[Federal Register Volume 66, Number 124 (Wednesday, June 27, 2001)]
[Notices]
[Pages 34193-34198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16124]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-50040A; FRL-6784-6]


Correction to Chemical Nomenclature for Monomer Acid and 
Derivatives for TSCA Inventory Purpose

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: An August 2, 1985 letter from EPA erroneously equated monomer 
acid and its derivatives with Tall Oil Fatty Acid (TOFA) and its 
corresponding derivatives for Toxic Substances Control Act (TSCA) 
Inventory purposes when, in fact, they are chemically distinct. As a 
result, many manufacturers of monomer acid derivatives have not 
submitted Premanufacture Notices (PMNs) under TSCA section 5, because 
the letter incorrectly indicated that monomer acid derivatives were 
covered by TOFA derivatives already on the Inventory. This notice 
implements a correction to the 1985 letter on nomenclature of monomer 
acid and derivatives. With this correction, monomer acid derivatives 
that are not on the Inventory will be considered new chemical 
substances under section 5 of TSCA. Manufacturers of monomer acid 
derivatives not on the Inventory have 1 year to complete the PMN 
process to comply with this nomenclature correction. Today's 
nomenclature correction finalizes the Federal Register notice of 
October 31, 2000.

DATES: This action will become effective June 27, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number

[[Page 34194]]

OPPTS-50040A in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: For general information 
contact:Barbara Cunningham, Acting Director, Environmental Assistance 
Division (7401), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone numbers: 202-554-1404; e-mail address: 
[email protected].
    For technical information contact:Kenneth Moss, New Chemicals 
Prenotice Branch (7405), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 260-3395; fax number: 
(202) 260-0118; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:   

I. General Information

A. Does this Document Apply to Me?

    You may be affected by this document if you are, or may in the 
future be, a manufacturer or importer of a monomer acid derivative that 
requires submission of a Premanufacture Notice (PMN) under the Toxic 
Substances Control Act (TSCA). Special rules apply to persons who 
manufactured, between August 2, 1985, and the effective date of this 
Federal Register notice, monomer acid derivatives that, in reliance on 
EPA's guidance of August 2, 1985, could have been viewed as covered by 
corresponding TOFA chemicals listed on the TSCA Inventory. Potentially 
affected entities may include, but are not limited to the following:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Chemical manufacturers or         325, 32411          Anyone who
 importers                                             manufactures or
                                                       imports, or who
                                                       plans to
                                                       manufacture or
                                                       import, a monomer
                                                       acid derivative
                                                       or other
                                                       ``downstream''
                                                       substance based
                                                       on monomer acid
                                                       for a non-exempt
                                                       commercial
                                                       purpose
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under 
theFederal Register--Environmental Documents. You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/. To 
access information about EPA's New Chemicals Program, go directly to 
the Home Page at http://www.epa.gov/oppt/newchems/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-50040A. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the TSCA Nonconfidential Information Center, North 
East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. 
The Center is open from noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Center is (202) 
260-7099.

II. Background

A. What Action is the Agency Taking?

    An August 2, 1985 letter from EPA erroneously equated monomer acid 
and its derivatives with Tall Oil Fatty Acid (TOFA) and its 
corresponding derivatives for TSCA inventory purposes when, in fact, 
they are chemically distinct. As a result, many manufacturers of 
monomer acid derivatives have not submitted PMNs under TSCA section 5, 
because the letter incorrectly indicated that monomer acid derivatives 
were covered by TOFA derivatives already on the Inventory. This notice 
implements a correction to the 1985 letter on nomenclature of monomer 
acid and derivatives. With this correction, monomer acid derivatives 
that are not on the Inventory will be considered new chemical 
substances under section 5 of TSCA. Today's nomenclature correction 
finalizes theFederal Register notice of October 31, 2000 (65 FR 64944) 
(FRL-6746-7).

B. What is the Agency's Authority for Taking this Action?

    Section 5 of TSCA requires any person who intends to manufacture 
(defined by statute to include import) a new chemical (i.e., a chemical 
not on the TSCA Inventory) to notify EPA and comply with the statutory 
provisions pertaining to the manufacture of new chemicals. Section 8(b) 
of TSCA requires EPA to compile, keep current, and publish a list of 
each chemical substance which is manufactured or processed in the 
United States (the TSCA Inventory). This requirement includes defining 
the scope of the chemical listings on the Inventory.

