By Bob Baker

This issue, we will continue our coverage of the ASHRAE winter meeting by relating some of the remarks made by Mr. Frank Sanders. Mr. Sanders is head of the Antimicrobials Division at EPA. His opening statement set the tone for the presentation, "We are living in times were every thing you or government does comes under intense scrutiny. Today public policy direction needs to be supported by data. That data must be developed under peer review, by scientific panels or highly creditable associations or committees." He went on to make some important points about the policy direction of his department.

Basis for EPA Policy

The use of Antimicrobial products, biocides, or germicides in Heating Ventilating or Air Conditioning systems, is currently a highly visible issue. There are many questions and few answers supported by data. The principle public policy focus with respect to registering Antimicrobial products is that they be efficacious and that do no harm to the users, the public or the environment. The laws that govern regulation of Antimicrobial products also require that the risk of using a product be balanced with the risk of not doing anything. This is a difficult tradeoff for the EPA to make since well-controlled studies showing the relationship between high levels of microbial growth and health effects do not exist.

Most individuals working in the field though feel that it is logical to expect that a facility that free from excessive growth will be a healthier place to live or work. It is also helpful that the EPA Scientific Advisory Panel has stated that reduction of growth concentration (as opposed to a total kill) is desirable public policy. For some products, this is not an important issue because EPA normally rules that a margin of safety greater than 100 to 1 is evidence that the benefit of using a product is greater than the risk. This leaves the only challenge for industry to develop ways to accurately measure the risk of exposure to a proposed product and calculate the resulting margin of safety to the satisfaction of the scientific community. This is still a challenging task. The difficulty is finding ways to accomplish this without it costing a fortune and without taking forever and that methods used to confirm safety and efficacy are reasonable.

How EPA gets involved

EPA Antimicrobial Division activity toward Heating Ventilation Air Condition System products is triggered when:

a) A Company applies for approval of a product to be used as a Germicide, Biocide, Disinfectant, Sanitizer or Antimicrobial to kill bacteria, spores, viruses and fungi.

b) A registered product is used inconsistent with its label.

c) A product is used that is not registered and is being used or is making claims that are not registered with the EPA.

d) The label language is not clear or precise enough and may need to be clarified.

Several principles fall out of this:

1. Products used in HVAC systems that make claims to kill microorganisms (protozoa, algae, viruses, bacteria and fungi) require registration by the EPA.

2. Products making odor-reducing claims may require registration as well.

3. Products making health claims need to meet special criteria.

4. Applicators are responsible for using proper products and applying them according to directions. This is a special concern. (The agency points out that, just because a product is registered for hard surfaces, that does not mean it can be used on hard surfaces in HVAC systems.)

EPA Headquarters IAQ

EPA policy in this area has been strongly affected by a series of events in the EPA headquarters building starting in 1989. They experienced a series of indoor air problems that disrupted operations and led to employee legal actions. Some believe that some of these problems were caused by improper use of Antimicrobial products in the HVAC systems in the building.

Whatever the causes of the headquarters problems, EPA believes it has a basis to be concerned about HVAC applications. They plan to take some actions to notify applicators that treat HVAC systems that unless a product is specifically labeled and registered by the EPA for use in HVAC systems that they should not under any circumstances apply these products in that way. The Antimicrobials Division is trying to formulate an action plan for the direction that they will take. A number of alternatives are under consideration. The final direction will probably be a combination.

Options Being Considered

A. Label improvement initiative - This would require all products to include on their labels a statement that clearly excludes certain products from use in HVAC systems.

B. Data call in - This would require a company to submit efficacy and exposure data to support a claim for HVAC use if they do not want to exclude such use on their label.

C. Pesticide Regulation Notice (PR Notice) - This document would outline all of the issues and whatever actions are proposed. There will also be a comment period (normally 30 days) before the notice is finalized. They plan to ask ASHRAE and other groups and associations to distribute the PR notice to their membership so it will be available outside the normal distribution channels. The PR notice is likely to change substantially before it is issued. There are six subjects that are currently being considered. In the next issue, we will discuss those and their possible impact on contractors.

Mr. Baker's field of expertise is the control of contamination in air-conditioning and ventilating systems by mold, mildew and bacteria. He writes and speaks frequently about the efficacy, legal risks, and regulatory issues involved in various control strategies. He serves on ASHRAE Technical Committee TC 2.3, TC 2.4, TC 9.8, and Sampling of Airborne Particulate Concentration in Commercial and Residential Buildings GPC 17P. He also serves as a member of ASTM D22.06 (Indoor Air Quality) and is on the Board of Directors of the Indoor Air Quality Association and the Florida Public Health Foundation. Because HVAC applications encompass new uses from an U.S. EPA regulatory standpoint, Mr. Baker works closely with the EPA and industry groups, including serving as the chair of the IAQ committee of the Consumer Specialty Products Association, to help formulate policy in this area.

Bob Baker is Chairman and CEO of BBJ Environmental Solutions, Inc., a company specializing in providing clean air through environmentally responsible products, such as BBJ MicroBiocide , BBJ Micro Coil Clean , "FreshDuct Odor Eliminator ", and BBJ Mold and Mildew Remover™ as well as the revolutionary new Power Coil Clean™. For additional information, Mr. Baker can be reached at (800) 889-2251 or through the company web site at http://www.bbjenviro.com.