Kathy Davis Kathy Davis (7506P)

Certification & Worker Protection Branch

Field and External Affairs Division

US EPA

Dear Ms Davis:

This email is intended to make a few points about the issues before the

EPA’s PPDC.

Respirators and Personal Protective Equipment (PPE)

The EPA worker protection standards do not include several very important aspects of proper use of respirators and other personal protective equipment. There are no requirements within the standard for several essential activities such as fit testing, medical clearance for respirator use, proper respirator selection, maintenance and cleaning, cartridge change out and respirator use under special conditions such as facial hair and facial deformity. The EPA has taken upon itself the responsibility for protecting these agricultural workers who use pesticides. The EPA has made PPE a central tool for protecting workers from the hazards of pesticides. Assuring that PPE will fit, function, and protect takes more than requiring that it be worn. Proper fitting, medical clearance to wear what is often physiologically burdensome equipment, and training of workers on the proper use, maintenance and fit of respirators is critical for PPE to be effective in protecting

workers from the hazards associated with these chemicals.

The following is and excerpt from the table of contents from the NIOSH guide to Industrial Respiratory Protection. Sept 1987 (http://www.cdc.gov/niosh/87-116.html).

Chapter 4 Respirator Use

Part I. Federal Regulatory Requirements

Part II. The Respiratory Protection Program

A. Employer Responsibility

B. Employee Responsibility

Part III. Program Elements

A. Program Administration

B. Program Components

1. Written Standard Operating Procedures

2. Medical Surveillance

3. Training

4. Fitting

5. Respirator Inspection, Cleaning, Maintenance, and Storage6. Surveillance of Work Area Conditions and Worker Exposure.

7. Respirator Program Evaluation

Melody Kawamoto has provided EPA with documentation about several health hazard evaluations done in agricultural settings illustrating how despite the use of PPE, inadequate PPE programs led to failure to protect. She has supplied other supporting information on this topic as well. Please refer to the material sent in to EPA in July 2006 entitled “Pesticide Exposure and Worker Protection from CDC/NIOSH.” sent to Cathy

Davis.

HIPAA and Pesticide Surveillance

A second issue I want to address is the cluster of problems presented by the new Health Insurance Portability and Accountability Act (HIPAA) of 1996. Because of the onerous penalties associated with the release of health care information (including overexposure events) by clinicians, this act have a chilling effect on the willingness of clinicians to report pesticide health events. While, state surveillance systems, which require such reporting, trump the HIPAA restrictions, the fear of violating HIPAA will strongly discourage participation in reporting despite the requirements to do so. Because there is no national reporting system for human pesticide health events, that might override HIPAA information protection, the overall effect of the HIPA act will be to reduce reporting of human health events, and thus severely impair the ability of EPA to estimate population health effects from pesticides. This act will have a particularly negative impact on reporting by pesticide companies through the 6(a)(2) program. Human health event reporting is certainly going to decrease as protected health information is rigorously guarded by health care providers, denying the companies the essential elements required to trigger reporting through the 6(a)(2) program requirements. EPA could counteract the effect of the HIPAA legislation by instituting a national pesticide poisoning reporting surveillance system. Federal (or state) reporting requirements accompanied by provider education could counteract the chilling effect

of HIPAA and restore the flow of data needed for EPA to make informed decisions about marketed pesticides.

A third issue I want to address is cause labeling. It strikes me as highly risky to allow messages, symbols, emblems or language onto pesticide labels that might in any way counteract the warnings on the labels. The example presented to the PPDC at our last meeting, that of the Red Cross endorsing chlorine bleach is an excellent example. I believe that allowing information on the pesticide label (such as the Red Cross symbol) that could potentially suggest, subliminally or overtly, that a product was safer than it is, is extremely dangerous. Illiterate and semi literate or foreign language speaking populations would be most at risk for such misinterpretation and I believe will be poorly served by this practice. I am fervently against this “cause labeling” and believe EPA should prohibit it.

Finally, I want to address a point I have brought up on several occasions at PPDC meetings. As a clinician who, for many years has been involved in pesticide health research and health care for patients with pesticide overexposure, I believe that unlike many other products on the market, pesticides pose a unique set of diagnostic issues to the clinical community. And the nature of pesticide use imposes a unique responsibility on those who would benefit from the sale of these chemicals. Pesticides are (aside from antipersonnel gases), the only toxins that we intentionally release into the environment intending to do harm to living beings. Most other toxicants that enter the environment, either the work environment or the open environment, do soby accident, neglect or as a waste product. Pesticides manufacturers, therefore, are benefiting from the direct and intentional release of their products into the environment we share with the target of the pesticide. The health effects of pesticidal chemicals in humans are often difficult to distinguish from non pesticidal health problems. Patients often present with symptoms that are vague and non-pathognomonic way (pathognomonic means a presentation unique enough as to make the diagnosis virtually certain). Thus the diagnosis of pesticide overexposure is often difficult to make. Presently, most tests that could confirm that an overexposure to a particular pesticide has occurred, can only be performed in research facilities under carefully controlled conditions. These tests are rarely available to the average clinician. As clinicians, aside from only a few tests (such as cholinesterase, helpful only with a baseline value available), our diagnostic tool kit is devoid of the tests we need to make confident diagnoses in pesticide overexposure cases. I suggest that the EPA establish as a requirement for pesticide registration, that a registrant develop and validate a clinical test for diagnosis of illness due to their chemical. This would put into the hands of the clinicians who provide care to overexposed patients the ability, not only to diagnose an illness that is due to an overexposure to a specific chemical, but the ability to demonstrate that said chemical is not responsible for the

illness when it is not.

Thank you for considering these suggestions.

Sincerely,

Matthew Keifer MD MPH

Associate Professor of Public Health and Medicine, University of Washington