[Federal Register Volume 69, Number 15 (Friday, January 23, 2004)]
[Rules and Regulations]
[Pages 3240-3257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1540]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0373; FRL-7342-1]


Sulfuryl Fluoride; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
sulfuryl fluoride and inorganic fluoride from postharvest fumigation 
uses of sulfuryl fluoride in or on stored commodities. Dow AgroScience 
LLC requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA). This action reflects the first food use on sulfuryl 
fluoride in the United States. Sulfuryl fluoride has been registered 
for fumigation of structures for termites under the brand name Vikane 
for many years. Sulfuryl fluoride is considered to be a methyl bromide 
replacement for some of these post-harvest fumigation uses. Under the 
Profume product label, grain processing facilities and stored cereal 
grains, dried fruits and tree nuts will be fumigated at a maximum use 
rate of 1,500 ounces/hours/1,000 ft\3\ (1,500 milligrams/hours/liter 
(mg/hr/L) or 200 mg-hr/L under vacuum conditions. Commodities treated 
with Profume must be aerated for at least 24 hours before entering 
commerce.

DATES: This regulation is effective January 23, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0373, 
must be received on or before March 23, 2004.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dennis McNeilly, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; 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 potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    [sbull] Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    [sbull] Food manufacturing (NAICS 311), e.g., agricultural workers; 
farmers; greenhouse, nursery, and floriculture workers; ranchers; 
pesticide applicators.
    [sbull] Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.

[[Page 3241]]

    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0373. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title--40/ 40cfr1 80--00.html/, 
a beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background

    In the Federal Register of February 15, 2002 (67 FR 7156) (FRL-
6822-2), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 1F6312) by Dow AgroScience LLC, 9330 
Zionsville Road, Indianapolis, IN 46268. That notice included a summary 
of the petition prepared by DowAgroScience, the registrant. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the insecticide sulfuryl fluoride and the 
metabolite fluoride, from sulfuryl fluoride postharvest use, in or on:
    1. Fluoride in or on the following raw agricultural commodities: 
Date at 5 parts per million (ppm), fig at 5 ppm, plum, prune, dried at 
5 ppm, grape, raisin at 5 ppm, fruit, dried at 5 ppm, almond at 10 ppm, 
pecan at 23 ppm, pistachio at 18 ppm, walnut at 30 ppm, beechnut; 
butternut; cashew; chestnut; chinquapin; filbert; nut, brazil; nut, 
hickory; and nut, macadamia at 30 ppm, barley, grain at 10 ppm, corn, 
field, grain; and corn, pop, grain at 7 ppm, oat, grain at 17 ppm, 
rice, grain at 10 ppm, wheat, grain at 25 ppm, millet, grain; rice, 
wild, grain; sorghum, grain; and triticale, grain at 25 ppm and on the 
processed products corn, field, flour at 26 ppm, corn, field, grits at 
10 ppm, corn, field, meal at 28 ppm, corn, field, oil at 3 ppm, rice, 
brown at 14 ppm, rice, polished rice at 18 ppm, rice, bran at 31 ppm, 
rice, hulls at 35 ppm, wheat, bran at 40 ppm, wheat, flour at 10 ppm, 
wheat, germ at 98 ppm, wheat milled by products at 35 ppm, wheat, 
shorts at 38 ppm, corn, field, refined oil at 3 ppm.
    2. Sulfuryl fluoride in or on the following raw agricultural 
commodities: Date at 0.03 ppm, fig at 0.05 ppm, plum, prune, dried at 
0.01 ppm, grape, raisin at 0.01 ppm, fruit, dried at 0.05 ppm, almond 
at 0.2 ppm, pecan at 6.0 ppm, pistachio at 0.5 ppm, walnut at 6.0 ppm, 
beechnut; butternut; cashew; chestnut; chinquapin; filbert; nut, 
brazil; nut, hickory; and nut, macadamia at 6.0 ppm, barley, grain at 
0.01 ppm, corn, field, grain and corn, pop, grain at 0.04 ppm, oat, 
grain at 0.01 ppm, rice, grain at 0.04 ppm, wheat, grain at 0.05 ppm, 
millet, grain; rice, wild, grain; sorghum, grain; triticale, grain at 
0.05 ppm and on the processed products corn, field, flour at 0.01 ppm, 
corn, field, grits at 0.01 ppm, corn, field, meal at 0.01 ppm, corn, 
field, refined oil at 9.0 ppm, rice, brown at 0.01 ppm, rice, polished 
rice at 0.01 ppm, rice, bran at 0.01 ppm, rice, hulls at 0.08 ppm, 
wheat, bran at 0.01 ppm, wheat, flour at 0.03 ppm, wheat, germ at 0.01 
ppm, wheat milled byproducts at 0.01 ppm, wheat, shorts at 0.01 ppm.
    The Agency has previously established temporary tolerances for 
sulfuryl fluoride and fluoride on stored walnuts and raisins in 
connection an Experimental Use Permit (EUP) for post-harvest sulfuryl 
fluoride use (See 67 FR 5735, February 7, 2000) (FRL-6834-4). Sulfuryl 
fluoride has never been used on stored walnuts and raisins, however, 
because the California Department of Pesticide Regulation has not 
issued the necessary state authorization to allow the EUP to proceed. 
Because Dow Agrosciences has now requested that its EUP for sulfuryl 
fluoride use on walnuts and raisins be withdrawn and EPA, in today's 
action, is establishing permanent tolerances for sulfuryl fluoride on 
walnuts and raisins, these temporary tolerances are being revoked, also 
as a part of today's action. The Agency received a Hearing Request 
dated April 8, 2002 in response to the temporary tolerance final rule 
from Fluoride Action Network. Because the tolerances that were objected 
to have now been revoked, the objections are moot and are denied on 
that ground. EPA fully considered, however, all of the Fluoride Action 
Network's objections as a part of today's action and has responded to 
each significant objection lodged by the Fluoride Action Network.
    The Agency received 17 sets of written comments (including 5 sets 
of late comments) on the notice of filing published on February 15, 
2002 (67 FR 7156). In addition, the Agency had previously received 
comments on prior Federal Register tolerance documents related to the 
establishment of tolerances for sulfuryl fluoride and inorganic 
fluoride, including two sets of comments on the notice of filing of a 
pesticide petition to establish temporary tolerances for residues of 
fluoride and sulfuryl fluoride in or on walnuts and sulfuryl fluoride 
in or on raisins, and to establish an exemption from the requirement of 
a tolerance for inorganic fluoride in or on raisins published on June 
15, 2001 (66 FR 32618) (FRL-6788-2), and 89 sets of comments (including 
10 late comments) on the proposed rule to establish temporary 
tolerances for sulfuryl fluoride and inorganic fluoride residues 
resulting from application of sulfuryl fluoride in or on walnuts and 
raisins published on September 5, 2001 (66 FR 46415). In

[[Page 3242]]

addition, an objection and request for hearing was submitted in 
response to the establishment of temporary tolerances for sulfuryl 
fluoride and inorganic fluoride residues resulting from application of 
sulfuryl fluoride in or on walnuts and raisins published on February 7, 
2002 (67 FR 5735).
    The Agency has prepared a detailed response to the public comments 
regarding the establishment of tolerances for sulfuryl fluoride and 
inorganic fluoride on food including all public comments made to the 
documents noted above resulting from the application of sulfuryl 
fluoride as a post-harvest fumigant. This document has been made part 
of the public docket OPP-2003-0373 for this regulatory action, and is 
also available for review on the Internet (http://www.epa.gov/fedrgstr/
).
    In general, the comments addressed either procedural issues 
concerning the process of establishing tolerance levels for sulfuryl 
fluoride and total fluoride or substantive issues concerning the human 
health and other consequences that would result from the use of 
sulfuryl fluoride and increased human exposure to fluorides. Most of 
the comments relate to fluoride exposure, fluoride toxicology and 
issues related to the exposure to fluorides from fluoridated drinking 
water. The longest and most significant of these comments came from the 
Fluoride Action Network (FAN), which, among its comments, questioned 
the safety of the current Maximum Contaminant Level Goal (MCLG) and 
Secondary Maximum Contamination Level (SGML) for fluoride in drinking 
water established by the Agency's Office of Water, under the Safe 
Drinking Water Act. The Safe Drinking Water Act (SDWA) requires EPA to 
review each National Primary Drinking Water Regulation (NPDWR) at least 
once every 6 years and revise them, if appropriate. As part of this 
review process, the Office of Water, has requested the National Academy 
of Science (NAS) to review the current drinking water standards for 
fluoride. The project scope from the NAS website states:
    A subcommittee of the National Research Council's (NRC) 
Committee on Toxicology (COT) will review toxicologic, 
epidemiologic, and clinical data, particularly data published since 
1993, and exposure data on orally ingested fluoride from drinking 
water and other sources (e.g., food, toothpaste, dental rinses). 
Based on those reviews the subcommittee will evaluate independently 
the scientific basis of the EPA's maximum contaminant level goal 
(MCLG) of 4 milligram per liter (mg/L) and secondary maximum 
contaminant level (SMCL) of 2 mg/L in drinking water. The 
subcommittee will advise EPA on the adequacy of its fluoride MCLG 
and SMCL to protect children and others from adverse effects. The 
subcommittee will consider the relative contribution of various 
fluoride sources (e.g., food, dental-hygiene products) to total 
exposure. The subcommittee will also identify data gaps and make 
recommendations for future research relevant to setting the MCLG and 
SMCL for fluoride. The subcommittee will not address questions of 
economics, risk-benefit assessment, or water-treatment technology.

