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Briefing Paper On Issues Surrounding EPA Action Against Sulfuryl Fluoride January 14, 2011

On January 10, 2011 EPA announced its intention to propose a phased-in revocation of the tolerances for residues of sulfuryl fluoride (SF, or trade name ProFume) on food. This paper describes just some of the important issues affecting the milling industry as a result.

EPA’s action is forced by what was first a petition and later a legal request for stay of the agency’s tolerances for fluoride residues on foods. In response, EPA conducted a new risk assessment of fluoride in the diet. The government has concluded that fluorosis (over-exposure to fluoride) is no longer a “cosmetic effect” but rather is an “adverse health effect.” This triggered remedial action by the agency required by law.  At the same time EPA is denying the request for stay that would have resulted in an immediate revocation.

Specifically, the agency announced it will propose to revoke the food tolerances in a tiered fashion. It will accept public comments for 90 days, review the public comments and then issue a final rule (this could take months). NAMA’s Technical Committee will review and develop comments on the proposal, with input from the IAOM Food Protection Committee which will discuss this matter at its regularly scheduled meeting next week.

Under the proposal, 60 days after the final decision is announced (on date uncertain), EPA will immediately cancel SF uses for dried eggs and milk powder. Dow AgroSciences, the manufacturer, removed them from the label years ago.

Ninety days after the decision EPA proposes to revoke another group of tolerances including DIRECT INTENTIONAL fumigation of other foods including raw wheat, corn and oats and their milled products. This would NOT include small amounts of those products that remain in sifter boxes, roll stands, spouting, conveyors etc. during a general space fumigation.

Three years after the final decision EPA would revoke the remaining tolerances, including those for foods INCIDENTALLY treated during a general mill fumigation. In its announcement EPA states that an alternative would be for mills to achieve “complete removal” of all food from the facility during fumigation with sulfuryl fluoride.” Of course the question for millers here is whether ALL milled grain products can be removed from the milling systems.

Further, post-revocation, if a market sample of flour were found to contain residues it would be impossible to know whether that product were fumigated intentionally (clearly illegal at that point) or whether the residues were picked up as product moved through the milling system after the fumigation.

Once revocation of the residue tolerances occurs, NAMA pesticide counsel expects FDA would follow its “Channels of Trade” policy to allow some time for residue-containing foods already in commerce to work their way out of the marketplace. (available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/ChemicalContaminantsandPesticides/ucm077918.htm)

EPA states that the revocation may encourage millers that had already transitioned away from methyl bromide to go back to it. Under NAMA’s Critical Use Exemption for methyl bromide, this industry’s use of that fumigant has been cut roughly 90 percent. Already spot shortages have occurred, and this may add to them.

The agency admits “Older processing facilities constructed mainly of wood may have no options other than to cease production unless Dow AgroSciences seeks and obtains a registration amendment for sulfuryl fluoride that insures that sulfuryl fluoride is used in a manner not resulting in residues in food. Even so, it is unknown whether use of sulfuryl fluoride under such an approach is economically feasible.”

For wooden structures, EPA believes the entire three year phase-out period is appropriate. However, the agency states that heat treatment will be a feasible alternative for most mills and “a relatively short transition period may be appropriate” and proposes to allow SF use in concrete structures only “for a period no longer than necessary to accomplish the transition to heat technology.” The agency has not stated what that deadline might be but clearly it would be less than three years. The agency also does not comment on those mills that contain a combination of construction materials including both concrete and wood.

NAMA will seek answers from EPA on these questions as well as others that are identified in the technical review of the 109-page document. Further, NAMA will aggressively advocate the industry’s case to ease the transition should the agency act as it has proposed and seems highly likely.

January 2011

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