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Correction to Chemical Nomenclature for Monomer Acid and Derivatives for TSCA Inventory Purpose
[Federal Register: June 27, 2001 (Volume 66, Number 124)] [Notices] [Page 34193-34198] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27jn01-80] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: TSCA-Hotline@epa.gov. 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: moss.kenneth@epa.gov. 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