1,3-Dichloropropene and metabolites; Pesticide Tolerance, 8212-8218 [E8-2480]
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Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations
FR 28355, May 22, 2001) because it is
not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and
Advancement Act
Section 12 of the National Technology
Transfer and Advancement Act
(NTTAA) of 1995 requires Federal
agencies to evaluate existing technical
standards when developing a new
regulation. To comply with NTTAA,
EPA must consider and use ‘‘voluntary
consensus standards’’ (VCS) if available
and applicable when developing
programs and policies unless doing so
would be inconsistent with applicable
law or otherwise impractical.
The EPA believes that VCS are
inapplicable to this action. Today’s
action does not require the public to
perform activities conducive to the use
of VCS. This action merely determines
that the Imperial County area has not
attained by the applicable attainment
date, reclassifies the Imperial County
area as a moderate ozone nonattainment
area, and adjusts applicable deadlines.
Therefore, EPA did not consider the use
of any voluntary consensus standards.
J. 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 the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). This rule
will be effective March 14, 2008.
K. Petitions for Judicial Review
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by April 14, 2008.
Filing a petition for reconsideration by
the Administrator of this final rule does
not affect the finality of this rule for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 81
Environmental protection, Air
pollution control, Incorporation by
reference.
Authority: 42 U.S.C. 7401 et seq.
Dated: January 24, 2008.
Jane Diamond,
Acting Regional Administrator, Region IX.
Part 81 of chapter I, title 40 of the
Code of Federal Regulations is amended
as follows:
I
PART 81—[AMENDED]
1. The authority citation for part 81
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
2. In § 81.305 the ‘‘California-Ozone
(8-Hour Standard)’’ table is amended by
revising the entry for ‘‘Imperial
County:’’ to read as follows:
I
§ 81.305
California.
CALIFORNIA-OZONE
[8-hour standard]
Designation
Classification
Designated area
Date1
*
*
*
Imperial County, CA: Imperial County ....................................
*
1 This
*
*
*
....................
*
Nonattainment ...............
*
Date
Classification
*
3/14/08
*
*
*
Subpart 2/Moderate.
*
date is June 15, 2004, unless otherwise noted.
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
[FR Doc. E8–2698 Filed 2–12–08; 8:45 am]
BILLING CODE 6560–50–P
40 CFR Part 180
[EPA–HQ–OPP–2007–0637; FRL–8345–1]
1,3-Dichloropropene and metabolites;
Pesticide Tolerance
SUMMARY: This regulation establishes a
tolerance for combined residues of 1,3dichloropropene and metabolites in or
on grape. Dow AgroSciences, LLC
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EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0637. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
ADDRESSES:
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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This regulation is effective
February 13, 2008. Objections and
requests for hearings must be received
on or before April 14, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION ).
DATES:
ENVIRONMENTAL PROTECTION
AGENCY
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Type
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and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
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4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Mary L. Waller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9354; e-mail address:
waller.mary@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
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also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2007–0637 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before April 14, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2007–0637, 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.
II. Petition for Tolerance
In the Federal Register of September
19, 2007 (72 FR 53575–53577) (FRL–
8144–3), EPA issued a notice pursuant
to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 1F6253) by Dow
AgroSciences, LLC, 9330 Zionsville
Road, Indianapolis, IN 46268. The
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petition requested that 40 CFR part 180
be amended by establishing a tolerance
for residues of the fungicide, 1,3dichloropropene, in or on grape at 0.009
parts per million (ppm). That notice
referenced a summary of the petition
prepared by Dow AgroScience, LLC, the
registrant, which is available to the
public in the docket, at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing. Based upon review of
the data supporting the petition, EPA
has revised and raised the tolerance
level to include the combined residues
of the parent chemical, cis- and trans1,3 dichloropropene, and the
metabolites, cis- and trans-3chloroacrylic acid and cis- and trans-3chloroallyl alcohol which are
considered to be of equal toxicity to the
parent chemical.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’ These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerance for the combined residues of
cis- and trans-1,3-dichloropropene, cisand trans-3-chloroacrylic acid, and cisand trans-3-chloroallyl alcohol (1,3dichloropropene and metabolites) on
grape at 0.018 ppm. EPA’s assessment of
exposures and risks associated with
establishing the tolerance follows.
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A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
The toxicology database is considered
to be adequate to support the proposed
and existing uses of 1,3dichloropropene. 1,3-Dichloropropene
showed moderate acute toxicity by the
oral and dermal exposure routes
(Toxicity Category II), was moderately
irritating to the eye and skin, and was
a dermal sensitizer in guinea pigs. It is
classified as Toxicity Category IV for
acute inhalation toxicity and produced
tremors, convulsions, salivation,
lacrimation, diarrhea, lethargy and
death at concentrations 647 ppm or
higher.
Consistent with the irritant properties
of 1,3-dichloropropene, there was
evidence of degenerative changes in the
nasal olfactory epithelium and
histopathological changes of the
respiratory epithelium in rats and mice
after subchronic inhalation exposure.
Following chronic inhalation exposure,
the olfactory region of the nasal cavity
appeared to be the target organ in rats
while lung adenomas were induced in
mice. Similarly, following oral
exposure, 1,3-dichloropropene induced
histopathological lesions in rats and/or
mice including forestomach squamous
cell papillomas and carcinomas, liver
masses/neoplastic nodules, urinary
bladder carcinomas, and alveolar/
brochiolaradenomas. Increases in
hematopoietic activity and decreased
body weights were also noted in dogs
and mice, respectively. Accordingly,
1,3-dichloropropene has been classified
as ‘‘likely to be carcinogenic to humans’’
via both the oral and inhalation routes.
As a result, cancer potency factors (Q1*)
have been calculated for both routes of
exposure.
Specific information on the studies
received and the nature of the adverse
effects caused by 1,3-dichloropropene
and metabolites as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov. The risk
assessment dated January 24, 2008 is
available in the docket established by
this action, which is described under
ADDRESSES, and is identified as EPA–
HQ–OPP–2007–0637 in that docket.
