Proposed FDA food regulations will come at a price
Two new regulations proposed by the U.S. Food and Drug Administration (FDA) to prevent the contamination of produce and processed foods could cost businesses nearly half a billion dollars a year to implement, but the rules are expected to reduce the Centers for Disease Control’s estimated 3,000 U.S. deaths a year caused by foodborne illness.
The new rules—part of the Food Safety Act passed by Congress in 2011—could cost large farms $30,000 a year, according to the FDA. The agency did not break out costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually. It was unclear how consumers will bear some of the expense of the proposed new rules.
Shelly Burgess, an FDA spokesperson, said the FDA will "pursue a variety of mechanisms" to find resources, including shifting money from other programs, partnering with states and charging fees for activities such as repeat inspections.
"While user fees will help, the lion’s share of the cost of implementing strong regulations will come from congressional appropriations," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, a consumer group based in Washington, D.C.
"These are challenging times in terms of congressional appropriations, but over the long run, this is the basic function of the government to have adequate inspections and to have safe food," she said.
The first rule would require manufacturers of processed foods sold in the United States to come up with a plan to reduce the risk of contamination by correcting problems and keeping records that government inspectors could audit.
The second rule would apply to the harvesting and production of fruits and vegetables to try and combat bacterial contamination such as E. coli.
"These new rules really set the basic framework for a modern, science-based approach to food safety and shift us from a strategy of reacting to problems to a strategy for preventing problems," Michael R. Taylor, deputy commissioner for foods and veterinary medicine, said after the announcement in early January.
The Grocery Manufacturers Association lauded the proposed rules and said implementing the Food Safety Act "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."
Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America, said, "Preventive controls and produce safety are cornerstones of the FDA’s new preventive system. We are eager to review the proposals and provide comments to the agency."
FDA officials said the agency planned to release three more proposed rules. One would require importers to verify that food grown or processed overseas is as safe as its domestic counterparts, and another would strengthen the quality of overseas third-party food safety audits. The third rule would address prevention controls for animal food facilities.
The formal proposed rules were expected to be released to the public in mid to late January. After that, the public will be able to comment and provide feedback to the FDA within 120 days.
It could take the agency about a year to analyze the feedback, make any revisions and release final versions of the regulations.
- Armour, Stephani, and Anna Edney, "Food Safety Victims Laud New FDA Rules But Say Funding’s a Concern," Bloomberg News, Jan. 7, 2013, www.mercurynews.com/bay-area-living/ci_22326386/food-safety-victims-laud-new-fda-rules-but.
- Larsen, Linda, "OMB, FDA Finally Release Two Food Safety Modernization Act Rules," Food Poisoning Bulletin, Jan. 4, 2013, http://foodpoisoningbulletin.com/2013/omb-fda-finally-release-two-food-safety-modernization-act-rules.
- Jalonick, Mary Clare, "New FDA Rules: Safer Food, $500 Million Cost," Christian Science Monitor, Jan. 6, 2013, www.csmonitor.com/business/latest-news-wires/2013/0106/new-fda-rules-safer-food-500-million-cost.
- Schnirring, Lisa, "FDA Unveils 2 New Rules Based on 2011 Food Safety Law," Center for Infectious Disease Research & Policy News, Jan. 4, 2013, www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/jan0413rules.html.
- Strom, Stephanie, "FDA Offers Broad New Rules to Fight Food Contamination," New York Times, Jan. 4, 2013, www.nytimes.com/2013/01/05/business/fda-offers-rules-to-stop-food-contamination.html?_r=1.
For Supplier Woes in 2013
While more than 75% of suppliers said they are confident they can fulfill their customers’ needs this year, one-third of respondents to ASQ’s 2013 Manufacturing Outlook Survey said they expect a shortage of parts or services because of a supplier problem.
To head off potential supplier problems, these respondents said they are working with their suppliers on process improvements to address volume capacity, while more than 26% are partnering with their suppliers’ competitors. Other manufacturers said they are stockpiling parts in advance and expanding facilities to make the needed parts.
Problems with suppliers was a familiar issue for many manufacturers: 80% of respondents said they have been adversely affected by a supplier’s inability to meet their needs in the past, and they’ve had to go to other suppliers for parts or work with suppliers to improve processes.
"Any shortage of parts or services can have a dramatic effect on a manufacturer, so it’s important for companies to communicate openly with suppliers to avoid any disruption in production," said Dick Gould, an ASQ fellow and a supplier management trainer and consultant.
"Conversely, it’s important to suppliers to work with manufacturers to provide them with the quality parts or services to ensure a long-term relationship," he said.
