EPA Announces Availability of Final Test Guidelines for Antimicrobial Products

On June 27, 2012, the U.S. Environmental Protection Agency (EPA) announced the availability of two sets of final test guidelines: Series 810 — Product Performance Test Guidelines, specifically public health uses of disinfectants and sanitizers for use on fabrics and textiles (OCSPP 810.2400), air sanitizers (OCSPP 810.2500), and disinfectants and sanitizers for use in water (OCSPP 810.2600); and Series 850 — Ecological Effects Test Guidelines (Groups B, C, D, and F). These guidelines are issued by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). Studies conducted according to these test guidelines may be used to satisfy FIFRA data requirements in 40 C.F.R. Parts 158 and 161, data-call-ins issued pursuant to FIFRA Section 3(c)(2)(B), data requirements appropriate for specific pesticide registration applications as needed, or data requirements to demonstrate the safety of a tolerance or tolerance exemption under FFDCA Section 408. EPA notes that, as guidance documents, the test guidelines are not binding on either EPA or any outside parties. The test guidelines are available online.

The following final test guidelines for Group B — Antimicrobial Efficacy Test Guidelines in OCSPP Series 810 — Product Performance Test Guidelines are available:

• Disinfectants and Sanitizers for Use on Fabrics and Textiles — Efficacy Data Recommendations (OCSPP 810.2400);
   
• Air Sanitizers — Efficacy Data Recommendations (OCSPP 810.2500); and
   
• Disinfectants and Sanitizers for Use in Water — Efficacy Data Recommendations (OCSPP Guideline 810.2600).

These final test guidelines address efficacy testing for antimicrobial agents intended to be used on fabrics and textiles and in water and air and that bear label claims as disinfectants and sanitizers. EPA last updated the product performance guidelines for antimicrobial agents in 1982 under the “Pesticide Assessment Guidelines — Subdivision G, Product Performance.” Since then, EPA has presented several issues at two separate meetings of the FIFRA Scientific Advisory Panel (SAP) related to conducting studies for antimicrobial agents. The first meeting was held September 9-10, 1997, and included discussion of efficacy testing issues concerning public health antimicrobial pesticides. Information regarding the first meeting, including the final report, is available online. The second meeting to discuss guidance on test methods for demonstrating the efficacy of antimicrobial products was held July 17-19, 2007. Information regarding the second meeting is available online. EPA also published the test guidelines for comment on September 15, 2011, and revised them based on comments received from industry. In addition, formatting changes to incorporate the test guidelines into the OCSPP test guideline Series 810 were made.

EPA also announced the availability of final test guidelines for Series 850 — Ecological Effects Test Guidelines, consisting of Group B –Terrestrial Wildlife; Group C — Terrestrial Beneficial Insects, Invertebrates, and Soil and Wastewater Microorganisms; Group D — Terrestrial and Aquatic Plants, Cyanobacteria, and Terrestrial Soil Core Microcosm; and Group F — Field Test Data Reporting Guidelines. Between these four groups, 24 individual test guideline documents have been made newly available as final guidance; a list appears at the end of this update. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA. The test guidelines provide guidance for conducting the tests and are also used by EPA, the public, and companies subject to data submission requirements under TSCA, FIFRA, and/or FFDCA.

For all the test guidelines, EPA notes that at places in this guidance it uses the word “should.” According to EPA, in this guidance, use of “should” regarding an action means that the action is recommended rather than mandatory. EPA states that while the procedures contained in the test guidelines are recommended for generating the data that are the subject of the test guideline, “EPA recognizes that departures may be appropriate in specific situations.” Alternatives to the recommendations described in the test guidelines may be proposed, and EPA will assess them for appropriateness on a case-by-case basis.

Specific Changes to Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents

The final Product Performance Guidelines for Public Health Uses of Antimicrobial Agents were revised based on comments (unspecified) and formatted to incorporate the test guidelines into OCSPP test guideline Series 810.

Specific Changes to Ecological Effects Test Guidelines

Based on FIFRA SAP recommendations and public comments, EPA made the following revisions between the draft and final test guideline documents:

• Changing the title of Group D “Nontarget Plants Test Guidelines” to “Terrestrial and Aquatic Plants, Cyanobacteria, and Terrestrial Soil Core Microcosm Test Guidelines.”
   
• Renumbering and moving the following test guidelines involving plants to Group D:
  • Algal Toxicity — OCSPP 850.4500 (Public Draft OPPTS 850.5400); and
     
  • Terrestrial Soil-Core Microcosm Test — OCSPP 850.4900 (Public Draft OPPTS 850.2450).
     
• Changing the title of Group C “Beneficial Insects and Invertebrates Test Guidelines” to “Terrestrial Beneficial Insects, Invertebrates, and Soil and Wastewater Microorganisms Test Guidelines” and expanding the scope to include testing of microorganisms other than the aquatic algae.
   
• Moving the “Earthworm Subchronic Toxicity Test” from the Public Draft Group F “Chemical Specific Test Guidelines” to Group C and renumbering it from OPPTS 850.6200 to OCSPP 850.3100.
   
