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

RE: Meeting between Dow AgroSciences (DAS ) and EPA to Discuss Risk Concerns Related to Occupational Exposures
List of Documents

1. Meeting Summary Page 1 2. Meeting Sign in Sheet Page 2 3. DAS PowerPoint Presentation s Page 3
Meeting Summary
On Thursday, April 2, 2015, EPA met with DAS, one of the chlorpyrifos t echnical registrants. The chlorpyrifos revised human health risk assessment (RHHRA) released in January 2015 identified a number of use scenarios that showed risk concerns to workers. This meeting initiated discussion on ways to mitigate risk concerns to workers. Discussions will continue with DAS and the other technical registrants.

# EPA REVISED OCCUPATIONAL ASSESSMENT IN THE REVISED HUMAN HEALTH ASSESSMENT FOR CHLORPYRIFOS Joe Velovitch, Senior Risk Assessor, Dow AgroSciences LLC



### April 2 nd 

### , 2015| 2 

# 1. Key EPA Assumptions for Occupational Risk Assessment


# 2. Examples of Deconstructed Scenarios 3. Refinement/Mitigation Opportunity Occupational RA Methodology Review| 3 

## • MOE = 100 based on

 

### FQPA SF (2014) raised from 1X to 10X

 

### Intraspecies UF of 10X (for period during pregnancy)



## • Lower PoD used in calculation



## • Traditionally, HED typically classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six months as intermediate

- term

,

 for this RA the steady state endpoint (21

- d ) selection was used for chlorpyrifos which overlaps HED’s traditional short

- term exposure duration endpoint selection and is considered health protective for both short

- and intermediate

- term exposures 

# EPA’s Assumptions for Occupational RA in the Revised Human Health Assessment| 4 

## • DAS Effort : Complete deconstruction of the occupational risk components in the Revised HH Assessment for all uses

 

## Assessments and deconstruction to individual crop and application scenario level was complex



## • DAS Goal : Full understanding of all chlorpyrifos crop and non

- crop use occupational scenarios to determine options for refinement of assessments and consideration of mitigation options 

# DAS Review of Occupational RA| 5  

### The deconstruction analysis: 1) summarized the EPA summary (placed into Excel) 2) unbundled crop groupings used by EPA, to crop by crop 3) separated each unbundled crop by Mixer/Loaders, Applicators, Mixer/Loader/Applicators / (Flaggers) evaluated

• How we did the analysis:

 

### Contracted with Exponent, Inc, as consultant to the project

 

### Exponent deconstructed actual EPA Revised HH RA and Occupational and Residential Handler RA groupings for combinations of similar use patterns (crop, rate, application scenario) 

# DAS Occupational Exposure Assumptions| 6 

# Occupational: What we did

– example

*Chlorpyrifos: Updated Occupational and Residential Exposure Assessment for Registration Review. D424484. December 29, 2014 Mixer/ Loader+ Mixing/ Loading Liquids for Ground

boom Applicati

on (1c) 

### App. M/L paired with App



### .| 7 

# Occupational: What we did

– example

1c AA

- DAS Mixing/Loading Liquids

for Ground

- Boom Application *Tree nut orchard floors (almonds, walnuts): App rate 4.0 lb ai /A and 80 Acres treated passes with EC None passed in EPA revised assessment

7a A

- DAS Ground

- Boom

Applications *Tree nut orchard floors (almonds, walnuts): App rate of 4.0 lb ai /A and 80 Acres treated passes at SL/G PF5 R, SL/G PF10 R, and DL/G PF10 R *Tree nut orchard floors (almonds, walnuts): App rate of 4.0 lb ai /A and 80 Acres treated passes with EC 1) Converted : Table F.1. Chlorpyrifos Occupational Handler Non

- Cancer Risk Estimates from HH RA to Excel, then, 2) Grouped M/L with Applicator for same EPA grouped crops...allowing transparency to determine which scenario met an MOE of 100 (in this example, 1c vs 7a) 

### Mixer/ Loader

App. 

# +| 8 • Next, we wanted to understand RA [specific] crop x [specific] crop, against each Exposure Scenario that EPA evaluated in the Revised HH Assessment.....

