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J/.L.11~ FROM: Danette Drew, Chermst W~- "Tl

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J/.L.11~ FROM: Danette Drew, Chermst W~- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM Date: 23-MAR-2020 SUBJECT: Inorganic Sulfites. Draft Human Health Risk Assessment in Support of Registration Review. PC Codes: 077601 and 111409 DP Barcode: D455747 Decision No.: 558683 Registration No.: NA Petition Nos.: NA Regulatory Action: Registration Review Risk Assess Type: Single Chemical Aggregate Case No.: NA TXR No.: NA CAS No.: 7681-57-4 and 7446-09-5 MRID No.: NA 40 CFR: § 180.444 . J/.l.11~ FROM: Danette Drew, Chermst w~- "tl. 0 William Donovan, Chemist ~ _ John Liccione, Toxicologist ~ Kelly Lowe, Environmental Scientist ~ ~~ Risk Assessment Branch V Health Effects Division (7509P) THRU: Michael S. Metzger, Chief Risk Assessment Branch V NII Health Effects Division (7509P) TO: Matthew B. Khan, Chemical Review Manager Risk Management & Implementation Branch I Pesticide Re-evaluation Division (7508P) Page 1 of 40 Inorganic Sulfites Draft Human Health Risk Assessment D455747 Table of Contents 1.0 Executive Summary .............................................................................................................. 3 2.0 Established and Recommended Tolerances .......................................................................... 6 2.1 International Harmonization .............................................................................................. 6 3.0 Data Requirements and Label Recommendations ................................................................ 6 4.0 Inorganic Sulfites Formulations and Use Patterns ................................................................ 7 5.0 Hazard Assessment ............................................................................................................. 12 5.1 Absorption, Distribution, Metabolism & Elimination (ADME) ..................................... 12 5.2 Toxicity of Sulfur Dioxide and Sodium Metabisulfite .................................................... 12 5.3 Regulatory Values for Sulfur Dioxide and Inorganic Sulfites ........................................ 15 5.4 FQPA Considerations ...................................................................................................... 16 5.5 Endocrine Disruptor Screening Program ......................................................................... 16 6.0 Anticipated Exposure Pathways ......................................................................................... 17 7.0 Residue Chemistry .............................................................................................................. 17 8.0 Dietary Exposure ................................................................................................................ 19 9.0 Residential Exposure .......................................................................................................... 19 10.0 Aggregate Exposure and Risk Assessment ......................................................................... 19 11.0 Non-Occupational Spray Drift Exposure and Risk Estimates ............................................ 19 12.0 Non-Occupational Ambient Inhalation Exposure and Risk Estimates ............................... 20 13.0 Non-Occupational Bystander Exposure and Risk Estimates .............................................. 20 14.0 Occupational Exposure ....................................................................................................... 30 14.1 Acute and Short-/Intermediate-Term Occupational Handler Exposure ....................... 30 14.2 Acute and Short-/Intermediate-Term Occupational Post-Application Exposure ......... 31 14.2.1 Occupational Post-application Dermal Exposure .................................................. 31 14.2.2 Occupational Post-application Inhalation Exposure .............................................. 32 15.0 Public Health and Pesticide Epidemiology Data ................................................................ 34 16.0 Environmental Justice ......................................................................................................... 34 17.0 Cumulative Risk Assessment .............................................................................................. 35 18.0 Human Studies .................................................................................................................... 36 19.0 References ........................................................................................................................... 36 Appendix A. Toxicology Database-Sulfur Dioxide Regulatory Limits ...................................... 38 Appendix B. Chemical Identification/ Physical and Chemical Properties .................................. 39 Appendix C. International Residue Limit Status Sheet. .............................................................. 40 Page 2 of 40 Inorganic Sulfites Draft Human Health Risk Assessment D455747 1.0 Executive Summary As part of Registration Review, the Pesticide Reevaluation Division (PRD) of the Office of Pesticide Programs (OPP) has requested that the Health Effects Division (HED) evaluate the hazard and exposure data and conduct dietary and non-dietary (occupational and residential) exposure assessments, as needed, to estimate the risk to human health that will result from the currently registered uses of pesticides. This memorandum serves as HED’s draft human health risk assessment (DRA) for the currently registered conventional pesticidal uses of the inorganic sulfites [i.e., sulfur dioxide (SO2) and sodium metabisulfite (an SO2 generator)] in support of Registration Review. There is a registered antimicrobial use of sodium metabisulfite. The registered product is formulated as packaging stickers (containing (18.8% active ingredient), which are placed inside storage and shipment containers containing items such as, footwear, clothing, luggage, handbags, purses, wallets, gloves, hats, belts, leather goods, sporting goods, and other associated materials. The stickers release sulfur dioxide within the containers as they absorb moisture. This use has been assessed by the Antimicrobials Division (AD) in a separate memo (D4554711). For the conventional uses, sulfur dioxide is used as a postharvest fumigant treatment for grapes held in cold storage in enclosed spaces (e.g. warehouses and transportation vehicles) to control gray mold disease, which is caused by Botrytis cinerea. In addition, sulfur dioxide is used as a fumigant for sanitation of wine corks and barrels. The sodium metabisulfite products are composed of the anhydrous, solid active ingredient contained in semi-sealed pads (or liners) that are used for the fungicidal control of B. cinerea in table grapes. The sodium metabisulfite pads are placed in containers holding grapes for shipping and storage. As the pads absorb ambient moisture, they release sulfur dioxide within the crate. Humans may be exposed to inorganic sulfites in food, since sulfur dioxide may be applied directly to grapes after harvest. Exposures through drinking water are not expected since residues are not expected in water due to the use pattern. There are no uses resulting in direct residential exposures; however, there is the potential for non-occupational bystander inhalation exposures to sulfur dioxide. Dermal exposures are not expected given the high vapor pressure of sulfur dioxide and based on the labeled delivery systems. Occupational inhalation exposures are possible. Occupational handlers may be exposed while handling the pesticide prior to application and immediately after application and clearance. Occupational post-application inhalation exposures may also occur from activities associated with cold storage of commodities treated with sulfur dioxide. Hazard Assessment The inorganic sulfites pesticides include sulfur dioxide and sodium metabisulfite. There is a large volume of published data detailing the toxicity of inorganic sulfites, and consequently the toxicity of inorganic sulfites has been well established. EPA’s Office of Air Quality Planning and Standards (OAQPS) has worked extensively on sulfur dioxide, including setting national 1 D455471. Denning, A. 03/23/2020. Registration Review Draft Risk Assessment for the Antimicrobial Use of Sodium Metabisulfite. Page 3 of 40 Inorganic Sulfites Draft Human Health Risk Assessment D455747 ambient air quality standards (NAAQS) for sulfur dioxide, a gaseous air pollutant. The U.S. Food and Drug Administration (FDA) has also performed an extensive review of sulfiting agents (including sulfur dioxide, sodium metabisulfite, and sodium bisulfite) that have been added to any food or to any ingredient in any food. For this assessment, HED is relying on established OAQPS regulatory values for sulfur dioxide (bystander inhalation assessment) and the established FDA regulatory value for sulfite (dietary assessment). For occupational workers, HED is also relying on various regulatory levels for inhalation exposure to sulfur dioxide. These include the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL), the National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limit (REL) and Short-Term Exposure Limit (STEL), and the American Conference of Governmental Industrial Hygienists (ACGIH) STEL. Sulfur Dioxide: The primary mechanism of action of sulfur dioxide is that of an irritant, the respiratory system being the primary target. The most sensitive endpoints are increased airway resistance and decreased forced
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