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8212 Federal Register / Vol. 73, No.

30 / Wednesday, February 13, 2008 / Rules and Regulations

FR 28355, May 22, 2001) because it is J. Congressional Review Act extend the time within which a petition
not a significant regulatory action under The Congressional Review Act, 5 for judicial review may be filed, and
Executive Order 12866. U.S.C. 801 et seq., as added by the Small shall not postpone the effectiveness of
Business Regulatory Enforcement such rule or action. This action may not
I. National Technology Transfer and be challenged later in proceedings to
Advancement Act Fairness Act of 1996, generally provides
that before a rule may take effect, the enforce its requirements. (See section
Section 12 of the National Technology agency promulgating the rule must 307(b)(2).)
Transfer and Advancement Act submit a rule report, which includes a List of Subjects in 40 CFR Part 81
(NTTAA) of 1995 requires Federal copy of the rule, to each House of the
agencies to evaluate existing technical Congress and to the Comptroller General Environmental protection, Air
standards when developing a new of the United States. EPA will submit a pollution control, Incorporation by
report containing this rule and other reference.
regulation. To comply with NTTAA,
EPA must consider and use ‘‘voluntary required information to the U.S. Senate, Authority: 42 U.S.C. 7401 et seq.
the U.S. House of Representatives, and
consensus standards’’ (VCS) if available Dated: January 24, 2008.
the Comptroller General of the United
and applicable when developing States prior to publication of the rule in Jane Diamond,
programs and policies unless doing so the Federal Register. A major rule Acting Regional Administrator, Region IX.
would be inconsistent with applicable cannot take effect until 60 days after it
law or otherwise impractical. ■ Part 81 of chapter I, title 40 of the
is published in the Federal Register. Code of Federal Regulations is amended
The EPA believes that VCS are This action is not a ‘‘major rule’’ as as follows:
inapplicable to this action. Today’s defined by 5 U.S.C. 804(2). This rule
action does not require the public to will be effective March 14, 2008. PART 81—[AMENDED]
perform activities conducive to the use K. Petitions for Judicial Review
of VCS. This action merely determines ■ 1. The authority citation for part 81
Under section 307(b)(1) of the Clean continues to read as follows:
that the Imperial County area has not
Air Act, petitions for judicial review of
attained by the applicable attainment Authority: 42 U.S.C. 7401 et seq.
this action must be filed in the United
date, reclassifies the Imperial County States Court of Appeals for the
area as a moderate ozone nonattainment ■ 2. In § 81.305 the ‘‘California-Ozone
appropriate circuit by April 14, 2008. (8-Hour Standard)’’ table is amended by
area, and adjusts applicable deadlines. Filing a petition for reconsideration by
Therefore, EPA did not consider the use revising the entry for ‘‘Imperial
the Administrator of this final rule does County:’’ to read as follows:
of any voluntary consensus standards. not affect the finality of this rule for the
purposes of judicial review nor does it § 81.305 California.

[8-hour standard]

Designation Classification
Designated area
Date1 Type Date Classification

* * * * * * *
Imperial County, CA: Imperial County .................................... .................... Nonattainment ............... 3/14/08 Subpart 2/Moderate.

* * * * * * *
1 This date is June 15, 2004, unless otherwise noted.

[FR Doc. E8–2698 Filed 2–12–08; 8:45 am] requested this tolerance under the and select the ‘‘Submit’’ button. Follow
BILLING CODE 6560–50–P Federal Food, Drug, and Cosmetic Act the instructions on the
(FFDCA). website to view the docket index or
access available documents. All
ENVIRONMENTAL PROTECTION DATES: This regulation is effective documents in the docket are listed in
AGENCY February 13, 2008. Objections and the docket index available in
requests for hearings must be received Although listed in the
40 CFR Part 180 on or before April 14, 2008, and must index, some information is not publicly
[EPA–HQ–OPP–2007–0637; FRL–8345–1]
be filed in accordance with the available, e.g., Confidential Business
instructions provided in 40 CFR part Information (CBI) or other information
1,3-Dichloropropene and metabolites; 178 (see also Unit I.C. of the whose disclosure is restricted by statute.
Certain other material, such as
AGENCY: Environmental Protection ADDRESSES: EPA has established a copyrighted material, is not placed on
Agency (EPA). docket for this action under docket the Internet and will be publicly
ACTION: Final rule. identification (ID) number EPA–HQ– available only in hard copy form.
pwalker on PROD1PC71 with RULES

OPP–2007–0637. To access the Publicly available docket materials are

SUMMARY: This regulation establishes a electronic docket, go to http:// available in the electronic docket at
tolerance for combined residues of 1,3-, select ‘‘Advanced, or, if only
dichloropropene and metabolites in or Search,’’ then ‘‘Docket Search.’’ Insert available in hard copy, at the OPP
on grape. Dow AgroSciences, LLC the docket ID number where indicated Regulatory Public Docket in Rm. S–

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Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations 8213

