Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 23
--> 2 The American Type Culture Collection The American Type Culture Collection (ATCC) is a private, nonprofit organization dedicated to the acquisition, preservation, authentication, and distribution—the "APAD" activities—of diverse biological materials. ATCC was founded by scientists in 1925 to serve as a national repository and distribution center for cultures of microorganisms. Since that time, viruses, animal and plant cell cultures, and recombinant DNA materials have been added. ATCC is now the largest general service culture collection in the world, with collections in six areas: Bacteriology, Cell Culture, Molecular Biology, Mycology, Protistology, and Virology. The mission of ATCC is to serve as the world's leading repository for standard reference cultures, related biological materials, and associated data. ATCC provides for the permanent preservation and availability of these materials for use by qualified people engaged in science, industry, and education. In pursuit of its mission, ATCC's principal goals are to acquire, preserve, propagate, and distribute cell cultures, microorganisms, viruses, cellular products, and biological materials used in and derived from recombinant DNA technology; to maintain the highest standards of authentication, documentation, and maintenance of the characteristics and viability of the materials entrusted to the collections; to pursue research based on or related to the collections; to provide the highest-quality service to members of the scientific, commercial, and public sectors who work with collection materials;
OCR for page 24
--> to educate scientists and the public about ATCC holdings and activities via training programs, lectures, publications, databases and other means; and to collect, manage, disseminate, and exchange information applicable to the materials in the collections. ATCC is affiliated with 22 professional scientific organizations, the primary users of its cultures and services. ATCC policies are determined by a 15-member board of directors composed of representatives from these organizations and the community at-large. General Facilities ATCC employs a staff of 220 individuals. The facility is presently located in Rockville, Maryland, on approximately 5 acres of land. The Carlson building (53,000 square feet) was designed and equipped specifically for the study and maintenance of cultures. It houses the six collections, a library, conference/seminar areas, a workshop laboratory, a greenhouse, and Manufacturing. Two other buildings house Sales and Marketing, Shipping, Information Services, and the administrative offices. ATCC animal facilities are accredited by the American Association for Accreditation of Laboratory Animal Care and registered by the U.S. Department of Agriculture (USDA). The greenhouse and all laboratories in which plant pathogens are handled are inspected by state and federal (USDA Animal and Plant Health Inspection Service/Plant Protection and Quarantine) officials for compliance with quarantine regulations. Buildings have restricted access and are monitored 24 hours a day. In emergency situations, an auxiliary generator supplies power to freezers, refrigerators, and other critical instruments. For added security, a duplicate supply of all freeze-dried material is stored in Blacksburg, Virginia; backup liquid nitrogen storage for frozen material is located in Frederick, Maryland. The ATCC scientific programs are supported by Manufacturing, Sales and Marketing, Bioinformatics, and Publications. Manufacturing occupies almost 7,000 square feet of space. Its staff assists in the freezing and freeze-drying of cultures and maintains the culture inventory. Presently there are more than 500,000 ampules of bacteria and fungi and 400,000 ampules of virus antisera stored in walk-in cold rooms at +4°C and -20°C and 68,000 ampules of viruses stored in mechanical freezers at -70°C. More than 500,000 vials of cell lines, protists, and seed material for other collections are stored in vacuum-insulated freezers cooled with liquid nitrogen at -196°C.
