[Federal Register: October 3, 2007 (Volume 72, Number 191)]
[Proposed Rules]
[Page 56325-56330]
[DOCID:fr03oc07-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0546; FRL-8151-6]

Thiabendazole; Threshold of Regulation Determination

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to establish by rule that there is no need
for a tolerance or tolerance exemption under the Federal Food Drug and
Cosmetic Act (FFDCA) for the use of the fungicide thiabendazole as a
seed treatment on dry peas. This determination is based on EPA's
finding that any residues that remain in food from this use will be
both non-detectable and below the level of regulatory concern.

DATES: Comments must be received on or before December 3, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0546, 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>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0546. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. 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.
Although listed in the index, some information is not publicly
available, e.g., 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 either 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 hours of operation of this
Docket Facility are 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0546. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is<PHONE_NUMBER>.

    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing that the use of the fungicide thiabendazole, 2-(4-
thiazolyl) benzimidazole, as a seed treatment on dry peas does not need
an FFDCA tolerance or tolerance exemption based on EPA's finding that
any residues that remain in food from this use will be both non-
detectable and below the level of regulatory concern.
    In the Federal Register of October 27, 1999 (64 FR 57881),
available at http://www.epa.gov/fedrgstr/EPA-PEST/1999/October/Day-27/p28047.htm
, EPA announced the availability of a policy document titled

``Threshold of Regulation (TOR) Policy - Deciding Whether a Pesticide
with a Food Use Pattern Requires a Tolerance.'' This policy document
describes:
    (a) EPA's authority for determining whether a tolerance or
tolerance exemption is, or is not, required for a pesticide use.
    (b) Relevant criteria that EPA would consider in determining
whether a tolerance is required for a pesticide use in, on, or near
food that produces no detected residues in the food.
    (c) Data, including toxicology and residue chemistry studies, that
EPA would generally consider when deciding whether a tolerance is
required.
    (d) The procedures that would guide EPA in evaluating whether new
or existing pesticide uses fall below the level of regulatory concern.
    (e) The procedures that EPA would follow to establish a regulation
in title 40 of the Code of Federal Regulations (CFR) for each use found
to be below the level of regulatory concern.
    You may obtain electronic copies of the TOR policy document from
the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides/.
 On the Office of Pesticide Programs' Home Page, select

``Science and Policy,'' then select ``Policy and Guidance''and look up
the TOR entry under ``TRAC Science Policy Issues and Documents.''
    Designation of a pesticide use as below the level of regulatory
concern means EPA has determined that no tolerance or exemption is
required under section 408. Accordingly, for the purposes of
registration of the pesticide use under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq., a
tolerance or exemption from tolerance would not be deemed necessary
under 40 CFR 152.112(g). Designation of a pesticide use as below the
level of regulatory concern does not legalize any detectable residues
of that pesticide on food.
    This proposed decision applies only to the use of the fungicide
thiabendazole as a seed treatment on dry peas when applications are
made according to the following label directions:

    A single application of thiabendazole may be made as a seed
treatment at the rate of 0.075 pounds of active ingredient per 100
pounds of seed (dry pea (including field pea), pigeon pea, chickpea
or lentil). Applications will be made as a spray mist or slurry
treatment maintained under constant agitation. Vines and hay grown
from treated seed may not be fed to livestock.

    EPA proposes that there is no need for a tolerance or tolerance
exemption for this use under the FFDCA since (a) using a reliable and
appropriately sensitive analytical method to measure residues in dry
peas, no residues were detected in the commodity under the expected
conditions of use; and (b) using reasonably protective criteria, the
estimated potential risk of any theoretically possible residues in food
is not of concern. The information EPA relied on in proposing this
decision is summarized below.
    1. Toxicology considerations--i. Toxicological profile. EPA has
evaluated the available toxicity data for thiabendazole 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. EPA has concluded that there are sufficient data to
characterize the hazard posed by any potential exposures to
thiabendazole. Specific information on the toxicity of thiabendazole is
available in the Reregistration Eligibility Decision (RED) document,
issued by the Agency in October 2002, and available electronically on
the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides/.
 On the Office of Pesticide Programs' Home Page, under

``Featured Sites'' select ``REDs & Pesticide Reregistration Status;''
then look up the RED for Thiabendazole and its salts in the
alphabetical listing.
    ii. 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 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 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/pesticides/factsheets/riskassess.htm
.

