Attachment E - Process Diagram

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

EPA Monitors
Responses

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

Agency

8.

End

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

EPA Processes Data Submission

1. Documents receipt of response
2. Processes response as appropriate

EPA Processes Initial Response

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

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

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

EPA Issues EDSP Order(s)

1.

3.

2.

7. (A)

7. (B)

Respondent
Submits Data

Respondent/
Consortia Submits
Other Information
per Response.

6. (B)

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6. (A)

Respondent Submits Progress Report
within 12 months of Order Issuance.

5.

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 Implements Their Response

4.

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

Respondent Provides Initial Response

Respondent

Overall Process for EDSP Orders

Consultations

Start

Attachment E

Respondent

Agency

Submit Progress
Report w/in 12
Months of Order
Issuance

Submit Final
Report
& Data to EPA w/in
24 months of Order
Issuance

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

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

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

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

Generate
Data

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

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

If Respondent agrees to generate new data . . .

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

Respond to
Agency followup, if any

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

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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

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

Cite or submit OSRI?

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

Determine &
Submit
Initial
90 Day
Response
w/in
Response
90 days of Order
Period Begins
Issuance

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

Respondent

Agency

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

Submit
Progress
Reports

Submit Final
Report
& Data to EPA

Follow same procedures for
generating new data, i.e.,

(04/03/2009) Page 4 of 11

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

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

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

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

Generate
Data

Develop Joint Data
Agreement

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

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

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

Respondent

Agency

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

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

1. Make decision on claim
2. Communicate decision

OPPTS/AA

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

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

Follow-up to
Agency
action, as
needed

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

Respondent

Agency

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

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

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

Complete any followup action to
implement request

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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

Submit w/in 90-days
of Order Issuance:
Request for voluntary
Cancellation using
existing procedures.

If order Involves Registered Pesticide AND Respondent
chooses to request a voluntary cancellation . . .

Respondent

Agency

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

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

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

Complete any followup action to
implement request

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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

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

If order Involves Registered Pesticide AND Respondent
chooses to reformulate the product(s) . . .

Respondent

Agency

1.
2.
3.
4.

Complete any
follow-up action
to implement
request

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

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.

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

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

If order Involves Registered Pesticide AND Respondent
chooses to claim a formulators’ exemption . . .

Respondent

Agency

Complete any
follow-up action
to implement
request

(04/03/2009) Page 9 of 11

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

OPP

- Documentation to demonstrate:
a) they have already discontinued the
manufacture or import OR
b) are in the process of discontinuing the
manufacture or import

Submit with 90-day response:

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

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

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

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. . .

Respondent

Agency

4.
5.
6.

1.
2.
3.

Complete any
follow-up action
to implement
request

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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

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

Submit with 90-day response:

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

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

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

If order involves a pesticide inert ingredient AND the Respondent chooses
to discontinue sales of the chemical in the pesticide market . . .

Respondent

Agency

Respondent

Agency

90 Day
Response
Period Passes

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

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

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?

No response

If Respondent chooses not to respond . . .