### 1 

# Process for Issuing & Responding to EDSP Tier 1 Orders

Respondent Provides Initial Response

1. Read Order (& consult Policy, if applicable)
2. Determine Response to the Order, includes

- Cite or Submit existing Data or ORSI

- Generate new data (Individually or form Consortium)

- See following diagrams for a quick overview of the response options outlined in policies & order. 3. Submit Initial Response within 90 days. 4. Consortium Submits Initial Response within 150 days. EPA Issues Tier 1 Order(s )

1. Identify Chemical(s) for Tier 1 Screening
2. Determine which Order to issue:

- FIFRA/FFDCA

- SDWA/FFDCA
2 . Identify Order Recipient(s )

- Registrant of pesticide active ingredient

- Manufacturer or Importer of inert ingredient

- Manufacturer or Importer of SDWA chemical 3. Complete & Issue Order(s )
4. Post list of recipients 

## Start Agency

End Respondent

EPA Processes Initial Response 1. Documents receipt of response 2. Processes response as appropriate Respondent Implements Their Response

1. Uses applicable procedures to implement the action

indicated in their Initial response.
2. Consults with EPA as needed.

Respondent Submits Data EPA Processes Data Submission 1. Documents receipt of Data 2. Processes data as appropriate
3. Uses data in decision

- making (including determination regarding Tier 2 testing. 4. Communicates decision, etc. EPA Monitors

Responses:
1. Takes action on

non

- responders 2. Completes follow

up on commitments, as appropriate. Consultations: Using existing procedures, EPA and Order Recipients (Respondents) may
consult on various aspects of the Order and response activities throughout this process. 1.

2.

3. 4.

6. (A) 7. (A)

8. Respondent/
Consortia Submits
Other Information per Response 6. (B)

7. (B) Respondent Submits Progress Report within 12
months of Order Issuance, if applicable 5. Start: This process diagram
starts with the
identification of a
chemical for Tier 1 Screening under the
EDSP.

End: This process diagram
ends when the data is
submitted and EPA closes out the Order. 

### (04/03/2013) Page 1 of 11

# If Respondent agrees to generate new data . . .AgencyRespondent 

### Generate
Data Submit Progress Report w/in 12
Months of Order
Issuance Submit Final Report & Data to EPA w/in 24
months of Order
Issuance

Process Reports/Data: 1. Receive and process reports & final data submission according to existing procedures 2. Complete documentation on receipt of the order Process Initial Response:
1. Receive 90

- day response.
2. Document receipt of response. Determine & Submit Initial Response w/in 90 days of Order
Issuance Request an extension? Consult w/EPA (e.g., on modified methodologies)? Cite or submit other scientifically relevant information (OSRI)?



### (04/03/2013) Page 2 of 11 Review Reports/Data: 1. Coordinate Agency review of data received
2. Recommend decision regarding Tier 2 testing

Make Decision:
1. Make decision regarding Tier 2 testing 2. Communicate decision This option applies to recipients of FIFRA/FFDCA Orders and SDWA/FFDCA Orders.

# If Respondent chooses to cite or submit existing data . . .AgencyRespondent 

## 90 Day Response Period Begins Respond to Agency follow

up, if any

Process Initial Response:
1. Receive 90

- day response
2. Document receipt of response Process Reports/Data:
1 . Receive submitted data or citations 2. Process submission per existing procedures 3. Complete documentation on receipt of the order 

### Determine & Submit Initial Response w/in 90 days of Order
Issuance

Review Reports/Data:
1 . Coordinate Agency review of data 2. If data are not responsive to order notify recipient

- Consult as needed
3. If data meet order requirements, coordinate Agency review of
data
4. Recommend decision regarding Tier 2 testing 

### Submit with 90

- day response: A: Existing data B: Citation to published data

Make Decision:
1 . Make decision regarding Tier 2 testing 2. Communicate decision



### ( 04/03/2013) Page 3 of 11 Cite or submit OSRI? This option applies to recipients of FIFRA/FFDCA Orders and SDWA/FFDCA Orders.

