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Sulfuryl Fluoride - Proposed Pesticide Temporary Tolerances 8/01

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301166; FRL-6799-6]
RIN 2070-AC18
Sulfuryl Fluoride; Proposed Pesticide Temporary Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish temporary tolerances for
sulfuryl fluoride and inorganic fluoride residues resulting from
application of sulfuryl fluoride in or on walnuts and raisins under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. This fumigant is being proposed as a methyl
bromide alternative in the post-harvest fumigation of stored walnuts
and raisins. These temporary tolerances would support a proposed 3-year
experimental use permit (EUP) effective between September 24, 2001 and
September 24, 2004, conducted by Dow AgroSciences entirely in the state
of California. The temporary tolerances will expire April 1, 2006. This
will allow approximately 18 months after the end of the EUP, for all
the treated commodities to clear commerce.

DATES: Comments, identified by docket control number OPP-301166 must be
received on or before October 5, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify docket control
number OPP-301166 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis McNeilly, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460;
telephone number: (703) 308-6742; e-mail address:
mcneilly.dennis@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules," and then look up the
entry for this document under the "Federal Register--Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301166. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-301166 in the subject line on
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described in this unit. Do not submit any information electronically
that you consider to be CBI. Electronic comments must be submitted as
an ASCII file avoiding use of special characters and any form of
encryption. Comments and data will also be accepted on standard disks
in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic
form must be identified by docket control number OPP-301166. Electronic
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or
collection activity.
    7. Make sure to submit your comments by the deadline in this
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket

control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. Background and Statutory Findings