• Renumbering and moving the following test guidelines involving plants to Group C:
  • Soil Microbial Community Toxicity Test — OCSPP 850.3200 (Public Draft OPPTS 850.5100); and
     
  • Modified Activated Sludge, Respiration Inhibition Test — OCSPP 850.3300 (Public Draft OPPTS 850.6800).
     
• Adding two background and special consideration test guidelines: OCSPP 850.2000 — Background and Special Considerations — Tests with Terrestrial Wildlife and OCSPP 850.3000 — Background and Special Considerations — Tests with Terrestrial Beneficial Insects, Invertebrates, and Soil and Wastewater Microorganisms. The addition of these test guidelines are in response to comments regarding harmonizing the organization of test guidelines and improving the consistency of terminology and guidance applicable across test guidelines in a group.
   
• Removing terms “Tier I, II, and III” as the terms are not necessary and are misleading as they have different regulatory meanings under the EPA Office of Pesticide Programs (OPP) and the Office of Pollution Prevention and Toxics (OPPT).
   
• Dividing the Algal Toxicity Test into two separate guidelines: OCSPP 850.4500 — Algal Toxicity and OCSPP 850.4550 — Cyanobacteria (Anabaena flos-aquae) Toxicity.
   
• Changing the Group G designation to Group F, and renumbering the test guideline contained within it (Public Draft OPPTS 850.7100) to OCSPP 850.6100.
   
• Removing the title for Group E, as it no longer contains any test guidelines — Group E and its title, however, are reserved.
   
• Standardizing test guidelines to include the same organizational format as well as the tables summarizing test conditions for appropriate test guidelines such that they contain consistent concepts across test guidelines.
   
• Making the following technical changes:
  • Providing a limit test to reduce the number of animals to be tested and/or save resources;
     
  • Modifying the limit dosage of concentration “cut-off” values;
     
  • Adding passerine species and alternative species as test species for the Avian Acute Oral Toxicity Test — OCSPP 850.2100 as well as changing the protocol for carrying out the study;
     
  • Harmonizing the Honey Bee Acute Contact Toxicity Test — OCSPP 850.3020 and Honey Bee Toxicity of Residues on Foliage — OCSPP 850.3030 with OECD 214 “Honeybees, Acute Contact Toxicity Test” as well as with comments from the SAP; and
     
  • Modifying Group D test guidelines to clarify both objectives and test acceptability in terms of definitive and limit tests, as well as, protocol changes.

List of Ecological Effects Test Guidelines

The following final test guidelines for Ecological Effects Test Guidelines are available:

1. Group B — Terrestrial Wildlife
   1. Background and Special Considerations — Tests with Terrestrial Wildlife — (OCSPP 850.2000);
       
   2. Avian Acute Oral Toxicity Test — (OCSPP 850.2100);
       
   3. Avian Dietary Toxicity Test — (OCSPP 850.2200);
       
   4. Avian Reproduction Test — (OCSPP 850.2300);
       
   5. Wild Mammal Toxicity Testing — (OCSPP 850.2400); and
       
   6. Field Testing for Terrestrial Wildlife — (OCSPP 850.2500).
       
2. Group C — Terrestrial Beneficial Insects, Invertebrates, and Soil and Wastewater Microorganisms
   1. Background and Special Considerations — Tests with Terrestrial Beneficial Insects, Invertebrates and Microorganisms — (OCSPP 850.3000);
       
   2. Honey Bee Acute Contact Toxicity Test — (OCSPP 850.3020);
       
   3. Honey Bee Toxicity of Residues on Foliage — (OCSPP 850.3030);
       
   4. Field Testing for Pollinators — (OCSPP 850.3040);
       
   5. Earthworm Subchronic Toxicity Test — (OCSPP 850.3100);
       
   6. Soil Microbial Community Toxicity Test — (OCSPP 850.3200); and
       
   7. Modified Activated Sludge, Respiration Inhibition Test — (OCSPP 850.3300).
       
3. Group D — Terrestrial and Aquatic Plants, Cyanobacteria, and Terrestrial Soil Core Microorganisms
   1. Background and Special Considerations-Tests with Terrestrial and Aquatic Plants, Cyanobacteria, and Terrestrial Soil-Core Microcosms (OCSPP 850.4000);
       
   2. Seedling Emergence and Seedling Growth (OCSPP 850.4100);
       
   3. Vegetative Vigor (OCSPP 850.4150);
       
   4. Early Seedling Growth Toxicity Test (OCSPP 850.4230);
       
   5. Terrestrial Plants Field Study (OCSPP 850.4300);
       
   6. Aquatic Plant Toxicity Test Using Lemna spp. (OCSPP 850.4400);
       
   7. Aquatic Plants Field Study (OCSPP 850.4450);
       
   8. Algal Toxicity (OCSPP 850.4500);
       
   9. Cyanobacteria (Anabaena flos-aquae) Toxicity (OCSPP 850.4550);
       
   10. Rhizobium-Legume Toxicity (OCSPP 850.4600);
        
   11. Plant Uptake and Translocation Test (OCSPP 850.4800); and
        
   12. Terrestrial Soil-Core Microcosm Test (OCSPP 850.4900).
        
4. Group F — Field Test Data Reporting Guidelines
   1. Environmental Chemistry Methods and Associated Independent Laboratory Validation (OCSPP 850.6100).