The Virus-Serum-Toxin Act: A Brief History and Analysis

The Virus-Serum-Toxin Act: A Brief History and Analysis

Order Code RS22014
January 3, 2005
CRS Report for Congress
Received through the CRS Web
The Virus-Serum-Toxin Act:
A Brief History and Analysis
name redacted
Analyst in Agricultural Policy
Resources, Science, and Industry Division
Summary
The Viruses, Serums, Toxins, Antitoxins, and Analogous Products Act (21 U.S.C.
151-159), also known as the Virus-Serum-Toxin Act (VSTA), is intended to assure the
safe and effective supply of animal vaccines and other biological products. The act and
its applicable regulations are administered by the Animal and Plant Health Inspection
Service (APHIS) of the United States Department of Agriculture (USDA).
The VSTA was enacted in 1913, and revised once in 1985. A 2002 law affected
the VSTA by transferring border and import inspection functions from USDA to the
Department of Homeland Security.
Origins in 1913 (62nd Congress)
The Viruses, Serums, Toxins, Antitoxins, and Analogous Products Act (21 U.S.C.
151-159) was enacted in 1913 (the Act of March 4, 1913, ch. 145, sec. 1) and is known
commonly as the Virus-Serum-Toxin Act (VSTA).1 It was enacted primarily in response
to substantial losses from the unregulated manufacture and distribution of anti-hog
cholera serum. The authority to license and regulate the production and trade of affected
products is granted to the Secretary of Agriculture. The act states that:
It shall be unlawful for any person, firm or corporation to prepare sell, barter, or
exchange [in the United States], or ship or deliver for shipment in or from the United
States ... any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or
analogous product intended for use in the treatment of domestic animals.2
1 This report draws upon CRS Report RL32414, The Private Testing of Mad Cow Disease: Legal
Issues, by Stephen R. Viña, which discusses the VSTA in terms of regulating diagnostic tests.
2 21 U.S.C. 151.
Congressional Research Service ˜ The Library of Congress

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In 1913, a USDA official testified that the bill was necessary “to protect the farmer
and stock raiser from improperly made and prepared serums, toxins, and viruses.”3 The
1913 Senate report for the VSTA stated that the legislation would prevent:
the introduction into the United States of dangerous and worthless viruses, serums and
analogous products for use in the treatment of domestic animals, some of which
products may be the means of introducing disease not now known in the United
States, and also for the purpose of controlling the use, by preventing the interstate
shipment, of similar dangerous and worthless products that may be manufactured
within the United States.4
Revisions in 1985 (99th Congress)
After seven decades, the original provisions in the VSTA faced challenges from a
modernized agricultural sector and a more complicated regulatory environment. Congress
amended the VSTA in the Food Security Act of 1985 (P.L. 99-198, Title XVII, Sec.1768)
to (1) authorize USDA regulate intrastate, as well as interstate, movement of biological
products, (2) broaden the Secretary’s authority to issue regulations, (3) enhance
enforcement powers, and (4) recognize a congressional view that regulation is “necessary
to prevent and eliminate burdens on commerce and to effectively regulate commerce.”5
A Senate report cited the need for “national uniform standards” in the preparation
and sale of biological products.6 The same report refers to jurisdictional issues between
USDA and the Food and Drug Administration (FDA) regarding the need to update the law
and preserve USDA authorities:
Two recent Federal court decisions have created confusion and concern among the
producers of animal biological products and those who utilize them. The thrust of
these decisions is that USDA has primary regulatory authority over finished products
physically moving in interstate commerce, but all other products, such as those made
and sold within a single State, are subject only to Food and Drug Administration
jurisdiction. These “intrastate” products are not subject to USDA licensure, and FDA
has, so far, not asserted its authority over them in a comprehensive manner. In the
meantime, “interstate” products remain firmly under the jurisdiction of USDA.
The narrow “intrastate” versus “interstate” distinction found in the VSTA no longer
exists for any class of comparable products. Federal laws make no such distinctions
for human-use pharmaceuticals, animal drugs, food additives, color additives, medical
devices, processed food, meat and poultry products, or pesticides; all are subject to
uniform Federal regulatory standards, whether they cross state lines or not.7
3 Hearing before the Committee on Agriculture on the Estimates of Appropriations for the Fiscal
Year Ending June 30, 1914 (H.R. 28283), 62nd Cong. 24 (1913) (statement of Dr. A. M.
Farrington, Asst. Chief Bureau of Animal Industry, Dept. of Agriculture).
4 S.Rept. 62-1288 (1913).
5 21 U.S.C. 151, 154, 159.
6 S.Rept. 99-145, pp. 338-339.
7 Ibid.