A previous NAS review of fluoride was published in 1993 (NRC 1993) and 
served as the basis for the retention of the 4 mg/L MCLG and 2 mg/L 
SMCL by EPA in 1993.
    The comments cited a total of 120 scientific studies and other 
published articles and books (see Unit VII.); these citations have all 
been considered by the Agency and are discussed in further detail in 
the assessment of the toxic effects resulting from exposure to fluoride 
provided in Unit III. as well as within the detailed response to public 
comments document. The analysis of the acceptability of fluoride 
exposure is based on the current MCLG and SMCL for fluoride in drinking 
water. The NAS is currently reviewing the adequacy of the present 
drinking water standards for fluoride in light of relevant scientific 
data that has been published subsequent to the 1993 review (National 
Research Council (1993). Health effects of ingested fluoride. National 
Academy Press, Washington, DC.). In connection with the sulfuryl 
fluoride tolerance petition, EPA has separately reviewed the cited 
studies (Dellarco 2003; Baetcke et al. 2003) and concludes that the 
cited scientific data that has been published since 1993 does not 
support adopting a reference point for evaluating the adverse health 
effects of fluoride than that underlying the MCLG.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    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 of FFDCA 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).
    Consistent with section 408(b)(2)(D) of FFDCA, 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) of FFDCA, for a tolerance for residues of sulfuryl fluoride 
and fluoride on numerous commodities at the levels specified in the 
tables below. 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 
are discussed in Table 1 of this unit as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies reviewed.

[[Page 3243]]



            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
     Study Type/Guideline No.                     Results
------------------------------------------------------------------------
2-Week inhalation study--rat       NOAEL = 83/89 (Male/Female)
                                    milligrams/kilogram/day (mg/kg/day)
                                   LOAEL = 249/267 (M/F) mg/kg/day based
                                    on slightly increased kidney
                                    weights, minimal histopathology in
                                    kidney. At 495/534 high mortality,
                                    decreased body weights, severe
                                    histopathology in the kidney, gross
                                    and histopathology in many tissues/
                                    organs (secondary to kidney
                                    effects); severe inflammation of
                                    respiratory tissues in one survivor.
                                    No treatment-related neurotoxicity).
------------------------------------------------------------------------
2-Week inhalation study--dog       NOAEL = 26/27 (M/F) mg/kg/day
                                   LOAEL = 79/80 (M/F) mg/kg/day based
                                    on M&F intermittant tremors and
                                    tetany during exposure, minimal
                                    inflammatory changes in upper
                                    respiratory tract, decreased body
                                    weight (F only).
                                   Note: Increased serum fluoride at >=
                                    26/27 mg/kg/day
------------------------------------------------------------------------
2-Week inhalation study--rabbit    NOAEL = 30/30 (M/F) mg/kg/day
                                   LOAEL = 90/90 (M/F) mg/kg/day based
                                    on for both M&F malacia (necrosis)
                                    in cerebrum, vacuolation of
                                    cerebrum, moderate inflammation of
                                    respiratory tissues
                                   At 180/180 mg/kg/day for M&F
                                    convulsions, hyperactivity, malacia
                                    (necrosis) in cerebrum, vacuolation
                                    of cerebrum, moderate inflammation
                                    of respiratory tissues
------------------------------------------------------------------------
90-Day inhalation toxicity--rat    NOAEL = 24/25 (M/F) mg/kg/day
(870.3100).......................  LOAEL = 80/83 (M/F) mg/kg/day based
                                    on dental fluorosis*
                                   At 240/250 (M/F) vacuolation of
                                    caudate-putamen nucleus and white
                                    fiber tracts of the internal capsule
                                    of the brain, decreased body weight,
                                    inflammation of nasal passages,
                                    alveolar histiocytosis; slight
                                    hyperplasia of renal collecting
                                    ducts (F only)
------------------------------------------------------------------------
90-Day inhalation toxicity--mouse  NOAEL = 38/36 (M/F) mg/kg/day
(870.3100).......................  LOAEL = 125/121 (M/F) mg/kg/day based
                                    on for both M/F miscroscopic lesions
                                    in caudate-putamen nucleus and
                                    external capsule of the brain,
                                    decreased body weight, decreased
                                    body weight gain, follicular cell
                                    hypertrophy in thyroid.
                                   Note: Increased serum fluoride at >=
                                    26/27 mg/kg/day
------------------------------------------------------------------------
90-Day inhalation toxicity--dog    NOAEL = 25/26 (M/F) mg/kg/day
(870.3150).......................  LOAEL = 50/51 (M/F) mg/kg/day based
                                    on slight histopathology of the
                                    caudate nucleus of the basal
                                    ganglia, decreased body weight,
                                    decreased body weight gain,
                                    transient neurological signs
                                    (lateral recumbancy, tremors,
                                    incoordination, salivation, tetany,
                                    inactivity) starting at day 19 in
                                    one M
------------------------------------------------------------------------
90-Day inhalation toxicity--       NOAEL = 8.6/8.5 (M/F) mg/kg/day
 rabbit                            LOAEL = 29/28 (M/F) mg/kg/day based
(870.3150).......................   on for both M&F decreased body
                                    weight, decreased liver weight,
                                    dental fluorosis*, vacuolation of
                                    white matter of the brain (F only).
                                    At 86/85 mg/kg/day for both M&F
                                    malacia (necrosis) and vacuolation
                                    of putamen, globus pallidus and
                                    internal and external capsules in
                                    the brain, decreased body weight
                                    gain, alveolar histiocytosis,
                                    histopathology in nasal epithelium.
------------------------------------------------------------------------
Prenatal developmental--rat        Maternal
(870.3700).......................  NOAEL = 225 ppm or 243 (F) mg/kg/day
                                   LOAEL = >225 ppm or >243 (F) mg/kg/
                                    day based on no observed effects.
                                   Developmental
                                   NOAEL = 225 or 243 (F) mg/kg/day
                                   LOAEL = >225 ppm or 243 (F) mg/kg/day
                                    based on no observed adverse
                                    developmental effects
------------------------------------------------------------------------
Prenatal developmental--rabbit     Maternal
(870.3700).......................  NOAEL = 75 ppm or 29 (F) mg/kg/day
                                   LOAEL = 225 ppm or 86 mg/kg/day based
                                    on decreased body weight and body
                                    weight gain during treatment
                                   Developmental
                                   NOAEL = 75 ppm or 29/29 (M/F) mg/kg/
                                    day
                                   LOAEL = 225 ppm or 86 (F) mg/kg/day
                                    based on decreased fetal body
                                    weight, decreased crown-rump length,
                                    possible increased fetal liver
                                    pathology (pale liver)
------------------------------------------------------------------------
Reproduction and fertility         Parental/Systemic
 effects                           NOAEL = 5 ppm or 3.6/3.6 (M/F) mg/kg/
(870.3800).......................   day
                                   LOAEL = 20 ppm or 14/14 (M/F) mg/kg/
                                    day based on pale foci in lungs,
                                    increased alveolar macrophages in
                                    lungs
                                   Reproductive
                                   NOAEL = 14/14 (M/F) mg/kg/day
                                   LOAEL = >150 ppm or 108/108 (M/F) mg/
                                    kg/day based on no adverse effects
                                    up to 150 ppm
                                   Offspring
                                   NOAEL = 20 ppm or 14 mg/kg/day
                                   LOAEL = 150 ppm or 108 mg/kg/day
                                    based on decreased pup weight in the
                                    F1 and F2 generations (probably
                                    secondary to maternal body weight
                                    loss
------------------------------------------------------------------------

[[Page 3244]]

