&EPA United States Office of Research and Development Environmental Protection National Health and Environmental Agency Effects Research Laboratory Research Triangle Park, NC 27711 September 2000 Standard Operating Procedure for Technical Information Management ------- 0 Standard Operating Procedure for ;hnical Information Management September 2000 / National Health and Environmental Effects Research Laboratory Office of Research and Development U.S. Environmental Protection Agency Research Triangle Park, NC 27711 ------- FOREWORD This document is intended as a guide for the National Health and Environmental Effects Research Laboratory (NHEERL) in managing technical information as a major program. As required by EPA Order 2200.4a, all ORD work products issued in the name of the Agency must also undergo review and clearance before publication and external distribution. Information is provided for processing all work products of the organization to ensure that NHEERL adheres to Agency and ORD official policies and procedures for review, processing, clearance, tracking, publication, and dissemination of all NHEERL scientific and technical information products. It is important to note that the review process applies not just to EPA employees, but also to contractors and others performing research or publishing statements on behalf of EPA/ORD. With the issuance of this SOP, NHEERL Division Directors are delegated responsibility for ensuring the quality of their Division's work products and that proper technical reviews are completed and undergo clearance before products are published. The guidance in this SOP is for technical information product Categories 3 and 4. l ------- NHEERL Technical Information Management Standard Operating Procedure CONTENTS Foreword i I. Introduction 1 A. Background 1 B. Purpose 1 C. Responsibility 1 D. Technical Information Work Products 2 E. Review Policy 3 II. Authorship Requirements 4 A. Policy 4 B. Level of Contribution 4 III. Clearance and Reviews Required 4 A. Reviews Required 4 B. Review and Clearance of Non-technical Products 4 C. Responsible Officials for Clearance of Tech Info Documents 5 D. Purpose of Technical Review and ORD Peer Review Categories 6 E. Editorial Review 7 F. Technical Review 7 G. Quality Assurance (QA) Review 7 H. Policy Issue Responsibilities 8 IV. Forms and Requirements for Processing 8 A. ORD Clearance Form, ORD Form 362 (Cin-Rev. 12/99) 8 B. Technical Manuscript Review Form, EPA Form 363 (Cin) (5/82) 9 V. Reference Chart for Processing Publications (By Type) 9 VI. Disclaimers and Other Notices 9 A. Disclaimers, Other Notices, and/or Other Related Information 10 1. Journal Article (In-House) 10 2. Journal Article (Extramural) 10 3. Symposium Paper, Book Chapter 10 4. Presentation Abstract (Oral and Poster) 10 5. Project Report 10 6. Internal Report 11 7. Other Product Types 11 a. Unpublished Reports 11 li ------- NHEERL Technical Information Management Standard Operating Procedure b. Reports Prepared Under an Assistance Agreement 11 B. Web Page Disclaimers 12 1. Copyright Status 12 2. Disclaimer of Endorsement 12 3. Disclaimer of Liability 12 VII. Copyright 13 VIII. Publication Tracking 13 A. Work Outcome/Output Product System (WOOPS) 13 B. Reports That Can Be Generated from WOOPS 14 C. Responsibilities 14 1. TIMs 14 2. National TIPM 15 D. Reporting 15 IX. Publication Requirements 16 A. Journal Article 16 B. Research Report 16 C. Project Reports 17 D. Project Summary 17 E. Unpublished Reports 17 F. EPA-Sponsored Technical Conferences and Proceedings 17 G. Technical Newsletter 17 H. Papers/Articles/Symposium Presentations, Book Chapters and Any Other Technical Product Published by Other than EPA 18 I. Applications Guides (User's Guides, Design Manuals, Handbooks) 18 J. Summaries/Syntheses (also known as Environmental Research Briefs), Bulletins, Technical Brochures, Diskettes, Fact Sheets (that are intended for publication) 18 K. Flyers 19 L. Internal Reports 19 M. Electronic Documents Posted on NHEERL Internet/Intranet 19 N. Report Numbers 19 O. Records Management 19 P. Product Distribution 20 Q. Printing 20 X. Attachments 20 XI. References 21 iii ------- NHEERL Technical Information Management Standard Operating Procedure I. Introduction A. Background The National Health and Environmental Effects Research Laboratory (NHEERL) was created by an Office of Research and Development (ORD) reorganization in 1995. NHEERL was formed by the consolidation of several research laboratories located throughout the country and with various research responsibilities. These former laboratories are: Corvallis Environmental Research Laboratory, Corvallis, OR Duluth Environmental Research Laboratory, Duluth, MN Gulf Breeze Environmental Research Laboratory, Gulf Breeze, FL Health Effects Research Laboratory, Research Triangle Park, NC Narragansett Environmental Research Laboratory, Narragansett, RI The consolidation of these organizations centralizes EPA's and ORD's national research in the health effects and ecological research program areas and combines unique opportunities for investigating new and emerging problems. A new standard operating procedure (SOP) for processing scientific and technical information products that reflects the organizational changes is essential to the successful management and documentation of NHEERL's progress and contributions to the scientific community and the public. B. Purpose This SOP establishes the official policies and procedures for review, processing, clearance, tracking, publication, and dissemination of all NHEERL scientific and technical information products. It is EPA's policy that all scientific and technical information to be published or presented in the name of the Agency must undergo the peer review process. The review process applies not just to EPA employees, but also to contractors and others performing research or publishing statements on behalf of EPA/ORD. The technical information product review and clearance processes that are identified within this SOP meet or exceed the Agency's requirements for management of technical information as a major program. C. Responsibility The NHEERL National Technical Information Program Manager of the National Outreach, Information and Technology Staff (NOITS) has responsibility for providing oversight and guidance to the NHEERL Division Technical Information Managers (TIMs) so that there is a consistent record for accomplishing the processing and tracking actions required for management of NHEERL's technical information products. With the issuance of this SOP, NHEERL Division Directors are delegated responsibility for ensuring the quality of their Division's work products and that proper technical reviews are com- pleted and undergo clearance before products are published. In addition, Division Directors must ensure that a TIM has been designated for their Divisions for processing their technical information products in accordance with this SOP. A list of the NHEERL TIMs is included as Attachment A. 1 ------- NHEERL Technical Information Management Standard Operating Procedure The NHEERL Division Directors are delegated authority to have their own internal SOPs. For example, the Ecology Divisions may wish to include the Associate Director for Science in the clearance process; however, only the Division Director is delegated responsibility for approval, and this authority cannot be redelegated below the Division Director level. D. Technical Information Work Products Scientific or technical work products are defined as ORD reports, manuals, journal articles, papers, presentations, test methods, and all other documents authored/co-authored, printed, or issued by EPA/ORD or its personnel or published in peer-reviewed and non-peer-reviewed journals. Examples of product types are: 1. Journal Article (Non-Peer Reviewed and Peer Reviewed) - articles proposed for publication in scientific, peer-reviewed and non-peer-reviewed journals. The majority ofNHEERL's publications are journal articles. 