4400, One Potomac Yard (South Bldg.), also access a frequently updated petition requested that 40 CFR part 180
2777 S. Crystal Dr., Arlington, VA. The electronic version of EPA’s tolerance be amended by establishing a tolerance
Docket Facility is open from 8:30 a.m. regulations at 40 CFR part 180 through for residues of the fungicide, 1,3-
to 4 p.m., Monday through Friday, the Government Printing Office’s pilot dichloropropene, in or on grape at 0.009
excluding legal holidays. The Docket e-CFR site at parts per million (ppm). That notice
Facility telephone number is (703) 305– ecfr. referenced a summary of the petition
5805. prepared by Dow AgroScience, LLC, the
C. Can I File an Objection or Hearing
FOR FURTHER INFORMATION CONTACT: registrant, which is available to the
Mary L. Waller, Registration Division public in the docket, at http://
(7505P), Office of Pesticide Programs, Under section 408(g) of FFDCA, any There were no
Environmental Protection Agency, 1200 person may file an objection to any comments received in response to the
Pennsylvania Ave., NW., Washington, aspect of this regulation and may also notice of filing. Based upon review of
DC 20460–0001; telephone number: request a hearing on those objections. the data supporting the petition, EPA
(703) 308–9354; e-mail address: You must file your objection or request has revised and raised the tolerance a hearing on this regulation in level to include the combined residues
accordance with the instructions of the parent chemical, cis- and trans-
SUPPLEMENTARY INFORMATION: provided in 40 CFR part 178. To ensure 1,3 dichloropropene, and the
I. General Information proper receipt by EPA, you must metabolites, cis- and trans-3-
identify docket ID number EPA–HQ– chloroacrylic acid and cis- and trans-3-
A. Does this Action Apply to Me? OPP–2007–0637 in the subject line on chloroallyl alcohol which are
You may be potentially affected by the first page of your submission. All considered to be of equal toxicity to the
this action if you are an agricultural requests must be in writing, and must be parent chemical.
producer, food manufacturer, or mailed or delivered to the Hearing Clerk
III. Aggregate Risk Assessment and
pesticide manufacturer. Potentially as required by 40 CFR part 178 on or
Determination of Safety
affected entities may include, but are before April 14, 2008.
not limited to those engaged in the In addition to filing an objection or Section 408(b)(2)(A)(i) of FFDCA
following activities: hearing request with the Hearing Clerk allows EPA to establish a tolerance (the
• Crop production (NAICS code 111), as described in 40 CFR part 178, please legal limit for a pesticide chemical
e.g., agricultural workers; greenhouse, submit a copy of the filing that does not residue in or on a food) only if EPA
nursery, and floriculture workers; contain any CBI for inclusion in the determines that the tolerance is ‘‘safe.’’
farmers. public docket that is described in Section 408(b)(2)(A)(ii) of FFDCA
• Animal production (NAICS code ADDRESSES. Information not marked defines ‘‘safe’’ to mean that ‘‘there is a
112), e.g., cattle ranchers and farmers, confidential pursuant to 40 CFR part 2 reasonable certainty that no harm will
dairy cattle farmers, livestock farmers. may be disclosed publicly by EPA result from aggregate exposure to the
• Food manufacturing (NAICS code without prior notice. Submit this copy, pesticide chemical residue, including
311), e.g., agricultural workers; farmers; identified by docket ID number EPA– all anticipated dietary exposures and all
