Thiabendazole; Threshold of Regulation Determination, 56325-56330 [E7-19542]
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Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Proposed Rules
40 CFR Part 81
Environmental protection, Air
pollution control, National parks,
Wilderness areas.
Authority: 42 U.S.C. 7401 et seq.
Dated: September 25, 2007.
J.I. Palmer, Jr.,
Regional Administrator, Region 4.
[FR Doc. E7–19513 Filed 10–2–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0546; FRL–8151–6]
Thiabendazole; Threshold of
Regulation Determination
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
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AGENCY:
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: https://
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
(703) 305–5805.
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
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without change and may be made
available on-line at https://
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 email. 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 https://
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 https://
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
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(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; fax number: (703) 305–
0599; e-mail address:
stanton.susan@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 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 https://
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 (703) 305–5805.
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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.
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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 https://
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.
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(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 https://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
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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 https://
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 https://
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
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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
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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
Exposure/Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional FQPA, SF
FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Not Applicable (N/A)
N/A
No effect attributable to a single dose identified in the database.
Acute dietary (General population including infants and
children)
N/A
N/A
No effect attributable to a single dose identified in the database.
Chronic dietary (All populations)
NOAEL= 10 mg/kg/day
SF = 100
Chronic RfD = 0.1 mg/kg/day
FQPA SF = 1
cPAD = chronic RfD ÷
FQPA SF = 0.1 mg/kg/
day
2–Year Feeding/Chronic Carcinogenicity Study
in the Rat. LOAEL = 30 mg/kg/day based on
decreased body weight gains and liver hypertrophy.
Cancer (Oral, dermal, inhalation)
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Acute dietary (Females 13–50
years of age)
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
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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.
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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
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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
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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
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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: (410) 305–2905; email address: residuemethods@epa.gov.
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
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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).
ebenthall on PRODPC61 with PROPOSALS
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
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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
PO 00000
Frm 00055
Fmt 4702
Sfmt 4702
56329
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:
§ 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.
E:\FR\FM\03OCP1.SGM
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56330
Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Proposed Rules
Pesticide Chemical
Use/Limits
Analytical Method
148–79–8
Thiabendazole
CAS Reg. No.
As a seed treatment for dry pea (including
field pea), pigeon pea, chickpea or lentil,
using a maximum application rate of
0.075 pounds of active ingredient per
100 pounds of seed. Vines or hay grown
from treated seed may not be fed to livestock.
High Performance Liquid Chromatography/Florescence
Detector method1; Modification of Ion-Pairing Liquid
Chromatographic Determination of Benzimidazole Fungicides in Foods, Gilvydis and Walters, JAOAC, vol. 73,
no. 5, 1990.
1 Available from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address: residuemethods@epa.gov.
[FR Doc. E7–19542 Filed 10–2–07; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 635
RIN 0648–AU89
Atlantic Highly Migratory Species;
Atlantic Shark Management Measures;
Amendment 2 to the Consolidated
Highly Migratory Species Fishery
Management Plan
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; extension of
comment period.
AGENCY:
ebenthall on PRODPC61 with PROPOSALS
SUMMARY: Due to public, Regional
Fishery Management Council, and
Atlantic States Marine Fisheries
Commission requests, NMFS is
extending the comment period to
provide additional opportunity for
public comment on the draft
Amendment 2 to the Consolidated
Highly Migratory Species (HMS) Fishery
Management Plan (FMP) and its
proposed rule. NMFS is extending the
comment period until November 2,
2007. The original comment period was
scheduled to conclude on October 10,
2007. The draft Amendment 2 to the
Consolidated HMS FMP and its
proposed rule describe a range of
management measures that could
impact fishermen and dealers for HMS
fisheries.
DATES: The deadline for receiving
written comments on the July 27, 2007
VerDate Aug<31>2005
15:16 Oct 02, 2007
Jkt 214001
(72 FR 41392), proposed rule and the
draft Amendment 2 to the Consolidated
HMS FMP is extended from October 10,
2007, to 5 p.m. on November 2, 2007.
