                                       
The Office of Pesticide Program's Pilot Fragrance Notification Program:  Request for Comments
                                March 23, 2011
                                       
I.  Overview

      EPA's Office of Pesticide Programs (OPP) is publishing for comment a proposed Pilot Fragrance Notification Program (PFNP) for registrants seeking to add new or modify existing fragrances in new or currently registered pesticide products.  OPP intends to implement the PFNP for two years as a process improvement effort to streamline the current process used to amend registrations when fragrance ingredients are added, removed, or modified. 
      EPA is taking this action as a follow up to the 2007 Fragrance Notification Pilot Program and it is very similar in conduct.  The objectives of the current pilot are to improve public transparency, reduce the amount of paperwork required of the company and decrease tracking.  The number of fragrance documents needing to be tracked would be decreased because they would be submitted twice a year versus with every application. These efficiencies will allow resources to be focused on other regulatory work without compromise to public health or the environment.

      In 2006, the Fragrance Materials Association (FMA) voluntarily developed a Fragrance Ingredient List (FIL). The FIL was comprised of more than 1500 fragrance component ingredients contained in pesticide products previously reviewed and registered by the Agency.  They represent fragrance ingredients which have undergone an evaluation by EPA to determine their suitability for safe use as components of fragrances used in nonfood use pesticide product formulations.  The Agency's evaluation consisted of a consideration of the available toxicity data on these ingredients, as well as a comprehensive review of other risk assessments performed on these substances in association with their uses as food flavoring additives and/or cosmetics as well as a determination of potential exposures to humans and the environment resulting from use as pesticide product fragrance ingredients. In April, 2007, EPA initiated the Fragrance Notification Pilot Program, a 3-month effort to examine both the completeness and accuracy of the FIL and to gain experience with a potential future notification process for certain fragrance formulations.  Outcomes from the 2007 Pilot included:  a) an updated FIL, b) valuable experience for registrants and fragrance suppliers and c) OPP "front end" document processing improvements. A description of the 2007 pilot and the updated FIL are available at:  www.epa.gov/opprd001/inerts/. 


II. Current Amendment Process

      Currently, registrants wishing to add or modify fragrances in registered products do so by amendment to the Confidential Statement of Formula (CSF).  Often, the fragrance composition is known only to the fragrance supplier.  The current amendment process requires that fragrance suppliers provide a confidential declaration of the fragrance ingredients under separate cover to the Agency.  A finished fragrance normally includes many fragrance ingredients.  Each fragrance formula is separately reviewed by the Inert Ingredient Assessment Branch in OPP's Registration Division (RD).  Once the Agency has reviewed the components of a fragrance and has determined that the fragrance is acceptable for use, the amended CSF is accepted.
      
III. Eligibility for Participation in the Pilot Fragrance Notification Program 

      Under the eligibility criteria outlined here, registrants seeking to add or modify fragrances in new or currently registered products would have the option of using the OPP Pilot Fragrance Notification Program.  Participation in the OPP Pilot Fragrance Notification Program would be 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 FIL.
   
   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 pesticide 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 support 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 individual 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. 

   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 amendment can be submitted for that fragrance under the Pilot Fragrance Notification Program.

   8) Annual self certification is required every year. The fragrance supplier and/or registrant is responsible for recertifying (self-certifying) its fragrance(s) in order to continue being listed.  

   9)  It is the responsibility of the registrant to contact the fragrance supplier to ensure that the fragrance composition is submitted to the Agency.  The fragrance composition consists of the complete listing of all components that make up the fragrance.  The approved identity is to be submitted twice a year (no later than July 31 and December 31 of each calendar year).  

   10) Auditing of the program would be done yearly by OPP. Requests for composition data for a portion of the new fragrances registered by notification would be used in the periodic auditing procedure.   
     
IV. Pilot Fragrance Notification Program Requirements

   A.  Registrants filing a Fragrance Notification would be responsible for submitting the following:

* EPA Form 8570-1 identifying the submission as an addition of a fragrance eligible for the Pilot Fragrance Notification Program.  The form is available at www.epa.gov/opprd001/forms.
* Fragrance Supplier Certification Letter (See Attachments I and II) certifying that all fragrance ingredients in the newly proposed fragrance are on the FIL.
* Confidential Statement of Formula (CSF).  The form is available at www.epa.gov/opprd001/forms.

      Registrants would submit a revised CSF reflecting the new or modified fragrances; an EPA Form 8570-1 identifying the new or modified fragrance and a copy of the Fragrance Suppliers Certification Form certifying that all of the fragrance ingredients are on the FIL.
      
B.  The fragrance supplier agrees to submit certification that the composition of approved fragrances to the Inert Ingredient Branch in the Registration Branch of the Office of Pesticide Programs  	

V.  Submission instructions

      Registrants submitting the information identified above for Fragrance Notifications would follow the instructions 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. Environmental Protection Agency 
      Room S-4900, One Potomac Yard 
      2777 South Crystal Drive 
      Arlington, VA 22202-4501 

VI.   Contact Information

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

      Prakashchandra Shah
      Inert Ingredient Assessment Branch (IIAB)
      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
      OPP, Antimicrobials Division
      Edwards.dennis@epa.gov
      703-308-8087
                                       
VII.    Comments

      Comments should be sent by [date30 days from FRN Announces] to:
      
      SanYvette Williams, DVM
      Special Assistant, RMB1
      USEPA/OSCPP/OPP/AD
      Williams.sanyvette@epa.gov
      EPA will consider the comments received and publish the final procedures and specifications of the notification program.
      
ATTACHMENT I
                                       
        Certification for the OPP Pilot Fragrance Notification Program
                                       
Version I:  For 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 www.epa.gov/opprd001/inerts/ingredient.pdf  and meet the other requirements of the 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 5years after I cease selling this formula to [name of registrant] and to provide this documentation 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 Fragrance Notification Program and (3) to certify that the composition of approved fragrances will be submitted twice a year and no later than July 1 and December 31 of each year.  The Registrant is to contact the fragrance suppliers to ensure that the submissions are made to the Agency. 



____________________________				_________________
Signature, Fragrance Supplier					Date
(Name, Fragrance Supplier, Address, Phone)



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 Notification 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 FIFRA. This statement is added by OECA (Office of Enforcement and Compliance) to point out and ensure that the company understands and does not take this responsibility casually. 



____________________________				__________________
Signature, Registrant Company				Date
(Registrant Name)
(Registrant Address)
(Registrant city, state, zip code)
                                 ATTACHMENT II
                                       
                             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 List (FIL) at www.epa.gov/opprd001/inerts/ingredient.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. This statement is added by OECA (Office of Enforcement and Compliance) to point out and ensure that the company understands and does not take this responsibility casually. 








____________________________				__________________
Signature, Registrant Company				Date
(Registrant Name)
(Registrant Address)
(Registrant city, state, zip code)
                                ATTACHMENT III
                                       
                      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 fragrances 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 Program 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 composition data for each fragrance, registrants 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 similar 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. 



