Document ID: EPA-HQ-OPP-2020-0124-0037
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-03-22T04:00Z

SC Johnson & Son, Inc. Response to the SAP on Scientific Issues Associated with Product Performance Data 
SPECIES
   1. Species Bridging (Appendices I and V)
         a. SCJ welcomes and supports a scientific and yet sensible approach to bridging efficacy data across taxon. 
         b. However, the proposed species grid is way too restrictive and will create an undue burden on registrants.  
                 i. We advocate a process of qualifying claims.  For example, if spiders are claimed, we recommend qualifying the claim as "spiders (non-poisonous)", rather than always testing Black Widow or Brown Recluse spiders for a spider claim.  The same argument can be made for ants.  If a registrant does not want to claim fire ants, they should not be required to test them.  Rather, a qualified exclusion would also achieve the same goal, and place less testing burden on registrants. 
                 ii. Scorpions.  Only one species is listed, which is way too restrictive.  Many more options are needed here.
                 iii. Filth flies.  In cases where a direct spray application is proposed, we see no reason to test more species than the house fly.  Only in the cases of more specialized claims (like fly bait efficacy) should more species be mandated.
                 iv. Mosquitoes.  Anopheles stephensi is missing as a common, representative lab insect.
                 v. Bed bugs.  In the U.S., only one species is important to the vast majority of consumers, and thus only one species needs to be tested to support this kind of product registration. 
                 vi. True bugs.  Common stink bug species are missing here.
METHODOLOGY
   2. Universal/International Guidelines (page 34).  With all of the methodology that has been published, reputable companies like SCJ combine the methodologies from various sources.  As such, they are "hybrid methods".  None the less, they are still rooted in these published methods.  With proper documentation of these source methods, SCJ believes that EPA should "accept" company "hybrid methods" for efficacy studies.
   3. Method Flexibility
         a. EPA cannot possibly anticipate all methodology variations needed to substantiate the highly specific and/or proprietary nature of our claims.  Registrants must be given scientific leeway to develop/use specialized, proprietary methodologies to substantiate these specialized claims.
         b. EPA is currently not timely in reviewing our new methods/protocols.  A suggestion that companies "pre-submit" them is not workable because history shows that these reviews greatly delay product development work.     
         c. Companies like SCJ have used (successfully) in-house methodologies for years.  We also consider them to be proprietary and/or a competitive advantage.  Changing over to prescribed methods, for us is a step backwards in our registration approach.  
   4. Mutual acceptance of data:  EPA should recognize that global companies such as SCJ must spend enormous resources to develop and support their global efficacy packages.  SCJ recommends that for test methodologies that meet BPD standards also be mutually recognized/accepted by EPA.
EFFICACY TESTS
   5. Sample sizes and statistics (page 29):  EPA must recognize that the only one treatment is evaluated in most lab efficacy studies.  Discussion around sizes and statistics is generally meaningless, except for selected instances.  A more realistic approach is  something like: 
         a. "Generally, 5 replicates are needed to show product efficacy"
         b. "Descriptive statistics such as means and a variance parameter are generally needed"  
   6. Positive controls or reference standards (page 29).  For GLP product efficacy, this is mostly meaningless because it requires full characterization of the other test substance, which is a costly and often impossible burden for registrants (these are often proprietary). 
   7. GLP data for public health pests (page 28).  EPA is proposing GLP data for all public health pests.  This is the current SCJ process.  However, we also know that this requirement is not consistently enforced across all registrants.  We want a level playing field for all registrants.  We also would like to continue to be able to submit peer-reviewed, published data that is relevant to a claim (page 37),  with the understanding that most of this data will not be GLP.
   8. Specific Cockroach Testing comments
         a. Repellency Tests (page 31).  There are many other (and some even more sophisticated) ways to demonstrate repellency for crawling insects.  These fall under the heading of "free-choice" testing. Options other than Ebbling Choice boxes should be allowed, as long as they demonstrate sufficient scientific rigor and "free choice".
         b. Field tests for cockroach baits (page 31).  We see no valid, product-specific argument for mandating field studies for these baits.  Reliable test labs can produce reliable efficacy data in simulated-use methods/arenas.   Furthermore, we believe that the EU BPD is right in their rule, by not requiring field data for most consumer-use products. 

