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

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM

Date: March 21,2013

SUBJECT: Sulfur: Updated Revi e w of Human Incidents

PC Code: 0775 0 I DP Barcode: D41 0259 Decision No.: 470688 Petition No.: N A Risk Assessment Type: NA TXRNo

. : NA MRIDNo. : NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 7704

- 34

- 9 40CFR: NA

FROM: Shanna Recore, Industrial Hygienist 

# f a Toxicology and Epidemiology B r anch

### ~~~ Health Effects Division (7509P) and El i zabeth Evans, Environmenta l Protection Specialist Toxicology and Epidemiology B r anch Health Effects Division (7509P) Ver.Apr.08

THROUGH: David Miller, Acting Branch

# Chief**-/ ~)**  fifi(

# ~I-IJ'hV-liJ!J Toxicology and Epidemiology

# Bran**~<h** Health Effects Division (7509P)

TO: Kelly O'Rourke, Risk Assessor Risk Assessment Branch IV Health Effects Division (7509P) and Jose Gayoso, Chemical Review Manager Risk Management & Implementation Branch II Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

Sulfur incid e nts were previously analyzed in 2009 (S. Winfield and M

. Hawkins, 1/28/2009, Sulfur; Upd a ted Incident Report, D346953)

. In this review, there were 10 single chemical incidents identified in Incident Data System (IDS) from 2000 to 2008; there were 958 incidents identified in Poison Control Center Data from 1993 to 2005; there were 63 incidents identified in

Page 1 of6Page 2 of 6 CA PISP data from 2002-2006; and 189 incidents were reported to Center s for Disease Control and Prevention/National Institute for Occupationa l Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk -Pesticides (SENSOR) data from 1998 to 2005. Winfield and Hawkins concluded that “based on review of incident data from the IDS, AAPCC, PISP and SENSOR databases, the risk posed to hu man health by sulfur appears low. Across the databases, the relative number of reported incidents was low, th e severity of reported health effects was low, and for most databases the de rmal, ocular and respiratory symptoms/health effects were reflective of the known irritating prop erties of sulfur. The incident information supports the risk conclusions in the RED and the EPA poisoning manual, which states that sulfur has irritating properties but it is a relativ ely low mammalian toxicity pesticide.”

This updated incident report includes analyses of incidents reported to the Main and Aggregate IDS from January 1, 2009, to January 24, 2013 and from incidents reported to NIOSH SENSOR-Pesticides database from 2006-2009. The results are consistent with the previous analyses. The results are as follows:

 For the Main IDS, from January 1, 2007 to September 4, 2012, there was 1 incident reported for single chemical only in the data base and 16 additional incidents reported involving more than one chemical. The singl e chemical incident was classified as moderate severity.

 In Aggregate IDS, from January 1, 2007 to September 4, 2012, there were 43 reported incidents involving sulfur. These incident s were classified as minor severity.

 A query of the SENSOR-Pesticides datase t from 2006-2009 (years of additional data subsequent to the previous analysis) identified a total of 50 reported cases involving the single active ingredient sulfur; 40 additional cases involved multiple active ingredients. Of the 50 single AI cases, 33 were low in severity, 16 were moderate in severity and 1 case was high in severity.

 The Agricultural Health Study (AHS) is al so a potential source of information associated with the human health effect asso ciated with certain pesticides. Sulfur is not included in the AHS, and therefore th is study does not provide information for this report.

In summary, based on the continued low frequency and severity of incident cases reported for sulfur, HED concurs with the previous conclusion and there does not appear to be a concern at this time that would warrant further investiga tion. The Agency will continue to monitor the incident information and if a concern is tr iggered, additional analysis will be conducted.

Detailed ReviewPage 3 of 6 I. ACTION REQUESTED

Sulfur is a pesticide being c onsidered under the FQPA-mandate d Registration Review program established to review, on a 15 year cycle, pe sticides for which a Re-registration Eligibility Decision has been made. One component of th e Agency’s Registration Review Program is consideration of human incident data. In conjunc tion with a human health risk assessment based on other data sources, such human incident data can assist the Agency in better defining and characterizing the risk of pesticides/pesticide pr oducts. This review is intended to provide an update to the previously prep ared incident report (S. Winf ield and M. Hawkins, 1/28/2009, Sulfur; Updated Incident Report, D346953).

II. BACKGROUND

The element sulfur is a ubiquitous, natural compone nt of the environment. Currently, sulfur is registered by EPA for use as an insecticide, fungicide and rodenticide on several hundred food and feed crop, ornamental, turf a nd residential sites. It is also used as a fertilizer or soil amendment for reclaiming alkaline soils. Sulfur is applied in dust, granular or liquid form.

For this evaluation, both the OPP IDS and NIOSH SENSOR da tabases were consulted for pesticide incident data on th e active ingredient sulfur (PC Code 077501). The purpose of the database search is to identify pot ential patterns in the frequency a nd severity of the health effects attributed to sulfur exposure.

III. RESULTS/DISCUSSION

a. IDS

OPP’s IDS includes reports of alleged human h ealth incidents from various sources, including mandatory Federal Insecticide, Fungicide and Ro denticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state hea lth and environmental agencies, and individual consumers. Since 1992, OPP has compiled these repor ts in IDS. IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

IDS records incidents in one of two m odules: Main IDS and Aggregate IDS.

 Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specific. This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident. Main IDS in cidents involving only one pesticide are considered to provide more certain informa tion about the potential effects of exposure from the pesticide.

