Source: http://www.lexology.com, June 25, 2015
By: William J. Walsh, Pepper Hamilton LLP
Business and legal risks to health care companies reach far beyond scientific uncertainties in the prevention protocols for infectious diseases due to lack of clarity among regulators with public health responsibilities.
THE DILEMMA
The host of exposure and risk issues raised by the treatment in the United States of health care workers exposed to the Ebola virus is the latest evidence that infectious diseases generate substantial public concern and trigger a wide spectrum of responses from agencies charged with protecting the public health. Although the Centers for Disease Control and Prevention (CDCP) assured the public that the risk of a large-scale Ebola “outbreak” in the United States was very low and that well-established infectious disease prevention protocols are adequate to protect human health, the governmental response, at times, has been incomplete, and continued diligence and oversight is warranted. Initial CDCP and state health advisories have changed based on reactions to conditions encountered in assessing the exposure of individuals and the treatment of patients in health care facilities. Guidance often was reactive and not “forward looking” and did not address such issues as how to handle, transport or dispose of the highly infectious waste generated by even a handful of Ebola patients.
The Environmental Protection Agency (EPA) (working in conjunction with the CDCP) exhibited a welcome degree of flexibility in its issuance of new guidance detailing when, and in what manner, manufacturers of disinfectants, sterilants and the like could claim these chemicals are effective in reducing or eliminating the spread of the Ebola virus specifically on “hard, non-porous surfaces” in health care settings (e.g., on tables or floors).1 Prior to the EPA’s issuance of this proactive guidance, reliable information on the effectiveness of disinfectants in reducing the risk of Ebola infection to patients, health care providers and the public from such hard, nonporous surfaces was needed, but not available, because no disinfectant had been tested specifically on Ebola.2
Therefore, no disinfectant manufacturer or distributor had received EPA regulatory approval to make claims that these existing disinfectants could kill or reduce the growth of the Ebola virus on hard surfaces. As a result, the EPA published a list of EPA-registered disinfectants that were expected to be effective in preventing the growth or killing of the Ebola virus on hard, nonporous surfaces based on the studies in its files on the effectiveness of these disinfectants on similar, often more difficult to kill, microorganisms.3
Although it may surprise some in the health care industry to learn that the EPA (not the Food and Drug Administration (FDA)) was the prime regulator in that circumstance, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) has long regulated the sale or use in commerce of any substance or mixture of substances (including disinfectants, sterilants and the like) when used to destroy or suppress the growth of bacteria, viruses and other microorganisms that are harmful to humans and animals (including, but not limited to, the Ebola virus, EV-D68 andLegionella) when on inanimate objects and surfaces (e.g., tables, walls, floors) (i.e., the “pests” in “pesticide” are not just rodents and bugs). For simplicity, the remainder of the article will generally refer to disinfectants, rather than pesticides.
Attention should not be limited to the Ebola situation. Regulators will focus on all infectious diseases. For example, in 2014, the CDCP found a sharp rise in the number of children hospitalized for severe respiratory illness in Missouri and Illinois with Enterovirus D68. As a result, the EPA and the CDCP issued guidance concerning which disinfectants, in fact, are effective in preventing the spread of the Enterovirus D68 microorganism.4
Similarly, from 2000 to 2013, there was a fourfold rise in the annual cases of Legionnaires’ disease (or Legionellosis, a lung disease caused by the Legionellabacteria, that often leads to a serious, potentially lethal form of pneumonia). Based on the author’s discussions with EPA staff, the EPA, in collaboration with the CDCP and state co-regulators, is revising its Legionnaires’ disease guidance.5 There are also predictions that the number of new strains of infectious diseases may rise over the next few decades. As a result, the frequency of events involving infectious diseases (and the concomitant infectious wastes generated by patients) is likely to increase.
Business and legal risks to health care companies reach far beyond scientific uncertainties in the prevention protocols for infectious diseases or lack of clarity among regulators with public health responsibilities. Whenever a new or controversial health-based risk come to light, not far behind are opportunistic individuals seeking to exploit these circumstances and be “first to the market” with miracle solutions that solve the problem. We saw this phenomenon in response to the Legionnaires’ disease and AIDS epidemics, where a flood of products appeared on the market without prior review and approval by state and federal authorities. Health care organizations’ procurement personnel and end users (doctors, nurses, dentists and other health care professionals) could not readily distinguish between products that complied with regulatory requirements designed to ensure product efficacy and safety before being offered for sale in the United States and those that did not. As a consequence, patients, the public and health care workers were exposed unnecessarily to infectious diseases. In both of these instances, the EPA aggressively exercised its statutory enforcement authority, resulting in stop-sale orders, injunctions, substantial fines and bad press for those entrepreneurs who tried to short circuit the rules. Unfortunately, the unintended consequence of this governmental action was an uptick in third-party claims against well-intentioned health care providers and a significant disruption of the health care industry supply chain. If past is prologue, regulators or those potentially injured by infectious agents from noncompliant goods in the marketplace may seek to hold health care institutions and professionals liable, even where regulators blundered, simply acted too slowly, or were incomplete in their response actions.
