[Federal Register Volume 60, Number 60 (Wednesday, March 29, 1995)]
[Rules and Regulations]
[Pages 16298-16311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7709]




[[Page 16297]]

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Part III





Environmental Protection Agency





_______________________________________________________________________



40 CFR Parts 704, 720, 721, and 723



Revisions of Premanufacture Notification Regulations; Expedited Process 
to Issue Significant New Use Rules for Selected New Chemical 
Substances; Revisions of Exemptions for Polymers; and Revision of 
Exemptions for Chemical Substances Manufactured in Small Quantities-Low 
Release and Exposure Exemptions; Final Rules

Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / 
Rules and Regulations 
[[Page 16298]] 

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 704, 720 and 721

[OPPTS-50593B; FRL-4921-8]
RIN 2070-AC14


Premanufacture Notification; Revisions of Premanufacture 
Notification Regulations; Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: Pursuant to section 5 of the Toxic Substances Control Act 
(TSCA), EPA is promulgating procedural amendments to the premanufacture 
notification (PMN) rule to incorporate a number of regulatory 
initiatives designed to streamline and reduce the administrative costs 
and burdens of the section 5 new chemicals program. These actions will 
allow EPA to concentrate its limited resources on identifying and 
controlling those new chemical substances most likely to present an 
unreasonable risk of injury to human health and the environment.
DATES: This rule will become effective May 30, 1995. In accordance with 
40 CFR 23.5, this rule shall be promulgated for purposes of judicial 
review at 1:00 p.m. eastern savings time on April 12, 1995.

FOR FURTHER INFORMATION CONTACT: James B. Willis, Acting Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551.

SUPPLEMENTARY INFORMATION: EPA published its final PMN rule (40 CFR 
part 720) on May 13, 1983 (48 FR 21722) and subsequently amended 
certain parts of the rule on September 13, 1983 (48 FR 41132) and April 
22, 1986 (51 FR 15096). On February 8, 1993, EPA proposed additional 
amendments to the PMN rule (58 FR 7661). Please consult those documents 
for further information on the PMN rule and the proposed amendments. 
The docket control number for this action is OPPTS-50593B.

I. Background

A. Statutory Authority

    Section 5(a)(1) of TSCA requires that persons notify EPA at least 
90 days before they manufacture or import a new chemical substance for 
commercial purposes. For the purposes of TSCA, a new chemical substance 
is one that is not listed in the Master File of the TSCA Chemical 
Substance Inventory (``the Inventory'') compiled under TSCA section 
8(b), which consists of substances originally reported under the 
Inventory reporting regulations (40 CFR part 710) and substances added 
via notices of commencement of manufacture or import (NOCs)(40 CFR 
720.102) from submitters of PMNs.

B. History

    Since 1979, EPA has reviewed over 25,000 section 5 notices for new 
chemical substances. During the intervening years, EPA has implemented 
a number of initiatives which have enabled the Agency to review a 
growing number of new chemical substances more efficiently. As 
discussed in the February 8, 1993 proposed rule (58 FR 7661), EPA is 
amending the PMN rule at 40 CFR part 720 to further reduce the costs of 
administering the Agency's new chemicals program and to implement other 
efficiencies for EPA and submitters. Please consult the proposed rule 
for a more detailed discussion of the objectives and rationale for 
these amendments.

II. Discussion of Final Amendments and Response to Comments

    The final rule adopts the proposed amendments with minor revisions. 
The Agency reviewed and considered all comments received on the 
proposed amendments. A complete copy of all comments received is 
available in the public docket for this rulemaking, along with EPA's 
response to comments not addressed in this document. A discussion of 
the final amendments including a summary of significant comments and 
the Agency's response follows:

A. Correct Chemical Identity

    EPA is amending Sec. 720.45(a) of the PMN rule to require that 
submitters of section 5 notices provide the currently correct Chemical 
Abstracts (CA) Index Name or CA Preferred Name for each chemical 
substance included in the notice (``reported substance'') that is 
consistent with TSCA Inventory listings for similar substances. Persons 
who request a search of the confidential Inventory by demonstrating a 
bona fide intent to manufacture or import a chemical substance for 
commercial purposes (``bona fide'') will also be required to provide CA 
nomenclature and chemical identity information in accordance with 
amended Sec. 720.25, as discussed later in this document. The rule also 
requires that a currently valid Chemical Abstracts Service (CAS) 
Registry Number (CASRN) consistent with the CA name be reported for the 
substance if a CASRN already exists for that substance. Until now, the 
PMN rule has indicated that CA nomenclature is the preferred, but not 
required chemical nomenclature system for PMN reporting. Therefore, 
submitters were able in the past to identify the PMN substance using 
alternative nomenclature. Having the currently correct CA 
identification for a substance is important to EPA because the 
reporting of incorrect, inconsistent, ambiguous, or obsolete chemical 
names, molecular formulae, or chemical structure information, or names 
that are not CA Index or CA Preferred Names, causes extra resources to 
be spent by EPA in establishing the best descriptions for substances 
under TSCA for searching the Inventory.
    Although a CASRN has not been routinely required for a reported 
substance if a CASRN is not already available and the amendment only 
requires that CASRNs be reported for substances that already have them, 
EPA strongly recommends that submitters provide CASRNs for all reported 
substances, especially when the chemical identity is not being claimed 
as confidential business information (CBI). The fact that a CASRN 
exists does not prohibit a submitter from claiming this information as 
confidential. Having more substances reported with CASRNs will save EPA 
resources involved with chemical review and Inventory searching.
    Submitters must provide a CA Index Name or CA Preferred Name that 
is consistent with the application of the Ninth Collective Index (9CI) 
of CA nomenclature rules and conventions. (This definitive guide to CA 
nomenclature has been used since 1972.) Whether to report a CA Index 
Name or Preferred Name for a substance depends on whether the chemical 
identity of the substance is well-defined or poorly defined.
    For well-defined substances appropriately named using CA Index 
nomenclature, the specific chemical name chosen as most accurately 
describing the substance should be based on all information that the 
submitter can reasonably ascertain about its chemical structure, 
including, where applicable, the degree of structural specificity of 
the substance (e.g., whether specific isomers are intended to be 
manufactured in the reaction that produces the substance). For poorly 
defined substances properly named using CA Preferred nomenclature, the 
specific name of choice should be based on the 
[[Page 16299]] submitter's knowledge of the identities of the chemical 
precursors used, the sources of the reactants (synthetic, isolated by 
processing from certain naturally occurring materials, etc.), the 
nature of the reaction, and the types of chemical substances 
constituting the product combination, etc. For naming any kind of 
substance, the submitter's knowledge of impurities or byproducts is 
also a consideration.
    When more than one substance results from a reaction, one should 
determine whether the product combination can be viewed for TSCA 
purposes as a mixture of separately reportable substances. For example, 
when the intended product combination is known to always be completely 
composed of a specific number of identified substances that do not 
react with one another, the combination can be represented as a mixture 
of individual components. If this is not the case, a single chemical 
name must be used to collectively describe the product combination as 
one substance. Where the chemical components can be represented as a 
mixture, they may be reported in a single PMN as long as the components 
are not intended to be separated. Otherwise, multiple PMNs or a 
consolidated PMN (requiring pre-approval by EPA) must be submitted.
    The PMN rule retains all of the other chemical identity information 
required at Sec. 720.45(a), including molecular formula and chemical 
structure information. However, for substances not able to be 
characterized by a single chemical structure, the amendments require 
the submitted representative or partial structural diagram to be as 
complete as known to or reasonably ascertainable by the submitter. 
Failure to fully comply with the chemical identification elements of 
this requirement will result in the notice being declared incomplete by 
EPA pursuant to Sec. 720.65(c)(1). Such incomplete notices will not be 
processed or reviewed by the Agency until the chemical identification 
requirement is satisfied.
    Concerning the degree of chemical structure information that can be 
reasonably ascertained for a given substance, submitters should 
understand that, for TSCA Inventory purposes, all substances are 
categorized by EPA into two groups according to the degree of certainty 
about the chemical structure of a substance: Class 1 and Class 2. Class 
1 substances are those of precisely known chemical composition for 
which a single, complete structural diagram can be drawn. Class 2 
substances are those having chemical compositions not completely 
definite or known; therefore, they cannot be characterized by definite, 
complete chemical structure diagrams. This rule amendment requires 
complete structural diagrams to be provided for Class 1 substances; for 
Class 2 substances, partial structure diagrams are required that are as 
complete as can be reasonably ascertained from the Class 2 chemical 
identity.
    All of the chemical identification requirements described above 
should be satisfied if the submitter uses the CAS Registry Services 
Inventory Expert Service, which is a special extension of CAS for 
identifying substances to be submitted under TSCA. Submitters may also 
choose to use the services of another chemical information service or 
consultant that the submitter considers capable of generating correct 
CA names, chemical structure diagrams or molecular formulae where 
appropriate, and obtaining existing CASRNs. Alternatively, the 
submitter can search publicly available databases to retrieve this 
information, if available, or attempt to generate a name without 
assistance from another person or organization, if the submitter has 
sufficient knowledge about the Ninth Collective (9CI) Index of CA 
nomenclature rules and conventions and about how similar substances are 
named for the Inventory.
    Information describing CA nomenclature rules and conventions can be 
obtained from CAS. In addition, the Agency is preparing a series of 
Inventory nomenclature papers that are intended to generate better 
understanding of how various classes of substances or types of complex 
product combinations are identified for TSCA purposes. The Inventory 
papers provide informal technical guidance that is intended solely to 
illustrate how various types of substances are represented on the TSCA 
Inventory based on the information provided by the submitters. The 
papers are not intended to be used for identifying substances for 
reporting purposes or for determining the need to report. Generally, 
EPA has attempted to maintain a consistent Inventory by closely 
following the guidance contained in the papers. However, EPA cannot 
guarantee that the guidance discussed in these papers has been applied 
to all substances listed on the Inventory. The initial Inventory 
reporting utilized four types of reporting forms with very different 
format and data requirements, making it difficult to ensure complete 
consistency. The Inventory papers will be available from the TSCA 
Assistance Information Service at (202) 554-1404; TTD (202) 554-0551; 
on line service modem (202) 554-5603.
    An information sheet on the CAS Registry Services is also available 
from the TSCA Assistance Information Service. Printed copies of the 
non-confidential Inventory can be purchased from the Government 
Printing Office; computer tapes, CD ROM, and PC diskettes, (up-dated 
semi-annually) containing this Inventory information can be purchased 
from the National Technical Information Service (NTIS).
    Regardless of how submitters determine correct CA chemical 
nomenclature, submitters should provide the party generating the CA 
nomenclature with the same chemical identity information that the 
submitter would have to send to EPA if reporting the substance in a 
PMN: the same types of information, levels of detail, degrees of 
specificity, byproduct and impurity information, etc. The party 
assigning a chemical identity should ensure that the name choice 
reflects the current CA nomenclature rules and conventions, as well as 
how similar substances are named for the Inventory, or the chemical 
name will be incorrect and the notice may be declared incomplete by the 
Agency.
    The final rule at Sec. 720.45(a)(3)(i) and (ii) sets forth the 
required mechanism for obtaining CA nomenclature directly from CAS or 
alternative sources, as follows:
    Method 1. A submitter using this method obtains the correct 
chemical identification directly from the CAS Registry Services 
Inventory Expert Service prior to submitting a notice to EPA. CAS will 
provide such services pursuant to arrangements between CAS and persons 
informing CAS that their substances will be reported to EPA in a 
notice. Submitters should call or write to the CAS Registry Services 
for information. Submitters must provide EPA with a copy of the 
chemical identification report obtained from CAS along with the 
completed notice, to verify that they obtained the information directly 
from CAS.
    EPA believes that most submitters will find it advantageous to 
utilize the services of CAS to meet this requirement. As discussed in 
the proposed rule, due to CAS' authoritative position in the field of 
chemical identification and its familiarity with TSCA Inventory and 
nomenclature policies, EPA believes that chemical names and other 
chemical identity information assigned by CAS according to this method 
should be acceptable to the Agency. For these reasons, EPA strongly 
recommends that submitters use the services of CAS to satisfy the 
amended provisions. [[Page 16300]] 
    Submitters should note, however, that if EPA disagrees with the 
identification assigned by CAS to a given substance, the Agency 
reserves the final authority to designate how a reported substance 
should be named and represented for the Inventory. This will not delay 
processing of the PMN by EPA. In the event EPA does not agree with a 
chemical name, CASRN, chemical structure or molecular formula provided 
to a submitter by CAS for TSCA purposes according to Method 1, EPA will 
work with CAS to either modify the submitted chemical identity when 
necessary or confirm that CAS' identification is most appropriate, to 
ensure that a correct TSCA description is assigned. Using Method 1, 
there will be no delay in EPA review or additional cost to the 
submitter resulting from an identification error by CAS or an identity 
verification request by EPA provided that the submitter has given 
complete chemical information to CAS that is identical to the chemical 
identity information contained in the section 5 notice to EPA. EPA will 
assume responsibility for resolving chemical identity problems 
occurring when Method 1 is used. However, if EPA determines that the 
chemical identity information submitted to EPA is not identical to that 
provided CAS, the notice may be deemed incomplete in accordance with 
Sec. 720.65(c)(1).
    Method 2. Using this method, a submitter may obtain the required 
chemical identity information from any chemical information service or 
consultant, or can retrieve or develop the proper CA identifications 
without assistance. EPA emphasizes that with this method submitters 
will need to provide for each substance a correct CA Index or Preferred 
Name and other chemical identity information, as required under 
Sec. 720.45(a)(1) and (2), that is consistent with Inventory listings 
for similar substances. It will be the submitter's responsibility under 
Method 2 to seek the required information from a source the submitter 
believes to be sufficiently knowledgeable about CA nomenclature 
conventions and TSCA Inventory listings.
    In contrast to Method 1, if a submitter uses Method 2 and reports 
any chemical identity information that is considered incorrect by EPA, 
the submitter, not the Agency, will be considered responsible for 
correcting the chemical identification. EPA will declare such a notice 
incomplete under Sec. 720.65(c)(1) and will not further process or 
review it until the submitter provides the fully correct chemical 
identity information specified in this amendment.
    Concerning the task of generating correct CA nomenclature, it 
should be noted that there are many chemical names on the CAS Registry 
File, particularly CA names for indefinitely described substances, that 
are not appropriate for uniquely identifying substances on the 
Inventory. Thus, the application of just the CA nomenclature rules to 
name a new substance may not necessarily guarantee an acceptable 
chemical name for TSCA purposes. One must also be familiar with the 
ways in which similar substances are listed in the Inventory. As stated 
above, EPA is developing papers on specific Inventory nomenclature 
issues for public distribution.
    Whether a submitter uses CAS or another method to obtain CA 
nomenclature, EPA will assume that upon sending a notice to the Agency, 
the submitter agrees with the chemical identity information provided by 
the source. Regardless of which method is chosen by a submitter for 
properly identifying a reported substance, EPA remains the final 
authority for naming new substances for the TSCA Inventory.
    For submitters to have ample time to become familiar with the 
process of obtaining chemical identity information from CAS, another 
chemical information service, or a consulting party for obtaining 
chemical identifications, submitters should contact their chosen source 
at least 1 or 2 months before the intended submission date of a notice. 
This is especially important the first time one would have to report 
under this amendment.
    EPA anticipates that many submitters would consider chemical 
identity information and/or submitter identity information given to CAS 
(by Method 1) or another third party (by Method 2) to be CBI. Until 
submitted to EPA under a provision of TSCA, CBI is not subject to EPA's 
procedural and security protections under TSCA. Therefore, provisions 