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B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which no adverse effects are observed
(the NOAEL) in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the lowest dose
at which adverse effects of concern are
identified (the LOAEL) is sometimes
used for risk assessment. Uncertainty/
safety factors (UFs) are used in
conjunction with the LOC to take into
account uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic risks by comparing
aggregate exposure to the pesticide to
the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-,
and long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the margin of
exposure (MOE) called for by the
product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
A summary of the toxicological
endpoints for 1,3-dichloropropene and
metabolites used for human risk
assessment can be found at https://
www.regulations.gov in the document
titled 1,3-Dichloropropene: Proposed
New Use for Drip Irrigation in
Vineyards: HED Human Health Risk
Assessment at page 21 in docket ID
number EPA–HQ–OPP–2007–0637.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to 1,3-dichloropropene and
metabolites, EPA considered exposure
under the petitioned-for tolerance.
There are no other tolerances for 1,3dichloropropene and metabolites. EPA
assessed dietary exposures from 1,3-
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dichloropropene and metabolites in
food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
No such effects were identified in the
toxicological studies for 1,3dichloropropene and metabolites;
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, or 1998
Continuing Survey of Food Intake by
Individuals (CSFII). As to residue levels
in food, EPA relied upon anticipated
residues and assumed 100 percent crop
treated (PCT). Residues of cis- and trans1,3-dichloropropene and three of the
four metabolites were assumed to be at
one-half the limit of detection (0.001
ppm) since residues were nondetectable in all field trials at shorter
pre-harvest intervals (PHI) than the
proposed use pattern. Residues at the
proposed PHI in one trial of one
metabolite were at the limit of
quantitation (0.003 ppm), so the LOQ
was used. The metabolites were
assumed to have equal toxicity to the
parent compound, so the total
anticipated residue used in the dietary
assessment for the chronic analyses was
0.0055 ppm.
iii. Cancer. The cancer dietary
exposure assessment utilized the same
data and assumptions used in the
chronic dietary exposure assessment.
For dietary exposure to 1,3dichloropropene, an oral cancer potency
factor (Q1* of 1.22 X 10-1 (mg/kg/day)-1)
was used to assess cancer risk.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must pursuant to
FFDCA section 408(f)(1) require that
data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of this tolerance.
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2. Dietary exposure from drinking
water. The Agency lacks sufficient
surface water monitoring data to
complete a comprehensive dietary
exposure analysis and risk assessment
for 1,3-dichloropropene and metabolites
in drinking water. Because the Agency
does not have comprehensive surface
water monitoring data, drinking water
concentration estimates from surface
water sources are made by reliance on
simulation or modeling taking into
account data on the environmental fate
characteristics of 1,3-dichloropropene
and metabolites. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS), the estimated
environmental concentrations (EECs) of
1,3-dichloropropene and metabolites for
chronic exposures are estimated to be
16.2 parts per billion (ppb). The limited
surface water monitoring data available
from areas of high use did not show
detectable residues of 1,3dichloropropene in 123 samples.
There is sufficient data for tap water
from groundwater wells available for
1,3-dichloropropene and metabolites. A
total of 518 wells were selected in the
Central Columbia Plateau, Upper Snake
River Basin, North Platte River,
Albermarle-Pamlico Sound, and the
George/Florida basins. The wells were
intended to be among the most
vulnerable wells available for sampling
in each region because they were in
high use areas, were among the
shallowest in each region, and were
located in close proximity to fields that
had received 1,3-dichloropropene
applications in the recent past. 1,3Dichloropropene and metabolites were
not found above 0.145 ppb in 5,800
samples.1,3-Dichloropropene or its
degradates were detected in 12% of the
wells. Only three wells had two
detections over the course of the study;
no wells had more than two detections.
Of the approximately 5,800 samples,
only 68 detections were observed for
either the parent compound or the
metabolites.
Modeled surface water estimates of
drinking water concentrations and the
maximum ground water concentration
from monitoring data were directly
entered into the dietary exposure model.
For chronic dietary risk assessment, the
surface drinking water concentration
value of 16.2 ppb was used and the
ground drinking water concentration
value of 0.14 ppb was used to assess the
contribution to drinking water.
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3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
1,3-Dichloropropene is not registered
for use on any sites that would result in
residential exposure. However, due to
the volatility of 1,3-dichloropropene,
residential bystander exposure may
occur when 1,3-dichloropropene is
applied to agricultural fields near
residential areas. Residential bystander
exposure may occur because of
emissions from treated fields. These
emissions can travel to non-target areas
and are referred to as bystander
exposure. Bystander exposure can occur
as a result of being in contact with
residues that are emitted from a known
single source (e.g., a single application
to an agricultural field near a residential
area) and from multiple sources (e.g.,
applications to numerous agricultural
fields) within a localized agricultural
region (ambient air exposure).
i. Inhalation exposure from a single
source. Acute exposures to bystanders
from single post-plant agricultural field
fumigation events and their associated
risks were calculated using the
distributional/probabilistic modeling
method. Distributional modeling was
done with the Probabilistic Exposure
and Risk Model for Fumigants
(PERFUM). Exposures were also
analyzed using the actual field study
data (i.e, the monitoring method).
Additional information on the methods
used to assess bystander risks are given
in Section 6.1.1 from the Phase 5
Registration Eligibility Decision.:
Methods Used to Calculate Bystander
Exposures and Risks From Known
Sources located at https://
www.regulations.gov in docket ID
number EPA–HQ–OPP–2005–01240052, page 27.
a. Acute exposure was estimated by
using the maximum 24–hour timeweighted average (TWA) from each field
volatility study.
b. Short-term exposure was estimated
by using the highest 7–day average for
each direction from each field volatility
study.
c. Intermediate-term exposures
(consecutive exposures lasting 30 days
to several months) is expected to be less
likely since 1,3-dichloropropene
products are only used 1 to 2 times per
field each year.
d. Chronic exposure is not expected
since it is unlikely that bystanders will
be continually exposed to significant
concentrations of 1,3-dichloropropene
for 6 consecutive months or longer.
