Document kQMppVBERz3bkp8XRZYxBNgD

/ TO: Distribution XF: fyO^^____________ Interoffice Communication FROM: DATE: SUBJ: T. G. Grumbles July 26, 1990 PRODUCT DEVELOPMENT MEETING ACTION ITEMS The Action Items from our 5/23 meeting required multiple changes in the Product Development Manual. Attached are revised, or new, pages and text to be discussed at our 7/30 meeting. I 'VMAu T. G. Grumble dlj Distribution: M. F. Cox, T. F. 0'Brien-Houston K. L. Matheson, D. L. Smith, 0. C. Kerfoot, W. A. Dickenson, J. T. Fenton, D. A. Penney, D. PlummerAus tin VVV 000013330 o REVISED SEQUENCE OF PRODUCT DEVELOPMENT, RESPONSIBILITY AND DOCUMENTATION FOR NEW PRODUCT DEVELOPMENT ACTION RESPONSIBILITY DOCUMENTATION j_a) Determination of TSCA Inventory Status Individual Researcher lb) Adequacy of Exp. MSDS and labels Researcher w/ safety & health professional or R & D Toxicologist Inventory Status Letter to new product file. Timing transmittal is at discretion of the Product Manager or Supervisor Documentation of reviewrevised MSDS's & labels to new product file. Timing of transmittal is at discretion of the Product Manager or Supervisor. /. NOTE! Sample size may dictate Step 2 ( ), DOT classification to occur prior to :sample shipment. Review Sequence Step 2 ( ) prior to sample shipment. SAMPLE SENT - BUSINESS AREA COMMITMENT 2a) Development of physical & chemical data Researcher Laboratory reports to new product file 2b) Review of product toxiccology testing needs Product Manager & VPSAG or Supervisor Request form from Product Manager or Supervisor and response letter from VPSAG 2c) Initial end use regulatory review 2d) Complete and file PMN if needed Individual Researcher, Biomedical and Env. Affairs, and Marketing Individual Researcher Biomedical & Env. Affairs, and R&D Biological Technology Dept. Memo to new product file detailing review File copies of PMN at location and in Biomedical and Env. Affairs 2e) Product design review (inadvertent contaminants, etc.) 2f) Hazard assessment Manufacturing; R&D VPSAG, Biomedical & Env. Affairs 2g) Review of Plant Impact (If process changes/modifications required) rN Development of commercial MSDS and label text Plant Engineering, Environmental Coord, Safety Director Biomedical & Env. Affairs Memo's to new product file, on steps, results Memo to new product file to include all regulatory classifications determined *1 X Completed review checklist to new product Product Manager or Supervi sor written request, file documents & copy of MSD5-$and label text to new product file 2i) DOT classification for COEDS entry Biomedical & Env. Affairs COEDS entry form or request! letter for non-COEDS entries COMMERCIAL PRODUCT SHIPPED Additional items needed for goo< bus Luces practice/liability control. *r 3a) File commencement to manufacture notice Manufacturing location (Env. Coord.) Copy to new product file. *. 3b) End use Regulatory/ Industry Standards Review 3c) Addition of appropriate data to other company literature (Tech Data Sheets, ST&s manual, etc.) R & D; Biomedical & Env. Affairs; Mkt. Dvpt. Product Manager (ii) Memo of results to new product file Letter of transmittal; 'Mk` to system managers VVV 000013331 ;; 0 REVISED SEQUENCE OF PRODUCT DEVELOPMENT, RESPONSIBILITY AND DOCUMENTATION FOR NEW PRODUCT DEVELOPMENT IF NEW PRODUCT INVOLVES PLANT/PROCESS MODIFICATIONS THEN THE FOLLOWING MUST BE DONE ACTION RESPONSIBILITY DOCUMENTATION 4a) Addition to plant hazard communication program Plant Safety Director Specific to each plant location 4b) Employee monitoring Plant Safety Director Comply with OSHA regulatory requirements (iii) VVV 000013332 NEW PRODUCT DEVELOPMENT PROCESS MANUAL INTRODUCTION Vista has established a process to assure new products and new product end uses are developed in full compliance with all applicable regulatory requirements, with documented consideration of product hazards and handling risks, and are distributed with effective warnings. Successful implementation of this process requires the awareness and commitment of employees at multiple levels in multiple areas of the company. The purpose of the New Product Development Manual is to describe the specific steps necessary to implement the process, pinpoint responsibilities and describe the documentation needed for each step. When possible the timing required for each step is also defined. PROCESS ADMINISTRATION The PRODUCT MANAGER or PRODUCT SUPERVISOR for the product area in which the new product or product use is being developed is responsible for the management and administration of the New Product Development Process. The Product Manager or Supervisor is responsible for maintaining new yVV 000013333 O product files containing the required documentation for all new products developed and is responsible for assuring the required steps and actions are initiated in a timely manner. Multiple employees or departments are responsible for generating information and documentation for this process, however, initiation and authority to proceed with many of the steps are the responsibility of the product manager or supervisor. DEFINITIONS The following are key definitions in understanding the process. NEW PRODUCT - This is difficult to define in the Vista system but the following should be considered. a. New Mol^ ^ ?le: Any product for which a PMN will be required. b. New Commercial Product: Any product which has never been "sold" by vista. For example, a process intermediate that has never been moved outside the plant or Vista facilities is upgraded and a market is found for it. This