for handling any CBI first submitted to CAS or another outside party 
must be arranged directly with that party. Submitters should not assume 
that CAS or another outside party is required to adhere to EPA's TSCA-
CBI procedures regarding the possession, handling, labelling, storage, 
tracking, auditing, or other processing of this information.
    However, based on currently available information, it is EPA's 
understanding that any confidential, proprietary, or trade secret 
information that CAS would receive according to Method 1 of this rule 
amendment prior to the information being reported to EPA would be 
handled in accordance with the long-established security procedures and 
policies that CAS has implemented to safeguard any confidential 
information provided by its customers.
    When submitting chemical substance identity information to CAS or 
any other information service, a submitter who indicates that the 
substance identity is CBI should be aware that a CASRN for that 
substance may already exist due to CAS's prior knowledge of the 
existence of that substance from another source. In such a case, the 
chemical identity would already have been assigned a CASRN and placed 
by CAS in its publicly accessible files.
    Based on its knowledge of CAS's procedures, EPA believes that CAS 
currently does not place the substance identity into the publicly 
available CAS Registry File, if not already present there, when a 
submitter has requested confidential treatment of the information. 
However, EPA cannot ensure that CAS will continue this practice in the 
future, nor can EPA ensure how other services handle this type of 
information. As always, it is the submitter's responsibility to ensure 
that the information service it uses properly protects the 
confidentiality of its data. Submitters choosing to use either Method 1 
or Method 2 should inquire how the information service, consultant, or 
party receiving their confidential information will handle, protect, 
and use such information.
    The final rule at Sec. 720.45(a)(4) and (5) sets forth procedures 
for importers and manufacturers who do not possess the complete 
chemical identity information required to submit a notice to EPA about 
a substance they intend to import or manufacture because of proprietary 
claims by the U.S. or foreign supplier of the new chemical substance or 
a reactant used to manufacture the new chemical substance. Section 
720.45(a)(4) requires that the importer of a proprietary new chemical 
substance have the foreign supplier follow the procedures for obtaining 
CAS nomenclature for the new chemical substance from CAS or alternative 
sources as specified in Sec. 720.45(a)(3). The foreign supplier would 
provide the chemical identity information on the new chemical substance 
specified in Secs. 720.45 (a)(1) and (2) directly to EPA as part of a 
joint submission or letter of support clearly referencing the 
importer's notice and in the case of PMNs, the user fee identification 
number of the PMN submission established by the U.S. submitter (see 40 
CFR 700.45(e)(3)).
    Section 720.45(a)(5) contains provisions for manufacturers who 
cannot provide complete chemical [[Page 16301]] identity information 
because the new chemical substance is manufactured using a reactant 
whose identity is claimed confidential by its supplier. In this 
situation, however, due to logistical obstacles to generating correct 
CA nomenclature and other chemical identity information for a substance 
based on multiple submissions from different sources, each containing 
part of the overall chemical identity, EPA will not require the 
submitter to first develop or obtain a correct CA chemical 
identification for the given substance before submitting a section 5 
notice. Instead, the final rule requires that the manufacturer provide 
all the information known by the manufacturer about the chemical 
identity of the reported substance and the proprietary reactant. This 
would typically include tradename, generic chemical name, or partial 
composition information about the confidential reactant such as that 
listed in a Material Safety Data Sheet (MSDS) or in other product 
literature and any other chemical identity information the submitter 
may know or reasonably ascertain about the confidential reactant or 
reported substance. In addition, the manufacturer must ensure that the 
supplier of the proprietary reactant sends a letter of support directly 
to EPA providing the specific chemical identity of the confidential 
reactant, including the CAS number, if available, and the appropriate 
PMN or exemption number, if applicable. This should be information 
known to or reasonably ascertainable by the supplier since that person 
is responsible for determining that the proprietary reactant is either 
on the Inventory or being manufactured under terms of an applicable 
section 5 exemption.
    As indicated above, Secs. 720.45(a)(4) and (5) require that persons 
providing information as part of a joint submission or letter of 
support clearly reference the importer or manufacturer's notice and 
user fee identification number (See 40 CFR 700.45(c)(3)), if 
appropriate so that EPA can be sure of properly linking the two 
submissions. In addition, any CBI claims must be clearly marked in the 
notice or letter of support along with a statement that this 
information must not be shared with the notice submitter. The statutory 
review period for a section 5 notice will not begin until EPA receives 
all parts of a joint notice, or all necessary supporting documents 
providing chemical identity information for a notice.
    Comment.  EPA should resolve nomenclature issues leading to 
inconsistency (1) within the TSCA Inventory, (2) between CAS and TSCA 
nomenclature and (3) between how a substance is named for TSCA purposes 
and how it is named by the chemical industry for marketing purposes.
    Response. Basically, there is only one set of nomenclature rules 
used for the TSCA Inventory; the CA nomenclature system has always been 
utilized by EPA to represent and name substances for Inventory 
purposes. However, recognizing the complexity of the various types of 
commercial chemical substances that would be reported under TSCA and 
the need for accurately representing these substances on the Inventory, 
EPA held numerous meetings with trade associations at the time the 
Initial Inventory was compiled to develop guidelines for identifying 
these substances. Before the Inventory was initially compiled, EPA 
worked with CAS to refine some of the nomenclature policies for certain 
categories of chemical substances, such as (1) substances of variable 
composition, (2) natural fats, and (3) polymers.
    The TSCA Inventory was initially compiled from information 
submitted by chemical manufacturers, importers, and processors. 
Perceived Inventory inconsistencies reflect the different ways in which 
similar substances were described and reported by submitters. 
Differences in commercial intent, author emphasis, and level of detail 
or knowledge of composition resulted in some variation in names. This 
flexibility in nomenclature was considered necessary by the chemical 
industry at the time of the Initial Inventory reporting. The Agency 
checked the original 160,000 reports for the Initial Inventory using a 
computer program that was designed to identify obvious discrepancies; 
the Agency then worked with the submitters of problem substances to 
correct the Inventory reports. If there were no obvious discrepancies, 
the Agency was not able to identify substances that were identified 
incorrectly by the submitters, and consequently, some incorrectly 
identified substances might have been added to the Inventory. However, 
when the Agency adds substances to the Inventory through the PMN 
program, it works with the submitters and CAS to attempt to ensure that 
consistent nomenclature is used.
    The Agency will continue using its current nomenclature system, 
striving to maintain consistency. As discussed above, a series of 
Inventory nomenclature guidance papers (that will be available through 
TSCA's Assistance Information Service) is under development at the 
Agency to publicly articulate Agency nomenclature practices used for 
Inventory representation of various types of chemical substances.
    Comment. CA nomenclature should not be required for TSCA 
submissions; CAS should not have an exclusive interest.
    Response. EPA developed the TSCA Inventory using CA nomenclature 
and numbers; CAS has been assisting EPA in compiling, maintaining and 
updating the Inventory since 1977. CA nomenclature and numbers are used 
by all major industrial countries for their chemical inventories. This 
form of international harmonization enhances international trade and 
conserves the resources of chemical industries and governments. Many 
major chemical manufacturers now utilize CA nomenclature, too. The use 
of one nomenclature system minimizes confusion in regulatory matters 
and trade, and facilitates compliance monitoring. Moreover, the Agency 
has the authority to specify the form of nomenclature for TSCA 
purposes. Therefore, the Agency believes that the use of CA 
nomenclature is appropriate. Submitters have the choice of which 
nomenclature service to use, as long as names are consistent with TSCA 
nomenclature requirements.
    Comment. Problems with nomenclature not provided by CAS should not 
delay Agency review.
    Response. Chemical identification errors by submitters result in 
wasted resources and significant delays for both EPA and submitters. 
For this reason, the Agency has determined that it will consider 
submissions incomplete and thus delay their review if the incorrect 
nomenclature is received from a source other than CAS. The Agency 
believes, as a result of its years of experience using CAS 
nomenclature, that chemical substance identities provided by CAS 
specifically for TSCA purposes will rarely be in error and that any 
errors would be relatively minor. EPA has insufficient experience with 
other chemical nomenclature services to allow EPA to assume that the 
nomenclature provided by such services would normally be consistent 
with Inventory nomenclature requirements.
    Comment. The burden of supplying CA nomenclature is significant, 
both in terms of time and financial resources.
    Response. The Agency disagrees with this comment. The Agency 
recognizes that the time and cost of submitting a notice will increase 
to some extent because of the requirement to use CAS nomenclature. This 
will be true for those who utilize the TSCA nomenclature services of 
CAS or other providers or choose to develop CAS nomenclature on their 
own. EPA does [[Page 16302]] not believe that this requirement will 
present significant problems because, in EPA's experience under the 
section 5 program, some submitters already use CAS private registry 
services, despite the absence of a requirement to do so under the 
previous PMN regulations, apparently with minimal added cost or delay.
    The Agency recognizes that the lead time required to prepare a PMN 
may increase. In most cases, submitters can be preparing other sections 
of their notices pending nomenclature assignments. The added up-front 
time in compiling a PMN should not be a major factor. According to EPA 
records many PMN substances are not manufactured until a month or more 
after the PMN review period ends. The Agency believes that submitters 
should always take the time necessary to ensure that their chemical 
substance is correctly identified upfront. The practice of relying on 
EPA to correct submitter errors, after the fact, has over the years 
consumed significant Agency resources. The Agency believes that this 
change in the procedural rule will place this responsibility where it 
legitimately belongs.
    Comment. The burden imposed on small manufacturers and importers is 
too large.
    Response. EPA does not consider this burden to be unreasonable, 
especially because small companies already save $2,400 on each of their 
PMN submissions compared with larger companies. Small companies have 
historically been responsible for a disproportionately large number of 
errors in chemical identities. The burden of generating CA nomenclature 
will be offset, in many cases, because with the inclusion of proper 
chemical names in the initial section 5 notice the review period will 
not be suspended for problems with chemical identity. Small companies 
may also benefit significantly from an early knowledge of the correct 
chemical identity, which may enhance their customer service, Inventory 
search efforts, and regulatory compliance.
    Comment. Requirements to generate CA nomenclature will create 
problems in protecting confidentiality.
    Response. The Agency does not believe that the requirement for CA 
nomenclature will create undue problems with confidentiality for 
submitters. All submitters must be responsible for the confidentiality 
of their information prior to submission to the Agency.
    Comment.  EPA should not require CA nomenclature for polymers and 
for bona fide inquiries (bona fides).
    Response. While submitters must report all monomers and other 
reactants used to manufacture reported polymers, CA nomenclature is 
required for polymers, in part, because in certain cases the 
appropriate CA name for the polymer is based on more than just the 
names of the monomers and other reactants. CA nomenclature for certain 
polymeric substances may be based on structural repeating units or 
other important structural features of the polymeric material. Examples 
include certain block polymers, certain post-treated or functionalized 
polymers, and siloxanes and silicones. The Agency has chosen to 
maintain a consistent policy for nomenclature using CA names for all 
substances, avoiding the potential confusion and compliance problems 
which could occur if only some substances required CA names.
    In a separate rulemaking published concurrently with this document, 
the Agency has decided not to require CAS nomenclature for polymers 
that are manufactured under terms of the polymer exemption in 
accordance with 40 CFR 723.250, since the Agency will no longer review 
exemption notices for exempted polymers. However, since chemical 
identity information is required as part of the recordkeeping 
requirements, persons who are manufacturing polymers under terms of the 
polymer exemption are encouraged to use standard CA nomenclature in 
their records.
    The Inventory search process is the same for both PMNs and for bona 
fides. In the case of bona fides, chemical identity issues frequently 
have interfered with the Agency's ability to give an accurate response 
to submitters within the 30-day period to which the Agency has 
committed itself. In general, there have been more problems with 
chemical identity for bona fides than for PMNs, in part because much 
less chemical information has been required for bona fides than for PMN 
submissions. Once a correct chemical name is developed for purposes of 
a bona fide, the same name can be used for a subsequent PMN submission 
without further expense.