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Chronic exposure from multiple
(ambient air) sources is more likely and
described in section 3 (ii)(c).
e. Cancer risks to 1,3-dichloropropene
were estimated for multiple (ambient
air) sources as that exposure scenario is
more representative of a lifetime of
exposure and are described in the
following section 3(ii)(d).
ii. Inhalation exposure from ambient
air sources. Exposure to 1,3dichloropropene from ambient air was
evaluated using monitoring data from
California. These data reflect existing
pre-plant fumigation uses that are
applied at rates over 10 times the rate
of the proposed post-plant fumigation
use on grapes. These data consist of two
basic types that include targeted
monitoring that occurred in a high use
area during the season of use. The other
type of data was collected as part of the
routine Toxic Air Contaminant (TAC)
program and focus on background levels
in urban environments.
a. Acute exposure was estimated by
using the maximum 24–hour timeweighted average (TWA) from the
monitoring data.
b. Short-term and intermediate-term
exposures were estimated by comparing
the mean of the weekly mean estimate
from the monitoring data.
c. Chronic exposures were calculated
using the targeted regional source
ambient data. These calculations should
be considered as rangefinder estimates
of exposure only because of a lack of
monitoring studies specifically designed
for this purpose. Short- and
intermediate-term estimates were
amortized to reflect a potential for
exposure of 180 days out of each
calendar year in order to calculate
chronic estimates of exposure. This was
based on the approximate use patterns
for 1,3-dichloropropene over a year in
high use areas. Results based on all of
these calculations, as indicated above,
do not represent a risk concern to the
Agency and in most cases risks were far
below the target level of concern (e.g.,
by orders of magnitude). There were no
ambient monitoring studies targeting
areas of high use that collected air
samples over an entire year that would
be considered representative of a
chronic exposure pattern. In these
studies the focus was more on the actual
season of use so these data were
typically collected for only 9 weeks or
so which represents the duration of the
typical application season. However, in
order to be able to evaluate the
possibility of chronic exposures in high
use areas the Agency utilized the
seasonal mean of means from the high
use areas and supposed that exposures
could be maintained at this rate for a
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sustained period of 6 months which is
twice as long as a normal application
season. This approach does have some
uncertainty associated with it but the
Agency believes that this approach does
not underestimate exposure because
monitoring data were collected in the
season of use in areas of high use.
Additionally, risks calculated based on
this method, as indicated above, are
typically well below the Agency’s level
of concern. In addition to using the
targeted monitoring data, the Agency
also used the urban background
monitoring data to calculate chronic
risks. In this case, the data were
intentionally designed to be used to
evaluate longer-term exposure levels.
Many of the samples collected in this
network did not even contain
measurable residues over the course of
the monitoring years in question but
chronic risks were still evaluated as a
precautionary measure.
d. For cancer risk assessment, the
lifetime average daily exposure (LADE)
was calculated using the mean of
weekly means and assumed that
exposure lasts the length of the longest
monitoring period (9 weeks/63 days).
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
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 1,3dichloropropene and any other
substances and 1,3-dichloropropene
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 1,3-dichloropropene 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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (‘‘10X’’) tenfold margin of
safety for infants and children in the
case of threshold effects to account for
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prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor. In applying this
provision, EPA either retains the default
value of 10X when reliable data do not
support the choice of a different factor,
or, if reliable data are available, EPA
uses a different additional FQPA safety
factor value based on the use of
traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There is no evidence (quantitative or
qualitative) of susceptibility and no
residual uncertainties with regard to
pre- and/or post-natal toxicity following
in utero exposure to rats or rabbits and
pre- and/or post-natal exposures to rats.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
decision is based on the following
findings:
i. The toxicity database for 1,3dichloropropene is complete.
ii. There is no indication that 1,3dichloropropene 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 1,3dichloropropene results in increased
susceptibility following in utero and/or
post-natal exposure in rats or rabbits in
the prenatal developmental studies or in
young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% crop
treated and average anticipated
residues. Conservative surface water
modeling estimates were used, and
sufficient monitoring data were used to
assess ground water concentrations.
There are no residential uses of 1,3dichloropropene and conservative
modeling was used to estimate
bystander exposure. These assessments
will not underestimate the exposure and
risks posed by 1,3-dichloropropene and
metabolites.
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the acute
population adjusted dose (aPAD) and
chronic population adjusted dose
(cPAD). The aPAD and cPAD are
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calculated by dividing the LOC by all
applicable UFs. For linear cancer risks,
EPA calculates the probability of
additional cancer cases given aggregate
exposure. Short-, intermediate-, and
long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the margin of
expsure (MOE) called for by the product
of all applicable UFs is not exceeded.
For the acute, short-, intermediate-,
and long-term assessments, the toxicity
endpoints selected for inhalation and
dietary exposures should not be
aggregated since no common endpoints
were identified at the LOAEL in studies
conducted via the oral or inhalation
routes. 1,3-Dichloropropene has been
classified as likely to be carcinogenic to
humans via the oral and inhalation
routes. However, the types of tumors
observed in the inhalation and oral
studies were different. Therefore, the
oral and inhalation exposures were not
aggregated.
1. Acute risk. An endpoint was not
selected for acute dietary risk
assessment because there were no
effects attributable to a single dose
(exposure) via the oral route. Therefore,
1,3-dichloropropene is not expected to
pose an acute dietary risk.
For residential bystander acute
inhalation risk resulting from exposure
to a single source, the lowest acute MOE
was 400 based on the application rate in
the field volatility data and the lowest
acute MOE was 160 based on the
maximum label rate. The risk estimates
did not exceed the level of concern
using the PERFUM modeling method.
For residential bystander acute
inhalation risk resulting from exposure
to ambient air sources, the lowest acute
MOE was 2,700 based on California
ambient air monitoring data. The MOEs
do not exceed the Agency’s level of
concern of < 30.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to 1,3-dichloropropene
and metabolites from food and water
(ground water sources) will utilize < 1%
of the cPAD for the most highly exposed
population group (children 1 to 2 years
old) and from food and water (surface
water sources) will utilize < 5% of the
cPAD for the most highly exposed
population group, infants < 1 year old.