The survey, conducted in November, took feedback from more than 1,250 manufacturing professionals from around the world. For more survey results, visit www.asq.org/media-room/press-releases/2012/20121220-suppliers-manufacturers-survey.html.
25 ASQ Members Named Fellows
Last month, the ASQ Board of Directors named 25 ASQ fellows. The 2012 fellows are:
- Ram R. Bishu, department of mechanical and materials engineering, University of Nebraska in Lincoln.
- John H. Breckline, Key Quality Consulting, Fort Worth and Haslet, TX.
- Terrance A. Burns, Burns and Associates Inc., Richmond, VA.
- Randy G. Canfield, Union Bank, Los Angeles.
- Michael J. Dreikorn, IPL Group LLC, Bokeelia, FL.
- Marc P. Kelemen, NanoSynopsis Consulting LLC, Westlake, OH.
- Andre Kleyner, Delphi Electronics and Safety, Kokomo, IN.
- Robert E. Kukla, CI Group Inc., Edwardsburg, MI.
- Nicholas C. Leifeld, Serigraph Inc., West Bend, WI.
- Eric D. Mead, Beechcraft Corp., Wichita, KS.
- Michael G. O’Connor, Medtronic Inc., Minneapolis.
- Sung Hyun Park, Seoul National University, South Korea.
- Michael A. Parrillo, Lapp Group, Florham Park, N.J.
- Teresa Laurene Pratt, TE Connectivity, Winston-Salem, N.C., and Plexus International, Minneapolis.
- Nicole Radziwill, James Madison University, Harrisonburg, VA.
- Timothy J. Robinson, University of Wyoming, Laramie.
- Debashis Sarkar, Asia’s service lean pioneer and author, Mumbai, India.
- Lalith Nimal Senaweera, Sri Lanka Standards Institution, Colombo, Sri Lanka.
- Dilip Anand Shah, E = mc3 Solutions, Medina, OH.
- Stefan H. Steiner, University of Waterloo, Ontario, Canada.
- Jerry L. VerDuft, California State University, Dominguez Hills, Carson, CA.
- Stuart Walker, Teleflex, Research Triangle Park, N.C.
- Steven Ellison Wilson, U.S. Department of Commerce Seafood Inspection Program, Silver Spring, MD.
- Guangbin Yang, Chrysler, Auburn Hills, MI.
- Mohamed Zairi, European Centre for Best Practice Management, Keighley, United Kingdom.
For more on the new fellows, visit www.asq.org/media-room/press-releases/2013/20130108-asq-fellows-named.html.
Word to the Wise
To educate newcomers and refresh practitioners and professionals, QP occasionally features a quality term and definition:
Taiichi Ohno originally enumerated seven wastes (muda) and later added underutilized people as the eighth waste commonly found in physical production. The eight are:
- Overproduction ahead of demand.
- Waiting for the next process, worker, material or equipment.
- Unnecessary transport of materials (for example, between functional areas or facilities, or to or from a stockroom or warehouse).
- Overprocessing of parts due to poor tool and product design.
- Inventories more than the absolute minimum.
- Unnecessary movement by employees during the course of their work (such as to look for parts, tools, prints or help).
- Production of defective parts.
- Underutilization of employees’ brainpower, skills, experience and talents.
"Quality Glossary," Quality Progress, June 2007, p. 45.
Who’s Who in Q
NAME: Andre Kleyner.
EDUCATION: Doctorate in mechanical engineering from University of Maryland in College Park.
CURRENT JOB: Global reliability engineering leader, Delphi Corp., electronics and safety division, in Kokomo, IN, and adjunct professor at Purdue University in West Lafayette, IN.
INTRODUCTION TO QUALITY: Kleyner took several college courses on the strength of materials and finite element analysis, which taught him about structural failures. His first job as a product assurance engineer gave him a real appreciation for quality and reliability.
PREVIOUS QUALITY EXPERIENCE: Kleyner said he has learned a lot developing new products as well as studying their field performance and later performing engineering analyses of warranty returns and statistical data processing.
ASQ ACTIVITIES: He’s a new ASQ fellow and the past vice chair of measures and reporting for the Reliability Division. A certified reliability engineer, quality engineer and Six Sigma Black Belt, Kleyner also has presented at many ASQ section and division meetings.
OTHER ACTIVITIES: Kleyner serves as the chairman of the advisory board for business programs at Ball State University in Muncie, IN, and is the editor for the Wiley Series in Quality and Reliability Engineering, an international book series. He also reviews manuscripts for several international technical journals. Kleyner holds several U.S. and foreign patents.