OCR for page 25
--> Sales and Marketing uses a computerized inventory, order processing, and invoicing system to provide customers with current information on usage, availability, and replacement of cultures. Bioinformatics assists in developing computerized data management systems. Publications is responsible for production of catalogues, newsletters, technical manuals, and other informational brochures. Programs ATCC has four program areas focused on the development and distribution of bioscience products and services, bioscience research, and technology transfer. Collection, Research, and Services Program The Collection, Research, and Services (CRS) Program is responsible for ATCC's primary mission of maintaining and providing the world's largest and most diverse collection of biological cultures and culture-derived materials. For 70 years, scientists throughout the world have donated biological materials to ATCC. Those to be accessioned are selected by the collection managers and CRS program directors. Although APAD activities differ slightly according to the type of material, the general criteria for accession are the same and include historical significance, amenability to preservation, level of characterization, and value to the scientific community. Before being accessioned and catalogued for distribution, biological material is subjected to a series of tests to check viability, purity, identity, preferred temperature and medium for growth and/or sporulation, and methods of preservation. For this reason, some have referred to ATCC as a de facto bureau of standards in biology (a field without an official bureau of standards). No fee is charged for deposits accepted into the collection, and no cultures are purchased from investigators. A depositor has a lifetime right to secure a culture of that deposit without charge. All collections use the seed stock system to maintain their distribution stock. As each deposit is accessioned, some ampules are set apart as seed stock and others are designated as order stock. When the order stock becomes depleted, an ampule of seed stock is opened and new specimens are prepared from it and freeze-dried or frozen as new order stock. The seed stock is always the closest material available to the original deposit. ATCC currently has more than 80,000 items catalogued and available for use by the scientific community. Collection materials are growing exponentially with the addition of cDNA clones from the Institute for Genomic
OCR for page 26
--> Research and the Integrated Molecular Analysis of Genome Expression Consortium (IMAGE). The material currently available consists of the following: Bacteriology (bacteria and bacteriophages) 15,203 items Cell Culture (cell lines and hybridomas) 3,403 items Molecular Biology (recombinant DNA materials) 31,339 items Mycology (filamentous fungi and yeasts) 27,370 items Plant tissue cultures 76 items Seeds 97 items Protistology (protozoa and algae) 1,330 items Virology (plant viruses and antisera) 1,010 items Animal viruses, chlamydiae, rickettsiae, and antisera 2,485 items Total 81,303 items ATCC distributes cultures for a fee to scientists and educators worldwide who have the appropriate documentation. Prices reflect the ATCC cost of preparing, testing, preserving, maintaining, and shipping cultures or reagents. ATCC complies with all domestic and international regulations and guidelines for packaging, labeling, and transporting infectious substances and potentially infectious materials. The packaging and labeling requirements of the U.S. Postal Service, Department of Transportation, and Public Health Service for domestic shipments, and International Air Transport Association requirements for international shipments, are followed. ATCC also works closely with other agencies, such as the USDA and the Department of Commerce, as well as the Public Health Service, to obtain all required permits and export licenses. In the last 15 years, a total of 1,133,945 items have been distributed. The following listing of annual totals reveals a recent slowing and even a reversal of the steady growth that characterized most of this period: 1980 — 36,846 1988 — 105,531 1981 — 40,740 1989 — 118,413 1982 — 47,642 1990 — 127,398 1983 — 60,144 1991 — 134,043 1984 — 67,714 1992 — 152,809 1985 — 71,631 1993 — 151,475 1986 — 78,794 1994 — 139,245 1987 — 92,240
OCR for page 27
--> Distribution figures for 1994 indicate that about one-third of ATCC materials are distributed to foreign countries for use in clinical, industrial, research, university, and government laboratories, with industrial labs (50 percent) and university labs (25 percent) accounting for the bulk of demand both here and abroad. CRS program directors and collection managers routinely examine collection holdings to determine their relevance to the scientific community. Taxonomically significant strains must be retained. All others are reviewed periodically for possible ''deaccessioning" or discarding. The same criteria used for accessioning biological material are used for deaccession. Each collection has an advisory committee composed of external scientists with recognized expertise in many disciplines that meets regularly with ATCC staff to provide advice and assistance in acquisition and authentication of materials. Professional Services Program The Professional Services Program provides several products and services that complement collection activities and expertise at ATCC. Established in 1949 as a depository for strains that were cited in U.S. patents, ATCC was designated in 1981 as the first International Depository Authority under the International Budapest Treaty for biotechnology patents. In addition to its patent deposit service, ATCC offers "safety deposit," a proprietary storage for customers. Contract laboratory services include a variety of standard and custom services in the areas of cell culture, molecular biology, microbiology, and others. Products are offered for propagating, testing, and preserving cultures. Education Services Program The Education Services Program provides training programs for the biological sciences. Conferences and courses are arranged by ATCC in direct response to needs identified by the collection staff or an outside source. Subjects include quality control measures; managing strain data; obtaining patents in biotechnology; and identifying, preserving, and maintaining cultures. The workshop program provides hands-on laboratory experience in areas such as cytogenic technology, diagnostics, fermentation microbiology, recombinant DNA technology, hybridomas and monoclonal antibody technology, hybridoma data management, and DNA sequencing and polymerase chain reaction (PCR) technology. Teaching kits and videos have been prepared by several ATCC scientists.
