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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460
January 6,1999
Dr. William A. Weppner, Director Environmental, Health, Safety & Regulatory Affairs Chemical Markets Group 3M Center, Bldg, 223-6S-04 SL Paul, MN 55144
OFFICE OF PREVENTION, PESTICIDES AND
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Dear Dr. Weppner:
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In response to your letter dated December 21,1998, and in followup to our meeting held on December 14, 1998, enclosed are copies of the template for a product stewardship Memorandum of Understanding (MOU) and the most relevant example of such a voluntary agreement.
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In developing some o f our voluntary product stewardship agreements, we have received an initial draft prepared by industry. However, and most typically, the development o f such agreements have involved rather extensive discussion and negotiation. Until we have had an ample opportunity to review the white papers you indicated are being prepared (on the relevant fluorochemistiy and a detailed review of the health effects information) as well as the preliminary exposure assessment o f products that are derived from perfluorooctane sulfonyl fluoride, it is difficult for us to conclude that a product stewardship agreement is the most appropriate course o f action for EPA to pursue at this time for these organic fluorochemicals and products. We look forward to receipt of these documents and plan to carefully review them.
Another meeting between EPA and 3M personnel (after adequate time for Agency review) seems appropriate to enhance our understanding of the issues and allow us to determine the appropriate level of and need for follow up actions/activities. We may have additional questions for you after our review in order to facilitate more productive discussions when we do meet again. We feel comfortable in tentatively planning for our next meeting in late February or early in March if the cited documents arrive on the schedule indicated in your letter. Please note that any information deemed "supplemental" to 3M 's TSCA Section 8(e) notices on the subject chemical, must be submitted to EPA in accordance with our Section 8(e) reporting procedures.
Please keep me apprised of your company's progress in preparing and submitting the aforementioned documents. Also, please feel free to use e-mail for further contact with me on this matter.
Sincerely,
Enclosures
Contain NO CBI
Frank D. Kover, Chief (Mail Code 7405) Chemical Information and Testing Branch Chemical Control Division/OPPT/OPPTS Phone: 202-260-3133 E-mail: kover.frank@epa.gov
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General Elements of a Testing-Related MOU
Background Purpose Legal Effect Scope General Aspects Specific Elements Measurements/Reporting Confidentiality Reporting Address Signatories Effective Date
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MOU General Elements Overview
Background
a short discussion on how/why the company(ies) and EPA arrived at the decision to enter into a formal MOU for a voluntary Product Stewardship Program (PSP) on the subject chemical(s)
Purpose
explains that the MOU establishes the specific elements of the PSP to which EPA and the company(ies) agreed
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MOU General Elements Overview
Leaal Effect
explains that the MOU is not enforceable under TSCA and does not establish any new legal requirements
Scope
explains that the MOU pertains to the subject
chemical(s) for as long a time as each signatory
company produces, imports, processes, distributes,
uses, and/or disposes of the subject chemical(s) or
products that contain the chemical(s)
affirms each company's commitment to the general
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tenets of Product Stewardship (e.g., those outlined in
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CMA's Responsible CARE Program)
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MOU General Elements Overview
General Aspects
explains that the PSP elements may include companyspecific programs and/or those developed jointly with others; also explains that implementation of the PSP will occur in a timely manner and will be commensurate with risks posed by exposure to the subject chemical(s).
Specific Elements
Description of Goals/Measures
specifies the date by which the company will submit j j
written goals for all PSP elements and describe the
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measures that will be used to evaluate performance against those goals.
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MOU General Elements Overview
Specific Elements (Continued)
Communications
communicate new risk information to workers/others via updated MSDSs, labels, and brochures/guides
enhance existing chemical safety training and exposure/source reduction programs
encourage workers/others to provide feed-back on safety/risk related matters
work with customers to improve identified unsafe practices ["stop sale" action is cited as an action that could be taken if such improper practices are not corrected]
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MOU General Elements Overview
Specific Elements (Continued)
New Data Development
identifies the subject chemical(s) and types of toxicity and/or exposure tests to be conducted under the MOU and states that the MOU allows for the conduct of future tests not listed
in the case of an exposure monitoring study, the MOU explains that a formal Quality Assurance Project Plan (QAPjP) must be approved by EPA study
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MOU General Elements Overview
Specific Elements (Continued)
Pollution Prevention
explains that the company will develop/implement
pollution prevention, waste minimization and other
exposure/source reduction plans designed to reduce
releases of and/or the exposure(s) to the subject
chemical(s)
implementation of such plans will include interactions with customers as a means to facilitate pollution
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prevention
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Specific Elements (Continued)
Environmental Justice
explains that the company(ies) will develop and implement the PSP in a manner consistent with the general principles of "environmental justice."
