Attachment II - Page 44 
50898 Federal Register / Vol. 49, No. 252 / Monday, December 31, 1984 / Notices 
I. Mandate of the USDA 
The mandate of the USDA, simply 
stated, is to protect and enhance 
agriculture and forestry in the United 
States. 
In order to implement this broad 
mandate, USDA's authority Includes 
responsibility to administer programs 
relating to research and development; to 
fund cooperative interaction, marketing 
and application of products research; to 
manage, protect, and enhance resources; 
and to regulate activities. In addition, 
the Department is chartered to develop 
new markets for U.S. agricultural 
commodities, to improve soil and land 
use techniques, and to improve 
agricultural production of animals and 
plants resistant to stress. 
II. Historical Perspective 
For decades, agriculturists and 
botanists have introduced 
nonindigenous organisms into the 
continental United States, enabling 
animals and plants not indigenous to 
North America to become an important 
part of our major food sources and to 
provide new ornamental species. USDA 
conducts research on these organisms 
and has developed regulatory processes 
which control the introduction of foreign 
organisms into the United States based 
on their potential application to natural 
and agricultural ecosystems. These 
processes have effectively safeguarded 
our agricultural ecosystems against the 
introduction of foreign pests and 
pathogens. 
Many plant and animal species have 
also been introduced through various 
genetic techniques. In fact, scientists 
have long been able to create new gene 
combinations within single organisms — 
even creating new species — through 
mutagenesis, cross-hybridization, and 
other breeding techniques. USDA has 
vast amounts of expertise and scientific 
data relevant to the evaluation of safety 
and efficacy of organisms or other 
products derived from modem 
biotechnology procedures, because 
these products are not fundamentally 
different from products obtained by 
coventional technology. 
The USDA has been in the forefront in 
the development of modern 
biotechnology. USDA representatives 
were active participants at the early 
meetings and workshops where policy 
decisions were made regarding 
recombinant DNA research. In 1978, a 
committee was formed in USDA for 
purposes of coordinating research 
policies among the various agencies in 
the Department, and between the USDA, 
the National Institutes of Health (NIH), 
and the National Science Foundation 
(NSF). This committee, authorized by 
the Secretary, is called the Agriculture 
Recombinant DNA Research Committee 
(ARRC). 
Further, with regard to DNA research 
the USDA recognized that a uniform set 
of guidelines should be followed for 
research regardless of the source of 
research funding. The Department 
endorsed and adopted the NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules for 
coordinating interagency research 
review, and established an internal 
policy requiring compliance with these 
guidelines as a condition for receiving 
funds for research.* 
III. Regulatory Philosophy 
USDA anticipates that agriculture'and 
forestry products developed by modem 
biotechnology will not differ 
fundamentally from conventional 
products. 
We believe that the existing 
regulatory framework of USDA 
combined with the NIH Guidelines 
which are mandatory for all research 
grants are adequate and appropriate for 
regulating research, development, 
testing and evaluation, production, and 
application, of these biotechnology 
products. Should any new processes or 
products be shown to require additional 
regulatory measures, USDA will amend 
its regulations or will request additional 
authority. 
IV. Existing Regulatory Framework 
A. Overview 
The various animal quarantine and 
related laws, namely 21 USC 102-105, 
111, 114a-114h, 115-130, 134-134h, and 
135-135b, provide the authority to 
regulate the importation, exportation, 
and interstate movement of certain 
animals to prevent the introduction and 
spread of contagious, infectious, or 
communicable diseases of animals or 
poultry. 
Under authority of various plant 
quarantine and related laws, namely 7 
USC 147a, 148, 148a-148e, 150aa-jj, 151- 
164a, 166-167, and 2801-2813, USDA: (1) 
regulates the importation into and 
dissemination within the United States 
of plant pests, nursery stock, and other 
plants and plant products, and any 
product or article which may contain a 
plant pest at the time of movement, (2) 
inspects plants and plant products 
offered for export, and (3) issues 
permits, promulgates quarantines, and 
regulates movement of noxious weeds 
* “Memorandum to Heads of Department 
Agencies: Guidelines for Research Involving 
Recombinant DNA Molecules," October 15, 1979. 
into and through the United States or 
interstate. 
The USDA is responsible for all 
veterinary biologies imported into’ the 
United States or shipped in interstate 
commerce. Pursuant to the Virus-Serum- 
Toxin Act (21 USC 151-158), USDA 
regulates the movement and/or 
production of viruses, sera, toxins, and 
analogous products intended for 
treatment of animals, and of organisms, 
vectors, and products used in research 
and evaluation. 
Within the framework of the Federal 
Meat Inspection Act (21 USC 801 et seq.) 
and Poultry Products Inspection Act (21 
USC 451 et seq.) USDA regulates the 
slaughtering and processing of meat and 
meat food products and poultry and 
poultry food products derived from 
animals which have been administered 
drugs, biologies, or pesticides for 
experimental testing. These regulations 
provide that no animal used in research 
involving an experimental biologic 
product, drug, or chemical shall be 
eligible for slaughter at an official 
establishment unless certain conditions 
are met. These conditions include 
demonstrating that the use of such 
biological product, drug, or chemical will 
not result in the products of such 
animals being adulterated. 
In addition to the above mentioned 
specific authorities, USDA cooperates 
with other federal agencies In 
determining the regulatory jurisdiction 
of genetically engineered organisms 
which fall within the regulatory 
jurisdiction of more than one agency. In 
this regard, a Memorandum of 
Understanding between USDA and EPA, 
dated October 3, 1984, defines the 
general principles of cooperaticr. 
coordination and communication to be 
utilized between the two agencies. 
Another Memorandum of 
Understanding, between USDA and the 
Food and Drug Administration, 
published in the Federal Register on 
June 8, 1982 (47 FR 26458), concerns 
resolution of jurisdictional questions 
involving animal biologic products. 
The attached regulatory matrix lists 
the current statutes defining USDA's 
oversight of biotechnology processes 
and products. Because the statutory 
authority of each USDA regulatory 
agency is unique, there is a need for an 
overall policy statement to harmonize 
regulatory activities, eliminate 
redundancy, and promote cooperation. 
Below are discussed the procedures 
required under the Virus-Serum-Toxin 
Act of 1913 (21 U.S.C. 151-158), the 
Federal Plant Pest Act of May 23, 1957 (7 
U.S.C. 150aa-150jj), the Plant Quarantine 
Act of August 20, 1912 (7 U.S.C. 151-184, 
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