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### Guidance for t he Office of Pesticide Program’s Pilot Fragrance Notification

P rogram

This document provides guidance for EPA’s Office of Pesticide Programs (OPP) Pilot

Fragrance N otification P rogram (PFNP) for registrants seeking to add new or modify existing

fragrances in new or currently registered pesticide products. The Pilot will be conducted for two

years starting on September 19 , 2011 . The PFNP is a process improvement effort to streamline

the current process used to amend registration s when fragrance ingredients are added, removed,

or modified. This guidance document includes the eligibility criteria for participation,

submission requirements and submission instructions. Certification forms and the audit

procedure are also included

.

I. Eligibility for Participation in the Pilot Fragrance Notification Program

R egistrants seeking to add or modify fragrances in new or currently registered products

have the option of using the OPP Pilot Fragrance Notification Program. Participation in the OPP

Pilot Fragrance Notification Program is subject to the following requirements and limitations :

1) Registrants must certify (see Attachment 1) that all fragrance component ingredients

in the newly

- proposed fragrance are included on the Fragrance Ing redient List ( FIL )

http://www.epa.gov/opprd001/inerts/fmaingredient.pdf

.

2) The concentration of the fragrance being added or changed must not exceed 1.0% ( by

weight ) of the total pesticide product composition

.

3) Individual fragrance component ingredients that would exceed 0.1% (by weight) of

the total pesticide product composition must have existing approval for use as

pesticide product inert ingredients.

4) Fragrance actions involving pestic ide products that are insect repellents or baits are

not eligible for the OPP Pilot Fragrance Notification Program. Also , antimicrobial

aerosol products that make public health claims are not eligible because confirmatory

efficacy data are required to sup port any change in an antimicrobial aerosol product

formulation intended to control public health microorganisms.

5) This notification program is for non

- food use pesticide products only. Food

- use

products are ineligible.

6) Requests for inclusion of i ndividual fragrance ingredients that are not on the FIL

should be submitted directly to the Inert Ingredient Assessment Branch in the

Registration Division for evaluation and a determination of appropriateness for

inclusion on the FIL.Page 2 of 8

7) Newly proposed fragrances that contain ingredients not listed on the FIL are not

eligible for the OPP Pilot Fragrance Notification Program. All ingredients of a

fragrance must be listed on the FIL and/or approved by the Agency before a

notification or amen dment can be submitted for that fragrance under the Pilot

Fragrance Notification Program.

8) It is the responsibility of the registrant to contact the fragrance supplier to ensure that

the fragrance composit ion is submitted to the Agency. The fragrance comp osition

consists of the complete listing of all components that make up the fragrance. The

approved identity of new fragrances is to be submitted to the Agency as outlined in

Section II ( B) below

.

9) OPP will a udit the program yearly

. As part of this process, OPP will use composition

data for a random sampling of the new fragrances

.

I I

. Pilot Fragrance Notification Program Requirements

A. Registrants filing a Fragrance Notification are re quired to submit the following:

1. EPA Form 8570

- 1 identifying the submiss i on as an addition of a fragrance or identifying

new or modified fragrances eligible for the Pilot Fragrance Notification Program

. The

form is available at www.epa.gov/opprd001/forms

.

2. Fragrance Supplier Certification Letter (See A ttach ments I and II ) certifying that all

fragrance ingredients in the newly proposed fragrance are on the FIL

.

3. Confidential Statement of Formula (CSF)

. The form is available at

www.epa.gov/opprd001/forms

.

B. The fragrance supplier agrees to submit the composition of approved fragrances annually to

the Ine r t Ingredient Assessment Branch in the Registration Division of the Office of Pesticide

Programs within the following time frames: 1 ) f or new fragrances approved by EPA by June

30 th , the fragrance supplier must submit the composition of that approved fragrance to the

Agency by December 31 st of the same calendar year ; a nd 2) f or new fragrances approved by

EPA between Ju ly 1 st and December 31 st , the fragrance supplier must submit the composition

of the approved fragrance to the Agency by June 30 th of the following calendar year.Page 3 of 8

III

. Submission instructions

1. Registrants submitting the information identified abov e for Fragrance Notifications

sh ould follow the i nstructions for submitting various types of applications to OPP found

in Pesticide Registration (PR) Notice 2006

- 1, April 12, 2006, entitled “ New Instructions

for Transmitting Information to the Office of Pesticide Programs”.

www.epa.gov/PR_Notices/

. Submissions would be sent to :

Document Processing Desk (Code ______ )

Office of Pesticide Programs (7504P)

U. S. Environmental Protection Agency

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460

Submissions via Hand Delivery or Courier Delivery : Deliveries by you or a commercial

courier should be directed to:

Document Processing Desk (Code ______ )

Office of Pesticide Programs (7504P)

U. S. Envi ronmental Protection Agency

Room S

- 4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

- 4501

2. The fr agrance supplier or registrant is responsible for ensuring that the information

related to the fragrance identity is submitt ed to the Age ncy for delivery to the Inert

Ingredient Assessment Branch in the Registration Division . This information should be

titled as “Fragrance Identity” and submitted by hard copy or in an excel format on a CD

. S ubmissions sh ould be sent to:

Document Processi ng Desk (Code ______ )

Office of Pesticide Programs (7504P)

U. S. Environmental Protection Agency

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460

Submissions via Hand Delivery or Courier Delivery : Deliveries by you or a commercial

courier should be directed to:

Document Processing Desk (Code ______ )

Office of Pesticide Programs (7504P)

U. S. Environmental Protection Agency

Room S

- 4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

- 4501Page 4 of 8

IV

. Contact Information

For information regarding the Fragrance Ingredient List (FIL) contact:

Prakashchandra Shah

Inert Ingredient Assessment Branch (IIAB)

USEPA/OCSPP/ OPP, Registration Division

Shah .pv@epa.gov

703

- 308

- 1846

For information regarding the OPP Pilot Fragrance Notification Program, contact:

Dennis Edwards

Chief, Regulatory Management Branch I

USEPA/OCSPP/OPP, Antimicrobials Division

Edwards.d ennis@epa.gov

703

- 308

- 8087Page 5 of 8 

### ATTACHMENT I

Certification for the OPP Pilot Fragrance Notification Program

Version I: F or use when the fragrance supplier knows the fragrance identities

and the registrant does not

( Basic Product Name)

EPA Reg. No.

Statement of Fragrance Supplier

On behalf of [name of fragrance supplier], I certify that all of the ingredients found in fragrance

formula ________to be used in EPA Reg. No.______ are listed in the Fragrance Ingredient List

(FIL) at http://www.epa.gov/opprd001/inerts/fmaingredient.pdf and meet the other requirements

of the Pilot Fragrance Notification Program. I understand that it is a violation of 18 U.S.C. §

1001 to willfully make any false statement in this letter . I agree

(1) to maintain records documenting the identities of the fragrances in this formula for a

period of 5 years after I cease selling this formula to [name of registrant] and to provide th is

document ation to the U.S. Environmental Protection Agency (EPA) upon request

, (2) to notify EPA and [name of registrant] if fragrance formula ________ changes in a

manner that makes the formula ineligible for the Pilot Fragrance Notification Program an d

(3) to certify that the composition of new f ragrances will be submitted annually

.

I understand that the registrant will contact the fragrance suppliers to ensure that the submissions

are made to the Agency.

____________________________ _________________ Signature, Fragrance Supplier Date

(Name, Fragrance Supplier, Address, Phone)Page 6 of 8

Statement of Registrant

As the registrant of EPA Reg. No.______

, I am aware that it is my responsibility to ensure that

(1) this product meets the terms of the OPP Pilot Fragrance Notification Program and

(2) EPA has access to complete and accurate formulation information for the pesticide.

I acknowledge that if this product does not meet the terms of the OPP Pilot Fragrance

No tification Program , including the requirement that all fragrance ingredients are on the FIL,

then the sale or distribution of this product may be in violation of FIFRA and I may be subject to

enforcement action and penalties under Sections 12 and 14 of FIF RA.

____________________________ __________________ Signature, Registra n t Company Date

(Registrant Name)

(Registrant Address)

(Registrant city, state, zip code)Page 7 of 8 

### ATTACHMENT I I

Certification Letter

for the OPP Pilot Fragrance Notification Program

Version II: for use when the registrant knows the fragrance identities

(Basic Product Name)

EPA Reg. No.

On behalf of [name of registrant ], I certify that all of the fragrances in EPA Reg. No._

____ are

listed in the Fragrance Ingredient L ist (FIL) at

http://www.epa.gov/opprd001/inerts/fmaingredient.pdf and meet the other requirements of the

OPP Pilot Fragrance Notification Program. I understand that it is a violation of 18 U.S.C. § 1001

to willfully make any false statement in this certification . I further understand that if this product

is not consistent with the terms of the OPP Pilot Fragrance Notification Program

, 40 CFR

152.46

, including the requirement that all fragrance ingredients are on the FIL, then the sale or

distribution of this product may be in violation of FIFRA and I may be subject to enforcement

action and penalties under Sections 12 and 14 of FIFRA.

_____ _______________________ __________________ Signature, Registrant Company Date

(Registrant Name)

(Registrant Address)

(Registrant city, state, zip code)Page 8 of 8 

### ATTACHMENT II I

Fragrance Supplier Audit Procedure

for the OPP Pilot Fragrance Notification Program

Recordkeeping /

Audit Procedure

The recordkeeping obligations and the audit procedure are required elements of the

OPP Pilot Fragrance Notification Program. Failure to comply with these voluntary

Program elements means that any changes in fragra nces from the most recent

Confidential Statement of Formula filed with EPA require approval from the Agency.

Sale or distribution of a formulation whose fragrances have neither been approved by

EPA nor qualify for the OPP Pilot Fragrance Notification Prog ram may result in

enforcement action and penalties under Sections 12 and 14 of FIFRA.

The OPP Pilot Fragrance Notification Program recordkeeping and audit procedures are as

follows:

1) Certification Statement/Fines & Penalties : In lieu of submitting compo sition data for

each fragrance, registrant s may sign and submit the “ Fragrance Supplier Certification

Letter ” (attached) or ensure that the fragrance supplier does so . A false statement on the

certification letter may violate 18 U.S.C. § 1001

2) Recordkeeping Requirements : The fragrance supplier and/or registrant will maintain a

record of the composition data for each fragrance in a registered pesticide product and

agrees to make such records available upon request by EPA ( Note : OPP uses a simil ar

model for efficacy data for non

- public health pesticides).

3) Audit Procedure : EPA, at its discretion, may conduct periodic audits of such records

by requesting that composition data for a portion of the new fragrances registered by

notification

.