**2. Legal framework in the US and Canada**

Vaccination is performed using: (1) classical standard licensed vaccines, which require extensive testing (i.e., safety, purity, efficacy, and potency) and thus are costly to develop (e.g., >2 million USD), and slow to license (e.g., 3 ± 10 years) [7–9]; (2) conditional licensed vaccines, which require moderate testing (i.e., safety, purity, and reasonable expectation of efficacy and potency) and are therefore less costly and require a moderate regulatory process; and (3) federal-licensed autogenous vaccines, which, by regulation, are inactivated and can include bacterial and viral antigens. These autogenous vaccines require basic testing (i.e., basic purity, basic safety) [15–20]. In addition to these three types of vaccines described, there is a fourth classification present only in the US-one that allows the production of live autogenous vaccine(s) that do(es) not require a federal licensing to be produced. This is based on a provision in the Title 9 Code of Federal Regulations Section 107 [20] that allows the owner of the affected animals or a veterinarian in the course of a state-licensed professional practice under a veterinarian-clientpatient relationship to manufacture products (i.e., vaccines) without the need of a federal license for the exclusive use of the animals under the ownership of the manufacturer or under the veterinarian's care. This provision requires communication and approval by the state veterinarian. It has been used by the poultry industry for control of significant problems caused by a pathogen's infection that cannot be resolved by adjustments to existing vaccination programs with licensed vaccines nor can they be controlled by inactivated autogenous vaccines or the addition of such into existing vaccination programs. Consequently, these problems require the manufacturing of an in-house live autogenous vaccine for the exclusive use of the poultry operation [21]. Specific examples include but are not limited to: infectious bronchitis virus (IBV) variant causing heavy condemnation losses (i.e., airsacculitis) [22]; field Hemorrhagic Enteritis virus capable of breaking maternal antibodies levels, causing severe immunosuppression [23]; turkey coccidia [24]; *Mycoplasma gallisepticum* [25]; and others. Caution should be exercised whenever using these live autogenous vaccines as potency and purity issues are common [24]. There is no legal provision for this fourth classification (live autogenous) in Canada. A list of advantages and disadvantages of each type of vaccine is shown in **Table 1** as modified from [13].

Autogenous vaccines are approved when commercial vaccines are not available in the location or are not effective against the challenge; need to be approved by a registered veterinarian under a veterinarian-client-patient relationship, and do not interfere with existing local and federal legislation or programs such as


*Autogenous Vaccines in the Poultry Industry: A Field Perspective DOI: http://dx.doi.org/10.5772/intechopen.110426*

*USDA—United States Department of Agriculture; CFIA—Canadian Food and Inspection Agency; VBG—Veterinary Biologics Guidelines; VSM—Veterinary Services Memorandum; NA—Not applicable.*

### **Table 1.**

*Advantages and disadvantages of vaccine types based on licensing requirements.*

eradication programs (i.e., high pathogenic avian influenza) or vaccination ban [26]—low pathogenic Avian Influenza (LPAI), not H5 or H7, from poultry or from other species that potentially affects poultry might find authorization for federal-licensed autogenous vaccine production [27]. Purity, safety, efficacy, and potency require to be tested at different degrees in each type of vaccine. Following definitions in Chapter 9 of federal regulations, Section 101.5, "Purity" refers that product should be "free of extraneous material (organic or inorganic) as determined by test methods or procedures established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product, but free of extraneous microorganisms or material, which in the opinion of the Administrator adversely affects the safety, potency, or efficacy of such product." "Safety" is defined as "freedom from properties causing undue local or systemic reactions when used as recommended or suggested by the manufacturer." "Efficacy" is the "[s]pecific ability or capacity of the biological product to effect the result for which it is offered when used under the conditions recommended by the manufacturer," while "[p]otency" is referred to as the "[r]elative strength of a biological product as determined by test methods or procedures as established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product" [20]. The Animal and Plant Health Inspection Service (APHIS)- part of the United States Department of Agriculture (USDA)- through its Investigative and Enforcement Services (IES), has the task to investigate alleged violations of the statutes that govern vaccine manufacturing (including autogenous vaccine manufacturing) and will issue warning letters, settlements, and penalties upon failure to follow APHIS-administered laws [28].