Residential bystander chronic
inhalation exposure from a single source
is not expected to occur and therefore,
does not pose an inhalation risk. For
residential bystander chronic inhalation
risk resulting from exposure to ambient
air sources, the lowest chronic MOE was
130 based on California ambient air
monitoring data. The MOE does not
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exceed the Agency’s level of concern of
< 30.
3. Short-term risk. For residential
bystander short-term inhalation risk
resulting from exposure to a single
source, the lowest short-term MOE was
60 based on the application rate in the
field volatility data and based on the
maximum label rate. For residential
bystander short-term inhalation risk
resulting from exposure to ambient air
sources, the lowest short-term MOE was
1,700 based on California ambient air
monitoring data. The MOEs do not
exceed the Agency’s level of concern of
< 30.
4. Intermediate-term risk. Residential
bystander intermediate-term inhalation
exposure from a single source is
unlikely to occur and therefore, does not
pose an inhalation risk. For residential
bystander intermediate-term inhalation
risk resulting from exposure to ambient
air sources, the lowest intermediateterm MOE was 70 based on California
ambient air monitoring data. The MOE
does not exceed the Agency’s level of
concern of < 30.
5. Aggregate cancer risk for U.S.
population. The aggregated food and
water risk represent upper bound risks
for a person living in agricultural areas
where 1,3-dichloropropene is used
extensively or where a person obtains
drinking water from an aquifer that led
directly from an area where 1,3dichloropropene was used. The
aggregate chronic dietary cancer risk
estimates for the general U.S.
population resulting from exposure to
1,3-dichloropropene and metabolites in
food and water (ground water sources)
is 7 X 10-7 and from exposure to 1,3dichloropropene and metabolites in
food and water (surface water sources)
is 4 X 10-5.
Although risk for drinking water from
surface water sources for 1,3dichloropropene exceeds the Agency’s
level of concern (risk estimates
generally in the range of 1 in 1 million,
interpreted as > 1 to 3 X 10-6); it should
be noted that concentrations of 1,3dichloropropene in tap water from
ground water wells were approximately
100 times lower than those found in the
field ground water study and several
orders of magnitude lower than
modeled estimates of 1,3dichloropropene in groundwater.
Therefore, it is highly likely that actual
drinking water concentrations of 1,3dichloropropene from surface water
sources would also be much lower. 1,3Dichloropropene and its metabolites are
highly volatile compounds, and the
models used to generate surface water
and ground water estimates are not
designed for volatile chemicals. The
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limited surface water monitoring data
available in areas of high use do not
show any detections of 1,3dichloropropene and its degradates.
Therefore, the Agency does not have a
concern for the aggregate cancer risk
from oral exposures to 1,3dichloropropene and its metabolites.
Cancer risk was estimated using 1,3dichloropropene ambient air monitoring
data collected from over 20 sites over
multiple years to estimate exposure over
a lifetime. These sites were in areas of
high use and in urban environments.
The cancer risk estimates for all but one
monitoring site, in a high use area,
ranged from 2 X 10-6 to 9 X 10-8, which
are below the Agency’s level of concern.
The monitoring data for the one site
resulted in a risk estimate of 6 X 10-6,
which does exceed the Agency’s level of
concern. However, risks calculated
using data from the same site in the
following year was almost two orders of
magnitude lower. Therefore, over a
lifetime of exposure, the risk estimates
would likely be below the level of
concern. It should be noted that in more
populated urban environments, air
concentrations were below the
analytical limit of detection in 21 of 28
sites/year combinations considered. In
the remaining seven site/year
combinations, values were measured
but did not result in cancer risks of
concern. Therefore, the Agency does not
have a concern for the cancer risk from
1,3-dichloropropene.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to 1,3dichloropropene and metabolites
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Dow AgroSciences, LLC submitted a
gas chromatography/massspectroscopy
(GC/MS) method, Method GRM
99.09.R1, for thedetermination of
residues of cis- and trans-1,3dichloropropene. The method was
adequately validated using fortified
samples of grape. Recoveries of cis-1,3dichloropropene ranged from 70% to
114% and recoveries of trans-1,3dichloropropene ranged from 77% to
113% from samples fortified at 0.003,
0.010, 0.050, and 0.50 ppm. The
fortification levels used in method
validation are adequate to bracket
expected residue levels. Adequate
independent laboratory validation (ILV)
datawere submitted for Method GRM
99.09.R1 using samples of grape.
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8217
Dow AgroSciences, LLC submitted a
GC/MS method, Method GRM99.18, for
the determination of residues of 3chloroallyl alcohol and 3-chloroacrylic
acid. The validated LOQ is 0.003 ppm
for each analytein grape. The method
was adequately validated using fortified
samplesof grape. Recoveries of cis-3chloroallyl alcohol ranged from 74% to
90%, recoveries of trans-3-chloroallyl
alcohol ranged from 82% to 95%,
recoveries of cis-chloroacrylic acid
ranged from 93% to 98%, and
recoveries of trans-chloroacrylic acid
ranged from 91% to 96% from samples
fortified at 0.003, 0.006, and 0.030 ppm.
The fortification levels used in method
validation are adequate to bracket
expected residue levels. The Agency has
tentatively concluded that the
metabolite method is suitable for
enforcement.
Adequate enforcement methodology
(GC/MS) is available to enforcethe
tolerance expression. The method may
be requested from: Chief,Analytical
Chemistry Branch, Environmental
Science Center, 701Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Canadian or Codex
Maximum Residue limits for residues of
1,3-dichloropropene for any commodity.
C. Conditions
1. An independent laboratory
validation of Method GRM 99.18
andmulti-residue method testing will be
required as confirmatory data.
2. In order to refine the exposure
estimates from PRZM-EXAMS, the
following data will be required: an
aerobic soil metabolism study on
additional soils (parent and
metabolites); an aerobic aquatic
metabolism study (parent and
metabolites); an aqueous photolysis
study (indirect and parent); a soil
photolysis study (parent); and a
photolysis/oxidation in air study
(parent).