greenhouse, nursery, and floriculture HQ–OPP–2007–0637, by one of the other exposures for which there is
workers; ranchers; pesticide applicators. following methods: reliable information.’’ This includes
• Pesticide manufacturing (NAICS • Federal eRulemaking Portal: http:// exposure through drinking water and in
code 32532), e.g., agricultural workers; Follow the on-line residential settings, but does not include
commercial applicators; farmers; instructions for submitting comments. occupational exposure. Section
greenhouse, nursery, and floriculture • Mail: Office of Pesticide Programs 408(b)(2)(C) of FFDCA requires EPA to
workers; residential users. (OPP) Regulatory Public Docket (7502P), give special consideration to exposure
This listing is not intended to be Environmental Protection Agency, 1200 of infants and children to the pesticide
exhaustive, but rather to provide a guide Pennsylvania Ave., NW., Washington, chemical residue in establishing a
for readers regarding entities likely to be DC 20460–0001. tolerance and to ‘‘ensure that there is a
affected by this action. Other types of • Delivery: OPP Regulatory Public reasonable certainty that no harm will
entities not listed in this unit could also Docket (7502P), Environmental result to infants and children from
be affected. The North American Protection Agency, Rm. S–4400, One aggregate exposure to the pesticide
Industrial Classification System Potomac Yard (South Bldg.), 2777 S. chemical residue....’’ These provisions
(NAICS) codes have been provided to Crystal Dr., Arlington, VA. Deliveries were added to FFDCA by the Food
assist you and others in determining are only accepted during the Docket’s Quality Protection Act (FQPA) of 1996.
whether this action might apply to normal hours of operation (8:30 a.m. to Consistent with FFDCA section
certain entities. If you have any 4 p.m., Monday through Friday, 408(b)(2)(D), and the factors specified in
questions regarding the applicability of excluding legal holidays). Special FFDCA section 408(b)(2)(D), EPA has
this action to a particular entity, consult arrangements should be made for reviewed the available scientific data
the person listed under FOR FURTHER deliveries of boxed information. The and other relevant information in
INFORMATION CONTACT. Docket Facility telephone number is support of this action. EPA has
(703) 305–5805. sufficient data to assess the hazards of
B. How Can I Access Electronic Copies and to make a determination on
of this Document? II. Petition for Tolerance aggregate exposure for the petitioned-for
In addition to accessing an electronic In the Federal Register of September tolerance for the combined residues of
copy of this Federal Register document 19, 2007 (72 FR 53575–53577) (FRL– cis- and trans-1,3-dichloropropene, cis-
through the electronic docket at http:// 8144–3), EPA issued a notice pursuant and trans-3-chloroacrylic acid, and cis-
pwalker on PROD1PC71 with RULES, you may access to section 408(d)(3) of FFDCA, 21 U.S.C. and trans-3-chloroallyl alcohol (1,3-
this Federal Register document 346a(d)(3), announcing the filing of a dichloropropene and metabolites) on
electronically through the EPA Internet pesticide petition (PP 1F6253) by Dow grape at 0.018 ppm. EPA’s assessment of
under the ‘‘Federal Register’’ listings at AgroSciences, LLC, 9330 Zionsville exposures and risks associated with You may Road, Indianapolis, IN 46268. The establishing the tolerance follows.

