FR Doc E7-17010

[Federal Register: August 29, 2007 (Volume 72, Number 167)]
[Rules and Regulations]
[Page 49646-49651]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au07-2]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0157; FRL-8143-9]

Propylene Oxide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
propylene oxide and for the reaction product, propylene chlorohydrin,
in or on fig; grape, raisin; and plum, prune, dried, when used as a
post-harvest fumigant. This rule additionally removes all directions
for use currently listed in 40 CFR 180.491. Aberco, Incorporated
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective August 29, 2007. Objections and
requests for hearings must be received on or before October 29, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0157. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site 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 http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The 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: Tony Kish, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9443; e-mail address: kish.tony@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

[[Page 49647]]

certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of the FFDCA, 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-2005-0157 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 October 29, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2005-0157, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

In the Federal Register of June 27, 2007 (72 FR 35242) (FRL-8133-
4), 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
5F6904) by Aberco, Incorporated, 9430 Lanham-Severn Road, Seabrook, MD
20706. The petition requested that 40 CFR 180.491 be amended by
establishing a tolerance for residues of the post-harvest fumigant
propylene oxide, in or on fig; grape, raisin; and plum, prune, dried at
3.0; 1.0; and 2.0; respectively parts per million (ppm); and that the
directions for use currently listed in 40 CFR 180.491 under paragraphs
(a)(2) and (a)(4) be deleted. The petition also identified propylene
chlorohydrin as a metabolite and included an enforcement method for
determination of residues of propylene oxide, propylene chlorohydrin,
and propylene bromohydrin in nutmeats, cocoa, and dried spices. That
notice referenced a summary of the petition prepared by Aberco,
Incorporated, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in

response to the notice of filing.
The current propylene oxide tolerances include some specific
directions for use regarding fumigation frequency, duration and
temperature. These directions are currently on affected labels. Because
these directions are already on the label, they do not need to be
duplicated as part of the tolerance. Furthermore, the propylene oxide
Reregistration Eligibility Document (RED) of August 2006 found that
these directions should be modified on the label to exactly match the
conditions under which residue trials were conducted. Therefore, all
directions in 40 CFR 180.491, paragraphs (a)(2) and (a)(4) are no
longer needed and can be removed. Similarly, the use directions and
other information in paragraphs (a)(1), and (a)(5) can also be removed.
As noted in the petition and the RED, use of propylene oxide can result
in residues of propylene oxide as well as the reaction product
propylene chlorohydrin. Commodities that contain salts that are treated
with propylene oxide can react with chloride ion to form the propylene
chlorohydrin. Propylene oxide and propylene chlorohydrin are considered
separately as residues of concern for risk assessment and tolerance
assessment. Based on the differences in physical-chemical properties
and toxicological effects, propylene oxide and propylene chlorohydrin
were assessed separately, and, EPA is establishing separate tolerances
for these chemicals within different paragraphs of tolerance regulation
for propylene oxide.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to the FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 residues of propylene oxide in or on fig; grape, raisin; and plum,
prune, dried at 3.0; 1.0; and 2.0 ppm, respectively; and in addition,
for residues of the reaction product propylene chlorohydrin at 3.0;
4.0; and 2.0, ppm, respectively. EPA's assessment of exposures and
risks associated with establishing the tolerance follows.

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

[[Page 49648]]

subgroups of consumers, including infants and children. Specific
information on the studies received and the nature of the adverse
effects caused by propylene oxide and propylene chlorohydrin, 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 http://www.regulations.gov under the docket number for this

rule.

