Food Laws and Regulations Division

Newsletter - Vol. 7, No. 2 Spring 1997

Table of Contents

Message from the Chair—

How quickly time passes when you’re having fun! This year we have accomplished a lot as a Division. Our Executive Committee conference-call meetings helped us keep in touch as the year progressed — we also have communicated through this newsletter, and David Haytowitz has created an outstanding WWW page for us, providing Division information and linking us to other food-law sites. (Note that IFT is restructuring its home page so that the Food Laws and Regulations page will be easier to find. Currently, to view the FLR information, you’ll need to look under "Membership" when you log onto IFT at http://www.ift.org.) Check us out! The Listserv remains busy as usual, with many useful (and often witty) contributions. With HACCP and DSHEA implementation approaching, the Listserv will be a valuable medium for discussing important issues arising from these policies.

Education Emphasized: We all realize that food law issues will never go away — objectives of the FLR Division include serving as an information conduit and devising new ways to educate our membership. For example, prior to the June national IFT meeting in Orlando, an international food law short course will be presented (contact Walt Clark for details). IFT’s international involvement is growing (18% of total membership), so this is key . . . we need more international links on our web pages.

Other IFT Divisions are also moving rapidly towards electronic communication and expanding their educational programs. The Extension Division will host a symposium in Orlando on the new 1997 Food Code, with emphasis on food service and retail stores (contact John Marcy jmarcy@comp.uark.edu). The Extension group is also putting together a multi-university training program on HACCP training, scheduled for Sept 21–23 in Denver and Oct 5–7 in Atlanta . . . check their Division page for more details. Jim Vetter is involved in several future IFT "on the road" short courses on food laws, regulations, and labeling. Finally, the Univ of Wisconsin–River Falls is running a course on the international aspects of food safety as related to the European Community Directive 93/94 on consumer foods, "Autonomous Total Quality Control". Contact P.C. Vasavada (Purnendu.C.Vasavada@uwrf.edu) for info.

Progress: Jim Heimbach, next year’s Chair, is now busy helping institute two symposia for the annual meeting in Orlando. Next year I will be chairing IFT’s Information Systems Committee. We will work to improve communications, such as through a Listserv for each Division and for the Executive Committee. This group is also working to improve cost-effectiveness and productivity by requesting that IFT distribute its member info to executive committees on diskette, thereby eliminating enormous stacks of paper printouts.

Thanks: I want to thank our newsletter editors (Tracy Altman and Jim Vetter) for an outstanding job . . . they are moving on to other responsibilities, so we are looking for a new editor. Mitzi Elkes has done a great job of placing employment information on the Internet. As Treasurer these past years, Karen Carson has made sure our finances are in order; Ralph Glover has been instrumental in handling new membership. Many others have contributed, and I thank them as well. Good luck to our FLR Division officers for 1997–98 (election results are listed below). Finally, I wish to thank you all for being FLR members and invite you to attend and participate in our Executive Committee meeting Monday morning at the national conference in Orlando, and to join us for the Division luncheon on Monday afternoon. (Reminder: pre-registration is required for the luncheon!)

. . . Ted Labuza

And the winner is . . .

Results from the recent Division election are in. Congratulations to the following individuals, who will serve as FLR officers during 1997–98:

We hear you!

Thanks to all who responded to our recent membership survey. Results are as follows:

Issues/concerns: Attendance at the annual meeting was a problem for some due to lack of financial support by employer, having time to take off, or the high costs of attending.

The most important reason cited for joining the Division was to keep up with new developments (95%). Also important: to support the profession (80%); learn about meetings and symposia (80%); business contacts and networking (70%); and employment and career services (70%).

55% of respondents have not attended a FLR Division-sponsored symposium or program. 25% have attended one or two, 11% three or four, and 8% five or more. Among those who have attended, 41% were satisfied, while 32% were neutral.

Particular areas of interest and motivation for attending programs were: international laws and regulations; labeling (including international markets); nutraceuticals; "foods in foods," "health foods," and functional foods; HACCP and ties to products liability; biotechnology; jurisdictional issues; and general legal principles.

Most members (86%) felt they received benefits from membership, but did not feel they had direct input into how the Division operates (54%). A majority of FLR members do not know how much money is spent by the Division (70%), or how (60%) — these respondents would like more input into these decisions.

Suggestions included: development of a Division membership directory; a greater role for the Division in providing networking and career opportunities; more international focus and more encouragement of membership from outside the U.S.; Division-sponsored workshops and symposia at different locations across the country; knowledge of how to get more involved.

Thanks to Barbara Rasco for implementing the survey and tabulating the results.

Membership Survey Results—

Newsletter editor(s) needed!