B. Revised Requirements for Bona Fides

    The Agency is amending Sec. 720.25 by revising certain provisions 
of the procedures to establish a bona fide intent to manufacture or 
import a substance. This amendment reduces or simplifies existing 
analytical information requirements, modifies and/or clarifies other 
existing information requirements, and requires some additional types 
of information in bona fides.
    The amendments eliminate the need for elemental analysis data 
[former Sec. 720.25(b)(2)(iv)] as well as reduce and simplify other 
analytical information requirements [former Sec. 720.25(b)(2)(v)] by 
identifying an infrared spectrum as the usual practice for 
characterizing the new chemical substance. Two other parts of this 
section, regarding chemical identity information, and the description 
of research and development (R&D) activities and use [former 
Sec. 720.25(b)(2)(i) and (iii), respectively] were modified and/or 
clarified. There are three new information requirements regarding the 
most probable manufacturing site and process to be used, as well as an 
approximate date when the submitter would be likely to submit a section 
5 notice for the substance if it is not found in the Inventory. EPA 
believes that the amendments represent a balanced trade-off of 
requirements between the former and amended provisions. The amendments 
will enable submitters to better demonstrate a bona fide intent while 
the Agency will be better able to protect the CBI of the original 
submitters of Inventory substances. The additional information or data 
required in the amendment is considered reasonably ascertainable by the 
submitter, and generally would have been determined already by the time 
the submitter has developed a bona fide intent to manufacture or import 
a substance for a commercial purpose. Under the amended 
Sec. 720.25(b)(2)(i), submitters of a bona fide must provide, as 
described in the amended provisions of Sec. 720.45(a) discussed in unit 
II.A above, a currently correct CA Index Name or CA Preferred Name, 
whichever is appropriate, and a currently correct CASRN (if the 
substance already has a CASRN assigned to it). In addition, the Agency 
requires a molecular formula and a complete or partial chemical 
structure diagram if these are known or reasonably ascertainable. 
Failure to fully comply with the chemical identification elements of 
this requirement will result in the bona fide being declared incomplete 
by EPA and returned to the submitter.
    The amendments modify the requirement for a description of R&D 
activities conducted to date on the substance and the purpose for 
manufacture or import [former Sec. 720.25(b)(2)(iii)]. Since in the 
past many submitters have inadvertently omitted one of these two 
different pieces of information in their notices, EPA is making the 
requirements clearer by separating the requests for the description of 
R&D activities and the [[Page 16303]] purpose for which the submitter 
will manufacture or import the substance into different subparagraphs 
of the amended rule [amended Sec. 720.25(b)(2)(iii) and (iv), 
respectively]. In addition, in the amended Sec. 720.25(b)(2)(iii)(A), 
EPA elaborates on the information required by listing some of the 
general types of R&D activities to be reported. Also, the year in which 
R&D was started by the submitter on the substance is required. EPA 
believes that these modifications will enable the submitter to indicate 
the scope and length of its commitment towards developing the substance 
for commercial use. EPA expects that this information be briefly 
stated.
    In the amended Sec. 720.25(b)(2)(iii)(B), EPA provides an 
alternative reporting requirement for importers who do not perform R&D 
activities on the substance and have no knowledge of R&D activities 
that may have been conducted outside of the United States. Such 
importers will be allowed, in lieu of presenting R&D information, to 
indicate for how long, and in which country a given substance has been 
in commerce outside the United States, as well as to state whether they 
believe that the substance has already been used outside of the United 
States for the same commercial applications intended by the submitter. 
This alternative requirement is similar to the informal EPA practice in 
the past of allowing such a prospective importer to satisfy the former 
Sec. 720.25(b)(2)(iii) by providing certain information on foreign 
commercial activity of the substance.
    In the amended Sec. 720.25(b)(2)(iv), for clarity, the term 
``purpose'' used in the former Sec. 720.25(b)(iii) has been replaced by 
the phrase ``major intended application or use'' because some 
submitters have misunderstood the type of information required and have 
not provided a description of the intended end use.
    EPA has simplified the analytical data requirements in the amended 
Sec. 720.25(b)(2)(v) to reflect the usual practice of submitters 
providing an infrared spectrum to characterize the chemical substance. 
An infrared spectrum is required, unless infrared analysis is not 
suitable for the substance or does not yield good structural 
information about the substance. In such cases, the amendment requires 
a spectrum or instrumental readout from another method of spectral or 
instrumental analysis that yields better structural or compositional 
information.
    Amended Sec. 720.25(b)(2)(vi) consists of a minor but new 
information requirement to estimate the month and year in which the 
person would intend to submit a section 5 notice for the substance if 
it is not found in the Inventory. EPA believes that submitters with a 
bona fide interest in a substance would have already considered a 
future timeframe for reporting the substance under section 5 if in fact 
it is a new chemical substance. The intent of this requirement is not 
to legally bind the submitter to a certain date for submission of a 
PMN. In addition to using this information to determine a demonstration 
of a bona fide intent to manufacture or import the substance, if EPA 
can anticipate how many bona fide submitters may report their 
substances in PMNs in a given year, the Agency may be able to better 
allocate resources for reviewing the expected PMNs.
    Amended Sec. 720.25(b)(2)(vii) requires the address of the facility 
under the submitter's control where the substance is most likely be 
manufactured or processed in the future for a commercial purpose. For 
imported substances it requires the facility at which processing is 
most likely to occur, if any.
    Amended Sec. 720.25(b)(2)(viii) requires a manufacturer to briefly 
describe either in words or with a process flow diagram the 
manufacturing process that the submitter would most likely use to 
produce commercial quantities of the substance. The process description 
does not have to be detailed or comprehensive. Importers are required 
to briefly describe how the substance would most likely be processed or 
used at a site controlled by them, or, if no processing or use of the 
substance is anticipated to occur at a submitter-controlled facility, 
an importer may state that such commercial activity is not expected to 
occur. This information is not intended to be legally binding, but 
rather to assist EPA in determining whether the submitter appears to 
have serious intentions for commercializing the substance in question.
    The Agency has also clarified the procedure for a foreign 
manufacturer or supplier to provide confidential chemical identity 
information directly to EPA, to complete a notice when the chemical 
identity is considered proprietary information by the foreign party and 
will not be disclosed to the bona fide submitter. As amended, it is the 
importer's responsibility at Sec. 720.25(b)(3)(i) to ensure that the 
foreign supplier provides the required chemical identity information in 
accordance with Secs. 720.45(a)(1), (2), and (3) to EPA in a timely 
manner so that EPA can easily link the information to the importer's 
bona fide.
    The amendments at Sec. 720.25(b)(3)(ii) indicate how to meet 
chemical identification requirements when submitters of substances to 
be manufactured or imported do not possess full knowledge of the 
chemical identity of the substance to be reported because a purchased 
reactant or component used in the reported material has a confidential 
chemical identity that is the proprietary information of the supplier. 
Similar to the procedures specified at Sec. 720.45(a)(5) for section 5 
notices involving confidential (often trademarked or tradenamed 
products) reactants or starting materials, the bona fide submitter 
reports all the information known by the submitter about the substance 
identity. In addition, the supplier must submit a letter of support to 
EPA providing the specific chemical identity of the proprietary 
reactant, including the CAS number, if available, and referencing the 
submitter's bona fide. As previously discussed in this Unit under 
Correct Chemical Identity, correct CA nomenclature is not required when 
a reported substance involves the use of a purchased proprietary 
reactant. This is due to logistical obstacles involved in generating 
correct CA identifications for substances based on multiple submissions 
of parts of the overall identity from different sources. However, the 
submitter must coordinate with the supplier to ensure that the 
remaining specific chemical identity information is sent by the 
chemical supplier directly to EPA in a timely manner, to complete the 
bona fide request and initiate review by EPA. If the appropriate 
supporting document from the supplier is not received within 30 days 
after EPA receives the submitter's bona fide, the bona fide will be 
considered incomplete.
    Further, EPA has included language in amended Sec. 720.25(b)(9) to 
describe what constitutes an incomplete bona fide, and how EPA will 
handle incomplete ones. When an incomplete bona fide is received and 
identified as such, EPA will immediately return the bona fide (minus 
any supplier-confidential portions) directly to the submitter. The 
submitter will then have to resubmit the completed bona fide, in its 
entirety, to have EPA perform the Inventory search and respond to the 
inquiry.
    Comment. Appropriate bona fide intent exists even though many bona 
fide substances are never submitted as PMNs.
    Response. Each bona fide request requires a certification statement 
about commercial intent. As a result, the Agency believes it is 
reasonable to expect that most bona fide submissions involving 
substances not found to be on the Inventory would result in 
[[Page 16304]] subsequent PMNs. This judgment takes into account the 
types of factors that could legitimately cause submitters to change 
their minds. The Agency expects that once the new requirements are in 
place, a larger percentage of bona fides will eventually result in 
submission of PMNs.
    Comment. The proposed bona fide requirements are burdensome and the 
existing requirements need not be changed; EPA should not require 
process information, specific manufacturing site, the year that 
research and development started (or the length of foreign use), or the 
estimated date of PMN submission in order to establish bona fide 
intent.
    Response. EPA believes that the information requested does not 
cause a significant burden because it should be known to or reasonably 
ascertainable by the submitter without developing or collecting 
additional data. EPA believes that submitters who have not yet 
considered these topics or developed this information are not at a 
commercial development stage consistent with showing bona fide intent.
    Comment. EPA should focus on abusers of the bona fide process 
rather than increasing the reporting burdens on all submitters.
    Response. The Agency believes that the perceived problem of 
submitter abuse of the bona fide process involves more than a few 
submitters. EPA believes that the best solution is to improve the 
integrity of the entire process through the new requirements so that 
all submitters will demonstrate a serious bona fide intent prior to 
receiving confidential Inventory information.
    Comment. Greatly increased requirements for bona fide intent may 
lead to more PMN submissions.
    Response. Rather than increasing the number of PMNs, EPA believes 
that the revised procedures will reduce the number of bona fides from 
persons who do not have a bona fide intent to manufacture the 
substance. In any event, persons who intend to manufacture or import a 
new chemical substance for a commercial purpose are free to submit a 
PMN without submitting a prior bona fide.

