Updated March 30, 2013
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
Inert Ingredient Frequently Asked Questions
1. What is an "inert ingredient"?
An inert ingredient is any substance (or group of structurally similar substances if designated by
the Agency), other than an "active" ingredient, which is intentionally included in a pesticide
product. It is important to note, the term "inert" does not imply that the chemical is nontoxic.
Inert ingredients play a key role in the effectiveness of a pesticidal product. For example, inert
ingredients may serve as a solvent, allowing the pesticide's active ingredient to penetrate a plant's
outer surface. In some instances, inert ingredients are added to extend the pesticide product's
shelf-life or to protect the pesticide from degradation due to exposure to sunlight. Pesticide
products may contain more than one inert ingredient; however, federal law does not require that
these ingredients be identified by name or percentage on the label. In general, only the total
percentage of inert ingredients is required to be on the pesticide product label, certain exceptions
apply.
All inert ingredients in pesticide products, including those in an inert mixture, must be approved for
use by the EPA. For those inert ingredients applied to food, a tolerance or tolerance exemption is
required. Impurities are not included in the definition of inert ingredient (see Question 17 for more
information on impurities).
2. Where can I find a list of approved inert ingredients?
e-CFR
For the most current list of inert ingredients approved for food use pesticide products see
the Electronic Code of Federal Regulations (e-CFR) at
htt d : //ecf r. a poa ccess. a ov/ca i /t/text/text-
idx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfrl80 main 02.tpl
The majority of inert ingredients can be found in 40 CFR 180.910-180.960. 40 CFR part 180
also contains a number of sections that include tolerances/ tolerance exemptions for specific
inert ingredients where their use is usually significantly limited. An example is § 180.1065
which is a tolerance exemption for 2-Amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(l,5-
alpha)pyrimidin-5-one when used as an emetic at not more than 0.3 percent in formulation
of paraquat dichloride.
InertFinder
InertFinder is an online searchable database that allows pesticide formulators and other
interested parties to easily identify chemicals approved for use as inert ingredients in
pesticide products (for trade names and/or mixtures please see "Trade Name Inert
Ingredients" below and Question 14). Users can search for inert ingredients by chemical
name or CAS Reg. No. to determine whether inert ingredients are approved in pesticide
products used on food or solely for nonfood uses, as well as being provided with any
applicable use limitations. The system does not include information about ingredients in
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individual pesticide products. The InertFinder can be found at
www.eDa.gov/Desticides/inertfinder
Trade Name Inert Ingredients
This voluntary database contains a listing of trade name inert ingredients for which the
manufacturer of the trade name inert ingredient has volunteered to participate in the
development of a publicly available list of trade name inert ingredients, along with the uses
for which they are approved, and the manufacturer's name. The public listing does not
include the composition of trade name inert ingredients, nor products in which they are
used. In addition, the posting of the trade name inert ingredient list does not imply any
endorsement by EPA of one trade name inert ingredient over another. The database is
intended solely to enhance public access to information related to the EPA approval status of
trade name inert ingredients used in pesticide products. The Trade Name Inert Ingredient
database can be found at http://iaspub.epa.aov/apex/pesticides/f?p=inertfinder:mixtures
Nonfood Inert Ingredients
EPA previously maintained a PDF file listing nonfood use inert ingredients, including those
that also have food uses. That list has been folded into InertFinder as appropriate, and is no
longer being updated. The old list of "Inert Ingredients Permitted for Use in Nonfood Use
Pesticide Products" can be found at
http://www.epa.gov/opprd001/inerts/inert nonfooduse.pdf.
Fragrances
Please see the InertFinder mentioned above for approved fragrances. For additional
information on the Pesticide Program's Pilot Fragrance Notification Program and Fragrance
Ingredient Database, please see Questions 26-28 and the following sites:
http://www.epa.gov/opprd001/inerts/fmaingredient.pdf
http://www.epa.gov/opprd001/inerts/fragrancenote.pdf
FIFRA 25fbl
For information on inert ingredients in FIFRA 25(b) pesticide products see Question 15.