ADDRESSES: You may submit comments,
identified by 0648–AU89, by any one of
the following methods:
• Electronic Submissions: Submit all
electronic public comments via the
Federal eRulemaking Portal https://
www.regulations.gov or by email to
ShkA2@noaa.gov. Please write in the
subject line ‘‘Comment on Amendment
2.’’
• Fax: 301–713–1917, Attn: Michael
Clark
• Mail: Attn: Michael Clark, 1315 EastWest Highway, Silver Spring, MD
20910. Please mark the outside of the
envelope ‘‘Comment on Amendment 2.’’
INSTRUCTIONS: All comments
received are part of the public record
and will generally be posted to https://
www.regulations.gov without change.
All Personal Identifying Information (for
example, name, address, etc.)
voluntarily submitted by the commenter
may be publicly accessible. Do not
submit Confidential Business
Information or otherwise sensitive or
protected information.
NMFS will accept anonymous
comments. Attachments to electronic
comments will be accepted in Microsoft
Word, Excel, WordPerfect, or Adobe
PDF file formats only.
Copies of the draft Amendment 2 to
the Consolidated HMS FMP and other
relevant documents are available on the
HMS Management Division’s website at
www.nmfs.noaa.gov/sfa/hms or by
contacting HMS at 301–713–2347.
FOR FURTHER INFORMATION CONTACT: For
more information concerning the draft
Amendment 2 to the Consolidated HMS
FMP and its proposed rule, contact:
PO 00000
Frm 00056
Fmt 4702
Sfmt 4702
Michael Clark at 301–713–2347 or fax
301–713–1917; or Jackie Wilson at 240–
338–3936 or fax 404–806–9188.
The
Atlantic HMS fisheries are managed
under the dual authority of the
Magnuson-Stevens Fishery
Conservation and Management Act
(Magnuson-Stevens Act) and the
Atlantic Tunas Convention Act (ATCA).
The Consolidated HMS FMP, finalized
in 2006, and amendments to that FMP
are implemented by regulations at 50
CFR part 635.
On July 27, 2007 (72 FR 41392),
NMFS published a proposed rule that
requested comments on the draft
Amendment 2 to the Consolidated HMS
FMP, and scheduled 10 public hearings
throughout August and September 2007
to receive comments from fishery
participants and other members of the
public regarding the proposed rule and
draft Amendment 2 to the Consolidated
HMS FMP. NMFS has since received
many requests to extend the comment
period in order to allow for more
adequate comment submissions. In
order to accommodate these requests
and to provide additional opportunities
for public comment by constituents,
NMFS is extending the public comment
period on the proposed rule and draft
Amendment 2 to the Consolidated HMS
FMP to 5 p.m., November 2, 2007.
SUPPLEMENTARY INFORMATION:
Authority: 5 U.S.C. 561 and 16 U.S.C. 1801
et seq.
Dated: September 28, 2007.
Samuel D. Rauch III,
Deputy Assistant Administrator for
Regulatory Programs, National Marine
Fisheries Service.
[FR Doc. E7–19544 Filed 10–2–07; 8:45 am]
BILLING CODE 3510–22–S
E:\FR\FM\03OCP1.SGM
03OCP1
]]>Agencies
[Federal Register Volume 72, Number 191 (Wednesday, October 3, 2007)]
[Proposed Rules]
[Pages 56325-56330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19542]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 (703) 305-5805.
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
https://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
https://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 https://
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: (703) 305-5218; fax number: (703) 305-0599; e-mail address:
stanton.susan@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 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 https://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 (703) 305-5805.
[[Page 56326]]
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 https://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 https://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 https://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 https://
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
[[Page 56327]]
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
[[Page 56328]]
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: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
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
[[Page 56329]]
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.
[[Page 56330]]
----------------------------------------------------------------------------------------------------------------
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: (410) 305-2905; e-mail address: residuemethods@epa.gov.
[FR Doc. E7-19542 Filed 10-2-07; 8:45 am]
BILLING CODE 6560-50-S