OCR for page 28
--> Many of the ATCC staff with expertise in specialized areas are available for consulting work. They can recommend strains for specific uses; preserving, packaging, and shipping techniques; laboratory practices and quality control procedures; and recording, managing, and administering nonclinical experiments. ATCC scientists can often provide specialized bibliographies to outside investigators. Sponsored visiting scientists are welcome to conduct research of mutual interest. Information Services Program The Information Services Program maintains the extensive databases of biological information developed and stored at ATCC. Information on material is gathered and updated through direct contact with depositors and computer-based literature searches. Data from accession forms and reprints are stored by means of database software. Reprints are transferred to microfiche files. Computer database information, backed up and stored off-site as a safety precaution, is retrieved for reports, product sheets, and catalogues. Each collection issues a catalogue of its holdings in hard copy every three to four years. Catalogues are concise compilations of the data and literature references of greatest interest to users. They are also available in electronic form in CD-ROM and PC diskette versions and on-line via the Internet. The catalogues are widely publicized by news releases and announcements in ATCC newsletters. Previously distributed free of charge, there is now a charge for new editions to cover printing and mailing costs. The ATCC Quarterly Newsletter, distributed free to about 15,000 scientists, lists all new materials and publicizes other important collection and organizational news. ATCC also publishes technical manuals on quality control measures, freezing and freeze-drying, packaging and shipping of biological materials, and specific uses of ATCC strains. The catalogues and manuals are regarded as general reference documents. The Bioinformatics section provides information to the scientific community through on-line systems and is involved in establishing international networks of microbial and cell line information resources. On-line access to collection databases is available via Internet Gopher server, the World Wide Web, the Microbial Strain Data Network (MSDN), and the World Data Center (WDC). At the present time, Bioinformatics is working to improve the availability and usefulness of collection information through an integrated scientific database (ISDB) with a centralized bibliographic reference system and a standardized terminology and synonym resource. The integrated system not only will facilitate the identification of strains with specific characteristics, regardless of which collection holds the strain, but also will enable ATCC to
OCR for page 29
--> efficiently update and modify information established after the strain was first deposited. Ownership and Access Issues The question of who owns the materials in the ATCC collections has recently been the impetus for a detailed explication of ATCC acquisition policy. Over the course of 70 years, donors have provided materials in a variety of ways. Some simply made gifts. Others gave only with very explicit restrictions. Individuals sometimes gave without approval by their institution, and institutions sometimes gave without sign-offs by the investigators. Sometimes one investigator gave without checking with his or her coinvestigators. As a result, most materials in ATCC, even if cited in valid patents, expired or invalid patents, abandoned patent applications, and pending patents—if not restricted by the applicant—have open access and open use. The rest of the material is in what are called special collections; they contain restricted access materials, unreleased patent cultures, safety deposit material, intramural R&D materials, materials from extramural partnerships, and from technology transfer materials. Thus, the categories of resources at ATCC in terms of intellectual property are free access (public), limited access (public), or limited access and use in the restricted category. In January 1996, in response to the increasingly frequent desire of potential donors to hold on to their materials or seriously limit their distribution, until the commercial value becomes clear, and in order to limit ATCC liability in intellectual property disputes, ATCC issued detailed policies covering all cultures acquired after that date: For single cultures or small numbers of related cultures, ATCC prefers that potential donors contribute cultures to one of the general collections in a gift format without any donor-imposed restrictions on access or use. ATCC thus acquires rights to use, propagate, and distribute the culture(s) to customers for a fee. In exchange, ATCC accepts the responsibility for authentication and preservation of the material. Any purchaser of such donated cultures (including ATCC) can use them to discover and develop new patentable products or processes. It is the responsibility of the purchaser to determine whether the new products or processes infringe the intellectual property rights of other parties. Should option 1 not meet the depositor's requirements, ATCC will discuss the option of deposit in a general collection with depositor-requested access or use restrictions. If a deposit is accepted with such restrictions, ATCC will communicate those restrictions to potential purchasers through catalogue records and product sheets.