C. Why is this Nonmenclature Correction Necessary?

    1. The 1985 letter. The August 2, 1985 EPA letter to an industry 
representative on the nomenclature for monomer acids states:
    The co-product produced during the catalytic dimerization of 
tall oil fatty acids and generally known as `monomer acid' or 
`monomer fatty acid' is considered to be the same as tall oil fatty 
acids for TSCA Inventory purposes.
    [and]
    Because the names oleic acid, octadecenoic acid, and tall oil 
fatty acid may have been used to represent the same substance on the 
Inventory, they are synonymous terms within the context of the 
Inventory. If one wishes to determine if a substance derived from 
monomer acid is on the Inventory, and he finds a similar derivative 
under any of these names, his product is on the Inventory.
(See docket OPPTS-50040 for full text.)
    2. Discussion. Tall oil is a source for natural fatty acids, 
commonly referred

[[Page 34195]]

to as Tall Oil Fatty Acids (``TOFA''). TOFA may be reacted with other 
substances to create TOFA derivatives. TOFA that is heated in the 
presence of an acid clay catalyst forms a ``dimer acid'' together with 
small amounts of ``trimer acid'' and higher oligomers. The ``dimer 
acid'' process also produces ``monomer acid'' as a co-product. The 
monomer acid is often used as an inexpensive fatty acid source to make 
monomer acid derivatives or other downstream products for use in 
lubricants, greases, hot melt adhesives, printing ink resins, ore 
flotation agents, corrosion inhibitors, etc.
    It is clear that the TOFA dimerization process yields distinct 
chemical substances that may be separated by distillation: dimer acid, 
trimer acid, and monomer acid. Whereas the natural source-derived TOFA 
largely consists of linear C18-unsaturated carboxylic acids, 
principally oleic and linoleic acids, monomer acid contains relatively 
small amounts of oleic and linoleic acids, and instead contains 
significant amounts of branched, and some cyclic, C18 acids, both 
saturated and unsaturated, as well as elaidic acid. The more diverse 
and significantly branched composition of monomer acid results from the 
thermal catalytic processing carried out on TOFA or analogous 
feedstocks.
    Further, the reaction of monomer acid with other chemical 
substances also yields unique, identifiable derivative substances which 
are chemically different from corresponding TOFA derivatives. 
Therefore, it is incorrect to equate monomer acid to TOFA, or a monomer 
acid derivative to a TOFA derivative.
    Oleic acid and octadecenoic acid are also unique, identifiable 
substances that are distinguished from monomer acid because of their 
essentially linear, unsaturated acid composition. Thus, the derivatives 
of oleic and octadecenoic acid are also unique, identifiable, and 
different from monomer acid derivatives.
    Through dialogue over the last 6 years, EPA and industry have 
worked toward a mutual understanding of the correct nomenclature for 
these chemical substances that previously were believed to be on the 
Inventory, and have mutually developed procedures to implement the 
nomenclature change. In 1994, the Pine Chemicals Association (PCA), 
then known as the Pulp Chemicals Association asked EPA to clarify the 
Agency's chemical nomenclature policy for dimer acids. At that time, 
several alternative listings for dimer acid were present in the 
Inventory. PCA and EPA agreed that one description, ``Fatty acids, C18-
unsatd., dimers (CAS Registry Number 61788-89-4),'' would describe 
dimer acids irrespective of the fatty acid source (except for the crude 
form of dimer acid that is not made from oleic acid or linoleic acid, 
and is used directly as a crude chemical intermediate, which is instead 
named ``Fatty acids, C16-18 and C18-unsatd., dimerized (CAS Registry 
Number 71808-39-4)''). Subsequently, over 100 Inventory corrections 
were filed and the dimer acid issue successfully resolved. During this 
program it was also realized that a similar issue existed for a co-
product, monomer acid, as there were at least two ways in which it was 
identified in the Inventory. As a consequence, different types of 
chemical names exist on the Inventory for derivatives and other 
downstream products based on monomer acids. EPA and PCA agreed that it 
would be necessary to correct the existing Inventory listings under a 
uniform nomenclature.
    EPA also acknowledged that the August 2, 1985, Agency letter had 
erroneously equated monomer acid derivatives with TOFA derivatives and 
derivatives of oleic acid or octadecenoic acid, when in fact they are 
chemically distinct. Because the guidance found in the 1985 letter led 
the manufacturers to believe that the products they manufactured were 
already on the Inventory under a name based on TOFA, oleic acid, or 
octadecenoic acid, since 1985 a number of manufacturers of monomer acid 
products have not submitted PMNs required under section 5 of TSCA.

