Major registration revision for antimicrobials
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May 21, 2013
Major registration revision for antimicrobials

Describing it as a "launching pad" for the application of 21st century science in pesticide decision making, the EPA has issued a final rule that significantly revises requirements for registering antimicrobial pesticides.  The rule takes effect July 8, 2013. 

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Antimicrobial pesticides are used to control microbiological contamination in healthcare applications and deterioration in industrial, commercial, and consumer products.  The common public health antimicrobial products include sterilants, disinfectants, and sanitizers.  Within the final rule, the EPA uses the term “antimicrobials” to collectively refer to antimicrobial pesticides, antifoulant coatings and paints, and wood preservatives. 

Among other things, the action codifies data requirements the EPA imposes on a case-by-case basis.  The Agency says it will continue to reserve the right to require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment.

Data requirements

Overall, the action adds 11 new data requirements that companies must meet to register their products.  In essence, the data requirements illustrate the questions the registrant must answer about the safety of the pesticide product before the EPA can register it.  The rule also codifies 12 antimicrobial use patterns.  In the registration process, use patterns dictate the type of data the Agency will require to determine if the pesticide will satisfy health and environmental safety standards. 

The eight new data elements the EPA proposed in 2008 and has now codified are developmental neurotoxicity; immunotoxicity; photodegradation in soil; soil residue dissipation; ready biodegradability study; porous pot study; activated sludge sorption isotherm study; modified activated sludge; and respiration inhibition test. 

Based on public comments, the rule adds two other new data requirements that serve as alternatives to tests that were proposed (and are now being finalized):

  1. Simulation tests to assess the biodegradability of chemicals in discharged wastewater
  2. Simulation test–aerobic sewage treatment: activated sludge units. 

Also based on comments, the nature of the residue on surfaces is being added as a new data element. 

Use patterns

The 12 general antimicrobial use patterns listed in the rule are agricultural premises and equipment; food-handling/storage establishments, premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifoulant paints and coatings; wood preservatives; swimming pools; and aquatic areas.

Additionally, the final rule:

  • Codifies data requirements/use pattern combinations not previously codified but typically required to register an antimicrobial pesticide product;
  • Provides improved definitions for antimicrobial pesticides used for public health and nonpublic health purposes; and
  • Codifies data requirements to determine risks to wastewater treatment plants and the potential for movement of antimicrobials and their degradates from the indoor environment to the outdoor environment via effluent discharge from a treatment plant.

The final rule was published in the May 8, 2013, FR.

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