3. Whv do I need to know the approval status of mv inert ingredient before submitting a
formulation to the Agency?
All Confidential Statements of Formula (CSF) submitted with a covered pesticide registration
application are screened to ensure that all inert ingredients are either approved or pending with the
Agency for the labeled use of the pesticide formulation. If a covered registration application is
associated with and dependent upon an already pending application for an inert ingredient action,
the dependent application must identify the pending inert action with its inert approval tracking
number assigned by the Agency, the name of the inert ingredient that is pending, and the name of
the inert ingredient's applicant's name. The decision review time for the dependent application
could be affected by the inert ingredient's decision review time. If an inert ingredient is not
currently approved for the intended use of the pesticide formulation nor is one pending before the
Agency for the intended use, then the application may be rejected and a portion of the Pesticide
Registration Improvement Act (PRIA) 3 fee (at least 25%) will be retained. See Question 18 for
information on PRIA 3 fees related to inert ingredients.
It is also important to ensure that the labeled uses of the pesticide product do not fall outside the
use limitation of the inert ingredients. Some inert ingredients are approved for nonfood use only
(e.g. ornamental plants, lawns, use in swimming pools, etc.) while others may be given a tolerance
or tolerance exemption for a limited food use application such as the example provided in Question
2.
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4. What is the difference between 40 CFR 180.910. 180.920. 180.930. 180.940. etc.?
The Federal Food Drug and Cosmetic Act (FFDCA) requires that all inert ingredients used in
pesticide products applied to food sites must have an applicable tolerance/tolerance exemption in
the Code of Federal Regulations under 40 CFR 180. These tolerance/tolerance exemptions often
contain limitations on how the inert ingredient can be used in food-use pesticide products. It is
important to keep this in mind when selecting an inert ingredient for use in a pesticide formulation.
Please note: In addition to the general limitations of the sections (e.g. 180.920, 180.940, etc.)
each tolerance exemption may have a chemical-specific limitation that affects its approval status.
For example, 3,6-Dimethly-4-octyn-3,6-diol is approved under § 180.920 for use on growing crops,
however, it is limited to applications to "soil prior to planting or to plants before the edible parts
form" when used as a surfactant or related adjuvants of surfactants. These limitations are listed in
the CFR citation.
40 CFR 180 organizes inert ingredients into sections by general limitation as follows:
• § 180.910 "Inert ingredients used pre- and post-harvest; exemptions from the
requirement of a tolerance."
• § 180.920 "Inert ingredients used pre-harvest; exemptions from the requirement
of a tolerance."
• § 180.930 "Inert ingredients applied to animals; exemptions from the
requirement of a tolerance."
• § 180.940 "Tolerance exemptions for active and inert ingredients for use in
antimicrobial formulations (Food-contact surface sanitizing
solutions)."
• § 180.950 "Tolerance exemptions for minimal risk active and inert ingredients."
• § 180.960 "Polymers; exemptions from the requirement of a tolerance."
NOTE- Inert Ingredients approved under 40 CFR 180.950 and 180.960 can be used for any food
and nonfood use pesticide product. For a more detailed description of the categories, please see
htt d : //ecf r. a poa ccess. a ov/ca i /t/text/text-
idx?c=ecfr&sid=8a4a95df289b02c534ebd6bbb353all9&tpl=/ecfrbrowse/Title40/40cfrl80 main 0
2.tpl
5. How do I get approval for the use of a new inert ingredient?
To assist you in this process, IIAB has created three comprehensive guidance documents for food
use, nonfood use, and Low Risk Polymer submissions. Please see these guidance documents for a
more in depth explanation of the inert approval process including tips and templates to assist you
in compiling your submission package. The guidance documents can be found on our website at
http://www.epa.aov/opprd001/inerts. For instructions on how to get a trade name/mixture
approved see Question 12.
Inert ingredient approvals are now a covered application under PRIA 3 which took effect on October
1, 2012. See the Fee Determination Decision Tree
(http://www.epa.aov/pesticides/fees/tool/index.html for descriptions of the ten new inert
categories, their PRIA 3 fees and corresponding decision review times.