    In the Federal Register of June 15, 2001 (66 FR 32618) (FRL-6788-
2), EPA issued a notice under section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a announcing the filing of an
Experimental Use Permit (EUP) and associated request for temporary
tolerances by Dow AgroSciences LLC. Dow AgroSciences requested
temporary tolerances for sulfuryl fluoride residue of the insecticide
sulfuryl fluoride, in or on walnuts and raisins at 2.0 and 0.004 part
per million (ppm), respectively. The June 15, 2001 Notice inadvertently
omitted reference to the requested 2.0 ppm tolerance for walnuts. In
addition, the company has since submitted a revised limit of
quantitation (LOQ) for sulfuryl fluoride in raisins of 0.004 ppm
instead of 0.003 ppm. Dow AgroSciences also requested a temporary
tolerance for fluoride residue of the insecticide sulfuryl fluoride, in
or on walnuts at 12.0 part per million (ppm) and an exemption from the
requirement of a tolerance for fluoride residues in or on raisins
resulting from treatment with the insecticide sulfuryl fluoride under
the USEPA's Threshold of Regulation Policy - Deciding Whether a
Pesticide with a Food Use Pattern Needs a Tolerance. EPA is issuing
this action as a proposal (rather than a final rule) because after
review of the initial petitions and Notice of Filing the Agency has
determined that:
    1. The original Notice of Filing did not include the 2.0 ppm
tolerance for sulfuryl fluoride residues in or on walnuts. In addition,
the company has revised the limit of quantitation of fluoride residues
in or on raisins from 0.003 ppm to 0.004 ppm.
    2. The Agency wanted to publish its planned approach for regulating
fluoride residues in or on raisins. This approach differs from that
proposed by Dow AgroSciences. Although Dow AgroSciences has submitted
data indicating that post-harvest use of sulfuryl fluoride is not
expected to result in finite residues of either sulfuryl fluoride or
fluoride in or on raisins, that data is limited and may not accurately
reflect residues that may occur in actual use. EPA also notes that the
existing 7.0 ppm tolerance in 40 CFR 180.145 established to regulate
fluoride residues in or on grapes from use of cryolite might be
affected by fluoride residues in or on raisins from sulfuryl fluoride
use. The enforcement analytical methods for both cryolite and sulfuryl
fluoride measure fluoride anion and cannot distinguish fluoride
resulting from cryolite application to grapes, sulfuryl fluoride
application to raisins, or even fluoride which may be a natural
constituent of grapes. Because this existing tolerance is expressed in
Sec. 180.145 as parts per million of cryolite, the Agency will add a
new paragraph (a)(3) to 40 CFR 180.145 expressing the temporary
tolerances for raisins and walnuts as parts per million fluoride, in
order to reduce the potential for confusion. The tolerance expression
will clarify that the tolerance for fluoride residues in or on raisins
covers residues from application of both cryolite to grapes, expected
to be the major source of fluoride residue, and residues of fluoride
from post-harvest treatment with sulfuryl fluoride. The fluoride
tolerance for raisins must also account for naturally occurring levels
of fluoride in raisins. Residues of fluoride from use of sulfuryl
fluoride on raisins are expected to be at most trace levels with most
raisins having non-detectable (1.1 ppm) residue levels.
    3. Sulfuryl fluoride is a fumigant that is being proposed as a
methyl bromide alternative for the post-harvest control of pests in
stored walnuts and raisins. In the future, it is likely that other
commodities may be proposed for post-harvest, stored commodity
fumigation using this fumigant.
    Section 408(r) of the FFDCA authorizes EPA to establish a temporary
tolerance or exemption for pesticide chemical residues resulting from
use of a pesticide pursuant to a FIFRA section 5 experimental use
permit (EUP). 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) 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) 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...."
Additionally, section 408(b)(2)(D) requires that 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."
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section
408(b)(2), for tolerances for residues of sulfuryl fluoride on walnuts
and raisins at 2.0 and 0.004 ppm, respectively. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure, consistent with section 408(b)(2), for temporary tolerances
for inorganic fluoride residues of sulfuryl fluoride on walnuts and
raisins at 12.0 and 30.0 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 subgroups of consumers, including infants and
children. The nature of the toxic effects caused by sulfuryl fluoride
and fluoride are discussed in the following discussion.
    Acute, subchronic, chronic, and other toxicity. Technical grade
sulfuryl fluoride (Profume Gas Fumigant, 99.8% active
ingredient) is marketed as a liquified gas in pressurized steel
cylinders. The acute oral LD50 of sulfuryl fluoride has been
estimated to be approximately 100 (milligrams/kilogram (mg/kg) in rats
(Toxicity Category II). The acute inhalation LC50 in mice (4
hour exposure) is 660 ppm (2.56 milligram/liter (mg/L) in males and 642
ppm (2.49 mg/L) in females. The acute inhalation LC50 in
rats (1 hour exposure) is 17.5 mg/L. Based on the use pattern for
sulfuryl fluoride and several reported incidences of human poisonings
in the Sulfuryl Fluoride Reregistration Eligibility Decision (RED)
(September, 1993) and elsewhere in the general toxicologic literature,
the Agency has classified sulfuryl fluoride as Toxicity Category I for
acute inhalation toxicity. The acute dermal toxicity study (assumed Toxicity Category of IV), the primary skin
irritation study (assumed Toxicity Category of IV), the primary eye
irritation study (assumed Toxicity Category of I), and the dermal
sensitization study (assumed to be a non-sensitizer) have been waived.
These studies were waived because they would not change the overall
signal word from DANGER, and/or alter personal protective equipment
requirements. In addition, the insecticide is a volatile gas. In a non-
guideline study in which rats were dermally exposed (with no inhalation
exposure) to vapors of sulfuryl fluoride gas at an exposure
concentration of 9,599 ppm for 4 hours, no treatment-related adverse
effects were observed.
    In 2-week inhalation studies in rats, dogs and rabbits, different
target organs were affected. In rats, the primary target organ was the
kidneys, in which severe histopathological lesions were observed. These
lesions included papillary necrosis, hyperplasia of the epithelial