    The toxicological endpoints used in making the TOR determination
for the proposed use of thiabendazole as a seed treatment on dry peas
are discussed below and summarized in Table 1 of this unit.
    a. Acute dietary endpoint. At the time of the thiabendazole RED,
EPA had selected acute dietary endpoints for the

general population and females, 13 years and older, based on reduced
fetal weights and decreased maternal body weights seen in the rat
developmental toxicity study. EPA has reconsidered these endpoints and
concluded that reduced fetal weights and decreased maternal body
weights are not effects that are likely to occur after a single dose of
a pesticide and are, therefore, not appropriate for use in assessing
acute risks. EPA has reviewed the toxicology database to determine if
there are other endpoints that would be appropriate for acute
assessment, giving careful consideration to the reproductive and
developmental effects noted in the database and in literature
citations. Since those effects were only observed at very high doses,
they were determined to be inappropriate for risk assessment at the
exposures expected for thiabendazole. EPA has concluded that there is
no appropriate endpoint in the toxicology database that is attributable
to a single dose of thiabendazole and that an acute risk assessment is
not required for this chemical.
    b. Chronic dietary endpoint. The chronic dietary endpoint (NOAEL of
10 mg/kg/day) is based on decreased body weight gains and liver
hypertrophy seen at the LOAEL of 30 mg/kg/day in the 2-year chronic
feeding/carcinogenicity study in the rat.
    c. Cancer. The Agency has classified thiabendazole as ``likely to
be carcinogenic at doses high enough to cause a disturbance of the
thyroid hormone balance. It is not likely to be carcinogenic at doses
lower than those which could cause a disturbance of this hormonal
balance.'' A mode of action was established in which these tumors were
attributed to interference with thyroid-pituitary homeostasis. EPA is
currently regulating chronic dietary risk using a cPAD that reflects a
dose level below levels at which thyroid hormone balance is impacted;
therefore, the chronic risk assessment is protective of potential
carcinogenic effects. A separate risk assessment for cancer is not
required.

 Table 1.--Summary of Toxicological Doses and Endpoints for Thiabendazole Used in the TOR Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          FQPA SF and Level of
          Exposure/Scenario                Interspecies and         Concern for Risk     Study and Toxicological
                                         Intraspecies and any          Assessment                Effects
                                         Traditional FQPA, SF
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  Not Applicable (N/A)     N/A                      No effect attributable
 age)                                                                                to a single dose
                                                                                identified in the
                                                                                database.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      N/A                      N/A                      No effect attributable
 including infants and children)                                                          to a single dose
                                                                                identified in the
                                                                                database.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 10 mg/kg/day      FQPA SF = 1              2-Year Feeding/Chronic
                                       SF = 100...............  cPAD = chronic RfD /      Carcinogenicity Study
                                       Chronic RfD = 0.1 mg/kg/  FQPA SF = 0.1 mg/kg/     in the Rat. LOAEL = 30
                                        day.                     day.                     mg/kg/day based on
                                                                                decreased body weight
                                                                                gains and liver
                                                                                hypertrophy.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)      NA                       NA                       Classified as ``not
                                                                                likely to be
                                                                                carcinogenic to humans
                                                                                at doses that do not
                                                                                alter rat thyroid
                                                                                hormone homeostasis.
----------------------------------------------------------------------------------------------------------------

