Registration Service Fees
Questions on Inert Ingredients
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Current as of November 16, 2011
Questions and Answers on:
- Do inert ingredient submissions require registration service fees under the Pesticide Registration Improvement Renewal Act (PRIA 2)?
- What types of actions would be included under the term "new inert ingredients"?
- Will all PRIA actions be screened during the 21 day initial content screen to determine if the inerts listed on the CSF are approved for the uses?
- How do I find out if an inert ingredient can be used in a pesticide product with a food use?
- What are other ways to find the chemical I am looking for on the Web, besides the name of the chemical?
- What if I cannot determine whether an inert ingredient is approved after using the InertFinder, the e-CFR and the Web?
- How will the Agency continue to improve its inert ingredient review process?
1. Do inert ingredient submissions require registration service fees under the Pesticide Registration Improvement Renewal Act (PRIA 2)?
Under PRIA 2, effective October 1, 2007, there are registration service fees for new product applications associated with a new inert ingredient petition/request. Specifically those conventional new product applications in which the product's registrant also submits an inert petition for new un-approved inert or a request for an amended inert tolerance exemption or a request for approval of a non-food use inert are subject to a registration service fee. New inert petitions or non-food inert requests submitted for use in biochemical, microbial, Straight Chain Lepepidopteran Pheromone (SCLP) or antimicrobial products reviewed by the Biopesticides and Pollution Prevention Division or the Antimicrobial Division do not have an associated registration service fee.
However, the Pesticide Registration Improvement Renewal Act (PRIA 2) provides that in fiscal years 2008 through 2012 between 1/8 and 1/7 of the maintenance fees collected in a fiscal year will be used to review and evaluate new inert ingredients, proposed new products that are similar or identical to existing products, and proposed label amendments that require no science data review and public health pesticide uses.
In general, a petition submitted to establish a new tolerance or a new exemption from the requirement of a tolerance for an inert ingredient or a request of approval of a new non-food use inert is considered a new action. The list of approved inert ingredients is available on the internet.
As a result of PRIA 2, inert ingredient actions have three categories:
- The new inert ingredient request and/or petition is submitted with a new pesticide product registration application and the active ingredient is a conventional pesticide: This action is covered under registration service fees. A fee will be due to the EPA at application and EPA has a timeframe within which to make a decision on the action. The 3 conventional fee codes are R311, R312, and R313.
- An inert ingredient tolerance exemption is requested for a marker for a Plant Incorporated Protectant reviewed in the Biopesticides and Pollution Prevention Division (BPPD). This action (B903) also requires a registration service fee. A fee will be due to the EPA at application and the EPA has a timeframe within which to make a decision on the action.
- The new inert ingredient approval request and/or petition is for an inert in an antimicrobial or biochemical or microbial product or is submitted by an inert manufacturer and not associated with a request to register a new product. These actions are not covered by PRIA 2. They have no fees associated with them and no timeframes within which the EPA is required to make a decision. PRIA 2 amended FIFRA section 4(k)(3)(A) to provide resources from annual maintenance fees to process these actions.
3. Will all PRIA actions be screened during the 21 day initial content screen to determine if the inerts listed on the CSF are approved for the uses?
Yes, all incoming submissions, are screened to determine whether the inerts listed on a CSF are approved for the uses as described in Footnote A in the 21 Day Initial Content Screen Review Worksheet (PDF). (6 pp, 60 KB, About PDF)
The Agency has an InertFinder on the web which will allow users to determine whether an ingredient has been approved for food and/or non food uses and any limitation on the use. Users will also be able to identify whether the data compensation regulations apply. In general, the only inert ingredients approved for use in pesticide products applied to food are those that have either tolerances or tolerance exemptions in the Code of Federal Regulations (CFR), 40 CFR part 180 (the majority are found in sections 180.910 - 960). The most up-to-date tolerances and tolerance exemptions are found in the electronic CFR (e-CFR). Links to the appropriate CFR citation are provided for each chemical name and CAS Reg. No. in the InertFinder*. Please note that many food-use inert ingredients have use limitations and restrictions.
*DISCLAIMER : InertFinder is intended solely to enhance public access to information related to the approval status of substances used as inert ingredients in pesticide products. The user should be aware that while an effort is made to ensure that the information in InertFinder is regularly updated and accurate, there are no express or implied guarantees. The Federal Register and the Code of Federal Regulations remain the official source for regulatory information related to the use of inert ingredients in pesticide products used on food.
5. What are other ways to find the chemical I am looking for on the Web, besides the name of the chemical?
Listed below are alternative ways to search - synonym or CAS number:
The chemical you are looking for may be listed by one of its synonyms. Often the name of a particular chemical is quite straightforward (e.g., sand) but other times a given chemical appears to go by two or three entirely different names (e.g., calcium stearate and octadecanoic acid, calcium salt are two different names for the same chemical). These different names are called synonyms.
To see if your chemical has a synonym, go to EPA's Substance Registry System (SRS). The SRS home screen will prompt you for three pieces of information:
Choose the Search & Retrieve Tab.
Use Substance Search to Search by:
- Synonym (Please enter a CAS name, Biological name, EPA Registry Name or other Synonym. Select the “Exact Match” radio button)
- Substance Identifier (Enter a CAS Number, TSN, EPA Identifier, Internal Tracking Number, or Alternate Identifier.)
- Substance Type (Use this to narrow your search by identifying the substance type from the drop down menu)
- Choose the Return Type
- Click Search (Select this button to run your search request. The chemical's different names (synonyms) should appear, along with its CAS number.).
You may be able to find the chemical by its CAS Registry number (commonly noted as CASRN or CAS). A CAS Number is a unique numeric identifier assigned to a particular chemical substance. CAS numbers are managed and assigned by the American Chemical Society's Chemical Abstracts Service.
Some chemicals are known by different names or synonyms; therefore it may be necessary to expand your search criteria to include those different names. To search for synonyms, go to EPA's Substance Registry System (SRS) and search by the same methods listed above under Synonym.
An Important Note about CAS Numbers and the e-CFR: The e-CFR includes many of the inert ingredient's CAS numbers, but not all. EPA is working to remedy this.
6. What if I cannot determine whether an inert ingredient is approved after using the InertFinder, the e-CFR and the Web?
The chemical may not be in 40 CFR 180, subpart D. It is possible that the chemical you are looking for may not be an inert ingredient that EPA has approved to be used in pesticide products. Or, it may be something that is difficult to find. If you need help, please contact the Inert Ingredient Assessment Branch (IIAB) (email@example.com). In your e-mail please try to be as specific as possible as to what chemical you are trying to locate.
EPA has improved the inert ingredient review process by establishing a branch devoted to inert ingredients, the Inert Ingredient Assessment Branch. The Branch has been successful in reducing the new inert ingredient petition backlog and is in the process of improving the information available on inert ingredients. In the near future, the Branch will start screening all incoming non-PRIA associated petitions and getting back to the petitioner with any questions or concerns or data issues within a 30-45 day time period. In this manner only viable petitions will be placed on the Inerts work plan for decision making. The Inert's Web page is regularly updated and provides the latest information on contacts for questions and improvement efforts.