessment Study and Toxicological Effects Cancer ( oral, dermal, inhalation Not applicable Not applicable This chemical is classified as `` not likely to be a human carcinogen C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.493) for the residues of dimethomorph, in or on [ grape; grape, raisin; hop, dried cones; lettuce, head; lettuce, leaf; potato, wet peel; tomato; tomato, paste; vegetable, bulb, group 3; and vegetable, cucurbit, group 9. Time limited tolerances are also established for residues of dimethomorph in connection with use of the pesticide under emergency exemptions pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act for cantaloupe, cucumber, squash, and watermelon at 1.0 ppm set to expire on December 31, 2003. Additionally, time limited tolerances are established for inadvertent or indirect residues of dimethomorph in or on the following raw agricultural commodities when present therein as a result of the application of dimethomorph to growing crops: grain, cereal group, fodder; grain, cereal group, forage; grain, cereal group, grain; grain, cereal group, hay; and grain, cereal group, straw at 0.15 ppm, set to expire on May 12, 2004. Risk assessments were conducted by EPA to assess dietary exposures from dimethomorph in food as follows: i. Acute exposure. A quantitative acute dietary exposure and risk assessment was not conducted for dimethomorph since an acute oral endpoint attributed to a single dose exposure could not be identified in any of the toxicology studies, including developmental and maternal toxicity in the developmental toxicity studies. No acute risk is expected from exposure to dimethomorph. ii. Chronic exposure. In conducting this acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEMTM/ FCID) which incorporates food consumption data as reported by respondents in the United States Department of Agriculture ( USDA) 1994   1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions was made for the chronic exposure assessment: The chronic dietary risk assessment for dimethomorph assumed tolerance level residues and 100% crop treated ( Tier 1) for all registered and proposed crops. iii. Cancer. EPA has classified dimethomorph as a `` not likely'' human carcinogen. Therefore, a quantitative cancer dietary exposure and risk assessment was not performed. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for dimethomorph in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of dimethomorph. The Agency uses the Generic Estimated Environmental Concentration ( GENEEC) or the Pesticide Root Zone Model/ Exposure Analysis Modeling System ( PRZM/ EXAMS) to estimate pesticide concentrations in surface water and Screening Concentrations in Ground Water ( SCI GROW), which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC ( a Tier 1 model) before using PRZM/ EXAMS ( a Tier 2 model) for a screening level assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific high end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. ince DWLOCs address total aggregate exposure to dimethomorph they are further discussed in the aggregate risk sections in Unit E. Based on the GENEEC and SCI GROW models the EECs of dimethomorph for acute exposures are estimated to be 79.8 parts per billion ( ppb) for surface water and 0.30 ppb for ground water. The EECs for chronic exposures are estimated to be 28.5 ppb for surface water and 0.30 ppb for ground water. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use EECs from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55830 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations dimethomorph they are further discussed in the aggregate risk Unit E. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Dimethomorph is not registered for use on any sites that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of the 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 does not have, at this time, available data to determine whether dimethomorph has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to dimethomorph and any other substances and dimethomorph does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that dimethomorph has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. The developmental and reproductive toxicity data did not indicate increased susceptibility of rats or rabbits to in utero and/ or postnatal exposure. 3. Conclusion. There is a complete toxicity data base for dimethomorph and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X. The FQPA SF is removed because: Acceptable developmental toxicity studies in the rat and the rabbit are available, as is an acceptable 2   generation reproduction study in the rat and there is no indication of qualitative or quantitative increased susceptibility of rats and rabbits to in utero or postnatal exposure. A developmental neurotoxicity study is not required for dimethomorph. The dietary ( food and water) exposure assessments are not expected to underestimate the potential exposures for infants and children from the use of dimethomorph. Residential exposure to dimethomorph is not expected since there are no registered residential uses for the pesticide.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water [ e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethomorph from food will utilize 7% of the cPAD for the U. S. population, 0.8% of the cPAD for all infants < 1 year old, 16% of the cPAD for children 1   2 years old ( the most highly exposed population subgroup), and 6% of the cPAD for females 13 49 years old. Based on the lack of residential uses, chronic residential exposure to residues of dimethomorph is not expected. In addition, there is potential for chronic dietary exposure to dimethomorph in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit:

VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55831 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations TABLE 2.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO DIMETHOMORPH Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. population 0.10 7 28.50 0.30 3,253 All infants (< 1 year old) 0.10 0.8 28.50 0.30 960 Children ( 1 2 years old) 0.10 16 28.50 0.30 842 Females ( 13 49 years old) 0.10 6 28.50 0.30 2,812 2. Short and intermediate term risk. Short and intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Dimethomorph is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 3. Aggregate cancer risk for U. S. population. Dimethomorph is no carcinogenic. This classification was based upon lack of evidence of carcinogenicity in rats and mice. The Agency concludes that the pesticidal uses of dimethomorph are not likely to pose a cancer risk to humans. 4. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to dimethomorph residues.

IV. Other Considerations A. Analytical Enforcement Methodology A reliable method for the determination of dimethomorph residues in fruiting vegetables crop group 8, leafy brassica greens subgroup 5B, taro leaves and roots exists; this method is the FDA Multi Residue Method, Protocol D, as published in the Pesticide Analytical Manual I. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755   5350; telephone number: ( 410) 305   2905; email address: residuemethods@ epa. gov.

B. International Residue Limits There are no established or proposed Codex, Canadian or Mexican maximum residue limits or tolerances for dimethomorph in or on taro, corm; taro, leaves; brassica, leafy greens, subgroup 5B; or vegetable, fruiting, group 8. V. Conclusion Therefore, the tolerances are established for residues of dimethomorph, in or on brassica, leafy greens, subgroup 5B; taro, corm; taro, leaves; and vegetable, fruiting, group 8.

VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons o `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0303 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 28, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55832 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0303, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

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

VIII. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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.

VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55833 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations Dated: September 22, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

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

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

 2. Section 180.493 is amended by removing the entries `` tomato'' and `` tomato, paste'' and by alphabetically adding the following commodities to the table in paragraph ( a) to read follows:

§ 180.493 Dimethomorph; tolerances for residues.

( a) * * *

Commodity Parts per million Brassica, leafy greens, subgroup 5B ............................... 20.0 * * * * *

Taro, corm ................................ 0.5 Taro, leaves .............................. 6.0 * * * * *

Vegetable, fruiting, group 8 ...... 1.5 * * * * * [ FR Doc. 03   24564 Filed 9   26   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0058; FRL   7327   9]

Glufosinate Ammonium; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for combined residues of glufosinate ammonium and its metabolites in or on certain raw agricultural commodities. Aventis CropScience USA, now Bayer CropScience, and Interregional Research Project Number 4 ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective September 29, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0058, must be received on or before November 28, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: 703   305   6224; e mail address: miller. joanne@ epamail. epa. gov.

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 categories and entities may include, but are not limited to:

  Crop production ( NAICS 111)

  Animal production ( NAICS 112)

  Food manufacturing ( NAICS 311)

  Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0058. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html/, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of May 19, 2000 ( 65 FR 31904) ( FRL   6558   2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide petition ( PP 0F6140) by Aventis CropScience USA, now Bayer CropScience, PO Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. There were no comments received in response to the notice of filing. In the Federal Register of July 24, 2002 ( 67 FR 48465) ( FRL   7184   6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide petition ( PP OF6210) by Aventis CropScience USA, now Bayer CropScience, PO Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. Comments on the petition were filed by Neil J. Carman, Ph. D. of the Sierra Club VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1