This will be the last newsletter put together by co-editors Tracy Altman and Jim Vetter (with the help of numerous contributors). Editing the FLR newsletter is a fun job, the executive committee cooperation is superb, plus only three newsletters a year have been required the past two years! Seriously, this is an excellent way to get involved and know what’s going on in the FLR Division. Even better, Mark Harrison (Univ of Georgia) handles all the publishing chores, mailing, etc., so only editing and layout are involved.

(How about one of you that expressed in the recent survey a desire to get involved? Here’s your chance.) To volunteer to take on this task, contact Jim Heimbach, Division Chair for 1997–98, at (202) 337-2625.

Don’t miss these important Symposia at the June conference

The FLR Division will co-sponsor three symposia at the annual meeting in Orlando (June 14–18). Check the program guide for exact locations and times:

News on Continuing Education . . .

This Division is cooperating with the IFT Continuing Education Committee in arranging, promoting, and implementing short courses on two subjects: 1) labeling of FDA-regulated foods, and 2) food laws & regulations. Our Division receives $1,000 each time one of these courses is offered. Jim Vetter has been serving as Division contact person, course director, and principle lecturer. These courses have been very well received.

The following seminars have been scheduled for the coming months:

The first food laws and regulations course (held this April) was a sellout, leading to the second offering, scheduled for September ‘97 in San Francisco.

. . . Jim Vetter

Fred Shank to Speak in Orlando—

The FLR Division is hosting a luncheon for members and guests on Monday, June 16th during the annual meeting in Orlando. The event will be held at the Omni-Rosen Hotel (check your ticket or program guide for the meeting room location). We are pleased that Fred Shank of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) will be the luncheon speaker; he will discuss current regulatory issues of particular importance to our members. The cost is $28 — tickets may be purchased with advanced registration, or on-site through Saturday, June 14th. Plan to attend and learn more about what your FLR Division is doing!

Employment Opportunities . . .

The Employment Recruitment Committee posts regulatory-related "Positions Available" ads on the food law Listserv as they are provided to the Committee. Electronic publication of the IFT Employment Services Jobs Bulletin was recently explored — unfortunately, electronic transmittal of the Bulletin is not a viable option at this time. Anyone interested in receiving the Jobs Bulletin should contact Nora Schabold, employment services manager at (312) 782-8424 for further information. The committee continues to explore other options for expanding the number of regulatory positions announced to members. To advertise a regulatory employment opportunity on the Listserv, send a brief job description with your company name, contact name, address, tel/fax number and e-mail address to Mitzi Elkes, Chairman of the Employment Recruitment Committee, at mjelkes@aol.com.

National Election Results . . . Bruce R. Stillings was elected President-Elect, and Aurora S. Hodgson and Ronald L. Richter were elected Membership Representatives on the Executive Committee. Congratulations to these new members of IFT’s leadership team.

Supreme Court Rules on Case Involving Food Dye Purification Patent

The U.S. Supreme Court recently reached a decision in Warner-Jenkinson Co. v. Hilton Davis Chem. Co., involving the "doctrine of equivalents" in patent law. Historically, this has allowed a patentee to recover damages for infringing products/processes that do not literally meet the claims of a patent — but perform substantially the same function, in substantially the same way, to achieve substantially the same result (this is known as the "FWR test"). The Court of Appeals for the Federal Circuit had previously maintained the viability of the FWR test, and added a further test requiring "insubstantial differences" between the accused product and the patented invention to find infringement.

The invention in this case involves a process for making dyes for food and drug products, including Red No. 40 and Yellow No. 6; the patent in question covered an improved process for removing impurities utilizing ultrafiltration, specifying a pH limitation of approximately 6–9. The accused process in this case functions in a manner substantially similar to the patented one, with the major difference being that it operates at a pH of 5. The Supreme Court decision in Warner-Jenkinson touches on several issues relevant to the food industry professional, including findings that:

1. The analysis must be based on an element-by-element analysis as opposed to a "claim as a whole" analysis,
2. The known interchangeability of components tends to a finding of equivalence, and
3. Equivalency must be determined at the time of infringement.

For instance, if a patented product has elements A, B, and C, another product must also possess A, B, and C (or their equivalent) to be an infringement (e.g., if a company is designing around an existing product, it should not be liable for patent infringement if its product is lacking either a literal or equivalent element claimed in the patent). This ruling will give courts less leeway in determining equivalents and should bring more predictability to infringement analyses. Likewise, it should allow introduction of competing products with greater assurance that they will not infringe.

However, the court also stated that "known interchangeability" tends to a finding of equivalence: If a company competes with a patented product, a simple substitution of an interchangeable element is not likely to avoid infringement (e.g., if compound A is used to lower pH in a patented food system, and compound B is considered a viable substitute, then use of B will not avoid infringement). Finally, one consequence of the requirement that equivalency must be determined at the time of infringement is that technological advances after granting of a patent do not avoid infringement; consequently, a developer is not required to protect against unknown equivalents in the drafting of its patent.

