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Guidance on the Registration of MUP/TGAI Products

March 17, 1998

Antimicrobials Division is currently reviewing many existing policy decisions on a case by case basis and making a determination on whether the prior policy is still applicable or whether there is a need to change or modify that policy. One of the areas we have recently reexamined deals with the registration of manufacturing use products (MUPS).

The data requirements to register a product usually consists of a core set of data plus use pattern specific data. For a MUP registration, the data requirements depend on the uses of end-use products that can be manufactured from the MUP. Core data may include chemistry data on the active ingredient and limited ecological effects and toxicology data. Use pattern dependent data can be much more extensive and can include additional toxicology data such as subchronic and chronic studies, other ecological effects and environmental fate data, exposure data and may require human and ecological risk assessments.

The APB/RD has in the past been willing to register a manufacturing use product (MUP) either as a new active ingredient or for a new use while the data associated with the end use product were still under review. This practice was started, in part, because of the long review times historically associated with a new use pattern or new active ingredient for an antimicrobial chemical. However, with the passage of the Food Quality Protection Act (FQPA) amendments to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) time frames for reviewing antimicrobial applications have changed. A major goal of FQPA is to ensure that pesticide registration actions occur in a timely manner. Section 3 (h) of the amended FIFRA establishes goals for the length of time the Agency can take to review and reach decisions on different types of pesticide applications. These review periods are months to years shorter than the length of time often taken in the past. Antimicrobials Division has met all of the FQPA review time frames for submissions received since FQPA was enacted and expects to continue to do so. Therefore, the Agency believes that review time frames should no longer be a consideration in approving registration applications. In addition, this practice of registering a MUP while the data associated with the end use product are still under review is inconsistent with the rest of the program which typically registers the end-use product and a MUP concurrently. AD, where appropriate, is striving to be consistent with the rest of the program with its review procedures and policies. AD is also concerned that it could register a product (MUP) or use pattern and then discover when all of the data are reviewed for the use pattern that there are risk concerns that might prohibit the registration of the end-use product. Finally, AD is concerned that its current practice is somewhat confusing and misleading to both the public and its own personnel because it gives the impression the use pattern is registered, although no actual use can take place until the end-use product is registered. For these reasons AD believes it is appropriate to change its policy regarding the registration of manufacturing use products.

The Antimicrobials Division will register a MUP, either as a new active ingredient or for a new use, only after the data for any associated end-use product have been reviewed and the end use product has been determined acceptable for registration.

An application for registration of a new active ingredient must include an end-use product registration application, although the end-use product application does not need to be from the same company. Applicants should coordinate to have these applications submitted at the same time. All data pertaining to the active ingredient must be submitted with the MUP application. The Agency intends to submit the MUP application and the end-use product applications to review concurrently. The same procedures will apply for new use patterns.

MUP registration application is required only when the criteria under 40 CFR 152.15 are met.

Effective Date
This policy is effective May 1, 1998.Any MUP applications presently in review or submitted for review prior to May 1, will be put into review without an end-use product application. However, the Agency asks that an end-use product application be submitted as soon as possible so that it can be reviewed prior to issuing the MUP registration.

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