cells of the papillae, and degeneration/regeneration of collecting
tubules and proximal tubules. In dogs, the primary target organ was the
upper respiratory tract, in which minimal inflammation was observed.
Intermittant tremors and tetany were also noted in dogs. In rabbits,
the primary target organ was the brain, in which malacia (necrosis) and
vacuolation were observed in the cerebrum. Inflammation of the upper
respiratory tract was also noted in rabbits.
    In subchronic (90-day) inhalation studies in rats, dogs, rabbits
and mice, the brain was the major target organ. Malacia and/or
vacuolation were observed in the white matter of the brain in all four
species. The portions of the brain most often affected were the
caudate-putamen nucleus in the basal ganglia, the white fiber tracts in
the internal and external capsules, and the globus pallidus of the
cerebrum. In dogs and rabbits, clinical signs of neurotoxicity
(including tremors, tetany, incoordination, convulsions and/or hind
limb paralysis) were also observed. Inflammation of the nasal passages
and histiocytosis of the lungs were observed in rats and rabbits; but
not in dogs, in which species inflammation of the upper respiratory
tract was more prominent in the 2-week study. In rats, kidney damage
was also observed. In mice, follicular cell hypertrophy was noted in
the thyroid gland. Decreased body weights and body weight gains were
also observed in rats, dogs and mice.
    In chronic (1-2 year) inhalation studies in rats, dogs and mice,
target organs were the same as in the 90-day studies. In rats, severe
kidney damage caused renal failure and mortalities in many animals.
Additional gross and histopathological lesions in numerous organs and
tissues were considered to be secondary to the primary effect on the
kidneys. Other treatment-related effects in rats included effects in
the brain (vacuolation of the cerebrum and thalamus/hypothalamus) and
respiratory tract (reactive hyperplasia and inflammation of the
respiratory epithelium of the nasal turbinates, lung congestion,
aggregates of alveolar macrophages). In dogs and mice, increased
mortalities, malacia and/or vacuolation in the white matter in the
brain, histopathology in the lungs, and follicular cell hypertrophy in
the thyroid gland were observed. Decreased body weights and body weight
gains were also noted in all three species. No evidence of
carcinogenicity was observed in either the combined chronic toxicity/
carcinogenicity study in rats or in the 18-month carcinogenicity study
in mice.
    In many subchronic and chronic inhalation studies in rats, dogs,
and rabbits, dental fluorosis was the most sensitive toxic effect
observed in the study. In two 90-day studies in rats and rabbits, in
which serum fluoride levels were determined, an increased serum level
of fluoride anions was observed at even lower dose levels. The
increased serum fluoride levels were due to the conversion of sulfuryl
fluoride to fluoride anions in the body.
    In specially designed acute and subchronic inhalation neurotoxicity
studies in rats, several electrophysiological parameters (EEGs) were
recorded in addition to observations for clinical signs of
neurotoxicity, functional observational battery (FOB) and motor
activity testing, and/or neurohistopathologic examination. Following
two exposures on consecutive days for 6 hours/day at 300 ppm of
sulfuryl fluoride (354 mg/kg/day), no treatment-related neurotoxic
effects were noted. In a 90-day study, changes in some EEG patterns
were observed at 100 ppm (80 mg/kg/day) and in several additional
patterns at 300 ppm (240 mg/kg/day). Vacuolation of the white matter in
the cerebrum was also observed at 300 ppm in this study. In a specially
designed 1-year chronic inhalation neurotoxicity study in rats, no
treatment-related neurotoxic effects were observed at 80 ppm (56 mg/kg/
day). EEGs were not recorded in this study.
    In a developmental toxicity inhalation study in rats, no
developmental toxicity was observed in the pups. Although no maternal
toxicity was observed in this study at the highest dose tested (225
ppm), significant maternal toxicity (decreased body weight, body weight
gain and food consumption; increased water consumption and kidney
weights; and gross pathological changes in the kidneys and liver) was
observed in a previously conducted range-finding study at a slightly
higher dose level (300 ppm). In a developmental toxicity inhalation
study in rabbits, decreased fetal body weights were observed in the
pups. At the same dose level, decreased body weight and body weight
gain were observed in the dams. In a 2-generation reproduction
inhalation study in rats, vacuolation of the white matter in the brain,
pathology in the lungs (pale, gray foci; increased alveolar
macrophages) and decreased body weights were observed in the parental
animals. Decreased pup body weights in the F1 and
F2 generations were observed in the offspring. No effects on
reproductive parameters were noted in this study. No quantitative or
qualitative evidence of increased susceptibility of fetuses or pups was
observed in the developmental toxicity or reproduction studies on
sulfuryl fluoride.
    A battery of mutagenicity studies was negative for genotoxic
potential. The studies included an Ames assay in Salmonella
typhimurium, an unscheduled DNA synthesis assay in primary rat
hepatocytes, and a micronucleus assay in mouse bone marrow cells.
    Sulfuryl fluoride is classified as a "not likely" human
carcinogen according to the EPA Draft Guidelines for Carcinogen Risk
Assessment (July, 1999)
    Poisonings and fatalities have been reported in humans following
inhalation exposure to sulfuryl fluoride. The severity of these effects
has depended on the concentration of sulfuryl fluoride and the duration
of exposure. Short-term inhalation exposure to high concentrations has
caused respiratory irritation, pulmonary edema, nausea, abdominal pain,
central nervous system depression, and numbness in the extremities. In
addition, there have been two reports of deaths of persons entering
houses treated with sulfuryl fluoride. One person entered the house
illegally and was found dead the next morning. A second person died of
cardiac arrest after sleeping in the house overnight following
fumigation. A plasma fluoride level of 0.5 mg/L (10 times normal) was
found in this person following exposure. Prolonged chronic inhalation
exposure to concentrations of sulfuryl fluoride gas significantly above
the TLV of 5 ppm have caused fluorosis in humans because sulfuryl fluoride is
converted to fluoride anion in the body. Fluorosis is characterized by
binding of fluoride anion to teeth (causing mottling of the teeth) and
to bone.

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences. There
are no additional uncertainty factors (other than the 3X FQPA Safety
Factor) used in this assessment, except a 3X factor used in long-term
occupational inhalation exposure/risk assessment. A 3X factor is used
there, rather than a 1X factor, because the toxicological end-point is
based on a 90-day inhalation study rather than a chronic study.
    For dietary risk assessment (other than cancer) the Agency
calculates an acute or chronic reference dose (acute RfD or chronic
RfD) where the RfD is equal to the NOAEL divided by the appropriate UF
(RfD = NOAEL/UF). Where an additional safety factor is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such an additional factor. The acute or
chronic Population Adjusted Dose (aPAD or cPAD) is a modification of
the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) EPA determines
a LOC. For example, when 100 is the appropriate UF (10X to account for
interspecies differences and 10X for intraspecies differences) the LOC
is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of
exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
    A summary of the toxicological endpoints for sulfuryl fluoride used
for human risk assessment is shown in the following Table 1:

  Table 1.--Summary of Toxicological Doses and Endpoints for sulfuryl fluoride for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
         Exposure Scenario\1\              Dose (mg/kg/day) Endpoint                  Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General Population      None UF = N/A FQPA       No toxicological         None
 including Infants and Children)        Factor = N/A endpoint attributable
                                                                 to a single exposure
                                                                 was identified in the
available toxicology
studies on sulfuryl
                                                                 fluoride.
                                                                Acute RfD = Not
                                                                 Required
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (General Population    NOAEL = 8.5; UF = 300; Vacuolation of white     90-Day inhalation-
 including Infants and Children)        FQPA Factor = 3 matter in the brain of   rabbits
                                                                 females.
Chronic RfD = 0.028 mg/
                                                                 kg/day
Chronic Population-
Adjusted Dose (cPAD) =
0.0093 mg/kg/day
----------------------------------------------------------------------------------------------------------------
Oral, Incidental (All Durations)       None; UF = N/A; FQPA     Due to sulfuryl          None
                                        Factor = N/A fluoride being a gas
                                                                 and its use pattern,
                                                                 no significant
incidental oral
                                                                 exposure is
                                                                 anticipated.
----------------------------------------------------------------------------------------------------------------
Dermal (All Durations)                 None; UF = N/A; FQPA     Due to sulfuryl          None
                                        Factor = N/A fluoride being a gas
                                                                 and its use pattern,
                                                                 no significant dermal
                                                                 exposure is
                                                                 anticipated.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (Occupational)   NOAEL = 30; MOE = 100; Malacia (necrosis) and   2-Week inhalation-
                                        FQPA Factor = N/A vacuolation in the       rabbits
cerebrum, inflammation
                                                                 of nasal tissues and
                                                                 trachea.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (Residential)    NOAEL = 30; MOE = 300; Malacia (necrosis) and   2- Week inhalation-
                                        FQPA Factor = 3 vacuolation in the       rabbits
cerebrum, inflammation
                                                                 of nasal tissues and
                                                                 trachea.
----------------------------------------------------------------------------------------------------------------
Inhalation Intermediate-Term           NOAEL = 8.5; MOE = 100; Vacuolation of white     90-Day inhalation-
 (Occupational)                         FQPA Factor = N/A matter in the brain of   rabbits
                                                                 females.
----------------------------------------------------------------------------------------------------------------
Inhalation Intermediate-Term           NOAEL = 8.5; MOE = 300; Vacuolation of white     90-Day inhalation-
 (Residential)                          FQPA Factor = 3 matter in the brain of   rabbits
                                                                 females.
----------------------------------------------------------------------------------------------------------------
Inhalation Long-Term (Occupational)    NOAEL = 8.5; MOE =300; Vacuolation of white     90-Day inhalation-
                                        FQPA Factor = N/A matter in the brain of   rabbits
                                                                 females.
----------------------------------------------------------------------------------------------------------------

Carcinogenicity Chronic Exposure       Classified as a "not Negative for             Chronic toxicity/
                                        likely" human carcinogenicity in       carcinogenicity, rats
                                        carcinogen carcinogenicity          and Carcinogenicity,
studies in rats and      mice
                                                                 mice
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.
\1\ The only significant route of exposure for inorganic fluoride is dietary exposure, which includes residues
  in drinking water. This risk assessment uses the maximum concentration limit goal (MCLG) of 4.0 ppm for
  fluoride as the basis for a maximum allowable exposure to inorganic fluoride (see the Cryolite Reregistration
  Eligibility Decision, 8/96, EPA- 738-R-96-016). Using the Agency default values of body weight (70 kg) and
  water consumption (2 liters/day), the MCLG converts to an exposure limit of 0.114 mg/kg/day. This exposure is
  used as the cPAD for inorganic fluoride in this risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have
ever been established in the United States for sulfuryl fluoride. This
is the first food use for sulfuryl fluoride in the U.S. tolerances have
been established for the insecticide cryolite (40 CFR 180.145) for
residues of fluoride, in or on a variety of raw agricultural
commodities. Cryolite degrades after application, with the metabolite
of toxicological concern being fluoride. Section 180.145 already
contains a tolerance for fluoride resulting from the use of cryolite in
or on grapes, measured as fluoride but expressed as 7 ppm cryolite
equivalents. Section 180.145 does not set a specific tolerance for
raisins, the 7.0 ppm tolerance for the raw agricultural commodity
grapes would apply to residues in the processed commodity raisins. See
40 CFR 180.1(f). A tolerance for fluoride (55 ppm expressed as
Cryolite) residue in or on raisins was proposed but has not been
finalized. See 62 FR 42546 (Aug 7, 1997). There is also uncertainty
concerning the extent of naturally occurring levels of fluoride in
raisins; and, a major purpose of this experimental use permit is to
generate comprehensive residue data collected from different storage
facilities. It is for these reasons that the Agency proposes setting a
30 ppm tolerance for fluoride (55 ppm cryolite divided by 1.84
conversion factor) that would adequately address residues from cryolite
application to grapes, sulfuryl fluoride application to raisins, and
naturally occurring background levels of fluoride in raisins. Risk
assessments were conducted by EPA to assess dietary exposures from
sulfuryl fluoride and the metabolite inorganic fluoride in food as
follows:
    i. Acute exposure. Acute dietary 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 one day
or single exposure. No toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies on sulfuryl
fluoride or inorganic fluoride (Cryolite RED) that would be applicable
for an acute dietary exposure.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992-nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. This survey indicates the following average daily
consumption for the total U.S. population for the commodities involved
in this EUP: 0.0000253 mg/kg/day for raisins and 0.0000040 mg/kg/day
for walnuts. To determine the estimated daily average consumption for a
"U.S. population" individual, simply multiple the daily average times
the body weight in kg.
    The existing tolerance for cryolite on grapes (40 CFR 180.145) is
in fact a tolerance for fluoride, because the approved analytical
method for enforcement tests only for fluoride, and not cryolite. There
is no analytical method for distinguishing between cryolite and
sulfuryl fluoride as the source of inorganic fluoride in or on grapes
or raisins, nor is there any toxicological reason to distinguish
between such residues.
    In order to assess compliance with the tolerances in 40 CFR
180.145, measured levels of fluoride in grapes are converted to
cryolite equivalents by multiplying the concentration (in parts per
million) of fluoride by a factor of 1.84 (molecular weight of cryolite
divided by molecular weight of fluoride, divided by the number of
fluoride atoms in cryolite; (210 amu)  (19 amu) x 6 = 1.84). A
tolerance for fluoride (55 ppm expressed as Cryolite) residue in or on
raisins was proposed but has not yet been finalized, see 62 FR 42546
(Aug 7, 1997). The Agency is proposing a 30 ppm tolerance for fluoride
(55 ppm cryolite divided by 1.84 conversion factor) that would
adequately address residues from cryolite use on grapes, sulfuryl
fluoride use on raisins, and background levels.
    In order to provide additional data concerning the residues of
fluoride in grapes treated with sulfuryl fluoride, the petitioner has
agreed to monitor fluoride levels in all batches of raisins fumigated
pursuant to the EUP and to provide the data to the Agency. The exposure
and risk estimates for Sulfuryl Fluoride and Fluoride Anion from the
fumigation of raisins and walnuts with Sulfuryl Fluoride are indicated
in the following Table 2:

