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ACTION ALERT and UPDATE on Sulfuryl fluoride.

EPA's latest effort to set tolerances for inorganic Fluoride residues "in and on" a large number of raw and processed food products.

February 19, 2002

From Ellen Connett <wastenot@northnet.org>, FAN's Pesticide webmaster

Background: Methyl Bromide is a widely used fumigant but its use is being phased-out because it is known to destroy the ozone layer. Sulfuryl fluoride has been touted as the alternative. The following information provides a glimpse of the potential for Sulfuryl fluoride use:

The toxicological endpoint of concern for Sulfuryl fluoride is inorganic fluoride. In brief, on February 7th, EPA approved Dow's request to use Sulfuryl fluroide with very high tolerances for inorganic fluoride residues: in or on raisins at 30 ppm; in or on walnuts at 12 ppm. On February 15th, Dow submitted another petition requesting tolerances for inorganic Fluoride residues on 40 food commodities and products. Comments are needed to be submitted to EPA on this request. Below is an abbreviated timeline of the first efforts to use Sulfuryl fluoride as a replacement for Methyl bromide as a fumigant on food.

June 2001: Dow petitioned the EPA for an Experimental Use Permit (EUP) to use Sulfuryl fluoride as a fumigant on raisins and walnuts. An EUP is a request for "time-limited" use. Concurrent with this petition was a request for tolerances for inorganic fluoride residues. (See Reference 1 below for more information on a EUP.)

Sept 5, 2001: EPA responded to Dow's petition by publishing a health assessment of Sulfuryl fluoride in the Federal Register. This was significant because up to this time Sulfuryl fluoride was only used as a structural fumigant, never on food. The assessment was a major move to set broader inorganic fluoride tolerances "in and on" food (see Table 3 below for Current Food Tolerances for inorganic fluoride from the use of Cryolite). Because Sulfuryl fluoride never had any food uses, several important studies on this highly toxic pesticide have not been performed. EPA's response to Dow's petition and EPA's health assessment published in the Federal Register are at: http://www.fluoridealert.org/pesticides/Sulfuryl.Flu.FR.Sept.5.2001.htm
See also my submission to EPA objecting to this petition at: http://www.fluoridealert.org/pesticides/Fed.Reg.Sulfuryl.F.comments.htm
Specifics of this proposal regarding inorganic fluoride residues:

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

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

Feb 7, 2002: In a "Final Rule" EPA approved "time-limited" tolerances for inorganic fluoride residues "in and on" raisins at 30 parts-per-million (ppm) and 12 ppm for walnuts (see Table 2 below). EPA's explanation for the very high tolerances of fluoride residues in or on raisins is that it accounts for the residues from the use of cryolite on grapes. Dow had initially requested an exemption for fluoride tolerances for raisins. While EPA disagreed, they did not state what the levels of fluoride residues are from the use of Sulfuryl fluoride. The current tolerance for fluoride in or on grapes is 7 ppm from the use of Cryolite. Because the new approved tolerances for raisins and walnuts are very high, EPA's rational for approving Dow's request will be more than a little interest to fluoride fighters. For example,

In consideration of the proposed temporary tolerances for 
walnuts and raisins, the Agency used the maximum concentration limit 
goal (MCLG) of 4.0 ppm (0.114 mg/kg/day) for fluoride as the basis for 
a maximum allowable exposure to inorganic fluoride (see the Cryolite 
Reregistration Eligilibility Decision, 8/96, EPA-738-R-96-016). This 
exposure was used as the chronic population adjusted dose for inorganic 
fluoride in the risk assessment supporting the temporary tolerances. 
The exposure to fluoride from this use is estimated to be insignificant 
when compared to typical exposures from fluoridated water supplies. In 
addition, fluoridation of water has been endorsed by the U.S. Surgeon General.