PUBLICATIONS: He has authored two books on reliability and warranty engineering, including co-authoring the fifth edition of Practical Reliability Engineering. Kleyner also has written more than 30 articles for technical journals and conference proceedings.
RECENT AWARDS: Kleyner received the P.K. McElroy Award for the best paper at the Annual Reliability and Maintainability Symposium.
FAVORITE WAYS TO RELAX: Skiing, jogging and playing guitar.
QUALITY QUOTE: In reliability and quality engineering, physics trumps mathematics.
Date in Quality History
QP occasionally looks back on a person or event that made a difference in the history of quality.
Feb. 12, 1919
Russell L. Ackoff, a man many knew as the leader of the systems-thinking community and a pioneer in the realm of operations research, was born on this date.
Unlike many in his field, Ackoff’s educational background was rooted in philosophy, a discipline for which he received a doctorate from the University of Pennsylvania in 1947. That foundation was shared by C. West Churchman, his colleague at Case Institute of Technology and a co-author of Introduction to Operations Research. That seminal work, published in 1957, is widely accepted as the most influential early textbook on operations research.
His work in the field was far-reaching and even infiltrated the White House under President Bill Clinton, who relied on Ackoff as a consultant at the White House Communications Agency as it implemented systems thinking.
Ackoff died Oct. 29, 2009, at the age of 90 from complications following hip replacement surgery.
THIS YEAR MARKS the International Year of Statistics, spearheaded by the American Statistical Association and more than 1,400 organizations in 11 countries. The worldwide Statistics2013 initiative will highlight the contributions of the statistics field to solving global challenges. For more information about activities and events related to the celebration, visit www.statistics2013.org.
OFFICERS HAVE BEEN elected for the U.S. Technical Advisory Groups (TAG) to the International Organization for Standardization/Technical Committee (TC) 176 on quality management and TC 207 on environmental management for the 2013-2015 term. The officers for TAG 176 are: Alka Jarvis, chair; and Mark Ames and Alan Daniels, vice chairs. The officers for TAG 207 are: Susan Briggs, chair; Joe Cascio, vice chair; and Susana Quirch, secretary.
THE ANSI-ASQ NATIONAL Accreditation Board/FQS has signed the Asia-Pacific Laboratory Accreditation Cooperation mutual recognition arrangement (MRA) for inspection. This means ACLASS and FQS become signatories of the International Laboratory Accreditation Cooperation MRA for inspection, calibration and testing. For more information, visit www.aclasscorp.com/news/2012/12/aclass-signs-aplac-mra-for-inspection.aspx.
THE COORDINATE METROLOGY Society has released the results of its third large-scale measurement study, developed to support the organization’s certification cognitive exam development process. The study’s main focus was to test the method of practical testing rather than the evaluation of the measurement results. To download the 83-page report, visit http://bit.ly/UPMe0X.
DIVE INTO THE DETAILS A 20-page brochure detailing the sessions, workshops and other events scheduled for the 13th annual ASQ Lean and Six Sigma Conference is now available. The event will be held March 3-4 in Phoenix. To download the brochure, visit http://asq.org/conferences/six-sigma.
DISCOUNT IN CONFERENCE PRICE ASQ members and nonmembers who want to attend this year’s ASQ World Conference on Quality and Improvement can save some money with early-bird discounted pricing that’s available through March 14. Visit http://wcqi.asq.org for more details about prices and the conference, to be held May 6-8 in Indianapolis.
RATE AND REVIEW Readers can now write comments and rate specific books that are available at ASQ’s online bookstore. Visit http://asq.org/quality-press/index.html to offer your thoughts and reviews on any specific ASQ Quality Press book you’ve read, or read what others have said.
PRESENT AT NQEC March 1 is the deadline to submit proposals for presentations at this year’s National Quality Education Conference. The event will be held Nov. 17-18 in Milwaukee. For more information, visit http://nqec.asq.org/index.html.
ASQ Journal Spotlight
Every month, QP will highlight an open-access article from one of ASQ’s seven other journals.
This month, be sure to check out "Insights on the Future of Quality Management Research," which appeared in last month’s issue of Quality Management Journal (QMJ). In the article, James R. Evans, the journal’s outgoing editor, and members of QMJ’s editorial board provide insights and ideas to help the contributors to the quality management field identify topics to build new knowledge and to sustain the discipline.
To access "Insights on the Future of Quality Management Research," click on the "Current Issue" link on QMJ’s website: http://asq.org/pub/qmj. From there, you also can find a link to information about subscribing to the quarterly publication.