III. TSCA New Chemicals Program Policy for Monomer Acid Chemical 
Nomenclature

    Today's nomenclature correction finalizes the Federal Register 
notice of October 31, 2000 (65 FR 64944), and constitutes official 
notice that EPA's August 2, 1985, letter was erroneous and that monomer 
acids are not equivalent to TOFA, oleic acid, or octadecenoic acid for 
Inventory purposes. Under this notice, PMNs are required for monomer 
acid derivatives that are not explicitly on the TSCA Inventory and 
which are manufactured on or after the effective date of this notice.

A. Discussion of the Public Comments on the Proposed Notice

    The Agency reviewed and considered the two comments that were 
received on the October 31, 2000 Federal Register notice. A complete 
copy of the comments is available in the public docket for this action.
    Comment. Both commenters agreed that monomer acid and its 
derivatives are not synonymous with tall oil fatty acid and its 
derivatives; however, they objected to the burdensome mechanism of PMN 
preparation and submission to correct the chemical nomenclature. One 
commenter suggested alternative methods, such as opening a TSCA 8(b) 
Inventory reporting period that would mirror the original compilation 
of the Inventory, or EPA working with the Chemical Abstract Services 
(CAS) to simply add the new CAS Registry Numbers to the Inventory as an 
Inventory correction. The commenter asserted that the latter 
alternative approach would be similar to what EPA proposed in its 
discussion with the Soap and Detergent Association (SDA) and fatty acid 
producers.
    Response. As mentioned in the October 31, 2000 Federal Register 
notice, because these monomer acid derivatives were not manufactured 
during the Initial Inventory reporting period and were never reported 
for the Initial TSCA Inventory, under the Inventory correction 
guidelines (July 29, 1980; 45 FR 50544) they are not eligible for 
Inventory correction as an alternative to PMN submission. Furthermore, 
the circumstances of this monomer acid nomenclature are not similar to 
the project proposed by the SDA regarding certain multi-component fatty 
acids and their derivatives. Under the proposed SDA project, the 
objective is to simplify and consolidate multiple existing Inventory 
listings under one preferred name for those substances that are 
considered to be identical. All of the substances that would be 
considered under the proposed SDA project are currently listed on the 
Inventory. There are no chemicals to be added to the Inventory. EPA 
believes that the monomer acid situation is more like that for polymer 
salts under 40 CFR 710.4(d)(7) and 720.30(h)(7), in which certain 
chemicals that did not qualify for the reporting exclusions under 40 
CFR 710.4(d)(7) and 720.30(h)(7) were never reported for the Inventory 
or reviewed by EPA under the PMN program due to a confusion in the 
regulatory language. In both the current case and the one involving the 
polymer salts, those chemicals in question that were reportable were 
manufactured after the close of the Inventory reporting period and PMNs 
would have been submitted had there not been any erroneous guidance 
from EPA. Therefore, the net PMN reporting burden should be no greater 
than if EPA had issued accurate guidance on

[[Page 34196]]

 monomer acid and its derivatives in 1985.
    Those who already reported monomer acid derivatives initially 
manufactured since August 2, 1985, will not need to do anything, while 
those who have not yet reported such substances must do so by the 
effective date of this notice. In this way, PMNs will finally have been 
submitted for all of the monomer acid derivatives initially 
manufactured for a non-exempt commercial purpose subsequent to the 
Agency's erroneous 1985 guidance (see exception for those monomer acid 
derivatives not currently being manufactured, under Unit III.F.). 
However, due to the confusion caused by EPA's 1985 erroneous guidance, 
the Agency wishes to minimize any inconvenience to the chemical 
industry by taking two specific steps to facilitate the PMN submission 
and review process: suspending EPA's policy of a limit of six chemical 
substances per consolidation notice and waiving PMN fees (see Unit 
III.C.).