Measurement/Reportinq
* explains that the company(ies) will submit to EPA
documentation (e.g.., existing product brochures; TRItype data) needed to establish a "base-line" for each
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element and report periodically substantive changes to
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that base-line
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MOU General Elements Overview
Confidentiality
explains that EPA discourages submission of TSCA Confidential Business Information (CBI) under the MOU and specifies the procedures that must be followed if CBI is submitted
Reporting Address
identifies the address at EPA to which all data and other information reported under the MOU is to be submitted
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Signatories
identifies the name, title, and address of each signator of the MOU (includes EPA signatories)
Effective Date provides the signing/effective date of the MOU
Attachment for TSCA CBI Data Submission
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in which TSCA CBI is submitted under the MOU
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Important Web Sites
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C hem ical T esting and Inform ation G athering
http://ww w.epa.gov/opptintr/chem test
C hem ical R ight-to-K now http://w w w .epa.gov/chem rtk
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FILE COPY
MEMORANDUM OF UNDERSTANDING
A. BACKGROUND
The 30th Report of the TSCA Interagency Testing Committee (ITC) to the EPA Administrator recommended 56 silicone chemicals for health effects testing to meet data needs expressed by the U.S. Food and Drug Administration (57 FR 30608; July 9, 1992). In response to that ITC recommendation, EPA issued an immediately final TSCA Section 8(d) information reporting rule (58 FR 28511; May 15, 1993) requiring manufacturers, importers, and processors of the 56 silicone chemicals to submit to EPA unpublished health and safety data on those chemicals; information concerning the uses of and exposure to the chemicals was submitted voluntarily by industry directly to the ITC. The ITC has been reviewing the available unpublished and published information on the 56 silicone chemicals and is considering the need for formal designations for testing under Section 4 of TSCA.
All six of the silicone chemicals covered by this Memorandum of Understanding (MOU) between EPA and the Dow Corning Corporation are included among the 56 silicone chemicals recommended by the ITC in its 30th Report to EPA. One of the six siiicone chemicals subject to this MOU, octamethylcyclotetrasiloxane (OMCTS; also known as D4), was designated previously by the ITC in its 15th Report to EPA for ecotoxicological and chemical fate testing (49 FR 46931; November 29, 1984). In response to that ITC testing designation, EPA and several OMCTS manufacturers negotiated a final TSCA Section 4 Enforceable Consent Agreement (ECA) under which the companies agreed to conduct the needed OMCTS studies (54 FR 818; January 10, 1989). All of the ecotoxicological and chemical fate tests on OMCTS required under that ECA have been completed and submitted to EPA along with some additional voluntarily conducted ecotoxicity studies. In addition, members of the U.S. chemical industry (including Dow Corning) are sponsoring OMCTS in the Screening Information Data Set (SIDS) program, a voluntary international testing program developed under the aegis of the Organization for Economic Cooperation and Development (OECD). The continuing commitment of members of the U.S. chemical industry to participate in the voluntary OECD/SIDS testing program indicates the importance those companies attach to being good stewards of the chemical substances and mixtures they produce, import, process and/or distribute.
The concept of Product Stewardship has been an integral part of Dow Coming's health and environmental research programs since the early 1980's. As an active and integrated effort, Dow Corning has and will continue to provide value added scientific information concerning potential health and environmental effects of its products, processes and wastes to employees, customers and the public at large. Under the umbreila of Dow Coming's
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proactive Product Stewardship Program (PSP) a comprehensive and far reaching health research program on six key siloxane materials has been developed and initiated. The six silicone chemicals selected are representative of a broad class of siloxane materials which have widespread use in industrial and consumer applications. Dow Corning believes that as part of its' PSP, open and ongoing communication and dialogue with EPA and others concerning the results from the siloxane research program (SRP) is essential and can be effectively accomplished by entering into this MOU.
B. PURPOSE AND EFFECTIVE DATE
This (MOU) sets forth the specific elements of the Product Stewardship Program (PSP) to which EPA and Dow Corning have agreed. This MOU is effective on the date both parties agree in writing to the terms of the MOU (see Part K).