product would need to go through the system to assure a full hazard assessment is done and warning information complete d VVV 000013334 Q c. Modified Commercial Products - "Relatively minor" modifications in product design, specification or even commercial name may necessitate a revised hazard assessment, change in regulatory classification or allowable uses. At a minimum, modification in MSDS's and labels may be required for regulatory and/or commercial reasons. These changes all require parts of the process to be initiated. d. Anv COEDS Chance - The COEDS entry form is the final control point before commercialization. A COEDS entry form arriving in Environmental will initiate questions or possible delays in entry if no information on the product is available regardless of the reason for the change. RESEARCHER - For the purposes of the New Product Development Process, "researcher" is defined as the initiator of the development work, or the person that is closest to the production of the initial samples or test run. In general, it is the person in a position to know the most about the chemical identity of the new product the earliest. This is typically a staff person in R&D , or a chemist in a plant laboratory. However, it could be the Product Manager or Supervisor if R&D is not involved in the initial development. For example, if a process change is requested by a Product Manager, such as a new solvent split, the Product Manager is in effect the researcher and would be responsible for assuring the initial steps of the process are taken. VVV 000013333 Q WHEN TO INITIATE THE PROCESS The decision to begin a new product file and commit resources to the steps necessary must be guided by judgement on the potential for the product to be put in commerce. It is not the intent of the process that every experimental sample be put through the whole process, but it is to assure that experimental products with "commercial" potential be assessed at an early stage to assure the following: a. Timely development of data required for hazard assessments and regulatory classifications. b. Time to assimilate data into quality and compliant warning materials. c. Identification of potential barriers to product development such as a lengthy PMN process, expense of required toxicity testing, regulatory issues in plant production, and possible unacceptable product liability risks. Many of the issues above may have significant impact on the decision to proceed with commercialization and timely assessment of them may result in cost savings as well as avoiding unrealistic commercial or customer expectations. Based on the past experience the Product Manager or Supervisor may decide to begin development of a new product files for only those VVV 000013336 Q experimental products that have been evaluated by customers and additional sampling is anticipated. (Steps 1(a) and 1(b) would still need to be completed for regulatory and liability reasons). Once again, it will be up to the judgment of the Product Manager or Supervisor how to manage the process in their business area. VVV 000013337 DOCUMENTATION (Step l(a^ For each new product being developed, the individual researcher must prepare a TSCA Inventory Status letter either prior to or as soon as possible after the initial formulation of the chemical substance. A form of such a letter is included in Appendix 1(a) hereto. It is essential that this regulatory status be determined at the earliest possible date so that if exemption procedures are required to be followed, they can be established prior to manufacture and distribution of any of the chemical substance and prior to exposure of any personnel to such chemical substance and prior to exposure of any personnel to such chemical substance. AN INVENTORY STATUS FORM SHOULD BE COMPLETED FOR ALL DETERMINATION, EVEN IF THE PRODUCT OR CONSTITUENTS OF THE PRODUCT ARE ON THE INVENTORY. The inventory status letter must be sent to the new product manager or supervisor for inclusion in the new product files maintained by them. The timing of this transmittal is determined by the product manager and they should be consulted for direction. Additional copies of the Status Letter may be maintained in accordance with any procedures established locally. VVV 00001333a 1 SEQUENCE STEP 1(b) ADEQUACY OF EXPERIMENTAL MSDS AND LABELS ACTION There are specific federal Occupational Safety and Health Act ("OSHA") requirements for product labeling and distribution of Material Safety Data Sheets ("MSDS") for hazardous products (see Sequence Step 2(H)), and TSCA requirements for customer warnings for experimental products. (See Sequence Step 1(a)). In addition, it is Vista practice to provide MSDS's for all products. These requirements and practices apply regardless of volume. (See detailed description of these requirements in Sequence Step 2 (h)). To meet these requirements for experimental products various MSDS's and labels have been prepared to cover classes, or ranges, of products presenting similar hazards. However, as products are developed that are significantly different than our existing products, a careful review of the adequacy of these warning materials must be done. Where existing warning materials are found to be inadequate new MSDS and labels must be prepared prior to sample shipment. It should be noted that preparation of these warning materials may take several days or longer. CHECK EARLY!! RESPONSIBILITY 2 vvv 000013339 The responsibility to initiate the MSDS and label review rests with the individual researcher. The