V. Conclusion
Therefore, the tolerance is established
for combined residues of cis- and trans1,3-dichloropropene, cis- and trans-3chloroacrylic acid, and cis- and trans-3chloroallyl alcohol, in or on grape at
0.018 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
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Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
to this rule. In addition, This rule does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
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Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
LEGAL SERVICES CORPORATION
VII. Congressional Review Act
Income Level for Individuals Eligible
for Assistance
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 1, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.636 is added to subpart
C to read as follows:
I
§ 180.636 1,3-dichloropropene; tolerances
for residues.
(a) General. Tolerances are
established for the combined residues of
the fungicide cis- and trans-1,3dichloropropene and its metabolites cisand trans-3-chloroacrylic acid, and cisand trans-3-chloroallyl alcohol in or on
the following commodities.
Parts per
million
Commodity
Grape ........................................
0.018
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E8–2480 Filed 2–12–08; 8:45 am]
BILLING CODE 6560–50–S
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45 CFR Part 1611
Legal Services Corporation.
Final rule—correction.
AGENCY:
ACTION:
SUMMARY: The Legal Services
Corporation (‘‘Corporation’’) is required
by law to establish maximum income
levels for individuals eligible for legal
assistance. On January 30, 2008 the
Corporation issued a document
updating the specified income levels to
reflect the annual amendments to the
Federal Poverty Guidelines as issued by
the Department of Health and Human
Services. This notice corrects a typo
appearing in the supplementary
information, but does not affect the
income levels set forth in the charts.
Specifically, in the sentence in the last
paragraph of the SUPPLEMENTARY
INFORMATION, 73 FR 5458, Jan. 30, 2008,
beginning ‘‘These charts are for
references purposes * * *,’’ the first
percentage referred to should be
‘‘125%’’ instead of ‘‘200%.’’
DATES: Effective Date: This rule is
effective as of January 30, 2008.
FOR FURTHER INFORMATION CONTACT:
Mattie Cohan, Senior Assistant General
Counsel, Legal Services Corporation,
3333 K St., NW., Washington, DC 20007;
(202) 295–1624; mcohan@lsc.gov.
SUPPLEMENTARY INFORMATION: Section
1007(a)(2) of the Legal Services
Corporation Act (‘‘Act’’), 42 U.S.C.
2996f(a)(2), requires the Corporation to
establish maximum income levels for
individuals eligible for legal assistance,
and the Act provides that other
specified factors shall be taken into
account along with income.
Section 1611.3(c) of the Corporation’s
regulations establishes a maximum
income level equivalent to one hundred
and twenty-five percent (125%) of the
Federal Poverty Guidelines. Since 1982,
the Department of Health and Human
Services has been responsible for
updating and issuing the Federal
Poverty Guidelines. The revised figures
for 2008 are equivalent to 125% of the
current Federal Poverty Guidelines as
published on January 23, 2008 (73 FR
3971).
LSC published the charts listing
income levels that are 200% of the
Federal Poverty Guidelines at 73 FR
5458, Jan. 30, 2008. These charts are for
reference purposes only as an aid to
grant recipients in assessing the
financial eligibility of an applicant
whose income is greater than 125% of
the applicable Federal Poverty
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Agencies
[Federal Register Volume 73, Number 30 (Wednesday, February 13, 2008)]
[Rules and Regulations]
[Pages 8212-8218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2480]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0637; FRL-8345-1]
1,3-Dichloropropene and metabolites; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
of 1,3-dichloropropene and metabolites in or on grape. Dow
AgroSciences, LLC requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 13, 2008. Objections and
requests for hearings must be received on or before April 14, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0637. 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. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-
[[Page 8213]]
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address: waller.mary@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 those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0637 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before April 14, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0637, 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.
II. Petition for Tolerance
In the Federal Register of September 19, 2007 (72 FR 53575-53577)
(FRL-8144-3), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1F6253) by Dow AgroSciences, LLC, 9330 Zionsville Road,
Indianapolis, IN 46268. The petition requested that 40 CFR part 180 be
amended by establishing a tolerance for residues of the fungicide, 1,3-
dichloropropene, in or on grape at 0.009 parts per million (ppm). That
notice referenced a summary of the petition prepared by Dow
AgroScience, LLC, the registrant, which is available to the public in
the docket, at https://www.regulations.gov. There were no comments
received in response to the notice of filing. Based upon review of the
data supporting the petition, EPA has revised and raised the tolerance
level to include the combined residues of the parent chemical, cis- and
trans-1,3 dichloropropene, and the metabolites, cis- and trans-3-
chloroacrylic acid and cis- and trans-3-chloroallyl alcohol which are
considered to be of equal toxicity to the parent chemical.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for the combined residues of cis- and trans-1,3-dichloropropene, cis-
and trans-3-chloroacrylic acid, and cis- and trans-3-chloroallyl
alcohol (1,3-dichloropropene and metabolites) on grape at 0.018 ppm.
EPA's assessment of exposures and risks associated with establishing
the tolerance follows.
[[Page 8214]]
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The toxicology database is considered to be adequate to support the
proposed and existing uses of 1,3-dichloropropene. 1,3-Dichloropropene
showed moderate acute toxicity by the oral and dermal exposure routes
(Toxicity Category II), was moderately irritating to the eye and skin,
and was a dermal sensitizer in guinea pigs. It is classified as
Toxicity Category IV for acute inhalation toxicity and produced
tremors, convulsions, salivation, lacrimation, diarrhea, lethargy and
death at concentrations 647 ppm or higher.
Consistent with the irritant properties of 1,3-dichloropropene,
there was evidence of degenerative changes in the nasal olfactory
epithelium and histopathological changes of the respiratory epithelium
in rats and mice after subchronic inhalation exposure. Following
chronic inhalation exposure, the olfactory region of the nasal cavity
appeared to be the target organ in rats while lung adenomas were
induced in mice. Similarly, following oral exposure, 1,3-
dichloropropene induced histopathological lesions in rats and/or mice
including forestomach squamous cell papillomas and carcinomas, liver
masses/neoplastic nodules, urinary bladder carcinomas, and alveolar/
brochiolaradenomas. Increases in hematopoietic activity and decreased
body weights were also noted in dogs and mice, respectively.