2. Symposium Paper - paper prepared for presentation at scientific symposia.. 3. Symposium Proceedings - includes papers that have been previously reviewed and cleared. NOTE: Proceedings must be cleared before final publication and may be published by EPA or may also be published in Journals. 4. Book/Book Chapter - technical material prepared as a book or part of a book that has contributing authors in the noted area of expertise. 5. Research Report - may be the results of a single major research project, a synthesis of several related research projects, or a special technical report deemed necessary to meet an important information need. The Research Report is a book-length presentation of the best of EPA/ORD's research findings and normally contain the most authoritative results of a research project on a critical area of interest in which the Agency is involved. These reports do not normally contain large volumes of supporting research data. 6. Project Report - most EPA research is documented and made available to the research community in a project report. Usually, these reports are required when (1) neither a journal article nor an EPA research report is produced, or (2) the journal article or EPA research report published is incomplete in terms of fully documenting the project or would require additional background data if challenged by the scientific community. 7. Project Summary - is a short synopsis of the key findings of a research project. Project summaries are primarily written to allow an individual to determine whether he/she wishes to purchase the full project report from the National Technical Information Service (NTIS). The summary should be as short as possible, ideally less than four printed pages in length, but they may be up to 12 pages. For every project report produced, a project summary must also be generated. 8. Applications Guides: User's Guide, Manual, Handbook - generally treated the same as project reports and summaries, but the content is more in-depth and may require more extensive review. 2 ------- NHEERL Technical Information Management Standard Operating Procedure 9. Software Programs/Diskettes - usually accompany User's Guides, Manuals, and/or Handbooks. The electronic format conveys technical information in an interactive format for users and typically contains a searchable database for information and/or problem solving techniques relevant to a research area. 10. Environmental Research Brief or Research Brief - a short technical summary of the status, results, or major advances in ORD research. 11. Abstract, Oral Presentation - brief summary of technical research that will be presented in a technical forum, such as the Society of Toxicology (SOT) or Society of Environmental Toxicology and Chemistry (SETAC). An abstract may also prepared for a planned poster session that will be presented at a conference. 12. Brochure (technical), Newsletter (technical), Bulletin (technical), Fact Sheet and other technical information materials for public distribution - includes technical documents that are published with an EPA number and distributed either as paper copy or posted on the Agency's/NHEERL's Internet (public) web pages. NOTE: Bulletins are used by ORD for the Superfund Innovative Technology Evaluation program or for Emerging Technologies, such as the technologies evaluated under the Environmental Technology Verification program and are not used for health and environmental effects research issues. 13. Flyer - usually one-page brief summary that conveys project status or related technical information to the research community and stakeholders but does not discuss specific research results. Flyers are also used to announce technical seminars or symposia. NOTE: requires administrative clearance only. 14. Internal Report - report of technical findings that must be cleared but is not intended for public distribution, i.e., outside of EPA. 15. Unpublished Report - report of technical findings that is reviewed, but a decision not to publish has been made for various reasons, such as policy concerns or implications. E. Review Policy EPA Order 2200.4a, "EPA Publications Review Policy," "...establishes policy and pro- cedural requirements for the review of materials published or issued by the Environmental Protection Agency...." All ORD work products issued in the name of the Agency must also undergo review and clearance before publication and external distribution. With the issuance of the EPA Order in 1984, the Agency delegated responsibility to ORD for review, clearance, and publication of its work products, and we must ensure that all products prepared and issued are of consistently high quality and are published in the most cost-effective manner. In addition, all non-scientific products and any products citing any new Agency policy may require review and approval by EPA's Office of Communications, Education and Media Relations (OCEMR). Non-scientific products must be approved in concept before actual document preparation. All proposed non-technical work products should be coordinated with the NHEERL National Technical Information Program Manager who will determine if there is a need to forward the product to ORD's 3 ------- NHEERL Technical Information Management Standard Operating Procedure Product Review Officer (PRO). The PRO has responsibility for liaison and coordination with OCEMR. For further guidance on communications products that are planned to promote awareness of health and environmental effects research, please contact the NHEERL National Technical Information Program Manager. II. Author Requirements A. Policy The names of those individuals who have made substantial contributions to a research project are typically included as authors and may be NHEERL federal employees, contract employees, or cooperative agreement or interagency agreement collaborators. B. Level of Contribution The principal investigator has responsibility for listing authors based on their contributions. To qualify as an author, the author must make significant contributions to the development of the research product in at least two of the areas listed below: 1. Formulation of hypotheses and conceptualization of a research approach. 2. Experimental design. 3. Hands-on laboratory work and technical support 4. Data interpretation and analysis. 