UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: December 17, 2013 SUBJECT: Thiophanate -methy l and Carbendazim: Tier I Review of Human Incidents PC Code: 102001,128872 Decision No.: 480779 Petition No.: NA DP Barcode: D416734 Registration No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.:NA CAS No.: 23564-05-8, I 0605-21

-7 40CFR:NA FROM:

THROUGH:

TO: Shanna Recore, Industrial Hygienist Toxicology and Epidemio logy Branch Health Effec t Division (7509P) and Elizabeth Evans, Env ironmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

# /2 $;
David Miller, Acting Branch Chief 

# elf;J), W, Toxicology and Epidemiology Branch Health Effects Di vis ion (7509P) Linnea Hansen, Risk Assessor Risk Assessment Branch IV Health Effects D ivis ion (7509P) and Russell Wasem, Chemical Review Manager Risk Management & Implementation Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver.Apr.08

Based on the low frequency and severity of incident cases reported for thiophanate -met hyl and carbendazim, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.
Page 1 of5Detailed Review 

### I
. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of inc ident data that were reported to the Agency, as we ll as to ensure human i n cident data and the Agricu ltural Health S tudy (AHS) are part of th e problem fo rmula tion phase of registrati on review. Reports of adverse health effects a ll egedly due to a specific pestic ide exposure (i.e., an "incident") are la

rge ly self -reported and therefore , generally speaki n g, neither ex posure to a pe stici de or reported sy mptom (or the connection between the two) is validate d o r o th erwi se confirmed. Typically, causation canno t be de termined based on incident data. However, incident informat io n can be an important source of feedback to the Agency: in c i dents of severe outcome , or a suggested pattern or trend among less severe incidents, can signa l the Agency to further inves tigate a particular c h emi cal or product. Observa ti onal epidemio l ogy studie s re late the risk o f d ise ase, 

### e.g., cancer , and exposure to an agent such as a pesticide product in the general population or spec ific sub

- groups li ke pesticide applicators. 

### II
. BACKGROUND TM is a systemic fung icide used on a variety of tree, vine, and root crops, as well as on canol a and w heat. Residential homeowners may use TM on lawn s and ornamen tals. MBC is registered as a systemic fungicide i n paints i n residential setti n gs, but has no registered food uses in the US, no r import tolerances. 1 For this evaluation , both the OPP Inc ident Data System (IDS) and the Centers for D i sease Control and Prevent io n/Nat ional Institute for Occupational Safety and Heal th (C D C/N IO S H ) Sentinel E vent Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on th e active ingredient thi ophan ate-methy l and carbendazim (PC codes: 102001, 128872). The p urpose of the database search is to identify potential pattern s 

### in the frequency and severity of th e health effec ts attri buted to Thiophanatemethyl e xp os ure . Thiophanate -methyl i s no t incl ud ed in th e AH S, and therefore this study does no t provide infonnation for this report. 

### III. RESULTS/DISCUSSION
a. IDS (Incident Data System) OPP's IDS inc ludes repo rts of alleg ed human h ealt h incidents f rom various sources, i nclu d ing mandatory Federal Insecticide , Fung icide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and env ironmental agenc ies, and individual consumers. Since 1992, OPP has co mpiled these reports in IDS
. ID S contains reports from across the U.S. and most incidents have all relevant product informat ion reco rded. Reports s u bmitted to the IDS rep resent anecdotal reports o r all egations only, unless otherwise stated i n the rep ort.

1 Excerpt from Thiophanate -M et hy l Factsheet, fo und onli ne at: http: // www.epa . gov / opps n d 1 /REDs/ fac ts heets/trn red fs
. pdf Page 2 of5IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

o Main ID S contains incidents resulting in higher severity outcomes and provides more detail w ith regard t o case specifics. This system stores incident data for death, major and moderate incidents, and it includes information about the locatio n , date and na ture of the incident. Main IDS incidents invo lvin g only one active ingredient (as opposed to pes ticide products with multiple active ingredients) are considered to prov i de more certain i nformation about the potent i al effects of exposure from the pesticide.

o Agg re gate IDS contains incidents resulting in less severe human incidents (mi nor, unknown , or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries
. For the Main IDS , from January 1, 2008 to September 11,2013, there were 5 incidents reported for sing le chemical only in the database. There were 

### 3 additi onal incidents reported involvin g more than one chemical. One inc i dent was classified as major severity (Table 1)
. The other inc idents reported were classified as moderate sever ity . In Aggregate IDS, from January 1, 2008 to September 11, 2013, there were 1 4 reported incidents i nvolv i ng thiophanate -methy l and carb endazim. Overall , th ere are few inci d ents involving thiophanate-methy l and carbendazim reported to IDS
. 

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### D eventy nc1 en 

## . r £ Th' h t M th 

### 1 escnp110ns or lOp ana e - e lYJ Human Inc ident Chemical: T hiophanate-Met hy l 

# IPC Codes: 102001, 128872
Incident Package Inc ident Reg Exp o s ure Report Date Location N umber Product Name Severity Incident Description Caller recently discovered that her husband had been storing multiple products under the crawl space of t he ir home for 3 years. The caller experienced symptoms during that same time period which she be l i eves 020111 000538- LAWN are related to indi rect exposure to the

- 00270 1/1/2008 NC 00088 FUNGUS Major product. Her symptoms i nc lude CONTROL tingling, nu mbness i n feet , hands and toes, pain and progress i ng burning sensation i n both arms and muscle twitches in legs

. She also has headaches and nausea. No one else in the family experi enced any symptoms.


### b. SENSOR

- Pesticides T he SENSOR-Pesticides database covers 1 1 states from 1998-2009, although reporting varies from state to state. Cases of p esticide

- related illnesses are ascertained from a variety of sources,
Page 3 of5including: report s from local Poison Control Centers , state Department of Labor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture, and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in th e database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is of particular value in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting , the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2009 finds 28 cases involving thiophanate-methyl and carbendazim
. Of these , nine cases involv e d a single active ingredient. Five of the nine cases were work-re l ated. All nine cases were low in severity. Case symptoms are summarized in Table 1.

Table 1. SENSOR-Pesticides 1 998 -2 009: Reported He alth Effects for Thiophanate -methy l Cases

Health Effect # of Times Reported Dermal 3 O cula r 0 Respiratory 2 Gastrointestinal 4 Renal 0 Nervous System 5 Cardiovascular 0 M iscellaneous I 

### * Cases may report multiple health effects



### c. Agricultural H ealth Study (AHS) The AHS is a high quality, prospectiv e epidemiology study evaluating th e link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findings relevan t to a particular pesticide going through registration review , the Agency will ensure they are considered in the problem formulat ion/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 50 diff erent p es ticide active ingredients commonly used in agriculture. Thiophanate-methyl and carbendazim are not included in the AHS, and therefore this study does not provide information for this report.

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### IV. CONCLUSION Base d on the low frequency and sever ity of incid ent cases reported for both thiophana t e -methyl and carbendazim in both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor th e incident information and if a concern is triggered , additional analysis will be included in the risk assessme nt.

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