### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , 

### D
. C
. 20460 OFFICE OF CH EM ICAL S AFE TY A ND POLLU T IO N PREV E N T ION

MEMORANDUM Da t e: 

### May 6. 20 l 5 SUB J ECT : Am icarbazone: T i e r I (Scop in g) Rev iew of Human Incident s

P C Co de : 114004 OP Ba r co d e : 0427 1 59 D ec is i o n N o.: 503062 Pe t it i o n No. : NA Ri s k Assess m e nt T y pe: NA T X R No. : NA l\ tRIO No.: NA Registrat io n No.: NA Re g ula t ory Action: NA Case No.: A CAS No. : 129909-90-6 40 C FR : NA Vcr.Apr.08 F R OM : Shan na Recore, Industrial H yg ien ist 

# o_ - C'\ • II Tox icology and Epidemiology Branch**~~ ~**  I Iealth Effect Di vis ion (7509P) and Elizabeth Evans. Environmental Protection Specia li st Toxicology and Ep idemiol ogy Branch Hea lth Effects Di v ision (7509 P ) /) T HR O UG H : Dav id Miller, Acting Bra nch C hi e f 

# if. fa :/**;tl,** Toxicolo gy and Epidemiolo gy Branch 

### TO : H ea lth Effects Di v i sion (7509 P) D ouglas D otso n, Risk Assessor Ri sk Assessmen t Branch II H ea lth Effects Di v ision (7509P) and Mar ia Piansay. Chemical Review Manager Risk Management & Implementation Branch 5 Pesticide Re-eval uation Di v ision (7508 P) Summary and Conclusions There we r e no in c ident cases rep o rted for am ic arbazo ne to e ith er ID S or SENS OR

- Pesticides. There docs no t appear to be a concern at thi s t im e that wou ld wa rr ant furth e r in vest igation. Th e Agency will cont inu e to monitor the incident info rm at io n and i f a concern is triggered , additional a n alys is w ill be in c l uded in the r i sk assessment.

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### Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill our requi rement to docket summaries of incident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (Al

- IS) are part of the problem formulation phase of registration review. Reports of adverse health effects allegedly due to a spec ific pesticide exposure 

### (i.e., an "inc ident") are largely self -r

eported and therefore. genera ll y speaking, neither exposure to a pesticide o r reported symptom (or the connection between the two) is validated or otherwise confirmed
. Typically, causation cannot be determined based o n incident data
. However. incident information can be an imp ortan t so urce of feedback to the Agency: incidents of severe outcome, or a suggested pattern or trend among less severe inci dents, can s ignal the Agency to further investigate a particular chemical or product. Observational epidemiology studies relate the risk of disease, 

### e.g. , cancer, and exposure to an agent such as a pesticide product in the genera l population or specific sub-groups like pesticide appl ic ators . 

### II. BACKGROUND Amicarbazone is an herbicide intended for use in field corn, in either conventional, conservation or no-tillage crop management systems and w ill be applied p r ep lant , preemergence , and early postemergence through ground application only
. Amicarbazone has herbicidal activity against annual broadleaf weeds. It select ively inhibits acetolactase synthase, and enzyme involved in photosystem II of plants. 1 

### For th i s evaluation, both the OPP Incident D ata System (IDS) and the Centers for Disease Contro l and Prevent ion /Nati o na l In stitute for Oc.cupational Safety and Health (C D C/NIOSH) Sent inel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were co n su l ted for pesticide incident data on the active ingredient amicarbazone (pc code: 114004). The purpose of th e database search is to identify potential patterns in the frequency and severity of the health effects attributed to amicarbazone exposure. Amicarbazone is not included in the AHS, and therefore th is study does not provide information for this report. III . 