 
Chronic toxicity--rodents          NOAEL = 3.5 for M and 16 for F mg/kg/
(870.4100).......................   day
                                   LOAEL = 20 ppm or 14 for M and 80 ppm
                                    or 62 for F mg/kg/day based on
                                    dental fluorosis* in males and for
                                    females greatly increased mortality
                                    (due mostly to severe kidney
                                    toxicity which led to kidney
                                    failure); and histopathology in
                                    brain (vacuolation in cerebrum and
                                    thalmus/hypothalmus), adrenal
                                    cortex, eyes, liver, nasal tissue
                                    and respiratory tract; and, dental
                                    fluorosis*.
                                   No evidence of carcinogenicity in M
                                    or F
------------------------------------------------------------------------
1-Year chronic inhalation          NOAEL = 5.0/5.1 (M/F) mg/kg/day
 toxicity--dog                     LOAEL = 20/20 (M/F) mg/kg/day based
(870.4100).......................   on for both M/F decreased body
                                    weight gain, increased alveolar
                                    macrophages in lungs, dental
                                    fluorosis*. At 50/51 mg/kg/day for
                                    both M/F increased mortality,
                                    malacia (necrosis) in caudate
                                    nucleus of brain, follicular cell
                                    hypertrophy in thyroid,
                                    histopathology in lung.
------------------------------------------------------------------------
18-Month carcinogenicity           NOAEL = 25/25 (M/F) mg/kg/day
 inhalation study--mouse           LOAEL = 101/101 (M/F) mg/kg/day based
(870.4200).......................   on for both M/F cerebral vacuolation
                                    in brain, decreased body weight
                                    gain, follicular hypertrophy in
                                    thyroid (M only), increased
                                    mortality (F only), heart thrombus
                                    (F only), and lung congestion (F
                                    only)
                                   No evidence of carcinogenicity in M
                                    or F
------------------------------------------------------------------------
2-Year combined chronic/           NOAEL = 3.5 for M and 16 for F mg/kg/
 carcinogenicity--rat               day
(870.4300).......................  LOAEL = 20 ppm or 14 for M and 80 ppm
                                    or 62 for F mg/kg/day based on
                                    dental fluorosis* in males and for
                                    females greatly increased mortality
                                    (due mostly to severe kidney
                                    toxicity which led to kidney
                                    failure); and histopathology in
                                    brain (vacuolation in cerebrum and
                                    thalmus/hypothalmus), adrenal
                                    cortex, eyes, liver, nasal tissue
                                    and respiratory tract; and, dental
                                    fluorosis*.
                                   No evidence of carcinogenicity in M
                                    or F
------------------------------------------------------------------------
Ames assay                         Negative without and with S-9
(870.5100).......................   activation
------------------------------------------------------------------------
Cytogenetics                       There was no significant increase in
(870.5395).......................   the frequency of micronucleated
                                    polychromatic erythrocytes in bone
                                    marrow at any sulfuryl fluoride
                                    concentration or treatment time used
                                    in the study (520 ppm).
------------------------------------------------------------------------
UDS Assay                          There was no evidence of unscheduled
(870.5550).......................   DNA synthesis over negative controls
                                    up to 1,020 ppm of sulfuryl
                                    fluoride.
------------------------------------------------------------------------
Acute inhalation neurotoxicity     Systemic
 study--rat (special design)       NOAEL = 300 ppm or 354 (F) mg/kg/day
(870.6200).......................  LOAEL = >300 ppm or >354 (F) mg/kg/
                                    day based on highest dose tested
                                   Neurotoxic
                                   NOAEL = 354 (F) mg/kg/day
                                   LOAEL = >354 (F) mg/kg/day based on
                                    highest dose tested
                                   Note: study included
                                    electrophysiological parameters, but
                                    no microscopic pathology.
------------------------------------------------------------------------
90-Day inhalation neurotoxicity    Systemic
 study-rat (special design)        NOAEL = 24/25 (M/F) mg/kg/day
(870.6200).......................  LOAEL = 80/83 (M/F) mg/kg/day based
                                    on for both M and F pale foci in
                                    pleura and macrophages in lungs,
                                    dental fluorosis*
                                   Neurotoxic
                                   NOAEL = 24/25 (M/F) mg/kg/day
                                   LOAEL = 80/83 (M/F) mg/kg/day based
                                    on for both M and F disturbances in
                                    electro-physiological parameters
                                    (slowing of VER and SER waveforms in
                                    F and ABR waveforms in M
------------------------------------------------------------------------
1-Year inhalation neurotoxicity    NOAEL = 3.5/3.9 (M/F) mg/kg/day
 study-rat (special design)        LOAEL = 14/16 (M/F) mg/kg/day based
(870.6200).......................   on dental fluorosis*. At 52/62 mg/kg/
                                    day (M/F) increased kidney and liver
                                    weights, progressive kidney disease
                                    and histopathology in lung.
                                   Neurotoxic
                                   NOAEL = 56/62 (M/F) mg/kg/day
                                   LOAEL = 56/62 (M/F) mg/kg/day based
                                    on highest dose tested
------------------------------------------------------------------------
Developmental neurotoxicity        No study available. Study will be a
(870.6300).......................   condition of registration.
------------------------------------------------------------------------
Metabolism and pharmacokinetics    Waived, Reregistration Eligibility
(870.7485).......................   Document, 1993
------------------------------------------------------------------------
Dermal penetration                 No study available. Not required for
(870.7600).......................   a gas.
------------------------------------------------------------------------
*As discussed later in this document, dental fluorosis is not considered
  an adverse health effect, and the identification of that effect in any
  of these toxicological studies has not served to define a safe level
  of exposure to sulfuryl fluoride under the FFDCA.


[[Page 3245]]

    Technical grade sulfuryl fluoride (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 mg/kg in rats (Toxicity Category II). The acute 
inhalation LC50 in mice (4-hour exposure) is 660 ppm (2.56 
mg/L) in males and 642 ppm (2.49 mg/L) in females. The acute inhalation 
LC50 in rats (1 hour exposure) is 4,512 ppm (17.5 mg/L). 
Based on the use pattern for sulfuryl fluoride and several reported 
incidences of human poisonings in the general toxicologic literature, 
the Agency has classified sulfuryl fluoride as Toxicity Category I for 
acute inhalation toxicity. When released from pressurized steel 
cylinders, sulfuryl fluoride causes freezing of skin and eye tissues on 
contact. Therefore, no dermal studies or eye irritation studies have 
been required to be submitted. The acute dermal toxicity study (assumed 
Toxicity Category IV), the primary skin irritation study (assumed 
Toxicity Category IV), the primary eye irritation study (assumed 
Toxicity Category I), and the dermal sensitization study (assumed to be 
a non-sensitizer) have been waived. 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 9,600 ppm (40.3 
mg/L) 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, mice, dogs and 
rabbits, 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 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 a reverse gene mutation assay in 
Salmonella typhimurium, an unscheduled DNA synthesis assay in primary 
rat hepatocytes, and a micronucleus assay in mouse bone marrow cells.
    In carcinogenicity studies in male and female rats and in male and 
female mice, sulfuryl fluoride did not demonstrate evidence of 
carcinogenic potential. Sulfuryl fluoride is classified as ``not likely 
to be carcinogenic to humans'' according to the July 2, 1999 EPA Draft 
Proposed Guidelines for Carcinogen Risk Assessment.
    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

[[Page 3246]]

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 exposures to concentrations of sulfuryl fluoride gas 
significantly above the threshold limit value (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. 
Sulfuryl fluoride and fluoride anion are the residues of concern 
associated with sulfuryl fluoride.
    Fluoride anion. In assessing the risks associated with exposure to 
fluoride, the Agency has relied on the toxicological assessment and 
Maximum Contaminant Levels (MCLs) and Maximum Contaminant Level Goals 
(MCLG) established by the Agency's Office of Water. The MCGL is the 
maximum level of a contaminant in drinking water at which no known or 
anticipated adverse effect on the health of persons would occur, and 
which allows an adequate margin of safety. A MCL is an enforceable 
level that is set as closely as feasible to the MCLG of a contaminant. 
MCLGs are non-enforceable health goals. For fluoride, both the MCL and 
the MCLG have been set at 4.0 ppm in order to protect against crippling 
skeletal fluorosis. The Office of Water has also established a 
secondary MCL (SMCL) for fluoride at 2.0 ppm. The SMCL is a non-
enforceable level established to be protective against the cosmetic and 
aesthetic effects of objectionable dental fluorosis.