    2. Safety Factor for Infants and Children. 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 uncertainty (UFs) and/or considerations
specifically raised in the FQPA, as appropriate.
    EPA has determined that reliable data show that it would be safe
for infants and children to reduce the FQPA safety factor for
thiabendazole to 1X. That decision is based on the following findings:
    i. The toxicity database for thiabendazole is complete.
    ii. There is no indication that thiabendazole 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 thiabendazole results in increased
susceptibility in in utero rats, rabbits or mice in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. In the prenatal developmental toxicity studies in rats, rabbits,
and mice and in the 2-generation reproduction study in rats,
developmental effects in the fetuses or neonates occurred at or above
doses that caused maternal or parental toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary exposure assessment of the TOR use, discussed
below in Unit II.A.3., was performed assuming 100% crop treated and a
conservative residue estimate. The assessment will not underestimate
the exposure and risks posed by the use of thiabendazole as a seed
treatment on dry peas.
    3. Residue data and analytical method considerations. For a use to
be below the level of regulatory concern it is important for it not to
result in detectable residues under a reasonably sensitive analytical
method and for any theoretical residues that are present to pose
essentially a zero risk. Considering the range of sensitivities of
tolerance analytical methods, EPA believes that a reasonably sensitive
method should have a limit of quantitation (LOQ) in the range of 0.01
parts per million (ppm). However, the sensitivity of the method is not
chosen in a vacuum and consideration should be given to how the
sensitivity of the method affects any