B. What is the Basis for and Scope of this Nomenclature Correction?

    EPA no longer considers as valid the nomenclature interpretation in 
the August 2, 1985 EPA letter which stated:
    The co-product produced during the catalytic dimerization of 
tall oil fatty acids and generally known as `monomer acid' or 
`monomer fatty acid' is considered to be the same as tall oil fatty 
acids for TSCA Inventory purposes.
    [and]
    Because the names oleic acid, octadecenoic acid, and tall oil 
fatty acid may have been used to represent the same substance on the 
Inventory, they are synonymous terms within the context of the 
Inventory. If one wishes to determine if a substance derived from 
monomer acid is on the Inventory, and he finds a similar derivative 
under any of these names, his product is on the Inventory.
    The nomenclature correction affects anyone who manufactures or 
imports, or who plans to manufacture or import, a monomer acid 
derivative or other ``downstream'' substance based on monomer acid for 
a non-exempt commercial purpose. Monomer acid is considered to be the 
combination of non-dimerized fatty acids formed and separated as a co-
product from the manufacture of dimer acid containing 36 carbon atoms 
that is listed in the TSCA Inventory as ``Fatty acids, C18-unsatd., 
dimers'' (CAS Registry Number 61788-89-4). The correct nomenclature now 
required for monomer acid is ``Fatty acids, C16-18 and C18-unsatd., 
branched and linear'' (CAS Registry Number 68955-98-6). For TSCA 
Inventory purposes, derivatives and other downstream products made from 
monomer acid must be named consistently with this nomenclature for 
monomer acid.

C. What are the Key Dates and Special Provisions of this Nomenclature 
Correction?

    The effective date for this new nomenclature interpretation, 
described in Unit III.A., will be June 27, 2002. Prior to this date, 
EPA will allow manufacturers to continue commercial production of 
existing monomer acid derivatives and downstream products under the old 
nomenclature. After the effective date, companies that manufacture 
monomer acid derivatives and downstream products under the old 
nomenclature will no longer be in compliance with TSCA section 5. 
Therefore, companies should submit PMNs at least 90 days before the 
effective date to ensure that Agency review is completed before this 
nomenclature correction takes effect. EPA encourages conversion to the 
new nomenclature immediately instead of delaying the correction to the 
effective date of this notice.
    EPA is taking two additional steps to facilitate the Premanufacture 
Notice process for chemical substances currently using the incorrect 
nomenclature. For the purposes of this nomenclature correction only, 
EPA is (1) Suspending its TSCA New Chemicals Program policy of a limit 
of six chemical substances per consolidated PMN and (2) Waiving PMN 
fees for any PMN submissions required as a result of the nomenclature 
correction. However, in order to facilitate the review of these special 
PMN submissions, submitters should use the Chemical Abstracts Service 
(CAS) Inventory Expert Service to develop correct Chemical Abstracts 
(CA) names for all of their reported substances in accordance with 
Method 1 as described at 40 CFR 720.45(a)(3)(i).

D. What Special Information Should be Included When Filling Out the PMN 
Form?

    On the first page of the PMN form, the PMN submitter or filing 
organization should insert the word ``WAIVER'' in the boxes reserved 
for the User Fee (``TS'') Numbers, because these PMNs are exempt from 
the user fee. On page 2 of the PMN form, submitters should check the 
box for the $2,500 user fee certification statement and also type the 
following statement: ``No fee required, per EPA's ``Correction to 
Chemical Nomenclature for Monomer Acid Derivatives for TSCA Inventory 
Purposes'' June 27, 2001. For item 3 on page 3 of the PMN form, 
submitters should list Prenotice Communication number ``PC 4078.'' ``PC 
4078'' has been established for all pre-notice communication regarding 
this nomenclature correction, except that, if an individual company or 
group of companies submits a consolidated PMN covering more than one 
chemical substance, they will need to request a separate PC number for 
the consolidated notice. The individual manufacturers and importers of 
monomer acid derivatives will be the submitter of record for each PMN 
chemical substance. Other information, such as toxicity data on the PMN 
chemical substance that are in the possession or control of the PMN 
submitter, or known to or reasonably ascertainable by the PMN 
submitter, must also be submitted or described by each individual 
manufacturer or importer, as specified in 40 CFR 720.50.