# If Respondent enters a joint agreement to provide the data . . .

Develop Joint Data Agreement **Follow same procedures for generating new data, i.e.,** AgencyRespondent 

### Determine & Submit Initial Response w/in identified
deadline from Order
Issuance:

- Individuals w/in 90 days;

- Consortium w/in 90

- 150 days

Process Initial Response:
1 . Receive response from individual companies within 90 days. 2. Receive response from consortia (within 90 days, but no later than 150 days)
3. Document consortia formation & receipt of response Generate
Data 

### Submit Final Report
& Data to EPA Submit Progress Reports

Process Reports/Data:
1. Receive and process Reports & Final data submission according to existing procedures
2. Verify Agreement & Data Development
3. Complete documentation on receipt of the order

Review Reports/Data:
1 . Coordinate Agency review of data received
2. Recommend decision regarding Tier 2 testing Request an extension? Cite or submit OSRI? Consult w/EPA (e.g., on modified methodologies) ?

Make Decision:
1 . Make decision regarding Tier 2 testing 2. Communicate decision



### ( 04/03/2013) Page 4 of 11 Note: The Consortia may also cite existing data for one or more of the assays. This option applies to recipients of FIFRA/FFDCA Orders and SDWA/FFDCA Orders.

# If Respondent claims they are not subject to the order . . .

Follow

- up to Agency action, as

neededAgencyRespondent 

### Determine & Submit Initial Response w/in 90 days of

Issuance

Review Claim:
1. Coordinate Agency Review to verify claim
2. Recommend decision on the claim Process Initial Response:
1. Receive 90

- day response
2. Document receipt of response 

### With 90 day response: Explain basis for claim of not being subject

Make Decision:
1. Make decision on claim
2. Communicate decision & close out the Order



### ( 04/03/2013) Page 5 of 11 This option applies to recipients of FIFRA/FFDCA Orders and SDWA/FFDCA Orders.

Process Receipt of Claim:
1. Receive and process claim
2. Complete documentation on receipt of the order

## If order Involves Registered Pesticide AND Respondent chooses to request a

voluntary cancellation . . .

Complete any follow

up action to implement request

Review/Process Request:
1. Process request per existing procedures for Voluntary Cancellations

- See procedures at 40 CFR 152.99

- Includes public notice & comment (using Federal Register)AgencyRespondent 

### Determine & Submit Initial Response w/in 90 days of Order
Issuance

Process Initial Response:
1. Receive 90

- day response
2. Document receipt of response 

### Submit w/in 90

- days
of Order Issuance: Request for voluntary

Cancellation using existing procedures.

Take Final Action on Request: 1. The pesticide’s registration is cancelled, per request
2. Communicate decision (Issue FR Notice)
3. Close

- out the Order



### ( 04/03/2013) Page 6 of 11 This option ONLY applies to recipients of FIFRA/FFDCA Orders. It does NOT apply to recipients of SDWA/FFDCA Orders.

Process Receipt of Request:
1. Receive and process request for Voluntary Cancellation
2. Complete documentation on receipt of the order

# If order Involves Registered Pesticide AND Respondent chooses to

reformulate the product(s) . . .

Complete any follow

up action to implement request

Review/Process Request:
1. Process the request per existing procedures

- Includes public notice & comment (using FR Notice)AgencyRespondent 

### Determine & Submit Initial Response w/in 90 days of Order
issuance

Process Initial Response:
1. Receive 90

- day response
2. Document receipt of response 

### Submit w/in 90

- days
of Order Issuance: Request to reformulate using existing procedures.

Note:
This applies to registered pesticide products. Inert ingredients are handled differently

. See the EDSP FIFRA/FFDCA Policy & Procedures Document (2009).



### ( 04/03/2013) Page 7 of 11 Make Decision:
1. The pesticide’s registration is amended, per request 2. Close

- out the Order This option applies to recipients of FIFRA/FFDCA Orders. It does NOT apply to recipients of SDWA/FFDCA Orders.

Process Receipt of Request:
1. Receive and process request to reformulate
2. Complete documentation on receipt of the order

# If order Involves Registered Pesticide AND Respondent chooses to

claim a formulators’ exemption . . .

