Attachment E: Overall Process for EDSP Orders

Overall Process for EDSP Orders
Start

1.

Agency

Respondent
2.

EPA Issues EDSP Order(s)

Respondent Provides Initial Response

1. Identify Chemical for EDSP
2. Identify Order Recipient(s)

Consultations
Using existing
procedures, EPA
and Order
Recipients
(Respondents)
may consult on
various aspects of
the order and
response activities
throughout this
process.

EPA Monitors
Responses
1. Takes action on
non-responders
2. Completes
follow-up on
commitments, as
appropriate.

1. Read Order
2. Determine Response to the Order
3. Submit Initial Response within 90 days.

(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

3.

4.

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.

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

5.

Respondent Submits Progress Report
within 12 months of Order Issuance.

EPA Processes Data Submission
1. Documents receipt of Data
2. Processes data as appropriate
3. Makes decision for Tier 2 testing
4. Communicates decision, etc.

6. (A)

7. (A)

Respondent
Submits Data

8.

7. (B)

6. (B)

Respondent/
Consortia Submits
Other Information
per Response.

End
(04/03/2009) Page 1 of 11

Agency

Respondent

If Respondent agrees to generate new data . . .
Determine &
Submit Initial
Response w/in
90 days of Order
Issuance

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

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

OPP
1. Receive 90-day response.
2. Document receipt of response.

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

OSCP/OPP
1. Coordinate Agency review of data received
2. Recommend decision for Tier 2 testing

OPPTS/AA
1. Make decision for Tier 2 testing
2. Communicate decision
(04/03/2009) Page 2 of 11

Respondent

If Respondent chooses to cite or submit existing data . . .
Determine &
Submit
Initial
90 Day
Response
w/in
Response
90 days of Order
Period Begins
Issuance

Submit with 90-day response:
A: Existing data
B: Citation to published data
Cite or submit OSRI?

OPP
1. Receive 90-day response
2. Document receipt of response

Agency

Respond to
Agency followup, if any

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

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

OPPTS/AA
1. Make decision for Tier 2 testing
2. Communicate decision

(04/03/2009) Page 3 of 11

Respondent

If Respondent enters a joint agreement to provide the data . . .
Determine &
Submit Initial
Response w/in
90 days of Order
Issuance

Develop Joint Data
Agreement

Generate
Data

Follow same procedures for
generating new data, i.e.,
Submit
Progress
Reports

Submit Final
Report
& Data to EPA

Agency

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

OPP
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

Note: The Consortia may also cite
existing data for one or more of
the assays.

OPP
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

OPPTS/AA
1. Make decision for Tier 2 testing
2. Communicate decision

(04/03/2009) Page 4 of 11

Respondent

If Respondent claims they are not subject to the order . . .
Determine &
Submit Initial
Response w/in
90 days of
Issuance

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

OSCP/OPP
1. Coordinate Agency Review to verify claim
2. Recommend decision

Agency

OPP
1. Receive 90-day response
2. Document receipt of response

Follow-up to
Agency
action, as
needed

OPPTS/AA
1. Make decision on claim
2. Communicate decision

(04/03/2009) Page 5 of 11

Respondent

If order Involves Registered Pesticide AND Respondent
chooses to request a voluntary cancellation . . .
Determine &
Submit Initial
Response w/in
90 days of Order
Issuance

Agency

OPP
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.

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 request
4. Close-out the Order

Note: This applies to registered
pesticides (active ingredients).
Inert ingredients are handled
differently.

(04/03/2009) Page 6 of 11

Respondent

If order Involves Registered Pesticide AND Respondent
chooses to reformulate the product(s) . . .
Determine &
Submit Initial
Response w/in
90 days of Order
issuance

Agency

OPP
1. Receive 90-day response
2. Document receipt of response

Submit w/in 90-days
of Order Issuance:
Request to reformulate
using existing procedures.

Complete any followup action to
implement request

OPP
1. Receive request to reformulate
2. Request is processed per existing procedures
- Includes public notice & comment
3. The pesticide’s registration is amended, per request
4. Close-out the Order

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

(04/03/2009) Page 7 of 11

Respondent

If order Involves Registered Pesticide AND Respondent
chooses to claim a formulators’ exemption . . .
Determine &
Submit Initial
Response w/in
90 days of Order
issuance

Submit with 90-day response:
Request for formulator’s
exemption

Agency

OPP
1. Receive 90-day response
2. Document receipt of response

1.
2.
3.
4.

Complete any
follow-up action
to implement
request

OPP
Receive claim for formulator’s exemption
Claim is processed per existing procedures
Confirm claim of eligibility for this exemption
Close-out the Order

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

Respondent

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

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

Agency

OPP
1. Receive 90-day response
2. Document receipt of response

Complete any
follow-up action
to implement
request

OPP
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
5. Close-out the Order

Note: This applies to inert
ingredients only. Active
ingredients are handled
differently.

(04/03/2009) Page 9 of 11

Respondent

If order involves a pesticide inert ingredient AND the Respondent chooses
to discontinue sales of the chemical in the pesticide market . . .
Determine &
Submit Initial
Response w/in
90 days of
Order Issuance

Submit with 90-day response:
- Commitment to discontinue sales in the
pesticide market
- Copy of contract provision that prohibits
sales in the pesticide market.

Agency

OPP
1. Receive 90-day response
2. Document receipt of response

1.
2.
3.
4.
5.
6.

Complete any
follow-up action
to implement
request

OPP
Receive commitment & copy of contract provision
Add respondent to “approved inert supplier” list.
Review the confidential statements of formula (CSFs) on file to
identify use of this inert from this source.
If used, notify Registrant that they must amend CSF.
Process requests to amend CSF
Close-out the Order

Note: This applies to inert
ingredients only. Active
ingredients are handled
differently.

(04/03/2009) Page 10 of 11

Respondent

If Respondent chooses not to respond . . .
90 Day
Response
Period Passes

No response

Agency

OPP
1. Document non-response from Order recipient
2. Coordinate with EPA legal team
3. Recommend applicable action based on existing procedures for addressing nonresponders to DCIs, e.g., suspend registration?

OPPTS/AA
1. Make decision on action to take
2. Communicate decision

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

(04/03/2009) Page 11 of 11