6.1 want to add a use to an already approved chemical, do I need to submit a new
petition?
All changes/amendments regarding food use pattern (e.g. having a tolerance exemption under
180.920 and wanting to include use patterns under 180.910 or revisions to any limitation
associated with an existing tolerance exemption) require a new petition. This petition must include
a discussion on how the new proposed use pattern will affect the risk of adverse effects to human
health and the environment. Make sure to summarize the data even if this submission is relying on
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a previous EPA assessment. Simply referencing a previous risk assessment without summarizing
the data is not acceptable. Further details are provided in the guidance documents on our website
('http://www.epa.aov/opprd001/inerts').
A new submission is also required to add a new nonfood use to an already approved nonfood use
inert ingredient. Please contact IIAB prior to your submission to discuss your request; IIAB will
assist in determining what additional information, if any, would be necessary for a complete
petition/submission.
Inert ingredient approvals are now a covered application under PRIA 3 which took effect on October
1, 2012. See the Fee Determination Decision Tree
fhttp://www.epa.aov/pesticides/fees/tool/index.html for descriptions of the ten new inert
categories, their PRIA 3 fees and corresponding decision review times.
7. Are there instructions or templates for how to do a Notice of Filing (NOF)?
NOF templates can be found at http://www.epa.gov/pesticides/bluebook/federal-register/nof-
templates.html. Be sure to choose the NOF for the Registration Division. Instructions for filling out
the NOF for food use inert ingredients and Low Risk Polymers can be found in the respective
guidance documents for food use and polymer petitions discussed in Question 5. Nonfood
submissions do not require a NOF.
8. What data is required for a complete submission?
Unlike active ingredients, inert ingredients do not have a "required" data set; however, the Agency
must have sufficient data to make a safety determination regarding human health and the
environment. For detailed information please see the Food Use, Nonfood Use, and Polymer
Guidance Documents on our website (http://www.epa.gov/opprd001/inerts'). We encourage you to
contact us prior to submitting your petition to determine if additional information is necessary.
These presubmission meetings can be conducted by telephone or in person. To set up a meeting
please contact us at InertsBranch@epa.gov.
9. Do I need to submit a MSDS with mv petition?
Sources of information that may be submitted to the Agency include, but are not limited to, OSCPP
guideline studies; publically available literature and data, including peer-reviewed assessments and
journals (e.g. WHO, OECD SIDS, IUCLID, EPA HPV, IRSI, etc.); modeled data; and
analog/surrogate data. A MSDS is only useful if the product contains 100% of the chemical in
question and it clearly states this on the MSDS. In addition, a copy of the study/data cited on the
MSDS must be provided in order for the Agency to use this information in the risk assessment
process.
10. How long does the review process take?
Inert ingredient approvals are now a covered application under PRIA 3 which took effect on October
1, 2012. See the Fee Determination Decision Tree
(http://www.epa.gov/pesticides/fees/tool/index.htm') for descriptions of the ten new inert
categories, their PRIA 3 fees and corresponding decision review times.
11. Will I be notified when a decision is made on mv submission?
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that for all food use tolerance
petitions, the Agency must publish a determination in the form of a Final Rule in the Federal
Register. Only after a Final Rule granting the use of the inert ingredient is published in the Federal
Register is the chemical legally allowed to be used in a pesticide formulation.
Companies requesting the use of a nonfood inert ingredient will receive a letter regarding the
Agency's safety determination and subsequent approval status of the chemical. Once a letter has
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been issued granting the nonfood use of the inert ingredient, the chemical may be used in nonfood
use pesticide formulations.
Newly approved nonfood use chemicals will be added to InertFinder within a week of their
approval.
12. How do I get a trade name/mixture approved?
The Agency evaluates trade name products based on the individual components of that product.
Each component of the trade name/mixture must be approved for use as an inert ingredient. If all
of the ingredients are approved for use then the trade name or mixture is permitted in pesticide
products based on the component with the most restrictive use pattern. For example, Mixture A is
made up of chemicals X, Y, and Z. If X and Y are approved for food use under 180.950 and Z is
only approved for nonfood use, then Mixture A can only be used in nonfood products.
In order to determine the status of a trade name product or inert mixture the following information
will need to be submitted to the attention of the Inert Ingredient Assessment Branch (see Question
24 for contact information) by the manufacturer on company letter head:
1. The full product name
2. The chemical name/s and CAS Reg. No. of each ingredient
3. The % (by wt) in formulation of each component* of the final trade name product (not the
starting materials used to make the final product)- components must total 100%.
4. If there are impurities remaining in the final product, those components should be listed as
such along with their percentage in the final formulation (See Question 17 for more
information on impurities). Compositional information should be submitted using the
address in Question 24.
*Please note- If the product contains a component that is itself a mixture or trade name product,
EPA needs to receive the above information for all of the proprietary products.
See Question 30 for more information on the public facing "Trade Name Inert Ingredient Database"
and Question 13 regarding the acceptability of submitting an MSDS for the trade name review.
13. Is a MSDS acceptable to get a trade name product/inert mixture in Agency's
database?
The Agency requires that all components in a trade name/mixture be clearly identified by chemical
name and CAS Reg. No. and that the components must total 100%. If the manufacturer's MSDS
contains all of the information outlined in Question 12, the MSDS would be adequate.
14. How do I find out if an inert trade name and/or mixture is already approved?
We ask that you start by consulting the Trade Name Inert Ingredient database. If you are unable to
find the trade name in the database please contact your supplier for the approval status. If after
consulting these two resources you are still unable to determine the approval status, please contact
IIAB at inertsbranch@epa.aov. We are unable to confirm any of the components of the trade
name/mixture; the Agency considers this information to be Confidential Business Information. We
will, however, provide the overall approval status of the trade name product.
The Trade Name Inert Ingredients Database can be found at
http://iaspub.epa.gov/apex/pesticides/f7pHnertfinder:mixtures. This voluntary database contains
a listing of trade name inert ingredients for which the manufacturer of the trade name inert
ingredient has volunteered to participate in the development of a publicly available list of trade
name inert ingredients, along with the uses for which they are approved, and the manufacturer's
name. The public listing does not include the composition of trade name inert ingredients, nor
products in which they are used. In addition, the posting of the trade name inert ingredient list
does not imply any endorsement by EPA of one trade name inert ingredient over another. The
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database is intended solely to enhance public access to information related to the EPA approval
status of trade name inert ingredients used in pesticide products.
For instructions on how to add your trade name or mixture to the database please see
http://www.epa.aov/opprd001/inerts/tradename.pdf
15. Which inert ingredients are approved for use in FIFRA 25(b) products?
The following link lists the inert ingredients permitted in FIFRA 25(b) Pesticide Products
http://www.epa.aov/opprd001/inerts/section25b inerts.pdf. On December 31, 2012 a proposed
rule (77 FR 76979) was published in the Federal Register to more clearly describe the active and
inert ingredients permitted in products eligible for the exemption from regulation for minimum risk
pesticides. Until this regulatory process is completed and new regulations are established, no
substances will be added or removed from the "Inert Ingredients Eligible for FIFRA 25(b) Pesticide
Products."
For more information on FIFRA 25(b) Pesticide Products please see
http://www.epa.QOv/oppbppdl/biopesticides/reatools/25b/25b-inerts.htm. If additional information
is required please contact the Biopesticide and Pollution Prevention Division Ombudsperson Nicole
Berckes at berckes.nicole@epa.aov or (703) 308-0152.
16. How do I aet mv chemical added to the "4A" Minimal risk inert ingredients list?
The List Category policy (i.e. the classification of inert ingredients as List 1, 2, 3, and 4A/4B),
created in 1987, has now served its purpose as a tool for prioritizing the evaluation of inert
ingredients. Now that reassessment of food tolerances/tolerance exemptions under the Food
Quality Protection Act (FQPA) is complete, the approval determinations of inert ingredients are no
longer classified as List 1, 2, 3, or 4A/4B and these lists are no longer being updated by the Office
of Pesticide Programs.