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8214 Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations

A. Toxicological Profile B. Toxicological Endpoints dichloropropene and metabolites in

EPA has evaluated the available food as follows:
For hazards that have a threshold i. Acute exposure. Quantitative acute
toxicity data and considered its validity, below which there is no appreciable
completeness, and reliability as well as dietary exposure and risk assessments
risk, the toxicological level of concern are performed for a food-use pesticide,
the relationship of the results of the (LOC) is derived from the highest dose
studies to human risk. EPA has also if a toxicological study has indicated the
at which no adverse effects are observed possibility of an effect of concern
considered available information (the NOAEL) in the toxicology study
concerning the variability of the occurring as a result of a 1–day or single
identified as appropriate for use in risk exposure.
sensitivities of major identifiable assessment. However, if a NOAEL
subgroups of consumers, including No such effects were identified in the
cannot be determined, the lowest dose toxicological studies for 1,3-
infants and children. at which adverse effects of concern are
The toxicology database is considered dichloropropene and metabolites;
identified (the LOAEL) is sometimes therefore, a quantitative acute dietary
to be adequate to support the proposed used for risk assessment. Uncertainty/
and existing uses of 1,3- exposure assessment is unnecessary.
safety factors (UFs) are used in
dichloropropene. 1,3-Dichloropropene ii. Chronic exposure. In conducting
conjunction with the LOC to take into
showed moderate acute toxicity by the the chronic dietary exposure assessment
account uncertainties inherent in the
oral and dermal exposure routes EPA used the food consumption data
extrapolation from laboratory animal
(Toxicity Category II), was moderately from the USDA 1994–1996, or 1998
data to humans and in the variations in
irritating to the eye and skin, and was Continuing Survey of Food Intake by
sensitivity among members of the
a dermal sensitizer in guinea pigs. It is Individuals (CSFII). As to residue levels
human population as well as other
classified as Toxicity Category IV for in food, EPA relied upon anticipated
unknowns. Safety is assessed for acute
acute inhalation toxicity and produced residues and assumed 100 percent crop
and chronic risks by comparing
tremors, convulsions, salivation, treated (PCT). Residues of cis- and trans-
aggregate exposure to the pesticide to
lacrimation, diarrhea, lethargy and 1,3-dichloropropene and three of the
the acute population adjusted dose
death at concentrations 647 ppm or four metabolites were assumed to be at
(aPAD) and chronic population adjusted
higher. one-half the limit of detection (0.001
dose (cPAD). The aPAD and cPAD are
Consistent with the irritant properties ppm) since residues were non-
calculated by dividing the LOC by all
of 1,3-dichloropropene, there was detectable in all field trials at shorter
applicable UFs. Short-, intermediate-,
evidence of degenerative changes in the pre-harvest intervals (PHI) than the
and long-term risks are evaluated by
nasal olfactory epithelium and proposed use pattern. Residues at the
comparing aggregate exposure to the
histopathological changes of the proposed PHI in one trial of one
LOC to ensure that the margin of
respiratory epithelium in rats and mice metabolite were at the limit of
exposure (MOE) called for by the
after subchronic inhalation exposure. quantitation (0.003 ppm), so the LOQ
product of all applicable UFs is not
Following chronic inhalation exposure, was used. The metabolites were
the olfactory region of the nasal cavity assumed to have equal toxicity to the
appeared to be the target organ in rats For non-threshold risks, the Agency parent compound, so the total
while lung adenomas were induced in assumes that any amount of exposure anticipated residue used in the dietary
mice. Similarly, following oral will lead to some degree of risk and assessment for the chronic analyses was
exposure, 1,3-dichloropropene induced estimates risk in terms of the probability 0.0055 ppm.
histopathological lesions in rats and/or of occurrence of additional adverse iii. Cancer. The cancer dietary
mice including forestomach squamous cases. Generally, cancer risks are exposure assessment utilized the same
cell papillomas and carcinomas, liver considered non-threshold. For more data and assumptions used in the
masses/neoplastic nodules, urinary information on the general principles chronic dietary exposure assessment.
bladder carcinomas, and alveolar/ EPA uses in risk characterization and a For dietary exposure to 1,3-
brochiolaradenomas. Increases in complete description of the risk dichloropropene, an oral cancer potency
hematopoietic activity and decreased assessment process, see http:// factor (Q1* of 1.22 X 10-1 (mg/kg/day)-1)
body weights were also noted in dogs was used to assess cancer risk.
and mice, respectively. Accordingly, November/Day-26/p30948.htm. iv. Anticipated residue and percent
1,3-dichloropropene has been classified A summary of the toxicological crop treated (PCT) information. Section
as ‘‘likely to be carcinogenic to humans’’ endpoints for 1,3-dichloropropene and 408(b)(2)(E) of FFDCA authorizes EPA
via both the oral and inhalation routes. metabolites used for human risk to use available data and information on
As a result, cancer potency factors (Q1*) assessment can be found at http:// the anticipated residue levels of
have been calculated for both routes of in the document pesticide residues in food and the actual
exposure. titled 1,3-Dichloropropene: Proposed levels of pesticide residues that have
Specific information on the studies New Use for Drip Irrigation in been measured in food. If EPA relies on
received and the nature of the adverse Vineyards: HED Human Health Risk such information, EPA must pursuant to
effects caused by 1,3-dichloropropene Assessment at page 21 in docket ID FFDCA section 408(f)(1) require that
and metabolites as well as the no- number EPA–HQ–OPP–2007–0637. data be provided 5 years after the
observed-adverse-effect-level (NOAEL) C. Exposure Assessment tolerance is established, modified, or
and the lowest observed-adverse-effect- left in effect, demonstrating that the
level (LOAEL) from the toxicity studies 1. Dietary exposure from food and levels in food are not above the levels
can be found at http:// feed uses. In evaluating dietary anticipated. For the present action, EPA The risk exposure to 1,3-dichloropropene and will issue such data call-ins as are
pwalker on PROD1PC71 with RULES