5. Manuscript preparation. The first author is usually responsible for steps 1, 2, and 5, while the co-author(s) may be primarily responsible for steps 2, 3, and 4, plus manuscript review. All co-authors should be able to describe the purpose of the research, the procedures employed, any unique adaptations made, techniques developed, unique or unusual devices developed, and the analysis of data and results obtained. III. Clearance and Reviews Required A. Reviews Required All ORD work products, including non-scientific products, issued in the name of the Agency must undergo review and clearance before publication and external distribution. The procedures outlined in this SOP are intended for processing the majority of NHEERL's work products which are included in Peer Review Categories 3 and 4. For category definitions, please refer to Section III, |C below. In addition, Attachment B provides a crosswalk that identifies and compares ORD and NHEERL minimum review and clearance requirements for technical information products that are discussed in Section I, " D B. Review and Clearance of Non-technical Products Any proposed non-technical work products should be coordinated with the NHEERL Techni- cal Information Program Manager who will determine if there is a need to forward the product to ORD's Product Review Officer (PRO). The PRO has responsibility for liaison and coordination with OCEMR. 4 ------- NHEERL Technical Information Management Standard Operating Procedure If NOITS approves the concept and it is determined to be non-technical/non-scientific in nature, the ORD PRO and then OCEMR have responsibility for final approval of the concept before the product is created. Once approval is received, the final product must be reviewed and cleared within NHEERL, and then submitted through NOITS to the ORD PRO, who is located in the office of the ORD Assistant Administrator, Washington, DC. The PRO provides liaison between ORD and OCEMR. The OCEMR Product Review Guide is located on their web site at URL http://intranet.epa. gov/ocemr-review/. This web site includes examples of what does and does not need OCEMR review. For NHEERL advice and guidance on management of this process, contact the NHEERL Technical Information Program Manager.. C. Responsible Officials for Clearance of Tech Info Documents Once all reviewers' comments have been addressed in the draft document, the package is submitted to the first level supervisor for review and concurrence. When management believes the manu- script is of high quality, it is then transmitted to the next level of supervision for approval. Authority for approval (signature on the ORD Form 362 for clearance) is delegated as follows for technical information products in Peer Review Categories 3 and 4: 1. Division Directors have authority for approval of products prepared by employees in their respective Divisions. Approval levels are: (1) Branch Chief (concurrence), and (2) Division Director (approval). 2. For products prepared by the Division Director (authored or co-authored), approval authority is delegated to the Associate Director for Health for Health Divisions and to the Associate Director for Ecology for the Ecology Divisions. 3. For products prepared by the Associate Directors for Health and Ecology, and the Director, RPCS, the Laboratory Director is the approving official. 4. For products prepared by the Directors, NARMS and NOITS, approval authority is delegated to the Deputy Director for Management. 5. For products prepared by BRSS, approval authority is delegated to the Associate Director for Health. 6. For products prepared by the ALD's, approval authority is delegated to the Director, RPCS. 7. For products prepared by EMAP-RTP, approval authority is delegated to the Associate Director for Ecology. 8. Any products affecting policy or recommending new policy must be concurred by the immediate supervisor and all management in the line of authority and approved by the Laboratory Director. A memorandum must be attached to the clearance package explaining the policy issues. D. Purpose of Technical Review and ORD Peer Review Categories 5 ------- NHEERL Technical Information Management Standard Operating Procedure A uniform technical review process ensures that ORD's scientific and information products are of high quality and based on credible scientific and technical data and knowledge. NHEERL prefers the designation of reviews for products in Categories 3 and 4 as technical reviews, although the Agency and ORD use the general name of peer review for all Categories 1-4. The distinction is based on the guidance and review requirements outlined in the "Science Policy Council Handbook" for Category 1 and 2 work products. The four ORD peer review categories are discussed in the following paragraphs. 1. Category 1 - Major Scientific or Technical Work Products Scientific, engineering, and economic work products that are used to support a regulatory program or policy position and that meet at least one, and probably more, of the following criteria: a. Supports major regulatory decisions or policy/guidance of major impact b. Establishes a significant precedent, model, or methodology c. Addresses controversial issues d. Focuses on significant emerging issues e. Has significant cross-Agency/interagency implications f. Involves a significant investment of Agency resources g. Considers an innovative approach for a previously defined problem/process/methodology h. Satisfies a statutory or other legal mandate for peer review Category 1 products are those that are thought to have a higher probability for major public discussion (e.g., scientific, technical, economic). Generally, the more novel or complex the science or technology, the greater the cost implications of the impending decision, and the more controversial the issue, then the stronger the indication for more extensive and involved peer review-thus another indicator of a candidate for Category 1 classification. Products are selected for Category 1 review by the NHEERL Director and approved by the Assistant Administrator for Research and Development (AA/ORD). Examples of Category 1 products would be Criteria Documents, risk assessment guidelines, or risk assessment methodologies. These types of products require extensive external review, written comments, and responses to the comments and may involve publication in the Federal Register and posting on the Internet for public comment periods, as well. Publication of these documents is approved by the AA/ORD. 2. Category 2 - Important Scientific or Technical Work Products Work products that are important to EPA decision making that may not have an immediate impact on current or pending regulations or policy and do not fall into Category 1 are candidates for Category 2 review. While the distinction between Categories 1 and 2 is subjective, Category 2 work products are not likely to be the subject of major public discussion. NHEERL Category 2 research is defined as research of high programmatic relevance which is expected to complement Agency rulemaking, regulations, or policy. Examples of Category 2 products are chemical-specific assessments, risk metho- dology/guidance, or models. These work products are approved for publication by the NHEERL Director. 