17. Do I need to list impurities on the trade name/mixture formulations? How are thev
evaluated? Is there a de minimis level for which reporting is not necessary?
Impurities are not considered to be "pesticide chemicals" and are not subject to have a tolerance or
tolerance exemption established under 40 CFR Part 180. Therefore, there is no formal petition
process for impurities in inert ingredient formulations. However, all impurities in inert formulations
need to be reported and are evaluated on a case by case basis. There is no "de minimis" level for
impurities related to inert ingredients. The Agency looks at the amount in the formulation, the
manufacturing information, and what steps are taken to limit or remove impurities. This
information would be needed to make a determination regarding the need for further action.
For more information on how to list impurities of a pesticide formulation on a CSF see OSCPP Test
Guideline Series 830.1700 and 40 CFR 158.340.
18. Is there a PRIA fee associated with inert ingredients?
Inert ingredient approvals are a covered application under PRIA 3 which took effect on October 1,
2012. See the Fee Determination Decision Tree
(http://www.epa.gov/pesticides/fees/tool/index.htm) for descriptions of the ten new inert
categories, their PRIA 3 fees and corresponding decision review times. Additional information on
fee waivers and a link to the "21-Day Initial Content Screen Worksheet" can be found at
http://www.epa.aov/pesticides/fees and
http://www.epa.gov/opprd001/reaistrationmanual/chapter5.html
19. What is a pesticide adjuvant and how is it regulated bv EPA?
While there are a number of definitions for pesticide adjuvant, it is generally broadly defined as any
substance separately added to a pesticide product (typically as part of a spray tank mixture), that
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will improve the performance of the pesticide product. Since pesticide adjuvant products don't
make pesticidal claims, they are not pesticides and the components of adjuvants are therefore not
pesticide inert ingredients. However, it should be noted that residues of pesticide adjuvants in or
on food commodities are subject to the requirements of the Federal Food, Drug and Cosmetic Act,
which means that a food additive regulation or exemption from the requirement of a tolerance is
needed for any substance used as a pesticide adjuvant that is applied to food crops.
20. Are data submitted on inert ingredients subject to data protection and exclusive use
rights? How are mv data rights protected?
Under Section 408(i) of the Federal Food Drug and Cosmetic Act (FFDCA), data submitted to
support tolerances or tolerance exemptions (i.e., food use data) for inert ingredients are entitled to
data compensation and exclusive use data rights "to the same extent as provided by" [Section 3
of] the Federal Insecticide, Fungicide, and Rodenticide Act. Data protection rights for submitters of
data for nonfood use inert ingredients are limited to certain cases for which data are submitted
directly in response to test orders issued under FFDCA section 408(p) as part of the Endocrine
Disruptor Screening Program (EDSP). Generally, data compensation is for 15 years from the date
the data was submitted. Exclusive use, in general, is granted for 10 years from the time the final
rule is published granting use of the chemical.
EPA screens all new pesticide registration/registration amendment applications to ensure that for
all inert ingredients for which data rights have been asserted, the applicant has done one or more
of the following: 1) made an offer to pay for the use of data; 2) obtained authorization for the use
of data; 3) purchased the chemical from the data owner; 4) purchase the chemical from a
company that has made an offer to pay to the data submitter or 5) submitted its own data to
satisfy the data obligation.
21. If I am sending in a petition/submission for an inert ingredient and another company
is submitting data on mv behalf can thev send it to the Agency prior to the submission of
the petition?
Provided that the submitted data have been assigned a Master Record Identification Number
(MRID) by the EPA, which is cited in your petition/submission, these data would be acceptable.
22. Are aromatic solvents acceptable for use as inert ingredients in food use pesticide
formulations?