OCR for page 30
--> Any purchaser of such ''depositor-restricted" cultures (including ATCC) should do so in conformance with those restrictions. It is the responsibility of the purchaser to determine whether any new products or processes developed using these cultures infringe on the intellectual property rights of the depositor or other parties. ATCC will offer potential depositors of large numbers of related biological materials the opportunity of establishing a special collection. This is ATCC's preferred option. ATCC will help the potential depositor identify sources of funds to support such collections, but the depositor will arrange to endow the special collection with sufficient funds for its long-term support. Special collections may contain donated and/or donor-restricted materials. ATCC will continue to offer, for an annual fee, two additional forms of deposit under which access or use restrictions are permitted. These are the Patent Depository, for use in conjunction with a pending patent application, and Safe Deposit, whereby ATCC maintains the materials without advertising. Should none of the options described above meet the needs of originators of desirable materials, ATCC may propose alternative arrangements such as contracts, joint ventures, partnerships, or other means of working with the originator to develop new products, processes, or services. This may include licensing arrangements, with the right of sublicensing to third parties, or agency arrangements whereby technology transfers are made on behalf of the originator. It remains to be seen what effect these policies and options will have on donations, but ATCC's clear delineation of conditions and strong affirmation of the tradition of unrestricted sharing are certainly welcome. Not covered by these new policies, but clearly a problem for ATCC, is the issue of appropriate credentials for purchasers. At the moment, a knowledgeable-sounding request on institutional stationery appears sufficient for most purchases. ATCC, understandably, does not want to become an enforcer, but a mishap last summer in which three vials of Yersinia pestis (the agent of bubonic plague) were shipped to an individual in Ohio who fraudulently portrayed himself as a legitimate scientist has made it clear that more stringent criteria are necessary for at least clearly hazardous biological materials. Cost Issues No collection of living germ plasm has ever become financially self-sufficient. It is common practice for the user community to partially absorb the cost of curatorial functions. The major portion of ATCC's funding is provided by culture fees. The fees charged for materials are not directly related to the
OCR for page 31
--> total costs involved in the authentication and documentation of materials being accessioned into the collection, studies on long-term preservation methods, maintenance and long-term storage expenses, and the cost of distribution. Eighty percent of ATCC collections do not generate any revenue. While the demand for collection services has been increasing, the conventional areas of financial support for ATCC have been steadily decreasing. Federal support for collection activities dropped to 16 percent in 1995, and federal money for infrastructure has disappeared completely. Responsibility for covering this shortfall has been transferred to ATCC and its users as summarized in the following table: TABLE 2-1 ATCC Revenues, 1993–1995 % of Total Revenues Grants and Contracts Year Total Revenues Culture and Service Fees APAD Research 1993 16,127,000 71.53 24.50 3.97 1994 16,934,000 75.95 19.84 4.21 1995 17,932,235 76.44 16.57 6.99 NOTE: APAD = acquisition, preservation, authentication, and distribution. Not apparent from the table is the fact that ATCC increased prices sharply between 1989 and 1994, and probably cannot continue to do so without a negative effect on sales. Private collections and commercial repositories are already a significant source of competition, the latter doing so by "cherry-picking." That is, they are maintaining and distributing only those materials for which there is a heavy current demand, and are ignoring the less popular materials that comprise 80 percent of ATCC's collections and impose significant additional cost on ATCC operations. ATCC leadership believes that maintaining these "unprofitable" cultures is an indispensable part of its mission, not simply because some may later prove useful (the bacterium Thermus aquaticus was discovered years before its extraordinary heat resistance made it the key to PCR and the explosive growth of biotechnology), but also because biology as a science depends on access to a wide variety of well-characterized specimens. Although the committee agrees with this position in principle, it is obvious that no modern-day Noah can aspire to maintain a representative of every living organism. ATCC itself has acknowledged this in its new policies regarding acquisition of orphan collections and other special collections, and concedes that some deaccessioning policy and procedures are badly needed.
OCR for page 32
--> Other Issues and Problems Related to both the increasing competition and the need for a deaccessioning policy are some issues of international relations that must be addressed before their adverse effects on microbiology become irreparable. Prominent among these is the growth of foreign culture collections which are totally subsidized by foreign governments. In many instances, ATCC is asked to help stock these collections. The question arises as to whether foreign collections will be equally available to citizens of the sponsoring country and to scientists from other countries. The time is past when only the United States was capable of establishing and maintaining a first-class repository for biological materials, and it is time for the international scientific community to take advantage of this fact rather than squander funds in unnecessary duplication. ATCC may be the largest and most diverse collection in the world, but it is not the largest and most diverse in every area. The German national collection, for example has just announced it will be funding 77 scientists with long-term support for one of the best mycology collections in the world. ATCC currently has three Ph.D. mycologists. A precedent for the sort of international agreement required already exists in the Budapest Treaty governing patent deposits, 35 countries are signatories to this treaty, the most important point of which is the agreement to recognize deposits made in any of 28 international depository authorities (IDAs). A different and more difficult international issue arises from the belief increasingly expressed by developing countries that indigenous germ plasm is being appropriated unfairly by the developed nations and serving as the basis of lucrative commercial enterprises. The result has been a plethora of national policies restricting export of indigenous materials and establishing highly proprietary national collections, even to the point of renaming organisms.
Representative terms from entire chapter: