[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Proposed Rules]
[Pages 46415-46425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22283]


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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.

[[Page 46416]]


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: 
[email protected].

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: [email protected], 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

[[Page 46417]]

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

[[Page 46418]]

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

[[Page 46419]]

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.
----------------------------------------------------------------------------------------------------------------

[[Page 46420]]

 
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

[[Page 46422]]

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: 
[email protected].

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

[[Page 46423]]

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.

[[Page 46424]]

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.

[[Page 46425]]



------------------------------------------------------------------------
                                                            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]
BILLING CODE 6560-50-S