Animal Food, Feed, and Pet Food

Under the Federal Food, Drug, and Cosmetic Act (FD&C), food is defined as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”  While both human and animal foods are regulated by the act, there are distinct differences.  ToxStrategies consulting services include assigning scientists who have broad experience in regulatory affairs and understand the unique challenges of the animal-food industry. Additionally, our scientists understand the unique challenges facing the pet-food sector and other aspects of the animal-food industry. Our professionals have extensive expertise in conducting safety assessments for ingredients, with demonstrated success in bringing new ingredients to the market for both human food and animal food.  We have also supported or expanded the uses of existing ingredients.  Beyond safety, ToxStrategies consulting scientists can assist animal food and feed ingredient manufacturers with the development and substantiation of technical product claims and addressing the many regulatory challenges that confront the industry.  Our primary goal is to meet the specific needs of our clients, and we can work in a partnership role with your existing technical staff, or for companies that do not have a dedicated technical staff, we can serve as your go-to resource.  Selected examples of relevant staff experience include the following:

Ingredient & Formulation Safety

  • New ingredients
    • Food additive petitions
    • AAFCO petitions for ingredient approval or amendment process
    • GRAS determinations
    • Technical guidance
    • Food contact notification
    • New dietary ingredient notifications
  • Existing ingredients & product formulations
    • Contaminant issues
    • Consumer complaint issues
    • Development of Safety Data Sheets

Microbiological Safety

  • New production (fermentation) micro-organism safety
    • GRAS determinations
    • EPA’s ‘Microbial Commercial Activity Notice’ (MCAN)

Issue Management

  • Risk communication expertise
  • Evaluation of existing scientific data
  • Scientific and regulatory support for recalls
  • Assistance with protection of brand integrity
  • Monitoring the external environment

Product & Ingredient Claims

  • Assist with the development of new claims including qualified health, structure function, and nutrient content claims
  • Review scientific data in support of claims employing FDA’s evidence-based ranking system
  • Develop written claims support strategies and defense
  • Assist in submissions for premarket approval

Regulatory/Scientific Affairs Support & External Influencing

  • Regulatory and government affairs
    • Assist with state and federal product and facility registrations
    • Review labels for compliance, and provide guidance on regulatory requirements
    • Monitor up-coming regulations and guidance (GMO, FDAAA)

Trade Associations

  • Representation
  • Materials review and feedback
  • Strategic direction & guidance
  • Assist with positioning of science and regulatory information

Institutional Memory

  • Develop approaches for capturing key scientific information and contributions
  • Create of in-house and/or external databases
  • Develop issues management summary documents

Food Safety Modernization Act (FSMA)

  • Simplify and disseminate information
  • Assist with identification of areas of vulnerability
  • Build institutional memory for easy recall of key documents
  • Facilitate discussion with multidisciplinary teams
  • Provide credentialed review of hazard and control point determinations
  • Assist with development of written food safety plan
  • Develop training programs

Worker Safety

  • Nuisance dusts
  • Allergens in the workplace
  • Lab safety programs
  • Contact sensitizers
  • Respiratory sensitizers
  • Indoor air exposure modeling

Training Programs

  • Food safety
  • Worker safety
  • Laboratory safety
  • Environmental exposure (more specifically, related to pet food)