E. What are the Consequences of Not Submitting a PMN and Completing PMN 
Review on a Monomer Acid Derivative Before the Effective Date of this 
Nomenclature Correction Notice?

    On the effective date of this nomenclature correction notice, TOFA, 
oleic acid, or octadecenoic acid will no longer be considered 
equivalent to monomer acid. Starting on the effective date, anyone 
manufacturing a chemical substance based on monomer acid that is not 
specifically listed on the TSCA Inventory using the correct 
nomenclature for the monomer acid component of the chemical substance 
will be in violation of TSCA. A person may, of course, continue to 
manufacture TOFA derivatives and derivatives of oleic acid or 
octadecenoic acid that are listed on the Inventory without submitting a 
PMN.

F. Is a PMN Required for Everyone Who Did Not Submit One Since 1985 
Because of the Incorrect EPA Guidance, Regardless of Whether this 
Person Still Manufactures the Substance Today?

    A PMN must be submitted by those persons who intend to manufacture, 
on or after the effective date of this nomenclature correction notice, 
monomer acid derivatives and other downstream products based on monomer 
acid that are not on the TSCA Inventory. For example, if you initially 
manufactured such a monomer acid derivative in 1986 but are not 
currently manufacturing or intending to resume manufacture, you are not 
required to submit a PMN now.Note, however, that the substance will not 
appear on the TSCA Inventory by virtue of your previous manufacture of 
it. Moreover, if you plan to manufacture the monomer acid derivative on 
or after the effective

[[Page 34197]]

date of this nomenclature correction notice and the substance has not 
in the interim been placed on the Inventory due to another company's 
manufacture or import, you will need to submit a PMN at least 90 days 
before commencing manufacture.

G. Do the Special Procedures Announced in this Notice Apply to Monomer 
Acid Derivatives That Were Never Manufactured Between August 2, 1985, 
and the Date of this Notice, or for Which There Is No Corresponding 
TOFA Listing on the TSCA Inventory?

    No. The special procedures described above in Unit III.C. (i.e.; 
waiver of user fee, allowing consolidated PMNs of more than 6 
chemicals, and the PMN requirement becoming effective 1-year from 
publication of this notice) apply only to persons who manufactured, 
between August 2, 1985, and the date of this Federal Register notice, a 
monomer acid derivative that, in reliance on EPA's erroneous guidance, 
could be viewed as covered by a corresponding TOFA listing already on 
the TSCA Inventory. These procedures do not apply to monomer acid 
derivatives that either: (1) were never manufactured between August 2, 
1985, and the date of this Federal Register notice, or (2) for which 
there is/was no corresponding TOFA listing on the TSCA Inventory. 
Manufacture of monomer acid derivatives that were never manufactured 
between August 2, 1985, and the date of this Federal Register notice, 
or for which there is no corresponding TOFA listing on the TSCA 
Inventory, requires compliance with all the regular PMN rules of TSCA 
section 5 and 40 CFR part 720.

H. Are There any Special Considerations for Consolidated PMNs Submitted 
as Part of an Organized Filing by Multiple Companies?

    EPA expects that there will be both individual and consolidated 
PMNs submitted as a result of this nomenclature correction. It may be 
possible that only one consolidated PMN is necessary for each chemical 
class of product based on monomer acid. Notices can be submitted by 
individual companies or as part of an organized effort to submit 
consolidated PMNs. Where there is an organized filing of consolidated 
PMNs, PMN Standard Form pages 8 through 11 of each consolidated PMN may 
be filled out by the filing group of companies (this information is 
expected to be of a more general nature, applicable to a given class of 
monomer acid derivative). Pages 1 through 7, however, pertain to 
information that is specific to individual submitters, and will need to 
be filled out by the individual manufacturers and importers.