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 intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors''; the ``special FQPA safety 
factor''; and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for data base deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 x 
10-\5\), one in a million (1 x 10-\6\), or one in 
ten million (1 x 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for sulfuryl fluoride used 
for human risk assessment is shown in Table 2 of this unit:

  Table 2.--Summary of Toxicological Dose and Endpoints for sulfuryl fluoride for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary                          None, UF = N/A           Not applicable           No toxicological
                                                                                          endpoint attributable
                                                                                          to a single exposure
                                                                                          was identified in the
                                                                                          available toxicology
                                                                                          studies on sulfuryl
                                                                                          fluoride
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 8.5 mg/kg/day    Special FQPA SF = 1X     90-Day inhalation--
                                       UF = 3,000.............  cPAD = chronic RfD/       rabbit
                                       Chronic RfD = 0.003 mg/   Special FQPA SF =       LOAEL = 28 mg/kg/day
                                        kg/day.                  0.003 mg/kg/day.         based on vacuolation
                                                                                          of white matter in the
                                                                                          brain of females.
----------------------------------------------------------------------------------------------------------------

[[Page 3247]]

 
Incidental oral (all durations)        None                     Not applicable           Due to sulfuryl
                                                                                          fluoride being a gas
                                                                                          and pattern of use, no
                                                                                          significant incidental
                                                                                          oral exposure is
                                                                                          anticipated.
----------------------------------------------------------------------------------------------------------------
Dermal (all durations)                 None                     Not applicable           Due to sulfuryl
                                                                                          fluoride being a gas
                                                                                          and pattern of use, no
                                                                                          significant incidental
                                                                                          dermal exposure is
                                                                                          anticipated. No hazard
                                                                                          identified, therefore,
                                                                                          no quantification is
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days)   Inhalation study         Residential LOC for MOE  2-Week inhalation--
                                       NOAEL = 30 mg/kg/day      = 1,000 Occupational     rabbit
                                        (100 ppm; 0.42 mg/L).    LOC = 100               LOAEL = 90 mg/kg/day
                                                                                          (300 ppm; 1.25 mg/L)
                                                                                          based on malacia
                                                                                          (necrosis) and
                                                                                          vacuolation in brain,
                                                                                          inflammation of nasal
                                                                                          tissue and trachea
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 to 6   Inhalation study         Residential LOC for MOE  90-Day inhalation-
 months)                               NOAEL = 8.5 mg/kg/day     = 1,000                  rabbit
                                        (100 ppm; 0.42mg/L).    Occupational LOC for     LOAEL = 28 mg/kg/day
                                                                 MOE = 100.               (100 ppm; 0.42 mg/L)
                                                                                          based on vacuolation
                                                                                          of white matter in the
                                                                                          brain of females.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (>6 months)       Inhalation study         Residential LOC for MOE  90-Day inhalation--
                                       NOAEL = 8.5 mg/kg/day     = 3,000                  rabbit
                                        (30 ppm; 0.13 mg/L).    Occupational LOC for     LOAEL = 28 mg/kg/day
                                                                 MOE = 300.               based on vacuolation
                                                                                          of white matter in the
                                                                                          brain of females
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                Classified as not likely to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------

    For sulfuryl fluoride, the end-point from an inhalation study is 
being used to calculate the chronic RfD which is used to perform risk 
assessments for oral exposure. In addition to being the only practical 
way to administer a gas test material, the Agency believes this is a 
very conservative methodology which is supported by the following 
considerations:
    The absorption of test material from inhalation exposure is 
generally presumed to be 100%, where as absorption via oral exposure is 
often times determined to be less than 100%.
    A higher and more persistent level of parent test material in the 
body may occur following inhalation exposure as compared to an oral 
exposure because the parent test material is immediately distributed 
throughout the circulatory system following inhalation, rather than the 
first being directly shunted to the liver (where most metabolism 
occurs) as in the case of oral exposure.
    In addition, for sulfuryl fluoride, the NOAEL on which the chronic 
RfD was calculated is from a study in rabbits (which is the most 
sensitive species for the neurotoxic effects) and the LOAEL in this 
study was close to a threshold effect level (the effect was observed 
only in the female rabbit).
    Fluoride anion. In assessing the risks associated with exposure to 
fluoride, the Agency relied on the toxicological assessment and MCLG 
established by the Agency's Office of Water for fluoride of 4.0 ppm. At 
this time, based on the information available to the Agency, EPA is not 
concluding that dental fluorosis associated with fluoride exposure is 
an adverse health effect under the FFDCA. The current arguments that 
dental fluorosis is more than a cosmetic effect are not sufficiently 
persuasive to warrant regulation as an adverse health effect under the 
FFDCA. Accordingly, consistent with the action taken by the Office of 
Water under the Safe Drinking Water Act, 50 FR 47142 (November 14, 
1985) (WH-FRL-2913-8(b)), the Agency believes the appropriate endpoint 
for regulation under the FFDCA is skeletal fluorosis.
    While the tolerance safety determination under the FFDCA is a 
health based standard, FIFRA requires the balancing of all costs, 
taking into account the economic, social, and environmental effects as 
well as health based risks, against the benefits associated with the 
pesticide use. Therefore, the Agency will consider dental fluorosis in 
determining whether sulfuryl fluoride meets the requisite standard 
under FIFRA.
    Using body weight and water consumption estimates, the MCLG, 
expressed mg/kg/day, for the population groups addressed in the 
fluoride risk assessments are as follows:
    U.S. population . . . . . . . . . . . 0.114 mg/kg/day
    Infants (< 1 year old). . . . . . . . . . 0.571 mg/kg/day
    Children 1-2 years old. . . . . . 0.308 mg/kg/day
    Children 3-5 years old. . . . . . . 0.182 mg/kg/day
    Children 6-12 years old . . . . . 0.100 mg/kg/day
    Youth 13-19 years old . . . . . . 0.133 mg/kg/day
    Adults 20+ years old. . . . . . . . 0.114 mg/kg/day
    Females 13-49 years old . . . . . 0.131 mg/kg/day
    For fluoride risk assessments addressed in this document, the term 
``% of MCLG (as mg/kg/day)'' is analogous to a reference dose (RfD).
    Percent of MCLG (expressed as mg/kg/day) use in acute risk 
assessments. None. The Agency has not identified any toxicological 
endpoint attributable to a single exposure of fluoride that would be 
applicable to females (13-50 years old) or to the general population 
(including infants and children).
    Percent of MCLG (expressed as mg/kg/day) use in non-acute risk 
assessments. For all short-term, intermediate-term, and chronic 
assessments, the Agency

[[Page 3248]]

has converted the MCLG of 4.0 ppm to a mg/kg/day basis using standard 
water consumption estimates and body weight data from the NHANES III 
survey (U.S. EPA, 2000). Body weight data from the NHANES survey were 
matched as closely as possible to the population subgroups addressed by 
the DEEM-FCID dietary exposure modelling software. Use of the NHANES 
data, rather than the Agency default body weights, avoids setting dose 
levels too high due to underestimated body weights. These doses in 
Table 3 below were used for all risk assessment durations and pathways 
(oral, dermal, and inhalation) in a manner analogous to an RfD. That 
is, the Agency would have concerns about the level of estimated risk if 
the exposure estimates exceed 100% of ``MCLG (as mg/kg/day)'' as 
defined in this rule.
    The Agency notes that the EPA's Integrated Risk Information System 
(IRIS) lists an oral RfD of 1 ppm fluoride in water for dental 
fluorosis (IRIS Database). That RfD is based on a NOEL of 1 ppm with an 
LOEL of 2 ppm and no modifying or uncertainty factors since the effect 
was noted in a sensitive population and the duration of exposure was 
appropriate for the effect and the population. The IRIS value has not 
been used in this action since dental fluorosis is a cosmetic effect, 
not a human health effect.

                       Table 3.--Toxicological Doses Used in the Fluoride Risk Assessment*
----------------------------------------------------------------------------------------------------------------
                                                             Water Conc.
                                                              Protective      Water         Body     of MCLG (as
        Population Subgroup           Toxicological Effect    of Effect,  Consumption,   Weight, kg   mg/kg/day)
                                                                 ppm          L/day
----------------------------------------------------------------------------------------------------------------
U.S. population (total)              Skeletal fluorosis                4             2           70        0.114
----------------------------------------------------------------------------------------------------------------
All infants (<1 year)                Skeletal fluorosis                4             1            7        0.571
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                 Skeletal fluorosis                4             1           13        0.308
----------------------------------------------------------------------------------------------------------------
Children (3-5 years)                 Skeletal fluorosis                4             1           22        0.182
----------------------------------------------------------------------------------------------------------------
Children (6-12 years)                Skeletal fluorosis                4             1           40          0.1
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years)                  Skeletal fluorosis                4             2           60        0.133
----------------------------------------------------------------------------------------------------------------
Adults (20+ years)                   Skeletal fluorosis                4             2           70        0.114
----------------------------------------------------------------------------------------------------------------
Females (13-49 years)                Skeletal fluorosis                4             2           61        0.131
----------------------------------------------------------------------------------------------------------------
*Doses are used in a manner analogous to an RfD and are used for all exposure pathways