On June 22, 2011, an exemption from the requirement of a tolerance (i.e., a food use approval)
was established for C9 rich aromatic hydrocarbons, Ci0-u rich aromatic hydrocarbons, and Cu_i2
rich aromatic hydrocarbons (76_FfL_36356). Any new registration action submitted to the Agency
after June 22, 2011, that includes as a component of the product formulation an aromatic solvent
that falls under the tolerance exemption descriptors C9 rich aromatic hydrocarbons, Ci0-u rich
aromatic hydrocarbons, and Cu-i2 rich aromatic hydrocarbons will be considered to be exempt
from the requirement of a tolerance under 40 CFR 180.910 and will therefore be acceptable for use
as an inert ingredient in pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest.
Registrants that may be using or are contemplating using aromatic solvents as well as those
companies that may be manufacturing and/or supplying such products to pesticide formulators
should be aware that the establishment of tolerance exemptions for these specific aromatic
solvents may result in data protection rights being asserted by the original data submitter for C9
rich aromatic hydrocarbons, Ci0-u rich aromatic hydrocarbons, and Cu_i2 rich aromatic
hydrocarbons. Such rights would be in the form of data compensation rights that require that
registrants seeking a registration for a pesticide product containing an inert ingredient for which
data protection rights are claimed, to, as appropriate, 1) make an offer to pay for the use of data,
2) obtain authorization for the use of data prior to the Agency granting a registration 3) purchase
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the chemical from the data owner, or 4) purchase the chemical from a company that has made an
offer to pay to the data submitter. Alternatively, registrants or other interested parties may seek to
establish other tolerance exemptions for aromatic solvents. The Agency practice of allowing certain
aromatic solvents to be permitted to be used in food use pesticide formulations based on the
extant exemptions from the requirement of a tolerance for xylene under 40 CFR 180.910, 40 CFR
180.920 and 40 CFR 180.930 has been discontinued—the tolerance exemption for xylene will apply
only to xylene.
23. Are fertilizers permitted in pesticide formulations applied to food?
Fertilizers meeting the definition of a fertilizer as given by the American Association of Plant Food
Control Officials (AAPFCO), containing AAPFCO recognized plant nutrients, and used in pesticide
products solely for their plant nutrient value are acceptable for use in pesticide formulations applied
food crops. Fertilizers not meeting the AAPFCO definition or containing other components not
recognized by AAPFCO as acceptable fertilizer components would be evaluated on a case-by-case
basis by EPA.
24. How do I contact the Inert Ingredient Assessment Branch fllAB)?
Please submit all questions and comments to the Inert Ingredient Assessment Branch email at
InertsBranch@eDa.aov. This email is maintained by members of IIAB and it allows us to keep track
of the types of questions we are getting and areas that may need further clarification. Once a
question is received it is answered by one of the members of the IIAB Team. If you need further
assistance please contact IIAB Chief, PV Shah at shah.Dv@eDa.QOv or (703)308-1846.
General correspondence (e.g., trade name information) can be submitted to the mailing address
listed below. The mailing address for submitting petitions and/or nonfood submission and
associated data can be found in Question 25.
(1) By USPS mail
Attn: Inert Ingredient Assessment Branch
Registration Division (7505P)
Office of Pesticide Programs
U.S. EPA
1200 Pennsylvania Ave. N.W.
Washington D.C. 20460-0001
(2) By courier
Attn: Inert Ingredient Assessment Branch
Registration Division
Office of Pesticide Programs
U.S. EPA, Room S-4400
One Potomac Yard (South Bldg)
2777 S. Crystal Drive
Arlington, VA 22202-4501
25. How do I submit mv petition/submission/data to the Aaencv?
All submissions to IIAB are received and processed by our Document Processing Desk. If you would
like to submit your petition as an e-submission please see
http://www.epa.aov/pesticides/reaulatina/reaisterina/submissions/index.htm.
Applicants must submit fee payments at the time of application. EPA will reject any application that
does not contain evidence that the fee has been paid. Payments may be made by check, bank
draft, money order or online with a credit card or wire transfer. See Fee Payments
(http://www.epa.aov/pesticides/fees/auestions/fee payments.html for more information. The
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applicant must attach documentation that the fee has been paid with the application package. For
more information on what should be contained in the submission and formatting requirements
please see the Guidance Documents on our webpage (http://www.epa.gov/opprd001/inerts).
