There are 11 agencies within the Department of Health and Human Services (HHS) of which 5 are related to veterinary public health: Agency for Toxic Substances and Disease Registry (ATSDR), Center for Disease Control (CDC), Food and Drug Administration (FDA), Indian Health Service (IHS), and National Institutes of Health (NIH).
Agency for Toxic Substances and Disease Registry (ATSDR)
The ATSDR is charged with the prevention of exposure to toxic substances and the prevention of the adverse health effects and diminished quality of life associated with exposure to hazardous substances from waste sites, unplanned releases, and other sources of pollution present in the environment.
Center for Disease Control (CDC)
The CDC is the United States’s leading science-based, data-driven, service organization that protects the public’s health by working 24/7 to protect the United States from health, safety and security threats, both foreign and in the United States. The CDC Global Migration and Quarantine works with other federal agencies to protect US borders against diseases carried by animals and animal products.
The Federal Select Agent Program is jointly comprised of the CDC and APHIS-VS. This program oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. Additionally, the Federal Select Agent Program enhances the nation’s oversight of the safety and security of select agents by developing, implementing, and enforcing the Select Agent Regulations, maintaining a national database, inspecting entities that possess, use, or transfer select agents, ensuring that all individuals who work with these agents undergo a security risk assessment performed by the Federal Bureau of Investigation/Criminal Justice Information Service, and providing guidance to regulated entities on achieving compliance to the regulations through the development of guidance documents, conducting workshops and webinars, and investigation of any incidents in which non-compliance may have occurred.
National Institute for Occupational Safety and Health (NIOSH) was established by the Occupational Safety and Health Act of 1970 to develop new knowledge in the field of occupational safety and health and to transfer that knowledge into practice. NIOSH provides a testing, approval, and certification program assuring respirators used in the workplace meet the standards of 42 CFR Part 84 and maintains a searchable, online version of the Certified Equipment List.
As part of CDC’s public health mission, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) was passed as a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.
Food and Drug Administration (FDA)
The FDA is charged with ensuring that food is safe, pure, and wholesome; human and animal drugs, biological products, and medical devices are safe and effective; and electronic products that emit radiation are safe. The major act that governs FDA is the Federal Food, Drug, and Cosmetic Act (FFDCA) which tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government’s ability to enforce the law.
The FDA regulates:
- biologics (except for veterinary vaccines)
- dietary supplements
- drugs (both humans and animals, and vaccines for humans [whereas USDA CVB handles animal vaccines only] are safe and effective)
- foods (safe, wholesome and truthfully labeled)
- medical devices
- pet feeds and foods
- radiation-emitting electronic products (X-ray machines to microwave ovens)
- tobacco (product requirements, marketing, and labeling)
- transplanted tissues
Center for Food Safety and Applied Nutrition (CFSAN) is a part of FDA whose primary responsibilities include the safety of substances added to food (e.g., food additives and color additives), the safety of foods and ingredients developed through biotechnology, seafood and juice Hazard Analysis and Critical Control Point (HACCP) regulations, regulatory and research programs to address health risks associated with foodborne, chemical, and biological contaminants, regulations and activities dealing with the proper labeling of foods (e.g., ingredients, nutrition health claims), regulations and policy governing the safety of dietary supplements, infant formulas, and medical foods, food industry postmarket surveillance and compliance, industry outreach and consumer education, cooperative programs with state, local, and tribal governments, and international food standard and safety harmonization efforts.
The FDA 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 regulates:
- Animal drugs – any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed
- Animal feed and pet food – monitors and establishes standards for feed contaminants, approves safe food additives, and manages the FDA’s medicated feed and pet food programs
- Veterinary devices – authority under FFDCA
In 1996, the National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS) was established in collaboration among state and local public health departments, CDC, FDA, and the U.S. Department of Agriculture (USDA). The national public health surveillance system tracks changes in the antimicrobial susceptibility of certain enteric (intestinal) bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA) in the United States. The major bacteria currently under surveillance are Salmonella, Campylobacter, Escherichia coli, and Enterococcus. There are 3 arms of NARMS, the animal, human, and retail arms. The animal arm began in 1997 with monitoring of Salmonella, and later expanded to include Campylobacter (1998), E. coli (2000), and Enterococcus (2003). Animal isolates are gathered nationwide from a variety of sources including federally inspected slaughter and processing facilities and USDA National Animal Health Monitoring Studies on farms. The human arm initially included non-typhoidal Salmonella and E. coli O157 isolates from 14 state and local health departments. In 1999, testing of typhoidal Salmonella and Shigella was added. By 2003, NARMS conducted nationwide surveillance. Testing of Campylobacter from humans began in five FoodNet sites in 1997 and expanded to 10 FoodNet sites by 2003. The retail arm involves retail meat surveillance conducted through an ongoing collaboration between CVM, CDC, and FoodNet laboratories. Participating FoodNet sites purchase retail meats and culture them for Salmonella and Campylobacter. A select few sites also culture retail meats for E. coli and Enterococcus.
As part of food labelling regulations governed by FDA, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) identified eight foods as major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. The act was amended on April 23, 2021, by the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act to declare sesame as the 9th major food allergen recognized by the United States. The change went into effect on January 1, 2023.
In 2011, the FDA Food Safety Modernization Act (FSMA) was enacted to transform the food safety system in the United States by shifting the focus from responding to foodborne illness to preventing it. There are 7 rules of FSMA: Preventive Controls Rules for Human and Animal Food, Produce Safety Rule, Foreign Supplier Verification Program (FSVP) Rule, Accredited Third-Party Certification, Sanitary Transportation Rule, Intentional Adulteration Rule, and Complying with FSMA.
Multiple drug regulations governed by FDA are related to veterinary medicine including Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, Animal Drug Availability Act of 1996, and Minor Use/Minor Species Act of 2004. The Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 allows veterinarians to prescribe extra-label uses of certain approved animal drugs and approved human drugs for animals under certain conditions. Extra-Label Use is defined as the “Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.” The Animal Drug Availability Act of 1996 was an amendment to the Federal Food, Drug, and Cosmetic Act to provide new flexibility to the way FDA regulates new animal drugs and medicated feeds intended to increase the number of approved new animal drugs on the market. In 2015, the Animal Drug Availability Act was amended to implement veterinary feed directive (VFD) which provided oversight to drugs intended for use in or on animal feeds to require the supervision of a licensed veterinarian. The Minor Use/Minor Species Act of 2004 was intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in the major animal species. “Minor species” are all animals other than humans that are not one of the major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens). This includes animals such as zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish, game birds, and honeybees. “Minor use” drugs are for intended uses in major species for diseases that occur infrequently or in limited geographic areas and in only a small number of animals annually.
Indian Health Service (IHS)
The IHS is responsible for providing federal health services to American Indians and Alaska Natives with the mission to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level by ensuring comprehensive, culturally appropriate personal and public health services are available and accessible to American Indian and Alaska Native people and promoting excellence and quality through innovation of the Indian health system into an optimally performing organization
National Institutes of Health (NIH)
The NIH supports biomedical and behavioral research domestically and abroad, conducts research in its own laboratories and clinics, trains promising young researchers, and promotes acquisition and distribution of medical knowledge.