EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER Summary of Petition EPA has received a pesticide petition ([insert petition number]) from Productos Químicos y Alimenticios OSKU S.A. (OSKU), 5212 El Guanaco, Huechuraba, Santiago, Chile proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues o f sulfur dioxide (from sodium metabisulfite) in or on the raw agricultural commodity blueberries at 10 parts per million (ppm). Adorno & Yoss, LLP of Washington, D.C. serves as the agent for OSKU. EPA has determined that the petition contains data or inf ormation regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before E PA rules on the petition. A. Residue Chemistry
1. Plant metabolism. Residues studies (OPPTS 860.1300) were conducted in postharvest blueberries in order to characterize the fate of sulfur dioxide in the fruit. The residue of concern is sulfur dioxide released from sodium metabisulfite which is contained in pads as a sole active ingredient. The active ingredient sodium metabisulfite in the pads releases sulfur dioxide when it absorbs moisture generated by blueberries. Sulfur dioxide generating pads have been registered for use on post

- harvest table grapes as a fungicide. The metabolism of sulfur dioxide is well known in the literature. (See Reregistration Eligibility Decision (RED)

– Inorganic Sulfites, May 2007, which is available at the following EPA web site: http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf .)
2. Analytical method. An adequate residue analytical method is available for enforcement purposes. The modified Monier

- Williams method, which is the official method of analysis approved by the Association of Official Analytical Chemists (AOAC), is listed in 40 CFR Appendix B t o Part 425. 3. Magnitude of residues. The residue studies were performed in the United States under laboratory and commercial conditions in order to determine the magnitude of the residue in blueberries.
B. Toxicological Prof

ileSulfiting agents have been used for centuries in food processing as sanitizing agents,

preservatives, inhibitors of undesirable microorganisms in fermentation, inhibitors of browning and discoloration during the preparation, storage, and distributio n of many foods, and in other uses. Sulfiting agents, including sulfur dioxide (SO2) and SO2 generating sodium metabisulfite, are listed as the Generally Recognized As Safe (GRAS) status by the Food and Drug Administration (FDA), with limitations, as food preservatives, while the pesticidal use of sulfating agents on grapes falls under EPA’s jurisdiction. EPA established a tolerance limit of 10 ppm for sulfur dioxide. 40 CFR 180.444. Under section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDC A), EPA reassessed this tolerance in May 2007. Sufficient data were available to support the reassessment of the tolerance. An assessment of the toxic effects caused by sulfur dioxide is discussed in the Reregistration Eligibility

Decision (RED)

– Inorga nic Sulfites, EPA, May 2007, which is available at the following EPA web site: http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf

.

1. Animal metabolism. The metabolism of sulfur dioxide in mammals is adequately understood. (See Toxicological Profile for Sulfur Dioxide, U.S. Department of Health and Human Service, December 1998, which is available at the following web site: http://www.atsdr.cdc.gov/toxprofiles/tp116.pdf

. )

2. Metabolite toxicology

. The metabolism of sulfur dioxide is adequately known. (See Toxicological Profile for Sulfur Dioxide, U.S. Department of Health and Human Service, December 1998, which is available at the following web site: http://www.atsdr.cdc.gov/toxprofiles/tp116.pdf .)
3. Endocrine disruption

. Reproductive effects were not observed in rats exposed to 5

- 30 ppm sulfur dioxide for a period from 9 days prior to mating until 12

- 14 day s of pregnancy ; or in mice exposed to 25 ppm sulfur dioxide 7 hours/day on gestation days 6

- 15; or in rabbits exposed to 70 ppm sulfur dioxide 7 hours/day on gestation days 6

- 18. (See Toxicological Profile for Sulfur Dioxide, U.S. Department of Health and Human Service, December 1998, which is available at the following web site: http://www.atsdr.cdc.gov/toxprofiles/tp116.pdf .) C. Aggregate Exposure Based on the use pattern of sulfur dioxide and sodium metabisulfite, EPA has determined that aggregate exposure to sulfites does not pose a risk concern. (See Reregistration Eligibility Decision (RED)

– Inorganic Sulfites, EPA, May 2007, which is available at the following EPA web site: http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf .)
1. Dietary exposure. i. Food.Sulfur dioxide (21 CFR 182.3862) and sodium metabisulfite (21 CFR 182.3766) are listed as

GRAS by the FDA, with limitations, as food preservatives. Sulfiting agents are found in many foods, primarily

as a result of the GRAS preservative use. It is estimated the sulfite concentrations of >100 ppm may be found in dried fruits (excluding dark raisins and prunes), lemon and lime juices, wine, molasses and sauerkraut juice. Dried potatoes, grape juice, wine vinegar, gravies, fruit topping, and maraschino cher ries may contain between 50 and 100 ppm sulfur dioxide. Foods containing between 10 ppm and 50 ppm include pectin, fresh shrimp, corn syrup, sauerkraut, pickled foods, corn starch, hominy, frozen potatoes, maple sy rup, imported jams and jellies and fresh mushrooms. The World Health Organization (WHO) has emphasized the use of appropriate labeling for alerting individuals who cannot tolerate sulfites. After receiving and reviewing reports of adverse reactions in certain individuals following ingestion o f sulfating agents used as preservatives in food products, beverages, and fresh fruits and vegetables, the FDA required ingredient labels to list sulfite concentrations in excess of 10 ppm. The uses of products containing inorganic sulfites are limited to use as indoor fumigants and as fungicidal control agents on grapes. A tolerance limit of 10 ppm (expressed as sulfite) for sulfur dioxide is established in 40 CFR 180.444, and sufficient date are available to support the reassessment of this tolerance. This 10 ppm tolerance is relatively low compared to concentrations of sulfites in many common foods and viewed as GRAS by FDA. Further this level for which FDA requires labeling to alert sulfite