The application should be sent to:
(1) By USPS mail
Document Processing Desk (REGFEE)
Office of Pesticide Programs (7504P)
U.S. EPA
1200 Pennsylvania Ave. N.W.
Washington D.C. 20460-0001
(2) By courier
Document Processing Desk (REGFEE)
Office of Pesticide Programs
U.S. EPA, Room S-4400
One Potomac Yard (South Bldg)
2777 S. Crystal Drive
Arlington, VA 22202-4501
*Please note the mailing address is different depending on the type of delivery service you intend
to use.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the
Federal Food, Drug, and Cosmetic Act (FFDCA), there are standard data format requirements for all
study data submitted to the Agency. These requirements are outlined in (PR) Notice 2011-3.
Submitted data packages that do not conform to these requirements may be rejected by the
Agency's Document Processing Desk and returned to you for revision.
26. What is the Pesticide Fragrance Notification Pilot Program?
EPA's Office of Pesticide Programs (OPP) Pilot Fragrance Notification Program (PFNP) is a two year
pilot program (commenced 9/19/11) for registrants seeking to add new or modify existing
fragrances in new or currently registered nonfood use pesticide products. The PFNP is a process
improvement effort to streamline the current process used to amend registrations when fragrance
ingredients are added, removed, or modified. More information on the PFNP, including submission
requirements and application forms, can be found at
http://www.epa.aov/opprd001/inerts/fraarancenote.pdf .
All components of a fragrance formulation must be listed on the Fragrance Ingredient List (FIL)
http://www.epa.aov/opprd001/inerts/fmaingredient.pdf and/or approved by the Agency before a
notification or amendment can be submitted for that fragrance under the Pilot Fragrance
Notification Program. In order to qualify for the PFNP the concentration of the fragrance being
added or changed must not exceed 1.0% (by weight) of the total pesticide product composition. In
addition, the individual fragrance components must be less than or equal to 0.1% (by weight) of
the total pesticide product composition or, for those individual fragrance component ingredients
that exceed 0.1% (by weight) of the total pesticide product composition, have an existing approval
for use as a pesticide product inert ingredient.
Under the PFNP, the fragrance composition is to be submitted once a year. OPP will audit the
program yearly. As part of this process, OPP will use composition data from a random sampling of
the new fragrances. Fragrance actions involving pesticide products that are insect repellents or
baits are not eligible for the PFNP. Antimicrobial aerosol products that make public health claims
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are also not eligible because confirmatory efficacy data are required to support any change in an
antimicrobial aerosol product formulation intended to control public health microorganisms.
27. What if mv fragrance does not meet the requirements of the Pilot Fragrance
Notification Program (PFNP)?
Fragrance formulations that are not eligible under the PFNP (e.g., fragrances used in food use
pesticide products, fragrance formulations used at greater than 1%, fragrances used in insect
repellents, etc.) are evaluated on a case-by-case basis. For those fragrance formulations intended
for use in food use pesticide products, all components must have an exemption from tolerance in
40 CFR Part 180. For nonfood use fragrance formulations each fragrance component must have
approval as a food use inert ingredient, a nonfood use inert ingredient, and/or be on the Fragrance
Ingredient List (FIL).
28. How do I get a new fragrance ingredient on the Fragrance Ingredient List (FIL)?
What kind of data/information is reouired?
Fragrance components that do not currently have an exemption from tolerance under 40 CFR Part
180, are not approved as nonfood inert ingredients, or do not appear on the FIL will need to be
submitted for review and approved by the Agency prior to use in a fragrance formulation
incorporated into pesticide products. Depending upon the proposed use of the fragrance, new
fragrance components may be evaluated using either the conventional nonfood use or (when
appropriate) food use review process. Guidance documents are available on our web site
http://www.epa.aov/opprd001/inerts for both food use and nonfood use inert ingredient
submissions. The data needed to support the request for approval will depend on the use pattern of
the fragrance. Requestors are encouraged to have a presubmission meeting with IIAB to
determine the data necessary for a complete submission. To set up a meeting please contact us at
InertsBranch@epa.aov.