• Unbundled the crop group output:

• This allows crop by crop analysis 

# Occupational: What we did

– example| 9 

## • EPA assumes a 3 week exposure period (5 weekday exposed, 2 weekend days off)



## • Dow AgroSciences has surveyed growers and commercial applicators that use soybeans, wheat, corn, stone and pome 

## fruit, tree nuts, citrus

─ 

## Typical case: 1

- 2 days of consecutive exposure

─ 

## Infrequent case: >5 days for commercial applicators, >2

- 3 days for growers

 Commercial applicators more frequently use engineering controls 

## and use more PPE 

# Occupational Risk Refinement Example| 10 

## • Request contact at HED to work with and confirm acceptability of proposed refinements criteria (what) and options (how)

• What specific points and information should DAS ensure are included in official response on the methodology and in what form?



## • Any other suggestions are welcome! 

# Further Action Plans

# Questions / Discussion

# Discussion of Occupational Risk Assessment in the Revised Risk Assessment for Chlorpyrifos

George Oliver, Regulatory Leader, Dow AgroSciences, Indianapolis, IN April 2, 2015| 2 

### • George Oliver, Regulatory Leader for chlorpyrifos, Dow AgroSciences

• Joe Velovitch, Human Health Assessment, Dow AgroSciences

• Daland Juberg, Global Leader, Human Health Assessment, Dow AgroSciences

• Rick Reiss, Interim Group Vice President (Health) and Principal Scientist, 

### Exponent, Inc 

# Introductions| 3 

## 1. Share DAS methodology and results of analysis to individual crop use scenario level of EPA’s Occupational Risk Assessment from the Revised Human Health Assessment
2. Identify next steps

─ Further discussions on uses and refinement options

─ How best to submit the information to EPA 

# Overall objectives for today

Information presented represents a work in progress and should be considered preliminary information| 4 

## • Introduction and overview (G Oliver)

• Dow AgroSciences (DAS) approach and methodology for analysis of EPA’s occupational assessment. (J Velovitch)

 

### Focus on mixer/loader and applicator for crop and non

- crop uses



## • Initial results of breakdown of use scenarios (G Oliver)

• Discussion 

# Agenda for today| 5 

### • Preliminary Assessment was in 2011

• Revised Assessment :

 Released Dec 31, 2014

 Docket opened and start of comment period Jan 14, 2015

 Comment period extension to April 30, 2015



### • Revised Assessment:

 Complex (approx. 1000) pages

 New approaches

 New values for PoD, Uncertainty Factors (UF) and Safety Factors (SF)

 Complex analysis to reach individual crop use scenario 

# Background: The Revised Human Health Assessment

# Part 2 of today’s discussion Building from Part 1| 7 

## • Objectives

• Background

• Example of listing of crop use scenarios

– foundation for grouping into categories



## • Definition of use scenarios groupings

• Approximate breakdown of use scenarios by groupings

• Questions / discussion / next steps 

# Agenda for 2 nd 

# part of today’s meeting| 8 • Sharing of groupings of use scenarios built from our analysis of EPA occupational assessment in the Revised Human Health Assessment

• Discussion of next steps for working cooperatively for refinement and addressing remaining issues

• Feedback on best format for submitting extensive data tables

– both base presentation of individual use scenarios and background supporting data 

# Objectives for today’s meeting

– part 2| 9 EPA scenario code Application activity

description Crop Application rate (lbs ai / A) Acres treated Results for MOE of 100

3b Mixing/Loading Granulars for

Tractor Drawn Spreader Applications Sweet potato 2.1 80 *Sweet potato: App rate of 2.1 lb ai/Acre and 80 Acres treated passes for DL/G PF5 R, SL/No G PF10 R, SL/G PF10 R, and DL/G PF10 R

7b Tractor Drawn Granular

Spreader Applications Sweet potato 2.1 80 *Sweet potato: App rate of 2.1 lb ai/A and 80 Acres treated passes with SL/G PF5 R, DL/G PF5 R, SL/No G PF10 R, SL/G PF10 R, DL/G PF10 R 

### Recap

- Example showing what is considered an individual crop use scenario| 10 • Group A . Use scenarios where DAS requests discussion on further refinement options

• Group B . Use scenarios where MOE > 100 for PPE/EC currently on the DAS product labels.

• Group C . Use scenarios where rate mitigation may be possible for DAS uses to reach MOE of 100.

• Group D . Use scenarios proposed for further discussion with the Agency.

• Group E . Use scenarios not currently not on DAS labels.

• Group F . Use scenarios still undergoing further analysis by DAS 

### DAS: Current categories of draft use scenarios| 11 

### 6

32

1 6 

### 20 33 

## % of current total (276 use scenarios using MOE of 100)

A
B
C

D


### E
F Refer to previous slide for full explanation 

### Distribution of use scenarios by categories® Trademark of The Dow Chemical Company (“Dow”) or an affiliated company of Dow 

# Discussion