3. Category 3 - General Scientific or Technical Work Products 6 ------- NHEERL Technical Information Management Standard Operating Procedure These are work products that are published in recognized peer-reviewed journals or similar publications. Examples include journal articles, conference proceedings, books, or book chapters. 4. Category 4 - Other Scientific or Technical Work Products These work products are scientific or technical reports published with an EPA or ORD imprimatur that do not fall into Categories 1-3. Examples include environmental research briefs, technical assessments, or published research or project reports with general research findings and reference materials where more extensive presentation of material is more appropriate than could be done in a journal article. A table listing ORD Peer Review Categories and review and record keeping requirements is included as Attachment C. E. Editorial Review 1. Requirements It is ORD's and NHEERL's policy that all technical information products convey an image of consistently high quality. The author, principal investigator, and/or project officer are responsible for ensuring and obtaining adequate editorial review of technical information products. 2. How Accomplished, Sources of Expertise/Assistance If editorial support is not available within the Division, the Division has the option of providing financial resources to the NOITS management support contract to procure services or the Divisions may prefer to obtain their own editorial support through a small purchase procurement. F. Technical Review Technical reviews of NHEERL work products are required for almost every type of product. The Technical Manuscript Review Form (EPA-363) is used to initiate and document reviews. In general for Categories 3 and 4 as discussed in Section III, " D. ORD requires two technical reviews for each product, with requirements and exceptions noted in a chart included as Attachment D. If there are questions, issues, or comments by reviewers, the project officer must clearly resolve any all technical issues. These issues may be documented with a memorandum addressing how these questions have been resolved, or the project officer may make clearly marked notes on the manuscript which resolve any issues. This documentation will be included as part of the clearance package, along with the EPA-363 review forms. G. Quality Assurance (QA) Review NHEERL has an active QA program, with a National QA Manager who is responsible for directing and overseeing the Laboratory's quality assurance program to ensure NHEERL science meets the minimum requirements of the mandatory Agency-wide Quality System described in EPA Order 5360.1, Chg 1. Each Division also has quality assurance managers who are part of the NHEERL team with responsibility for ensuring that all Divisions have approved quality management plans, conduct assess- ments of the Division's QA programs, participate in technical systems reviews of research projects, and 7 ------- NHEERL Technical Information Management Standard Operating Procedure oversee the Laboratory's record keeping procedures to ensure that scientific and administrative records properly reflect and support the research programs. Before any research is conducted, a QA project plan must be approved. The quality assurance/quality control exercised under the jurisdiction ofNHEERL's QA program precludes further QA review of any externally peer-reviewed technical information product and is in compliance with NHEERL's Quality Management Plan and the Agency's mandatory guidance. Any non-peer-reviewed products, e.g., EPA report, must be reviewed by a QA Manager prior to release. It is the author's responsibility to ensure that QA approval is obtained from the QA Manager when required and to adhere to the Division's QA program requirements. H. Policy Issue Responsibilities If the author indicates "Yes" on the ORD Clearance Form 362 (Cin-Rev. 12/99) in Block 17, "This Product enunciates new policy or affects existing policy," then the author must identify the issues in a memorandum addressed to the Laboratory Director with concurrence from the immediate supervisor and all management in the line of authority for the author. A sample policy memorandum is included as Attachment F. The author should provide adequate information as listed below: 1. Identification of Policy Issues (Author/Principal Investigator) 2. Resolution (Author/Principal Investigator, et al.) 3. Concurrence (Branch Chief and Division Director) 4. Final approval/acceptance of identified issues and proposed resolution (Laboratory Director) (Block 18 of ORD Clearance Form 362) 5. Notify NOITS Public Affairs and work with the staff member to develop a Fact Sheet for the Laboratory Director which will be provided to the AA/ORD. NOITS will coordinate the development of the Fact Sheet with the author and provide guidelines and facilitate clearance by NHEERL management. IV. Forms and Requirements for Processing A. ORD Clearance Form, ORD Form 362 (Cin - Rev. 12/99) 1. Instructions for Completing Form (part of electronic file) a. Block 1 - leave blank. b. Block 2 - see instructions included with form. c. Block 3 - assign a draft number as discussed in the WOOPS database guidance. Each Division will assign a unique identifying number, such as AED (for Division's initials, fiscal year (two-digit format—00 for 2000), and a three-digit number (minimum of three digits is recommended). An example number would be: AED-00-001. d. Block 4 - see instructions included with form. e. Blocks 5-6 - self-explanatory. f. Block 7 - Internet address is the URL where the electronic version of the product may be or is planned to be posted on a server. g. Block 8 - include current fiscal year GPRA and research area numbers (FY 2000 chart attached) 8 ------- NHEERL Technical Information Management Standard Operating Procedure h. Block 9 - this is the EPA project officer and/or principal investigator i. Block 10 - self explanatory j. Block 11 - select appropriate product category k. Block 12 - include full citation as appropriate 1. Block 13 - TIM signature & date m. Block 14 - originator, management concurrences n. Block 15 - self-explanatory o. Block 16 - peer review categories (See Section III, "Clearance and Reviews Required" of this SOP for guidance for proper category selection. The majority of NHEERL's products are journal articles which are Category 3.) p. Block 17 - see Section III, |F of this SOP for further information, q. Block 18 - approving official. Delegations are listed in Section III, |C. 2. Blank Form on NHEERL@Work. URL for location of "fillable" electronic form in Adobe Acrobat portable document format (PDF) or in WordPerfect format is http://www.nheerl.epa.gov/admin/ See sample forms in Attachment E. B. Technical Manuscript Review Form, EPA Form 363 (Cin) (5/82) 1. Instructions for Completing Form a. Title/Draft No. 1 - self-explanatory b. Author(s) - add all author names c. Date Review Requested - self-explanatory d. Date Review Required - self-explanatory e. Project Officer/Organization Address - self-explanatory (EPA person) f. Reviewer/Organization Address - self-explanatory g. Type of Publication/Audience - put product type and if being presented include title of meeting and dates h. Review Coordinator (Division TIM) 2. Blank Form NHEERL@Work. URL for location of electronic form in PDF or WordPerfect format is http://www.nheerl.epa.gov/admin/ . See sample forms in Attachment E. V. Reference Chart for Processing Publications (By Type) A reference chart for processing requirements for each publication type is included as Attachment D. This chart is provided to facilitate the tech info management process for the author/principal investi- gator and TIMs. VI. Disclaimers and Other Notices Disclaimers are required for technical information products. Example disclaimers for product types are included and have been excerpted from "Technical Information Policy and Guide of the Office of Research and Development," EPA/600/9-91-004, June 1991, Appendix F, pgs 42-43, as well as the more recent publication, "Handbook for Preparing Office of Research and Development Reports," Third Edition EPA/600/K-95-002, August 1995. 