Attachment II - Page 39 
Federal Register / Vol. 49, No. 252 / Monday, December 31, 1984 / Notices 50893 
2. Applicability to isolated nucleic 
acid fragments. Because PMN 
requirements apply to all isolated “new 
chemical substances" used for non-R&D 
purposes, and not simply to the nucleic 
acid in the new microorganism, these 
requirements would apply to isolated 
DNA and RNA fragments and 
recombinant DNA and RNA (e.g., 
plasmids), as well as to the “final" 
recombinant organisms, if they were 
used or distributed for purposes other 
than R&D. However, EPA believes that 
DNA fragments and plasmids will 
generally be isolated only within the 
context of R&D activities and therefore 
would not be subject to PMN 
requirements. 
DNA fragments and plasmids could 
also be isolated for the purposes of 
medical testing. As either drugs or 
medical devices, such fragments would 
not be subject to PMN requirements. 
EPA requests comments on the 
practical implications of these 
requirements to persons engaged in 
commercial biotechnology. 
3. Confidentiality. Section 14 of TSCA 
provides for protection of confidential 
business information submitted under 
any authorities of the Act. 
Confidentiality provisions are addressed 
in detail in the preamble to the PMN 
rules and in the rule itself (40 CFR 720.80 
through 720.90). 
4 . Inventory and nomenclature issues. 
After a new chemical substance has 
completed PMN review and entered 
commercial production, it is listed on the 
TSCA Chemical Substance Inventory. 
Subsequently, anyone may make the 
substance described on the Inventory 
for purposes subject to TSCA without 
submitting a PMN. For this reason, 
Inventory listings, particularly listings of 
substances of unknown or variable 
composition or biological materials 
(UVCBs), are of central importance in 
defining PMN requirements. To specify 
the product adequately, these listings 
include not only the substance name, 
but also a brief definition. An overly 
broad definition for a complex 
substance might allow the manufacture 
of substances with significantly different 
properties without PMN review, because 
they would fall within the general 
description on the Inventory. An overly 
narrow definition, on the other hand, 
might unnecessarily require new PMN 
submissions because of slight 
modifications in process or product 
composition. Any system for listing 
complex substances on the Inventory, 
therefore, requires a balance between 
practical and risk-related 
considerations. 
In listing biotechnological substances 
on the Inventory, ETA must also decide 
how to identify isolated DNA and RNA 
segments and whether to identify 
nucleic acids within living organisms as 
nucleic acids or as microorganisms. 
ETA intends to work with interested 
members of the public to develop a 
listing scheme that defines 
microorganisms (or nucleic acids) 
unambiguously, is practical and 
comprehensible, and ensures that the 
listings are sufficiently narrow to allow 
review of legitimately “new” or different 
microorganisms with the potential for 
different risks. Currently, a number of 
microorganisms are listed on the 
Inventory by genus and species. EPA, 
however, believes that the way in which 
these microorganisms are listed is too 
broad for genetically engineered 
microbes. More specific descriptors 
might also go into the Inventory 
definition of a new microorganism to 
more clearly identify it and differentiate 
it from other microbes. For example, a 
microorganism produced by rDNA 
techniques might be listed by such 
factors as the name of the source 
organism, isolation methods, vectors 
used, the host, or other features. EPA is 
now investigating how these or other 
descriptors could be combined to 
develop adequate Inventory definitions. 
ETA recognizes that much of this 
information may be confidential, just as 
the identify of numerous chemical 
substances now listed on the Inventory 
is confidential. When a substance’s 
identity is confidential, EPA lists the 
substance on the publicly available 
Inventory by a generic name, shielding 
the confidential information. Inventory 
confidentially procedures are 
established in 40 CFR 710.7 and Subpart 
E of Part 720. 
OTS has prepared a background 
document discussing possible Inventory 
listing systems in more detail. Persons 
interested in the nomenclature issue 
may obtain this document from the OTS 
Public Information Office at the address 
listed at the beginning of this notice. The 
Agency encourages the public to 
comment on the approaches it is 
considering and to suggest alternatives. 
5. Issues related to other TSCA 
authorities. As discussed above, TSCA 
provides EPA a wide range of 
authorities to collect information, 
require testing of, and regulate exposure 
to TSCA-covered chemical substances 
and mixtures. However, EPA believes in 
general that the PMN authority will 
provide sufficient oversight of 
biotechnology products. Nevertheless, 
several existing requirements under 
TSCA impose responsibilities on 
manufacturers, processors, or 
distributors of all chemical substances. 
Therefore, these requirements may 
affect the biotechnology industry. The 
most importance of these authorities, 
sections 8(c), 8(e), and 13, are discussed 
briefly below. 
a. Section 8(c). EPA issued a final 
section 8(c) rule, published in the 
Federal Register of August 22, 1983 (48 
FR 38178), that requires manufacturers 
and certain processors of TSCA-covered 
chemical substances and mixtures to 
keep records of “significant adverse 
reactions to health or the 
environment . . . alleged to have been 
caused by the substance or mixture." 
Persons who manufacture or process 
microbial products that fall under the 
TSCA definition of "chemical 
substances" should consult the final 
section 8(c) recordkeeping rule. 
b. Section 8(e). Section 8(e) of TSCA 
requires manufacturers, processors, and 
distributors of chemical substances or 
mixtures to notify ETA immediately of 
any new information “which reasonably 
supports the conclusion that such 
substance or mixture presents a 
substantial risk of injury to health or the 
environment." ETA issued a section 8(e) 
policy statement published in the 
Federal Register of March 16 t 1978 (43 
FR 11110) providing guidance on this 
requirement. Persons manufacturing, 
processing, or distributing microbial 
products for TSCA purposes will be 
subject to this requirement and' should 
consult the policy statement to 
determine their responsibilities under 
section 8(e). 
c. Section 13. Section 13(a) of TSCA 
prohibits entry into the United States of 
any chemical substance or mixture that 
is not in compliance with TSCA 
statutory and regulatory requirements. 
To implement this provision, the U.S. 
Customs Service issued a rule requiring 
importers of chemical substances in 
bulk or as part of mixtures to certify at 
the port of entry (1) that the substances 
in the shipment are subject to TSCA and 
comply with all applicable TSCA rules 
and orders, or (2) that the chemicals are 
not subject to TSCA (August 1, 1983, 48 
FR 34734). EPA issued a notice 
published in the Federal Register of 
December 13, 1983 (48 FR 55462) 
interpreting these requirements. 
Importers of naturally occurring 
products, such as lumber, vegetable oils, 
and natural rubber, must comply with 
these certification requirements. Thus, 
importers of microbial products 
(including for use in R&D) are generally 
required to certify that their products 
comply with TSCA, or that they are not 
subject to the Act. Until PMN 
requirements for "new" microorganisms 
are in effect, the importer will be able to 
certify compliance, regardless of 
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