chapter  12
34 Pages

Regulatory Constraints on Disinfectants and Decontamination

WithMichael G. Sarli

CONTENTS 12.1 Introduction ............................................................................................. 232 12.2 Environmental Protection Agency....................................................... 235

12.2.1 Federal Insecticide, Fungicide, and Rodenticide Act ......... 235 12.2.1.1 FIFRA-Registrations .............................................. 236 12.2.1.2 FIFRA-Product Types ........................................... 238 12.2.1.3 FIFRA-Supportive Data ........................................ 239 12.2.1.4 FIFRA-Antimicrobial Efficacy ............................. 239 12.2.1.5 FIFRA-Ingredients ................................................. 243 12.2.1.6 FIFRA-Tolerances .................................................. 244 12.2.1.7 FIFRA-Pesticide Registration

Improvement Act ..................................................... 244 12.2.1.8 FIFRA-Postmarket Surveillance .......................... 245 12.2.1.9 State Pesticide Registrations................................... 245

12.2.2 Toxic Substance Control Act................................................... 245 12.2.3 Resource Conservation and Recovery Act ........................... 246 12.2.4 Clean Water Act........................................................................ 246 12.2.5 Clean Air Act............................................................................. 246 12.2.6 CERCLA and SARA................................................................. 247

12.3 Food and Drug Administration ........................................................... 247 12.3.1 Medical Devices ........................................................................ 248

12.3.1.1 Classification of Medical Devices.......................... 248 12.3.1.2 Quality System Regulation ..................................... 249 12.3.1.3 MedWatch ................................................................. 249 12.3.1.4 Guidance-Liquid Chemical

Sterilants=High-Level Disinfectants ...................... 249 12.3.2 Drugs........................................................................................... 251

12.3.2.1 Premarketing Requirements................................... 252 12.3.2.2 Postmarketing Requirements ................................. 252 12.3.2.3 Over-the-Counter Drug Products.......................... 252

12.3.2.4 Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health-Care Antiseptic Drug Products ....................................... 253

12.3.2.5 Alcohol Topical Antiseptic Products .................... 255 12.4 Occupational Safety and Health Administration .............................. 256 12.5 Transportation ......................................................................................... 257 12.6 International............................................................................................. 257

12.6.1 Europe......................................................................................... 257 12.6.1.1 Dangerous Substances Directive and

Dangerous Preparations Directive ........................ 257 12.6.1.2 Medical Device Products Directive....................... 258 12.6.1.3 Detergent Regulations ............................................. 258 12.6.1.4 Biocidal Products Directive .................................... 259 12.6.1.5 General Chemicals-REACH................................. 259

12.6.2 Canada........................................................................................ 259 12.6.2.1 Health Canada .......................................................... 259

12.6.3 Harmonization .......................................................................... 262 12.7 Glossary of Terms................................................................................... 263 12.8 Conclusion ............................................................................................... 263 References ........................................................................................................... 263

The broad spectrum of cutting edge, technical advancements made in disinfection and decontamination are a testament to the human desire to continuously strive to learn about and control the negative impact of our environment upon us. These efforts are highly laudable and provide a worthy challenge to our best and brightest. However, our best and brightest must also be fully cognizant of the impact of our technological advancements upon humans, animals, and our environment; inventors do not have the luxury of ‘‘caveat emptor.’’ Even in this age of instant and ubiquitous communication, consumers cannot make their own value judgment in determining the safety and effectiveness of decontamination and disinfection technologies. This is where the regulators step in as advocates and protectors of the public, armed with an intricate, far-reaching, and oftentimes confusing arsenal of regulations. The regulators and the regulated community philosophically share the same vocation of protecting public health, but disagreements over the implementation of that philosophy do arise.