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1. Adjuvants and Inerts in the USA –
How They are Regulated by USEPA
Brasilia, December 9, 2013
Debra Edwards, Ph.D., Consultant
Former Director of EPA Pesticide Programs
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2. Legal and Regulatory Definitions
Inert Ingredients
The Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA), Section 2(m) defines an inert ingredient as “an
ingredient which is not active.”
The Code of Federal Regulations (40 CFR 152.3)
further describes an inert ingredient as “any
substance . . . other than an active ingredient,
which is intentionally included in a pesticide
product, . . .”
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3. FIFRA Safety Standard
Inert Ingredients
Registration and reregistration of pesticide
products under FIFRA include a determination
that each pesticide product formulation will not
result in “any unreasonable risk to man or the
environment, taking into account the economic,
social and environmental costs and benefits of
the use . . . “
The entire pesticide product formulation, including
inert ingredients, must meet this standard.
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4. Tolerances under FFDCA Required for
Food Use Inerts
The Federal Food, Drug and Cosmetic Act
(FFDCA) requires that inert ingredients in
pesticide products used on food and feed crops,
agricultural commodities, or livestock must have
a tolerance or tolerance exemption in place
under the Code of Federal Regulations (CFR),
Title 40, Part 180.
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5. FFDCA Safety Standard
Food-Use Inerts
Determination that “there is a reasonable
certainty that no harm will result from aggregate
exposure to the pesticide chemical residue,
including all anticipated dietary exposure and all
other exposures for which there is reliable
information.”
FFDCA defines a “pesticide chemical” to include all
active and inert ingredients within the product.
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6. Adjuvants
• Adjuvants are broadly defined as any substance separately
added to a pesticide product (typically as part of a spray tank
mixture) that will improve the performance of the pesticide
product.
• EPA treats any tank-mixed substance used on food and feed
crops, agricultural commodities, or livestock as part of the
pesticide and thus needing an FFDCA food additive regulation
or tolerance exemption.
FIFRA 2(u): “The term “pesticide” means any substance
or mixture of substances . . . “
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7. FDA Regulation of Adjuvants
• FDA officially has the authority to establish direct
food additive regulations for “adjuvants for
pesticide use dilutions” (21 CFR 172.710) or
“adjuvants for pesticide chemicals” (21 CFR
182.99).
• Ten direct food additive regulations for
surfactants and related adjuvants for pesticide
use dilutions are published in 21 CFR 172.710.
The remainder are covered under 21 CFR 182.99.
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8. 21 CFR 182.99
The vast majority of adjuvant food additive
regulations are addressed by FDA under 21 CFR
182.99, which states:
“Adjuvants, identified and used in accordance with
40 CFR 180.910 and 180.920, which are added to
pesticide use dilutions by a grower or applicator
prior to application to the raw agricultural
commodity, are exempt from the requirement of
tolerances under section 409 of the FFDCA.”
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9. EPA sets tolerance exemptions under
40 CFR 180.910 and 180.920
Thus, though FDA officially has the responsibility
for setting food additive regulations for
adjuvants that are sold separately from a
pesticide product, that responsibility has, in
effect, been delegated to EPA.
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10. 40 CFR Part 180 - Exemptions from the
requirement of a tolerance for inert
ingredients, including adjuvants
• 180.910 – Inert ingredients used pre- and
post-harvest
• 180.920 – Inert ingredients used preharvest
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11. 40 CFR Part 180 – Other exemptions
from the requirement of a tolerance
for active and inert ingredients
• 180.930 – Inert ingredients applied to animals
• 180.940 – Active and inert ingredients for use
in food contact surface sanitizing solutions
• 180.950 – Minimal risk active and inert
ingredients
• 180.960 - Polymers
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12. Limitations on Tolerance Exemptions
Each exemption may have a chemical-specific
limitation that affects its approval status.
Example:
3,6-Dimethyl-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.
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13. Procedures for Requesting
Establishment of a New/Amended
Inert Ingredient Tolerance Exemption
• Request a presubmission call or meeting with
the Inert Ingredient Assessment Branch of
EPA’s Office of Pesticide Programs
• Prepare and Submit a Petition, which must
include a “Notice of Filing,” a Petition
Summary, and toxicity and exposure data.
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14. Presubmission Meeting
• Informal discussion to determine if the applicant
has enough information to proceed with the
petition process.
• Applicant provides a brief summary of
information regarding the chemical, including use
information, limitations, applicable sections of
the Code of Federal Regulations, and toxicity and
environmental fate data.
• EPA staff then advises the applicant as to
additional information that will be needed in the
petition.
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15. Petition Contents
Notice of Filing
• Summary of the request for an exemption
from tolerance for an inert ingredient,
including all supporting data.
• Published in the US Federal Register with a
public comment period of 30 days.
• Published Notice of Filing states that EPA has
not evaluated the application or decided if the
data support granting of the tolerance
exemption.
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16. Petition Contents
Summary of the request
Name, chemical identity and
composition
Purpose, including use pattern
Any proposed limitations
Current uses of the chemical and existing
tolerances or exemptions
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17. Petition Contents
Summary of the Data
• Relevancy of each submitted study
• Study results and conclusions
• Discussion of missing data and justification as
to why this information is not needed to grant
the tolerance or exemption
• Summarize applicant’s position regarding
human health and environmental risks, based
on the data and information provided.
