Attachment II - Page 33 
Federal Register / Vol. 49, No. 252 / Monday. December 31, 1984 / Notices 50887 
The conclusion that nucleic acids as 
well as living organisms are “chemical 
substances” under TSCA is consistent 
with the TSCA legislative history, which 
makes it clear that the term "chemical 
substance" is to be interpreted broadly. 
The 1976 House Committee report notes 
that “the Committee recognizes that 
basically everything in our environment 
is composed of chemical substances and 
therefore the definition of chemical 
substance is necessarily somewhat 
broad." In recognition of this fact, the 
statute explicitly extends the term 
"chemical substance” to naturally 
occurring substances (section 3(2)(A)). 
Furthermore, EPA believes that TSCA 
authority over chemical substances 
extends to biotechnology products — 
including microorganisms used for 
purposes subject to TSCA — because 
Congress intended this Act to provide 
authority over substances not covered 
by other health and environmental laws. 
Other Federal authorities address 
specific types of products, such as 
pesticides, drugs, food, and certain 
agricultural products. However, certain 
uses of microbes now being developed 
do not fall under these other authorities. 
EPA jurisdiction over these new types of 
products (e.g., microorganisms used to 
degrade toxic pollutants) is consistent 
with TSCA’s coverage of other chemical 
substances similarly used. 
2. General types of products subject to 
TSCA. TSCA coverage extends to 
chemical substances and mixtures used 
in a wide range of general industrial, 
commercial, and consumer applications. 
In the context of biotechnology, 
products potentially subject to review 
under TSCA include microorganisms in 
certain physically contained uses (such 
as the production of pesticides and other 
commercial chemicals and the 
conversion of biomass for energy) and in 
certain uses involving direct release to 
the environment (e.g., pollutant 
degradation, enhanced oil recovery, 
metal extraction and concentration, and 
certain non-food agricultural 
applications, such as nitrogen fixation). 
Section 3(2)(B) of TSCA, however, 
specifically excludes from the definition 
of "chemical substances" certain 
products regulated under other statutes. 
The most important of the excluded 
products are pesticides, tobacco and 
tobacco products, nuclear materials, 
foods, food additives, drugs, and 
cosmetics. 
In implementing the Act. EPA has 
interpreted TSCA authority to cover 
pesticide intermediates, but not food, 
food additive, drug, or cosmetic 
intermediates. EPA explicitly stated this 
position in the reporting rules for the 
TSCA Chemical Substances Inventory in 
1977, published in the Federal Register 
of December 13, 1977 (42 FR 64586). The 
Agency has followed the policy since 
then, and it intends to maintain the 
policy for products of biotechnology. 
Consistent with this policy, 
microorganisms used to produce 
pesticides would fall under TSCA 
jurisdiction, while the pesticide itself 
would fall under FIFRA. Microorganisms 
used to producer foods, food additives, 
drugs, and cosmetics, although they 
could be considered “intermediates" 
subject to TSCA, would not be reviewed 
under TSCA because they are already 
reviewed by the Food and Drug 
Administration (see the FDA'Statement 
of Policy elsewhere in this notice). With 
respect to nuclear materials, those 
substances regulated under the Atomic 
Energy Act (source material, special 
nuclear material, or byproduct material) 
would not be subject to TSCA, but 
microorganisms (or chemical substances 
produced by microorganisms) that 
contain radionuclides will be subject to 
TSCA if used for TSCA purposes. EPA 
will work through interagency 
mechanisms to ensure that existing 
Federal coverage is adequate. 
3. Plants and animals. The policy 
proposed in this notice applies to 
microorganisms, but not to plants and 
animals. Most genetically engineered 
plants and animals will be used for food 
or food-related purposes, which are 
excluded from TSCA. However, it is 
also likely that plants and animals will 
in the future be genetically engineered 
for non-food uses, such as production of 
fibers, wool, and rubber. Because of 
USDA’s extensive involvement in this 
area and the fact that the major Federal 
expertise on plants and animals lies in 
USDA and DOI, EPA, is not proposing 
that living plants or animals, either as 
whole organisms or in vitro cultures, be 
made subject to TSCA requirements. 
One exception would be the insertion of 
gene segments from plants or animals 
into microorganisms subject to TSCA. In 
this case, plant or animal genetic 
material would be subject. 
B. Premanufacture Notice Requirements 
1. Description of authority. Section 
5(a) of TSCA requires companies to 
notify EPA at least 90 days before 
beginning to manufacture or import a 
"new chemical substance” for 
commercial purposes. This reporting 
requirement is known as 
premanufacture notification, or PMN. 
New chemical substances are defined 
under the Act as substances not listed 
on EPA’s Chemical Substances 
Inventory, a list of chemical substances 
in commerce (Ref. 35). Any chemical 
substance that is not listed by name on 
the Inventory or that is not "naturally 
occurring" is "new” and therefore 
subject to PMN requirements before 
commercial manufacture. (See Unit 
UI.B.2.b for an explanation of the 
distinction between new and naturally 
occurring.) 
EPA has implemented TSCA section 5 
requirements in a rule published in the 
Federal Register of May 13, 1983 (48 FR 
21722) and clarified in a notice 
published in the Federal Register of 
September 13, 1983 (48 FR 41132). This 
rule specifies review procedures and 
information requirements for new 
chemical substances. The following 
units describe the proposed applicability 
of these requirements to genetically 
engineered microorganisms. 
2. Applicability of PMN requirements 
to certain products of biotechnology. 
Because genetically engineered 
microorganisms and nucleic acids are 
neither "naturally occurring" nor listed 
on the TSCA Inventory, EPA believes 
they are subject to PMN requirements. 
The units below propose definitions of 
"new” microorganisms (which are 
subject ot PMN review), and “naturally 
occurring" microorganisms (which are 
not subject to PMN review) within the 
context of biotechnology. For a 
discussion of PMN applicability to 
isolated nucleic acids, refer to sections 
III.B.2.c.i and III.D.2. 
a. Summary of applicability, i. 
Consistent with its treatment of other 
chemical substances, EPA has 
concluded that microorganisms whose 
nucleic acids were produced through 
chemical synthesis are "new" and 
subject to PMN. EPA has also concluded 
that microorganisms produced by 
certain techniques that can be used to 
combine genetic material from 
organisms that do not exchange genetic 
material in nature should also be subject 
to PMN. The techniques that EPA 
considers as falling in this category 
include rDNA, rRNA and cell fusion. 
Cell microinjection and cell 
microencapsulation can also be used to 
combine genetic materiel across genetic 
boundaries, but these techniques are 
just recently being adapted to 
microorganisms and it is not yet clear 
whether they could be successfully used 
to produce ^commercial substances. EPA 
requests comment on whether cell 
microinjection and cell 
microencapsulation are likely to be 
successfully used in microorganisms and 
therefore whether products of these 
techniques should also be conr-'dered 
“new." 
Although EPA has concluded th’ 
substances produced by rDNA, rRN 
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