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 followup 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 . . . Agency Respondent

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 . . . Agency Respondent

90 Day 

Response 

Period Begins

Respond to 

Agency followup, 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.,

Agency

Respondent

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 

needed

Agency Respondent

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 followup 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)

Agency Respondent

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 followup action to 

implement request

Review/Process Request: 

1. Process the request per existing procedures

- Includes public notice & comment (using FR Notice)

Agency Respondent

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 exemption

Agency Respondent

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 procedures

Agency Respondent

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 procedures

Agency Respondent

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.

Agency Respondent

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 nonresponders 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.