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 (UF) 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 uncertainty/safety factors. 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 uncertainty/safety factors 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: http://www.epa.gov/oppfead1/trac/science http://www.epa.gov/pesticides/.

ides/.

aggregate.pdf.
A summary of the toxicological endpoints for propylene oxide and
propylene chlorohydrin used for human risk assessment can be found at
http://www.regulations.gov in the risk assessment document ``Propylene Oxide-

Revised HED Risk Assessment for Reregistration Eligibility Decision
Document, July 31, 2006'' at Table 4.4.10 on page 49/95 in Docket ID
EPA-HQ-OPP-2005-0157. This identical table can also be found in the
Propylene oxide RED document at the following website address: http://www.epa.gov/oppsrrd1/REDs/propylene_oxide_red.pdf
.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propylene oxide and propylene chlorohydrin, EPA considered
exposure under the petitioned-for tolerances as well as all existing
propylene oxide tolerances in (40 CFR 180.491). EPA assessed dietary
exposures from propylene oxide and propylene chlorohydrin 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.
In estimating acute dietary exposure for propylene oxide and
propylene chlorohydrin, EPA used food consumption information from the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA relied upon
average field trial residue data and percent crop treated information
for all commodities covered by existing tolerances.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide (CSFII). As to residue levels in food, EPA relied
upon average field trial residue data for propylene oxide, tolerance
level residues for propylene chlorohydrin, and percent crop treated
information for all commodities covered by existing propylene oxide
tolerances.
iii. Cancer. The cancer assessment for propylene oxide incorporated
new residue and percent crop treated data for nutmeats and omitted guar
(edible gums) as a fumigated commodity. No cancer exposure assessment
is needed for propylene chlorohydrin because the cancer data which were
negative for both rats and mice, showed no cancer risk to humans.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the 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 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 section 408(f)(1) of
FFDCA. Data will be required to be submitted no later than 5 years from
the date of issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
a. The data used are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide residue;
b. The exposure estimate does not underestimate exposure for any
significant subpopulation group; and
c. Data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by section 408(b)(2)(F)
of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows:
The percent crop treated values used were as follows: Herbs,
spices, and bulb vegetables at 1%; tree nuts at 2%; cocoa bean at 1.3%;
and 100% for the new proposed uses -- fig grape; raisin; and plum,
prune, dried.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. The Agency is reasonably certain that the percentage of
the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no

[[Page 49649]]

regional population is exposed to residue levels higher than those
estimated by the Agency. Other than the data available through national
food consumption surveys, EPA does not have available information on
the regional consumption of food to which propylene oxide may be
applied in a particular area.
2. Dietary exposure from drinking water. For propylene oxide
fumigations, residues of propylene oxide and propylene chlorohydrin
from drinking water are expected to be negligible because
i. Fumigations are either in closed chambers with emission
reduction technology, or in temporary/intermittent outdoor field
locations (tents, tarps, rail cars, etc.) at a use rate 53 times lower
than that used in closed chambers, both of which result in minimal
emissions, and
ii. Due to atmospheric dilution and the physical-chemical
characteristics of propylene oxide, negligible residues are expected to
be able to enter soil and any nearby water. Therefore, water exposures
were not included in the risk assessment.
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).
Propylene oxide and propylene chlorohydrin are not registered for
use on any residential sites. However, exposure could occur to people
residing near fumigation facilities. Propylene oxide and propylene
chlorohydrin emissions monitoring data necessary to quantitatively
estimate exposures and risks from sterilization/fumigation facilities
are unavailable. Therefore, a qualitative assessment was conducted
comparing the risks associated with fugitive emissions from the use of
a similar chemical, ethylene oxide, in similar commercial fumigation
scenarios. With the use of required buffer zones at designated
distances to be added to labels, the assessment found that propylene
oxide and propylene chlorohydrin residential exposure risks are not
expected to be of concern.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to propylene oxide or
propylene chlorohydrin and any other substances and propylene oxide or
propylene chlorohydrin do not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that propylene oxide or
propylene chlorohydrin have 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 http://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 uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. For propylene oxide, there
is no quantitative susceptibility between the rat fetuses and the dams
from the rat developmental study. The study indicated a possible
qualitative susceptibility since the skeletal variations (increased
litter incidence for the accessory 7th cervical rib) were observed at
the same dose which produced maternal toxic effects (ie. decreased body
weight gain, food consumption and food efficiency). The effects in the
rat fetuses are being treated as only possible evidence of qualitative
sensitivity because it is questionable as to whether an accessory 7th
cervical rib, which is a developmental variation, is properly
characterized as a more severe effect than decreased body weight gain.
Although further analysis, including consideration of historical
control information on this effect, might resolve this question, in the
absence of this analysis, EPA is taking the conservative position that
this particular skeletal variation is possible evidence of qualitative
sensitivity.
Susceptibility in rabbits could not be adequately ascertained due
to the absence of an acceptable rabbit developmental study. In the 2-
generation reproduction study, there is no evidence for quantitative or
qualitative susceptibility in pups exposed to propylene oxide since no
offspring effects were seen at doses which produced significant
systemic toxicity in parents. The degree of concern for the possible
qualitative susceptibility effects seen after in utero exposures in
rats was low because the effects (ie. increased incidence of the 7th
cervical rib) are:
i. Skeletal variations and not malformations,
ii. Were seen in the presence of maternal toxicity,
iii. A clear NOAEL was identified, and
iv. This endpoint is used for assessing potential acute dietary
risk to the population of concern (Females 13-49). For propylene
chlorohydrin, in the reproduction study, quantitative susceptibility
effects were evident because decreased pup weights were observed at a
dose which had no systemic toxicity in the dams. However, the degree of
concern is low for the quantitative susceptibility seen in the
reproduction study because a clear NOAEL was identified, and that dose
and the endpoint of this study is used for assessing chronic dietary
risk in conjunction with the retaining of a 10X database uncertainty
factor.
3. Conclusion. For both propylene oxide and propylene chlorohydrin,
EPA has determined it is necessary to retain the additional 10X safety
factor for the protection of infants and children due to the absence of
a propylene oxide developmental toxicity study in rabbits, and a
chronic study in non-rodents by the oral route; and for propylene
chlorohydrin, due to the absence of a developmental toxicity study in
rats and rabbits, a chronic toxicity study in nonrodents, and a chronic
carcinogenicity study in rats and mice (because the doses used in the
existing studies found in the literature are inadequate). Because no
acute endpoint has been identified for propylene chlorohydrin, EPA has
applied the additional 10X safety factor to the chronic endpoint in
assessing acute risk for propylene chlorohydrin. This is a very
conservative approach to assessing

