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Intermediate Treated
Articles in the United
States
Adrian Krygsman
Director, Product Registration
TROY CORPORATION
BIOCIDES USA 2016
(Antimicrobials) Regulation
Conference
April 11-12, 2016
Intermediate Treated Articles
Content/Focus: ● Intermediate Treated Articles in the U.S.:
▪ Past
• Treated Article Regulation
▪ Present
• Current Regulatory Approach
➢Possible Implications
➢EU BPR Proposal
▪ Future
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Intermediate Treated Articles
Understanding Intermediate Treated Articles (ITA’s) starts with an appreciation of Treated Articles (TA’s)…..
In a galaxy far, far away……..
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Intermediate Treated Articles
Some Regulatory Fundamentals:
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) states:
●Pesticide is defined as: “Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest” FIFRA §2(u)(1)
●Definition does not include language pertaining to treated articles or intermediates.
●Treated Article regulations did not come into play until 1988 in the form of 40 CFR § 152.25(a)
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Intermediate Treated Articles
Treated Articles Exemption 40 CFR
§152.25(a) states:
Registration is not required for:
Treated articles or substances. An article or
substance treated with, or containing a pesticide to
protect the article or substance itself (e.g. pesticide to
protect the paint film or wood products treated to
protect the wood from insect or fungal infestation) if
the pesticide is registered for such use.
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Intermediate Treated Articles
Treated Articles Exemption 40 CFR §152.25(a)
In order to qualify for the treated articles exemption
both conditions must be met:
1) Pesticide used is registered for use in or on the article
or substance and:
2) Sole purpose is to protect the article or substance
Remember: Articles meeting these requirements are still
considered pesticides but are exempt from all the
provisions of FIFRA when intended for use, and used only
in the manner specified. 8
Intermediate Treated Articles
Additional policy was provided in the form of a PR Notice
published March 6, 2000 as PR Notice 2000-1 primarily
due to concerns raised over labeling of products.
Key event: 1999 Chicago home goods convention
where EPA observed gross mislabeling and misuse of
regulatory language on products (e.g. cutting boards)
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Intermediate Treated Articles
Transition from the TAs (40 CFR §152.25(a) to
ITAs: What are Intermediate Treated Articles (Masterbatches)?
●Used in multiple industries:
▪ Paints/coatings
▪ Metalworking Fluid (MWF)
▪ Plastic
▪ Textile
●Can employ third party compounders who, provide additional
processing/manufacture of an article.
▪ This has been an area where historically, intermediates were not
registered.
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Intermediate Treated Articles
Transition from the TAs (40 CFR §152.25(a) to
ITAs:
●No mention of ITAs under TA exemption or the TA
Policy under PR Notice 2000-1
●In order to address registrants EPA provided
interpretations in the form of two letters:
▪ Frank Sanders (Director, Antimicrobial Division) to
James Palmquist, Chair Treated Articles Coalition-
April 12, 2001;
▪ Jeff Kempter (Senior Advisor, Antimicrobial
Division) to A.L. Snow, ChemReg Intl.- Sept. 9,
2003.
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Intermediate Treated Articles
Examining each letter in more detail……
●Sanders Letter (memo) of April 12, 2001:
Treated article intermediate products “ are substances or
materials that are treated with or contain a pesticide registered
for such use and that are further made into other treated article
intermediate products or into treated article end use products
….. [T]he Agency offers the following guidance: (1) treated
article intermediate products are not required to be registered
provided such products comply in all respects with 40 CFR
152.25(a); and (2) if such a pesticide product does not meet
each of the elements specified in 40 CFR 152.25(a), it must be
registered…”
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Intermediate Treated Articles
Examining each letter in more detail……
●Kempter Letter (memo) of Sept. 9, 2003 provides a response to
submittal of three examples of ITA’s by L. Snow, ChemReg
International:
Example 1- A paint company buys a pesticide registered under FIFRA section
3 for use as a preservative for paint. The paint company adds the preservative
to a liquid component of the paint as part of the manufacturing process. This
process is due to pH considerations in an otherwise normal way that solid
materials are incorporated into the paint. That is, neither a preservative
material nor any other component is mixed into the paint as a final step but
rather is put into the paint during an early manufacturing step. All of the
manufacturing steps are conducted at the paint company’s facility. Under these
circumstances, the stepwise addition of the registered preservative is for a short
period in the form of a treated article (in this case a substance) intermediate
and is therefore not different from any other treated article intermediate.
