Institutional Products
We manage and document adverse events and medical information inquiries for the Institutional Product Market complying with FIFRA and TSCA requirements
The Institutional Products industry is comprised primarily of institutional cleaning products, including some of the following product segments: sanitation and janitorial cleaners, industrial and technical cleaners, kitchen and catering cleaning agents, food and dairy processing cleaners, laundry agents and others. Skin cleansers and skin sanitizing products utilized within the health care and food industry which are classified as drugs are also prevalent within the Institutional Products industry.
SafetyCall manages and documents adverse events and medical information inquiries for the Institutional Product Market. We provide comprehensive documentation of events surrounding any adverse event, industrial chemical contact or spill. Using our proprietary data base, our experts are able to provide assistance and compliance for regulatory reporting to the EPA, FDA and Health Canada. As with every industry that we serve, we provide our clients with 24/7 access to their data through our highly secure (SSL encrypted) web based, proprietary software, SafetySearch™.
| Regulatory Agencies | Applicable Federal Laws |
|---|---|
| US Environmental Protection Agency (EPA) | Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) Section 6(a)(2) Toxic Substances Control Act (TSCA): 8c and 8e |
| Food and Drug Administration (FDA) |
PLAW-109publ462.pdf 21 CFR 310.305 21 CFR 314.80 |
| Health Canada – Marketed Health Products Directorate (MHPD) | Food and Drug Act |
Highlights – Rules & Regulations
Three important regulations applicable to the Institutional Products industry that are a focus of SafetyCall services are highlighted below:
- FIFRA: Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires pesticide product registrants to submit adverse effects information about their products to the US Environmental Protection Agency (EPA).
- TSCA Section 8(c): Companies are required to record, retain and in some cases report “allegations of significant adverse reactions” to any substance or mixture that they produce, import, process, or distribute and that is not subject to mandatory surveillance compelled by other regulations such as FIFRA 6(a)(2) or the regulations of other agencies such as the FDA.
- TSCA Section 8(e): Any person who manufactures, processes or distributes a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to human health or the environment shall immediately inform the EPA of such information unless such person has actual knowledge that the EPA has been adequately informed of such information.
Click for more details on Regulatory Compliance services available from SafetyCall.
Your Industry Obligations
In addition to the mandatory reporting of domestic incidents involving pesticides within prescribed timelines, pesticide registrants must also consider the following compliance obligations:
- Causality is not a prerequisite for tracking and reporting adverse events associated with the use of pesticides registered with either the EPA or PMRA. Even if a registrant does not believe there is sufficient scientific evidence to support an assertion that an alleged adverse event may have been caused by a pesticide, the registrant is still mandated to report such incidents to the EPA or PMRA.
- FIFRA: EPA-registered products with like formulations sold in other countries may require that foreign incidents involving these formulations also be reported to the EPA in compliance with FIFRA section 6(a)(2).
Guidance Documents Forms Read more at epa.gov
FIFRA-6a2-Forms.pdf - TSCA Section 8(c) & 8(e): Under TSCA, EPA inspectors may ask companies to readily retrieve records showing that significant incidents involving regulated chemicals have been systemically documented and reviewed for consistency to known toxicological profiles. Using SafetyCall’s powerful web-based search engine , SafetySearch, Clients are able to easily retrieve data on incidents that have been flagged for potential TSCA 8c or 8e reporting purposes.
Guidance Documents - 21 CFR 310.305 & 21 CFR 314.80
Guidance Documents Forms Read more at fda.gov Read more at fda.gov - Food and Drug Act
Guidance Documents Forms Read more at hc-sc.gc.ca
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