[[Page 49650]]

acute risk because repeated exposure to a pesticide would typically
result in lower NOAELs than an acute exposure. For propylene oxide,
there is no evidence for quantitative or qualitative susceptibility in
pups exposed to the chemical. For propylene chlorohydrin, the degree of
concern is also low for the quantitative susceptibility seen in the
reproduction study since the dose and the endpoint of this study is
used for assessing chronic dietary risk in conjunction with the
retaining of the 10X database uncertainty factor. No additional FQPA
factor above 10X is required for either propylene oxide or propylene
chlorohydrin. Propylene oxide is missing an adequate rabbit
developmental study and a chronic study in a non-rodent species, but an
existing developmental study in rabbits indicates effects occur at high
doses and a chronic study in rodents is available, therefore a factor
of 10X is sufficient. For propylene chlorohydrin, although there are
data gaps, there are acceptable longer term studies including chronic
studies in rats and mice and a reproduction study in rats. Given these
chronic data, an additional safety factor of 10X should be sufficient
for the protection of infants and children, as well as the general
population and other major identifiable subgroups, from chronic
exposure to propylene chlorohydrin. Further, use of the chronic
endpoint and the additional 10X safety factor to assess acute risk is
such a conservative approach to assessing acute risk that no further
safety factor for this risk assessment. Other relevant factors here are
that:
i. There is no indication that propylene oxide or propylene
chlorohydrin are neurotoxic chemicals and there is no need for
developmental neurotoxicity studies or additional uncertainty factors
to account for neurotoxicity; and
ii. The exposure databases is unlikely to underestimate exposure
because it is based on reliable data on anticipated residues and
percent crop treated information.

