UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C. 20460

Date: February 6, 2014 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

SUBJECT: Inorganic Sulfites. Response to Comments on the Human Health Risk Assessment for Registration Review. PC Code: 077601 and 1 11409 Decision No
. : 486347 DP Barcode: 0417022 Registration No
. : NA Petition No.: NA Risk Assessment Type: NA TXRNo.: NA MRIDNo.:NA Regulatory Action: Regi stration Review Case No.: NA CAS No.: 7681-57-4 and 7446-09-5 40 CFR: § 180.444


### FROM:



### THRU:

TO: Idel iz Negron-Encarnacion, Ph.D., Cf" h jl •

# J:?/u L Alexandra LaMay , M.Sci., Bio logist 

# v{ -{f( Risk Assessment Branch V Health Effects Division (7509 P)
Michael Metzger, Branch C Seyed Tadayon , Chemist Risk Assessment Branch Jeff rey Dawson,**Chemist** Immediate Office Health Effects Division (7509P)
Khue Nguyen, Risk Manager Reviewer Neil Anderson, Branch Chief Risk Management & Implementation Branch VII Pesticide Re-evaluation Division (7508P)
Snowden Enterpises Inc
. , Quimetal Industrial S.A. and Quimas S.A. , and Imal Ltda. have submitted comments on the Health Effect's Division (HED) document titled Inorganic 

### Sulfites. Human Health Assessment Scoping Document in Support of Registration Review. (09/1 1/ 13; D411060)
. HED has presented the registrants ' comments (Docket E PA-HQ

- OPP-2013-0598) along with the corresponding HED response.

Page 1 of4Snowden Enterprises Inc. Comment 1: The registrant corrects the tolerance reference in page 3 ofthe scoping document. Re s ponse: HED appreciates the correction and acknowledges that the reference is 40 CFR 180.444. Comment2: • The registrant indicates that the scoping document specifies that sulfites are not a residue of concern (ROC)
. • The registrant expresses concern in aggregating non-pesticidal uses of sulfites with pesticidal uses of sulfites in the dietary assessment and requests the Agenc y to confine any reassessment oftolerances fo r sulfites only to pesticida l uses of sulfur dioxide and inorganic sulfites. Response: • The scoping document indicates that sulfate is not considered a ROC. Sulfite is identified as a residue of concern. • Section 408(b)(2)(ii) of FFDCA requires EPA to make a finding for each tolerance or tolerance exemption "tha t there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all ant icipated dietary exposures and all other exposures for which there i s reli able information. " The Agency will determine the best way to incorporate all residues of sulfites into its assessment consistent with this legal mandate. Comment 3: The registrant states that they are currently reviewing all the residue data and comparing it to the label. Respons e : The Agency requests that th e registrant submit any residue data which supports current pesticidal use patterns and has not b een previously considered by EPA. Comment 4: The registrant provided detail s regarding faci lities that do not use wet scrubbing and directly vent treated air. Considering the restriction in the 

### RED that facilities cannot release concentration more than 30 ppm ofS02 through venting, the registrant believes there is sufficient information that a bystander risk assessment is not needed. The registrant is willing to work with the Agency to provide information regarding use and release of S02 to clarify outstanding issues or concerns. Response: A bystander assessment will be completed, either quantitatively or qualitatively, depending on the specific information available describing the potentia l for these exposures . HED will work with the registrants as necessary to identify data needs. 

### Comment 5: The registrant is 

### not aware of human incidents invol ving the appropriate use of sulfur dioxide products. Page 2 of 4Response: HED appreciates the registrant input on human incidents and safety measures associated with the use of sulfur dioxide. Comment 6: The registrant would like to confirm that the reques t for monitor ing data on fumigated commodities is required for sodium metabisulfite products only. HED Response: The Agency confirms that the request for monitoring data is required for sodium metabisulfite pads only. Please refer to Appendix F of the scoping document for more information regarding this data requirement. Quimetal Industrial S.A. and Quimas S.A. Comment 1: The registrant states that labeling indicating tha t the combined use of pads and liners is not allowed is a misunderstanding ofthe use pattern. Response: An initial fumigation with sulfur dioxide followed by the us e of pads is recommended on the label of some sodium metabisulfite pads only. The labels of other end us e products formulated with sodium metabisulfite do not contain this restriction. HED recommends a statement on the label ofthese products indica ting that the combined use ofpads and fumigation with sulfur dioxide is not allowed. This prohibition is only proposed for tho se label s of sodium metabisulfite products which currently do not have this restriction. Alternatively, the registrant can submit data to show that the combined use of sulfur dioxide and those sodium metabisulfite products would not res ult in over-tolerance residues. Comment 2: The registrant is concerned with the request for monitoring data and propose s the use of laboratory experimental data to establish the levels of 

## so2 during transport, and upon opening packaging containers. Response: The Agency will consider all manner of research options for the data requirement. EPA will review and consider the laboratory data mimicking the conditions of use ofthe sodium metabisulfite pads and will determine if the data fulfill the data requirement. Adequate description ofhow the commercial conditions of use of the pads are reproduced in the laboratory and adequate justification of how the data are protective of actual occupational exposure should be submitted for consideration to determine ifthe study fulfills the data requirement. A protocol describing the proposed study s hould be submitted for Agency consideration before beginning the work.
Imal Ltda. (Holzworth & Kato on behalf ot) Comment 1: The regi s trant states that sodium metabisulfite is not considered a fumigant in their industry. Page 3 of4Response: HED considers the sulfur dioxide generated by sodium metabisulfite responsible of the pesticidal activity. This gas is formed and released by the pads and considered a fumigant. Comment 2: The registrant requests that the anticipated data needs are specified with respect to the active ingredient to which they apply. Response: The registrant is referred to Appendix F ofthe seeping document which includes additional description of the active ingredient to which the each data requirement applies. The data requirements and respective active ingredients are: inhalation exposure study for applicators (compressed sulfur dioxide); product usage information (compressed sulfur dioxide); post-application inhalation exposure study (compressed sulfur dioxide); and monitoring data on fumigated commodities (sodium metabisulfite). Comment 3: The registrant is concerned with inclusion of label statement restricting the use of both sulfur dioxide pads and fumigation with sulfur dioxide gas but will wait to comment until more information is shared during registration review. Response: The registrant is referred to the response to Comment 1 of Quimetal Industrial S.A. and Quimas S.A. for additional information.

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