9 ------- NHEERL Technical Information Management Standard Operating Procedure A. Disclaimers, Other Notices, and/or Other Related Information 1. Journal Article (In-House) The information in this document has been funded wholly (or in part) by the U. S. Environmental Protection Agency. It has been subjected to review by the National Health and Environmental Effects Research Laboratory and approved for publication. Approval does not signify that the contents reflect the views of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommend- ation for use. 2. Journal Article (Extramural - work prepared under contract, interagency agreement, cooperative agreement) (Point of Contact or Project Officer should be NHEERL employee) Although the research described in this article has been supported by the U. S. Environmental Protection Agency through (insert contract, interagency agreement, or cooperative agreement number) to (insert organization name and applicable information), it has not been subjected to Agency review and therefore does not necessarily reflect the views of the Agency and no official endorsement should be inferred. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. (Add disclaimer statement for documents containing proprietary information, if applicable.) 3. Symposium Paper, Book Chapter This document has been reviewed in accordance with U. S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. 4. Presentation Abstract (Oral and Poster) This is an abstract or a proposed presentation and does not necessarily reflect EPA policy. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. 5. Project Report The information in this document has been funded wholly or in part by the U. S. Environmental Protection Agency under (insert contract, interagency agreement, or cooperative agreement number) to (insert organization name and applicable information). It has been subjected to review by the National Health and Environmental Effects Research Laboratory and approved for publication. Approval does not signify that the contents reflect the views of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use. 6. Internal Report 10 ------- NHEERL Technical Information Management Standard Operating Procedure This document is intended for internal Agency use only. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. 7. Other Product Types a. Unpublished Reports Unpublished reports are those for which a decision has been made that publication would not be in the public interest for one or more of the following reasons: (1) the quality of the work was substandard, misleading, or so inconclusive as to have no scientific value; (2) the results duplicate those of a prior investigation; (3) the results are to be incorporated in subsequent reports (definitely planned, and early dissemination of partial results would not prove cost-effective; or (4) the publication was prepared under an assistance agreement (e.g., interagency agreement, grant, or cooperative agree- ment), and EPA cannot publish the material under its name. For (4), the project officer is an EPA/ORD employee, and the product should undergo review and clearance and be classified as an unpublished report (Block 11 of ORD Form 362). A memorandum justifying the decision not to publish or explaining the circumstances of (4) must be included with the clearance package. An unpublished report should not be posted on EPA's Internet. For purposes of satisfying a deliverable for a project as noted in (4) above, the report should undergo review and admin- istrative clearance so that the project officer can receive credit for the deliverable. However, NHEERL can reference the material on its web site and link to the assistance agreement organization's web pages for the complete document. The link to an organization outside of EPA's domain should include the appropriate disclaimer included in the paragraph below: "The information in this document has been funded wholly or in part by the U. S. Environmental Protection Agency under (insert interagency agreement, grant or cooperative agreement number) to (insert organization name and applicable information). It has been subjected to review by the National Health and Environmental Effects Research Laboratory and has been approved for publication, but research results will be published elsewhere (e.g., refer to URL of web site of assistance organization or under assistance organization's imprimatur). Approval does not signify that the contents reflect the views of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use." b. Reports Prepared Under an Assistance Agreement (i.e., Interagency Agreement, Grant, or Cooperative Agreement) Cannot be Published by EPA Research results documented in reports under the auspices of an assistance agreement may or may not include one of the authors who is an NHEERL employee. However, an NHEERL employee should be the project officer. For purposes of satisfying a deliverable for a project, the report should undergo review and administrative clearance so that the project officer can receive credit for the deliverable. In these cases, EPA cannot publish the material under its name. However, NHEERL can reference the material on its web site and link to the assistance agreement organization's web pages (if they exist) for the complete document. The link to an organization outside of EPA's domain would include the appropriate web page disclaimer and graphic. If the organization does not have a web page, then the EPA web statement could refer to a point of contact, telephone number, and mailing address of the assistance organization 11 ------- NHEERL Technical Information Management Standard Operating Procedure for further information. The "referring" paragraph on the web page should be similar to the disclaimer: "The information in this document has been funded wholly or in part by the U. S. Environmental Protection Agency under (insert interagency agreement, grant or cooperative agreement number) to (insert organization name and applicable information). It has been subjected to review by the National Health and Environmental Effects Research Laboratory and has been approved for publication, but research results will be published elsewhere , e.g., web site of assistance organization or under assistance organization's imprimatur. Approval does not signify that the contents reflect the views of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use." B. Web Page Disclaimers Disclaimers are also required for electronic media (for electronic media, excerpted from EPA web guide URL http://www.epa.gov/webguide/) 1. Copyright Status: The U.S. Government retains a nonexclusive, royalty-free license to publish or reproduce these documents, or allow others to do so, for U.S. Government purposes. These documents may be freely distributed and used for non-commercial, scientific, and educational purposes. Commercial use of the documents available from this server may be protected under the U.S. and Foreign Copyright Laws. Individual documents on this server may have different copyright conditions and these conditions will be noted in those documents. 