Consumer Products
SafetyCall professionals manage adverse events and medical information inquiries for Consumer Product Industry, including skin care, nutritionals and more
Consumer Products cover a broad range of products including consumer durables, non-durables and soft goods. Included in this industry category is merchandise for daily use ordinarily bought by individuals or households for private consumption. The industry includes companies that design, manufacture and/or market cleaning products, household pesticides, personal care products and food among others.
The health care professionals at SafetyCall have over 30 years of experience responding to issues related to consumer products. All adverse events are reported, documented and stored in SafetyNotes, our proprietary case management software application. Clients have access to their incident data 24/7 utilizing SafetySearch, a secured password protected web-based search engine.
| Regulatory Agencies | Applicable Federal Laws |
|---|---|
| US Environmental Protection Agency (EPA) | Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) Toxic Substances Control Act (TSCA): 8c and 8e |
| Health Canada Pest Management Regulatory Agency (PMRA) | Pest Control Products Act (PCPA) |
| Consumer Product Safety Commission (CPSC) | CPSA.pdf |
| Health Canada | Canadian Consumer Product Safety Act (CCPSA) |
Highlights – Rules & Regulations
Several important regulations applicable to the Consumer Products Industry 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.
- PCPA: Pest Control Products Incident Reporting Regulations (SOR/2006-260) requires mandatory reporting of pesticide-related incidents to the Canadian Pest Management Regulatory Agency (PMRA).
- CCPSA: The Act requires industry to provide information to Health Canada concerning consumer product safety incidents or product defects that result, or could reasonably be expected to result, in death or serious harmful health effects.
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Your Industry Obligations
Consumer product 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 - PCPA: Incidents occurring in the United States involving EPA-registered products containing active ingredients that are also registered in Canada may require mandatory reporting to the PMRA depending on severity. Furthermore, for each active ingredient associated with 10 or more reportable incidents over a prescribed 12 month period, the registrant must provide an annual summary report identifying the total number of incidents reported and provide a concise critical analysis of the data.
Guidance Documents Forms PMRA-Guidance-Document.pdf PMRA-Incident-Form.pdf - CCPSA: Incidents occurring outside of Canada may also fall under this new regulation if the consumer product involved is also sold in Canada. The act also applies to inadequate labeling or instructions that could lead to serious injury, and to recall orders or other corrective measures initiated in other jurisdictions for human health or safety reasons.
Guidance Documents Forms Read more at hc-sc.gc.ca