Companies and professionals in the health care industry need to understand the full extent of regulatory controls affecting the industry and its suppliers. There is no shortage of potential legal issues — e.g., those concerning patient treatment protocols and their uncertainties, the ability to dispose of or transport infectious waste, and the applicability of the provisions of the Occupational Safety and Health Act, the Americans with Disabilities Act, and the National Labor Relations Act — and many other questions must be addressed.6 This article narrowly focuses on the role that the EPA plays in regulating the sale and marketing of products to prevent the spread of infectious diseases.
THE LESSONS LEARNED (AND PERHAPS RELEARNED) BY THE EBOLA AND EV-D68 DEVELOPMENTS
Infectious disease events can challenge even the best of regulatory schemes (and recent events suggest that we do not have, as yet, the best of schemes). Jurisdictional boundaries among regulators are blurred, and prior approvals literally may not apply to an outbreak involving a different infectious microorganism (such as Ebola or Enterovirus D68), even though the prior approval involved a very similar, but not identical, infectious agent. The role of the CDCP in detecting disease outbreaks and providing advice on measures to minimize disease transmission (among other duties) is relatively well known. The FDA is the acknowledged regulator of drugs and other patient therapies. Less recognized is the EPA’s role in regulating products imported or produced in the United States and offered for sale as effective in destroying or suppressing the growth of disease-causing viruses and other microorganisms.
EPA’s Legal Authority
FIFRA regulates the sale or use in commerce of any substance or mixture of substances, including disinfectants used to destroy or suppress the growth of specific microorganisms that are harmful to humans and animals, such as bacteria, viruses or fungi, including, but not limited to, the Ebola virus, EV-D68 and Legionella, on inanimate objects, surfaces, or in the case of Legionella in water (e.g., tables, walls or floors).
FIFRA requires registration of such products for their intended uses by the EPA (and approval of specific marketing claims by the agency) prior to sale or distribution for sale in the United States. The EPA’s jurisdiction includes, among other things, offering for sale, distributing for sale, holding for sale, shipping, holding for shipment, delivering for shipment or releasing for shipment. 40 C.F.R. § 152.3.
To obtain the right to sell or distribute a disinfectant, a company must submit data demonstrating (a) the exposure over a lifetime, given the intended use, will not present an unreasonable risk to human health or the environment (e.g., to the health care workers who come in contact with the disinfectant over their entire working careers) and (b) the efficacy of the treatment claim on the label for the specific microorganism (e.g., that the use of the chemical as directed on the label kills 99.99 percent or higher of microorganism X within a given period of time).7 The EPA will not approve the generic use of a product; rather, approval, i.e., registration, only will be issued for a “specific” use of a “specific” substance on a “specific” inanimate object at “specific” concentrations over “specific” durations to support a “specific” claim that the substance is effective.
The EPA also must approve the precise language for the label, and that approved language limits all advertising claims for the “registered” disinfectant product. The approval even may be limited to the “specific” type of application surfaces (nonporous or porous) or clothing versus hard surfaces. Even physical devices (such as filters claiming to remove microorganisms from water) are deemed to be “pesticide devices” (because they physically remove harmful microorganisms from water), albeit they are subject to less stringent regulation under certain provisions of FIFRA.
When the Exception May Not Prove the Rule: The Treated Article Exemption
Generally, the EPA exempts from registration products “treated with, or containing, a . . . [regulated disinfectant] to protect the article or substance itself (for example, paint treated with a pesticide [e.g., a mold inhibitor] to protect the paint coating [from the growth of mold], or wood products treated to protect the wood against insect or fungus infestation [that deteriorate the wood]), if the pesticide is registered for such use.” 40 CFR § 152.25(a). Thus, the EPA FIFRA registration and label, on its face, must authorize the “specific” use (i.e., in the examples above, the label must state that treatment of wood or paint, respectively, were approved in the registration).
More importantly, the EPA excludes from this exemption (i.e., requires registration with the EPA) any product treated with a chemical if the manufacturer or distributor makes a public health claim8 (e.g., the EPA rejected the use of the treated article exemption for a product that treats air conditioning systems to prevent the spread ofLegionella).9 Any claim to treat germs, bacteria, viruses or other disease-causing microorganisms will be closely reviewed by the EPA.
Compliance Issues
It is clear that the sale and distribution of a disinfectant with claims that it will prevent the spread of any strain of harmful virus or any other “specific” microorganism is prohibited, unless that disinfectant is “specifically” registered with the EPA for the “specific” microorganism and use. For example, in the cases of Ebola and Enterovirus D68 discussed above, the EPA allowed manufacturers, suppliers and distributors to inform their customers of the EPA’s determination. However, the EPA, out of necessity, warned manufacturers, based on current EPA-approved labels of registered disinfectants (none of which mention Ebola), that the manufacturers/distributors could not claim on their product labels that these disinfectants are effective on Ebola or Enterovirus D68.10 However, marketing material could cite to the EPA’s list of registered disinfectants that the EPA determined will be effective in controlling Ebola and the EPA and the CDCP Ebola guidances.
