Registration Service Fees
Questions on Inert Ingredients
Current as of September 2012
Questions and Answers on:
- Do inert ingredient submissions require registration service fees under the Pesticide Registration Improvement Extension Act (PRIA 3)?
- 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 do I find out if an inert ingredient approval application by another applicant is currently pending before the Agency and for what uses?
1. Do inert ingredient submissions require registration service fees under the Pesticide Registration Improvement Extension Act (PRIA 3)?
Inert ingredient approvals are now a covered application under PRIA 3 which took effect on October 1, 2012. There are now 10 new inert categories with fees and specific decision review times. See the PRIA 3 Fee Schedule Tables or the Fee Determination Decision Tree for descriptions of the ten new inert categories, their PRIA 3 fees and corresponding decision review times.
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.
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 or are pending before the Agency for approval for the uses as described in Footnote A in the 21 Day Initial Content Screen Review Worksheet (PDF). (6 pp, 60k, 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) (firstname.lastname@example.org). In your e-mail please try to be as specific as possible as to what chemical you are trying to locate.
7. How do I find out if an inert ingredient approval application by another applicant is currently pending before the Agency and for what uses?
Due to CBI concerns, the Agency, in general, cannot provide information regarding the status of a pending inert ingredient application. Information on whether an inert ingredient application is currently pending with the Agency and for what uses should come from the inert ingredient applicant. In cases where another covered application, such as a product registration application, intends to associate with and depend upon an already pending application for an inert ingredient approval, the applicant must identify the pending inert ingredient action in its application. To identify the inert, the applicant must provide the inert approval tracking number assigned by the Agency, name of the inert ingredient(s) that is pending and the inert ingredient’s applicant’s name. This information can be requested from the pending inert ingredient applicant. The Agency will not provide information to the applicant of the dependent covered application regarding the status of the pending inert ingredient approval action beyond information that must be shared to adjust the decision review time due date for the dependent application at the start of the review. PRIA 3 requires that the decision review times for inert ingredient applications and applications associated with and dependent upon them be in sync.
For further guidance on inert ingredient applications see:
- General Guidance for Petitioning the Agency for the Establishment of a New/Amended Food Use Inert Ingredient Tolerance or Tolerance Exemption (PDF) (5 pp, 42k, About PDF);
- General Guidance for Requesting a New Nonfood Use Inert Ingredient (PDF)(4 pp, 5k, About PDF);
- Guidance to Petitioners for Low Risk Polymer Submissions (PDF) (6 pp, 41k, About PDF);
- Inert Ingredient Frequently Asked Questions (PDF) (8 pp, 49k, About PDF).