DOSE 
   9. Minimum Effective Dose/Diagnostic Dose/Dose Response (pages 26-27)
         a. This requirement will create an undue burden on industry because we foresee a new dose study for every claim.  This requirement would mean that every claim (including different species, use patterns, substrates, environments, different strains, different behaviors even within a species, etc.) would require new dose response data.  
         b. Formulation companies like SCJ often do not have access to these data, as they are often the property of AI manufacturers.
         c. EPA's "need" for these data is far from being universal.  SCJ minimally proposes exemptions for:
                 i. Uses for an AI (or closely related AIs) that are already in the market place
                 ii. Closely related products/registrations
         d. Although recommended by other international agencies, we believe that these dose response studies are not requirements for registration under these international authorities. 
   10. Minimum effective rates (page 63).  As good product stewards, SCJ strives for minimum effective rates.  However, mandating these rates is just not cost-effective.  EPA must recognize that effective rates can vary across species, species behaviors, substrates, strains, etc.  To mandate minimum effective rates is not appropriate considering the breadth of uses and use scenarios that appear on labels.  SCJ recommends that this requirement be abandoned because these rates are by no means universal to all parts of a label.

PERFORMANCE STANDARDS
   11. Performance Standards (page 25 and Appendix V).  
         a. Consumer vs. Professional Use:  SCJ believes that, like BPD, there is a need for two sets of efficacy standards; one for Consumer, and one for Professional. 
                 i. On the other hand, consumers expect much more efficacy when products are applied by professionals, since the objective is to eradicate the infestation.  
         b. Around the 80% efficacy level:  Our belief is that consumers can readily identify, and then accept cost-effective benefits from performance of house-hold products around the 80% efficacy level. 
                 i. This "level of benefit" should not be ignored by the EPA for consumer products; it's both real and important to consumers.  Consumers look more for immediate knockdown when using Consumer products, not so much a certain % mortality.  
                 ii. Additionally, consumers usually use more than one product form (IPM approach) to "get the job done", e.g., aerosol, fogger and bait to try to combat a roach problem.  Not just one product alone needs to provide 95% mortality to be registrable.  
         c. Irrelevant sources:  SCJ also wants to mention that of the sources cited for use in determining performance standards, only the European Commission one is relevant.  Nowhere in the WHOPES documents do they suggest a performance standard.  Actually, quite the opposite, they all state the purpose of the documents is to harmonize procedures to aid in generating comparable data, and that performance standards should be determined by national regulatory authorities.  The Health Canada citation only covers the treatment of plant pests therefore is not applicable to public health pests.    
            
LABEL CLAIMS
   12. Linking claim verbiage (pages 64-66).  SCJ urges EPA that this whole discussion be for example purposes only, not prescriptive.  Registrants should have much more flexibility than this in devising their own wording for claims.  This is extremely important for consumer products where we strive to make labels as easy to read and understand as possible for consumers.
            
DEFINITIONS
   13. Incapacitated insects (page 56).  SCJ urges EPA to recognize both the benefits and practicality of adopting in their EPA Definitions a new definition for "incapacitated insects".  These insects are truly "unavailable" for biting and/or nuisance to the consumer.  For all practical purposes, the insects will die, even though they may move after probing.  Moribund insects are often viewed as a valuable benefit to consumers who may remove them, or ignore them.  SCJ urges EPA to relax its definition of a "dead insect", to a state of "moribund" as the test's end point.  

MINIMUM RISK PESTICIDES
   14. 25b exemptions (page 13).  EPA is considering a proposal to remove personal mosquito and tick repellents from the minimum risk pesticides exemption.  SCJ heartily agrees with this approach.