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18. Petition Contents
Data
•
•
•
•
•
•
Physical/chemical properties
Toxicity
Human/animal metabolism
Exposure
Environmental fate and effects
Ecotoxicity
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19. Petition Contents
Toxicity Data
• Acute (oral, dermal, inhalation, skin and eye
irritation, and skin sensitization)
• Chronic/repeat dose
• Reproduction/Developmental
• Mutagenicity
• Carcinogenicity (or Quantitative Structure Activity
Relationship/QSAR modeling)
• Neurotoxicity
• Endocrine
• Immunotoxicity
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20. Petition Contents
Human/Animal Metabolism Data
• Is the chemical absorbed by the body?
• How much of the chemical is excreted and
how is it excreted (e.g., urine, feces)?
• Will it bioaccumulate?
• Are the degradates/metabolites of the
chemical more toxic than the parent
chemical?
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21. Petition Contents
Exposure Data
• Dietary - intended crops, application rate, % in
formulation
• Drinking water (if EPA default modeling indicates
a concern) - Surface and Ground Water modeling
• Occupational – Anticipated exposure to workers
mixing, loading and applying the inert + post
application re-entry workers
• Residential – home use handler and post
application exposure - % in formulation
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22. Petition Contents
Environmental Fate and Ecotoxicity Data
•
•
•
•
•
Biodegradation/Persistence
Expected “fate” of the chemical
Aquatic organism toxicity
Avian organism toxicity
Invertebrate organism toxicity
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23. “EPI Suite” and “ECOSAR”
The publicly available EPI Suite (Estimation Program
Interface) model may be used if no environmental
fate data are available:
 http://www.epa.gov/oppt/exposure/pubs/episuit
e.htm
The publicly available EPI Suite or ECOSAR
(Ecological Structural Activity Relationship) models
may be used if no ecotoxicity data are available:
 http://www.epa.gov/oppt/newchems/tools/21ec
osar.htm
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24. Acceptable Sources of Data
• EPA guideline studies:
http://www.epa.gov/ocspp/pubs/frs/home/guide
lin.htm
• Publically available literature and data, including
peer-reviewed assessments and journals
• Modeled data:
http://www.epa.gov/pesticides/science/models_
db.htm#models
• Analog/surrogate data
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25. Unacceptable Sources of Data
• MSDS sheets are only useful if the product
contains 100% of the chemical in question and
it clearly states this on the MSDS. Also, any
studies cited (e.g., toxicity) on the MSDS must
be provided.
• Unpublished studies that are submitted
without the full study report are not
acceptable.
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26. EPA Petition Review Process
• 21-day screen of the petition for
adequacy/completeness
• 45- to 90-day technical screen to determine if the
application and data are accurate and complete
• Full review and risk assessment
• Proposed and Final “Rule” (regulation) published
in the Federal Register, to grant the tolerance or
tolerance exemption. Proposed Rules generally
provide a 90- to 120-day public comment period.
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27. EPA Decision Review
Time Frames and Fees
• New food use inert = 12 months/$18,900
• Amendment of a currently approved food use
inert with new data = 10 months/$5250
• Amendment of a currently approved food use
inert without new data = 8 months/$3150
• Adjuvants that are not inert ingredients (i.e., not
part of a product formulation) currently have no
established time frame for review or any fee
schedule.
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28. Pesticide Product Registration and
Inert Ingredients
• All inert ingredients in a pesticide product
must be approved by EPA before the product
can be registered.
• Confidential statements of formula (CSFs) are
screened to ensure that all inert ingredients
are approved for the labeled use of the
pesticide formulation.
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29. Inert Ingredients in Proprietary
Mixtures
• Pesticide products may contain proprietary
mixtures of multiple inert ingredients.
• Each component of the mixture must be
approved by EPA.
• EPA maintains a confidential master file of
proprietary mixtures that contains the
complete compositional information
(provided to EPA by the manufacturer of the
mixture product).
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30. Data Protection and Exclusive Use
• Section 408(i) of the FFDCA states that data
submitted to support tolerances or tolerance
exemptions for inert ingredients are entitled to
data compensation and exclusive use data rights.
• Exclusive Use = 10 years from publication of the
final tolerance or tolerance exemption rule
• Data compensation = 15 years from the date the
data were submitted.
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31. EPA Role in Data Protection and Exclusive
Use Rights for Inert Ingredient Data
EPA screens pesticide product registration
applications to ensure that the applicant has:
1.
2.
3.
4.
Made an offer to pay for the use of data,
Obtained authorization for the use of data,
Purchased the chemical from the data owner,
Purchased 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 obligation.
The data protection/exclusive use situation for
adjuvants not in pesticide products is unclear.
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32. For more information on EPA inert
ingredient regulation . . .
• Guidance documents and procedural information:
 http://www.epa.gov/opprd001/inerts
 “Inert Finder” - Search engine for approved food and
non-food inert ingredients:
 http://iaspub.epa.gov/apex/pesticides/f?p=175:1:
• Questions?
 InertsBranch@epa.gov
 P.V. Shah, Branch Chief, (703) 308-1846
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