Accordingly, 1,3-dichloropropene has been classified as ``likely to be
carcinogenic to humans'' via both the oral and inhalation routes. As a
result, cancer potency factors (Q1*) have been calculated for both
routes of exposure.
Specific information on the studies received and the nature of the
adverse effects caused by 1,3-dichloropropene and metabolites as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest
observed-adverse-effect-level (LOAEL) from the toxicity studies can be
found at https://www.regulations.gov. The risk assessment dated January
24, 2008 is available in the docket established by this action, which
is described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0637
in that docket.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for 1,3-dichloropropene
and metabolites used for human risk assessment can be found at https://
www.regulations.gov in the document titled 1,3-Dichloropropene:
Proposed New Use for Drip Irrigation in Vineyards: HED Human Health
Risk Assessment at page 21 in docket ID number EPA-HQ-OPP-2007-0637.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 1,3-dichloropropene and metabolites, EPA considered
exposure under the petitioned-for tolerance. There are no other
tolerances for 1,3-dichloropropene and metabolites. EPA assessed
dietary exposures from 1,3-dichloropropene and metabolites in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
1,3-dichloropropene and metabolites; 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,
or 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to
residue levels in food, EPA relied upon anticipated residues and
assumed 100 percent crop treated (PCT). Residues of cis- and trans-1,3-
dichloropropene and three of the four metabolites were assumed to be at
one-half the limit of detection (0.001 ppm) since residues were non-
detectable in all field trials at shorter pre-harvest intervals (PHI)
than the proposed use pattern. Residues at the proposed PHI in one
trial of one metabolite were at the limit of quantitation (0.003 ppm),
so the LOQ was used. The metabolites were assumed to have equal
toxicity to the parent compound, so the total anticipated residue used
in the dietary assessment for the chronic analyses was 0.0055 ppm.
iii. Cancer. The cancer dietary exposure assessment utilized the
same data and assumptions used in the chronic dietary exposure
assessment. For dietary exposure to 1,3-dichloropropene, an oral cancer
potency factor (Q1* of 1.22 X 10-1 (mg/kg/day)-1)
was used to assess cancer risk.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must pursuant
to FFDCA section 408(f)(1) require that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of this tolerance.
[[Page 8215]]
2. Dietary exposure from drinking water. The Agency lacks
sufficient surface water monitoring data to complete a comprehensive
dietary exposure analysis and risk assessment for 1,3-dichloropropene
and metabolites in drinking water. Because the Agency does not have
comprehensive surface water monitoring data, drinking water
concentration estimates from surface water sources are made by reliance
on simulation or modeling taking into account data on the environmental
fate characteristics of 1,3-dichloropropene and metabolites. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS), the estimated environmental concentrations (EECs)
of 1,3-dichloropropene and metabolites for chronic exposures are
estimated to be 16.2 parts per billion (ppb). The limited surface water
monitoring data available from areas of high use did not show
detectable residues of 1,3-dichloropropene in 123 samples.
There is sufficient data for tap water from groundwater wells
available for 1,3-dichloropropene and metabolites. A total of 518 wells
were selected in the Central Columbia Plateau, Upper Snake River Basin,
North Platte River, Albermarle-Pamlico Sound, and the George/Florida
basins. The wells were intended to be among the most vulnerable wells
available for sampling in each region because they were in high use
areas, were among the shallowest in each region, and were located in
close proximity to fields that had received 1,3-dichloropropene
applications in the recent past. 1,3-Dichloropropene and metabolites
were not found above 0.145 ppb in 5,800 samples.1,3-Dichloropropene or
its degradates were detected in 12% of the wells. Only three wells had
two detections over the course of the study; no wells had more than two
detections. Of the approximately 5,800 samples, only 68 detections were
observed for either the parent compound or the metabolites.
Modeled surface water estimates of drinking water concentrations
and the maximum ground water concentration from monitoring data were
directly entered into the dietary exposure model. For chronic dietary
risk assessment, the surface drinking water concentration value of 16.2
ppb was used and the ground drinking water concentration value of 0.14
ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
1,3-Dichloropropene is not registered for use on any sites that
would result in residential exposure. However, due to the volatility of
1,3-dichloropropene, residential bystander exposure may occur when 1,3-
dichloropropene is applied to agricultural fields near residential
areas. Residential bystander exposure may occur because of emissions
from treated fields. These emissions can travel to non-target areas and
are referred to as bystander exposure. Bystander exposure can occur as
a result of being in contact with residues that are emitted from a
known single source (e.g., a single application to an agricultural
field near a residential area) and from multiple sources (e.g.,
applications to numerous agricultural fields) within a localized
agricultural region (ambient air exposure).
i. Inhalation exposure from a single source. Acute exposures to
bystanders from single post-plant agricultural field fumigation events
and their associated risks were calculated using the distributional/
probabilistic modeling method. Distributional modeling was done with
the Probabilistic Exposure and Risk Model for Fumigants (PERFUM).