    Carcinogenicity. In its assessment of the health effects of 
fluoride, the National Research Council (NRC) concluded that the 
available laboratory data are insufficient to demonstrate a 
carcinogenic effect of fluoride in animals. The NRC also concluded that 
the weight of the evidence from more than 50 epidemiological studies 
does not support the hypothesis of an association between fluoride 
exposure and increased cancer risk in humans. National Research 
Council, 1993.
    The Agency for Toxic Substances and Disease Registry (ATSDR) and 
the World Health Organization have come to similar conclusions. Based 
on the findings of those bodies and the Agency's own review, the Agency 
believes fluoride poses a negligible cancer risk.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. This is the first 
food-use for sulfuryl fluoride. Temporary tolerances were established 
(40 CFR 180.575) for the residues of sulfuryl fluoride, in or on a 
walnuts and raisins. Tolerances already exist for fluoride residues in 
food in 40 CFR 180.145 to support use of cryolite in on on various raw 
agricultural commodities. This action involves adding a new section 
(1)(a)(3) to 40 CFR 180.145, i.e., an entry adding postharvest use of 
Profume on stored commodites. Risk assessments were conducted by EPA to 
assess dietary exposures from sulfuryl fluoride and 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 1-day or 
single exposure.
    No toxicological endpoint attributable to a single exposure was 
identified in the available toxicology studies for either sulfuryl 
fluoride and/or fluoride; therefore, no acute dietary exposure analysis 
was conducted.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID), which incorporates food 
consumption data as reported by respondents in the U.S. Department of 
Agriculture 1994-1996 and 1998 Nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII). The following assumptions were made for 
the chronic exposure assessments: The chronic analysis for sulfuryl 
fluoride used anticipated residues (average residue) from residue 
trials reflecting the maximum proposed use rate, percent market share 
estimates and a dilution factor for flour commodities to reflect the 
pre-fumigation draw down practice in grain mills. This assessment 
includes quantitative estimates of dietary exposure from background 
levels of fluoride in food, fluoride in water, and fluoride from the 
pesticidal food uses of cryolite and sulfuryl fluoride; non-dietary 
exposure from the use of fluoridated toothpaste, and non-dietary 
exposure from fluoride residues in air. For each of these pathways of 
exposure, residue estimates are conservative to moderately conservative 
in nature. Other potential sources of fluoride exposure have not been 
included in this assessment in a quantitative manner, primarily due to 
lack of demographic and/or exposure information. Non-quantified 
pathways of exposure are not expected to significantly increase 
exposure estimates for the various population subgroups at large.
    The chronic analysis for sulfuryl fluoride used average residue 
values from residue trials reflecting the maximum proposed use, percent 
market share estimates, and a dilution factor for flour commodities to 
reflect the pre-fumigation draw-down practice in grain processing 
mills. Based on these

[[Page 3249]]

assumptions, the refined chronic dietary risk estimates for all 
population subgroups are less than 1% of the chronic population-
adjusted dose (cPAD) of 0.003 mg/kg/day.

                       Table 4.--Chronic Dietary Exposure Assessment for Sulfuryl Fluoride
----------------------------------------------------------------------------------------------------------------
                                                                Estimated Exposure, mg/
         Population Subgroup            Chronic PAD, mg/kg/day           kg/day              Risk, % of cPAD
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                                  0.003                 0.000003                       <1
----------------------------------------------------------------------------------------------------------------
All infants (<1 year)                                    0.003                 0.000002                       <1
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                     0.003                 0.000004                       <1
----------------------------------------------------------------------------------------------------------------
Children (3-5 years)                                     0.003                 0.000004                       <1
----------------------------------------------------------------------------------------------------------------
Children (6-12 years)                                    0.003                 0.000003                       <1
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years)                                      0.003                 0.000001                       <1
----------------------------------------------------------------------------------------------------------------
Adults (20-49 yrs)                                       0.003                 0.000003                       <1
----------------------------------------------------------------------------------------------------------------
Adults (50+ years)                                       0.003                 0.000004                       <1
----------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                    0.003                 0.000003                       <1
----------------------------------------------------------------------------------------------------------------

    In addition to assessing the exposure to sulfuryl fluoride in food, 
EPA assessed fluoride exposure from residues in foods from the use of 
sulfuryl fluoride and/or cryolite as well as background levels in 
foods. Also addressed quantitatively are exposure from the use of 
fluoridated toothpaste, inhalation of fluoride from the atmosphere, and 
consumption of fluoride-containing water. Other known potential sources 
of fluoride exposure were not addressed quantitatively due to lack of 
data regarding residues and/or data regarding the demographics of 
exposure. Details regarding the residue profiles of the various 
fluoride sources are discussed below.
    Background fluoride in foods. Monitoring studies indicate fluoride 
is ubiquitous in the food supply (e.g., World Health Organization. 
2002; Rao,G. S. 1984; Sherlock, JC. 1984). The primary sources for 
residues used in this background food assessment were Taves, D.R. 
(1983) for plant-based foods, bovine and porcine commodities, and eggs; 
Fein, N.J. and Cerklewski F.L. (2001) for poultry; and residue trials 
for tree nuts and dried fruits (MRID 45510304). Average residue values 
were used when available. In cases were a range was listed, the maximum 
value in the range was used. In the 1983 study by Taves, 93 food items 
from a hospital in an area with fluoridated water were analyzed for 
fluoride content. The use of the Taves data accounts for the increase 
in fluoride residues that may occur when foods are processed/prepared 
in fluoridated water. Note that the residue estimates for dried fruits 
and tree nuts are at the LOQ for the residue trial method and are most 
likely overestimates of fluoride, based on the residue levels in other 
commodities. Overall, these should be considered to be conservative to 
slightly refined estimates of fluoride residues.
    Cryolite. In evaluating the exposure to fluoride from the 
agricultural uses of cryolite, residue trial data were matched as 
closely as possible to the current maximum use patterns for this active 
ingredient. Empirically derived processing factors were used for 
processed commodities of grapes, citrus, mint, and tomato. Default 
processing factors from DEEM Version 7.81 were used for all other 
commodities. Overall, these should be considered to be moderately 
refined estimates of residues.
    EPA has concluded that dietary exposure to fluoride will utilize 
30% of the MCLG (expressed as mg/kg/day) for the U.S. population, 18% 
of the MCLG (expressed as mg/kg/day) for youth 13-19 years, 29% of the 
MCLG (expressed as mg/kg/day) for children 3-5 years, and 27% of the 
MCLG (expressed as mg/kg/day) for All infants less than 1 year. These 
risk estimates are below the Agency's level of concern.

              Table 5.--Total Chronic Exposure and Risk Estimates for Fluoride from Dietary Sources
----------------------------------------------------------------------------------------------------------------
                                                 Dietary Fluoride Anion Exposure Estimates, mg/kg/day   Risk, %
                                        Tox.   -------------------------------------------------------  of MCLG
        Population Subgroup          Dose, mg/   Sulfuryl                                     Total    (as mg/kg/
                                       kg/day    Fluoride   Cryolite     Food      Water     Dietary      day)
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                  0.114     0.0004     0.0006     0.0068     0.0269     0.0347         30
----------------------------------------------------------------------------------------------------------------
All infants (<1 year)                    0.571     0.0005     0.0009     0.0093     0.1424     0.1531         27
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                     0.308     0.0013     0.0031     0.0175     0.0407     0.0626         20
----------------------------------------------------------------------------------------------------------------
Children (3-5 years)                     0.182     0.0012     0.0020     0.0149     0.0338     0.0519         29
----------------------------------------------------------------------------------------------------------------
Children (6-12 years)                    0.100     0.0007     0.0008     0.0094     0.0227     0.0336         34
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years)                      0.133     0.0004     0.0003     0.0062     0.0176     0.0245         18
----------------------------------------------------------------------------------------------------------------

[[Page 3250]]

