[Federal Register: January 31, 2007 (Volume 72, Number 20)]
[Rules and Regulations]
[Page 4435-4441]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja07-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0962 FRL-8111-1]
Thiabendazole; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of thiabendazole in or on Brussels sprout, cabbage, and
cauliflower. This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on Brussels sprout, cabbage, and cauliflower. This regulation
establishes a maximum permissible level for residues of thiabendazole
in these food commodities. The tolerances expire and are revoked on
December 31, 2009.
DATES: This regulation is effective January 31, 2007. Objections and
requests for hearings must be received on or before April 2, 2007, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0962. All documents in the
docket are listed on the regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available 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 Building), 2777 S. Crystal Drive 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
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-2505; e-mail address: groce.stacey@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
[[Page 4436]]
producer, food manufacturer, or pesticide manufacturer. Potentially
affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0962 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before April 2, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0962 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
Building), 2777 S.Crystal Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing time-limited tolerances for residues of
the fungicide thiabendazole in or on Brussels sprout, cabbage, and
cauliflower at 0.05 parts per million (ppm). These tolerances expire
and are revoked on December 31, 2009. EPA will publish a document in
the Federal Register to remove the revoked tolerances from the Code of
Federal Regulations (CFR).
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Thiabendazole on Brussels sprout, cabbage,
nd cauliflower and FFDCA Tolerances
The fungus Phoma lingam is the cause of a destructive disease
(black leg disease) on crucifer crops and has caused periodic epidemics
in the United States. The applicants from California and Washington
state that an emergency situation has existed since the registration
for the pesticide product that had been the industry standard was
cancelled in 2002. The applicants asserted that without the requested
use of thiabendazole to control this disease, significant economic
losses would occur. EPA has authorized under FIFRA section 18 the use
of thiabendazole on Brussels sprout, cabbage, and cauliflower seeds for
control of black leg disease caused by Phoma lingam in California and
Washington State. After having reviewed the submission, EPA concurs
that emergency conditions exist for these States.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of thiabendazole in
or on Brussels sprout, cabbage, and cauliflower. In doing so, EPA
considered the safety
[[Page 4437]]
standard in section 408(b)(2) of the FFDCA, and EPA decided that the
necessary tolerances under section 408(l)(6) of the FFDCA would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemptions in
order to address the urgent non-routine situations and to ensure that
the resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6) of the FFDCA. Although these tolerances expire and
are revoked on December 31, 2009, under section 408(l)(5) of the FFDCA,
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on Brussels sprout, cabbage, and cauliflower
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether thiabendazole
meets EPA's registration requirements for use on Brussels sprout,
cabbage, and cauliflower seeds or whether permanent tolerances for
these uses would be appropriate. Under these circumstances, EPA does
not believe that these time-limited tolerances serve as a basis for
registration of thiabendazole by a State for special local needs under
FIFRA section 24(c). Nor do these time-limited tolerances serve as the
basis for any States other than California and Washington to use this
pesticide on these crop seeds under section 18 of FIFRA without
following all provisions of EPA's regulations implementing FIFRA
section 18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemption for thiabendazole, contact the
Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/[fxsp0
]fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
thiabendazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of thiabendazole in or on Brussels sprout,
cabbage, and cauliflower seeds at 0.05 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing these
tolerances follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints used for human risk assessment is discussed in Table 1 on
page 8 of the human health risk assessment dated November 20, 2006:
Section 18 Exemptions for the Use of Thiabendazole on Brussels sprout,
Cabbage, and Cauliflower as a Seed Treatment, available in the docket
for this action.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.242) for the residues of thiabendazole in or on
a variety of raw agricultural commodities. Tolerances have also been
established for thiabendazole and its metabolite 5-hydroxythiabendazole
at 0.4 ppm in milk, 0.1 ppm in eggs, and 0.1 ppm in meat, fat, and meat
byproducts of livestock and poultry. Risk assessments were conducted by
EPA to assess dietary exposures from thiabendazole in food as follows:
i. Acute exposure. Since there are no toxic effects noted in the
database that are likely the result of a single exposure to
thiabendazole, no acute dietary endpoints have been selected.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the chronic exposure assessments: The chronic dietary exposure
analysis for thiabendazole is partially refined. For the use of
thiabendazole as a seed treatment, the Agency used the analytical
method limit of quantitation (LOQ) of 0.05 ppm as the appropriate
residue value for Brussels
[[Page 4438]]
sprout, cabbage, and cauliflower and assumed 100% crop treated as
inputs into the DEEM chronic dietary analysis. Inputs into the DEEM
analysis for all existing uses incorporated PDP data for many
commodities, experimental processing factors, anticipated residues for
animal commodities and percent crop treated information. Further,
estimated thiabendazole residues in drinking water were incorporated
directly into the dietary assessment using the highest chronic
estimated environmental concentration (EEC) value for surface water.