Exposures were also analyzed using the actual field study data (i.e,
the monitoring method). Additional information on the methods used to
assess bystander risks are given in Section 6.1.1 from the Phase 5
Registration Eligibility Decision.: Methods Used to Calculate Bystander
Exposures and Risks From Known Sources located at https://
www.regulations.gov in docket ID number EPA-HQ-OPP-2005-0124-0052, page
27.
a. Acute exposure was estimated by using the maximum 24-hour time-
weighted average (TWA) from each field volatility study.
b. Short-term exposure was estimated by using the highest 7-day
average for each direction from each field volatility study.
c. Intermediate-term exposures (consecutive exposures lasting 30
days to several months) is expected to be less likely since 1,3-
dichloropropene products are only used 1 to 2 times per field each
year.
d. Chronic exposure is not expected since it is unlikely that
bystanders will be continually exposed to significant concentrations of
1,3-dichloropropene for 6 consecutive months or longer. Chronic
exposure from multiple (ambient air) sources is more likely and
described in section 3 (ii)(c).
e. Cancer risks to 1,3-dichloropropene were estimated for multiple
(ambient air) sources as that exposure scenario is more representative
of a lifetime of exposure and are described in the following section
3(ii)(d).
ii. Inhalation exposure from ambient air sources. Exposure to 1,3-
dichloropropene from ambient air was evaluated using monitoring data
from California. These data reflect existing pre-plant fumigation uses
that are applied at rates over 10 times the rate of the proposed post-
plant fumigation use on grapes. These data consist of two basic types
that include targeted monitoring that occurred in a high use area
during the season of use. The other type of data was collected as part
of the routine Toxic Air Contaminant (TAC) program and focus on
background levels in urban environments.
a. Acute exposure was estimated by using the maximum 24-hour time-
weighted average (TWA) from the monitoring data.
b. Short-term and intermediate-term exposures were estimated by
comparing the mean of the weekly mean estimate from the monitoring
data.
c. Chronic exposures were calculated using the targeted regional
source ambient data. These calculations should be considered as
rangefinder estimates of exposure only because of a lack of monitoring
studies specifically designed for this purpose. Short- and
intermediate-term estimates were amortized to reflect a potential for
exposure of 180 days out of each calendar year in order to calculate
chronic estimates of exposure. This was based on the approximate use
patterns for 1,3-dichloropropene over a year in high use areas. Results
based on all of these calculations, as indicated above, do not
represent a risk concern to the Agency and in most cases risks were far
below the target level of concern (e.g., by orders of magnitude). There
were no ambient monitoring studies targeting areas of high use that
collected air samples over an entire year that would be considered
representative of a chronic exposure pattern. In these studies the
focus was more on the actual season of use so these data were typically
collected for only 9 weeks or so which represents the duration of the
typical application season. However, in order to be able to evaluate
the possibility of chronic exposures in high use areas the Agency
utilized the seasonal mean of means from the high use areas and
supposed that exposures could be maintained at this rate for a
[[Page 8216]]
sustained period of 6 months which is twice as long as a normal
application season. This approach does have some uncertainty associated
with it but the Agency believes that this approach does not
underestimate exposure because monitoring data were collected in the
season of use in areas of high use. Additionally, risks calculated
based on this method, as indicated above, are typically well below the
Agency's level of concern. In addition to using the targeted monitoring
data, the Agency also used the urban background monitoring data to
calculate chronic risks. In this case, the data were intentionally
designed to be used to evaluate longer-term exposure levels. Many of
the samples collected in this network did not even contain measurable
residues over the course of the monitoring years in question but
chronic risks were still evaluated as a precautionary measure.
d. For cancer risk assessment, the lifetime average daily exposure
(LADE) was calculated using the mean of weekly means and assumed that
exposure lasts the length of the longest monitoring period (9 weeks/63
days).
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 1,3-dichloropropene and
any other substances and 1,3-dichloropropene 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 1,3-
dichloropropene 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 EPA's website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence
(quantitative or qualitative) of susceptibility and no residual
uncertainties with regard to pre- and/or post-natal toxicity following
in utero exposure to rats or rabbits and pre- and/or post-natal
exposures to rats.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for 1,3-dichloropropene is complete.
ii. There is no indication that 1,3-dichloropropene 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 1,3-dichloropropene results in
increased susceptibility following in utero and/or post-natal exposure
in rats or rabbits in the prenatal developmental studies or in young
rats in the 2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated and average anticipated residues. Conservative
surface water modeling estimates were used, and sufficient monitoring
data were used to assess ground water concentrations. There are no
residential uses of 1,3-dichloropropene and conservative modeling was
used to estimate bystander exposure. These assessments will not
underestimate the exposure and risks posed by 1,3-dichloropropene and
metabolites.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of expsure (MOE) called for by the product of
all applicable UFs is not exceeded.
For the acute, short-, intermediate-, and long-term assessments,
the toxicity endpoints selected for inhalation and dietary exposures
should not be aggregated since no common endpoints were identified at
the LOAEL in studies conducted via the oral or inhalation routes. 1,3-
Dichloropropene has been classified as likely to be carcinogenic to
humans via the oral and inhalation routes. However, the types of tumors
observed in the inhalation and oral studies were different. Therefore,
the oral and inhalation exposures were not aggregated.
1. Acute risk. An endpoint was not selected for acute dietary risk
assessment because there were no effects attributable to a single dose
(exposure) via the oral route. Therefore, 1,3-dichloropropene is not
expected to pose an acute dietary risk.
For residential bystander acute inhalation risk resulting from
exposure to a single source, the lowest acute MOE was 400 based on the
application rate in the field volatility data and the lowest acute MOE
was 160 based on the maximum label rate. The risk estimates did not
exceed the level of concern using the PERFUM modeling method. For
residential bystander acute inhalation risk resulting from exposure to
ambient air sources, the lowest acute MOE was 2,700 based on California
ambient air monitoring data. The MOEs do not exceed the Agency's level
of concern of < 30.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to 1,3-
dichloropropene and metabolites from food and water (ground water
sources) will utilize < 1% of the cPAD for the most highly exposed
population group (children 1 to 2 years old) and from food and water
(surface water sources) will utilize < 5% of the cPAD for the most
highly exposed population group, infants < 1 year old.
Residential bystander chronic inhalation exposure from a single
source is not expected to occur and therefore, does not pose an
inhalation risk. For residential bystander chronic inhalation risk
resulting from exposure to ambient air sources, the lowest chronic MOE
was 130 based on California ambient air monitoring data. The MOE does
not
[[Page 8217]]
exceed the Agency's level of concern of < 30.
3. Short-term risk. For residential bystander short-term inhalation
risk resulting from exposure to a single source, the lowest short-term
MOE was 60 based on the application rate in the field volatility data
and based on the maximum label rate. For residential bystander short-
term inhalation risk resulting from exposure to ambient air sources,
the lowest short-term MOE was 1,700 based on California ambient air
monitoring data. The MOEs do not exceed the Agency's level of concern
of < 30.