Furthermore, “[g]enerally, it is unlawful to use any registered pesticide [including a registered disinfectant] in a manner inconsistent with its labeling under FIFRA sec. 12(a) (2) (G).”11 However, FIFRA section 2(ee)(2) does allow the use of an EPA-registered disinfectant “against any target pest [which includes Ebola and other disease-causing microorganisms] not specified on the labeling if the application is to the crop, animal, or site specified on the labeling,” if the label does not restrict the use to only certain pests (e.g., “for use only against rodents”), or if the label limits the use to only specified microorganisms.12
Therefore, using a disinfectant to suppress the growth of Ebola, Enterovirus D68 or other specific microorganisms also may be illegal if not authorized by the label. For example, arguably, the use of a registered disinfectant on porous surfaces or on garments may be a violation where the disinfectant’s EPA-approved label only mentions the treatment of hard, nonporous surfaces. Similarly, the use of an approved disinfectant may not be authorized if the label precludes use to treat any other microorganisms except those specified on the label. Although the EPA does not regulate the personal, private use of unregistered disinfectants (or other pesticides), the use of a disinfectant not registered for a given use by a hospital or a medical or veterinary practice may not be viewed by the EPA as personal use.
For example, the EPA does not allow bulletins written and distributed by agricultural extension services, universities or industry groups for “antimicrobial products with public health claims (i.e., targeted against human pathogens, 40 CFR §168.22(b) (5)) or other products with such claims.”13 More generally, the EPA has advised a manufacturer of burlap, jute or Hessian natural fabric packaging for handling and shipping harvested plants to nursery operators that the use of fabric treated for “rot resistance” does not qualify for the treated article exemption unless the EPA-registered label for the chemical has specifically been approved to treat fabric packaging for handling and shipping harvested plants to be rot resistant.14
Considering the EPA’s history of narrowly interpreting FIFRA and its aggressive and typically successful enforcement of this law, a careful analysis should be performed prior to either making claims in marketing materials about using a disinfectant in a manner that strictly may not be identified on the registered label or relying upon the treated article exemption. The business risks include not just enforcement by the EPA against the manufacturer or distributor, but could, in the appropriate circumstances, include enforcement against a company or an individual end user who misuses the pesticide (including disinfectants). In addition, a health care worker who becomes ill may seek damages for injuries, arguing, in part, that the illness was caused by the misapplication of the disinfectants or, at least, that the health care facility failed to warn the worker of the risks.
The Cost of Noncompliance
The cost of noncompliance can be substantial. The EPA may (and often does) order the manufacturer, supplier and/or distributor of an unregistered disinfectant to stop sales immediately and may bar imports at the port of entry, thereby disrupting the existing supply chain until an EPA registration can be obtained (a process that generally can take a year or more). The maximum civil penalty is $7,500 for each offense per FIFRA section 14(a)(1), as amended, which the EPA interprets as each sale.15
An indirect and noteworthy cost of noncompliance is that a stop-sale order not only lowers profits, but may expose the manufacturer or distributor to damage lawsuits due to disruption of the health care supply chain and, more importantly, damage to long-term commercial relationships. At the health care provider level, it is more difficult to provide services without the products that are essential for the protection of workers, patients and members of the public while appropriate federal product reviews are conducted. The old adage of “buyer beware” is still valid.
ADDRESSING POTENTIAL BUSINESS RISKS
There are business risks facing the health care industry, but each of those enumerated in this article can be addressed either by manufacturers/distributors, individual institutions, individual practitioners or their professional or industry trade associations on behalf of the members of the association.
First, the ever-growing and more complex EPA regulatory requirements should be tracked and communicated in a usable format to individual health care institutions, individual practitioners and, as appropriate, health care workers.
Second, rather than waiting for the next scare to hit the headlines, it may be prudent for those industry and professional organizations whose members are impacted to engage all of these agencies (but particularly the EPA) to modify their regulations and guidance to reflect the unique characteristics of infectious material and the nature of the industry.
Third, health care companies should consider requiring their suppliers to certify prior compliance with the appropriate legal requirements.
Fourth, since such self-certification may have its limits, some health care employers and purchasers of health care supplies may decide to perform an audit or a review to ensure that equipment and material suppliers’ products are cost-effective, the claims are accurate, and, at a minimum, the products comply with applicable EPA requirements. It is advisable that health care providers obtain an audit or have documentation demonstrating that the provider took steps to determine independently that the products acquired for use in its facilities and by health care employees are duly authorized for their intended uses and are efficacious, irrespective of whether the products are targeted for specific applications (e.g., disinfection against the Ebola virus) or more general health care infection exposure scenarios.