2. Disclaimer of Endorsement: Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government. The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government and shall not be used for advertising or product endorsement purposes. 3. Disclaimer of Liability: With respect to documents available from this server, neither the United States Government nor any of their employees, makes any warranty, express or implied, including the warranties of merchantability and fitness for a particular purpose, or assumes any legal liability or responsibility for the accuracy, completeness, or useful- ness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. While we try to keep the information timely and accurate, we make no expressed or implied guarantees. We will make every effort to correct errors brought to our attention. In addition, since EPA cannot guarantee protection from potential alteration or tampering of the materials on this server by outside parties, these materials do not constitute "official" versions, and they are not intended, nor can they be relied upon, to create any rights enforceable by any party in litigation with the United States. Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not necessarily constitute or imply its 12 ------- NHEERL Technical Information Management Standard Operating Procedure endorsement, recommendation, or favoring by the United States Government and shall not be used for advertising or product endorsement purposes. The documents on this server contain hypertext pointers to information created and maintained by other public and private organizations. Please be aware that we do not control or guarantee the accuracy, relevance, timeliness, or completeness of this outside information. Further, the inclusion of pointers to particular items in hypertext is not intended to reflect their importance, nor is it intended to endorse any views expressed or products or services offered by the author of the reference or the organization operating the server on which the reference is maintained. VII. Copyright It is important to note that no U. S. copyright can be applied to work prepared by a U. S. govern- ment employee. References are to the following guidance which provide legal information that is applicable to all ORD scientific and technical documents: A. "Technical Information Policy and Guide of the Office of Research and Development," EPA/600/9-91-004, June 1991, Appendix D, and B. "Handbook for Preparing Office of Research and Development Reports, Third Edition," EPA/600/K-95-002, August 1995, Chapter 2. VIII. Publication Tracking A. Work Outcome/Output Product System (WOOPS) WOOPS is a product tracking system designed to replace and expand older non-Oracle in-house systems that were used to track technical information products. WOOPS was developed using the Oracle relational database management system. It is accessed through Microsoft Windows™ on IBM PC-compatible desktop computers. The minimal configuration is a Pentium PC running Windows 3.1.1 or Windows 95 with at least 16 MB of RAM. WOOPS is the standard which NHEERL's nine divisions and staff offices use for tracking technical information products and replaces the previous technical publications tracking systems that were used. The system also has the expanded capability of identifying research products by Government Per- formance and Results Act (GPRA) goals and research areas. The Government Performance and Results Act (GPRA) requires government agencies to be accountable for its deliverables or outcomes of its research efforts. With the Laboratory-wide implementation of WOOPS, NHEERL has a consistent, centralized application that will support management's needs to monitor and document performance and research results and assist in future planning efforts. Guidance and WOOPS data entry instructions for NHEERL users have been provided to NHEERL TIMs. A WOOPS Manual produced by the National Environmental Exposure Laboratory is 13 ------- NHEERL Technical Information Management Standard Operating Procedure included with the guidance, as well as technical information document processing guidance. B. Reports that can be generated from WOOPS are: " 1. Count of Products by Author and Product Type "2. Count of Products by Division and Product Type "3. Count of Products per Fiscal Year by Type and Quarter "4. Count of Journal Articles per Calendar Year by Division "5. Count of Non-Journal Articles per FY by Type/Div "6. Citations by Author and Product Type "7. Citations by National Lab, Division, and Product Type "7A. Citations by Lab, Division and Product Type (Save to File) "8. Citations by Product Type "9. Monthly Technical Publications Report" NHEERL will typically use Report 7 to meet NHEERL's product tracking needs. Other reports may be developed in the future as needs arise. C. Responsibilities 1. TIMs NHEERL TIMs are responsible for coordination of all technical information products in their respective organizations. These duties and responsibilities include: a. Provide guidance for management and staff on technical information management issues, such as review policies, clearance of ORD products, printing requirements, distribution of products, and copyright issues. b. Maintain a comprehensive database (WOOPS) of all technical information products produced by the Division, which includes Division-specific numbers assigned by the TIM to all products initiated and cleared within the Division. c. Ensure that all technical information products are properly edited and formatted for publication and/or distribution. d. Ensure uniform application of Agency, ORD, and NHEERL procedures are followed for the review and approval (clearance) of technical information products. These procedures are included with this SOP. e. Ensure that required forms have been completed and processed appro- priately for each technical information product. These forms are: (1) ORD Clearance Form (ORD Form 362) - used for approval (clearance) of all technical information products. Requires management approval in author's management line of authority as delegated in Section III, |C of this SOP. 14 ------- NHEERL Technical Information Management Standard Operating Procedure (2) Technical Manuscript Review Form (EPA Form 363) - requests review and comment on technical information products. Documents reviewers' comments. (3) Technical Report Data (EPA Form 2220-1) - for submission of product to the National Technical Information Service (NTIS). (4) Printing, Distribution, and Inventory (EPA Form 2200-9) - if product is to be printed by EPA. (This form is located on E Forms on the Notes Mail database.) (5) Notification of Intent to Publish (Government Printing Office (GPO) Form 3868, 5/86) - for submission to GPO, primarily the Federal Depository Library Program. GPO's form is now available on the Internet at the following address: http ://www.access .gpo. gov/procurement/ditsg/forms .html If you want to fill out the form and submit it electronically, the Internet address is: http://www.access.gpo.gov/su docs/forms/3868/index.html (6) Other forms as identified in the "Technical Information Policy and Guide of the Office of Research and Development," June 1991, EPA/600/9-91-004. 