 
Adults (20-49 years)                     0.114     0.0003     0.0004     0.0057     0.0252     0.0316         28
----------------------------------------------------------------------------------------------------------------
Adults (50+ yrs)                         0.114     0.0003     0.0005     0.0050     0.0256     0.0314         28
----------------------------------------------------------------------------------------------------------------
Females (13-49 years)                    0.131     0.0003     0.0005     0.0054     0.0238     0.0300         23
----------------------------------------------------------------------------------------------------------------

    iii. Anticipated residue and percent crop treated (PCT) 
information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use 
available data and information on the anticipated residue levels of 
pesticide residues in food and the actual levels of pesticide chemicals 
that have been measured in food. If EPA relies on such information, EPA 
must require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. As required by section 408(b)(2)(E) of 
FFDCA, EPA will issue a data call-in for information relating to 
anticipated residues to be submitted no later than 5 years from the 
date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    A routine chronic dietary exposure analysis for the postharvest 
fumigant Profume was based on 20% of the nut crop, 40% of dried fruit, 
2% of the stored grain will be treated postharvest with Profume.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described in this document for Profume used on postharvest 
use on stored commodities is reliable and has a valid basis. Profume is 
a postharvest fumigant of stored commodities that will replace methyl 
bromide uses for which the Agency has good information about the actual 
amounts used. It is also possible that Profume could replace other 
fumigant products for which there are also use data available, although 
not as refined as for MeBr. This has been considered when making the 
percent crop treated estimates which are considered to be conservative, 
i.e., estimating the upper range of the stored commodity market that 
will likely be treated with Profume.
    Tree nuts. Methyl bromide is used on nearly all walnuts and about 
3% of almonds. Dow estimated sulfuryl fluoride use will not exceed 10% 
on almonds and 20% on other nuts. The Agency used a PCT of 20% for all 
tree nuts.
    Dried fruit. Methyl bromide is used on 64% of prunes and 28% of 
raisins. Sulfuryl fluoride and phosphine are expected to share the 
market as a replacement for methyl bromide used to treat dried fruit. 
The Agency used a PCT of 40% for all dried fruits.
    Stored grains. (1) At flour mills: Wheat flour mills are typically 
fumigated 2 to 3 times per year, and there is enough stored grain to 
support 2 days of production at a typical flour mill facility. Three 
fumigations per year would mean 6 days of exposed production or 6/350 = 
1.7% of the grain handled by the mill would be exposed to sulfuryl 
fluoride, assuming that all flour mill fumigations were done with 
sulfuryl fluoride. (2) Other stored grains. Phosphine is used to 
fumigate stored grain, and 10% to 15% of stored grain is presently 
fumigated. It is expected that sulfuryl fluoride will replace only 10% 
of the phosphine usage because some phosphine products may be easier 
for some users than sulfuryl fluoride (one formulation of phosphine 
only requires that you drop pellets compared to the application and 
monitoring equipment required for sulfuryl fluoride), phosphine is less 
expensive than sulfuryl fluoride, and many grain fumigations do not 
require the faster fumigation of sulfuryl fluoride. Sulfuryl fluoride 
is likely to used for resistance management in many situations. 
Overall, it is expected only 1% to 1.5% of other stored grains will be 
treated with sulfuryl fluoride. The Agency used a PCT of 2% for all 
stored grains.
    As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which Profume may be 
applied in a particular area.
    2. Dietary exposure from drinking water. The Agency has determined 
that because of the use pattern and physicochemical characteristics of 
sulfuryl fluoride, neither residues of sulfuryl fluoride nor of 
inorganic fluoride are expected to reach surface water or ground water 
due to the postharvest fumigation (an indoor use) of the commodities 
listed in Unit II. Residues of inorganic fluoride may be in drinking 
water due to intentional fluoridation.
    Monitoring data based on 16 states from 1983 to 1998 that has been 
extrapolated to the U.S. (U.S. EPA, 2003) indicate that approximately 
99% of the U.S. population is supplied with water containing, on 
average, less than 2 ppm fluoride anion. In the current risk

[[Page 3251]]

assessment, the Agency has assumed a residue level of 2 ppm for tap 
water and 1 ppm for water sources other than tap water. The optimal 
fluoridation level for water is approximately 1 ppm. This residue level 
is reflected in the final product (e.g., soft drinks) when production 
is in areas with fluoridated water. Because of the inclusion of all 
non-tap water at 1 ppm, these should be considered to be slightly 
refined overall estimates of fluoride residues. The use of 2 ppm 
fluoride in tap water and 1 ppm in other water sources likely results 
in an overestimation of exposure for the general population, especially 
those on public water systems (93% of the U.S. population based on 2002 
Census figures). However, it may underestimate the level of residues 
present in drinking water for certain regional populations in the U.S. 
who are supplied by well water that is naturally high in fluoride. In 
monitoring data (1991-2002) from the National Water Quality Assessment 
(NAWQA) Program (http://water.usgs.gov/nawqa/), the concentration of 
fluoride in groundwater samples designated as being used for domestic 
purposes exceeded 2 ppm in at least one sample from 13 of 49 study 
units. Study units are major river basins and aquifers across the 
nation and typically encompass approximately 4000 square miles. 
Examination of data from each of those 13 study units indicates that 
there is a fair degree of spatial variability in fluoride levels. 
Similar finding regarding spatial difference in fluoride concentration 
have been noted in local monitoring studies. For example, data from 
Lakewood Township, Minnesota show a fluoride concentration of 0.4 ppm 
in a well located at a similar depth and only a few hundred feet from a 
well with a fluoride concentration of 14.0 ppm (Hastreiter, et al., 
1992). Similar variations in fluoride levels over small geographic 
areas were noted. Data are not available describing fluoride levels for 
a specific source over time, and it is unclear whether or not there is 
temporal, as well as spatial, variability in well water fluoride 
concentrations. If temporal variability is similar in magnitude to the 
spatial variability, then the 2-ppm estimate for fluoride in tap water 
is conservative for even those populations living in high-fluoride 
areas. Overall, the conservative values used for both fluoride residues 
in drinking water and drinking water consumption as well as 
conservative assumptions on exposure to fluoride through food and other 
non-dietary sources should not understate exposure to the general 
population or any major identifiable population subgroup.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (i.e., for sulfuryl fluoride, termiticide use).
    Sulfuryl fluoride is currently registered for use on the following 
residential non-dietary sites: fumigation of residential sites for 
termites. The risk assessment was conducted using the following 
residential exposure assumptions: Sulfuryl fluoride is registered for 
fumigation of domestic structures. Exposure could occur when residents 
re-occupy a fumigated home; however, the label restricts reentry to the 
residence until the measured levels of sulfuryl fluoride are very low. 
The Agency has determined, based the available exposure data supporting 
the Vikane registration and the Vikane label restriction on reentry 
that there is negligible exposure to sulfuryl fluoride from home 
fumigation (B. Daiss, May 15, 2001, DP Barcode 274960).
    Fluoride exposure may occur from non-dietary sources, including 
incidental ingestion of toothpaste and inhalation of airborne fluoride. 
Other non-dietary exposures may occur; however, the Agency has included 
only these two in its quantitative assessment due to lack of data 
regarding residue levels and/or exposure demographics. In order to take 
into account these other sources of non-dietary exposure, the Agency 
has used conservative assumptions when estimating exposure from 
toothpaste and air in an effort to ensure that exposures are not 
underestimated. Exposure estimates for fluoride from toothpaste and air 
for all of the population subgroups (i.e., in DEEM-FCID) are addressed.
    Toothpaste. A number of studies available in the open literature 
have been conducted to determine the exposure to fluoride from the 
incidental ingestion of toothpaste (e.g., Levy et al., 1995; Naccache 
et al., 1992, 1990; Simard et al., 1989; Bruun and Thylstrup, 1988; 
Barnhart et al., 1974). Due to the different techniques used to assess 
toothpaste ingestion and the different foci in those studies, the 
estimates of fluoride exposure from toothpaste are quite varied. A few 
common threads can be found, however: (1) incidental toothpaste 
ingestion decreases with age as children gain better control of the 
swallowing reflex; and, (2) ingestion of toothpaste can be a 
significant contributor to overall fluoride exposure.
    Despite the variability in the estimates of ingested toothpaste, 
maximum exposures to fluoride observed in those studies appear to 
converge to approximately 3 mg/day. In assessing fluoride from 
toothpaste, HED has used this maximum estimate of 3 mg/day and 
normalized to body weight using the NHANES dody weight data for the 
various population subgroups. The exposure estimates range from 0.005 
to 0.03 mg/kg/day and should be considered conservative in nature; 
especially for older population subgroups since exposure estimates were 
not adjusted for the age-related decrease in toothpaste ingestion.
    Air. Estimates of fluoride residues in air are presented in a 
number of review articles (e.g., World Health Organization, 2002; Burt, 
1992). In the U.S., airborne fluoride concentrations are highest around 
smelters and industrialized area. In such areas, the fluoride 
concentration does not typically exceed 3 [mu]g/m\3\. The Agency has 
used standard respiration rates derived from OPP/HED Science Advisory 
Council for Exposure Policy No. 12 (2/22/2001) and body weights to 
convert 3 [mu]g/m\3\ to a mg/kg/day basis. Exposure estimates range 
from 0.0006 to 0.0026 mg/kg/day. As with toothpaste, the risk estimates 
derived from these exposure estimates are below the Agency's level of 
concern.