See EPA's Final Rule published in the Federal Register at: http://www.fluoridealert.org/pesticides/Sulfuryl.F.FR.Feb.7.2002.htm
Note: To object to this Final Rule will require a lot of work:
- To submit an Objection to a Final Rule can be a costly affair - approx. $8,000 unless it can be proved to EPA that one does not have a "financial interest" in the outcome. We qualify for that.
- The brief to be submitted by April 8, 2002, requesting a Hearing to Object to the Final Rule needs to be substantive and relevant. Anyone who wants to work on this with Ellen please email her at: <wastenot@northnet.org>. Also, anyone with information that could lend support to the notion that the production of Sulfuryl fluoride could impact the ozone layer please contact Ellen.

Feb 15, 2002: Dow petitioned EPA for tolerances of inorganic fluoride residues for 40 different raw and processed food commodities (see Table 1 below). Objections to this proposal must be submitted to EPA by March 18. See Dow's petition published in the Federal Register at: http://www.fluoridealert.org/pesticides/Sulfuryl.F.FR.Feb.15.2002.htm -
Comments MUST be identified with Docket control number PF-1068 and must be received on or before March 18, 2002.
Email comments to: <opp-docket@epa.gov>
or mail them to:
Public Information and Records Integrity Branch (PIRIB)
Information Resources and Services Division (7502C)
Office of Pesticide Programs (OPP)
Environmental Protection Agency
1200 Pennsylvania Ave., NW., Washington, DC 20460
(Please send us a copy.)

Note: Sulfuryl fluoride has been identified as a "BAD ACTOR" pesticide by the Pesticide Action Network because of its Acute Toxicity. See FAN's data on Sulfuryl Fluoride at: http://www.fluoridealert.org/pesticides/SULFURYL-FLUORIDE-PAGE.htm.

See also: The Cryolite Task Force petition for increased fluoride tolerances (see Table 4 below) published in the Federal Register on August 7, 1997.

Table 1: Tolerances proposed by Dow on February 15th. Note that two sets of tolerances have been requested.

Table 2: Tolerances approved by EPA on Feb 7 for Dow's "Experimental Use Permit".

Note the difference in tolerances compared to Dow's Request of Feb 15:

Table 4: On August 7, 1997, the Federal Register published a petition from the Cryolite Task Force, comprised of Elf Atochem North America and the Gowan Company, that requested higher fluoride tolerances. EPA has yet to act on their request. The petition proposes
(1) Increasing the established tolerances for residues of the insecticidal fluorine compounds cryolite and /or synthetic cryolite in or on the agricultural commodities as listed below;
(2) establishing separate tolerances for the residues in or on head and leaf lettuce; and
(3) establishing tolerances for the residues in the processed foods, raisins at 55 ppm, and tomato paste at 45 ppm.

Reference 1:

Experimental Use Pemits: The U.S. Code of Federal Regulations for Experimental Use Permits has many subsets. Listed below is just one. For more information see: http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr172_00.html
§  172.5  The permit.

(a) Issuance. The Experimental Use Permit shall be issued when the Administrator determines that the conditions of section 5 of the Act, and the regulations thereunder, have been met subject to such terms and conditions as the Administrator determines are warranted.

(b) Duration. Permits will be effective for a specified period of time, normally one year, depending upon the crop or site to be tested and the requirements of the testing program submitted. The applicant should propose a suitable duration of the permit commensurate with the program submitted. Permits and associated temporary tolerances may be renewed, extended, or amended upon request if circumstances warrant.

(c) Limitations. The quantity of a pesticide allowed by a permit may be less than requested if it is determined that the available information on efficacy, toxicity or other hazards, the need for data, or the adequacy of program supervision does not justify the quantity of the pesticide requested. Other limitations may also be placed in the permit if necessary for the protection of the public health and the environment.

(d) Additions. With respect to an experimental use pesticide containing any chemical or combination of chemicals not included in any previously registered pesticides, the Administrator may require that additional studies be conducted during the permit period to gather data to support the establishment of tolerances and/or registration. To the extent practicable, the applicant will be notified of any such requirements before or at the time an experimental use permit is issued.

(e) Maintenance of records. All producers of pesticides produced pursuant to an experimental use permit shall maintain records in accordance with part 169.