Fresh Fruit and Produce Sanitizing Wash: Questions
Questions For SAP
1. Since this is a new and unique area for the Agency, are the current testing methodologies and performance standards sufficient to determine the efficacy of products which are used to sanitize fresh produce (fruits/vegetables) at the homeowner (household) level?
2. If the current procedures are not appropriate, then what efficacy methodology(ies) and performance standards would need to be developed to ensure acceptable sanitization by the consumer?
3. If further research is needed to develop new methodologies and standards, are there interim methodology(ies) and performance standards that the Agency can utilize in assessing the efficacy of such sanitization techniques?
For purposes of the following discussion on "fresh produce sanitizers" some of the major terms used throughout this discussion are described as follows:
"Sanitizer" means an agent that reduces contaminants in the inanimate environment to levels considered safe as determined by Public Health Ordinance, or that reduces the bacterial population by significant numbers where public health requirements have not been established. Sanitizers meeting Public Health Ordinance requirements are generally used on food contact surfaces and are recognized as sanitizing rinses.
A sanitizing rinse for produce is recognized by the Agency as a cleaning wash, but one that does not equal a sanitizer claim and does not carry claims against pathogenic microbes. (This is somewhat confusing, but essentially these rinses are cleaning washes for produce.) An example is attached to the hard copy of this document.
The Agency registers both public health and non-public health antimicrobial pesticide products. Public health pesticide products include all antimicrobial products intended to control microorganisms infectious for man in any area of the inanimate environment where these microorganisms may present a hazard to human health. For these products efficacy test data are required to be submitted to support registration. (Note: the label claims for an antimicrobial product determine whether or not it is considered to be related to human health.) Antimicrobial products which fall in the public health area include (but are not limited to) uses that : sterilize, disinfect, and sanitize. Thus, produce sanitizers (but NOT sanitizing rinses) with claims against pathogenic organisms are considered public health uses.
For non-public health antimicrobial pesticide products (e.g., control of odor-causing bacteria), the Agency does not require submission of efficacy data. However, the registrant is still responsible for ensuring that these products perform as intended by developing efficacy data which must be kept on file. The Agency still has the responsibility of making sure that the use directions proposed for non-health related claims are appropriate and adequate. Therefore, the Agency retains the option of requiring the submission of efficacy data for non-health related claims, should a product or the use directions on the proposed label on a product pose reasonable doubt as to its efficacy as a non-public health related antimicrobial product. Antimicrobial products which fall in the non-public health area include preservation and bacteriostatic claims - that is, uses which control or inhibit: odor-causing bacteria; bacteria causing spoilage, deterioration, or fouling of materials such as paint or industrial fluids (i.e., preservation of materials); and microorganisms infectious only for animals, where product failure against the specified pests would not have human health consequences.
However, the area of focus in this discussion concerns public health claims. The remainder of this discussion will focus on this area. And, as background, we present the following product uses that may carry sanitizing claims:
A. Public Health Uses - Sanitizing and Residual (Self-Sanitizing) Claims
Sanitizing (non-residual) claims for:
1a. Non-food contact (hard, inanimate) surfaces;
2a. Previously cleaned, food contact (hard, inanimate, non-porous only) surfaces;
3a. Pre-soak treatments of soiled fabrics prior to routine laundry operations;
4a. Additives for use during laundering;
6a. Mattresses, upholstered furniture, and pillows.
8a. Toilets (bowl and urinal surfaces, toilet and urinal bowl water, and toilet in-tanks); and
Self-sanitizing (residual) claims for:
1b. Non-food contact (hard, inanimate) surfaces;
2b. Food contact (hard, inanimate, non-porous only) surfaces; and
3b. Impregnated fabrics and textiles.
The Agency is facing unique scientific/technical issues concerning fruit and vegetable sanitizers that make it difficult to easily place these products into our current regulatory scheme. However, the best fit seems to be in product use category 2a. Considering this, a brief discussion and comparison of existing Test Methods and Performance Standards (as outlined in Subdivision G, Product Performance/Efficacy Guidelines) is presented for this use area (2a):
1. Hard Inanimate Surfaces: Sanitizing/Non-Residual Claims; Use 2a Above:
Typically, the Agency registers liquid and spray sanitizers (with sanitizing claims) for use on non-food (e.g., floors, walls) and food (e.g., eating and drinking utensils) contact surfaces. Further, for food contact surfaces EPA has allowed only a two-step treatment process on hard, non-porous surfaces: (1) the user cleans the surface first to remove excessive dirt and filth; and (2) the user then applies the sanitizer as a terminal rinse to the surface.
For non-food contact sanitizers the recommended Test Method is the Sanitizer Test for Hard Inanimate Non-food Contact Surfaces. The Performance Standard for this Test Method is as follows: EPA concludes efficacy is demonstrated when a reduction of at least 99.9% (a 3-log reduction) in the number of each test microorganism over the parallel control count is observed within 5 minutes.
For food contact sanitizers (non-halide products) the recommended Test Method is the AOAC Germicidal and Detergent Sanitizers Method. The Performance Standard for this Test Method is as follows: EPA concludes efficacy is demonstrated when a reduction of at least 99.999% in the number of each test microorganism over the parallel control count is observed within 30 seconds.