I. How will EPA Handle CBI in PMNs Involving Multiple Submitters?

    Consistent with 40 CFR 720.40(e), multiple persons submitting 
information required in a specific PMN or consolidated PMN may make 
separate submissions to EPA so as not to disclose confidential business 
information (CBI) to one another. For example, a customer of a PMN 
submitter of record who also is a manufacturer of a monomer acid 
derivative may submit a letter of support, confidential from the 
supplier, directly to EPA for TSCA section 5 notification, giving 
complete chemical identity, health and safety, use, production volume, 
and/or process information, etc., for his or her substance. This 
enables the customer to disclose any specific CBI to EPA but not to the 
other parties in the PMN.

IV. Do Any of the Regulatory Assessment Requirements Apply to this 
Action?

A. General

    No. This document is not a rule. It only makes a correction to TSCA 
Inventory nomenclature. As such, this action does not require review by 
the Office of Management and Budget (OMB) under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993) 
or Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997).
    Because this action is not economically significant as defined by 
section 3(f) of Executive Order 12866, this action is not subject to 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997).
    This action will not result in environmental justice related issues 
and does not, therefore, require special consideration under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994).
    This action is not subject to notice-and-comment requirements under 
the Administrative Procedure Act or any other statute, and is not 
subject to the provisions of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), or to sections 202 and 205 of the Unfunded 
Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, 
this action does not significantly or uniquely affect small governments 
or impose a significant intergovernmental mandate, as described in 
sections 203 and 204 of UMRA. This action will not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Nor does this action have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 6, 2000).
    This action does not involve any technical standards that require 
the Agency's consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).
    In issuing this action, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).
    EPA has complied with Executive Order 12630, entitled Governmental 
Actions and Interference with Constitutionally Protected Property 
Rights (53 FR 8859, March 15, 1988), by examining the takings 
implications of this action in accordance with the ``Attorney General's 
Supplemental Guidelines for the Evaluation of Risk and Avoidance of 
Unanticipated Takings'' issued under the Executive Order.

B. Paperwork Reduction Act (PRA)

    This document does not contain any new information collection 
requirements that would require additional OMB review and approval. The 
information collection activities related to the submission of 
information pursuant to TSCA section 5 have been already approved by 
OMB under OMB control number 2070-00012 (EPA ICR No. 574). The annual 
respondent burden for this information collection activity is estimated 
to average 100 hours per respondent, including time for reading the 
regulations, processing, compiling and reviewing the requested data,

[[Page 34198]]

generating the request, storing, filing, and maintaining the data. The 
additional reporting requirement is estimated to be 100 additional PMNs 
over and above the current annual projections of PMN submissions. The 
ICR projects about 185,000 burden hours annually. An additional 100 
PMNs at 100 hours each would be covered by this current estimate.
    As defined by the PRA and 5 CFR 1320.3(b), ``burden'' means the 
total time, effort, or financial resources expended by persons to 
generate, maintain, retain, or disclose or provide information to or 
for a Federal agency. This includes the time needed to review 
instructions; develop, acquire, install, and utilize technology and 
systems for the purposes of collecting, validating, and verifying 
information, processing and maintaining information, and disclosing and 
providing information; adjust the existing ways to comply with any 
previously applicable instructions and requirements; train personnel to 
be able to respond to a collection of information; search data sources; 
complete and review the collection of information; and transmit or 
otherwise disclose the information.

V. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1966, does not 
apply because this action is not a rule for purposes of 5 U.S.C. 
804(3). Nevertheless, EPA has provided a courtesy copy of this action 
to each House of the Congress and the Comptroller General of the United 
States.

List of Subjects

  

    Environmental protection, Chemical substances, Hazardous 
substances, Reporting and recordkeeping requirements.

    Dated: June 18, 2001.
Stephen L. Johnson,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 01-16124 Filed 6-26-01; 8:45 am]
BILLING CODE 6560-50-S