Document ID: EPA-HQ-OPP-2004-0162-0055
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-11T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

April 24, 2008

MEMORANDUM	

SUBJECT:	NAPROPAMIDE [PC Code 103001], Acute Mammalian Toxicity Batching
Appendix for Napropamide RED Document.

FROM:	Marianne Lewis, Biologist      [sign. M.Lewis 4/24/08]

Product Reregistration Branch

Special Review and Reregistration Division (7508C)

TO:	     	James Parker, CRM

Reregistration Branch I 

Special Review and Reregistration Division (7508C)       

Attached is the updated batching appendix for Napropamide.  Please let
me know if you have any questions regarding this document. 

 		

											Sent to CRM on 10/19/05

Resent to CRM 11/29/05

Updated and resent to CRM 4/24/08

EPA'S BATCHING OF NAPROPAMIDE PRODUCTS FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION

In an effort to reduce the time, resources and number of animals needed
to fulfill the acute toxicity data requirements for reregistration of
products containing NAPROPAMIDE as the active ingredient, the Agency has
batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent composition
and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling
(e.g., signal word, use classification, precautionary labeling, etc.). 
Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.

Using available information, batching has been accomplished by the
process described in the preceding paragraph. Not-with-standing the
batching process, the Agency reserves the right to require, at any time,
acute toxicity data for an individual product should the need arise. 

Registrants of products within a batch may choose to cooperatively
generate, submit or cite a single battery of six acute toxicological
studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other
registrants, only some of the other registrants, or only their own
products within a batch, or to generate all the required acute
toxicological studies for each of their own products.  If a registrant
chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material.  If a registrant chooses
to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards
(see acceptance criteria attached), the formulation tested is considered
by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material
by EPA Registration Number. If more than one confidential statement of
formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.

In deciding how to meet the product specific data requirements,
registrants must follow the directions given in the Data Call-In Notice
and its attachments appended to the RED. The DCI Notice contains two
response forms which are to be completed and submitted to the Agency
within 90 days of receipt.  The first form, "Data Call-In Response,"
asks whether the registrant will meet the data requirements for each
product.  The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product,
including the standard six acute toxicity tests.  A registrant who
wishes to participate in a batch must decide whether he/she will provide
the data or depend on someone else to do so.  If a registrant supplies
the data to support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data,
he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share
(Option 3), or Citing an Existing Study (Option 6). If a registrant does
not want to participate in a batch, the choices are Options 1, 4, 5 or
6. However, a registrant should know that choosing not to participate in
a batch does not preclude other registrants in the batch from citing
his/her studies and offering to cost share (Option 3) those studies.

 Twenty one products were found which contain NAPROPAMIDE as the active
ingredient.  These products have been placed into eight batches and a No
Batch group in accordance with the active and inert ingredients and type
of formulation. 

NOTE: The technical acute toxicity values included in this document are
for informational purposes only.  The data supporting these values may
or may not meet the current acceptance criteria.

Batching Instructions:

								

No Batch:  Each product in this Batch should generate their own data. 

Batch 1	EPA Reg. No.	Percent Active Ingredient

	33658-22	97.0

	70506-35	95.7

Batch 2	EPA Reg. No.	Percent Active Ingredient

	83223-1	80.0

	83223-2	80.0

	83223-3	80.0

Batch 3	EPA Reg. No.	Percent Active Ingredient

	83223-4	75.0

	83223-5	75.0

Batch 4	EPA Reg. No.	Percent Active Ingredient

	70506-36	50.0

	70506-38	50.0

	70506-115	50.0

Batch 5	EPA Reg. No.	Percent Active Ingredient

	70506-31	43.2

	70506-37	43.2

Batch 6	EPA Reg. No.	Percent Active Ingredient

	70506-63	24.1

	70506-64	24.1

Batch 7	EPA Reg. No.	Percent Active Ingredient

	70506-33	2.0

	70506-39	2.0

Batch 8	EPA Reg. No.	Percent Active Ingredient

	83223-6	2.0

	83223-7	2.0

No Batch	EPA Reg. No.	Percent Active Ingredient

	34704-771	Napropamide:  4.0

Oxadiazon:  2.0

	70506-34	10.0

	83223-8	10.0