                                             Table 6.--Estimated Fluoride Exposure from Non-Dietary Sources
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Estimated Exposure, mg/kg/day
                 Population Subgroup                      Body Weight, kg       Standard Respiration,  -------------------------------------------------
                                                                                       m\3\/day                Toothpaste                  Air
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population (total)                                                    70                     13.3                   0.0043                   0.0006
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year)                                                       7                      4.5                   0.0429                   0.0019
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                                       13                      8.7                   0.0231                   0.0020
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 3252]]

 
Children (3-5 years)                                                       22                      8.7                   0.0136                   0.0012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (6-12 years)                                                      40                      8.7                   0.0075                   0.0007
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth (13-19 years)                                                        60                     13.3                   0.0050                   0.0007
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults (20-49 years)                                                       70                     13.3                   0.0043                   0.0006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults (50+ years)                                                         70                     13.3                   0.0043                   0.0006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                                      61                     11.3                   0.0049                   0.0006
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In response to the EUP for sulfuryl fluoride, the Agency received 
comments regarding, among other things, sources of fluoride that were 
not considered in the EUP assessment. Most of those sources have been 
addressed quantitatively above; however, the use of fluoride 
supplements and the potential for increased exposure following food 
preparation in Teflon-treated cookware were specific issues that were 
not addressed numerically. Fluoride supplements are prescribed only by 
a health care professional. The community of health care professionals 
is aware of the potential for fluorosis and the use of supplements is 
only advocated when aggregate exposure is insufficient to provide 
protection against dental caries. Because the amount of fluoride 
prescribed is made in consideration of other fluoride sources, the use 
of fluoride supplements would not result in overexposure to fluoride. 
With respect to increased exposure to fluoride from the use of Teflon-
treated cookware, Full and Parkins (1975) report an approximately 3-
fold increase in the fluoride concentration of water boiled in a 
Teflon-coated pan relative to that of stainless steel or Pyrex glass. 
Due to their experimental design and the manner in which final fluoride 
concentrations are expressed, it is not possible to discern whether or 
not the increased fluoride concentration was due to leaching of 
fluoride from the Teflon or differential evaporation noted for the 
Teflon cookware versus other materials. Given the inert nature of 
Teflon and the strength of the covalent C-F bonds in the 
tetrafluoroethylene polymer, it is unlikely that fluoride would be 
released in sufficient quantities to increase its concentration in the 
water by 3 times. Based on the uncertainties associated with the 
experimental data and the properties of Teflon, the Agency does not 
believe that Teflon-treated cookware is a significant source of 
fluoride exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether sulfuryl fluoride or fluoride has a common mechanism of 
toxicity with other substances. Unlike other pesticides for which EPA 
has followed a cumulative risk approach based on a common mechanism of 
toxicity, EPA has not made a common mechanism of toxicity finding as to 
sulfuryl fluoride or fluoride and any other substances. Sulfuryl 
fluoride does produce the metabolite fluoride also produced by the 
insecticide cryolite and this risk assessment has included exposure 
from both exposure sources. For the purposes of this tolerance action, 
therefore, EPA has not assumed that sulfuryl fluoride and/or fluoride 
has a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the policy statements released by EPA's OPP 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional 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 data base on toxicity and exposure 
unless EPA determines based on reliable data 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 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. In the sulfuryl fluoride 
developmental toxicity study in rats, neither quantitative nor 
qualitative evidence of increased susceptibility of fetuses to in utero 
exposure to sulfuryl fluoride was observed. In the sulfuryl fluoride 
developmental study in rabbits, neither quantitative nor qualitative 
evidence of increased susceptability of fetuses to in utero exposure to 
sulfuryl fluoride was observed. In the sulfuryl fluoride 2-generation 
reproductive study in rats, neither quantitative nor qualitative 
evidence of increased susceptability of fetuses to sulfuryl fluoride 
was observed.
    A very large body of information regarding the toxicology of 
fluoride is available in the open literature. A complete review or re-
presentation of that information is beyond the scope of this 
assessment. For a comprehensive review of the toxicology of fluoride, 
the reader is referred to publications by the World Health Organization 
(2002), the National Research Council (1993), the Medical Research 
Council (1992), and

[[Page 3253]]

the Department of Health and Human Services (Draft Document 1993). In 
conducting the assessment for fluoride, the Agency has used the 
toxicological assessment and Maximum Contaminant Level Goals (MCLGs) 
established by the Agency's Office of Water. The MCLG was established 
in 1986 and is based on an LOAEL of 20 mg/day, a safety factor of 2.5, 
and an adult drinking water intake of 2 L/day. The use of a safety 
factor of 2.5 ensures public health criteria while still allowing 
sufficient concentration of fluoride in water to realize its beneficial 
effects in protecting against dental caries.
    3. Conclusion. There is a complete toxicity data base for sulfuryl 
fluoride with the exception of a developmental neurotoxicity (DNT) 
study in rats. The exposure data are sufficiently complete or are 
estimated based on data that reasonably accounts for potential 
exposures. Based on the available evidence, the Agency is requiring an 
inhalation developmental neurotoxicity (DNT) study in rats (Guideline 
No. 870.6300) as a condition of registration in order to more clearly 
and fully characterize the potential for neurotoxic effects in young 
animals.
    The Agency has determined that a 10X FQPA safety factor in the form 
of a data base uncertainty factor (UFDB) is needed to account for the 
lack of the DNT study since the available data provide no basis to 
support reduction or removal of the default 10X factor. The following 
points were considered in this determination:
    [sbull] The current regulatory dose for chronic dietary risk 
assessment is the NOAEL of 8.5 mg/kg/day (30 ppm; 0.13 mg/L) selected 
from a 90-day inhalation toxicity study in rabbits. This dose is also 
used for intermediate- and long-term inhalation exposure risk 
assessments. The current dose for the short-term inhalation exposure 
risk assessment is the NOAEL of 30 mg/kg/day (100 ppm; 0.42 mg/L) from 
a 2-week inhalation toxicity study in rabbits.
    [sbull] After considering the dose levels used in the neurotoxicity 
studies and in the 2-generation reproduction study, it is assumed that 
the DNT study with sulfuryl fluoride will be conducted at dose levels 
similar to those used in the 2-generation reproduction study (0, 5, 20, 
150 ppm; 0, 0.02, 0.08, 0.6 mg/L). It is considered possible that the 
results of the DNT study could impact the endpoint selection for risk 
assessments because the lowest dose that may be tested in the DNT (5 
ppm or 0.02 mg/L), based on the Agency's dose analysis, could become an 
effect level which would necessitate an additional factor resulting in 
doses which would then be lower than the current doses used for chronic 
dietary (8.5 mg/kg/day), intermediate and long-term inhalation (30 ppm 
or 0.13 mg/L) and short term inhalation (100 ppm or 0.42 mg/L) risk 
assessments. Given these circumstances, the Agency does not have 
sufficient reliable data justifying selection of an additional safety 
factor for the protection of infants and children lower than the 
default value of 10X. Therefore, a UFDB of 10X will be applied to 
repeated dose exposure scenarios (i.e. chronic RfD, and residential 
short, intermediate and long term inhalation) to account for the lack 
of the DNT study with sulfuryl fluoride.
    The Agency has determined that there is no need for a special FQPA 
safety factor (i.e., 1X) since there are no residual uncertainties for 
pre- and/or post-natal toxicity based on the following:
    [sbull] In the developmental toxicity study in rats, neither 
quantitative nor qualitative evidence of increased susceptibility of 
fetuses to in utero exposure to sulfuryl fluoride was observed.
    [sbull] In the developmental toxicity study in rabbits, neither 
quantitative nor qualitative evidence of increased susceptibility of 
fetuses to in utero exposure to sulfuryl fluoride was observed.
    [sbull] In the 2-generation reproduction toxicity study in rats, 
neither quantitative nor qualitative evidence of increased 
susceptibility of fetuses to sulfuryl fluoride was observed.
    Fluoride. Given the wealth of reliable human data on fluoride, EPA 
believes no additional safety factor for the protection of children is 
necessary (1X). Relying on the extensive data bearing on skeletal 
fluorosis, EPA's Office of Water reduced the traditional intraspecies 
safety factor to 2.5X. This is reasonable, especially given that the 
NAS has recommended that a safe dose for fluoride should be set using 
no intraspecies safety factor or any other safety factor.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. No toxicological endpoint attributable to a single 
exposure was identified in the available toxicology studies for either 
sulfuryl fluoride and/or fluoride; therefore, no acute risk is expected 
from exposure to these compounds.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that aggregate exposure to 
sulfuryl fluoride food will utilize less than 1% of the cPAD for the 
U.S. population, less than 1% of the cPAD for all population subgroups.
     EPA has concluded that aggregate exposure to fluoride from food 
will utilize 35% of the MCLG (as mg/kg/day) for the U.S. population, 
23% of the MCLG (as mg/kg/day) for youth 13-19 years, 37% of the MCLG 
(as mg/kg/day) for children 3-5 years, 35% of the MCLG (as mg/kg/day) 
for all infants less than 1 year, and 28% of the MCLG (as mg/kg/day) 
for children 1-2 years. These risk estimates are below the Agency's 
level of concern.

