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Federal Regulatory Activities

The U.S. Congress creates laws and delegates authority for implementation of the laws to federal regulatory agencies. The agencies then draft regulations for implementing the laws, and this process involves a public comment period. On behalf of members, the AVMA monitors, reviews, and responds to proposals made by federal regulatory agencies that impact the profession and the practice of veterinary medicine.

Here is a sample of regulatory issues the AVMA is currently working on:

Animal Health

• Approval and labeling of food made from AquAdvantage Salmon (November 22, 2010)
• Bovine brucellosis (October 5, 2009)
• Bovine tuberculosis (October 5, 2009)
• USDA-APHIS and genetically engineered animals (September 19, 2008)
• National Veterinary Accreditation Program – Supplemental to proposed rulechanges 2/27/07 (February 27, 2007)
• Pet Event Tracking Network (September 27, 2010)
• Pet Spot-On Analysis and Mitigation Plan (March 18, 2010)
• National Animal Identification Numbering System Implementation (July 27, 2009)
• USDA Interstate Animal Movement Traceability Regulations (December 9, 2011)
• USDA's New Animal Disease Traceability Program Concept (May 5, 2010)

Animal welfare

• Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye Hazards: Revised Criteria Necessary to Maintain Equivalent Hazard Classification; Request for Comments (September 26, 2011)
• Commercial transportation of equines to slaughter (January 7, 2008)
• Endangered and Threatened Wildlife and Plants; U.S. Captive-Bred Inter-Subspecific Crossed or Generic Tigers (September 19, 2011)
• Foreign quarantine regulations, proposed revision of HHS/CDC animal-importation regulations (November 30, 2007)
• Handling of Animals; Contingency Plans (December 9, 2008)
• Horse Protection Act; Requiring Horse Industry Organizations to Assess and Enforce Minimum Penalties for Violations (July 26, 2011)
• Minimum age requirements for transport of animals (July 8, 2008)
• National Organic Program; Access to pasture (Livestock) (December 23, 2008)
• National Organic Standards Board, Livestock Committee, Animal welfare
  recommendations (October 19, 2009)
• Non-Ambulatory Disabled Veal Calves and Other Non-Ambulatory Disabled Livestock at Slaughter; Petitions for Rulemaking (April 4, 2011)
• Requirements for the Disposition of Cattle That Become Non-Ambulatory Disabled Following ante-Mortem Inspection (September 29, 2008)

Aquatic veterinary medicine

• National Oceans Policy (July 2009 – February 2010)
• National Aquatic Animal Health Plan for the United States (August/October 2009)
• National Oceanic and Atmospheric Administration Aquaculture Policy (September 3, 2009)
• Viral Hemorrhagic Septicemia; Interstate movement and import restrictions on certain live fish (September 2008 – January 2009)
• Issuing health certificates for export of live finfish, crustaceans, molluscs, and their products (December 3, 2004)

Emergency preparedness and response

• Homeland Security National Response Framework
• DHS FEMA National Advisory Council meeting
• Draft supporting documents to the National Response Framework
• National Infrastructure Protection Plan review and revision
• PETS Act

Environmental issues

• BMP for unused pharmaceuticals at health care facilities
• Disposal of hazardous pharmaceutical wastes
• Docket ID number: EPA-HQ-OPPT-2010-0768 – EPA's role in advancing sustainable products
• Docket ID number: FWS-R9-FHC-2008-0015 – Injurious Wildlife Species; Listing the boa constrictor, four python species, and four anaconda species as injurious reptiles.
• Docket ID number: EPA-HQ-OPP-2009-0815 - Receipt of petition requesting EPA to classify all rodenticide products containing strychnine as restricted use pesticides.
• Draft Framework for the U.S. – Mexico Environmental Program: Border 2020, Docket Number [FRL-9466-2], (November 2011)
• Gulf of Mexico Regional Ecosystem Restoration Strategy (EPA-HQ-OA-2011-0798)
• Injurious Wildlife Species; Petition to list all live amphibian in trade as injurious unless free of Batrachochytrium dendrobatidis
• Meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT) Subcommittee on Promoting Environmental Stewardship
• National Pollutant Discharge Elimination System (NPDES) Concentrated Animal Feeding Operation (CAFO) Reporting Rule, [EPA-HQ-OW-2011-0188], (October 2011)
• North American Waterfowl Management Plan, Docket Number [FWS-R9-MB-2011-N148], (September 2011)
• Petition EPA to suspend the registration of Rozol Prairie Dog Bait and cancel certain application sites (EPA-HQ-OPP-2009-0684)
• Petition requesting EPA to issue a Notice of Intent to Cancel the registrations of M-44 Sodium Cyanide Capsules and Sodium Fluoroacetate (EPA-HQ-OPP-2007-0944)
• Possible changes in EPA certification for pesticide use
• Study of unused pharmaceuticals from medical and veterinary facilities
• United States Fish and Wildlife Service White-Nose Syndrome in bats; draft national plan

