Environmental Protection Agency (EPA).
An August 2, 1985 letter from EPA erroneously equates 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 proposes a correction to the 1985 letter on nomenclature of monomer acid and derivatives. With this proposed correction, monomer acid derivatives that are not on the Inventory would be considered new chemical substances under section 5 of TSCA.
Comments, identified by the docket control number [OPPTS-50040], must be received by EPA on or before January 2, 2001.
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 OPPTS-50040 in the subject line on the first page of your response.Start Further Info Start Printed Page 64945
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, Chemical Control Division (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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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) or Significant New Use Notice (SNUN) under the Toxic Substances Control Act (TSCA). Special rules apply to persons who manufactured (or processed) these chemicals between August 2, 1985, and 12 months following the date of publication of the final nomenclature correction notice in the Federal Register. Potentially affected entities may include, but are not limited to the following:
|Category||NAICS Codes||Examples of Potentially Affected Entities|
|Chemical manufacturers or importers||325, 32411||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|
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 the ``Federal 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-50040. 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.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50040 in the subject line on the first page of your response.
1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 260-7093.
3. Electronically. You may submit your comments electronically by e-mail to: ``email@example.com,'' or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.1 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50040. Electronic comments may also be filed online at many Federal Depository Libraries
D. How Should I Handle Confidential Business Information That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to be confidential business information (CBI). You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person identified under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.Start Printed Page 64946
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice or collection activity.
7. Make sure to submit your comments by the deadline in this notice.
8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.
A. What Action is the Agency Taking?
An August 2, 1985 letter from EPA erroneously equates 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 proposes a correction to the 1985 letter on nomenclature of monomer acid and derivatives. With this proposed correction, monomer acid derivatives that are not on the Inventory would be considered new chemical substances under section 5 of TSCA.
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 listings on the Inventory.
C. Why is this Proposed Nomenclature Correction Necessary?
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. . . .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 for full text.)
Tall oil is a source for natural fatty acids, commonly referred 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 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, and PCA and EPA agreed that one description, “Fatty Acids, C18 unsaturated, dimers (CASRN 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 (CASRN 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 four separate 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. Proposed TSCA New Chemicals Program Policy for Monomer Acid Chemical Nomenclature
Today's proposed nomenclature correction 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 proposed notice PMNs are required for monomer acid derivatives that are not on the TSCA Start Printed Page 64947Inventory and which are manufactured on or after the effective date of the final notice. In accordance with Inventory correction guidelines (45 FR 50544; July 29, 1980), because these monomer acid derivatives were not manufactured during the Initial Inventory reporting period and were never reported for the Initial TSCA Inventory, they are not eligible for Inventory correction as an alternative to PMN submission.
A. What is the Basis for and Scope of this Proposed 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. . . .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 proposed 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. 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 acids must be named consistently with this nomenclature for monomer acid.
B. What are the Key Dates and Provisions of this Proposed Nomenclature Correction?
The proposed effective date for this new nomenclature interpretation, described in Unit III.A., will be 12 months following the date of publication of the final nomenclature correction notice in the Federal Register. Prior to this effective 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 would need to submit PMNs at least 90 days before the effective date to ensure that Agency review is completed before this nomenclature correction takes effect.
EPA will work closely with chemical manufacturers and importers to resolve chemical nomenclature of specific monomer acid derivatives whose Inventory status is uncertain. EPA is taking two specific steps to facilitate the Premanufacture Notice process for chemical substances currently using the incorrect nomenclature. For the purposes of this proposed nomenclature correction only, EPA is suspending its TSCA new chemicals program policy of a limit of six chemical substances per consolidation notice and waiving PMN fees for any PMN submissions required as a result of the proposed nomenclature correction. However, consistent with the Agency's chemical nomenclature requirements for consolidated notices, submitters must use the Chemical Abstract 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 in the Revision of Premanufacture Notification Regulations (60 FR 16298; March 29, 1995) (FRL-4921-8), 40 CFR 720.45(a). EPA encourages conversion to the new nomenclature immediately instead of delaying the correction to the effective date of this proposed notice.
EPA expects that there will be at least several consolidated PMNs submitted as a result of this proposed nomenclature correction, and there may also be individual PMNs filed. It may be possible that only one consolidated PMN is necessary for each chemical class of product based on monomer acid. These notices can be submitted by individual companies or as part of an organized effort to submit consolidated PMNs. It is expected that the affected manufacturers and importers of monomer acid and its derivatives or other downstream products, supported by PCA, will prepare consolidated PMNs. In such cases, PMN Standard Form pages 8 through 11 of each consolidated PMN may be filled out by PCA or another organization (this information is expected to be more generally 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. 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. There may be some manufacturers that do not wish to participate in a consolidated PMN; these manufacturers can submit individual notices separately for their corrected nomenclature.
If a person intends to manufacture a monomer acid derivative or monomer acid-based downstream product for the first time before the effective date, and there is no corresponding Inventory listing using the old nomenclature for that particular substance, this person must submit a regular PMN, using the correct nomenclature, at least 90 days before manufacture of that substance. The special consolidated PMN reporting process involving PCA, as described in this section, cannot be used to report such new derivatives or downstream products.
C. What are the Consequences of Not Submitting a PMN and Completing PMN Review on a Monomer Acid Derivative before the Effective Date of this Proposed Nomenclature Correction Notice?
On the effective date of the final 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 name will be in violation of TSCA. A person may, of course, continue to manufacture TOFA derivatives and derivatives of oleic acid or octadecenoic acid listed on the Inventory without submitting a PMN.
D. 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 monomer acid and its derivatives and other downstream products not on the TSCA Inventory on or after the effective date of the final nomenclature correction notice. For example, if you 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. However, if you Start Printed Page 64948later plan to manufacture the monomer acid derivative after the effective date of the final nomenclature correction notice, you will need to submit a PMN 90 days before commencing manufacture.
E. How will EPA Handle CBI in Consolidated PMNs?
Consistent with current law, policy and practice in the New Chemicals Program, multiple persons submitting information required in a specific consolidated PMN may make separate submissions to EPA so as to not disclose CBI to one another. For example, a customer of a PMN submitter of record who also is a manufacturer of monomer acid derivatives 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, or process information, etc. This enables the customer to disclose any specific CBI to EPA but not to the other parties in the consolidated PMN.
IV. Do Any of the Regulatory Assessment Requirements Apply to this Action?
No. This document is not a rule. It only seeks comment on a proposed 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) (Pubic 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. Nor does this action significantly or uniquely affect the communities of tribal governments as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 10, 1998). 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).
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
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 has 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, generating the request, storing, filing, and maintaining the data. The additional reporting requirement is estimated to be six additional PMNs over and above the current annual projections of PMN submissions. The renewal ICR projects about 875 PMNs and 185,000+ burden hours annually. An additional six PMNs at 100 hours each would be covered by these current estimates.
As defined by the Paperwork Reduction Act 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.
Comments regarding the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, should be submitted as described in Unit I.C.Start List of Subjects
List of Subjects
- Environmental protection
- Chemical substances
- Hazardous substances
- Reporting and recordkeeping requirements
Dated: October 20, 2000.
Susan H. Wayland,
Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.
[FR Doc. 00-27927 Filed 10-30-00 8:45 am]
BILLING CODE 6560-50-S