By Bob Baker

In the past several issues, we have been reviewing possible changes in US regulations that will impact users of Antimicrobial products in HVAC systems. This issue, we will briefly review current regulations. There are three types of microbial control products: a) Chemical Products - Antimicrobials, b) Mechanical Contrivances - Devices, c) Impregnated Articles - Treated Articles

Types of Products

Antimicrobials Are substances intended to prevent, destroy, mitigate, repel microbial pests. Microbial pests include bacteria, viruses, mold, mildew, dust mites, fungi, microbial spores, bioslimes, protozoa, and protozoan cysts. Antimicrobials must be registered for use with EPA under Sec. 3 of FIFRA (The Federal Insecticide, Fungicide, and Rodenticide Act). Few products are registered for use in HVAC systems. No products are currently registered for use on fiberglass duct board or fiberglass lined ducts.

Devices are instruments or contrivances intended for trapping, destroying, repelling or mitigating any pest or any other form of plant or animal life. Devices are not subject to FIFRA registration but must be labeled in accordance with the act, must be effective, and must be produced in an EPA registered establishment. Devices used in HVAC systems or to control microorganisms in the indoor air setting include electronic air cleaners, ion generators, mechanical filters, pleated (i.e. HEPA) filters, activated charcoal impregnated filters, ozone generators, UV light and thermal mechanisms. The difference between an Antimicrobial and a Device is that the Antimicrobial acts by chemical means and the device functions by mechanical or other means. Thus, charcoal impregnated filters are devices but silver or iodine impregnated filters are Antimicrobials. Although the law grants EPA regulatory authority over devices, they have never implemented regulations. Enforcement is by exception.

Cleaning agents, bleaching agents and deodorizing agents that do not purport either explicitly or implicitly to prevent destroy, mitigate, or repel pests are not regulated. Neither are products intended to exclude pests only by providing a physical barrier against pest access, which contain no toxicants and are marketed without Antimicrobial claims.

There are four ways a chemical product/apparatus can be deemed to be an unregistered Antimicrobial/device: a) Direct Claims; b) Indirect claims; c) Contains active ingredient with no other function; and d) Being used as an Antimicrobial and producers know it. Certain "Hot button" words such as: Antimicrobial, antiviral, virucidal, sterilize, sanitize, disinfect, bacteriostatic, biocidal, controls or kills microorganisms are taken as evidence that a product should be registered. There are also classes of indirect claims. These often require experts to tell if they are claims requiring registration or not.

Antimicrobial Treated articles or substances Are Exempt From FIFRA Regulation, but only if treated to protect the article or substance itself where the Antimicrobial used for treatment is registered for such use. This is the treated article exemption. Historically, the exemption was understood to cover antifouling and antideterioration applications. EPA guidance also recognized certain aesthetic claims for odor and stain control. Most Practitioners agree that public health claims for treated articles were never intended under the exemption.

EPA has issued a draft PR Notice dealing with treated articles. EPA's draft PR notice takes the position that the treated article exemption no longer applies to aesthetic claims. EPA's position is that aesthetic claims provide benefits for people and not merely protection of the article. Aesthetic claims concern the control of discoloration and odors. Odor and stain control relate to the proper function and product performance of an article. Discoloration and odors also frequently are due to deterioration and spoilage. EPA has failed to make a distinction between aesthetic claims associated with deterioration and spoilage of the treated product itself and aesthetic claims that are unrelated to protecting the product. The problem is, EPA has not yet provided test protocols. As a result, there is much confusion here. Treated filters and duct liners are examples of treated articles that EPA intends to require registration for and so are not currently legal.

Summary of What The Law Requires

1. FIFRA 12 (a) (1) (a)

a) Unlawful to sell or distribute an unregistered pesticide or device.
b) Unlawful to advertise, or otherwise offer for sale in any medium, an unregistered pesticide or device.

2. FIFRA 12 (a) (1)(b)

a) Unlawful to make claims for a registered pesticide that differ substantially from those accepted in connection with registration.
b) Unlawful to advertise, or otherwise offer for sale in any medium, a registered pesticide for an unregistered use.

3. FIFRA 12 (a)(1)(e) & (f)

a) Unlawful to sell or distribute a pesticide which is misbranded.

4. FIFRA 12 (a)(2(g)

a) Unlawful to use a registered pesticide in a manner inconsistent with its labeling.

Penalties

A. Civil Penalties -Registrants, supplemental registrants, producers, distributors, advertisers (that have an economic interest in the potential sale), for-hire applicators, and users can be subject to FIFRA prohibitions. Registrants, wholesalers, dealers, retailers, and other distributors may be assessed a civil penalty of up to $5,000 for each violation of FIFRA. Private users may be assessed a civil penalty of up to $1,000 for each violation of FIFRA. Penalties can be assessed for each shipment, sale or incidence of misuse.

B. Criminal penalties - Criminal Penalties are for knowing violations. Registrants or producers: Up to $50,000 fine or up to 1-year imprisonment, or both. Others: Up to $25,000 fine or up to 1-year imprisonment or both. Civil and criminal penalties can provide powerful incentives for lawful behavior particularly where multiple counts are alleged but civil penalties can be assessed only after an opportunity for a hearing, which is time consuming.

This subject will continue to receive considerable discussion and debate during the coming months (and possibly years). As long as microbial contamination is perceived to be a major source of IAQ problems, users will demand Antimicrobial products. EPA and other agencies will attempt to protect public interests. Current science provides limited objective guidance. These facts make for a challenging situation that will not be quickly resolved.

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.