biocides usa 2016 (antimicrobials) regulation conference ... · troy corporation biocides usa 2016...

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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PAST

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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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Examples of Treated Articles:

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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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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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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


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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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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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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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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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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●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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● 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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● 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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PRESENT …… What’s happened since the

Kempter letter?

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● 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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► 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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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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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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► 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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► 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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FUTURE

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►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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THANK YOU!

Adrian Krygsman

[email protected]

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mailto:[email protected]



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