E. Aggregate Risks and Determination of Safety

Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. 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 MOE called for by the product of
all applicable uncertainty/safety factors is not exceeded. As discussed
prior, because propylene oxide and propylene chlorohydrin residues
which could enter water are expected to be negligible, water exposures
were not included in the aggregate risk assessments.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from only food to
propylene oxide will occupy 7% of the aPAD for the population group
(females 13-49 years old) receiving the greatest exposure. Because no
acute endpoint has been identified for propylene chlorohydrin, EPA has
assessed acute risk for propylene chlorohydrin using the cPAD for
propylene chlorohydrin. Using the exposure assumptions discussed in
this unit for acute exposure, the acute dietary exposure from only food
to propylene chlorohydrin will occupy 90% of the cPAD for the
population group receiving the greatest exposure (infants less than one
year old).
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to propylene
oxide from only food will utilize 14% of the cPAD for the population
group (children 3-5 years). Using the exposure assumptions described in
this unit for chronic exposure, EPA has concluded that exposure to
propylene chlorohydrin from only food will utilize 29% of the cPAD for
the population group (children 1-2 years). There are no residential
uses for propylene oxide or propylene chlorohydrin, but residential
bystanders may be exposed to air emissions from fumigation facilities
or structures. However, dietary and bystander exposure for either
propylene oxide or propylene chlorohydrin cannot be combined for this
assessment because the endpoints selected for these exposures are not
based on a common effect. Therefore, risk from dietary and inhalation
routes were not aggregated.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Though residential exposure could occur with the use of propylene
oxide, the potential short-term exposures to propylene oxide and
propylene chlorohydrin were not aggregated with chronic dietary food
and water exposures for the same because the toxic effects are
different.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Though residential exposure could occur with the use of propylene
oxide, the potential intermediate-term exposures propylene oxide and
propylene chlorohydrin were not aggregated with chronic dietary food
and water exposures for the same because the toxic effects are
different.
5. Aggregate cancer risk for U.S. population. The cancer dietary
risk estimates for propylene oxide are below EPA's level of concern;
the cancer dietary excess lifetime risk estimate for the U.S. general
population is 4x10^-7. EPA considers risks in the range of 1
x 10^-6 (such as the cancer risk for propylene oxide) to be
negligible and thus pose a reasonable certainty of no harm. There is no
cancer risk for propylene chlorohydrin as evidenced by the cancer data
which were negative for both rats and mice.
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 propylene oxide and propylene chlorohydrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology is available to enforce the
tolerance expression. An acceptable method was submitted (ABC.METHOD
46306-PPO/Hydrins Rev 1.0; MRID 45301902) which is able to quantify
propylene oxide and propylene chlorohydrin residues in various
commodities using headspace gas chromatography with flame ionization
detection. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

B. International Residue Limits

There are no Codex Maximum Residue Levels (MRLs) for residues of
propylene oxide and propylene chlorohydrin in any commodity. No
Canadian or Mexican MRLs have been established.

V. Conclusion

Therefore, tolerances are established for residues of propylene
oxide when used as a post harvest fumigant, in or on fig; grape,
raisin; and plum, prune, dried, at 3.0; 1.0; and 2.0; respectively

[[Page 49651]]

ppm, and separate tolerances are established for the reaction product,
propylene chlorohydrin, in or on fig; grape, raisin; and plum, prune,
dried, at 3.0, 4.0, and 2.0 ppm, respectively. The use directions
currently listed in 40 CFR 180.491 paragraphs (a)(1), (a)(2), (a)(4)
and (a)(5) are also being removed.

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 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: August 17, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.491 is amended by revising paragraph (a) to read as
follows:

Sec. 180.491 Propylene oxide; tolerances for residues.

(a) General. (1) Tolerances are established for residues of
propylene oxide when used as a postharvest fumigant in or on the
following food commodities:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cocoa bean, bean........................................... 300
Fig........................................................ 3.0
Grape, raisin.............................................. 1.0
Gum, edible................................................ 300
Nutmeat, processed, except peanuts......................... 300
Plum, prune, dried......................................... 2.0
Spices, processed.......................................... 300
------------------------------------------------------------------------

(2) Tolerances are established for the reaction product, propylene
chlorohydrin, from use of propylene oxide as a postharverst fumigant,
in or on the following food commodities:

* * * * *

[FR Doc. E7-17010 Filed 8-28-07; 8:45 am]

BILLING CODE 6560-50-S