### RESULTS/DISCUSSION
a. 

### IDS (Incident Data System) OP P 's IDS includes reports of alleged human health incidents from various sources, including mandatory Federal In secticide, Fung ic ide a nd Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and envi ronmental agencies , and individual cons umers. Since 1 992 , OPP has compi l ed these reports in IDS. ID S contains reports from across the U.S. and most incidents have a ll relevant product in fo rm ation recorded. Reports submitted to the ID S r epresent anecdotal reports or a ll egati ons only, unless otherwise stated in the report .

1 http: //www.epa.gov/pesticides/chem

_search /reg_actions/registration/fs

_ PC- I 14004
_04-0ct-05.pdf 

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### ID records incident s in o ne of two m od ul es : Main IDS and Aggregate ID S :
o Main ID S contains incident s res ultin g in higher severity outcomes and provides more detail with regard to case s pecific s . This system s to r es incident data for death , m a jor and moderate incident s, and it includes information about the loc a ti on, date a nd nature of the in c ide nt. Main IDS incide nt s involving onl y one ac ti ve in g red ient (as opposed to pesticide products with multiple active in gredients) are co n s idered to provide more certain information about the potentia l effects of exposure from the pesticide.
o Agg rega te 

### ID S co ntain s incid en ts res ultin g in le ss seve re human incidents ( minor, unknown, or no effects outcomes). T hes e are reported b y reg istrants only as count s i n what are agg regate s ummaries. Fo r the Main IDS , from J a nuary I , 20 I 0 to Feb ru a r y 4, 2015. there were n o incident s reported involving amicarbazone. I n Aggregate IDS , from January I, 20 I 0 to F eb ru ary 4. 2015, there we re no i nc id e nt s reported in vo l v in g amicarbazone. 

### b. SENSOR- Pe sticid es The SEN SOR- Pesticides database covers 1 2 states from 1998-2011 , although reporting varies from s tate to state. Cases o f pe s ticide

- relate d illn esses are ascertained fr o m a variety of sources, including: report s from loca l Poison Control Cen te rs. s tate Department of L abo r workers· compe n sat io n claims when r epor te d by physicians. re p orts from State D epa 11me nt s o f Ag ri cu lture, and physician rep orts to state D epartments of Health. A lth ough both occupational and non-occupational in cide nt s ar e includ ed in the database
. SE SOR-Pesticides focuses on occupa tional pesticide incidents. and is of particular v alu e in providing that information. Th e s tate coordinator at each of th e 12 respecti ve s ta te D e partm e nt s of Health co nduct s case followup activities s uch as obtaining medical record s to verify sy mptom s and seve rity. Us ing s tandardi ze d protocol and case defin i t ions d e rived fr o m po ison center rep o rting , the state

E SOR

- Pesticide coordinator e nters the incid e nt information into the s ta te -based sys tem which is sen t to NIOSH an nu a ll y to be aggregated. A re v iew of SE SOR-Pes ti cides 1998-2011 identifies no cases in volvi n g amicarbazo ne.


### c. Ag ri c ultura l Hea lth S tud y (A HS) The A H S i s a hi g h quality. prospective epidemiology s tud y evaluating th e link between pesticid e u se and vari ous health outcomes including cancer. The AI-IS includes privat e and commerc ial pesticide applicators a nd th e ir s pouses. If there a re A HS find ings relevant l o a particu lar pesticide going through reg is tration review , th e Agency will en s ure th ey a r c cons idered in th e problem fo rmul a ti on/scop in g phase of th e process a nd
. 

### if appropriate. fully r ev i ewe d in the risk assess m e nt phase of the p r ocess . The AHS includes in fo rmation o n u se of 80 different pesticid e active in g redient s common ly used in agriculture. Amic arb azo ne is not included in the AHS. a nd therefore this study does n o t provide information for this rep o rt.

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### IV
. CONCLUSION Ther e were no in cident cases reported for am ic arbazone to either ID S or SENSOR-Pestic ides. There does not appear to be a concern at this time that would warrant further invest igat ion . The Age ncy w ill continue to mo n itor the incident information and if a concern is triggered , add itional analysis will be included in the risk assessment.

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