29. I would like to use a chemical that is not listed as an approved inert ingredient:
however, it falls under a chemical grouping that has been approved for use as inert
ingredients. Does this mean that mv chemical is also approved and can be use?
No, if a chemical is not specifically listed as an approved inert ingredient it cannot be used in
pesticide formulation even if the chemical grouping has been approved. All inert ingredients must
be reviewed by the EPA before they can be used in pesticide products. There are two PRIA 3 fee
categories (1010 and 1007) to address these types of requests.
An application that proposes to amend a tolerance exemption descriptor by adding one or more
CAS Registry Numbers (CASRN) to an existing tolerance exemption expression in which the
tolerance exemption descriptor is for grouping of closely related substances with associated
CASRNs rather than a single chemical entity would be submitted under PRIA Fee Category 1010
"Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data".
An application that proposes a new nonfood use for an inert ingredient which is proposed to be
compositionally similar with a similar use pattern to an approved nonfood use inert ingredient
would fall under PRIA fee category 1007, "Approval of substantially similar nonfood use inert
ingredients when original inert is compositionally similar with similar use pattern"
A full description of the fee categories can be found at http://www.epa.aov/pesticides/fees/pria-
interpretations-table.pdf
30. Why aren't all approved trade name/mixtures in the "Trade Name Inert Ingredients"
database?
While the Agency maintains a confidential database of all approved inert ingredient trade names
and mixtures, the public facing "Trade Name Inert Ingredients"
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fhttp://iaspub.epa.aov/apex/pesticides/f?p=inertfinder:mixtures') is a voluntary database and
therefore, only trade name/mixtures that have specifically been submitted for inclusion by the
manufacturer are presented in this database. If you are the manufacturer of a trade name inert
ingredient and wish to have your trade name inert ingredient included in a publicly available list of
trade name inert ingredients please see http://www.epa.QOv/opprd001/inerts/tradename.pdf
31. I am submitting a petition for the exemption from tolerance of a new inert
ingredient, can I also have the trade names for this chemical simultaneously approved?
We ask that you submit your trade names only after the chemical has been approved by the
Agency. Trade names that are submitted with a petition will not be added to the database. The
petition review process or nonfood approval process is for the review of the chemical itself and not
the trade name. For more information on how to have a trade name and/or mixture approved see
Question 12
32. How do I find out if an inert ingredient approval application bv another applicant is
currently pending before the Agency and for what uses?
As stated in the Registrations Service Fee, Questions on Inert Ingredients, "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."
33. What is the new Preliminary Technical Screen under PRIA 3?
FIFRA section 33(f)(4)(B), "Initial Content and Preliminary Technical Screenings" directs the
Agency to conduct a preliminary technical screen of the application. This screening is conducted no
later than 45 days after the start of the decision review period for actions with decision review time
periods equal to or less than 6 months and no later than 90 days after the start of the decision
review period for actions with decision review time periods greater than 6 months. In conducting
this technical screen, the Agency determines whether:
1. the application and the data and information submitted with the application are accurate
and complete, and
2. the application, data and information are consistent with the proposed labeling and any
proposed tolerance or tolerance exemption, and
3. the application, data and information are such that subject to full review could result in
the granting of the application.
If the application fails the technical screen, and the deficiencies cannot be corrected by the
applicant within 10 business days after receipt of the Agency's notification of the failure, the
Agency will reject the application. See
http://www.epa.QOv/opprd001/reaistrationmanual/chapter5.html for more information.
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34. Is there a de minimis level for which inert ingredient do not have to be reported on a
CSF and therefore, do not need a exemption from tolerance or a nonfood approval?
No, all intentionally added inert ingredients must be approved for the intended use and need to be
listed on the CSF, regardless of their percentage in formulation. See Question 17 for information on
impurities.
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