estimation of risk. Accordingly, on a case-specific basis, EPA may
accept a higher or lower LOQ if an appropriate rationale, including a
consideration of risks estimated based on exposure as measured by that
LOQ, supports such a decision.
    Interregional Research Project No. 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, submitted field trial data for
thiabendazole on dry pea. A total of five field trials were conducted
in Zone 11 (2 trials in Idaho and 3 trials in Washington) during the
1996 growing season. Thiabendazole (30% flowable concentrate
formulation) was formulated with water and seed dye and applied to dry
pea seed at a seed treatment facility, at a nominal rate of 0.075
pounds of active ingredient per 100 pounds of seed. Treated seed was
planted within 10 days of seed treatment, and samples of dry pea were
collected from the field trial sites at maturity, 83-90 days after
planting.
    Samples of dry pea were analyzed for residues of thiabendazole per
se using a High Pressure Liquid Chromatography/Fluorescence Detector
(HPLC/FLD) method with a lower limit of the method validation (LLMV) of
0.05 ppm. The method (MRID 45428201) is a modification of the
method Ion-Pairing Liquid Chromatographic Determination of
Benzimidazole Fungicides in Foods, Gilvydis and Walters, JAOAC, vol.
73, no. 5, 1990. The mobile phase hold times were increased to obtain
adequate separations. Duplicate samples were analyzed for residues of
thiabendazole at each of the five field trial locations. Residues of
thiabendazole were less than the method limit of detection (LOD) of
0.02 ppm in all 10 field trial samples.
    No data were provided on residues of benzimidazole, a regulated
metabolite of thiabendazole in or on dry pea grown from treated seed.
However, based on residue studies in three diverse crops (wheat,
soybean and sugar beets) in which residues of benzimidazole were
consistently lower than residues of the parent compound, thiabendazole,
EPA does not expect detectable residues of benzamidazole in dried peas
grown from thiabendazole treated seed.
    The analytical method used to measure thiabendazole residues
appeared in the JAOAC, The Journal of the Association of Official
Analytical Chemists, a peer reviewed publication. Further, adequate
method validation data were provided in both the journal article and in
conjunction with the submitted residue data. EPA concludes that the
method would be suitable for enforcement purposes. The analytical
method's reported LLMV of 0.05 ppm is higher than the 0.01 ppm value
that has been identified as a target LOQ by the policy document on
identifying uses below the threshold of regulatory concern.
Nevertheless, EPA has concluded that the analytical method used to
generate the residue data is sufficiently sensitive to support the
threshold of regulation determination based on the following supporting
information.
    i. The LLMV is an artifact of the concentrations chosen for the
study validation, and the actual analytical limits of quantitation
(LOQ) and limits of detection (LOD) may be significantly below that
value. EPA carefully examined the method chromatograms. Based on peak
heights relative to concentration, peak shape and signal to noise
ratio, the method's LOD was determined to be no greater than 0.02 ppm.
    ii. EPA also considered data on the nature of the residue in
soybeans submitted by Gustafson, Inc. The study was entitled ``Total
14C Thiabendazole Residues in Soybeans from Treated Seed
Grown Under Field Conditions'' (1998, MRID 45200301). In this study,
soybean seeds were treated with 38 ppm 14C Thiabendazole
(0.00382 lb. a.i./100 lbs. seed). The treated seeds were then planted
in the field and samples were taken of mature dry bean (82 days after
treatment). Samples were assayed by combustion and analysis of
14CO2 by liquid scintillation spectrometry. The
total radioactive residue (TRR) in soybean seed was < 0.001 ppm (< 1
ppb). EPA considers soybeans to be an appropriate surrogate for dry
pea. Taking into account the higher application rate currently
requested for dry peas, the study supports the conclusion reached in
the field trial data that residues will not exceed the estimated LOD of
0.02 ppm in dry pea grown from treated seed at the currently requested
use rate, and may be lower than 0.02 ppm.
    iii. Statistical data on the thiabendazole analytical method
submitted by IR-4 further support the conclusion that the actual LOD is
likely below the conservatively estimated value of 0.02 pm and
indicates that the statistical LOD is much closer to 0.01 ppm.
    iv. Finally, EPA's risk assessment of the proposed use assumed
theoretical residues in dry peas equal to one-half the estimated LOD,
which is 0.01 ppm. The resulting risk estimates were essentially zero,
indicating that the method is sensitive enough to demonstrate that any
potential residues in food are not of concern. The risk assessment is
discussed in detail in the next section.
    Taking all of these factors into consideration, EPA concludes that
the analytical method used to generate the residue data is sufficiently
sensitive to support a conclusion that the use will not result in
detectable residues in food using a reasonably sensitive method. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    4. Dietary risk assessment. For a use to be below the level of
regulatory concern, any theoretical residues present from the use
should pose essentially zero dietary risk. As a starting point for
analysis of this question, EPA's policy document has recommended that
essentially zero dietary risk is evidenced by a showing that
incremental risk from exposure to potential residues in food resulting
from use of a pesticide should generally be less than 1/1000 of the
acceptable risk. For a pesticide such as thiabendazole that exerts
``threshold'' effects, this means that incremental acute or chronic
potential exposure from the use should occupy less than 0.1% of the
acute or chronic population-adjusted dose (aPAD or cPAD) for the
pesticide. EPA assessed dietary exposure to thiabendazole from its use
as a seed treatment on dry peas 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 thiabendazole; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). EPA
assumed residues of thiabendazole would be present in dry peas at one-
half the LOD, equal to 0.01 ppm. Only dry peas were included in the
dietary assessment, and 100% of dry peas were assumed to be treated
with thiabendazole.
    Using these assumptions, EPA has concluded that chronic dietary
exposure to thiabendazole from residues theoretically present in dry
peas will not exceed 0.01% of the cPAD for the U.S. population or any
population subgroup, including infants and children. The estimated
chronic risk for

