Guidance and Reference Materials

2004 draft. GHS criteria summary

*****!!!!*****{includes discussion of establishment of cPAD and other human safety levels} "MRDlG of 0.3 mg/l for chlorine dioxide. The proposed MRDlG was based on a RID of 3 ... health risk for chlorite and chlorine dioxide considering the new CMA study (EPA, ... Carcinogen Risk Assessment (EPA, based on a ..."

2019 Oct {All committee members recommended, but motion failed from lack of public demand & availability of preventional care as alternative, etc.} "Sodium chlorite for generation of chlorine dioxide gas"

2014 edition {Regulations for transport as a hazardous substance}

{Includes "How to Request Pesticide Incident Data from NPIC"}

"Topics found in this search include guidance on advisory committees, clinical trials and good clinical practice, combination products, imports and exports, administrative and procedural processes, and topics that apply to multiple regulated products. "

June 2020

Under U.S. patent law, any person who "invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent." In general, this means you must satisfy the following four requirements to qualify for a patent:

Economic and business development. {Mentions Research and Development (R&D) Tax Credit}

Ensure that the detergents or enzymatic cleaners selected are compatible with the metals and other materials used in medical instruments. Ensure that the rinse step is adequate for removing cleaning residues to levels that will not interfere with subsequent disinfection/sterilization processes. ***Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, multiple scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.***

***Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, many scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, the user must follow all applicable label instructions on EPA-registered products. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.

Aug 2020

{Related to Predictive Models and Tools for Assessing Chemicals under the Toxic Substances Control Act (TSCA)} Providing quantal response models, which are also used in the U.S. EPA benchmark dose software suite, and generates a model-averaged dose response model to generate benchmark dose and benchmark dose lower bound estimates.

The mission of the NIOSH research program for Immune, Dermal & Infectious Diseases is to eliminate occupational injuries, illnesses, and fatalities among workers in these industries through a focused program of research and prevention. Primary efforts are focused on hazard identification since when potential hazards are recognized, work-related dermal and immune diseases can often be prevented or their effects minimized. Research to better understand the impact of occupational exposures to chemical, biological, or infectious agents.

{Extremely large collection of wide variety of searchable Data sheets, maps, etc. on environmental, health and other topics} "EnviroAtlas provides geospatial data, easy-to-use tools, and other resources related to ecosystem services, their chemical and non-chemical stressors, and human health. "

{Includes many reports and studies regarding chlorine dioxide, sodium chlorite, etc}

{Search for Chlorine Dioxide products' info}

EPA Science Models and Research Tools (SMaRT) Search searches ORD's methods, models, and tools database.

EPA tests certain antimicrobial products (hospital disinfectants and tuberculocides) to ensure that products in the marketplace are effective. See how we do this and find a list of tested products.

Provides a crosswalk between the 91b Series non-public-health test guidelines and the new 810 Series test guidelines

For questions about policy on Sterilizers, disinfectant devices, and purifiers: CDRH-COVID19-SterilizersDisinfectantsPurifiers@fda.hhs.gov