. . . Contributed by David D’Zurilla

[David D’Zurilla is an attorney with Lane, Aitken & McCann in Washington, D.C. This article is not to be construed as legal advice, which can be given only after thorough analysis of the facts in a particular situation. Questions or comments may be directed to him via tel: (202) 337-5556 or e-mail: lam@access.digex.net.]

IFT speaks out on agricultural research, extension, and education

IFT President Bob Smith wrote on behalf of Institute membership to Richard Lugar, Chairman of the Senate Committee on Agriculture, Nutrition, and Forestry, in response to a letter from the Senator. President Smith included detailed responses to questions raised by the Senator concerning research system structure, funding mechanisms and issues, private sector issues, coordination, and priority setting. IFT urged improvement in the focus, coordination, structure, and efficiency of the research network that underlies our agricultural system, while emphasizing that these systems must remain the bulwark of the core of the agricultural research system.

Congratulations to . . . Division member Walt Clark for being honored with the Calvert L. Willey Award for demonstrating meritorious and imaginative service to IFT. Attend the opening session at the Orlando meeting to applaud Walt for this latest in a long list of achievements!

IFT’s Congressional Science Fellow Has Full Plate

Joe M. Regenstein, IFT’s Congressional Science Fellow for 1996–97, contributes the following account of his recent experiences working in Washington — he is serving in the office of New York Senator Al D’Amato:

"I am learning a great deal about the legislative process and office routine. The staff welcome Congressional science fellows. We are considered part of the ‘leg’ team and are included in substantive political conversations. . . . [T]he pace of activities is clearly increasing. In fact, the office has recently taken on a few more fellows. My legislative responsibility includes agriculture, food safety, aquaculture, and to a lesser extent fisheries. The assignment was made, in part, to relieve the former legislative assistant (LA in DC jargon). . . . I also respond on the Senator’s behalf to inquiries on a variety of issues from executive branch agencies; these letters are not as technical as I might write on my own, so it’s been a real learning experience for me. . . .

"I will be asked to help formulate responses, suggest how the Senator might vote, and explore appropriate opportunities to cosponsor new legislation. Some of the issues I have been monitoring include: the Food Quality Protection Act, which needs a lot of attention from the food industry if we are to continue to have a full range of foodstuffs available in the United States; bovine spongiform encephalopathy and ruminant-to-ruminant feeding; the safety of fruits and vegetables, particularly acidic juices; President Clinton’s food safety initiative; the research and extension reauthorization for the U.S. Department of Agriculture, through work with the Coalition on Funding Agricultural Research Missions (CoFARM); . . . urban extension activities; milk marketing orders, dairy pricing, and the role of the National Cheese Exchange in controlling the basic formula price; agricultural trade with Canada, including Canadian tariffs (over 350 percent in some instances); the peanut planting quota; illegal imports of honey from China via Canada; . . . the new shark fishery plan, where the National Marine Fisheries Service is not giving fishermen sufficient time to respond; and the failure of USDA to implement the portion of the 1990 Farm Bill that mandates cooling of eggs during storage and transport. The Hill also has many briefings and meetings — many of which are excellent. Finding the time to attend is the problem with an already full plate.

". . . resources [are] available. For example, I use the Congressional Research Service (CRS) as much as possible. CRS staff members are Congress’ analysts. The staff (1) prepare oral or written responses to questions on almost any subject; (2) summarize the history of various legislative ideas, constituting the ‘institutional memory’; (3) write detailed briefing and background papers on almost everything (about 1,000 are written each year, ranging from 2 to 20 pages, some of which are updated as often as every two months); (4) brief various staff or members (i.e., a senator or representative); and (5) give detailed reviews of a legislative proposal. Strict confidentiality prevails. . . . It is exciting to try to craft new bills, and I am currently involved in two such projects. The first would be called the Food Labeling Improvement Act of 1997 and would deal with labeling of inadvertent allergens and religious foods. . . . [I am] working with CRS’s religion specialist to ensure that the bill does not violate the establishment clause of the Constitution. Eventually, we will seek co-sponsors before submitting the bill in the Senate. I am also working with a number of executive agencies to see if we can craft an aquaculture bill that would promote the orderly development of aquaculture in the United States. . . . This promises to be a real challenge. . . . [and] is a fantastic experience."

[For more information on the annual science fellowship, contact Therese Schaley,
IFT Science Communications, tel: (312) 782-8424 or email: tlschaley@ift.org.]

This page is maintained by the Food Law and Regulations Division of the Institute of Food Technologists. To submit materials for posting on the Division's home page or to make other comments, contact David Haytowitz

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Last Modified: Sunday, December 28, 1997