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Transfer of Functions in 2002 (107th Congress)
The Homeland Security Act of 2002 (P.L. 107-296, Title IV, Sec. 421, 6 U.S.C. 231)
transferred most major border inspection functions (immigration, customs, and
agriculture) to the Department of Homeland Security (DHS). The VSTA was one of
seven agricultural laws affected by this transfer. The law did not change provisions in
VSTA, but only moved certain functions from one department to another. The purpose
was to unify all major border inspection activities under the jurisdiction of one department
after the terrorist attacks of September 11, 2001.
Although DHS now conducts the physical inspection of imports, USDA continues
to have jurisdiction over VSTA regulations and policies, including setting such policies
for imports. The Secretaries of USDA and DHS are to consult each other and coordinate
their regulatory and inspection practices.
For more on border inspections, and the transfer of inspection functions to DHS, see
CRS Report RL32399, Border Security: Inspections Practices, Policies, and Issues.
Analysis of Provisions and Regulatory Action8
Except as permitted in the act, the VSTA makes it unlawful for any person to
prepare, sell, barter, or exchange anywhere in the United States, or to ship or deliver in
or from the United States, any dangerous or harmful virus, serum, toxin, or analogous
product intended for use in the treatment of domestic animals.9
The VSTA further requires that a person who prepares, sells, barters, exchanges, or
ships any virus, serum, toxin, or analogous product do so in compliance with USDA
regulations through an establishment holding an unsuspended and unrevoked USDA
license.10 The VSTA authorizes the Secretary to issue, suspend, and revoke licenses for
the maintenance of establishments that prepare viruses, serums, toxins, or analogous
products for use in the treatment of domestic animals. In 21 U.S.C. 152, the VSTA also
prohibits the importation of any virus, serum, toxin, or analogous product except under
a permit from the Secretary of Agriculture.
The Secretary of Agriculture is also authorized to make and promulgate rules and
regulations as may be necessary to prevent the preparation, sale, barter, exchange, or
shipment of a dangerous virus, serum, toxin, or analogous product for use in the treatment
of domestic animals or otherwise to carry out the VSTA. Consequently, the Animal and
Plant Health Protection Service has issued a comprehensive set of regulations governing
the licensing of viruses, serums, toxins, or analogous products (9 C.F.R. 101-124).
Regulations for the VSTA broadly catagorize viruses, serums, toxins, or analogous
products as “biological products” at any stage of production intended for use in the
8 Drawn primarily from CRS Report RL32414, The Private Testing of Mad Cow Disease: Legal
Issues, by Stephen R. Viña.
9 21 U.S.C. 151.
10 Ibid.

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treatment of animals and which act primarily through the direct stimulation,
supplementation, enhancement, or modulation of the immune system or immune
response. A “biological product” includes but is not limited to:
vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants,
certain cytokines, antigenic or immunizing components of live organisms, and
diagnostic components, that are of natural or synthetic origin, or that are derived from
synthesizing or altering various substances or components of substances such as
microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens,
allergens, or antibodies.11
“Treatment” under the regulations means the prevention, diagnosis, management,
or cure of diseases of animals.12 “Prepare” or “preparation” is generally referred to as the
manufacture or production of a biological product and has been defined as the steps and
procedures used in the processing, testing, packaging, labeling, and storing of a biological
product. With respect to licensing, the regulations require every person who “prepares”
biological products subject to the VSTA to have a valid U.S. Veterinary Biologics
Establishment License and at least one valid U.S. Veterinary Biological Product License.13
A USDA permit is also required for every person importing a biological product.14
The VSTA explicitly addresses preparation, sale, barter, exchange and shipment, but
does not address use or distribution. However, USDA regulations authorize certain use
and distribution restrictions. These include distribution of experimental products prior
to licencing (9 C.F.R. 103.3), exemptions concerning USDA’s use in emergencies and
experimental programs (9 C.F.R. 106.1), packaging and labeling requirements (9 C.F.R.
112), and possession, use, and transfer of biological agents and toxins (9 C.F.R. 121).15
11 9 C.F.R. 101.2.
12 Id.
13 Id. at 102.2.
14 Id. at 104.1.
15 Authority for 9 C.F.R. 121 concerning possession, use, and transfer of biological agents and
toxins (“select agents”) comes from the Public Health Security and Bioterrorism Preparedness
and Response Act (P.L. 107-188, sec. 211-213, June 12, 2002), but is directly applicable to the
products covered by the VSTA.

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