iii. Cancer. Thiabendazole has been classified as ``not likely to
be carcinogenic to humans at doses that do not alter rat thyroid
hormone homeostasis.'' Chronic dietary risk is currently being
regulated with a chronic RfD that reflects a dose level below the dose
levels at which thyroid hormone balance is impacted. Since chronic
dietary risk is below the Agency's level of concern, there is no
concern for dietary cancer risk arising from existing uses as well as
the use of thiabendazole as a seed treatment on Brussels sprout,
cabbage, and cauliflower.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for thiabendazole in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of thiabendazole. Further, information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
The treatment of seeds for purposes of the section 18 request is
expected to be an indoor activity with no potential concern for
leaching to ground water or run off to surface water. However, there is
some potential for transfer of residues of thiabendazole to the
environment with the planting of treated seed in the field. Drinking
water was incorporated directly into the dietary assessment by
extrapolation of the drinking water concentrations generated as a
result of planting treated seed. Based on the GENEEC and SCI-GROW
models, the estimated environmental concentrations (EECs) of for acute
exposures are estimated to be 2.4 parts per billion (ppb) for surface
water and 0.01 ppb for ground water. The EECs for chronic exposures are
estimated to be 0.52 ppb for surface water and 0.01 ppb for ground
water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). The Agency has
concluded that there is low potential for residential exposure based on
thiabendazole's use profile, and the proposed section 18 uses of
thiabendazole on Brussels sprout, cabbage, and cauliflower seeds do not
result in new residential exposure scenarios. Currently, there are no
thiabendazole products registered for use by residential users.
However, thiabendazole is incorporated in low concentrations into
paints, adhesives, paper, and carpet. This incorporation greatly
reduces the potential for exposure. The Agency has calculated worst
case scenarios for thiabendazole exposure to thiabendazole treated
carpet and paint. A summary of the residential exposure and risk
estimates for thiabendazole are summarized in Table 6 on page 16 of the
human health risk assessment dated November 20, 2006: Section 18
Exemptions for the Use of Thiabendazole on Brussels sprout, Cabbage,
and Cauliflower as a Seed Treatment, available in the docket for this
action.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to thiabendazole and any
other substances and thiabendazole does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that thiabendazole has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
C. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Developmental toxicity studies. The toxicity database for
thiabendazole includes an acceptable prenatal developmental toxicity
study in rats and rabbits, which shows no increased sensitivity to
fetuses. A neurotoxicity study is not required since there is no
evidence in the database that supports a requirement for a
developmental neurotoxicity study.
3. Reproductive toxicity study. Based on data submitted to the
Agency as well as data from the open literature, there was no evidence
of reproductive toxicity in the prenatal developmental toxicity studies
in rats, rabbits, and mice or in the two-generation reproduction study
in rats.
4. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility in rats, rabbits, or mice to in utero or early
postnatal exposure to thiabendazole based on the prenatal developmental
toxicity study rats, rabbits, and mice and in the two-generations
reproduction study in rats. The developmental effects in the fetuses
occurred at or above doses that caused maternal or paternal toxicity.
5. Conclusion. There is a complete toxicity database for
thiabendazole and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. In terms of
hazard, there are low concerns and no residual uncertainties regarding
prenatal and/or postnatal toxicity.
D. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs), which are used
as a point of comparison against estimated drinking water
concentrations
[[Page 4439]]
(EDWCs). The DWLOC values are not regulatory standards for drinking
water, but are theoretical upper limits on a pesticide's concentration
in drinking water in light of total aggregate exposure to a pesticide
in food and residential uses. More information on the use of DWLOCs in
dietary aggregate risk assessments can be found at http:/www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
More recently, the Agency has
used another approach to estimate aggregate exposure through food,
residential and drinking water pathways. In this approach, modeled
surface water and ground water EDWCs are directly incorporated into the
dietary exposure analysis, along with food. This approach provides a
more realistic estimate of exposure because actual body weights and
water exposures are then added to estimated and water consumption form
the CSFII are used. The combined food and water exposures are then
added to estimated exposure from residential sources to calculate
aggregate risks. The resulting exposure and risk estimates are still
considered to be high end, due to the assumptions used in developing
drinking water modeling inputs. The risk assessment for thiabendazole
used in this tolerance document uses this approach of incorporating
water exposure directly into the dietary exposure analysis.