  Table 2.--Exposure and Risk Estimates for Sulfuryl Fluoride and Fluoride Anion from the Fumigation of Raisins
                                       and Walnuts with Sulfuryl Fluoride
----------------------------------------------------------------------------------------------------------------
Sulfuryl Fluoride            Fluoride Anion
-----------------------------------------------------
                    Population Subgroup                         Risk, %     Exposure,   Exposure, mg/   Risk, %
cPAD\a\     mg/kg/day      kg/day       MCLG\b\
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.000008         <1        0.000808         <1
----------------------------------------------------------------------------------------------------------------

[[Page 46421]]

All Infants (<1 Year) 0.000000         <1        0.000065         <1
----------------------------------------------------------------------------------------------------------------
Children (1-6 Years of Age) 0.000016         <1        0.002447          2
----------------------------------------------------------------------------------------------------------------
Children (7-12 Years of Age) 0.000014         <1        0.000862         <1
----------------------------------------------------------------------------------------------------------------
Females (13-50 Years of Age) 0.000009         <1        0.000600         <1
----------------------------------------------------------------------------------------------------------------
Males (13-19 Years of Age) 0.000005         <1        0.000420         <1
----------------------------------------------------------------------------------------------------------------
Males (20+ Years of Age) 0.000005         <1        0.000547         <1
----------------------------------------------------------------------------------------------------------------
Seniors (55+ Years of Age) 0.000007         <1        0.000870        <1
----------------------------------------------------------------------------------------------------------------
\a\ Exposure  cPAD (0.009 mg/kg/day) x 100
\b\ Exposure  Max. Conc. Limit Goal for fluoride anion (0.114 mg/kg/day) x 100