                                              Table 7.--Aggregate Exposure and Risk Estimates for Fluoride
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Estimated Fluoride Exposure by Source, mg/kg/day
                                                     MCL/SMCL, -------------------------------------------------------------------------------
                Population Subgroup                  mg/kg/day   Sulfuryl             Background                                               % of MCLG
                                                                 Fluoride   Cryolite     Food       Water    Toothpaste     Air       Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population (total)                                  0.114     0.0004     0.0006      0.0068     0.0269      0.0043     0.0006     0.0397         35
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year)                                    0.571     0.0005     0.0009      0.0093     0.1424      0.0429     0.0019     0.1980         35
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                     0.308     0.0013     0.0031      0.0175     0.0407      0.0231     0.0020     0.0877         28
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (3-5 years)                                     0.182     0.0012     0.0020      0.0149     0.0338      0.0136     0.0012     0.0668         37
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (6-12 years)                                      0.1     0.0007     0.0008      0.0094     0.0227      0.0075     0.0007     0.0419         42
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 3254]]

 
Youth (13-19 years)                                      0.133     0.0004     0.0003      0.0062     0.0176      0.0050     0.0007     0.0302         23
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults (20-49 years)                                     0.114     0.0003     0.0004      0.0057     0.0252      0.0043     0.0006     0.0365         32
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults (50+ years)                                       0.114     0.0003     0.0005      0.0050     0.0256      0.0043     0.0006     0.0364         32
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                    0.131     0.0003     0.0005      0.0054     0.0238      0.0049     0.0006     0.0355         27
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    The Agency determined there is no need to quantify the inhalation 
risk resulting from a single residential or occupational inhalation 
exposure to sulfuryl fluoride. No treatment-related neurotoxic or other 
effects were observed in a specially designed acute neurotoxicity 
inhalation study in which rats were exposed on two consecutive days for 
6 hours/day to concentrations up to 300 ppm of sulfuryl fluoride 
(equivalent to 1.25 mg/L). Further, no appropriate endpoints resulting 
from a single inhalation exposure were identified in any of the 
available toxicity studies on sulfuryl fluoride. Therefore, no hazard 
attributable to a single inhalation exposure was identified and 
quantification of risk for single inhalation exposures was determined 
to be unnecessary. The Agency notes that 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. These acute poisonings in humans, however, occurred only 
after label directions were grossly violated and persons were 
subsequently exposed to extremely high concentrations of sulfuryl 
fluoride. Therefore, based on the best available data and current 
policies, potential risks do not exceed the Agency's level of concern 
if label directions and precautions are followed.
    Fluoride is not expected to pose a short-term risk.
     4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Intermediate-
term residential exposure is not expected to occur with the use of 
sulfuryl fluoride. Furthermore, sulfuryl fluoride residues will not 
occur in water due to its extreme volatility as a gas; and based on the 
toxicology of fluoride and the behaviors associated with fluoride 
exposure a chronic risk assessment is appropriate not an intermediate-
term risk assessment. Therefore, based on the best available data and 
current policies, potential risks do not exceed the Agency's level of 
concern.
    Fluoride is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Sulfuryl fluoride and 
fluoride are not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to sulfuryl fluoride and inorganic fluoride residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology are available to enforce the 
tolerance expressions. The methods may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are no CODEX MRLs established. These are the first food 
tolerances for sulfuryl fluoride in the United States.

C. Conditions

    The conditions for registration are discussed in the Profume Notice 
of Registration. The Agency does note that the current MCLG and SMCL 
are under review by the National Academy of Science as requested by the 
Office of Water. This review is expected to be completed in 2005. 
Should there be a change in the MCLG and/or SMCL by the Office of Water 
then the registration of Profume may require revision.

V. Conclusion

    Therefore, tolerances are established for sulfuryl fluoride and 
inorganic fluoride residues of sulfuryl fluoride, in or on various 
commodities at the level specified in the tables below.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

[[Page 3255]]

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0373 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before March 23, 
2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0373, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., 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 section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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

[[Page 3256]]

``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 
final 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 section 408(n)(4) of FFDCA. 
For these same reasons, the Agency has determined that this 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 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 rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: January 13, 2004.
James Jones,
Director, Office of Pesticide Programs.

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

PART 180--AMENDED

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

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


0
2. Section 180.145 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  180.145  Flourine compounds; tolerances for residues.

    (a) * * *
    (3) Tolerances are established for residues of fluoride in or on 
the following commodities from the postharvest fumigation with sulfuryl 
fluoride for the control of insects:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, bran, postharvest..................................         45.0
Barley, flour, postharvest.................................         45.0
Barley, grain, postharvest.................................         15.0
Barley, pearled, postharvest...............................         45.0
Corn, aspirated grain fractions, postharvest...............         55.0
Corn, field, flour, postharvest............................         35.0
Corn, field, grain, postharvest............................         10.0
Corn, field, grits, postharvest............................         10.0
Corn, field, meal, postharvest.............................         30.0
Corn pop, grain, postharvest...............................         10.0
Fruit, dried , postharvest (other than raisin).............          3.0
Grape, raisin, postharvest.................................          7.0
Millet, grain, postharvest.................................         40.0
Nut, tree, Group 14, postharvest...........................         10.0
Oat, flour, postharvest....................................         75.0
Oat, grain, postharvest....................................         25.0
Oat, rolled, postharvest...................................         75.0
Pistachio, postharvest.....................................         10.0
Rice, bran, postharvest....................................         31.0
Rice, grain, postharvest...................................         12.0
Rice, hulls, postharvest...................................         35.0
Rice, polished, postharvest................................         25.0
Rice, wild, grain, postharvest.............................         25.0
Sorghum, grain, postharvest................................         40.0
Triticale, grain, postharvest..............................         40.0
Wheat, bran, postharvest...................................         40.0
Wheat, flour, postharvest..................................        125.0
Wheat, germ, postharvest...................................        130.0
Wheat, grain, postharvest..................................        40.04
Wheat, milled byproducts, postharvest......................        130.0
Wheat, shorts, postharvest.................................         40.0
------------------------------------------------------------------------


[[Page 3257]]

* * * * *
0
3. Section 180.575 is amended by revising paragraph (a) to read as 
follows:


Sec.  180.575  Sulfuryl fluoride; tolerance for residues.

    (a)(1) General. Tolerances are established for residues of sulfuryl 
fluoride in or on the following commodities from the postharvest 
fumigation with sulfuryl fluoride for the control of insects:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, bran, postharvest..................................         0.05
Barley, flour, postharvest.................................         0.05
Barley, grain, postharvest.................................          0.1
Barley, pearled, postharvest...............................         0.05
Corn, aspirated grain fractions, postharvest...............         0.05
Corn, field, flour, postharvest............................         0.01
Corn, field, grain, postharvest............................         0.05
Corn, field, grits, postharvest............................         15.0
Corn, field, meal, postharvest.............................         0.01
Corn pop, grain, postharvest...............................         0.05
Fruit, dried, postharvest..................................         0.05
Millet, grain, postharvest.................................          0.1
Nut, tree, Group 14, postharvest...........................          3.0
Oat, flour, postharvest....................................         0.05
Oat, grain, postharvest....................................          0.1
Oat, rolled, postharvest...................................          0.1
Pistachio, postharvest.....................................          3.0
Rice, bran, postharvest....................................         0.01
Rice, grain, postharvest...................................         0.04
Rice, hulls, postharvest...................................          0.1
Rice, polished, postharvest................................         0.01
Rice, wild, grain, postharvest.............................         0.05
Sorghum, grain, postharvest................................          0.1
Triticale, grain, postharvest..............................          0.1
Wheat, bran, postharvest...................................         0.05
Wheat, flour, postharvest..................................         0.05
Wheat, germ, postharvest...................................         0.02
Wheat, grain, postharvest..................................          0.1
Wheat, milled byproducts, postharvest......................         0.05
Wheat, shorts, postharvest.................................         0.05
------------------------------------------------------------------------

    (2) To assure safe use of this pesticide commodities treated with 
sulfuryl fluoride must be aerated for at least 24 hours prior to 
entering commerce.
* * * * *

[FR Doc. 04-1540 Filed 1-22-04; 8:45 am]
BILLING CODE 6560-50-S