EPA conducted partially refined chronic dietary assessments, which
included the use of thiabendazole used as a seed treatment in/on
Brussels sprout, cabbage, cauliflower seeds in addition to the existing
use for thiabendazole that results in a chronic dietary exposure (food
and water) for the U.S. population equivalent to 1.4% of the cPAD. The
most highly exposed population subgroup is children 1 to 2 years of age
with a chronic dietary exposure (food and water) which is equivalent to
4.2% of the cPAD. Since chronic dietary (food and water) estimates of
risk for the U.S. population and all subgroups are below 100% of the
cPAD, the Agency has no concern for chronic dietary risk from the use
of thiabendazole as a seed treatment for use on Brussels sprout,
cabbage, and cauliflower seeds.
1. Acute risk. EPA did not assess acute dietary risk for
thiabendazole because no acute dietary endpoint of concern was
identified for the general population or any subpopulation.
2. Chronic risk. EPA concluded that chronic aggregate exposure to
thiabendazole from food and water will utilize 4.2% of the cPAD for the
most highly exposed population subgroup, which is children 1 to 2 years
of age. This chronic aggregate risk estimate is based on dietary risk
from food and water. Since the estimated thiabendazole chronic
aggregate dietary exposure from food and water for the general
population and all subpopulations results in an estimated risk value
less than 100% of the cPAD, EPA has no concern for chronic aggregate
risk. Using the exposure assumptions described in this unit for chronic
exposure, EPA has concluded that exposure to from food will utilize
1.4% of the cPAD for the U.S. population, 4.2% of the cPAD for the most
highly exposed subpopulation (children 1-2 years of age) and 1.2 % of
the cPAD for females 13 to 49 years of age.
3. Short and Intermediate-term risk. Short-and intermediate-term
aggregate exposure takes into account non-dietary, non-occupational
exposure plus chronic exposure to food and water (considered to be a
background exposure level). EPA does not expect short-and intermediate-
term aggregate exposure to exceed the Agency's level of concern. The
Agency has concluded that there is low potential for residential
exposure based on thiabendazole's use profile. There are currently no
thiabendazole products registered for use by residential users.
However, thiabendazole is incorporated in low concentrations into
paints, adhesives, paper, and carpet. This incorporation greatly
reduces the potential for exposure. To assess short-and intermediate-
term aggregate exposure likely to result from the use of thiabendazole
on Brussels sprout, cabbage, and cauliflower as a seed treatment, as
well as existing uses, the Agency combined average food and water
exposure values with estimates of residential exposure. For adult
populations, the Agency assumed that both painting with thiabendazole
treated paint and contact with thiabendazole treated carpet could occur
simultaneously and combined those exposures for the purpose of
calculating the aggregate risk estimates. For infant and child
populations, the Agency assumed that residential exposure was a result
of contact with treated carpet only.
More detailed information on the short-and intermediate-term
exposure and risk estimates for thiabendazole are summarized and can be
found in the document entitled Section 18 Exemptions for the Use of
Thiabendazole on Brussels sprout, Cabbage, and Cauliflower as a Seed
Treatment, dated November 20, 2006 in Table 7 on page 17 of the human
health risk assessment, by going to http:http://www.regulations.gov, and
searching for docket ID number EPA-HQ-OPP-2006-0962. Double - click on
the document to view the referenced information.
4. Aggregate cancer risk for U.S. population. Thiabendazole has
been classified as ``not likely to be carcinogenic to humans at doses
that do not alter rat thyroid hormone homeostasis.'' Since the chronic
aggregate exposure is below the level that would alter rat thyroid
hormone homeostasis, there is no concern for aggregate cancer risk
arising from existing uses or the use of thiabendazole use as a seed
treatment in/on Brussels sprout, cabbage, and cauliflower seeds.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population and to infants and children from aggregate
exposure to thiabendazole residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
No specific CODEX, Canadian or Mexican maximum residue limits
(MRLs) or tolerances have been established for thiabendazole in or on
Brussels sprout, cabbage, or cauliflower. Therefore, international
harmonization is not an issue at this time.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
thiabendazole in or on Brussels sprout, cabbage, or cauliflower at 0.05
ppm. These tolerances expire and are revoked on December 31, 2009.
VII. Statutory and Executive Order Reviews
This final rule establishes time-limited tolerances under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211,
[[Page 4440]]
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 18, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
Section 180.242 is amended by alphabetically adding the following
commodites to paragraph (b) to read as follows:
Sec. 180.242 Thiabendazole; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Brussels sprout................... 0.05 12/31/09
Cabbage........................... 0.05 12/31/09
Cauliflower....................... 0.05 12/31/09
* * * * *
------------------------------------------------------------------------
[[Page 4441]]
* * * * *
[FR Doc. E7-1234 Filed 1-30-07; 8:45 am]
BILLING CODE 6560-50-S