Animal Health

SafetyCall is the only licensed adverse event call center that handles both animal and human markets

Animal Health products that SafetyCall supports include both veterinary pharmaceutical products regulated by the FDA, and products used to control ectoparasites on companion animals (premise sprays, ointments, powders, spot-ons, etc.) that fall under EPA guidelines. Also included in the animal health industry are animal nutritional supplements, pet food, and pet treats. etc.

The experienced professionals at SafetyCall assist veterinarians and animal health product manufacturers with their adverse event management and reporting requirements. The health care professionals at SafetyCall have over thirty years of experience responding to animal health and veterinary product issues. All adverse events are reported, documented and stored in SafetyNotes, our proprietary case management tool. Our clients can access their secured data online at any time 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)
Health Canada Pest Management Regulatory Agency (PMRA) Canadian Pest Control Products Act (PCPA)
US Food and Drug Administration Center for Veterinary Medicine (FDACVM) Food, Drug and Cosmetic Act, 21 CFR 514.80(b)

Highlights – Rules & Regulations

  • 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).
  • 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).
  • Food, Drug and Cosmetic Act, 21 CFR 514.80(b): The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, companion animals and livestock. Under section 21 CFR 514.80(b) of the FDA’s regulations, applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) are required to report adverse drugs events and product and manufacturing defects within 3, 15 or 365 days depending on the adverse event.

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Your Industry 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:
    Guidance Documents Forms
    Read more at epa.gov FIFRA-6a2-Forms.pdf
  • PCPA:
    Guidance Documents Forms
    PMRA-Guidance-Document.pdf PMRA-Incident-Form.pdf
  • Food, Drug and Cosmetic Act, 21 CFR 514.80(b):
    Guidance Documents Forms
    Read more at fda.gov FDA-1932_50810.13.pdf
Regulatory Agencies Applicable Federal Laws
US Department of Agriculture, Animal and Plant Health Inspection Service (USDA APHIS) Virus-Serum-Toxin Act (VSTA), 21 USC 151-159

Highlights – Rules & Regulations

  • Virus-Serum-Toxin Act (VSTA), 21 USC 151-159: APHIS regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective. Under VSTA, Veterinary biologics for commercial use must be produced at a USDA-approved establishment, and be demonstrated to be pure, safe, potent, and efficacious.
Regulatory Agencies Applicable Federal Laws
US Environmental Protection Agency (EPA) Federal Insecticide, Fungicide & Rodenticide Act (FIFRA): 6(a)(2) and 3(c)(7)

Highlights – Rules & Regulations

  • 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 EPA.
  • 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.
  • Section 3(c)(7): of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the conditional registration of pesticides. Conditional registrations are intended to allow market entry for a product in the absence of certain data where the Agency can make appropriate findings. Those findings include a determination that granting the application will not cause unreasonable adverse effects on the environment and on the condition that the missing data will be provided in a timely manner.

Click for more details on Regulatory Compliance services available from SafetyCall.