C. ``Two percent rule'' for Polymers

    Section 720.45(a)(2)(iii) allows submitters to indicate on the PMN 
form which monomers and other reactants used at 2 weight percent or 
less (based on the dry weight of the polymer) should be included as 
part of the polymer description on the Inventory. This gives a 
manufacturer the flexibility of increasing the weight percent above the 
2 percent level without submitting another PMN, but also requires that 
the monomer or reactant always be present at some level in the polymer. 
In practice, many polymer manufacturers currently request Agency pre-
approval of a consolidated PMN to allow the manufacture of a new 
polymer with levels of monomers above and below the two percent level 
(i.e., with and without the monomer in the polymer's chemical 
identity). As a general rule, if the weight of monomer or reactant 
charged to the reaction vessel is 2 percent or less, the monomer or 
reactant is not considered part of the chemical identity of the 
polymer, unless indicated by the submitter on the PMN form. The 2 
percent limit for polymers, referred to as the ``two percent rule'', 
has been in place since the Inventory reporting regulations were 
published on December 23, 1977 (see 40 CFR 710.5(c)) and was adopted 
because the Agency and the regulated community believed it would be 
difficult to identify the exact amount of monomers or other reactants 
actually incorporated in the final polymer. Accordingly, polymer 
manufacturers can use other monomers or reactants at 2 percent or less 
without changing the chemical identity of an Inventory-listed polymer.
    Under the final rule, persons may continue to determine the weight 
percentage of monomer or other reactant based on the weight of monomer 
or other reactant actually ``charged'' to the reaction vessel. However, 
Sec. 720.45(a)(iii)(B) now allows persons the flexibility, where 
technically feasible, to determine the minimum weight of monomer or 
other reactant required in theory to account for the actual weight of 
monomer or other reactant molecules or fragments chemically 
``incorporated'' (chemically combined) in the polymeric substance 
manufactured. Consequently, a PMN submitter or a person relying on 
existing polymer Inventory listings may determine which monomers or 
other reactants constitute the polymer identity on the basis of either 
method.
    During the compilation of the Inventory, the method of reporting 
the percent composition of monomers and other reactants ``as charged'' 
was viewed as a reasonable approach by chemical and polymer industries. 
However, due to advanced analytical capabilities developed over the 
intervening years, certain polymer manufacturers asked EPA to revise 
the ``two percent rule'' to allow manufacturers the option of 
determining the amounts of monomers and other reactants that are 
present ``in chemically combined form'' (incorporated) in a polymer as 
an alternative to the practice of requiring reporting based on the 
amounts added (charged) to the reaction vessel. The final rule allows 
this option. The Agency believes that allowing submitters to report on 
the basis of amounts incorporated in the polymer will provide a better 
indicator of physical, chemical, and toxicological properties of 
polymers. At the same time, this action will allow manufacturers 
greater flexibility in commercial innovation, reduce the number of 
unnecessary PMNs representing slight variations in polymer composition, 
and provide greater consistency with international reporting policies. 
However, the Agency believes that manufacturers should be aware that 
there may be certain drawbacks and burdens involved in using the method 
of computation based on incorporated amounts of monomers and other 
reactants. For example, use of the ``incorporated'' method may have 
regulatory consequences if process modifications (such as a change in 
catalyst or solvent used or method and/or order of charging the 
reactants) affect the degree of chemical incorporation such that the 2 
percent level is exceeded for a monomer or other reactant not specified 
as part of the chemical identity for the polymer, as discussed in the 
proposed rule (58 FR 7664).
    If a person determines those monomers or other reactants used at 2 
percent or less on the basis of the amount incorporated in the polymer, 
EPA believes that it is reasonable to require that such manufacturers 
maintain in their records analytical data or appropriate theoretical 
calculations (if it can be documented that an analytical determination 
is not feasible or not necessary) to demonstrate that the amounts of 
monomers and other reactants incorporated in the manufactured polymer 
have been accurately determined [Sec. 720.45(a)(2)(iv)]. Additional 
guidance on appropriate measurements or theoretical calculations is 
available in EPA's Draft Technical Guidance Document on the Polymer 
Exemption Rule. That document is in the docket for that rulemaking 
(OPPTS 50594B) and is available through the TSCA Assistance Information 
Service.
    EPA recognizes that it was a matter of convenience, rather than one 
of science, to have thus far required reporting of the amounts of 
polymer reactants charged rather than the amounts incorporated; the 
former method requires only ``bookkeeping'', while the latter may 
require extensive and expensive analytical work. After 16 years of 
experience with the Inventory and PMN [[Page 16305]] reporting rules, 
however, EPA has come to realize that the ``amount charged'' approach 
has drawbacks. In particular, this approach of identifying many 
polymers based on monomers and other reactants charged to the reactor 
in quantities significantly larger than the amounts found to be 
incorporated in the polymer may not adequately represent the physical, 
chemical, and toxicological properties of the polymer.
    Until now under the PMN rule, inefficiently incorporated reactants, 
reactants charged in large excess, and reactants with other functions 
besides their reactant ones were often likely to produce reportable 
polymers, even though the degree of chemical incorporation may have 
been less than or equal to two percent. For example, free-radical 
initiators are often charged in quantities greater than two percent to 
start many polymer chains simultaneously and limit the amount of high-
molecular-weight polymer produced. Chemical incorporation of these 
initiators is inefficient, since many processes other than chain 
initiation can consume the initiator. The weight of the final polymer 
that can be attributed to fragments originating from the initiator is 
often less than 2 percent by weight. In the past, a manufacturer may 
have used many different initiators, all charged at greater than 2 
percent, to produce what would be the same polymer if the 
``incorporated'' method of computation was used. The result represented 
what many manufacturers believed to be excess reporting. Similar 
problems arose with solvents that have reactive functions, and with 
neutralizing agents used in excess of their salt-forming capacities. 
Technical details concerning the ``two percent rule'' are contained in 
EPA's Draft Technical Guidance Document on the Polymer Exemption Rule, 
which is available in the public docket for this rulemaking [OPPTS-
50593B].
    The Agency has always believed the actual content of a polymer is a 
better indicator of its physical, chemical, and toxicological 
properties, but adopted the ``amount charged'' method of computation as 
a matter of convenience to industry. The Agency believes that, in light 
of advanced analytical capabilities, it is now reasonable to also allow 
the submitter to optionally use the amounts of monomers and other 
reactants incorporated, as an alternative to the ``amounts-charged'' 
method.
    Comment. Several comments supported EPA's proposal to modify the 
``two percent rule'' by allowing polymer manufacturers to determine the 
amounts of monomers and other reactants that are ``incorporated'' in 
the polymer, as an alternative to the current practice of reporting 
based on the ``amounts charged'' to the reaction vessel. One comment 
stated that the use of the incorporation method, where the technology 
is available and feasible, more accurately represents the actual 
properties of the polymer. Commenters also stated that PMN submitters 
and/or manufacturers relying on existing listings of polymers on the 
Inventory should be able to use either method as long as they are in 
compliance with the ``two percent rule.''
    Response. The proposed amendment was intended to allow this 
flexibility. Persons relying on existing Inventory listings of polymers 
or persons submitting PMNs may use either method as long as they can 
demonstrate the percentage of monomers or other reactants either 
charged to the reaction vessel or incorporated in the polymer.
    Comment. The amendment to the ``two percent rule'' should be 
clearly stated to be an option rather than a regulatory requirement. 
EPA should abandon the proposed rule's arbitrary distinction and 
clarify that, for purposes of TSCA compliance, a polymer should be 
described either by analysis or by calculation.
    Response. EPA has clearly indicated in this preamble and in the 
regulatory text that a manufacturer may use either method to determine 
which monomers or other reactants constitute the polymer identity.
    Comment. EPA should establish a ``five percent rule'' for non-
monomer reactants such as free radical initiators, chain transfer 
reagents, and pH neutralizing agents. These reactants are known to 
correlate poorly with the amounts charged and incorporated. Routine 
analytical testing would be inconclusive.
    Response. EPA continues to believe, as stated in the preamble to 
the proposed rule (58 FR 7672), that a 5 percent rule would create a 
larger potential variation in those physical and chemical properties of 
a polymer that may have toxicological implications. Further, adopting a 
``five percent rule'' would not be consistent with the Agency's goal of 
harmonizing, to the extent possible, the reporting of polymers with 
other international reporting practices that use a 2 percent standard.
    In the past, industry has asserted that free radical initiators 
were not expected to be incorporated, so allowing a company to use the 
``incorporated'' method should already provide a greater measure of 
flexibility. Manufacturers who are unable to develop reliable 
analytical data or reasonable theoretical calculations to support their 
use of the ``incorporated'' method should continue to follow the 
current practice of calculating 2 percent based on the monomers and 
other reactants ``charged'' to the reaction vessel.
    Comment. EPA should allow use of any scientifically sound and 
technically appropriate incorporation measurement or theoretical 
calculation method. The proposal should be modified so that analytical 
and recordkeeping requirements for the incorporation method are not so 
onerous as to virtually negate the advantage of its use. A company that 
uses the ``incorporated'' method would be required to maintain 
analytical data to support this determination at the site of 
manufacture.
    Response. The rule does not specify any particular analytical 
methodology for the ``incorporated'' method. The Agency would also 
allow theoretical calculations if it can be documented that an 
analytical determination is not technically feasible or not necessary 
as discussed above. Further, EPA believes that it is reasonable to 
require that manufacturers who use the ``incorporated'' method maintain 
records of analytical data or appropriate theoretical calculations that 
demonstrate compliance with the ``two percent rule'' at the site of 
manufacture to verify compliance in a straightforward manner.

D. Multiple photocopies of section 5 submissions

    The Agency is amending Sec. 720.40(d)(2) to require submitters to 
provide EPA with one original and two complete copies of section 5 
notices, in addition to a sanitized copy in which CBI has been deleted 
under Sec. 720.80. Submitters are also required to provide one original 
and two additional copies of any test data.
    Comment. EPA should not require the submission of copies of test 
data. Test reports range from hundreds to thousands of pages and 
submitting extra copies would result in excessive volumes of material 
for EPA to handle.
    Response The two extra copies of test data will reduce the Agency's 
administrative burden and will facilitate scientific reviews of the 
data submitted. The Agency's request for these test results falls 
clearly within the General Information Collection Guidelines, 5 CFR 
1320.6 of the rules on the Paperwork Reduction Act of May 10, 1988 
promulgated by the Office of Management and Budget. Under these 
guidelines, the Agency is allowed to request an original and two copies 
of [[Page 16306]] any document that satisfies its statutory 
requirements.

E. Electronic Transmission of Section 5 Notices; Removal of PMN from 
the CFR

    EPA is amending the PMN rule at Sec. 720.40(a) to allow for future 
reporting via magnetic or other electronic media. This amendment is 
designed to promote the use of electronic media for data submission. 
EPA is investigating the use of magnetic tape, floppy diskettes, and 
electronic data interchange as means to submit information, and is 
participating in a nation-wide trend toward reducing reliance on paper 
for information transfer. EPA has already taken steps in TSCA and other 
program areas to encourage electronic submission, and intends to expand 
this effort to the PMN review program.
    Information may be submitted electronically (on magnetic or other 
media) once EPA publishes a format for electronic submissions. Pilot 
projects using electronic submissions for the Inventory Update Rule (40 
CFR part 710) and Toxic Release Inventory Rule (40 CFR part 372) will 
be used as a baseline for enhancements to developing a standard Agency-
wide format. Such submissions will have to meet this format and all 
other media specifications published by EPA.
    EPA is taking this opportunity to remove the full text of EPA form 
7710-25 (PMN form) from the Code of Federal Regulations (CFR)(40 CFR 
part 720, Appendix A) and also correct the address for availability (40 
CFR 720.40). The PMN form, which has been printed each year in the CFR, 
requires approximately 10 pages of publication and does not represent 
the most current document in use by PMN submitters. Removing the form 
from the CFR reflects standard Agency policy of not printing the full 
text of final forms in the CFR and will result in a significant cost 
savings for the Agency. In general, EPA has determined that it is not 
legally obligated to publish forms in full text. Under the 
Administrative Procedure Act (APA), 5 U.S.C. 552(a)(1)(c), EPA is 
obligated to describe forms and give a source of availability. In 
addition to removing the form, EPA is making conforming amendments to 
those sections that reference part 720, Appendix A to remove reference 
to Appendix A.
    In addition, the PMN form that appears in the CFR has been photo 
reduced and cannot be used in a practical sense by those who must 
comply with the reporting requirements. More importantly, the Agency 
has continued to implement editorial revisions to the form since it was 
first published as part of the final rule in 1983. These revisions are 
intended to reflect PMN regulations and the policy initiatives 
implemented during the intervening years. Any substantive removal or 
addition of reporting requirements is accomplished by notice and 
comment rulemaking.
    Comment. Comments were generally supportive of developing an 
electronic data interchange (EDI) with the Agency, although some 
reservations and concerns were expressed. Comments questioned (1) how 
practical it might be to submit some information, such as toxicity 
studies, electronically, (2) signature certification and (3) the 
security of CBI submissions. One comment suggested holding a workshop 
to address CBI concerns.
    Response. EPA will not implement an EDI application for TSCA 
section 5 submissions until an Agency policy is developed for EDI 
standard practices. Thus, submitters would not have to develop unique 
interchange devices for section 5.
    Electronic authentification technology is commercially available to 
address signature certification concerns and general security concerns. 
The Agency is required to protect CBI, and any EDI practices will 
ensure the confidentiality of data transmissions. The Agency is 
receptive to working with industry and other concerned parties to 
develop an EDI application for the New Chemicals Program, including CBI 
procedures. In the interim, the Agency encourages the use of PMN 
software developed by industry and approved for use by the Agency for 
generating hardcopy section 5 notices.
    In addition to EDI, the Agency is analyzing other electronic 
reporting media to determine which is most appropriate for these 
submissions, given the variety of documents and materials involved. All 
comments on electronic reporting are welcome.