 Aggregate IDS contains inci dents resulting in less seve re human incidents (minor, unknown, or no effects outcomes). These are re ported by registrants only as counts in what are aggregate summaries.Page 4 of 6 For the Main IDS, from January 1, 2007 to Se ptember 4, 2012, there was 1 incident reported for single chemical only in the data base and 16 additional incidents reported involving more than one chemical. The single chemical incident was cl assified as moderate se verity and is described further in table 1.

Table 1: Main IDS Incidents Involvi ng the Single Chemical Sulfur

Human Incidents Chemical: Sulfur PC Code: 077501

Incident Package Report Incident Date Location Registration Number Product Name Exposure Severity* Incident Description

022249 -

00001 6/5/2010 CA 000802- 00016 LILLY MILLER SULFUR DUST 1 LB HC Unknown age adult female used product on roses. It was windy and she may have inhaled some product. Within 8 hours she experienced a chest cold, dry nose, scratchy throat and loss of sense of smell. Two months later she reports that all the symptoms are improving except for her sense of smell. She went to MD who does not know the cause of her symptoms. * Severity Categories H-C Human Moderate Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic nature than minor sy mptoms; and involved some form of treatment, even though symptoms were not life threaten ing and the person returned to his/her preexposure state of health with no additional residual disability) from 40 CFR § 159.184

In Aggregate IDS, from January 1, 2007 to Se ptember 4, 2012, there were 43 reported incidents involving sulfur. These incidents we re classified as minor severity.

b. NIOSH SENSOR

The NIOSH-led SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: re ports from local Poison Control Centers, state Department of Labor workers’ compensation claims when reported by physicians, reports from State Departments of Agriculture, and physician repo rts to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, a nd is of particular va lue in providing that information. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms, circumst ances surrounding the e xposure, severity, and outcome. Using standardized protocol and case definitions, derived from poison centerPage 5 of 6 reporting, SENSOR coordinators at State Departments of Health enter the incide nt interview description provided by the case, medical report, physician and pa tient into the SENSOR data system.

A query of the SENSOR-Pesticides dataset fr om 2006 to 2009 identifies 90 cases involving sulfur (PC Code 077501); 40 of which involve mu ltiple active ingredients (AI) and 50 involve single AI cases. The 50 single AI cases will be an alyzed in this section. Of these 50 cases, 47 were work-related. Ten of the 50 cases are attribut able to drift from sulfur applications. At least 9 cases, up to 17 cases, involved grape/ vineyard workers in California.

Of the 50 single AI cases, 33 were low in sever ity, 16 were moderate in severity and one was high in severity. The high and moderate seve rity case descriptions from 2006-2009 are provided in Table 2. The high severity case mixed mothba lls and sulfur powder in the residence.

Table 2. SENSOR-Pesticides 2006-2009: High/Mod erate Severity Sulfur Case Descriptions
ID Year High Severity Case Description FL02347 2007 Female mixed mothballs and sulfur powder and spread around house to kill snakes.
ID Year Moderate Severity Case Descriptions

CA14574 2006 While driving an open cab onion harvester, she was exposed to a cloud of sulfur dust from an application to a nearby field.
CA14699 2006 Patient was cutting liqui d sulfur and with safety glass it still splashed into both eyes
CA15136 2007 Developed pain in his eye after spraying barrels with sulfur CA15145 2007 Working in field and felt something in his eyes CA15228 2006 Entered field after RE I had expired but still got sick
CA15235 2006 Drift from helicopter application. Workers at children's camp exposed
CA15243 2007 Line ruptured, burning him with steam and sulfur CA15382 2007 Loading a truck and sulfur blew into eyes CA15610 2007 Exposed to sulfur fumes at work
CA15611 2008 Spilled bucket of liquid sulf ur on head while spraying on tractor
CA15634 2008 Mixing wettable sulfur, powder flew up into his eyes CA15853 2006 Was trimming vines, was exposed to sulfur CA16032 2008 Opened a vat to check on grapes, inhaled sulfur

CA16829 2009 Tying a wire around grape vines when the wind blew powder off the leaves into his face and eye CA17778 2009 Exposed to burning sulfur while loading a duster plane

WA02421 2007 A 22 y/o farmworker felt drift from a pesticide application to apples as he dug a well. An hour later he experienced gastrointestinal symptoms.

The high severity case experienced a burning sens ation to the skin and face while mixing the products, then burning to the eyes and throat after spreading the products around the home. Twenty cases experienced ocular exposures (splas h, spray, or dust in the eye). Among all cases, eye pain/irritation/ inflammation was the most commonly reported symptom. A breakdown of symptoms reported by cases is provided in Table 3.Page 6 of 6 Table 3. SENSOR-Pesticides 2006-2009: Reported Health Effects for single AI (n=50) Sulfur Cases* Dermal 21 Ocular 24 Respiratory 18 Gastrointestinal 9 Renal 0 Nervous System 17 Cardiovascular 5 Misc. 3 * Cases may report multiple health effects

c. AHS

The AHS is a high quality, prospective epidemio logy study evaluating the link between pesticide use and various health outcomes including can cer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findi ngs relevant to a particular pesticide going through registration review, the Agen cy will ensure they are fully reviewed in the risk assessment phase of the process. The AHS includes info rmation on use of 50 different pesticide active ingredients co mmonly used in agriculture.

Sulfur is not included in the AHS , and therefore this study does not provide information for this report.

IV. CONCLUSION

Updated incident analyses of the Main and A ggregate Incident Data System (IDS) and NIOSH SENSOR are consistent with the previous analyses that based on review of incident data “the risk posed to human health by sulfur appears low.”

Based on the continued low frequency and severity of incident cases reported for sulfur, HED concurs with the previous conclusion and there doe s not appear to be a concern at this time that would warrant further investigation. The Agen cy will continue to monitor the incident information and if a concern is triggered, additional analysis will be conducted.