the U.S. population and all subpopulations of concern is significantly
below the level recommended in EPA's policy as showing essentially zero
risk (0.1% of the cPAD).
    iii. Cancer. Thiabendazole has been classified as ``not likely to
be carcinogenic to humans at doses that do not alter rat thyroid
hormone homeostasis.'' The Office of Pesticide Programs' Health Effects
Division is currently regulating chronic dietary risk with a chronic
cPAD that reflects a dose level below dose levels at which thyroid
hormone balance is impacted and, consequently, is also being protective
of potential carcinogenic effects. Therefore, a cancer dietary
assessment is unnecessary. Based on the results of the chronic dietary
assessment, the use of thiabendazole on dry peas is not expected to
pose a cancer risk.
    5. Threshold of regulation determination. Based on the information
discussed above, EPA has concluded that:
    i. Reliable residue data developed using an analytical method with
appropriate sensitivity show that no thiabendazole residues resulting
from the use of the pesticide as a seed treatment on dry peas are
detected in dry peas grown from treated seed when they enter interstate
commerce.
    ii. There are sufficient data to characterize the hazard posed by
any potential exposures to thiabendazole.
    iii. Risk estimates show that any thiabendazole residues
theoretically present in dry peas as a result of this use pose an
``essentially zero'' dietary risk.
    Therefore, EPA proposes to designate the use of thiabendazole as a
seed treatment on dry peas as below the threshold of regulatory concern
and thus as not requiring a tolerance or a tolerance exemption under
FFDCA. EPA proposes to identify the use as such under 40 CFR part
180.2010 (Threshold of regulation determinations).

B. What is the Agency's Authority for Taking this Action?

    The Federal Food, Drug and Cosmetic Act (FFDCA) section
408(e)(1)(C) authorizes the Agency to establish general procedures and
requirements to implement FFDCA section 408. FFDCA section 701(a)
authorizes the Agency to establish rules implementing the various
provisions of FFDCA, as follows: ``The authority to promulgate
regulations for the efficient enforcement of this Act, except as
otherwise provided in this section, is hereby vested in the
Secretary.'' The term ``Secretary'' means ``Administrator'' with
respect to those provisions of FFDCA for which the Administrator of
EPA, rather than the Secretary of Health and Human Services, has
responsibility. These provisions grant EPA the authority to identify by
regulation pesticide uses that do not need tolerances or exemptions
from tolerances under section 408 of FFDCA.

III. Statutory and Executive Order Reviews

    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, as amended by
Executive Order 13422, 72 FR 2763, January 18, 2007). Because this
action has been exempted from review under Executive Order 12866, this
action 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 or Safety Risks
(62 FR 19885, April 23, 1997). This action 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).
    In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby
certifies that this action will not have a significant adverse economic
impact on a substantial number of small entities because this action
does not have any adverse economic impacts.
    This action 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 (59 FR 22951, November 6,
2000) do not apply to this action. In addition, this action does not
impose an 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).

List of Subjects in 40 CFR Part 180

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

    Dated: September 26, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be 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), 346a and 371.

    2. Section 180.2010 is amended by adding text to read as follows:

Sec.  180.2010  Threshold of regulation determinations.

    The following pesticide chemical uses do not need a tolerance or
exemption from the requirement of a tolerance based on EPA's
determination that the uses are below the threshold of regulation.

----------------------------------------------------------------------------------------------------------------
          Pesticide Chemical               CAS Reg. No.             Use/Limits             Analytical Method
----------------------------------------------------------------------------------------------------------------
Thiabendazole                                    148-79-8   As a seed treatment for    High Performance Liquid
                                                             dry pea (including field   Chromatography/
                                                             pea), pigeon pea,          Florescence Detector
                                                             chickpea or lentil,        method\1\; Modification
                                                             using a maximum            of Ion-Pairing Liquid
                                                             application rate of        Chromatographic
                                                             0.075 pounds of active     Determination of
                                                             ingredient per 100         Benzimidazole Fungicides
                                                             pounds of seed. Vines or   in Foods, Gilvydis and
                                                             hay grown from treated     Walters, JAOAC, vol. 73,
                                                             seed may not be fed to     no. 5, 1990.
                                                             livestock.
----------------------------------------------------------------------------------------------------------------
\1\ Available 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>

[FR Doc. E7-19542 Filed 10-2-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Rules and Regulations]
[Pages 40511-40513]
[FR Doc No: 2012-16778]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0570]
RIN 1625-AA00

Safety Zone; GR Symphony Fireworks Display, Kalamazoo Lake,
Saugatuck, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Kalamazoo Lake in Saugatuck Michigan. This safety zone is intended to
restrict vessels from a portion of Kalamazoo Lake during the GR
Symphony Fireworks display. This temporary safety zone is necessary to
protect spectators and vessels from the hazards associated with a
fireworks display.

