Friday, January 4, 2013

Turf Wars in Healthcare Regulation; EPA, OSHA and FDA.

At first glance the Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and the Occupational Safety and Health Administration (EPA) are very different, but the purview of all three agencies overlaps in healthcare. OSHA is concerned with workplace safe, the FDA with drug and medical device safety for patients and the EPA with environmental safety and control of pesticides.

A disinfectant such as peracetic acid (PAA) is regulated by the EPA as a pesticide, but if the peracetic acid is being used to disinfect an endoscope it now falls under the FDA.

Exposure of hospital cleaning personnel to blood and other biological waste, especially those folks who have to ‘clean up the mess’ is a serious health risk and is addressed by OSHA’s Blood Borne Pathogen Standard 29 CFR 1910.1030 and OSHA requires the use of an appropriate cleaner.

   Contaminated work surfaces shall be decontaminated with an   appropriate disinfectant after completion of procedures;   immediately or as soon as feasible when surfaces are overtly   contaminated or after any spill of blood or other potentially   infectious materials; and at the end of the work shift if the   surface may have become contaminated since the last cleaning.   1910.1030(d)(4)(ii)(A)

So now, three agencies have potential jurisdiction over biocides.

It is the EPA’s function under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate pesticides and therefore it is up to the EPA to approve antimicrobial cleaners and the EPA maintains a list of approved disinfectants effective against certain blood borne/body fluid pathogens, Mycobacteria tuberculosis (tubercle bacteria), human HIV-1 virus, Hepatitis B, Hepatitis C viruses, as well as products classified as sterilizers. OSHA's 'appropriate cleaner' refers to the EPA list. The EPA also maintains a list of approved sterilant chemicals, such as ethylene oxide and hydrogen peroxide used to sterilize medical devices.

Generally workplace exposure to chemicals is regulated by OSHA, explicitly through its permissible exposure limits (PELs) and indirectly through the General Duty Clause of the 1970 Occupation Safety and Health Act. The EPA does not regulate workplace exposure guidelines, that is OSHA’s job, but the EPA will issue Acute Exposure Guidelines for some pesticides, especially those that OSHA has not issued PELs, such as peracetic acid. The AEGLs also differ from OSHA PELs in that the former refer to repeated exposure, whereas the AEGLs are for one off or occasional exposure.

The EPA and OSHA have issued several Memorandums of Understanding (MOUs to improve working relationships between the two government agencies. The MOUs say that the agencies will share phone numbers, share data, and generally work together.

The FDA and the EPA also have some overlapping jurisdiction, especially for high level disinfectants and sterilant chemicals. The FDA and EPA also have several MOUs discussing common areas of interest from food to drugs. There is a 1993 MOU concerning high level disinfectants and sterilants, in which the roles of the two agencies are delineated.

  • FDA will be primarily responsible for the premarket review of safety and efficacy requirements for liquid chemical germicides that are sterilants intended for use on critical or semicritical devices. Examples of critical devices are laparoscopes, surgical instruments, heart-lung oxygenators, and transfer forceps. Examples of semicritical devices are gastrointestinal endoscopes, endotracheal tubes, cystoscopes, anesthesia breathing circuits, and vaginal specula FDA will also be primarily responsible for premarket review of contact lens solutions.

  • EPA will be primarily responsible for premarket review of liquid chemical germicides that are general purpose disinfectants intended for use on devices other than critical or semicritical devices. Examples of noncritical devices are wheel chairs, medical beds, stands, certain operating room surfaces, medical lamps, dental units, and stethoscopes. …

Anytime there is overlapping jurisdiction there will be some friction and conflict; which causes delays, uncertainty and extra work for manufacturers and to a lesser extent users. These three agencies have taken steps to work more closely together including MOUs which included delineating responsibility. Three three agencies affect almost the entire population of the US and from a 'users' perspective, the potential overlapping jurisdiction would add greatly to the complexity of the regulations from these agencies. Fortunately, all three agencies try to work together, which benefits us all.

1 comment:

  1. The Food and Drug Administration (FDA) has taken steps to reduce the number of food borne illnesses. Most food borne illnesses are caused by bacteria, though infections due to norovirus are also very common. The CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.automateandvalidate