Review/Process Claim:
1. Process claim per existing procedures

- Confirm claim of eligibility for this exemptionAgencyRespondent 

### Determine & Submit Initial Response w/in 90 days of Order
issuance

Process Initial Response:
1. Receive 90

- day response
2. Document receipt of response 

## Complete any
follow

- up action

to implement request Submit with 90

- day response: Request for formulator’s exemption

Note: EPA expects that recipients of orders will only use this option if EPA made a mistake in identifying them, based on the approach
outlined in the EDSP FIFRA/FFDCA Policy &
Procedures Document (2009).



### ( 04/03/2013) Page 8 of 11 This option ONLY applies to recipients of FIFRA/FFDCA Orders. It does NOT apply to recipients of SDWA/FFDCA Orders.

Process Receipt of Claim:
1. Receive claim for formulator’s exemption
2. Complete documentation on receipt of the order

Make Decision:
1. If eligible, accept claim & close out the Order
2. If not eligible, communicate with submitter

## If order involves a pesticide inert ingredient AND the Respondent has or is in the

process of discontinuing the manufacture or import of the chemical. . .

Complete any
follow

- up action

to implement request

Review/Process Response:
1. Verify assertion
2. Review the confidential statements of formula (CSFs) on file to identify use of this inert from this source.
3. If used, notify Registrant that they must amend CSF.
4. Process requests to amend CSF using existing proceduresAgencyRespondent 

### Determine & Submit Initial Response w/in 90 days of
Order Issuance

Process Initial Response:
1. Receive 90

- day response
2. Document receipt of response 

### Submit with 90

- day response:

- Documentation to demonstrate:

a) they have already discontinued the manufacture or import OR b) are in the process of discontinuing the manufacture or import

Note:
This applies to pesticide inert ingredients only. Pesticide active ingredients are handled differently.



### ( 04/03/2013) Page 9 of 11 This option ONLY applies to recipients of FIFRA/FFDCA Orders. It does NOT apply to recipients of SDWA/FFDCA Orders.

Process Receipt of Response:
1. Receive response
2. Complete documentation on receipt of the order

Make Decision:
1. Verify all related actions are complete
2. Close

- out the Order

## If order involves a pesticide inert ingredient AND the Respondent chooses to

discontinue sales of the chemical in the pesticide market . . .

Complete any
follow

- up action

to implement request

Review/Process Response:
1. Receive commitment & copy of contract provision
2. Add respondent to “approved inert supplier” list.
3. Review the confidential statements of formula (CSFs) on file to identify use of this inert from this source.
4. If used, notify Registrant that they must amend CSF.
5. Process requests to amend CSF using existing proceduresAgencyRespondent 

### Determine & Submit Initial Response w/in 90 days of
Order Issuance

Process Initial Response:
1. Receive 90

- day response
2. Document receipt of response 

### Submit with 90

- day response:

- Commitment to discontinue sales in the pesticide market

- Copy of contract provision that prohibits sales in the pesticide market.



### ( 04/03/2013) Page 10 of 11 This option ONLY applies to recipients of FIFRA/FFDCA Orders. It does NOT apply to recipients of SDWA/FFDCA Orders.

Process Receipt of Response:
1. Receive response
2. Complete documentation on receipt of the order

Make Decision:
1. Verify all related actions are complete
2. Close

- out the Order

# If Respondent chooses not to respond . . .

Make Decision:
1. Make Decision on action to take.
2. Take appropriate action & communicate decision as appropriate.
3. Close

- out the Order/Transfer to Enforcement Case.AgencyRespondent 

## 90 Day Response
Period Passes 

## No response

Process Non

- Response:
1. Document non

- response from Order recipient

Review Non

- Response:
1. Coordinate with EPA legal team
2. Recommend applicable action based on existing procedures for addressing non

responders to EPA Orders?



### ( 04/03/2013) Page 11 of 11 This option applies to recipients of FIFRA/FFDCA Orders and recipients of SDWA/FFDCA Orders.