By Bob Baker

During the past year, the US EPA has taken two actions that will impact HVAC system uses of Antimicrobial products. On September 17, 1999 proposed regulations for Registration Requirements for Antimicrobial Products were published in the federal register. On March 6, 2000 EPA published a "PR Notice (2000-1)" on the Treated Articles Exemption.

Antimicrobial Products Regulations

Prior to the passage of the Food Quality Protection Act (FQPA) in 1996, Antimicrobial products were regulated under the regulations enacted for insecticides and crop pesticides. There are many such products and they are produced in tons as opposed to the pounds of Antimicrobials produced. Thus, insecticides have always received the bulk of attention and regulations have been written in anticipation of the high level of toxicity of such products. FQPA mandated a separate Antimicrobial Division to deal with the special composition and applications of products formulated and marketed for such applications.

In many ways, the regulations that were proposed were not a surprise to those in the industry. Frank Sanders, the Antimicrobials Division Chief, held a series of stakeholder meetings as the regulations were being developed. Thus interested parties had opportunity for a lot of input and to hear the direction the thinking of those in the new division was taking. There were, however, a couple of unexpected twists in the published proposal that have caused a lot of comments and delayed finalizing the regulations. As of this writing, the final regulations have not been published. The proposed regulations contain a provision that the registration of "public health" products will only be good for five years after which the product must be reregistered with new data demonstrating that it is still effective. Industry has objected to this provision because it may exceed the authority of the law and if enacted could greatly increase expenses for manufacturers. A knowledgeable source in the Antimicrobial industry speculated that the final rules may be published by September 2000.

A complete coverage of the new regulations is beyond the scope of this article. We will concentrate on those provisions that impact products for prevention and mitigation of indoor environmental problems. They include:

Public Health Claims

The proposed regulations make a strong distinction between so called public health products and environmental products. A public health claim means that advertising for the product can claim to prevent or lessen the transmission of disease. An example of such a product would be a disinfectant that is used on an exam table in a medical office between patients to lessen the possibility that germs from one patient will be passed to the next. Another example would be a disinfectant spray used on a kitchen counter after cutting up chicken to kill salmonella before cutting up ingredients for salad. Scientists have established through research that germs can be passed in these ways and cause disease. Thus EPA allows such claims when certain data is submitted at the time a product is registered.

Wall cavities, carpets, walls, ceilings, floors and the interiors of air-conditioning systems have not been proven to be vectors for the transmission of disease so EPA will not allow public health claims for products used in these locations. Even if well controlled studies demonstrate that disease can be transmitted from growths in wall cavities or in carpeting, EPA is still unlikely to allow public health claims for these products. There is no way to prove that a sufficient level of germ killing is achieved to prevent disease transmission. Such proof must be given according to the regulations before the claims will be allowed. A countertop is a simple surface and well-studied procedures are in place to quantify the level of control of germs on surfaces. Proving effectiveness in a wall cavity, a carpet, or in air ducts is not yet possible. Thus the claims will not be allowed. Environmental product claims are limited to protection of the surfaces that are treated with the product and control of odor producing organisms.

False and Misleading Statements

The proposed regulations provide considerable detail about unacceptable claims as related to antimicrobial products. This is the first time such specific a position has been taken. Some manufacturers like to make broad sweeping claims. They especially like to imply that their products prevent or cure disease. The new guidelines clearly prohibit much of this activity by specifically banning language such as: "controls infection" or "prevents cross infection". In other cases, what is allowed is clearly shown for example: "controls cross-contamination from treated surfaces". In the short run, there will be a lot of enforcement activity in bringing products into compliance. In the long run, better information will be available on labels and in advertising. Generally, a manufacturer must have testing data that backs up each claim made. That data will have to be reviewed by EPA before the claim may be included on the label or in advertising.

HVAC Related Claims

The proposed regulations for the first time includes some specific guidance on HVAC related applications. As the agency gains experience in issues related to the indoor environment, more guidance may be added. Matters specifically addressed include:

• Legionnaire's disease claims in cooling tower water are not acceptable.
• A product that functions by fogging may not bear claims of disinfection for duct surfaces, air or room surfaces.
• Circulate-in-place applications may not bear claims of disinfection...

During the hearings related to the rulemaking process, agency staffers expressed great interest in indoor air quality issues and requested information and opinions. Such interest is often a preview of rules or guidelines to come.

First Aid/Precautions

Every registered product label must include hazard-warning statements and guidelines on the type of protective equipment must be worn while using the product. The label also suggests first aid measures to use in the event of exposure. The existing regulations have been criticized because some of the precautions are overly strict for mild products and they relate to the concentration the product is sold in rather than the dilute product actually used. The guidance given is not very accurate and thus often ignored.

Products are often sold in highly concentrated form that may be somewhat toxic. This saves money by avoiding shipping water that is used to dilute down to the use strength. When products are diluted, the level of toxicity can be quite different. Most times highly toxic concentrates become much less toxic. In at least one case the dilute product is actually more toxic than the concentrate. Thus label precautions that deal only with the concentrated form are not very useful. The proposed regulations correct this by allowing manufacturers to develop data on both the concentrated and dilute forms and including both on the label. In addition, products that fall into the lowest toxicity category do not have to have any precautionary statements at all. Substances at this level are nearly non-toxic.

Treated Articles Exemption

Some years ago, EPA established an exemption from the usual requirements for registration of products that make claims against bacteria, fungi or like organisms. That exemption was if the "sole purpose of the treatment is to protect the article or substance itself." This exemption was created because preservatives are commonly used to protect items from spoilage related to the growth of bacteria or fungi. Latex paints for example will quickly spoil and become unusable unless a growth-retarding additive is included. EPA determined it would be wasteful and needlessly expensive to require manufacturers to go through the registration process for such products.

This worked quite well until some manufacturers began making claims that went beyond the scope the exemption was made for. Several years ago, the Enforcement Division at EPA began legal proceedings against several manufacturers alleging that they had far exceeded the intentions of the exemption. For example they cited a toy manufacturer who allegedly advertised that toys made from a plastic containing a preservative would prevent transmission of germs from one child to another. They gave additional examples of treated clothing that would not grow odor causing bacteria and cutting boards that would not support bacterial growth or allow it to be transmitted from one food to another. They began actions to have these products removed from the market. Also, several products used in indoor environmental applications were listed as being of concern. These included treated air filters; air duct coatings that would prevent mold growth, and carpets and ceiling tiles that would not support growth.

Pesticide Regulation notice 2000-1 was issued to clarify what the Treated Articles Exemption covers and does not. It also provides guidelines for wording of advertising of treated articles. For example, "Improves indoor air quality through reduction of microorganisms." Was given as an example of unacceptable wording while, "This paint contains a preservative that inhibits the growth of mildew on the surface of this paint film" was suggested as acceptable language. Now that the clarification has been issued, enforcement against non-conforming products will be stepped up. If manufacturers do not comply willingly, they will be subject to fines and other consequences.

Where to now?

All of this means that after years of pushing and prodding, the EPA has made a real commitment to regulating Antimicrobial products as a separate class of compounds. Although many of the regulations are simply repeats of those previously used to regulate insecticides and other highly toxic chemicals, some have been modified in useful ways. We must remember that EPA is a massive agency. Change comes slow. All changes must be supported by scientific facts and the new division is just beginning to study many areas.

In the years to come, new procedures and study methods will be developed and accepted. These will eventually lead to significantly improved information on product safety and effectiveness. Each change will come individually and progress will be slow. Progress will be measured in years and not months. The new regulatory unit is a welcome change even though the immediate impact will be slight.

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.