C. LEGAL EFFECT
This MOU does not supersede any current law or existing legal requirements or establish any additional legal requirements. This MOU is a voluntary agreement between the parties and is not an enforceable Consent Agreement or Order under 40 CFR Part 790 nor is it enforceable under 15 USC 2603 (TSCA 4) or 15 USC. 2614 (TSCA 15) and 2615 (TSCA 16), or any other provision of TSCA or other Federal or State statute. In accordance with the findings, policies, and intent expressed in 15 USC. 2601 (TSCA 2), EPA may consider voluntary actions, and/or the data generated pursuant to this agreement in TSCA regulatory actions concerning Dow Corning or the subject chemicals.
D. SCOPE OF THE PRODUCT STEWARDSHIP PROGRAM
This MOU and the PSP described herein pertain solely to the chemicals (the "subject chemicals") listed in Part F 3(a) of this MOU. Neither the MOU nor *he PSP described herein are applicable to any other chemical substance(s) produced, imported, processed, distributed, disposed of or used by Dow Corning.
As is expressed in "Implementing Product Stewardship: A Resource Guide" (Chemical Manufacturers Association (CMA), 1992), the primary purpose of a product stewardship program is "to make health, safety and environmental protection an integral part of designing, manufacturing, marketing, distributing, using, recycling and disposing" of such products. In signing this MOU with EPA, Dow Corning is affirming its commitment to the above cited tenets of product stewardship for Dow Corning products including the subject chemicals for as long a period of time as Dow Corning
manufactures, imports, processes, distributes, uses, and/or disposes of those chemicals.
E. GENERAL ASPECTS OF THE PRODUCT STEWARDSHIP PROGRAM
It is understood that the specific elements of the PSP described herein may include company-specific programs (many of which are already in place) or programs developed jointly with others.
Actions planned and taken by Dow Corning in implementing this PSP will be completed in a timely manner and will be commensurate with potential risks posed by exposure to the subject chemicals. These actions will be based on data and information obtained from the Dow Coming testing program, the PSP itself, and/or other appropriate sources.
F. SPECIFIC ELEMENTS OF THE PRODUCT STEWARDSHIP PROGRAM
1. Description of PSP Goals
Within 180 calendar days of the effective date of this MOU, Dow Corning agrees to submit to EPA written goals for all elements of the PSP, identifying, where possible, the potential health and environmental risks and management of such risks commensurate with the magnitude of those risks. Within the same time period, Dow Corning agrees to submit a description of the specific measures that will be used to evaluate performance of the PSP against these goals, consistent with the company's product stewardship programs.
2. Communication of Health and Safety Data
Throughout the course of the PSP, Dow Corning agrees to consider relevant health, environmental, and safety data in developing and/or refining company plans for the production, importation, processing, distribution, use, and disposal of the subject chemicals. Dow Coming's actions may include, but are not limited to, the following:
Updating Material Safety Data Sheets (MSDS's) and product labels to reflect information obtained through the testing program, the PSP itself, and/or other sources as necessary under the requirements of the OSHA Hazard Communication Standard (29 CFR 1910.1200).
Preparing product brochures or guides and updating such documents as necessary to reflect information obtained from the testing program, the PSP itself, and/or other sources.
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Determining the appropriate Federal and state authorities to be notified of significant new information, as determined by individual signatory company procedures, regarding health and environmental hazards/risks posed by exposure to the subject chemicals.
Communicating significant new health and environmental hazard/risk information to customers and others via the MSDS and/or other appropriate mechanisms.
Reviewing and implementing processes that encourage employees and customers to provide feedback pertaining to such issues as uses that could result in new, adverse health and/or environmental effects ascribed to exposure to the subject chemicals.
Reviewing and implementing programs designed to provide employees and customers with appropriate safety and handling guidance or training during the life cycle of each of the subject chemicals; such guidance/training may include available exposure and source/exposure reduction information.
If Dow Corning identifies improper customer practices involving any of the subject chemicals that might give rise to significant adverse health or environmental effects, Dow Corning will attempt to work with that customer to improve such improper practices. If, in Dow Coming's independent judgment, improvement is not evident, then Dow Corning will take such further corrective measures as the company deems necessary to secure improvement. Such measures could include terminating sale of the chemical(s) in question to that customer.