2. Produce Sanitizers: Non-Residual Claims:
For this use it has been proposed to the Agency that the Test Methods to be used are: (1) the AOAC Germicidal and Detergent Sanitizers Method. (The Performance Standard for this Test Method is as follows: EPA concludes efficacy is demonstrated when a reduction of at least 99.999% in the number of each test microorganism over the parallel control count is observed within 30 seconds.); and (2) a simulated, in-use study using the product under actual simulated conditions. (An example of a proposed methodology is attached to the hard copy of this discussion.)
However, there are difficulties in using this approach. No acceptable methodology to test produce sanitizers, especially, under homeowner conditions, is currently available. Furthermore, the current methodology for treating hard surfaces is a two step process, a pre-cleaning step and the actual sanitation step. However, the proposed homeowner use for the fresh produce sanitizer recommends a "one step" treatment approach: i.e., the product label recommends application by spraying fresh fruit and vegetables - no pre-cleaning step is involved. This leads to an inconsistency if the established methods are used to test these products. The test will not approximate the actual use conditions of the product.
As presented above, the Agency has Test Methods and Performance Standards for hard surface, non-porous, food contact surfaces. Over the years these methods and standards have worked well for such surface types where "typical" applications involve liquid and spray sanitizers applied to a hard surface However, Methods and Standards do not exist for fruit and vegetable sanitizers. We offer the following additional points:
1. The Agency questions the use of a hard surface carrier test, or modification thereof, as part of a testing scheme to address fresh produce sanitizers. We do believe that in-use (fresh produce) product testing appears appropriate. Furthermore, if the hard surface test is used, we are not sure how to relate data from this test to a product that is not applied to a hard surface. In addition, performance standards for the hard surface test would not seem to fit results from an in-use test, unless a functional relationship could be established between the two tests.
2. Other Protocols/Methodologies: The proposed in-use methodology is but one approach; we are not sure if other methodologies are appropriate or even exist.
3. Published literature: There is an abundance of documents concerning fruit and produce rinses, washes, sanitizers, and numerous meetings have been held among various governmental agencies on these issues. Many of these articles and efforts call for more research in this area with some recommending that further study is required on the survival and growth of pathogens as well as treatment methods during the food processing chain. Examples of such articles and discussions are attached to the hard copy of this discussion.
4. State-of-the-science: The Agency recognizes two major issues related to fresh produce sanitizers: (1) Can fruits and vegetables be effectively sanitized to current EPA standards by present chemical-treatment methods; and (2) if not, Is the Agency and/or the scientific community willing to accept lowered performance standards for sanitization of produce. Specifically, proposed homeowner uses involve a major change in the way sanitizers are typically applied. The usual procedure involves a two-step (pre-cleaning followed by sanitization) application to hard, non-porous surfaces. Application to fruits and vegetables involves a one step process (no pre-cleaning)to surfaces that vary tremendously (e.g., in surface area, dimension, type, consistency, texture). In addition, alternate means of application have been proposed for these products, but whether chemical applications by immersion, flooding, or spraying can achieve a "sanitization" effect, especially under homeowner conditions, is debatable. Further, a proposal for lowered performance standards (e.g. sanitation, disinfection and sterilization), if made, is a major change from recognized and scientifically accepted procedures which have been around for decades.
5. Greater Efficacy: Are proposed product sanitizers with non-chlorine compounds more efficacious than water or chorine rinses? The Agency has been unable to resolve this issue because an adequate methodology for testing the proposed sanitizing rinse is lacking. Therefore, the Agency believes it would be difficult to determine whether such sanitizers are likely to be more efficacious than water or chlorine rinses until adequate test methodologies have been developed.
6. Greater Benefits: Do proposed applications of homeowner sanitizers provide for more benefits than the application of water, soap and water, or chlorine? This question has also been posed to the Agency, but again we believe that to determine benefits would require knowing the efficacy of such proposed sanitizers, as well as their efficacy in comparison to other rinses. Also, the Agency believes that the state-of-the-science is not available for EPA to be able to perform a risk assessment for food borne pathogens. Smith, M. A. et al. at the Fourth Annual Meeting of the Center For Food Safety and Quality Enhancement, at The University of Georgia made the following comments:
"...There presently exists no accepted method for comparing risks associated with consumption of different food borne pathogens...The specific goal of our project is the development of a quantitative microbiological risk assessment model...A major factor in the risk analysis of food borne pathogens is determining or predicting the lowest population which results in adverse health effects. Epidemiological data generally contain information about populations resulting in severe health effects. For this reason, epidemiological data are usually not sufficient to directly determine a "safe" exposure population. Our current research efforts include correlating population-response information from outbreak data with available statistical models to predict health effects at low populations."
Considering the issues presented in this document, the Agency believes that an acceptable methodology presently does not exist for fresh produce (especially household) sanitizers. We believe that there are limited efficacy data available that can be utilized to address this subject. Also, numerous technical issues exist for developing proposed in-use (fresh produce) methodology(ies) as well as for determining the relationship between data generated from different efficacy study types, especially epidemiological data. A need exists for creating new levels of performance standards which must be scrutinized carefully and accepted by the scientific community. Considering these issues, we request that the SAP consider the usefulness of existing test methods and efficacy performance standards in determining acceptable sanitation of fresh produce. In addition, we ask for suggestions or guidance relative to the state-of-the-science for determining the appropriateness of public health claims associated with fresh produce sanitizers, especially, for household use.