    iii. Cancer. Sulfuryl fluoride is classified as "not likely to be
carcinogenic to humans." This classification is based on the lack of
evidence of carcinogenicity in male and female rats as well as male and
female mice and on the lack of genotoxicity in an acceptable battery of
mutagenicity studies performed on the technical grade material.
    iv. Anticipated residue and percent crop treated information. For
the purposes of these temporary tolerances, the Agency is assuming 100%
of the walnut and raisin crops will be treated with sulfuryl fluoride,
and that residues will be at the proposed tolerance levels. These
conservative assumptions over state the actual exposure but because
this is an experimental use permit reliable data on the actual percent
crop treated and residues are not available. The registrant estimates
that this experimental use permit may entail treatment of up to 14% and
32% of the domestically produced walnuts and raisins, respectively. In
this risk assessment, all walnuts are assumed to contain 2.0 ppm
residues of sulfuryl fluoride and 12.0 ppm residue of fluoride, and
raisins are assumed to contain 0.004 ppm residues of sulfuryl fluoride
and 30.0 ppm residues of fluoride.
    2. Dietary exposure from drinking water. The Agency has determined
that because of the indoor use pattern and physicochemical
characteristics of sulfuryl fluoride (such as low water solubility and
high volatility), neither residues of sulfuryl fluoride nor of
inorganic fluoride are expected to reach surface or groundwater due to
the post harvest fumigation of walnuts and raisins. There are no other
anticipated sources of sulfuryl fluoride in surface or ground water,
and EPA believes that it is not present in drinking water. Any releases
to wastewater treatment plants would be "stripped" from the
wastewater during the aeration of the activated sludge or trickling
filter processes (secondary treatment). Residues of inorganic fluoride
may be in drinking water due to intentional fluoridation or to natural
sources. Dietary exposure to fluoride from drinking water is estimated
to average 0.057 mg/kg/day (Cryolite RED, 8/96, EPA-738-R-96-016).
    3. From non-dietary exposure. The term "residential exposure" is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). The Agency has
determined that exposure of residents to sulfuryl fluoride resulting
from home fumigation is negligible. The only significant exposure
pathway for inorganic fluoride is via the diet (food + drinking water).
    Structural pest control, a residential non-dietary site, is the
only currently registered use of sulfuryl fluoride. Details concerning
residential exposure from the structural pest control use of sulfuryl
fluoride are discussed in the Sulfuryl Fluoride Reregistration
Eligibility Decision (RED) issued in September 1993 (EPA 738-R-93-016).
The Agency does note that this insecticide is a Restricted Use
Pesticide and there are no homeowner products registered.
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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." EPA does not have, at this time,
available data to determine whether sulfuryl fluoride per se has a
common mechanism of toxicity with other substances or how to include
this pesticide in a cumulative risk assessment. For the purposes of
this tolerance action, therefore, EPA has not assumed that sulfuryl
fluoride has a common mechanism of toxicity with other substances. On
this basis, the petitioner must submit, upon EPA's request and
according to a schedule determined by the Agency, such information as
the Agency directs to be submitted in order to evaluate issues related
to whether sulfuryl fluoride shares a common mechanism of toxicity with
any other substance and, if so, whether any tolerances for sulfuryl
fluoride need to be modified or revoked.
    Crop protection uses of cryolite, intentional fluoridation of
municipal drinking water, and the proposed uses of sulfuryl fluoride
appear to share a common mechanism of toxicity through residues of
their common degradate, inorganic fluoride. Exposure to fluoride from
chronic ingestion of cryolite-treated commodities combined with
residues of inorganic fluoride in drinking water is estimated to be
0.085 mg/kg/day. This is derived using 0.028 mg/kg/day for fluoride
from cryolite treated commodities + 0.057 mg/kg/day from fluoride
intentionally added to drinking water (Cryolite RED). Aggregate
exposure to inorganic fluoride from sulfuryl fluoride, cryolite, and
water fluoridation is estimated to be 0.087 mg/kg/day for the most
highly exposed population subgroup (children 1-6 years of age). This
exposure estimate is approximately 75% of the exposure-converted MCLG
for fluoride and indicates that the sulfuryl fluoride contributes a
negligible amount to the cumulative exposure estimate for inorganic
fluoride.
    The Agency has determined that because the use pattern and
physicochemical characteristics of sulfuryl fluoride, neither residues
of sulfuryl fluoride nor of inorganic fluoride are expected to reach
surface or ground water due to the post-harvest fumigation of walnut
and raisins. Specifically, the indoor use of this highly volatile
compound is not expected to result in residues in either surface or
ground water.
    For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the final rule for Bifenthrin
Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. Neither quantitative not
qualitative evidence of increased susceptibility of fetuses or pups to
sulfuryl fluoride was demonstrated in the prenatal developmental
toxicity studies in rats and rabbits or in the 2-generation
reproduction study in rats.
    3. Conclusion. There is an adequate toxicity database for sulfuryl
fluoride, for the purposes of this experimental use permit only.
Adequate exposure data for the purposes of this experimental use permit
are available or are estimated based on data that reasonably account
for potential exposures. The Agency has reduced the FQPA Safety Factor
from 10X to 3X in assessing the toxicity from exposure to sulfuryl
fluoride from all sources. The FQPA Safety factor was reduced because:
    (i) There is no qualitative or quantitative evidence of increased
susceptibility following in utero exposure to rats and/or following
pre-/postnatal exposure to rats.
    (ii) The dietary (food and drinking water) and non-occupational
exposure assessments will not underestimate the potential exposure to
infants, children, and/or women of childbearing age.
The FQPA Safety Factor was not reduced to 1X because of the lack of a
developmental neurotoxicity study in rats.

E. Aggregate Risks and Determination of Safety

    The potential exists for exposure to sulfuryl fluoride from dietary
and residential pathways. However, the risk from exposure to sulfuryl
fluoride via the residential pathway is considered negligible.
Accordingly, EPA has considered only dietary exposure as contributing
to the aggregate risk from sulfuryl fluoride. As explained in Unit III.
C.1.ii. of this preamble, chronic exposure was estimated using DEEM and
assuming 100% of the raisin and walnut crops would be treated and
contain tolerance level residues. The resulting dietary risk estimates
are less than 1% of the cPAD, except for "Children (1-6 years of
age)". The Agency's level of concern is risks > 100% of the cPAD. No
acute dietary risks were assessed since no toxicological endpoint
attributable to a single exposure could be identified.
    The only significant exposure pathway for inorganic fluoride is via
the diet (food + drinking water). EPA notes that anticipated fluoride
exposure resulting from post-harvest use of sulfuryl fluoride on
walnuts and raisins is negligible in comparison to fluoride levels
permitted under the Safe Drinking Water Act. The Agency's Office of
Water has set a MCLG of 4.0 ppm for fluoride. The Office of Pesticides
Programs has used this number as the exposure level in drinking water.
This concentration is a level that provides no known or anticipated
adverse health effects. The MCLG has been reviewed and is supported by
the Surgeon General. Risks from dietary exposure to inorganic fluoride
from the post-harvest fumigation of raisins and walnuts are estimated
to be less than 1% of the MCLG for fluoride when the MCLG is converted
to an exposure equivalent using Agency default values of body weight
and drinking water consumption. Total exposure to fluoride, including
that from fluoridated water, cryolite uses and from the proposed uses
of sulfuryl fluoride are discussed in Unit III.C.4. of this preamble.
As noted there, aggregate fluoride exposure for the most highly exposed
population is about 75% of the MCLG converted to an exposure
equivalent.
    Based on these risk assessments, EPA concludes that there is a
reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
sulfuryl fluoride and inorganic fluoride residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods of analysis for both sulfuryl fluoride and
fluoride anion are available. The methods are considered adequate as
tolerance enforcement methods for the purposes of these temporary
tolerances during the EUP. For a Section 3 registration, the registrant
will need to submit independent laboratory validations for both the
proposed sulfuryl fluoride and inorganic fluoride methods. For sulfuryl
fluoride, the method consists of blending the sample for 5 minutes in
an air-tight Eberbach blending device, equilibrating the sample for 5
minutes, and analyzing 30mL of headspace from the sample container by
gas chromatography. For fluoride anion, analysis is done by ion-
specific electrodes using a double standard addition procedure. Spike
and recovery submitted with the request show acceptable recoveries for
both sulfuryl fluoride and inorganic fluoride for raisins and walnuts.
    Adequate enforcement methodology (example: gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. Magnitude of Residues