3. New Data Development
a. Subject Chemicals
CAS Number
1. Octamethylcyclotetrasiloxane [D4] 2. Decamethylcyclopentasiloxane [D5] 3. Dodecamethylcyclohexasiloxane [D6] 4. Hexamethyldisiloxane [HMDS] 5. Polydimethylsiloxane [PDMS 10 cs] 6. Polydimethylsiloxane [PDMS 350 cs]
556-67-2 541-02-6 540-97-6 107-46-0 63148-62-9 63148-62-9
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b. Description of Planned Animal Toxicity Testing
The voluntary animal toxicity testing program covered by this MOU involves the following types of studies with the subject chemicals enumerated in 3 (a) above and includes:
1. Subacute Toxicity (28 day)-1, 2, 3, 4, 5, 6 2. Subchronic Toxicity (90 day)-1,2, 3, 4, 5, 6 3. Chronic Toxicity (2-Year)-1,2, 4, 5, 6 4. Pharmacokinetics/Metabolism/Disposition-1, 2, 3, 4, 5 5. Reproductive/Fertility/Developmental Toxicity with
Neurotoxicity Assessment-1, 2, 3, 4, 5 6. lmmunotoxicity-1,2, 3, 4, 5
All testing conducted under this MOU will be conducted in full compliance with current EPA Good Laboratory Practices Standards (40 CFR part 792).
c. Description of Planned Exposure/Monitorinq Program
The voluntary exposure monitoring program covered by this MOU addresses three materials:
D4 (octamethylcyclotetrasiloxane), D5 (decamethylcyclopentasiloxane), and D6 (dodecamethylcyclohexasiloxane) These materials are all basic building blocks of siloxane technology and are used as chemical intermediates in the production of other silicones and are sold for direct formulation into consumer products, chiefly in cosmetic applications. Dow Corning is considering exposure monitoring for HMDS. Because Dow Coming's current manufacture and use of HMDS is in a closed system, however, an HMDS exposure monitoring program will be considered lf toxicity test data on HMDS so warrant.
The exposure analysis is a two to three-year effort which will identify and enumerate populations potentially exposed to these materials, identify relevant exposure pathways (e.g., inhalation, dermal exposure), and quantify exposure (dose) received by each population. Exposures to be assessed include those in manufacturing, processing, and/or formulating these materials, and ambient exposures through incidental contact with these materials.
Study methods will include direct exposure monitoring (e.g., workplace cr fence-boundary sampling) and the use
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of mathematical models for exposure assessment. Empirical estimates of bioavailability will be used where possible to estimate absorbed (retained) dose. This analysis will serve as a prototype for study of the subject chemicals.
Dow Corning personnel and consultants will meet with EPA personnel to review the proposed study design. A draft Quality Assurance Project Plan (QAPjP) will be written and submitted to EPA within 180 days of signing this MOU. An EPA approved QAPjP will be used for collecting all new exposure monitoring data. EPA personnel will be briefed on study progress periodically.
d. Description of Additional Studies
If Dow Corning identifies areas where additional data are needed to adequately address the risks posed by exposures to the subject chemicals, Dow Corning will consider performing or provide support for conducting the appropriate testing. EPA and Dow Corning agree, however, that the conduct of such additional testing or the testing cited in Part 3(b) and 3(c) above will not foreclose EPA from exercising its statutory authority under TSCA or other statutes to require any type of testing of the subject chemicals in the future.
Prior to completion of the toxicity testing and exposure monitoring program outlined in this MOU, and after approaching other siloxane manufacturers for support, Dow Corning will consider taking the lead for U.S. sponsorship of the subject chemicals (other than OMCTS) under the OECD/SIDS program. As noted previously, OMCTS is already und^r U.S. sponsorship in the OECD/SIDS testing program.
4. Pollution Prevention Actions
Dow Corning agrees to inciude in the development and implementation of pollution prevention, waste minimization, and exposure reduction plans, appropriate steps deemed necessary to reduce releases of, and exposures to, the subject chemical substances in all Dow Corning operations and facilities. These plans will be designed to achieve company-specific improvement goals developed under this PSP.
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Dow Coming agrees to develop training programs, guidance documents, or other means to provide guidance, where possible, to Dow Corning customers on their individual company programs that may facilitate pollution prevention, waste minimization and exposure reduction practices. Dow Corning may also establish mechanisms for providing guidance to customers and others by working in concert with other members of the chemical industry.
5. Environmental Responsibility
Dow Corning will continue to design and/or modify its processes so as to minimize the consumption of natural resources and energy and to eliminate, to the extent feasible, the generation of waste materials and releases to the environment. In so doing, Dow Corning will continue to focus on source reduction as the preferred approach to waste management, followed by internal recycle/recovery and then waste destruction. Treatment and disposal will be employed as a last resort.
