[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR107.2]

[Page 604-605]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 107_EXEMPTIONS FROM PREPARATION PURSUANT TO AN UNSUSPENDED AND 
UNREVOKED LICENSE--Table of Contents
 
Sec. 107.2  Products under State license.

    (a) The Administrator shall exempt from the requirement of 
preparation pursuant to an unsuspended and unrevoked USDA establishment 
and product license, any biological product prepared solely for 
distribution within the State of production pursuant to a license 
granted by such State under a

[[Page 605]]

program determined by the Administrator to be consistent with the intent 
of the Act to prohibit the preparation, sale, barter, exchange, or 
shipment of worthless, contaminated, dangerous, or harmful biological 
products.
    (b) A request for exemption under this section must be made by the 
appropriate State authority and shall include information demonstrating 
that:
    (1) The State has the authority to license viruses, serums, toxins, 
and analogous products and establishments that produce such products; 
and
    (2) The State has the authority to review the purity, safety, 
potency, and efficacy of such products prior to release to the market; 
and
    (3) The State has the authority to review product test results to 
assure compliance with applicable standards of purity, safety, and 
potency prior to release to the market; and
    (4) The State has the authority to deal effectively with violations 
of State law regulating viruses, serums, toxins, and analogous products; 
and
    (5) The State effectively exercises the authority specified in 
paragraphs (b)(1) through (4) of this section consistent with the intent 
of the Act prohibiting the preparation, sale, barter, exchange, or 
shipment of worthless, contaminated, dangerous, or harmful viruses, 
serums, toxins, or analogous products.
    (c) Each product to be exempted and each establishment preparing 
such product shall be identified by the State and the State shall give 
written notification to the Administrator of each such product and 
establishment. The State shall also give written notice to the 
Administrator of each new license issued and of each license terminated.
    (d) In order to determine whether a State exercises its authority 
with respect to biological products and establishments and whether its 
laws and regulations are being achieved, the Administrator, in 
cooperation with proper State authorities, may conduct an on-site 
evaluation of the State's program which may include inspection of 
establishments and/or products to be included under the exemptions in 
this section.

[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991]