Attachment II - Page 49 
Federal Register / Vol. 49, No. 252 / Monday, December 31, 1964./ Notices 50903 
Once a new plant pest or disease is 
identified, a search of the literature is 
conducted and data from specialists is 
compiled. Once the plant pest surveys 
are completed to determine whether a 
plant pest population is established, the 
extent of the population, and the degree 
of damage done or which would be done 
to agriculture, a plan is developed for 
managing the plant pest This plan may 
include regulatory action, eradication, 
control, suppression, or other activities 
which may be implemented by USDA 
and its cooperators. 
To the extent that biotechnology 
results in the development of a plant 
pest which is released into the 
environment, USDA would apply these 
established detection, suppression, or 
eradication procedures. 
USDA is mandated by statute to 
impose the least drastic action adequate 
to prevent the dissemination of plant 
pests new to or not theretofore known to 
be widely prevalent or distributed 
within and throughout the United States. 
This mandate would be applicable to 
the regulation of plants, plant products 
or articles capable of carrying plant 
pests, and plant pests developed through 
biotechnology. 
Other Oversight Mechanisms 
Any plant or associated 
microorganisms that are developed to 
the point of commercialization, and in 
whkdt recombinant DNA techniques 
have been used, will be licensed, 
certified, or otherwise treated by USDA 
or state authorities in the same manner 
as organisms developed by conventional 
methodologies. A mechanism already 
exists for the development and 
evaluation of new crop varieties and 
associated microorganisms. This 
mechanism can easily accomodate 
biotechnology-derived organisms 
developed by both the public and 
private sectors. Relevant oversight 
mechanisms includes, at the national 
level, the National Germplasm Advisory 
Board (NGAB), crop advisory 
committees of NGAB for each crop 
species, and the national voluntary 
registration system for new varieties 
under the Plant Variety Protection Act (7 
U.S.C. 2321 et seq.) and Patent and 
Trademark Law (35 U.S.C. 1 et seq). At 
the state level, oversight mechanisms 
include local breeders’ release boards, 
state official and trademark variety 
testing, and state seed certification 
agencies. 
Currently, the USDA utilizes the 
ARRC, in an advisory capacity, for 
scientific review of genetically 
engineered plants and associated 
microorganisms to be released for 
research, field tests, and commercial 
purposes. The ARRC provides scientific 
evaluation of the impact of the release 
of these plants into the agricultural 
research environment. The scientific 
advisory review uses the NIH guidelines 
as the basis for evaluation. The 
continued use of this mechanism 
depends on its long term applicability to 
regulatory oversight needs. Once the 
biotechnology regulatory needs become 
fully known, further consideration will 
be made concerning the ARRC's 
continuing participation in the impact 
review prpcess. 
D. Seeds 
The Federal Seed Act (“FSA" 7 U.S.C. 
1551 et seqp defines USDA regulatory 
authority over the importation and 
interstate shipment of agricultural and 
vegetable seeds. It does not apply to the 
production or intrastate distribution of 
seeds or to seeds other than agricultural 
or vegetable seeds ("agricultural seeds” 
are grass, forage, and field crop seeds). 
The FSA prohibits interstate shipment 
of seed that contains noxious weed 
seeds at levels in violation of the laws of 
the state of destination or in excess of 
levels allowed by the Secretary of 
Agriculture. This provision applies 
primarily to seed adulterated with 
noxious weed seed. In a few instances, 
however, states have determined that a 
particular variety of agricultural or 
vegetable seed is itself a noxious weed. 
In these instances, FSA prohibits the 
interstate shipment of the seed into 
those states. The FSA also allows the 
Secretary to prohibit the importation of 
agricultural and vegetable seed which is 
adulterated with noxious weed seed or 
which is unfit for seeding purposes. 
The authority granted to the Secretary 
by the FSA to prohibit the interstate 
shipment or importation of seeds which 
are found to be detrimental to the 
agricultural interests of the United 
States applies to seeds genetically 
engineered with the modem 
biotechnology to the same extent as any 
other seeds. 
E. Meat and Poultry Products 
The Food Safety and Inspection 
Service (FSIS) is responsible for 
assuring the safety, wholesomeness, and 
proper labeling of food products 
prepared from domestic livestock and 
poultry. 
Although FSIS has no statutory 
provisions or regulations that address 
biotechnology directly, the laws and 
regulations under which the agency 
operates provide inspection authority to 
determine the safety and 
wholesomeness of animals that are 
slaughtered for human food. FSIS is 
required by statute to inspect cattle, 
sheep, swine, goats, equines, poultry, 
and food products prepared from them 
which are intended for use as human 
food to assure that they are wholesome, 
not adulterated, and properly labeled, 
marked, and packaged. Congress has 
conferred the authority to conduct these 
inspections to FSIS under the Federal 
Meat Inspection Act (FMIA) and the 
Poultry Products Inspection Act (PPLA). 
Inspection under these statutes is 
mandatory. The cost of inspection, 
except for overtime and holiday 
inspection, is required to be borne by 
the United States. Food, animals, and 
animal products other than those 
covered under the FMIA and PPLA may 
be inspected under a voluntary, 
reimbursable inspection program 
established under the Agricultural 
Marketing act of 1946. 
Within the framework of food safety 
statutes, FSIS has developed regulations 
for research on experimental animals 
that are administered animal drugs, 
biologies, and pesticides (9 CFR 309.17 
and 381.75). These regulations state that 
no animal used in any research 
investigation involving an experimental 
biological product drug, or chemical 
shall be eligible for slaughter at an 
official establishment unless certain 
conditions are met. These conditions 
include any of several different ways of 
demonstrating that the use of such 
biological product drug, or chemical will 
not result in the products of such 
animals being adulterated. 
Products Subject to Review. FSIS 
anticipated that many food animals 
which are subject to the new techniques 
of modern biotechnology will not differ 
substantially in appearance, behavior, 
or general health from currently 
inspected cattle, sheep, swine, goats, 
equines, and poultry. Providing that such 
living product* of biotechnology can be 
shown not to be adulterated, they would 
be subject to the same inspection 
procedures and regulations as 
traditionally inspected food animals. 
FSIS is aware that some genetically 
engineered animals, such as chimeras 
and some hybrids, may differ 
substantially from animals that are 
currently inspected under the FMLA ana 
PPIA. If such animals are ever intended 
for use as human food and are presented 
for inspection at an official 
establishment, a decision would have to 
be made as to whether such animals 
were covered under the FMLA of PPLA, 
and if not, whether FMLA or PPIA 
should be amended to require 
mandatory inspection of such animals 
and their products. 
Implementation of Review Authority. 
FSIS's approach toward the safety 
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