Overall Process for EDSP Orders

Respondent Provides Initial Response

1. Read Order2. Determine Response to the Order3. Submit Initial Response within 90 days.

EPA Issues EDSP Order(s)

1. Identify Chemical for EDSP2. Identify Order Recipient(s)

(Registrant of pesticide active ingredient & Manufacturer or Importer of inert (other) ingredient.)

3. Complete & Sign Order(s)4. EPA Issues Order(s)5. Publish list of Recipients

Start Agency

End

Respondent

EPA Processes Initial Response

1. Documents receipt of response2. Processes response as appropriate

Respondent Implements Their Response

Uses applicable procedures to implement the action indicated in their Initial response. See following diagrams for quick overview of the response options. Consults with EPA as needed.

Respondent

Submits Data

EPA Processes Data Submission

1. Documents receipt of Data 2. Processes data as appropriate3. Makes decision for Tier 2 testing4. Communicates decision, etc. 

EPA Monitors 

Responses

1. Takes action on non-responders2. Completes follow-up on commitments, as appropriate.

(04/03/2009) Page 1 of 11

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.

5.

Attachment E
If Respondent agrees to generate new data . . .

Respondent Agency 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 OPP 1. Receive and process reports & final data submission according to existing procedures 2. Complete documentation on receipt of the order OPP 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)?

(04/03/2009) Page 2 of 11

OSCP/OPP

1. Coordinate Agency review of data received2. Recommend decision for Tier 2 testing

OPPTS/AA

1. Make decision for Tier 2 testing2. Communicate decision
If Respondent chooses to cite or submit existing data . . .

Respondent Agency 90 Day Response Period Begins Respond to Agency follow- up, if any OPP 1. Receive 90-day response 2. Document receipt of response OPP 1. Receive submitted data or citations 2. Process submission per existing procedures - Use format for data submissions in PR-Notice 86-5 3. Complete documentation on the order Determine & Submit Initial Response w/in 90 days of Order Issuance OSCP/OPP 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, recommend decision for Tier 2 

testing

Submit with 90-day response:A: Existing dataB: Citation to published data

OPPTS/AA

1. Make decision for Tier 2 testing2. Communicate decision

(04/03/2009) Page 3 of 11

Cite or submit OSRI?
If Respondent enters a joint agreement to provide the data . . .

Develop Joint Data 

Agreement

Follow same procedures for 

generating new data, i.e.,

Respondent Agency Determine & Submit Initial Response w/in 90 days of Order IssuanceOPP 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 ReportsOPP 1. Receive and process Reports & Final data submission according to existing procedures 2. Verify Agreement & Data Development 3. Complete documentation on the order OSCP/OPP 1. Coordinate Agency review of data received

2. Recommend decision for Tier 2 testing

Request an extension ? Cite or submit OSRI?Consult w/EPA (e.g., on modified methodologies) ?

OPPTS/AA

1. Make decision for Tier 2 testing2. Communicate decision

(04/03/2009) Page 4 of 11

Note: The Consortia may also cite 

existing data for one or more of the assays.
If Respondent claims they are not subject to the order . . .

Follow-up to 

Agency

action, as 

needed

Respondent Agency Determine & Submit Initial Response w/in 90 days of Issuance OSCP/OPP 1. Coordinate Agency Review to verify claim 2. Recommend decision OPP 1. Receive 90-day response 2. Document receipt of response With 90 day response: Explain basis for claim of not being subject OPPTS/AA

1. Make decision on claim2. Communicate decision

(04/03/2009) Page 5 of 11
If order Involves Registered Pesticide AND Respondent 

chooses to request a voluntary cancellation . . .

Complete any followup action to 

implement request

OPP

1. Receive request for Voluntary Cancellation (RVC)2. RVC is processed per existing procedures for Voluntary 

Cancellations- See procedures at 40 CFR 152.99- Includes public notice & comment 

3. The pesticide’s registration is cancelled, per request4. Close-out the Order

Respondent Agency Determine & Submit Initial Response w/in 90 days of Order IssuanceOPP 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.

Note: This applies to registered 

pesticides (active ingredients).

Inert ingredients are handled 

differently.

(04/03/2009) Page 6 of 11
If order Involves Registered Pesticide AND Respondent 

chooses to reformulate the product(s) . . .

Complete any followup action to 

implement request

OPP

1. Receive request to reformulate2. Request is processed per existing procedures

- Includes public notice & comment 

3. The pesticide’s registration is amended, per request4. Close-out the Order

Respondent Agency Determine & Submit Initial Response w/in 90 days of Order issuanceOPP 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.

(04/03/2009) Page 7 of 11
If order Involves Registered Pesticide AND Respondent 

chooses to claim a formulators’ exemption . . .

OPP

1. Receive claim for formulator’s exemption 2. Claim is processed per existing procedures3. Confirm claim of eligibility for this exemption4. Close-out the Order 

Respondent Agency Determine & Submit Initial Response w/in 90 days of Order issuanceOPP 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: Recipients of orders will 

only use this option if EPA 

made a mistake in identifying 

them, based on the approach 

outlined in the EDSP Policy & 

Procedures Document.

(04/03/2009) Page 8 of 11
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

OPP

1. Verify assertion2. 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 CSF5. Close-out the Order

Respondent Agency Determine & Submit Initial Response w/in 90 days of Order Issuance OPP 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 inert 

ingredients only. Active 

ingredients are handled 

differently.

(04/03/2009) Page 9 of 11
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

OPP

1. Receive commitment & copy of contract provision2. 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 CSF6. Close-out the Order

Respondent Agency Determine & Submit Initial Response w/in 90 days of Order Issuance OPP 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.

Note: This applies to inert 

ingredients only. Active 

ingredients are handled 

differently.

(04/03/2009) Page 10 of 11
If Respondent chooses not to respond . . .

OPP

1. Take appropriate action, e.g., Issue Notice of Intent to Suspend2. Close-out the Order.

Respondent Agency 90 Day Response Period Passes No response OPP 1. Document non-response from Order recipient 2. Coordinate with EPA legal team 3. Recommend applicable action based on existing procedures for addressing non- responders to DCIs, e.g., suspend registration? OPPTS/AA

1. Make decision on action to take2. Communicate decision

(04/03/2009) Page 11 of 11