- sensitive individuals. Therefore, residues resulting from the postharvest use of sulfur dioxide and sodium metabisulfite on grapes are not expected to be at a level of concern for the general population or any population subgroups. OSKU believes the proposed 10 ppm tolerance for sulfur dioxide on blueberries wou ld not constitute a level of concern for the general population or any population subgroups.
ii. Drinking water. Based on the use pattern and fate characteristics of these chemicals, EPA has concluded that it does not have any

drinking water concern s for sulfur dioxide and sodium metabisulfite. (See Reregistration Eligibility Decision (RED)

– Inorganic Sulfites, EPA, May 2007, which is available at the following EPA web site: http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf .)
2. Non

- dietary exposure

. Since sulfur dioxide is primarily pr esent in gaseous form, the general public is exposed to it mostly by inhaling contaminated air. Exposures would be expected to be highest near industrial activities that involve fuel combustion. Occupational exposures to sulfur dioxide are associated wit h workers in steel processing, refinery, and chemical plants. It has been estimated that approximately 600,000 American workers may be occupationally exposed to sulfur dioxide. Some of the highest exposures occur when it is a by

- product, as in the metal smelting industry, and in the processing or combustion of high

- sulfur coalor oil. (See HSDB 1998, Hazardous Substances Data Bank, National Library of

Medicine, National Toxicology Information Program, February 1998.)
Le vels of occupational exposure vary from industry

to industry . Sulfite pulp worker exposure fluctuates but reaches levels greater than 10 ppm (26 mg/m3) in the 1950 ́s (studies in Finland, Norway, and the United States). (See IARC. 1992. IARC monographs on the evaluation of the carcino genic risk of chemicals to man: Occupational exposures to mists and vapours from strong inorganic acids, and other industrial chemicals. Vol. 54. Lyon, France: World Health Organization, International Agency for Research on Cancer .) Because of modernization of facilities and processes, these levels have been falling. Roasting of ores and the combustion of sulfur

- containing fuels in the metal industries have resulted in workplace exposure concentration means of 1

- 10 ppm (2.6

- 26 mg/m3) in copper smelters and 1 ppm (2.6 mg/m3) or less in other operations. Occupational exposure levels with a mean >1 ppm (2.6 mg/m3) have been measured during sulfuric acid and superphosphate fertilizer manufacture as well as during firefighting.

No information was found regarding the number of people potentially exposed in the vicinity of hazardous waste sites. However, since sulfur dioxide has been found near hazardous waste sites, people living near them may be exposed to higher than background levels.
D. Cumulative Effects Section 408 (b)(2)(D)(v) of the 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 pestici de residues and “other substances that have a common mechanism of toxicity”. EPA does not have, at this time, available data to determine whether inorganic sulfites, including sulfur dioxide, have a common mechanism of toxicity with other substances. Unl ike 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 inorganic sulfites, including sulfur dioxide, and any other substances, and inorganic sulfites do not appear to produce a toxic metabolite produced by other substances.

E. Safety Determination
1. U.S. population. EPA has determined that taking into consideration of all available information on sulfur dioxide and sodium metabisulfite, including the specific use pattern and limited exposure potential, FDA’s classification of GRAS, as well as the historical presence of sodium metabisulfite in cosmetics and hair care products, the use of sulfur diox ide and sodium metabisulfite on postharvest grapes is unlikely to pose a significant risk to the generalpopulation or any population subgroup. (See Reregistration Eligibility Decision (RED)

–

Inorganic Sulfites, EPA, May 2007, which is available at the following EPA web site: http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf .) OSKU believes that the use of sulfur dioxide and sodium metabisulfite on postharvest blueberries would not pose a significant risk to the general population.

2. Infants and children

. The re is sufficient toxicological information for sulfur dioxide and sodium metabisulfite to address FQPA considerations. The available information indicates that there is no evidence of increased quantitative or qualitative susceptibility of the offspring a fter in utero or post

natal exposure. Based on this information, OSKU believes that there is no concern, at this time, for increased sensitivity to infants and children to sulfur dioxide and sodium metabisulfite when used on posthaverst blueberries.

F. International Tolerances There is currently no Maximum Residue Level (MRL) established for sulfur dioxide on blueberries by

the Codex Alimentarius Commission. However, OSKU is aware that New Ze aland and the European Community are considering the inclusion of the use of sulfur dioxide on blueberries with permitted sulfur dioxide residues of up to 10 ppm.