Food Use Inert Ingredient Proposed Data Set
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Since the 2006 inert ingredient revocation actions were published by EPA
requiring the submission of an OECD 422 study or equivalent data and knowing
that EPA has the authority to require any additional study prior to approval under
FQPA and FIFRA the Inert Steering Committee (ISC) determined that we should
propose a data set that would satisfy the regulations.
In order to be considered a pesticide, a substance must be intended for use as a
pesticide. An inert ingredient which is not itself a pesticide would,
accordingly, be a chemical substance within the jurisdiction of TSCA and it
comes within the jurisdiction of FQPA and FIFRA only when it becomes a
component of a pesticide product. 42 FR 64586 (comment 39), Dec. 23, 1977.
Over the course of several meetings of the ISC, with the input of many member
companies, the ISC compiled a list of the data being required under the TSCA
PMN process and the Inert ingredient petitioning process. The goal was to
produce a comprehensive Data Set that would allow EPA to review and issue a
PMN close to the 90-day statuary requirement. Some have taken over 24 months
with at least two additional data requests and no TSCA inventory listing. The inert
ingredient exemption from the requirement of a tolerance issued within 8 months.
Many of these studies are not being requested for approval under FIFRA/FQPA
at the present time, and many could be withheld when a petition submission is
made under FIFRA. This limited data set would allow for approval of the
tolerance/tolerance exemption. The question of data compensation under FIFRA
is not clear at this time because EPA has not published a data compensation
regulation for inert ingredients.
Based on the experiences of the ISC member companies the following data set
has been adequate to obtain a tolerance exemption under FIFRA/FQPA in recent
months. EPA can request additional data at any time to fill any data gaps that
remain after their literature search and modeling efforts to support your
application:
–
Available Product Chemistry data and published information.
–
An Acute Toxicology six-pack.
–
An OECD 422 or equivalent study.
Food Use Inert Ingredient Proposed Data Set
The above data set must be considered the barest of minimums, however, and
additional data or the full data set recommended here would fully support your
tolerance or tolerance exemption petition.
Physical and Chemical Properties
Estimated Cost of studies $380,875
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Preliminary Analysis (5-batch) (830.1700)
pH (830.7000)
Water Solubility (830.7840)
Octanol: Water Partition Coefficient
Flash Point
Melting Point (830.7200)
Boiling Point (830.7220)
Vapor pressure (830.7950)
Hydrolysis (OECD 111)
Dissociation Constant (830.7370)
(R)b Absorption/Desorption (OECD 106)
Mammalian Toxicity Studies
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Acute Oral Toxicity limit test (UDP) – 3-Rat (870.1100)
5-Rat limit test (OECD 425)
LD 50
Acute Dermal Toxicity - Rat (870.1200/OECD 402)
Acute Inhalation - Rat (870.1300/OECD 403)
Acute Eye Irritation - Rabbit (870.2400/OECD 405)
Acute Dermal Irritation - Rabbit (870.2500/OECD 404)
Dermal Sensitization - guinea pig Buehler(870.2600/OECD 429)
OR
Dermal Sensitization - guinea pig Magnusson Kligman
OR
Mouse LLNA (870.2600/OECD 429)
OECD 422 - or equivalent
Ecotoxicological Studies
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Acute Invertebrate Toxicity – Daphnia (850.1010/OECD 202)
Acute Toxicity – Fish (Trout) (850.1075/OECD203)
Acute Avian (Quail) (850.2100b)
Algal Growth Inhibition (850.5400/OECD 201)
(R) Acute contact Honey bee (OECD 213)
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Food Use Inert Ingredient Proposed Data Set
Genetic Toxicity Studies (two endpoints)
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Ames Assay - (gene mutation endpoint)
Chromosomal Aberration Endpoint (or Mouse Micronucleus)
Environmental Fate Studies
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(R) Biodegradation: Ready/Inherent (835.3110)
(R) Non-target plants (Vegetative Vigor) (850.4150)
(R) = Reserved, may be required.
Conclusion
The manufacturer can submit the chemistry, acute data and OECD
422 or equivalent and let IIRB determine if there is sufficient data in
the literature and by modeling to allow EPA to approve the inert
ingredient or the submitter can conduct any additional data listed to
support the tolerance exemption.
EPA has no plans to publish a suggested or required data set for inert
ingredients at this time.
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