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Intermediate Treated Articles
●Kempter Letter (memo) cont’d:
Example 2-Involves the same paint company and same
registered preservative. In this example the paint company
contracts the manufacturing step of adding the registered
preservative to the paint component to a third party. The
contention provided to EPA was the component of paint
containing the registered preservative is now a treated article
intermediate and can be treated in the same manner as solid/solid
mixtures common to the plastics industry.
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Intermediate Treated Articles
● Kempter Letter (memo) cont’d:
Example 3: Similar to Example 2 except now the paint company
contracts separately with the registered pesticide manufacturer
to perform the intermediate manufacturing step of putting the
registered pesticide into a paint component. In this example it
is believed that the component of paint containing a registered
pesticide is now a treated article intermediate and can be
treated in the same manner as solid/solid mixtures common to
the plastics industry.
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Intermediate Treated Articles
● Kempter Letter (memo) cont’d
EPA’s Response:
For all three examples the Agency agrees that the liquid
intermediate component that has been treated with a pesticide
registered for use as a paint preservative during the
manufacture of the paint qualifies for the treated article
exemption because the conditions of 40 CFR 152.25(a) have
been met. Since this regulation may apply to an article or
substance of any kind, the treated intermediate liquid
component described in your three examples certainly fits
under the treated article exemption.
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Intermediate Treated Articles
● EPA has issued registrations for concentrate
products which can be diluted to provide
protection to final products.
● EPA has brought enforcement actions
against intermediate treated article
(masterbatches) including antimicrobials.
● Interpretation has been inconsistent.
● EPA presentation on “Intermediates” March,
2015 (J. Hebert and S. Murasaki)
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Intermediate Treated Articles
► EPA “Intermediates” Presentation Key
Points:
▪ The determination of whether a product is a
pesticide under FIFRA is the same regardless
of whether the product being distributed or
sold is an intermediate.
▪ Not all treated articles require registration-
reference to Treated Article Exemption under
40 CFR 152.25(a)
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Intermediate Treated Articles
► EPA “Intermediates” Presentation Key
Points:
▪ Issue of “Registered for Such Use”…….
• All aspects of the registration and label of the
incorporated pesticide apply (e.g. use patterns,
application methods, and application rates)
• TA manufacturers must be able to:
➢Identify the specific registered product that
was used to treat the product;
➢Demonstrate that the treated product is in
compliance with the label of the registered
product.
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Intermediate Treated Articles
► EPA “Intermediates” Presentation Key
Points:
▪ Issue of “Registered for Such Use”…….
• Products made from exempt treated articles
(including exempt “intermediates”) may, but
do not automatically, qualify under the
treated articles exemption.
• “Downstream” producers bear the burden of
establishing that their products qualify for the
TAE under section 152.25.
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Intermediate Treated Articles
► EPA “Intermediates” Presentation Example
provided:
► A material preservative is labeled to protect plastic at rates up
to 5% active ingredient (AI). An “intermediate” plastic pellet is
produced containing 20% AI.
1. If distributed/sold the pellets require registration
• Not “registered for such use” (exceeds allowed rate)
2. Production continues on-site (no sale/distribution of pellets)
and results in plastic sheet “intermediates” that contain 5% or
less AI. As long as the sheets are in compliance with the
label of the registered pesticide and only allowable claims are
made the sheets qualify under the TAE.
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Intermediate Treated Articles
► EPA “Intermediates” Presentation Example provided
(cont’d)
► A material preservative is labeled to protect plastic at rates up
to 5% active ingredient (AI). An “intermediate” plastic pellet is
produced containing 20% AI.
• If the plastic sheets are sold and used to make
shower curtains containing 2.5% AI and the
shower curtain is in compliance with the label of
the registered product and only allowable claims
are made the shower curtains qualify under the
TAE.
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Intermediate Treated Articles
►So where are we now? ► EPA continues in their approach- if a product is intended to
impart protection to another article the product must be
registered.
► There is some flexibility provided label rates are met and
claims are consistent with 152.25(a).
► Industry have met with the EPA on multiple occasions
• Focus/attention on business relationships/contracts
• New registrations with clearly delineated dilution
instructions and rates for downstream use.
• Need for a formal workshop
► EPA has indicated they will provide formal guidance….
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Intermediate Treated Articles
THANK YOU!
Adrian Krygsman
krygsmaa@Troycorp.com
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