individual researcher is in a position to know the most about the chemical identity and properties of the new product at the earliest possible time. The researcher should seek assistance from the location safety and health professional or, the R&D toxicologist, dependent on the location of the product development to identify and evaluate hazardous properties of the product and prepare the experimental MSDS and labels. DOCUMENTATION Memoranda should be prepared documenting the review and determination of the adequacy of the existing MSDS's and labels for each new product. When required, the basis for the development of new materials should be similarly documented. The memoranda should include specific rationale for determining adequacy, such as physical and chemical properties, toxicity information on similar materials, and transportation classifications. The memoranda with samples of the MSDS and labels should be maintained for placement in the New Product File which will be established and maintained by the product area manager or product area supervisor responsible for the product area in which the new product is being developed. The product manager or supervisor should be consulted for timing of the transmittal. 3 VVV 000013340 Q NOTE: Large Quantity samples or some relatively small samples of samples exhibiting specific hazards may require DOT classification, Step 2( ) prior to sample shipment. Please review sequence Step 2( ) page. vvv 000013341 4 n SEQUENCE STEP 2(a) DEVELOPMENT OF PHYSICAL AND CHEMICAL DATA ACTION To adequately complete a hazard assessment and assure appropriate regulatory classification of products, certain chemical and physical information is necessary. Specifically, the information required for sections 2, 3, 6, 7 and 9 of the MSDS are determined by this data. (See form MSDS in Appendix 2(h) hereto). The minimum data needed includes pH, flash point, solubility, volatility, reactivity and specific gravity. RESPONSIBILITY Responsibility for assuring that the appropriate data is obtained in a timely manner rests with the individual researcher. The individual researcher should consult the product manager or supervisor to determine the status of product development and/or get approval to expend the resources to develop the data. Judgement is required here, but timely production of the data is essential to many other steps in the process. The researcher has the best capability to determine sample volumes needed for the analysis and data generation and to arrange for sample production and analysis. Where the analysis is done will vary from location to location. OOOOl'3'*2 vvv Q The data must be obtained in time to assure development of the commercial MSDS and label. (See Sequence Step 2(h)). DOCUMENTATION All relevant laboratory reports documenting physical and chemical data should be placed in the New Product File which will be established and maintained by the product manager or product supervisor responsible for the product area in which the new product is being developed. Individual location procedures regarding record retention should be followed. VVV 0000133*3 6 SEQUENCE STEP 2 HO REVIEW OF PRODUCT TOXICOLOGICAL TESTING NEEDS ACTION To assure a complete hazard assessment and comply with several applicable regulations new products must be reviewed to determine if it is necessary to do toxicological testing. The testing required would be determined by multiple factors including similarity to existing Vista products, similarity to other commercial products, anticipated end-use or exposure potential to the product, and anticipated PMN requirements. Standard acute testing profiles for mammalian and aquatic toxicity have been developed for use by the Vista Product Safety Assessment Group. (See Appendix 2(b)). Chronic toxicity testing profiles will be developed on a case-by case where needed. RESPONSIBILITY The Product Manager or Supervisor is responsible for notifying the VPSAG in writing of the need to review the testing needs for each new product, or significant new product uses. The VTAC will then review the testing needs based on established protocol and principles. Once the review is complete, the VTAC will make testing recommendations to the appropriate product manager. 7 VVV 00001334-4 The actual commencement of testing is dependent on the commercial potential of the product. A decision on when to test will be made jointly by the product manager and the VPSAG. DOCUMENTATION All correspondence relating to the review of testing needs shall be placed in the New Product File which will be established and maintained by the product manager or product supervisor responsible for the product area in which the new product is being developed. This will include the written request for review, the VTAC documentation of its review, the determination letter or recommendation of testing needs to the product manager, and the results of such testing if conducted. vw 000013345 8 SEQUENCE STEP 2(dl COMPLETE AND FILE PREMANUFACTURE NOTIFICATION FORMS ACTION All products used, manufactured, or imported into the United States must be handled under specific exemption procedures (see Sequence Step 1(a)) or be on the Toxic Substances Control Act (TSCA) Chemical Substances Inventory. To get a substance on the inventory the initial step is to file a Premanufacture Notification (PMN) with EPA. (See form PMN in Appendix 2(d) hereto) . A PMN is a form containing specified test data, chemical identify, process and use descriptions, production volumes, and environmental release and exposure estimates. If it has been determined that a PMN is required , this step of the process should be Initiated as early as is feasible based on the potential resources needed to successfully complete a PMN and the timing desired for commercialization. A PMN can take as little as 90 days after submittal for approval, but if specific toxicological or environmental fate and effect data is needed the time to develop this data must be considered. It is not unlikely that it could take 6-12 months to generate data known to be required by the agency for certain classes of chemicals. Testing costs could easily exceed 100,000 in some cases. Early discussions with EPA may help identify necessary data. This process can be started by the VPSAG during Step 2(b) if indicated. 