F. Mandatory Form for Notice of Commencement of Manufacture or Import 
(NOC)

     Under this amendment, all PMN submitters are required to use a 
standard one-page form to submit a NOC. In addition, the NOC 
information requirements at Sec. 720.102(c) have been slightly 
expanded; however, all information can be provided on the one-page 
standard form (EPA Form 7710-56).
    Every NOC received at EPA on or after the effective date of these 
final rule amendments must contain the required information on the new 
standard NOC reporting form. This form will automatically be provided 
to each PMN submitter as an attachment to EPA's letter acknowledging 
PMN receipt letter sent to submitters shortly after each PMN is 
received. Persons who have not submitted NOCs for PMNs that have been 
previously submitted to EPA can obtain copies of the NOC form from the 
TSCA Assistance Information Office. Many submitters are already 
reporting voluntarily using a similar form.
    Previous NOC information reporting requirements, which are 
unaffected by these amendments, include specific chemical identity of 
the PMN substance, PMN number, the date manufacture or import 
commenced, and substantiation of CBI claims for chemical identity, 
which is required at the time a NOC is submitted. The amendment at 
Sec. 720.102(c)(ix) requests a clear indication of whether the 
submitter identity and/or other information on the form are also 
claimed as confidential. Confidentiality claims can only be asserted by 
the submitter if corresponding claims were made in the PMN.
    EPA is amending NOC reporting to require that complete submitter 
identity information be provided on the form. This would include the 
name and address of the submitter, the name and dated signature of the 
authorized official, and the name and telephone number of a technical 
contact in the United States.
    The amended NOC provisions also require a generic chemical name for 
a substance whose chemical identity is claimed as CBI. This name could 
either be (1) the same generic name provided in the PMN, (2) a generic 
name as revised by the submitter, as long as it masks no more of the 
chemical identity than the original generic name provided, or (3) an 
improved or corrected generic name agreed to via negotiation with EPA.
    Because the initial intention to manufacture or import a substance 
sometimes changes between the time of PMN submission and the NOC, 
submitters are required to specify in the NOC whether commencement 
occurred via manufacture or import and the address of the site(s) at 
which manufacture commenced.
    All of the above amendments to information requirements for NOCs 
involve information that the submitter will already know by the time 
manufacture or importation of the substance has commenced. 
Consequently, providing this information in the NOC will not constitute 
a significant reporting burden. EPA will not process a NOC that does 
not contain the chemical [[Page 16307]] identity, the date of 
commencement, and the PMN number.
    Comment. EPA needs to define in the regulations or form the ``date 
of commencement.'' Is this the first date that a chemical reaction 
occurs in the manufacturing operation; the date that the last amount of 
final product is produced in a batch operation; the first date that the 
PMN chemical is drummed off; or another date?
    Response. The Agency considers the date of commencement to mean the 
date of completion of manufacture for non-exempt commercial purposes of 
the first amount (e.g., batch, drum, etc.) of the chemical substance 
identified in the PMN. The Agency chose not to use the date on which 
the manufacturing process is started because that particular process 
may in some instances not result in the successful manufacture of the 
PMN substance. For importers, the date of commencement is the date the 
new chemical substance clears United States Customs. The final rule 
contains this definition.
    Comment. The information required for an NOC duplicates that 
already submitted in the PMN: site of manufacture, name and telephone 
number of technical contact. This information should not be required, 
since a manufacturer is free to change any of these items after the PMN 
review period has expired. The Inventory Update Rule is the appropriate 
vehicle for the Agency to gather this information.
    Response. An NOC may be filed years after the PMN was submitted. In 
the interim, the information provided in the original PMN may have 
changed due to change of location, change in ownership, etc. Up-to-date 
telephone numbers are important when problems need to be resolved. The 
Agency believes that the site of first manufacture or import is an 
important compliance monitoring tool. Although the Agency recognizes 
that a company may switch from import to domestic manufacture (or vice 
versa) after the PMN review period has expired, the Agency may find 
cause to investigate such changes that occur shortly after the 
expiration of the PMN review period.
    Comment. The NOC form should be made available for public comment 
prior to finalization.
    Response Although the form was not published in the Federal 
Register as part of the proposed rulemaking, it was available in the 
public docket and at the public hearings for this rulemaking held on 
April 26-27, 1993. Draft copies of the form have been available through 
the TSCA Assistance Information Office. The form has also been 
routinely distributed to all PMN submitters for use on a voluntary 
basis during the past year.
    Comment. EPA should clarify its statement that an NOC will be 
declared incomplete if any required information is missing. It is 
possible that EPA could declare an NOC incomplete past the 30-day 
period, potentially resulting in a compliance problem. EPA should 
provide that the original NOC filing date will be considered the 
effective date for determining compliance with the requirement that the 
NOC be filed within 30 days after the first day of commercial 
manufacture or importation. For example, if EPA determines that 
responses to CBI claims are inadequate, the NOC should not be declared 
untimely because it is considered incomplete.
    Response. EPA will continue its practice of adding a PMN substance 
to the Inventory as of the date the Agency receives the NOC from the 
PMN submitter with the correct chemical identity, date of commencement 
and PMN number. Further, EPA does not believe it is a significant 
burden for companies to submit a completed standard one-page NOC form 
that requests information that should be known to the submitter when 
manufacture or importation commences.
    Comment. The NOC form should be computer compatible or the 
submitter should be allowed to use a computer facsimile as long as it 
has the same format as the NOC form. Companies should not be required 
to receive advance approval of computer facsimiles.
    Response. The Agency will allow submitters to use a computer 
generated form, as long as the form is readable by Agency staff.
    Comment. EPA should allow an ``authorized official or designated 
representative'' to sign the NOC form. The term ``authorized official'' 
might be construed to mean a corporate vice president. This type of 
form should not require a corporate vice president's signature.
    Response. The ``authorized official'' has always been designated by 
the submitting company and should be a person that the submitting 
company deems responsible for the truth and accuracy of each statement 
in the certification.
    Comment. The NOC form and/or accompanying instructions should 
indicate clearly that a sanitized version must be submitted if any 
information is claimed confidential and that all submitter 
identification information will be treated as CBI. Furthermore, the 
submitter must be permitted to claim the signature of the authorized 
official as CBI.
    Response. EPA does not require submission of a sanitized copy of 
the NOC form because NOC submissions are not placed in the public 
files. Information on the NOC form that was claimed confidential in the 
original PMN submission may also be claimed confidential on the NOC 
form, although new confidentiality claims cannot be made in an NOC for 
information not claimed as confidential in the original PMN submission.

G. Comments on Other Issues

    The Agency also discussed certain issues relating to CBI claims in 
the proposed rule (58 FR 7665) but did not propose any additional PMN 
rule amendments at that time. The Public Docket for this rulemaking 
contains a complete set of comments on this issue, as well as comments 
received in response to a discussion on use of geographic locators by 
section 5 reporting facilities. Several industry commenters expressed 
concern about the discussion in the proposal regarding enhanced review 
of all confidential claims. Specifically, some commenters were 
concerned that the discussion signalled a change of rules on making CBI 
claims in the PMN process. As stated in the proposal, the purpose 
behind the discussion of CBI claims filed in PMNs was to remind the 
regulated community of its obligations concerning CBI claims. As noted 
at that time, there are no changes to the CBI procedures included in 
the PMN rule amendments.
    Industry submitters have an obligation to insure that only that 
information which needs to be kept confidential is claimed as CBI. 
Further, CBI claims are routinely reviewed and submitters who make 
broad, indiscriminate CBI claims will be contacted and requested to 
substantiate their claims pursuant to 40 CFR part 2.

III. Economic Analysis

    EPA has evaluated the potential costs of the amendments for 
potential submitters of section 5 notices. The Agency's complete 
economic analysis is available in the public record for this rule 
(OPPTS-50593B).
    The regulatory impact analysis estimates the costs and benefits 
attributable to the regulation. In this case, the analysis also 
contains estimates for the three additional amendments to section 5 
regulations that are published elsewhere in this Federal Register. 
These new provisions amend the PMN Exemptions for Polymers, Chemical 
Substances [[Page 16308]] Manufactured in Quantities of 1,000 Kilograms 
or Less per Year (40 CFR part 723), and the Expedited Process for 
Issuing Significant New Use Rules (40 CFR part 721). Because these 
regulations are amendments to current regulations, their costs and 
benefits are incremental as compared to the current regulations.
    The costs and benefits associated with these amendments are 
partially quantified; many of the benefits are unquantified but are of 
significant importance. Considering only the quantified costs and 
benefits, there is a slight cost increase for industry and a slight 
cost savings for EPA. Assuming either 1,000, 2,000, or 3,000 annual 
section 5 submissions, the savings as compared to the current 
regulation are estimated to be:

------------------------------------------------------------------------
                                 Annual Cost Savings ($ Million)        
    Annual Number of    ------------------------------------------------
      Submissions                Industry               Government      
------------------------------------------------------------------------
1,000..................            -0.1                     0.1         
2,000..................            -0.3                     0.2         
3,000..................            -0.4                  0.2 - 0.3      
------------------------------------------------------------------------

    The aspects of the amendments that have the greatest quantified 
cost impact on industry are the change in requirements for a bona fide 
TSCA Inventory search request and the requirement to provide correct 
chemical identification. Both requirements are expected to enable the 
Agency to utilize resources more effectively, thereby providing better 
service to industry. One of the major unquantified benefits of this 
amendment is increased flexibility under the ``two percent rule,'' 
allowing industry to make minor compositional changes, providing more 
manufacturing latitude to the submitter and possibly reducing the 
number of section 5 submissions. Another unquantified change is the 
requirement to use a standardized form for NOCs, the impact of which is 
expected to be minimal as many submitters are already using a similar 
form.