    The petitioner submitted data describing residues of sulfuryl
fluoride and inorganic fluoride in raisins and walnuts following a
number of fumigation regimes including: "To Determine and Evaluate the
Significance of Sulfuryl Fluoride Residues in Dried Fruits and Tree
Nuts Following Fumigation Treatments with Sulfuryl Fluoride at
Different Temperatures, Sample Locations, Desorption Rates, Repeated
fumigations, and A Comparison of Treatments Done Under Vacuum or Normal Atmospheric
Pressure Phase 1." Unpublished study sponsored by Dow AgroSciences LLC
6/1/2000. MRID 45170401.
    The fumigation of walnuts and raisins consisted of treatments at
either 10, 21, or 32  deg.C, multiple fumigations (up to 5) at 21
deg.C, or fumigation under vacuum versus ambient atmospheric pressure
(21  deg.C). As part of the studies, samples were collected from the
top, middle, and bottom of the fumigation chamber; additionally,
samples were collected at post-aeration intervals of up to 11 days
depending upon the treatment. For all treatments to raisins, residues
of sulfuryl fluoride were <1 LOQ (<0.004 ppm) and most residues were <1
LOD (<0.0011 ppm); residues of inorganic fluoride were <1 LOQ (2.2 ppm)
with approximately half falling below the LOD (< 0.75 ppm). Finite
residues of sulfuryl fluoride and inorganic fluoride were found in/on
walnuts and are summarized in Table 3 below.
    The proposed use pattern specifies a maximum cumulative per batch
rate of 2,500 oz-hours/1,000 ft\3\ for ambient pressure fumigations and
250 oz-hours/1,000 ft\3\ for vacuum fumigations. The multiple-
fumigation data submitted with the EUP reflect use rates of 2,500 oz-
hours/1,000 ft\3\ for each fumigation; thus, a batch fumigated 5 times
represents a 5X rate. In determining appropriate tolerance levels for
walnuts, only data from single fumigations were considered. The data
summarized below indicate that a 2.0 ppm tolerance for sulfuryl
fluoride and 12.0 ppm tolerance for inorganic fluoride in or on walnuts
are appropriate for the use rate being proposed in this experimental
use permit. In Table 3, only those commodities treated once reflect the
use rate proposed in this experimental use permit. The other data,
those samples reflecting more than one application, provide additional
information but reflect a higher use rate than proposed in the
experimental use permit and therefore are not directly used in
determining appropriate tolerances.

Table 3.--Summary of Residue Data For Sulfuryl Fluoride and Inorganic Fluoride in/on Walnuts
----------------------------------------------------------------------------------------------------------------
Sulfuryl Fluoride,    Fluoride Anion, ppm
                                                     No. of PAT,             ppm         ---------------------
                 Temp.,  deg.C                   Treatments\a\ Pressure               days\b\  ------------------
Mean       Max.       Mean       Max.
-----------------------------------------------------------------------------------------------------------------
10                             1 Ambient                          4      0.184      0.259 2.9        3.1
-----------------------------------------------------------------------------------------------------------------
10                             1 Ambient                          4      0.332      0.387 2.9        3.2
-----------------------------------------------------------------------------------------------------------------
10                             1 Ambient                          4      0.271      0.289 3.1        3.4
-----------------------------------------------------------------------------------------------------------------
21                             1 Ambient                          4      0.044      0.051 7.1        7.5
-----------------------------------------------------------------------------------------------------------------
21                             1 Ambient                          7      0.006      0.007 5.8        6.1
-----------------------------------------------------------------------------------------------------------------
32                             1 Ambient                          4      0.212      0.229 8.0        8.8
-----------------------------------------------------------------------------------------------------------------
32                             1 Ambient                          7      0.062      0.073 9.6       10.5
-----------------------------------------------------------------------------------------------------------------
21                             1 Ambient                          1      1.535      1.767 NS\c\          -
-----------------------------------------------------------------------------------------------------------------
21                             1 Ambient                          4      0.124      0.135 NS          -
-----------------------------------------------------------------------------------------------------------------
21                             1 Ambient                          7      0.007      0.010 <2.3        2.3
-----------------------------------------------------------------------------------------------------------------
21                             3 Ambient                          1      4.794      5.303 NS          -
-----------------------------------------------------------------------------------------------------------------
21                             3 Ambient                          4      0.884      0.927 NS          -
-----------------------------------------------------------------------------------------------------------------
21                             3 Ambient                          7      0.211      0.231 10.2       38.6
-----------------------------------------------------------------------------------------------------------------
21                             5 Ambient                          1      4.811      6.282 NS          -
-----------------------------------------------------------------------------------------------------------------
21                             5 Ambient                          4      2.069      2.355 NS          -
-----------------------------------------------------------------------------------------------------------------
21                             5 Ambient                          7      0.666      0.742 25.8       30.2
-----------------------------------------------------------------------------------------------------------------
21                             5 Ambient                         11      0.214      0.252 NS          -
-----------------------------------------------------------------------------------------------------------------
21                             1 Vacuum                           4      1.629      1.705 4.5        4.6
-----------------------------------------------------------------------------------------------------------------
21                             1 Vacuum                           7      0.540      0.719 5.8        6.2
-----------------------------------------------------------------------------------------------------------------
\a\ Each fumigation was conducted at a treatment rate of 2,500 oz-hours/1,000 ft\3\. The proposed use pattern is for
the cumulative treatment rate not
  to exceed 2,500 oz-hours/1,000 ft\3\ for ambient fumigations or 250 oz-hours/1,000 ft\3\ for vacuum fumigations.
\b\ PAT = Post-aeration Time.
\c\ NS = No sample