assessment dated January 24, 2008 is metabolites, EPA considered exposure required by FFDCA section 408(b)(2)(E)
available in the docket established by under the petitioned-for tolerance. and authorized under FFDCA section
this action, which is described under There are no other tolerances for 1,3- 408(f)(1). Data will be required to be
ADDRESSES, and is identified as EPA– dichloropropene and metabolites. EPA submitted no later than 5 years from the
HQ–OPP–2007–0637 in that docket. assessed dietary exposures from 1,3- date of issuance of this tolerance.

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Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations 8215

2. Dietary exposure from drinking 3. From non-dietary exposure. The Chronic exposure from multiple
water. The Agency lacks sufficient term ‘‘residential exposure’’ is used in (ambient air) sources is more likely and
surface water monitoring data to this document to refer to non- described in section 3 (ii)(c).
complete a comprehensive dietary occupational, non-dietary exposure e. Cancer risks to 1,3-dichloropropene
exposure analysis and risk assessment (e.g., for lawn and garden pest control, were estimated for multiple (ambient
for 1,3-dichloropropene and metabolites indoor pest control, termiticides, and air) sources as that exposure scenario is
in drinking water. Because the Agency flea and tick control on pets). more representative of a lifetime of
does not have comprehensive surface 1,3-Dichloropropene is not registered exposure and are described in the
water monitoring data, drinking water for use on any sites that would result in following section 3(ii)(d).
concentration estimates from surface residential exposure. However, due to ii. Inhalation exposure from ambient
water sources are made by reliance on the volatility of 1,3-dichloropropene, air sources. Exposure to 1,3-
simulation or modeling taking into residential bystander exposure may dichloropropene from ambient air was
account data on the environmental fate occur when 1,3-dichloropropene is evaluated using monitoring data from
characteristics of 1,3-dichloropropene applied to agricultural fields near California. These data reflect existing
and metabolites. Further information residential areas. Residential bystander pre-plant fumigation uses that are
regarding EPA drinking water models exposure may occur because of applied at rates over 10 times the rate
used in pesticide exposure assessment emissions from treated fields. These of the proposed post-plant fumigation
can be found at emissions can travel to non-target areas use on grapes. These data consist of two
oppefed1/models/water/index.htm. and are referred to as bystander basic types that include targeted
Based on the Pesticide Root Zone exposure. Bystander exposure can occur monitoring that occurred in a high use
Model/Exposure Analysis Modeling as a result of being in contact with area during the season of use. The other
System (PRZM/EXAMS), the estimated residues that are emitted from a known type of data was collected as part of the
environmental concentrations (EECs) of single source (e.g., a single application routine Toxic Air Contaminant (TAC)
1,3-dichloropropene and metabolites for to an agricultural field near a residential program and focus on background levels
area) and from multiple sources (e.g., in urban environments.
chronic exposures are estimated to be
applications to numerous agricultural a. Acute exposure was estimated by
16.2 parts per billion (ppb). The limited
fields) within a localized agricultural using the maximum 24–hour time-
surface water monitoring data available weighted average (TWA) from the
from areas of high use did not show region (ambient air exposure).
i. Inhalation exposure from a single monitoring data.
detectable residues of 1,3- b. Short-term and intermediate-term
source. Acute exposures to bystanders
dichloropropene in 123 samples. exposures were estimated by comparing
from single post-plant agricultural field
There is sufficient data for tap water fumigation events and their associated the mean of the weekly mean estimate
from groundwater wells available for risks were calculated using the from the monitoring data.
1,3-dichloropropene and metabolites. A distributional/probabilistic modeling c. Chronic exposures were calculated
total of 518 wells were selected in the method. Distributional modeling was using the targeted regional source
Central Columbia Plateau, Upper Snake done with the Probabilistic Exposure ambient data. These calculations should
River Basin, North Platte River, and Risk Model for Fumigants be considered as rangefinder estimates
Albermarle-Pamlico Sound, and the (PERFUM). Exposures were also of exposure only because of a lack of
George/Florida basins. The wells were analyzed using the actual field study monitoring studies specifically designed
intended to be among the most data (i.e, the monitoring method). for this purpose. Short- and
vulnerable wells available for sampling Additional information on the methods intermediate-term estimates were
in each region because they were in used to assess bystander risks are given amortized to reflect a potential for
high use areas, were among the in Section 6.1.1 from the Phase 5 exposure of 180 days out of each
shallowest in each region, and were Registration Eligibility Decision.: calendar year in order to calculate
located in close proximity to fields that Methods Used to Calculate Bystander chronic estimates of exposure. This was
had received 1,3-dichloropropene Exposures and Risks From Known based on the approximate use patterns
applications in the recent past. 1,3- Sources located at http:// for 1,3-dichloropropene over a year in
Dichloropropene and metabolites were in docket ID high use areas. Results based on all of
not found above 0.145 ppb in 5,800 number EPA–HQ–OPP–2005–0124- these calculations, as indicated above,
samples.1,3-Dichloropropene or its 0052, page 27. do not represent a risk concern to the
degradates were detected in 12% of the a. Acute exposure was estimated by Agency and in most cases risks were far
wells. Only three wells had two using the maximum 24–hour time- below the target level of concern (e.g.,
detections over the course of the study; weighted average (TWA) from each field by orders of magnitude). There were no
no wells had more than two detections. volatility study. ambient monitoring studies targeting
Of the approximately 5,800 samples, b. Short-term exposure was estimated areas of high use that collected air
only 68 detections were observed for by using the highest 7–day average for samples over an entire year that would
either the parent compound or the each direction from each field volatility be considered representative of a
metabolites. study. chronic exposure pattern. In these
Modeled surface water estimates of c. Intermediate-term exposures studies the focus was more on the actual
drinking water concentrations and the (consecutive exposures lasting 30 days season of use so these data were
maximum ground water concentration to several months) is expected to be less typically collected for only 9 weeks or
from monitoring data were directly likely since 1,3-dichloropropene so which represents the duration of the
entered into the dietary exposure model. products are only used 1 to 2 times per typical application season. However, in
For chronic dietary risk assessment, the field each year. order to be able to evaluate the
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surface drinking water concentration d. Chronic exposure is not expected possibility of chronic exposures in high
value of 16.2 ppb was used and the since it is unlikely that bystanders will use areas the Agency utilized the
ground drinking water concentration be continually exposed to significant seasonal mean of means from the high
value of 0.14 ppb was used to assess the concentrations of 1,3-dichloropropene use areas and supposed that exposures
contribution to drinking water. for 6 consecutive months or longer. could be maintained at this rate for a