2. National Technical Information Program Manager (TIPM) The National TIPM will ensure that NHEERL technical information products comply with policies established by NHEERL and the Agency. The employee will serve as the principal point of contact for the National Laboratory with ORD's Technology Transfer and Support Division (TTSD), which is part of the National Risk Management Research Laboratory located in Cincinnati, OH. TTSD is ORD's former Center for Environmental Research Information (CERI) and has ORD lead responsibility for publications management. The National TIPM is also responsible for developing policies and procedures to ensure the effectiveness of the Laboratory's technical information management system. The National TIPM guides the efforts of the NHEERL Division TIMs in processing paperwork related to technical information products, ensures TIMs enter data into the WOOPS tracking database, and provides oversight to ensure data completeness, accuracy, and consistency across NHEERL. D. Reporting 1. TIMs - reporting requirements NHEERL TIMs are responsible for entering technical information product records into WOOPS in a timely manner after the product is approved (cleared). Updates to the records, such as acceptance by the journal or other publication should be done in a timely manner. The TIMs will ensure that all information entered into WOOPS is consistently entered (formatting), accurate, and up to date. 2. National TIPM - reporting requirements 15 ------- NHEERL Technical Information Management Standard Operating Procedure The National TIPM will compile the consolidated NHEERL monthly report of tech- nical information products from the electronic database and submit it to the Deputy Director for Management, NHEERL Senior Managers, NHEERL Division Directors, and NHEERL TIMs. IX. Publication Requirements A. Journal Article 1. Letter of Acceptance After an article has been submitted to a journal for consideration and has been accepted for publication, the journal should notify the author/project officer in writing. Required documentation from the journal may be a formal letter of acceptance or an e-mail message, and either is acceptable. 2. Reprints Required The project officer, EPA author or co-author should provide three reprints of the article to the TIM. The TIM will submit the ORD Form 362 and one reprint to TTSD. 3. Records Management The TIM will keep one copy of the reprint and maintain the files of their Division's technical information products as the official record and update the WOOPS data base when appropriate. The WOOPS data base must be updated with the acceptance date for the article. All draft versions of the product are part of the official record, along with the technical manuscript review forms and reviewers' comments. For records management retention and disposition, consult with your Records Management Officer. B. Research Report After a research report has been reviewed and cleared for publication, the following is submitted to TTSD: 1. 2. 3. 4. 5. ORD Form 362 EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) (printing management is provided by TTSD) GPO Form 3868 - Notification of Intent to Publish (if report is to be printed by EPA) Final draft and electronic copy (diskette—if TTSD handles editing and production); camera copy (if editing and production take place elsewhere, e.g., by contractor) EPA 2220-1, Technical Report Data 16 ------- NHEERL Technical Information Management Standard Operating Procedure C. Project Reports After a project report has been reviewed and cleared for publication, the following is submitted to TTSD: 1. ORD Form 362 2. Camera copy 3. EPA Form 2220-1, Technical Report Data (for submission to NTIS) 4. EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) 5. GPO Form 3868 - Notification of Intent to Publish (if report is to be printed by EPA) D. Project Summary A project summary is a brief synopsis of key research findings that are included in a research report. The project summary accompanies the project report and undergoes technical review and clearance along with the project report. For printing and publication, the following is submitted to TTSD: 1. ORD Form 362 2. Final draft and diskette (normally submitted with project report) 3. EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) E. Unpublished Reports After a research report has been reviewed and a decision has been made that the product will not be published, the following is submitted to TTSD: 1. ORD Form 362 2. Memo signed by Division Director justifying unpublished status 3. Final draft F. EPA-Sponsored Technical Conferences and Proceedings All papers included in the Proceedings published by EPA must be reviewed and cleared prior to presentation at the symposium. The following should be submitted to TTSD: 1. ORD Form 362 2. Camera copy 3. EPA Form 2220-1, Technical Report Data (for submission to NTIS) 4. EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) 5. GPO Form 3868 - Notification of Intent to Publish (if report is to be printed by EPA) G. Technical Newsletter (for distribution outside of EPA) After a technical newsletter has been reviewed and cleared for publication, the following is submitted to TTSD: 17 ------- NHEERL Technical Information Management Standard Operating Procedure 1. ORD Form 362 2. Final draft and diskette (if TTSD typesets newsletter), or camera copy (if newsletter is typeset elsewhere). 3. EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) H. Papers/Articles/Symposium Presentations, Book Chapters and Any Other Technical Product Published by Other than EPA Any work products included in proceedings, books, or journals that are published by a source other than EPA must be reviewed and cleared before presentation and/or publication. The following is submitted to TTSD: 1. ORD Form 362 2. Draft Product 3. EPA Form 2220-1, Technical Report Data (for submission to NTIS) 4. Reprint and copy of ORD Form 362 after publication of product I. Applications Guides (User's Guides, Design Manuals, Handbooks); Software Programs/Diskettes After the technical product has undergone technical review and has been cleared for publication, the following is submitted to TTSD: 1. ORD Form 362 2. Camera copy 3. EPA Form 2220-1, Technical Report Data (for submission to NTIS) 4. EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) 5. GPO Form 3868 - Notification of Intent to Publish (if report is to be printed by EPA) J. Summaries/Syntheses (also known as Environmental Research Briefs), Bulletins, Technical Brochures, Diskettes, Fact Sheets (that are intended for publication) After the technical product has been reviewed and cleared for publication, the following is submitted to TTSD: 1. ORD Form 362 2. Final draft and diskette or just diskette if software 3. EPA Form 2220-1, Technical Report Data (for submission to NTIS) 4. EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) 5. GPO Form 3868 - Notification of Intent to Publish (if report is to be printed by EPA) 18 ------- NHEERL Technical Information Management Standard Operating Procedure K. Flyers After the technical product has been cleared for publication, submit to TTSD: 1. ORD Form 362 2. Final draft and diskette or just diskette if software 3. EPA Form 2220-1, Technical Report Data (for submission to NTIS) 4. EPA 2200-9, Printing, Distribution, and Inventory Form (available on E-Forms) 5. GPO Form 3868 - Notification of Intent to Publish (if report is to be printed by EPA) L. Internal Reports This technical product requires administrative clearance only since it will not be published and distributed outside of EPA. The following is submitted to TTSD: 1. ORD Form 362 2. One copy of final draft M. Electronic Documents Posted on NHEERL Internet/Intranet Consult with NHEERL's Web Coordinator or Communications Team Leader for procedures for approval and posting of files to the Agency's server. All materials intended for electronic publication must be reviewed and cleared before posting on a public web site. N. Report Numbers EPA publication numbers are obtained from NRMRL/TTSD and are issued according to product type. Some product types, such as Proceedings published by Journals, books, and book chapters do not receive numbers. All other product types, including unpublished and internal reports and reprints of journal articles, do require publication numbers. To obtain the publication number, call TTSD at 513/569- 7562. (NOTE: For publication numbers for journal reprints, send the ORD-362 and one reprint to TTSD. A publication number will be assigned, and you will be notified by TTSD. The publication should be added to the WOOPS database record.) When requesting your publication number, provide the product title, type, and your organization. If your product is an EMAP report, be sure to request a -620 series number. Use Attachment D as a reference chart for identifying which products require EPA publication numbers. O. Records Management The Divisions have responsibility for maintaining technical information records in accord- ance with established records management policies and procedures. For Category 3 products (e.g., peer- reviewed journal articles), only the final work product is required. For Category 4, the peer review record will include: (1) the draft work product submitted for peer review; (2) written comments received from reviewers; (3) response to the major comments of the peer review; and (4) the final work product. These file elements are in addition to the approved ORD-362 clearance and Technical Manuscript Review (EPA-363) forms. The Divisions shall create and maintain records for all cleared technical information products which includes record creation in the WOOPS database and update the WOOPS data base when appropriate, as well as paper copies identified with the WOOPS tracking ID number. The Ecology Divisions may establish 19 ------- NHEERL Technical Information Management Standard Operating Procedure their own recordkeeping requirements for technical information products in accordance with existing policies and procedures. For records management retention and disposition, consult with your Records Management Officer. P. Product Distribution After a product is cleared, the TIMs should provide a copy of the product to the appropriate NHEERL Assistant Laboratory Director (ALD). The product should be sent to the ALD as soon as the the product has been cleared/approved; do not wait to do this on a monthly basis. The ALDs would like to see all NHEERL products except for software packages. A list of NHEERL ALDs is included as Attachment H. Q. Printing 1. Requirements, Forms Required TTSD provides printing management for ORD products; if assistance is needed, please call TTSD at 513/569-7562 for guidance. Refer to Section IX, " B above for required forms for printing of technical information products by TTSD. Each Division is responsible for obtaining printing services to meet the Division's needs. 2. TIM Responsibilities The Division TIMs are responsible for completing all forms and forwarding the technical information product to TTSD for printing. 3. Forms/Approval Required Authority is delegated to the Division Director for approval of all required forms for printing technical information products. 4. Costs/Accounting NHEERL Divisions are responsible for providing all funds and accounting for printing technical information products by TTSD. The appropriate financial information should be included on the forms prior to being submitted to TTSD. X. Attachments A. List of NHEERL TIMs B. ORD Technical Review Requirements, Former NHEERL RTP and Ecology Divsion Review Requirements and New NHEERL-Wide Minimum Review Requirements for Category 3 and 4 Work Products C. ORD Peer Review Categories and Review Requirements D. Reference Chart for Processing & Publication of NHEERL Work Products E. Forms F. Format for Policy Memorandum G. Glossary H. List of NHEERL ALDs 20 ------- NHEERL Technical Information Management Standard Operating Procedure XI. References A EPA Order 2200.4a, "EPA Publications Review Policy," June 4, 1984. B. EPA Order 3120.1, "Conduct and Discipline," September 20, 1985 C. "Publication Review and Clearance Procedures," January 23, 1990, Western Ecology Division (WED-Corvallis), WED Policy #2260.1. D. "Technical Information Policy and Guide of the Office of Research and Development," EPA/600/9-91/004, June 1991. E. "Technical Information Handbook," July 1, 1991, HERL Publication Clearance/Tracking Procedures. F. "Narragansett Publication Review and Clearance Procedures," 02/92, Atlantic Ecology Division. G. "Publication Management, A Guide to Processes, Standards, and Style," EPA/175-K-92- 011, September 1992. H. "Office of Research and Development Standard Operating Procedures for Peer Review of Scientific or Technical Work Products," issued by September 30, 1994, memorandum from Robert J. Huggettto ORD Office Directors and Laboratory Directors. I. "Handbook for Preparing Office of Research and Development Reports, Third Edition," EPA/600/K-95-002, August 1995. J. Office of Research and Development Policies and Procedures Manual, Chapter 14, pp 14.2-- 18, September 15, 1995 K. "Review and Clearance of Publications, POP.02.01, Program Operations Guidelines," January 1, 1997, Gulf Ecology Division. L. "Science Policy Council Handbook - Peer Review," EPA 100-B-98-001, January 1998. M. "Manuscript and Presentation Policy," revised April 1998, Mid-Continent Ecology Division (MED), Duluth, MN. 21 ------- |