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 Storage 
6. 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 so 
by 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