Access EPA Dockets | EPA Docket Center | US EPA
Details surrounding EPA's use of Regulations.gov and what docket materials are accessible on Reguations.gov.
EPA Form 8570-4 (Rev.04-2016), Confidential Business Information ~EPA
OMB No.2070-0060; 2070-0174. This form is designed for reporting the ingredients used in the formulation of a pesticide product. It must be completed and submitted with each applicationfor new registration of a pesticide and application for amended registration if the revision involves a formula change.
Disinfection & Sterilization Guidelines for Healthcare Settings ~CDC
***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.
Disinfection & Sterilization Guidelines in Healthcare Settings ~CDC
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.***
Guidelines for Human Exposure Assessment | Risk Assessment | US EPA
Final Guidelines website
Human Health Risk Assessment explanations | Risk Assessment | US EPA
Ways to Obtain Assistance on Pesticide Labeling Issues | Pesticide Labels | US EPA
510(k) classification of Disinfectants as Medical Devices ~FDA
CFR - Code of Federal Regulations Title 21, Subpart G--General Hospital and ******Personal Use****** Miscellaneous Devices, Sec. 880.6890 General purpose disinfectants.
Recently Posted FDA Guidance Documents – One VCU Clinical Research
Medical Device User Fee Commitment Letter -FDA
Processes to accellerate FDA approvals, including of 510(k)s
Biocompatibility Testing of Medical Devices – Standards Specific Information for the **Accreditation Scheme** for Conformity Assessment (ASCA) Pilot Program ~FDA
Sept 2020. Lab and test standards and requirements.
Guidance on Conduct of **Clinical Trials of Medical Products** during COVID-19 Public Health Emergency ~FDA
"What factors should sponsors consider when deciding whether to change their clinical trial protocol during the COVID-19 public health emergency to include remote clinical outcome assessments?"
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin | FDA
Oct 20. Devices made with certain GRAS fabrics, etc with direct or indirect contact with skin. {Includes useful info on 501(k) submissions in general.}
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency ~FDA
Non-binding recommendations
COVID-19 Recovery ~American Supply Association
Economic and business development. {Mentions Research and Development (R&D) Tax Credit}
I need to disinfect a public space like a store or school. What do I need to know? | Coronavirus (COVID-19) | US EPA
Find information about how to disinfect a public space like a store or school to combat the novel coronavirus (COVID-19).
Explanation of FIFRA 2(ee) Recommendations
Example of in-state modifications to product instructions, allowed via FIFRA Sec. 2(ee) Recommendation
"This recommendation is made as permitted under FIFRA section 2(ee) and has not been submitted to or approved by the EPA. All applicable directions, restrictions, precautions and Conditions of Sale and Warranty on the EPA registered label are to be followed."
SDS Explanation | Environmental Health & Safety | Baylor University
Hazard Communication Standard: Safety Data Sheets - OSHA 3514 | Occupational Safety and Health Administration
Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry ~EPA
Contacts for Medical Devices During the COVID-19 Pandemic | FDA
For questions about policy on Sterilizers, disinfectant devices, and purifiers: CDRH-COVID19-SterilizersDisinfectantsPurifiers@fda.hhs.gov
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices | FDA
Unique Device Identification System (UDI System) | FDA
Details for device labelers on complying with UDI requirements and submitting data to GUDID.
FDA UDI System 101: The Basics | Registrar
Are there any exceptions to the UDI requirements?
Class I devices are entirely exempt from UDI requirements if FDA has exempted them from the good manufacturing requirements of 21 CFR 820. Class I devices that contain a Universal Product Code (UPC) on their labeling and packages are deemed to meet all UDI labeling requirements, but the labelers of such devices are still required to submit data to the GUDID. Other general exemptions include: Individual, single-use devices distributed in single packaging, Veterinary devices not intended for man distributed in single packaging
Registration of Food Facilities and Other Submissions | FDA
Overview and background of food facility registration and other submissions to CFSAN.
FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water | FDA
The U.S. Food and Drug Administration (FDA) announced a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water, which was developed through a collaboration with the U.S. Environmental Protection Agency (EPA).
Two Decades of Enhancing Children’s Environmental Health Protection at the U.S. Environmental Protection Agency
{Includes discussion of some age-dependent adjustment factors (ADAFs)}
Classification and Labelling (CLP/GHS)
{Info included on Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)}
Guidance on the Application of the CLP Criteria ~European Chemicals Agency
July 2017. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.