4. Intermediate-term risk. Residential bystander intermediate-term
inhalation exposure from a single source is unlikely to occur and
therefore, does not pose an inhalation risk. For residential bystander
intermediate-term inhalation risk resulting from exposure to ambient
air sources, the lowest intermediate-term MOE was 70 based on
California ambient air monitoring data. The MOE does not exceed the
Agency's level of concern of < 30.
5. Aggregate cancer risk for U.S. population. The aggregated food
and water risk represent upper bound risks for a person living in
agricultural areas where 1,3-dichloropropene is used extensively or
where a person obtains drinking water from an aquifer that led directly
from an area where 1,3-dichloropropene was used. The aggregate chronic
dietary cancer risk estimates for the general U.S. population resulting
from exposure to 1,3-dichloropropene and metabolites in food and water
(ground water sources) is 7 X 10-7 and from exposure to 1,3-
dichloropropene and metabolites in food and water (surface water
sources) is 4 X 10-5.
Although risk for drinking water from surface water sources for
1,3-dichloropropene exceeds the Agency's level of concern (risk
estimates generally in the range of 1 in 1 million, interpreted as > 1
to 3 X 10-6); it should be noted that concentrations of 1,3-
dichloropropene in tap water from ground water wells were approximately
100 times lower than those found in the field ground water study and
several orders of magnitude lower than modeled estimates of 1,3-
dichloropropene in groundwater. Therefore, it is highly likely that
actual drinking water concentrations of 1,3-dichloropropene from
surface water sources would also be much lower. 1,3-Dichloropropene and
its metabolites are highly volatile compounds, and the models used to
generate surface water and ground water estimates are not designed for
volatile chemicals. The limited surface water monitoring data available
in areas of high use do not show any detections of 1,3-dichloropropene
and its degradates. Therefore, the Agency does not have a concern for
the aggregate cancer risk from oral exposures to 1,3-dichloropropene
and its metabolites.
Cancer risk was estimated using 1,3-dichloropropene ambient air
monitoring data collected from over 20 sites over multiple years to
estimate exposure over a lifetime. These sites were in areas of high
use and in urban environments. The cancer risk estimates for all but
one monitoring site, in a high use area, ranged from 2 X
10-6 to 9 X 10-8, which are below the Agency's
level of concern. The monitoring data for the one site resulted in a
risk estimate of 6 X 10-6, which does exceed the Agency's
level of concern. However, risks calculated using data from the same
site in the following year was almost two orders of magnitude lower.
Therefore, over a lifetime of exposure, the risk estimates would likely
be below the level of concern. It should be noted that in more
populated urban environments, air concentrations were below the
analytical limit of detection in 21 of 28 sites/year combinations
considered. In the remaining seven site/year combinations, values were
measured but did not result in cancer risks of concern. Therefore, the
Agency does not have a concern for the cancer risk from 1,3-
dichloropropene.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to 1,3-dichloropropene and metabolites residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Dow AgroSciences, LLC submitted a gas chromatography/
massspectroscopy (GC/MS) method, Method GRM 99.09.R1, for
thedetermination of residues of cis- and trans-1,3-dichloropropene. The
method was adequately validated using fortified samples of grape.
Recoveries of cis-1,3-dichloropropene ranged from 70% to 114% and
recoveries of trans-1,3-dichloropropene ranged from 77% to 113% from
samples fortified at 0.003, 0.010, 0.050, and 0.50 ppm. The
fortification levels used in method validation are adequate to bracket
expected residue levels. Adequate independent laboratory validation
(ILV) datawere submitted for Method GRM 99.09.R1 using samples of
grape.
Dow AgroSciences, LLC submitted a GC/MS method, Method GRM99.18,
for the determination of residues of 3-chloroallyl alcohol and 3-
chloroacrylic acid. The validated LOQ is 0.003 ppm for each analytein
grape. The method was adequately validated using fortified samplesof
grape. Recoveries of cis-3-chloroallyl alcohol ranged from 74% to 90%,
recoveries of trans-3-chloroallyl alcohol ranged from 82% to 95%,
recoveries of cis-chloroacrylic acid ranged from 93% to 98%, and
recoveries of trans-chloroacrylic acid ranged from 91% to 96% from
samples fortified at 0.003, 0.006, and 0.030 ppm. The fortification
levels used in method validation are adequate to bracket expected
residue levels. The Agency has tentatively concluded that the
metabolite method is suitable for enforcement.
Adequate enforcement methodology (GC/MS) is available to enforcethe
tolerance expression. The method may be requested from:
Chief,Analytical Chemistry Branch, Environmental Science Center,
701Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-
2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Canadian or Codex Maximum Residue limits for residues
of 1,3-dichloropropene for any commodity.
C. Conditions
1. An independent laboratory validation of Method GRM 99.18
andmulti-residue method testing will be required as confirmatory data.
2. In order to refine the exposure estimates from PRZM-EXAMS, the
following data will be required: an aerobic soil metabolism study on
additional soils (parent and metabolites); an aerobic aquatic
metabolism study (parent and metabolites); an aqueous photolysis study
(indirect and parent); a soil photolysis study (parent); and a
photolysis/oxidation in air study (parent).
V. Conclusion
Therefore, the tolerance is established for combined residues of
cis- and trans-1,3-dichloropropene, cis- and trans-3-chloroacrylic
acid, and cis- and trans-3-chloroallyl alcohol, in or on grape at 0.018
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and
[[Page 8218]]
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this rule has been exempted from
review under Executive Order 12866, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 1, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.636 is added to subpart C to read as follows:
Sec. 180.636 1,3-dichloropropene; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the fungicide cis- and trans-1,3-dichloropropene and its metabolites
cis- and trans-3-chloroacrylic acid, and cis- and trans-3-chloroallyl
alcohol in or on the following commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Grape...................................................... 0.018
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E8-2480 Filed 2-12-08; 8:45 am]
BILLING CODE 6560-50-S