DATES: This rule will be effective between 8:45 p.m. until 11 p.m. on
July 17, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-0570]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box, and click ``Search.'' You may
visit the Docket Management Facility, 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
temporary rule, call or email CWO Jon Grob, U.S. Coast Guard Sector
Lake Michigan; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The final details for this event were
not known to the Coast Guard until there was insufficient time
remaining before the event to publish an NPRM. Thus, delaying the
effective date of this rule to wait for a comment period to run would
be both impracticable and contrary to the public interest because it
would inhibit the Coast Guard's ability to protect spectators and
vessels from the hazards associated with a maritime fireworks display,
which are discussed further below.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for a 30 day notice period run would
be impracticable and contrary to the public interest.

B. Basis and Purpose

    Between 8:45 p.m. and 11 p.m. on July 17, 2012, a fireworks display
will be held on Kalamazoo Lake in Saugatuck, MI. The Captain of the
Port, Sector Lake Michigan has determined that fireworks launched
proximate to a gathering of watercraft pose a significant risk to
public safety and property. Such hazards include premature and
accidental detonations, dangerous projectiles, and falling or burning
debris.

C. Discussion of Rule

    With the aforementioned hazards in mind, the Captain of the Port,
Sector Lake Michigan, has determined that this temporary safety zone is
necessary to ensure the safety of spectators and vessels during the GR
Symphony Fireworks. This zone will be effective and enforced from 8:45
p.m. until 11 p.m. on July 17, 2012. This zone will encompass all
waters of Kalamazoo Lake, Saugatuck, MI within a 700 foot radius of
position 42[deg]38'39.54'' N and 86[deg]12'17'' W (NAD 83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port, Sector Lake
Michigan, or his designated on-scene representative. The Captain of the
Port or his designated on-scene representative may be contacted via VHF
Channel 16.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS). We conclude that this rule is
not a significant regulatory action because we anticipate that it will
have minimal impact on the economy, will not interfere with other
agencies, will not adversely alter the budget of any grant or loan
recipients, and will not raise any novel legal or policy issues. The
safety zone created by this rule will be relatively small and enforced
for a relatively short time. Also, the safety zone is designed to
minimize its impact on navigable waters. Furthermore, the safety zone
has been designed to allow vessels to transit around it. Thus,
restrictions on vessel movement within that particular area are
expected to be minimal. Under certain conditions, moreover, vessels may
still transit through the safety zone when permitted by the Captain of
the Port.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
    This rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor in a portion of Kalamazoo Lake, Saugatuck, MI on the
evening of July 17, 2012.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
safety zone would be activated, and thus subject to enforcement, for
only a short period of time in the evening. Traffic may be allowed to
pass through the zone with the permission of the Captain of the Port.
The Captain of the Port can be reached via VHF channel 16. Before the
activation of the zone, we would issue a local Broadcast Notice to
Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INTFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of

Children from Environmental Health Risks and Safety Risks. This rule is
not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone and,
therefore it is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public
Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0570 to read as follows:

Sec.  165.T09-0570  Safety Zone; GR Symphony Fireworks Display,
Kalamazoo Lake, Saugatuck, MI.