Food safety

• AVMA's response to OMB on a single food safety agency (PDF)
• Use of the animal raising claims in the labeling of meat and poultry products
• Food irradiation
• National Incident Management System (NIMS)
• Pet food/animal feed
• Trichinae certification program

Practice issues

Drugs

• Bulk drugs
• Unapproved animal drugs
• Propofol
• Sample collection plan for dogs treated with slentrol
• Veterinary Feed Directive
• AVMA Response to Risk evaluation and mitigation strategies for human-labeled drugs; Reopening of comment period
• U.S. Food and Drug Administration versus Franck's Lab, Inc.
• Veterinary Medicine Advisory Committee; Notice of meeting
• Risk evaluation and mitigation strategies for certain opioid drugs
• Electronic prescriptions for controlled substances
• Disposal of controlled substances
• Electronic data collection
• Extralabel use of cephalosporins in food-producing animals
• Defining small number of animals for minor use designation
• Improving procedures for FDA Advisory Committee meetings
• Prescription drugs
• Proposed collection of drug adverse event information by the FDA

• Federal transparency initiative
  • AVMA Response to Food and Drug Administration environmental scan
  • Food and Drug Administration Transparency Task Force report
  • Food and Drug Administration Transparency Task Force

Vaccines

• Biologic labeling
• Vaccine mixing
• Biologic stability
• Comments on USDA CVB draft notice No. 327
• Electronic Freedom of Information Act involving veterinary biological products
• Guidelines for autogenous biologics
• Conversion formulas for S/P ratio to titer in diagnostic test kit inserts
• Instituting a post-marketing surveillance program for animal vaccine adverse events
• Improved vaccine labeling
• Improving vaccine expiration dating
• Labeling of equine influenza and swine influenza vaccines
• Packaging and labeling of viruses, serums, toxins, and analogous products
• Studies to support label claims of duration of immunity
• The need for effective canine influenza virus vaccine

Public health

• BSE and substances prohibited from use in animal food or feed
• FDA Draft Guidance #209 – Judicious use of medically important antimicrobial drugs
• Foreign quarantine regulations, proposed revision of HHS/CDC animal-importation regulations
• Monkeypox and restrictions on African rodents, prairie dogs, and certain other animals
• Public health action plan to combat antimicrobial resistance
• Transatlantic Task Force on Antimicrobial Resistance

Research

• Recommendations from the NIH Translational Medicine and Therapeutics Working Group
• Docket NIFA 2010-0001 – Agriculture and Food Research Initiative (AFRI)

Transparency in federal agencies

• Disclosure of external funds received by public health service grant recipients

Other regulatory areas in which the AVMA is involved:

Workplace safety

Concluded issues:

• Animal welfare: Change to the definition of Class B licensee
• Animal welfare: Petition to issue a notice of intent to cancel the registrations of M44 sodium cyanide capsules and sodium fluoroacetate
• Animal welfare: Requirements for the disposition of cattle that become non-ambulatory disabled following ante-mortem inspection
• Animal welfare: FDA draft guidance document 187: "Regulation of genetically engineered animals containing heritable rDNA constructs"
• Environmental: Proposed actions to reduce risks from rodenticides
• Food safety: Food safety of cloned animals
• Practice: Updating label requirements for conditionally licensed vaccines
• Practice: The requiring of a warning label on biological products of equine serum or plasma origin intended for use in horses.
• Practice: Evaluating the compatability of vaccine components in combination biological products formed by assembling previously licensed products.
• Practice: Index drugs: Making more drugs legally available for non-food minor species
• Practice: Making additional drugs available for minor species and minor uses in major species
• Practice: Prohibiting extralabel use of adamantane and neuraminidase inhibitor anti-influenza drugs in poultry
• Practice: Changing Bovine Viral Diarrhea Virus vaccine labels
• Practice: Including specific leptospiral serovar(s) on canine vaccine labels
• Practice: Making a new embutramide-based euthanasia solution a controlled substance
• Public health: Expanded importation from BSE minimal risk areas and the National Animal Identification System
• Public health: Department of Health and Human Services' strategic plan goals and objectives FS 2007-2012