IV. Rulemaking Record

    EPA has established a record for this rulemaking (docket control 
number OPPTS-50593B). The record includes basic information including 
public comments considered by the Agency in developing this rule 
amendment. A public version of the record without any confidential 
information is available in the TSCA Public Docket Office from 12 noon 
to 4 p.m., Monday through Friday, except legal holidays. The TSCA 
Public Docket Office is located in Rm. NE-G307 (Northeast Mall), 401 M 
St., SW., Washington, DC.

V. Other Regulatory Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51835, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the Order defines a ``significant regulatory action'' as an action that 
is likely to (1) have an annual effect on the economy of $100 million 
or more, or adversely and materially affect a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local or tribal governments or communities (also 
referred to as ``economically significant'') (2) create serious 
inconsistency or otherwise interfere with an action taken or planned by 
another agency; (3) materially alter the budgetary impacts of 
entitlement, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raise novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in this Executive Order.
    Pursuant to Executive Order 12866, it has been determined that this 
rule is not a ``significant regulatory action'' under section 3 (f) of 
the Order. This action is therefore not subject to OMB review.

B. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), 
the Agency has determined that this regulatory action will not impose 
any adverse economic impacts on small entities. EPA believes that, even 
if all of the section 5 notice submitters were small firms, the number 
of small businesses affected by this action will not be substantial.

C. Paperwork Reduction Act

    The information collection requirements in this rule have been 
approved by the OMB under the provisions of the Paperwork Reduction 
Act, 44 U.S.C. 3502 et seq and have been assigned OMB control number 
2070-0012. The public reporting burden for this collection of 
information is estimated to vary from 18 to 21 hours per response, with 
an average of 20 hours per response, including time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.

List of Subjects

40 CFR Part 704

    Chemicals, Confidential business information, Environmental 
protection, Hazardous substances, Imports, Reporting and recordkeeping 
requirements.

40 CFR Part 720

    Chemicals, Environmental protection, Premanufacture notification, 
Hazardous materials, Reporting and recordkeeping requirements.

40 CFR Part 721

    Administrative practice and procedure, Chemicals, Environmental 
protection, Hazardous substances, Imports, Labeling, Occupational 
Safety and Health, Reporting and Recordkeeping requirements.

    Dated: March 21, 1995.

Carol M. Browner,
Administrator.
    Therefore, 40 CFR chapter I, subchapter R, parts 704, 720 and 721 
are amended as follows:
    1. In part 704:

PART 704--[AMENDED]

    a. The authority citation for part 704 continues to read as 
follows:

    Authority: 15 U.S.C. 2607(a).

    b. Section 704.25 is amended by revising paragraph (d) to read as 
follows:


Sec. 704.25  11-Aminoundecanoic acid.

*    *    *    *    *
    (d) What information to report. Persons identified in paragraph (b) 
of this section must submit a Premanufacture Notice Form (EPA Form 
7710-25).
*    *    *    *    *
    c. Section 704.104 is amended by revising paragraph (d) to read as 
follows:


Sec. 704.104  Hexafluoropropylene oxide.

*    *    *    *    *
    (d) What information to report. Persons identified in paragraph (b) 
of this section must submit a Premanufacture Notice Form (EPA Form 
7710-25).
*    *    *    *    *
    2. In part 720:

PART 720 -- [AMENDED]

    a. The authority citation for part 720 continues to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2613.

    b. Section 720.25 is amended by revising paragraphs (a), (b)(1), 
(2)(i), [[Page 16309]] (2)(iii), (2)(iv), (2)(v), (3), and by adding 
paragraphs (b)(2)(vi), (2)(vii), (2)(viii), and (b)(9) to read as 
follows:


Sec. 720.25   Determining whether a chemical substance is on the 
Inventory.

    (a) A new chemical substance is any chemical substance that is not 
currently listed on the Inventory.
    (b)(1) A chemical substance is listed in the public portion of the 
Inventory by a specific chemical name (either a Chemical Abstracts (CA) 
Index Name or a CA Preferred Name) and a Chemical Abstracts Service 
(CAS) Registry Number if its identity is not confidential. If its 
identity is confidential, it is listed in the public portion of the 
Inventory by a TSCA Accession Number and a generic chemical name that 
masks the specific substance identity. The confidential substance is 
listed by its specific chemical name only in the confidential portion 
of the Inventory, which is not available to the public. A person who 
intends to manufacture or import a chemical substance not listed by 
specific chemical name in the public portion of the Inventory may ask 
EPA whether the substance is included in the confidential Inventory. 
EPA will answer such an inquiry only if EPA determines that the person 
has a bona fide intent to manufacture or import the chemical substance 
for commercial purposes.
    (2) *    *    *
    (i) Except as provided in paragraphs (b)((3)(i) and (ii) of this 
section, the specific chemical identity of the substance that the 
person intends to manufacture or import, using the currently, correct 
CA name for the substance and the other correct chemical identity 
information in accordance with Secs. 720.45(a)(1), (2)), and (3).
*    *    *    *    *
    (iii)(A) A brief description of the research and development 
activities conducted to date related to the substance, including the 
year in which the person first started to conduct research or 
development activity on the substance, and the general types of 
research and development activities conducted thus far (e.g., 
synthesis, substance isolation/purification, formulating, product 
development, process development, end-use application, toxicity 
testing, etc.). The person must also indicate whether any pilot plant 
or production-scale plant evaluations have been conducted involving the 
manufacture or processing of the substance.
    (B) If an importer is unable to provide the information requested 
in paragraph (b)(2)(iii)(A) of this section from the foreign 
manufacturer or supplier, the following information shall be submitted:
    (1) A brief statement indicating how long the substance has been in 
commercial use outside of the United States.
    (2) The name of a country in which it has been commercially used.
    (3) Whether the importer believes that the substance has already 
been used commercially, in any country, for the same purpose or 
application that the importer is intending.
    (iv) A specific description of the major intended application or 
use of the substance.
    (v) An infrared spectrum of the substance, or alternative spectra 
or other data which identify the substance if infrared analysis is not 
suitable for the substance or does not yield a reasonable amount of 
structural information. When using alternative spectra or instrumental 
analysis, the person must submit a spectrum or instrumental readout for 
the substance.
    (vi) The estimated date (month/year) in which the person intends to 
submit a Premanufacture Notice (PMN) for this substance if EPA informs 
the notice submitter that the substance is not on the Inventory.
    (vii) The address of the facility under the control of the 
submitter at which the manufacture or processing of the substance would 
most likely occur. For an imported substance, the facility under the 
control of the importer at which processing of the substance would 
likely occur, if any.
    (viii)(A) For substances intended to be manufactured in the United 
States, a description of the most probable manufacturing process that 
would be used by the submitter to produce the substance for non-exempt 
commercial purposes.
    (B) For substances intended to be imported, a brief description of 
how the submitter is most likely to process or use the substance for a 
commercial purpose. If the substance is not expected to be processed or 
used at any facility under the importer's control, a statement to this 
effect must be included along with a description of how the substance 
will be processed or used at sites controlled by others, if this 
information is known or reasonably ascertainable.
    (3)(i) If an importer cannot provide the chemical identity 
information required by paragraph (b)(2)(i) and (v) of this section 
because it is claimed confidential by its foreign manufacturer or 
supplier, the foreign manufacturer or supplier must supply the required 
information directly to EPA in accordance with Sec. 720.45(a)(1), (2), 
and (3) and reference the importer's notice. If the appropriate 
supporting document from the foreign party is not received within 30 
days after EPA receives the importer's notice, the notice will be 
considered incomplete.
    (ii) If a manufacturer cannot provide all of the required 
information in accordance with Sec. 720.45(a)(1), (2), and (3) because 
the new chemical substance is manufactured using a reactant that has a 
specific chemical identity claimed as confidential by its supplier, the 
notice must contain chemical identity information that is as complete 
as known by the manufacturer. In addition, a letter of support for the 
notice must then be sent to EPA by the chemical supplier of the 
confidential reactant, providing the specific chemical identity of the 
proprietary reactant. The letter of support must reference the 
manufacturer's notice. If the appropriate supporting document from the 
supplier is not received within 30 days after EPA receives the 
manufacturer's notice, the notice will be considered incomplete.
*    *    *    *    *
    (9) If the required chemical identity information has not been 
reported correctly or completely in the notice (except as provided 
under paragraph (b)(3)(ii) of this section) or if any other required 
data or information has been omitted or is incomplete, EPA will 
consider the whole notice to be incomplete. As soon as an incomplete 
notice is identified as such by EPA, the Agency will immediately return 
the notice directly to the submitter. The submitter must then resubmit 
the whole, completed bona fide notice to EPA in order to have the 
Agency perform the desired Inventory search and respond to the notice.
    c. Section 720.40 is amended by revising paragraphs (a) and (d) to 
read as follows:


Sec. 720.40   General.

    (a) Use of the notice form; electronic submissions. (1) Each person 
who is required by subpart B of this part to submit a notice must 
complete, sign, and submit a notice containing the information in the 
form and manner specified in this paragraph. The information submitted 
and all attachments (unless the attachment appears in the open 
scientific literature) must be in English. All information submitted 
must be true and correct.
    (2) Information may be submitted on paper, or electronically, as 
follows:
    (i) Information submitted on paper must be submitted in the form 
and manner set forth in EPA Form No. 7710-25, which is available from 
the [[Page 16310]] Environmental Assistance Division (7408), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Information which is not submitted on 
the EPA Form No. 7710-25 or a photocopy thereof (e.g., on a form 
created by commercial form-making software) must be in a format pre-
approved by the Agency.
     (ii) Information may be submitted electronically (on magnetic or 
other media) pursuant to an EPA published format for electronic 
submissions. Such submissions must comply with this format and all 
other media specifications published by EPA. Persons submitting 
electronically must still complete and submit on paper the 
Certification and Submitter Identification sections of Form 7710-25.
*    *    *    *    *
    (d) General notice requirements.  (1) Each person who submits a 
notice must provide the information described in Sec. 720.45 and 
specified on the notice form, to the extent such information is known 
to or reasonably ascertainable by the person. In accordance with 
Sec. 720.50, the notice must also include any test data in the person's 
possession or control, and descriptions of other data which are known 
to or reasonably ascertainable by the person and which concern the 
health and environmental effects of the new chemical substance.
    (2) A person who submits a notice to EPA under this part must 
provide EPA with an original and two complete copies of the notice, 
including all test data and any other information attached to the 
notice form. If information is claimed as confidential pursuant to 
Sec. 720.80, a sanitized copy must also be provided.
*    *    *    *    *
    d. Section 720.45 is amended by revising paragraph (a) to read as 
follows:


Sec. 720.45  Information that must be included in the notice form.