    (a) Location. The safety zone will encompass all waters of
Kalamazoo Lake, Saugatuck, Michigan within a 700 foot radius of
position 42[deg]38'54'' N and 86[deg]12'17'' W (NAD 83).
    (b) Effective and Enforcement Period. This regulation is effective
and will be enforced on July 17, 2012 from 8:45 p.m. until 11 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port, Sector Lake Michigan or his designated on-scene
representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port, Sector Lake Michigan or his
designated on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port,
Sector Lake Michigan is any Coast Guard commissioned, warrant or petty
officer who has been designated by the Captain of the Port, Sector Lake
Michigan to act on his behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port, Sector Lake Michigan or his
on-scene representative to obtain permission to do so. The Captain of
the Port, Sector Lake Michigan or his on-scene representative may be
contacted via VHF Channel 16. Vessel operators given permission to
enter or operate in the safety zone must comply with all directions
given to them by the Captain of the Port, Sector Lake Michigan, or his
on-scene representative.

    Dated: June 27, 2012.
M.W. Sibley,
Captain, U.S. Coast Guard, Captain of the Port, Sector Lake Michigan.
[FR Doc. 2012-16778 Filed 7-9-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 26, 2009 (Volume 74, Number 164)]
[Rules and Regulations]
[Page 43054-43055]
[DOCID:fr26au09-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0537]

Drawbridge Operation Regulation; Red River Waterway, Torras, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
LA 15 Highway Drawbridge across the Red River Waterway, mile 1.0, near
Torras, Louisiana. The deviation is necessary to allow time for
conducting needed maintenance to the bridge. This deviation allows the
bridge to remain in the closed-to-navigation position for a two week
period.

DATES: This deviation is effective from 7 a.m. on October 19, 2009, to
5 p.m. on October 30, 2009.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2009-0537 and are available online
by going to http://www.regulations.gov, selecting the Advanced Docket
Search option on the right side of the screen, inserting USCG-2009-0537
in the Docket ID box, pressing Enter, and then clicking on the item in
the Docket ID column. They are also available for inspections 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 Roger K. Wiebusch, Bridge Administrator, Coast Guard;
(314) 269-2378<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Louisiana Department of Transportation
and Development requested a temporary deviation for the LA 15 Highway
Drawbridge, across the Red River Waterway, Mile 1.0, near Torras,
Louisiana, to remain in the closed-to-navigation position for a two-
week period to facilitate critical maintenance. The LA 15 Highway
Drawbridge currently operates in accordance with 33 CFR 117.5, which
states the general requirement that drawbridges shall open promptly and
fully for the passage of vessels when a request to open is given in
accordance with the subpart. In order to facilitate the needed bridge
work, the drawbridge must be kept in the closed-to-navigation position.
This deviation allows the bridge to remain in the closed-to-navigation
position and is effective from 7 a.m., October 19, 2009, to 5 p.m.,
October 30, 2009.
    Navigation on the waterway consists primarily of commercial tows
and recreational watercraft. Access from the Lower Mississippi River to
the Atchafalaya River, Red River Waterway, and the Ouachita-Black
Waterway is reached by passing under the subject bridge. Navigation
will not be significantly impacted due to the scheduled closure of the
Lower Old River Lock, at the same river mile as the subject bridge, for
approximately 30 days commencing on or about October 15, 2009. The
scheduled lock closure will preclude any requests for a bridge drawspan
opening.
    The LA 15 Highway Drawbridge navigation span has a vertical
clearance of 74.0 feet above zero gauge at the bridge in the closed-to-
navigation position. Performing maintenance on the bridge, when the
number of vessels likely to be impacted is minimal, is preferred to
bridge closure requirements during other times when the lock is
operational. This temporary change to the drawbridge's operation has
been coordinated with the commercial waterway operators and the Army
Corps of Engineers.
    To get to Baton Rouge, Louisiana by an alternate route from the Red
River Waterway, users may transit down the Atchafalaya River and up the
Port Allen Route, adding approximately two days to the transit. For
vessels going further north or south of Baton Rouge, additional time
would be spent on the transit.
    This temporary deviation has been coordinated with waterway users.
No objections were received.

    Dated: August 7, 2009.
Roger K. Wiebusch,
Bridge Administrator, Eighth Coast Guard District (dwb).
[FR Doc. E9-20514 Filed 8-25-09; 8:45 am]

BILLING CODE 4910-15-P