Dow Corning will strive to design and/or modify its products and packaging in a manner that minimizes environmental impact throughout their entire life cycle, including ultimate disposal, and in a manner that assures that they meet or exceed any applicable regulatory requirements for Dow Coming and its customers.
Dow Corning will continue to maintain comparable corporate standards of environmental performance for all of its global operations, including joint ventures, and will transfer and utilize the most appropriate technology throughout its operations in order to assure sound environmental performance.
Dow Corning will continue to maintain an open dialogue with the public about concerns for the environment and will take a proactive role in working with the public and government bodies to find mutually acceptable solutions to common environmental issues.
In signing this MOU, Dow Corning agrees that the development and implementation of the comprehensive product stewardship program (PSP) outlined in the MOU, will be consistent with Dow Coming's interpretation of the concept of "environmental responsibility" to help to ensure protection of health and the environment for people, regardless of race, ethnic background, or socio-economic status.
G. MEASUREMENT AND REPORTING
As a means of measuring continuing improvement in implementing the PSP elements, Dow Corning will establish the baseline for each action, then
report periodically substantive changes to that baseline. For example, copies of representative MSDS's, product brochures and guides, will be submitted to EPA at the initiation of the PSP to establish a current baseline. To further establish the baseline Dow Corning also agrees to submit to EPA copies of the company's pollution prevention, waste minimization, and exposure reduction plans for the subject chemicals as soon as those plans are developed.
In the event that the testing which is conducted under this MOU or information obtained from the PSP and/or other sources reveals hazards or potential risks that previously were unknown and could be significant, Dow Corning agrees to amend specific documents (e.g., MSDS's, product brochures and guides) to reflect such new information. It is understood that such actions by the company are not an admission that newly discovered potential risks are real. Dow Corning also agrees to submit progress reports to EPA noting substantive changes made to specific documents, brochures and guides, based on information obtained from the company's testing program, the PSP itself, and/or other sources. As part of these progress reports, Dow Corning agrees to submit voluntarily for each of the subject chemicals a form containing release information of the type requested in EPA's current TRI/PPA Form R.
Dow Corning agrees to submit these PSP progress reports at the end of the first, second, and third years of the effective date of this MOU, and every other year thereafter until a final progress report is submitted to EPA one year after submission of the final report of the last study conducted under this MOU. Upon submission of the final progress report, Dow Coming's obligations under this MOU are deemed complete.
H. CONFIDENTIAL BUSINESS INFORMATION
Although EPA discourages the submission of confidential information under this MOU, EPA recognizes that there may be some circumstances in which information submitted pursuant to this MOU may be claimed as TSCA Confidential Business Information (CBI). All Dow Corning submissions under this MOU will be placed in the appropriate OPPT Public Docket unless confidentiality is claimed at the time of submission of the information in accordance with the procedures that are outlined in 40 CFR Part 2 Subpart B (see 41 FR 36902, September 1, 1976, as amended at 43 FR 40000, September 8, 1978, and 50 FR 51661, December 18, 1985, and 58 FR 461, January 5, 1993). If no claim of confidentiality is made at the time of submission, the submitted information will be made available to the public without further notice by EPA. If a confidentiality claim is made on all or part of information submitted under the MOU, the procedures set forth in the attached document entitled "Support Information for Confidentiality Claims" will be followed. In addition, each confidentiality claim will be substantiated at the time of submission by providing a full written response to each question posed in
the "Substantiating Claims of Confidentiality" section of the attached document. EPA will then determine whether the submitted information is entitled to confidential treatment under TSCA. Confidential information will only be disclosed by EPA to the extent, and by means of the procedures, set forth in the above cited regulations. Failure to provide a full written response to each substantiation question at the time of submission will be construed by EPA as a complete waiver of Dow Coming's confidentiality claim.
I. ADDRESSES FOR SUBMISSION OF INFORMATION
Reports of information from the studies described above in Part F.3. (b), (c), and (d) shall be submitted to EPA in full accordance with existing reporting requirements [e.g., final study reports shall be submitted to EPA as required under TSCA 8(d)]. All other information submissions made to EPA under this MOU, including the TRI/PPA-type forms, shall bear the OPPT Public Docket #42071-A and be transmitted to the Document Control Office (7407), Information Management Division, Office of Pollution Prevention and Toxics, US Environmental Protection Agency, 401 M Street, S.W., Washington D.C. 20460.