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8216 Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations

sustained period of 6 months which is prenatal and postnatal toxicity and the calculated by dividing the LOC by all
twice as long as a normal application completeness of the database on toxicity applicable UFs. For linear cancer risks,
season. This approach does have some and exposure unless EPA determines EPA calculates the probability of
uncertainty associated with it but the based on reliable data that a different additional cancer cases given aggregate
Agency believes that this approach does margin of safety will be safe for infants exposure. Short-, intermediate-, and
not underestimate exposure because and children. This additional margin of long-term risks are evaluated by
monitoring data were collected in the safety is commonly referred to as the comparing aggregate exposure to the
season of use in areas of high use. FQPA safety factor. In applying this LOC to ensure that the margin of
Additionally, risks calculated based on provision, EPA either retains the default expsure (MOE) called for by the product
this method, as indicated above, are value of 10X when reliable data do not of all applicable UFs is not exceeded.
typically well below the Agency’s level support the choice of a different factor, For the acute, short-, intermediate-,
of concern. In addition to using the or, if reliable data are available, EPA and long-term assessments, the toxicity
targeted monitoring data, the Agency uses a different additional FQPA safety endpoints selected for inhalation and
also used the urban background factor value based on the use of dietary exposures should not be
monitoring data to calculate chronic traditional UFs and/or special FQPA aggregated since no common endpoints
risks. In this case, the data were safety factors, as appropriate. were identified at the LOAEL in studies
intentionally designed to be used to 2. Prenatal and postnatal sensitivity. conducted via the oral or inhalation
evaluate longer-term exposure levels. There is no evidence (quantitative or routes. 1,3-Dichloropropene has been
Many of the samples collected in this qualitative) of susceptibility and no classified as likely to be carcinogenic to
network did not even contain residual uncertainties with regard to humans via the oral and inhalation
measurable residues over the course of pre- and/or post-natal toxicity following routes. However, the types of tumors
the monitoring years in question but in utero exposure to rats or rabbits and observed in the inhalation and oral
chronic risks were still evaluated as a pre- and/or post-natal exposures to rats. studies were different. Therefore, the
precautionary measure. 3. Conclusion. EPA has determined oral and inhalation exposures were not
d. For cancer risk assessment, the that reliable data show that it would be aggregated.
lifetime average daily exposure (LADE) safe for infants and children to reduce 1. Acute risk. An endpoint was not
was calculated using the mean of the FQPA safety factor to 1X. That selected for acute dietary risk
weekly means and assumed that decision is based on the following assessment because there were no
exposure lasts the length of the longest findings: effects attributable to a single dose
monitoring period (9 weeks/63 days). i. The toxicity database for 1,3- (exposure) via the oral route. Therefore,
4. Cumulative effects from substances dichloropropene is complete. 1,3-dichloropropene is not expected to
with a common mechanism of toxicity. ii. There is no indication that 1,3- pose an acute dietary risk.
Section 408(b)(2)(D)(v) of FFDCA dichloropropene is a neurotoxic For residential bystander acute
requires that, when considering whether chemical and there is no need for a inhalation risk resulting from exposure
to establish, modify, or revoke a developmental neurotoxicity study or to a single source, the lowest acute MOE
tolerance, the Agency consider additional UFs to account for was 400 based on the application rate in
‘‘available information’’ concerning the neurotoxicity. the field volatility data and the lowest
cumulative effects of a particular iii. There is no evidence that 1,3- acute MOE was 160 based on the
pesticide’s residues and ‘‘other dichloropropene results in increased maximum label rate. The risk estimates
substances that have a common susceptibility following in utero and/or did not exceed the level of concern
mechanism of toxicity.’’ post-natal exposure in rats or rabbits in using the PERFUM modeling method.
Unlike other pesticides for which EPA the prenatal developmental studies or in For residential bystander acute
has followed a cumulative risk approach young rats in the 2–generation inhalation risk resulting from exposure
based on a common mechanism of reproduction study. to ambient air sources, the lowest acute
toxicity, EPA has not made a common iv. There are no residual uncertainties MOE was 2,700 based on California
mechanism of toxicity finding as to 1,3- identified in the exposure databases. ambient air monitoring data. The MOEs
dichloropropene and any other The dietary food exposure assessments do not exceed the Agency’s level of
substances and 1,3-dichloropropene were performed based on 100% crop concern of < 30.
does not appear to produce a toxic treated and average anticipated 2. Chronic risk. Using the exposure
metabolite produced by other residues. Conservative surface water assumptions described in this unit for
substances. For the purposes of this modeling estimates were used, and chronic exposure, EPA has concluded
tolerance action, therefore, EPA has not sufficient monitoring data were used to that exposure to 1,3-dichloropropene
assumed that 1,3-dichloropropene has a assess ground water concentrations. and metabolites from food and water
common mechanism of toxicity with There are no residential uses of 1,3- (ground water sources) will utilize < 1%
other substances. For information dichloropropene and conservative of the cPAD for the most highly exposed
regarding EPA’s efforts to determine modeling was used to estimate population group (children 1 to 2 years
which chemicals have a common bystander exposure. These assessments old) and from food and water (surface
mechanism of toxicity and to evaluate will not underestimate the exposure and water sources) will utilize < 5% of the
the cumulative effects of such risks posed by 1,3-dichloropropene and cPAD for the most highly exposed
chemicals, see EPA’s website at http:// metabolites. population group, infants < 1 year old. Residential bystander chronic
E. Aggregate Risks and Determination of inhalation exposure from a single source
D. Safety Factor for Infants and Safety is not expected to occur and therefore,
Children Safety is assessed for acute and does not pose an inhalation risk. For
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1. In general. Section 408 of FFDCA chronic risks by comparing aggregate residential bystander chronic inhalation
provides that EPA shall apply an exposure to the pesticide to the acute risk resulting from exposure to ambient
additional (‘‘10X’’) tenfold margin of population adjusted dose (aPAD) and air sources, the lowest chronic MOE was
safety for infants and children in the chronic population adjusted dose 130 based on California ambient air
case of threshold effects to account for (cPAD). The aPAD and cPAD are monitoring data. The MOE does not

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Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations 8217