    Proposed tolerances - raisins. The data submitted with the EUP
request indicate that, at the proposed use rate, only trace residues of
sulfuryl fluoride are present in or on raisins, all below the LOQ.
Based on these data, a tolerance for sulfuryl fluoride in or on raisins
set at the LOQ, or 0.004 ppm, would not be exceeded through post-
harvest application of sulfuryl fluoride.

C. International Residue Limits

    There are no U.S. tolerances and/or CODEX MRLs established.

D. Conditions

    The proposed temporary tolerances are to support an experimental
use permit only. The registrant has agreed to analyzing every batch of
raisins for fluoride levels to verify tolerance levels for fluoride are
not exceeded. Other conditions may be specified on the Profume label.
The Agency will not complete a final label review until comments on the
proposed temporary tolerances are received and reviewed.
    The Agency reserves the right to make additional data requirements
for a Section 3 registration; however, the Agency knows that at least
the following additional data will be required:
    (1) Additional residue data to further define magnitude of the
residue for both sulfuryl fluoride and inorganic fluoride (background
levels vs. residues from Cryolite use).
    (2) Residue data to define background levels of fluoride naturally
occurring in both walnuts and raisins.
    (3) Residue dissipation data examining residue levels in/on walnuts
and raisins under post-fumigation storage conditions as a function of
time.
    (4) A comprehensive air monitoring study in and around the
fumigation chambers.
    (5) A Developmental Toxicity Study.

V. Conclusion

    Temporary tolerances are proposed for sulfuryl fluoride residues of
sulfuryl fluoride in walnuts and raisins at 2.0 and 0.004 ppm,
respectively.
    A temporary tolerance is also proposed for inorganic fluoride
residues of sulfuryl fluoride in walnuts and raisins at 12.0 and 30.0
ppm, respectively.

VI. Regulatory Assessment Requirements

    This proposed rule establishes a tolerance under FFDCA section
408(d) 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 proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed 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). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this proposed rule, do not require the issuance of
a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
"meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications."
"Policies that have federalism implications" is defined in the
Executive Order to include regulations that have "substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government." This
proposed rule directly regulates growers, food processors, food
handlers and food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this proposed
rule does not have any "tribal implications" as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
"meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications." "Policies that
have tribal implications" is defined in the Executive Order to include
regulations that have "substantial direct effects on one or more
Indian tribes, on the relationship between the Federal government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes." This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.

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 22, 2001.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

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

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

    1. Section 180.145 is amended by adding paragraph (a)(3) to read as
follows:

Sec. 180.145  Fluorine compounds; tolerances for residues.

    (a) * * *
    (3) Temporary tolerances are established for residues of fluoride
resulting from the post-harvest treatment with sulfuryl fluoride. The
tolerances are measured and expressed as ppm of fluoride. Total
residues of fluoride in or on raisins from use of cryolite on grapes
(addressed in paragraph (a)(1) of this section) or sulfuryl fluoride on
raisins shall not exceed the tolerance list in the following table.

------------------------------------------------------------------------
                                                            Expiration/
             Commodity                Parts per million     Revocation
                                                               Date
------------------------------------------------------------------------
Raisins                             30.0                         4/01/06
Walnuts                             12.0                         4/01/06
------------------------------------------------------------------------

* * * * *

    2. Section 180.575 is added to read as follows:

Sec. 180.575  Sulfuryl fluoride; tolerances for residues.

    (a) General. Temporary tolerances are established for residues of
sulfuryl fluoride resulting from the post harvest treatment with
sulfuryl fluoride.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
Raisins                                         0.004            4/01/06
Walnuts                                           2.0            4/01/06
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 01-22283 Filed 9-4-01; 8:45 am]