  
*    *    *    *    *
    (a)(1) The specific chemical identity of the substance that the 
person intends to manufacture or import, which includes the following:
    (i) The currently correct Chemical Abstracts (CA) name for the 
substance, based on the Ninth Collective Index (9CI) of CA nomenclature 
rules and conventions, and consistent with listings for similar 
substances in the Inventory. For each substance having a chemical 
composition that can be represented by a specific, complete chemical 
structure diagram (a Class 1 substance), a CA Index Name must be 
provided. For each chemical substance that cannot be fully represented 
by a complete, specific chemical structure diagram (a Class 2 
substance), or if the substance is a polymer, a CA Index Name or CA 
Preferred Name must be provided (whichever is appropriate based on CA 
9CI nomenclature rules and conventions). In addition, for a Class 2 
substance, the notice must identify the immediate chemical precursors 
and reactants by specific chemical name and Chemical Abstracts Service 
Registry Number (CASRN), if the number is available. Tradenames or 
generic names of chemical precursors or reactants are not acceptable as 
substitutes for specific chemical names.
    (ii) The currently correct CASRN for the substance if a CASRN 
already exists for the substance.
    (iii) For a Class 1 substance and for any Class 2 substance for 
which a definite molecular formula is known or reasonably 
ascertainable, the correct molecular formula.
    (iv) For a Class 1 substance, a complete, correct chemical 
structure diagram; for a Class 2 substance or polymer, a correct 
representative or partial chemical structure diagram, as complete as 
can be known, if one can be reasonably ascertained.
    (2) For a polymer, the submitter must also report the following:
    (i) The specific chemical name and CASRN, if the number is 
available, of each monomer and other reactant used, at any weight 
percent, to manufacture the polymer. Tradenames or generic names of 
chemical reactants or monomers are not acceptable as substitutes for 
specific chemical names.
    (ii) The typical percent by weight of each monomer and other 
reactant in the polymer (weight of the monomer or other reactant 
expressed as a percentage of the weight of the polymeric chemical 
substance manufactured), and the maximum residual amount of each 
monomer present in the polymer.
    (iii) For monomers and other reactants used at 2 weight percent or 
less (based on the dry weight of the polymer manufactured), indicate on 
the PMN form any such monomers and other reactants that should be 
included as part of the polymer description on the Inventory, where the 
weight percent is based on either (A) the weight of monomer or other 
reactant actually charged to the reaction vessel, or (B) the minimum 
weight of monomer or other reactant required in theory to account for 
the actual weight of monomer or other reactant molecules or fragments 
chemically incorporated (chemically combined) in the polymeric 
substance manufactured.
    (iv) For a determination that 2 weight percent or less of a monomer 
or other reactant is incorporated (chemically combined) in a polymeric 
substance manufactured, as specified in paragraphs (a)(2)(iii)(B) of 
this section, analytical data or appropriate theoretical calculations 
(if it can be documented that analytical measurement is not feasible or 
not necessary) to support this determination must be maintained at the 
site of manufacture or import of the polymer.
    (v) Measured or estimated values of the minimum number-average 
molecular weight of the polymer and the amount of low molecular weight 
species below 500 and below 1,000 molecular weight, with a description 
of how the measured or estimated values were obtained.
    (3) The person must use one of the following two methods to develop 
or obtain the specified chemical identity information reported under 
paragraphs (a)(1) and (2) of this section and must identify the method 
used in the notice:
    (i) Method 1. Obtain the correct chemical identity information 
required by paragraphs (a)(1) and (2) of this section directly from the 
Chemical Abstracts Service (CAS), specifically from the CAS Registry 
Services Inventory Expert Service, prior to submitting a notice to EPA. 
A copy of the chemical identification report obtained from CAS must be 
submitted with the notice.
    (ii) Method 2. Obtain the correct chemical identity information 
required by paragraphs (a)(1) and (2) from any source. The notice will 
be incomplete according to Sec. 720.65(c)(1)(vi) if the person uses 
Method 2 and any chemical identity information is determined to be 
incorrect by EPA.
    (4) If an importer submitting the notice cannot provide all the 
information specified in paragraphs (a)(1) and (2) of this section 
because it is claimed as confidential by the foreign supplier of the 
substance, the importer must have the foreign supplier follow the 
procedures in paragraph (a)(3) of this section and provide the correct 
chemical identity information specified in paragraphs (a)(1) and (2) of 
this section directly to EPA in a joint submission or as a letter of 
support to the notice, which clearly references the importer's notice 
and PMN User Fee Identification Number. The statutory review process 
will commence upon receipt of both the notice and the complete, correct 
information.
    (5) If a manufacturer cannot provide all the information specified 
in paragraphs (a)(1) and (2) of this section because the new chemical 
substance is [[Page 16311]] manufactured using a reactant having a 
specific chemical identity claimed as confidential by its supplier, the 
manufacturer must submit a notice directly to EPA containing all the 
information known by the manufacturer about the chemical identity of 
the reported substance and its proprietary reactant. In addition, the 
manufacturer must ensure that the supplier of the confidential reactant 
submit a letter of support directly to EPA providing the specific 
chemical identity of the confidential reactant, including the CAS 
number, if available, and the appropriate PMN or exemption number, if 
applicable. The letter of support must reference the manufacturer's 
name and PMN User Fee Identification Number under Sec. 700.45(c)(3) of 
this chapter. The statutory review period will commence upon receipt of 
both the notice and the letter of support.
*    *    *    *    *
    e. Section 720.80 is amended by revising paragraph (b)(2) to read 
as follows:


Sec. 720.80   General provisions.

  
*    *    *    *    *
    (b) *    *    *
    (2) If any information is claimed as confidential, the person must 
submit, in addition to the copies specified by Sec. 720.40, a sanitized 
copy of the notice form (or electronic submission) and any attachments.
    (i) The original and two copies of the notice, specified at 
Sec. 720.40 (or electronic submission) and attachments must be 
complete. The submitter must designate that information which is 
claimed as confidential in the manner prescribed on the notice form (or 
in EPA's electronic submission instructions).
     (ii) The sanitized copy must be complete except that all 
information claimed as confidential in the original must be deleted. 
EPA will place this sanitized copy in the public file.
    (iii) If the person does not provide the sanitized copy, or 
information in a health and safety study (except information claimed as 
confidential in accordance with Sec. 720.90), the submission will be 
deemed incomplete and the notice review period will not begin until EPA 
receives the sanitized copy or the health and safety study information 
is included, in accordance with Sec. 720.65(c)(1)(vii).
*    *    *    *    *
    f. Section 720.95 is amended by revising the third sentence to read 
as follows:


Sec. 720.95   Public file.

    *  *  * Any of the nonconfidential material described in this 
subpart will be available for public inspection in the TSCA 
Nonconfidential Information Center, Room B607, Northeast Mall, 401 M 
St., SW., Washington, DC between the hours of 1 p.m. and 4 p.m., 
weekdays, excluding legal holidays.
    g. Section 720.102 is amended by revising paragraphs (c) and (d) to 
read as follows:


Sec. 720.102   Notice of commencement of manufacture or import.

*    *    *    *    *
    (c) Information to be reported on form. (1) The notice must be 
submitted on EPA (Form 7710-56), which is available from the 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. The form must be signed and dated by an 
authorized official. All information specified on the form must be 
provided. The notice must contain the following information:
    (i) The specific chemical identity of the PMN substance.
    (ii) A generic chemical name (if the chemical identity is claimed 
as confidential by the submitter).
    (iii) The premanufacture notice (PMN) number assigned by EPA.
    (iv) The date of commencement for the submitter's manufacture or 
import for a non-exempt commercial purpose (indicating whether the 
substance was initially manufactured in the United States or imported). 
The date of commencement is the date of completion of non-exempt 
manufacture of the first amount (batch, drum, etc.) of new chemical 
substance identified in the submitter's PMN. For importers, the date of 
commencement is the date the new chemical substance clears United 
States customs.
    (v) The name and address of the submitter.
    (vi) The name of the authorized official.
    (vii) The name and telephone number of a technical contact in the 
United States.
    (viii) The address of the site where commencement of manufacture 
occurred.
    (ix) Clear indications of whether the chemical identity, submitter 
identity, and/or other information are claimed as confidential by the 
submitter.
    (2) If the submitter claims the chemical identity confidential, and 
wants the identity to be listed on the confidential portion of the 
Inventory, the claim must be reasserted and substantiated in accordance 
with Sec. 720.85(b). Otherwise, EPA will list the specific chemical 
identity on the public Inventory. Submitters who did not claim the 
chemical identity, submitter identity, or other information to be 
confidential in the PMN cannot claim this information as confidential 
in the notice of commencement.
    (d) Where to submit. Notices of commencement of manufacture or 
import should be submitted to:
    TSCA Document Control Office (7407), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460.
*    *    *    *    *

Appendix A [Removed]

    h. Appendix A to part 720 is removed.
    3. In part 721:

PART 721--[AMENDED]

    a. The authority citation for part 721 continues to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2652(c).

    b. Section 721.25 is amended by revising the last sentence of 
paragraph (a) to read as follows:


Sec. 721.25  Notice requirements and procedures.

    (a)*  *  * The notice must be submitted on EPA Form 7710-25, and 
must comply with the requirements of part 720 of this chapter, except 
to the extent that they are inconsistent with this part 721.
*    *    *    *    *

[FR Doc. 95-7709 Filed 3-24-95; 3:32 pm]
BILLING CODE 6560-50-F