exceed the Agency’s level of concern of limited surface water monitoring data Dow AgroSciences, LLC submitted a
< 30. available in areas of high use do not GC/MS method, Method GRM99.18, for
3. Short-term risk. For residential show any detections of 1,3- the determination of residues of 3-
bystander short-term inhalation risk dichloropropene and its degradates. chloroallyl alcohol and 3-chloroacrylic
resulting from exposure to a single Therefore, the Agency does not have a acid. The validated LOQ is 0.003 ppm
source, the lowest short-term MOE was concern for the aggregate cancer risk for each analytein grape. The method
60 based on the application rate in the from oral exposures to 1,3- was adequately validated using fortified
field volatility data and based on the dichloropropene and its metabolites. samplesof grape. Recoveries of cis-3-
maximum label rate. For residential Cancer risk was estimated using 1,3- chloroallyl alcohol ranged from 74% to
bystander short-term inhalation risk dichloropropene ambient air monitoring 90%, recoveries of trans-3-chloroallyl
resulting from exposure to ambient air data collected from over 20 sites over alcohol ranged from 82% to 95%,
sources, the lowest short-term MOE was multiple years to estimate exposure over recoveries of cis-chloroacrylic acid
1,700 based on California ambient air a lifetime. These sites were in areas of ranged from 93% to 98%, and
monitoring data. The MOEs do not high use and in urban environments. recoveries of trans-chloroacrylic acid
exceed the Agency’s level of concern of The cancer risk estimates for all but one ranged from 91% to 96% from samples
< 30. monitoring site, in a high use area, fortified at 0.003, 0.006, and 0.030 ppm.
4. Intermediate-term risk. Residential ranged from 2 X 10-6 to 9 X 10-8, which The fortification levels used in method
bystander intermediate-term inhalation are below the Agency’s level of concern. validation are adequate to bracket
exposure from a single source is The monitoring data for the one site expected residue levels. The Agency has
unlikely to occur and therefore, does not resulted in a risk estimate of 6 X 10-6, tentatively concluded that the
pose an inhalation risk. For residential which does exceed the Agency’s level of metabolite method is suitable for
bystander intermediate-term inhalation concern. However, risks calculated enforcement.
risk resulting from exposure to ambient using data from the same site in the Adequate enforcement methodology
air sources, the lowest intermediate- following year was almost two orders of (GC/MS) is available to enforcethe
term MOE was 70 based on California magnitude lower. Therefore, over a tolerance expression. The method may
ambient air monitoring data. The MOE lifetime of exposure, the risk estimates be requested from: Chief,Analytical
does not exceed the Agency’s level of would likely be below the level of Chemistry Branch, Environmental
concern of < 30. concern. It should be noted that in more Science Center, 701Mapes Rd., Ft.
5. Aggregate cancer risk for U.S. populated urban environments, air Meade, MD 20755–5350; telephone
population. The aggregated food and concentrations were below the number: (410) 305–2905; e-mail address:
water risk represent upper bound risks analytical limit of detection in 21 of 28
for a person living in agricultural areas sites/year combinations considered. In
where 1,3-dichloropropene is used B. International Residue Limits
the remaining seven site/year
extensively or where a person obtains There are no Canadian or Codex
combinations, values were measured
drinking water from an aquifer that led Maximum Residue limits for residues of
but did not result in cancer risks of
directly from an area where 1,3- 1,3-dichloropropene for any commodity.
concern. Therefore, the Agency does not
dichloropropene was used. The
have a concern for the cancer risk from C. Conditions
aggregate chronic dietary cancer risk
estimates for the general U.S. 6. Determination of safety. Based on 1. An independent laboratory
population resulting from exposure to validation of Method GRM 99.18
these risk assessments, EPA concludes
1,3-dichloropropene and metabolites in andmulti-residue method testing will be
that there is a reasonable certainty that
food and water (ground water sources) required as confirmatory data.
no harm will result to the general
is 7 X 10-7 and from exposure to 1,3- 2. In order to refine the exposure
population, or to infants and children
dichloropropene and metabolites in estimates from PRZM-EXAMS, the
from aggregate exposure to 1,3-
food and water (surface water sources) following data will be required: an
dichloropropene and metabolites
is 4 X 10-5. aerobic soil metabolism study on
Although risk for drinking water from residues.
additional soils (parent and
surface water sources for 1,3- IV. Other Considerations metabolites); an aerobic aquatic
dichloropropene exceeds the Agency’s metabolism study (parent and
level of concern (risk estimates A. Analytical Enforcement Methodology
metabolites); an aqueous photolysis
generally in the range of 1 in 1 million, Dow AgroSciences, LLC submitted a study (indirect and parent); a soil
interpreted as > 1 to 3 X 10-6); it should gas chromatography/massspectroscopy photolysis study (parent); and a
be noted that concentrations of 1,3- (GC/MS) method, Method GRM photolysis/oxidation in air study
dichloropropene in tap water from 99.09.R1, for thedetermination of (parent).
ground water wells were approximately residues of cis- and trans-1,3-
100 times lower than those found in the dichloropropene. The method was V. Conclusion
field ground water study and several adequately validated using fortified Therefore, the tolerance is established
orders of magnitude lower than samples of grape. Recoveries of cis-1,3- for combined residues of cis- and trans-
modeled estimates of 1,3- dichloropropene ranged from 70% to 1,3-dichloropropene, cis- and trans-3-
dichloropropene in groundwater. 114% and recoveries of trans-1,3- chloroacrylic acid, and cis- and trans-3-
Therefore, it is highly likely that actual dichloropropene ranged from 77% to chloroallyl alcohol, in or on grape at
drinking water concentrations of 1,3- 113% from samples fortified at 0.003, 0.018 ppm.
dichloropropene from surface water 0.010, 0.050, and 0.50 ppm. The
sources would also be much lower. 1,3- fortification levels used in method VI. Statutory and Executive Order
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Dichloropropene and its metabolites are validation are adequate to bracket

highly volatile compounds, and the expected residue levels. Adequate This final rule establishes a tolerance
models used to generate surface water independent laboratory validation (ILV) under section 408(d) of FFDCA in
and ground water estimates are not datawere submitted for Method GRM response to a petition submitted to the
designed for volatile chemicals. The 99.09.R1 using samples of grape. Agency. The Office of Management and

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8218 Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations

Budget (OMB) has exempted these types Transfer and Advancement Act of 1995 LEGAL SERVICES CORPORATION
of actions from review under Executive (NTTAA), Public Law 104–113, section
Order 12866, entitled Regulatory 12(d) (15 U.S.C. 272 note). 45 CFR Part 1611
Planning and Review (58 FR 51735,
VII. Congressional Review Act Income Level for Individuals Eligible
October 4, 1993). Because this rule has
been exempted from review under The Congressional Review Act, 5 for Assistance
Executive Order 12866, this rule is not U.S.C. 801 et seq., generally provides AGENCY: Legal Services Corporation.
subject to Executive Order 13211, that before a rule may take effect, the ACTION: Final rule—correction.
Actions Concerning Regulations That agency promulgating the rule must
Significantly Affect Energy Supply, submit a rule report to each House of SUMMARY: The Legal Services
Distribution, or Use (66 FR 28355, May the Congress and to the Comptroller Corporation (‘‘Corporation’’) is required
22, 2001) or Executive Order 13045, General of the United States. EPA will by law to establish maximum income
entitled Protection of Children from submit a report containing this rule and levels for individuals eligible for legal
Environmental Health Risks and Safety other required information to the U.S. assistance. On January 30, 2008 the
Risks (62 FR 19885, April 23, 1997). Senate, the U.S. House of Corporation issued a document
This final rule does not contain any Representatives, and the Comptroller updating the specified income levels to
information collections subject to OMB General of the United States prior to reflect the annual amendments to the
approval under the Paperwork publication of this final rule in the Federal Poverty Guidelines as issued by
Reduction Act (PRA), 44 U.S.C. 3501 et Federal Register. This final rule is not the Department of Health and Human
seq., nor does it require any special a ‘‘major rule’’ as defined by 5 U.S.C. Services. This notice corrects a typo
considerations under Executive Order 804(2). appearing in the supplementary
12898, entitled Federal Actions to information, but does not affect the
Address Environmental Justice in List of Subjects in 40 CFR Part 180
income levels set forth in the charts.
Minority Populations and Low-Income Environmental protection, Specifically, in the sentence in the last
Populations (59 FR 7629, February 16, Administrative practice and procedure, paragraph of the SUPPLEMENTARY
1994). Agricultural commodities, Pesticides INFORMATION, 73 FR 5458, Jan. 30, 2008,
Since tolerances and exemptions that and pests, Reporting and recordkeeping beginning ‘‘These charts are for
are established on the basis of a petition requirements. references purposes * * *,’’ the first
under section 408(d) of FFDCA, such as percentage referred to should be
the tolerance in this final rule, do not Dated: February 1, 2008. ‘‘125%’’ instead of ‘‘200%.’’
require the issuance of a proposed rule, Lois Rossi, DATES: Effective Date: This rule is
the requirements of the Regulatory Director, Registration Division, Office of effective as of January 30, 2008.
Flexibility Act (RFA) (5 U.S.C. 601 et Pesticide Programs.
This final rule directly regulates ■Therefore, 40 CFR chapter I is Mattie Cohan, Senior Assistant General
growers, food processors, food handlers, amended as follows: Counsel, Legal Services Corporation,
and food retailers, not States or tribes, 3333 K St., NW., Washington, DC 20007;
PART 180—[AMENDED] (202) 295–1624;
nor does this action alter the
relationships or distribution of power SUPPLEMENTARY INFORMATION: Section
■ 1. The authority citation for part 180
and responsibilities established by continues to read as follows: 1007(a)(2) of the Legal Services
Congress in the preemption provisions Corporation Act (‘‘Act’’), 42 U.S.C.
Authority: 21 U.S.C. 321(q), 346a and 371. 2996f(a)(2), requires the Corporation to
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this establish maximum income levels for
action will not have a substantial direct ■ 2. Section 180.636 is added to subpart individuals eligible for legal assistance,
effect on States or tribal governments, C to read as follows: and the Act provides that other
on the relationship between the national § 180.636 1,3-dichloropropene; tolerances
specified factors shall be taken into
government and the States or tribal for residues. account along with income.
governments, or on the distribution of Section 1611.3(c) of the Corporation’s
power and responsibilities among the (a) General. Tolerances are regulations establishes a maximum
various levels of government or between established for the combined residues of income level equivalent to one hundred
the Federal Government and Indian the fungicide cis- and trans-1,3- and twenty-five percent (125%) of the
tribes. Thus, the Agency has determined dichloropropene and its metabolites cis- Federal Poverty Guidelines. Since 1982,
that Executive Order 13132, entitled and trans-3-chloroacrylic acid, and cis- the Department of Health and Human
Federalism (64 FR 43255, August 10, and trans-3-chloroallyl alcohol in or on Services has been responsible for
1999) and Executive Order 13175, the following commodities. updating and issuing the Federal
entitled Consultation and Coordination Poverty Guidelines. The revised figures
Parts per
with Indian Tribal Governments (65 FR Commodity million for 2008 are equivalent to 125% of the
67249, November 6, 2000) do not apply current Federal Poverty Guidelines as
to this rule. In addition, This rule does Grape ........................................ 0.018 published on January 23, 2008 (73 FR
not impose any enforceable duty or 3971).
contain any unfunded mandate as (b) Section 18 emergency exemptions. LSC published the charts listing
described under Title II of the Unfunded [Reserved] income levels that are 200% of the
Mandates Reform Act of 1995 (UMRA) (c) Tolerances with regional Federal Poverty Guidelines at 73 FR
(Public Law 104–4). registrations. [Reserved] 5458, Jan. 30, 2008. These charts are for
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This action does not involve any reference purposes only as an aid to
(d) Indirect or inadvertent residues.
technical standards that would require grant recipients in assessing the
Agency consideration of voluntary financial eligibility of an applicant
consensus standards pursuant to section [FR Doc. E8–2480 Filed 2–12–08; 8:45 am] whose income is greater than 125% of
12(d) of the National Technology BILLING CODE 6560–50–S the applicable Federal Poverty

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