9 0000^3^ \|MM ... o A fee of $2,500 must accompany the PMN application. RESPONSIBILITIES The individual researcher is responsible for initiating the PMN application process. The Biomedical and Environmental Affairs Department and Biological Technology group in R&D should be consulted to obtain forms, instructions and technical guidance on completing the form. DOCUMENTATION A copy of the completed application should be sent to the New Product File maintained by the Product Manager and to the Biomedical and Environmental Affairs Department. 10 vvv 000013347 SEQUENCE STEP 2(f) HAZARD ASSESSMENT ACTION The federal Occupation Safety Health Act Hazard Communication Standard requires a hazard determination be done on all products to determine exact physical or health hazards. In addition, product liability concerns dictate a review of product design and inherent defect potentials, and potential misuses of the product. The results of the hazard determination determine Material Safety Data Sheet and warning label content, DOT classification, end use acceptability, and multiple regulatory classifications including SARA Tile III, Section 311, 312, and 313 status. The assessment is done according to established regulatory requirements and Vista procedures. (See Appendix 2(f))....Needs revision. RESPONSIBILITY The Vista Product Safety Assessment Committee and the Biomedical and Environmental Affairs Department are responsible for performing the hazard assessment. These two groups encompass the necessary expertise and regulatory knowledge to complete a total hazard assessment, and are in a position to have access to the data needed. 11 0013348 The assessment will be done following the receipt by the Biomedical and Environmental Affairs Department of the results from Sequence Steps 2(a) and 2(b). DOCUMENTATION All regulatory determinations and hazard classifications will be documented in writing and placed in the New Product File established and maintained by the product manager or product supervisor responsible for the product area in which the new product is being developed. The determinations will include OSHA class, DOT hazardous materials classification, SARA Title III determinations, FDA allowable uses and other applicable state or international categories. 12 VVV 000013349 SEQUENCE STEP 2 (a') REVIEW OF PLANT IMPACT ACTION If the new product production will require any changes in the raw material feedstocks, additives, catalysts, or process equipment at the manufacturing facility a detailed review of the impact of such changes upon plant operations and plant regulatory requirements must be made. The scope of this review will vary significantly between different new products depending upon the extent of changes from existing plant operations and materials. Beyond the plant operational and safety considerations which should be detailed in this review, a careful scrutiny of all potential regulatory aspects of introduction of the changes or new substances at the plant location should be carefully reviewed with plant, Legal, and Biomedical and Environmental Affairs personnel. Examples of potential impacts include wastewater system permit changes, air emissions permit changes, Superfund or SARA reporting changes, and worker personnel protective equipment changes. RESPONSIBILITY Responsibility for the plant impact review rests with the manufacturing facility engineering, environmental and safety personnel. The reason for this is based upon their familiarity with 13 both the plant process equipment and the regulatory programs directly affecting the manufacture of the new product. If the manufacture of a new product is to occur at a toll processor or other ex-plant location , the Ex-Plant Operations Group in Supply and Transportation should be contacted to conduct an audit and evaluation of the facility. DOCUMENTATION The plant impact review must be documented by a completed check list together with any supporting memoranda necessary to explain particular impacts identified by the review checklist. The plant impact review checklist and documentation must be completed in sufficient time to allow for the preparation and filing of any regulatory required documents, the design and implementation of any process changes or modifications, and in sufficient time to allow for the completion of all necessary changes prior to the production of commercial quantities of the new product. The completed review checklist must be forwarded to the New Product File maintained by the product manager or product supervisor responsible for the new product. Sample checklist is attached in Appendix 2(g). VVV 000013351 14 o SEQUENCE STEP 2(h) DEVELOPMENT OF COMMERCIAL MSPS AND LABEL TEXT ACTION The federal Occupational Safety and Health Act ("OSHA") Hazard Communication Standard requires that a Material Safety Data Sheet ("USDS") be prepared for all hazardous materials. The MSDS must be distributed to customers and other users or handlers of the products. Hazardous material containers must contain labels with the appropriate chemical identity and hazard warning. Further, product liability concerns and Vista procedures require MSDS's for all products, whether OSHA hazardous or not, and in some instances require labels for products that are not defined as hazardous by OSHA. RESPONSIBILITY After receiving a written request from the product manager or supervisor, the Biomedical and Environmental Affairs Department will prepare MSDS and label text for new commercial products according to established procedures. (See Appendix 2(h)). ... (Needs revision) The MSDS's are developed using data developed in the preceding sequence steps and a documented review done by appropriate Vista 15 VVV 000013352 personnel and departments. The label text is developed according to the ANSI Labeling of Hazardous Materials guidelines and entered into the computerized labeling system maintained by the Biomedical and Environmental Affairs Department, Additions to the standardized labeling scheme text may be appropriate on occasion. DOCUMENTATION The documented MSDS review records and the labeling text determination documents shall be sent to the New Product File maintained by the product manager or product supervisor for the new product. Additional copies of these documents will be maintained in the Biomedical and Environmental Affairs Department. 16 00001^^53 VVV SEQUENCE STEP 2(t) DOT CLASSIFICATION FOR COEDS ENTRY ACTION The federal Department of Transportation ("DOT") has established a regulatory classification scheme to describe and communicate the hazards of hazardous materials in transportation. There are specific criteria listed in the DOT regulations that dictate testing methods and physical and chemical characteristics that are to be used to classify chemicals. This classification is entered into Vista's Computerized Order Entry Data System ("COEDS") HAZ MAT section to assure appropriate descriptions and instructions are printed on our computer generated bills of lading for transportation of the product. For products being shipped in commercial quantities, such as drums, tank trucks or railcars, that are not given a new COEDS number the DOT review must be initiated by written request from the Product Manager. The results of this review must be sent to the shipping location to assure any hazardous materials descriptions, or other DOT requirements, are met by "hand" , since no BOL descriptions will be otherwise entered. RESPONSIBILITY 17 VVV 000013354 A procedure has been established to assure all COEDS entry forms are reviewed by the Biomedical and Environmental Affairs Department before entry into COEDS. The Product Manager is responsible for completing the COEDS entry form and forwarding it to the department. (See Appendix 2(i)). This Department will determine the correct DOT classification for the product, complete the COEDS entry form and forward to the Supply & Transportation Traffic Supervisor for COEDS entry. As described above, commercial products not being given a new COEDS number must also be reviewed. The product manager is also responsible for assuring this review by requesting it be done in writing. DOCUMENTATION A copy of the COEDS entry form will be sent to the New Product File maintained by the product manager or product supervisor responsible for the new product. Physical, chemical and toxicological data used to support the determination should be attached to the file copy of the entry form. VVV 000013355 18 ACTION SEQUENCE STEP 3(a) COMMENCEMENT TO MANUFACTURE NOTICE Under the Federal Toxic Substances Control Act EPA requires the submission of a Premanufacture Notification form for the manufacture or importation of a new chemical substance. (See Sequence Step 2(d)). Once a Premanufacture Notification has been submitted and approved, EPA must be notified of the commencement of manufacture or import. This Notice of Commencement must be submitted to EPA within 30 days after manufacture or import begins. The commencement notice must identify the chemical along with its premanufacture notice number and the date when commercial manufacture or importation began. It is critical that the Notice of Commencement is properly filed since the new chemical substance is not formally added to the Chemical Substance Inventory until the commencement notice has been received by EPA. RESPONSIBILITY Responsibility for insuring that a Commencement to Manufacture Letter is filed rests with the manufacturing location, in most instances the Environmental Department. The reason for this is that the manufacturing location producing or importing the new chemical substance is in the best position to know the exact time at which 19 VVV 00001335b the initial manufacturing or importation began, allowing for a prompt development and submission of the notice. DOCUMENTATION For each new product for which a Commencement to Manufacture Notice is required to be filed, a copy of the Commencement to Manufacture Letter should be promptly placed in the New Product File which will be established and maintained by the product area manager or product area supervisor responsible for the product areas in which the new product is being developed. A copy of the Sample Commencement to Manufacture Letter is included in Appendix 3(a) hereto. 20 & VVV 000013357