J. NAMES AND ADDRESSES OF SIGNATORY PARTIES
Kenneth B. Yerrick Executive Vice President Dow Coming Corporation 2200 W. Salzburg Rd. Auburn, Ml 48611
Richard H. Hoover Executive Director - Health & Environmental Policy Dow Corning Corporation 2200 W. Salzburg Rd. Auburn, Ml 48611
Joseph S. Carra, Deputy Director (7401) Office of Pollution Prevention and Toxics US Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460
William H. Sanders III, Dr. P.H., P.E. Director, Office of Pollution Prevention and Toxics (7401) US Environmental Protection Agency 401 M Street S.W. Washington, DC 20460
K. EFFECTIVE DATE This MOU is entered into by the Dow Corning Corporation and EPA as of
this day, April 9, 1996. For the Dow Corning Corporation: Kenneth B. Yerrick Executive Vice President Dow Corning Corporation
(JRichard HI.. HHoocover
Executive Director - Health & Environmental Policy Dow Corning Corporation
For the US Environmental Protection Agency Joseph S. Carra Deputy Director Office of Pollution Prevention and Toxics
William H. Sanders III, Dr. P.H., P.E. Director Office of Pollution Prevention and Toxics
Attachment ("Support Information for Confidentiality Claims")
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ATTACHMENT
Support Information for Confidentiality Claims
Support Information for Confidentiality Claims
Information submitted under specific reporting requirements of the Toxic Substances Control Act (TSCA) or in support of TSCA is subject to the provisions of Section 14 of TSCA and to EPA's Regulations on the Confidentiality of Business Information (see 40 CFR Part 2). You must comply with the following procedures to assert a claim of confidentiality for the information solicited in the attached letter. Failure to follow these procedures fully at the time you submit the information to EPA will be interpreted by the Agency as a waiver of your claim of confidentiality.
Asserting a Claim
Information claimed as confidential must be clearly marked by boxing, circling, or underlining. All pages containing such information should also be stamped "CONFIDENTIAL". Care should be taken to ensure that these markings do not obscure the submission's text.
Sanitized Copy
Two copies must be submitted of any documents containing information claimed as confidential. One copy should be complete, with the information being claimed as confidential marked in the manner described in the preceding.paragraph, The other copy should have all of the information claimed as confidential excised. This version will be placed in EPA's Public Files.
Substantiating Claims of Confidentiality
Detailed written responses to the following questions must be provided at the time you submit information for any portion of the information you claim as confidential. Your responses should be as specific as possible, with examples as appropriate, and should provide substantiation arguments for all types of information (e.g., sales or production/importation volumes, chemical identity, company identity) you claim as confidential.
1. For what period of time do you assert this claim of confidentiality? If a claim is to extend until a certain event or point in time, please indicate that certain event or time period. Explain why the information should remain confidential until such event or time.
2. Have there been any confidentiality determinations made by EPA, other Federal agencies, or courts in connection with this information? If so, please enclose copies.
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3. Has any of the information that you are claiming as confidential been disclosed to individuals outside your company? Will it be disclosed to such persons in the future? If so, what restrictions, if any, apply to use of further disclosure of the information?
4. Briefly describe any physical or procedural restrictions within your company relating to the use and storage of the information you are claiming as confidential. What other steps, if any, have you taken to prevent undesired disclosure of the information during its use or when an employee leaves your company?
5. Does the information claimed as confidential appear or is it referred to in any of the items listed below:
advertising or promotional materials for the chemical or the end product containing it;
safety data sheets or other similar materials for the chemical or the end product containing it;
professional of trade publication; or
any other media available to the public or to your competitors.
If you answered yes to any of the above questions, you must indicate where the information appears and explain why it should nonetheless be treated as confidential.
6. Would disclosure of this information be likely to result in substantial harm to your competitive position? If so, you must specifically describe the alleged harmful effects and indicate why they should be considered to be substantial. Also, you must describe how disclosure of the information would cause the harm.
7. If the information in question is "health and safety data" pursuant to 40 CFR Part 2.306(3)(i), do you assert that disclosure of the information you are claiming as confidential would reveal:
a) confidential process information;
b) confidential proportions of a mixture; or
c) information unrelated to the effects of the substance on human health or the environment?
If your answer to any of the above questions is yes, you must explain how such information would be revealed.
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