What's Going On With Validation?
UPDATE: USDA hearings on validation
In June 2010, USDA held two public meetings on the HACCP Draft Validation Guidance (transcripts can be found on the FSIS validation webpage. The hearings followed the release of a Validation Fact Sheet.
The fact sheet and hearings indicated that public concern about this issue had been heard. However, we feel that pressure should be maintained until final guidance is published.
Validation is how a meat processor shows that a HACCP plan is working as intended. On March 19, 2010, USDA's Food Safety and Inspection Service (FSIS) issued a document called "Draft Guidance: HACCP Systems Validation" that would create substantial new testing requirements for all meat processors. This PDF document includes an explanatory preface letter from the FSIS Administrator to a group of meat industry trade organizations. FSIS has requested public comments on the proposal by June 19, 2010.
The Niche Meat Processor Assistance Network submitted comments, posted below. Thanks to the more than 90 co-signers, who include meat processors, processor associations, livestock producers, NGOs, government agencies, consumers, and others. We are glad to see how many people around the country care about this issue.
When FSIS issues new draft guidance on validation, again for public comment, we will post information here and send it to our email list. To join our mailing list, please email email@example.com.
Please note: if you signed our comment letter, we did not add you to our mailing list unless you specifically requested to be added.
NMPAN Comments to FSIS on Draft Validation Guidance
To: Alfred Almanza, FSIS Administrator
cc: Tom Vilsack, Secretary of Agriculture; Jerold Mande, Acting Undersecretary for Food Safety; Kathleen Merrigan, Deputy Secretary of Agriculture
Dear Mr. Almanza,
Thank you for inviting comment on “Draft Guidance: HACCP Systems Validation,” published by USDA’s Food Safety and Inspection Service (FSIS) on March 19, 2010, proposing new and expanded testing and recordkeeping requirements for all meat and poultry establishments operating under inspection.
We submit these comments as the Niche Meat Processor Assistance Network (NMPAN), a national network of people and organizations that work with small and very small meat processors. NMPAN is comprised of university cooperative extension faculty, professionals from state departments of agriculture and health, non-governmental organizations, and meat processors, livestock producers, marketers, and buyers. Many of us have extensive involvement with FSIS and we all fully support the Agency’s staff and mission of ensuring the production of safe and unadulterated food.
We have three primary concerns with the proposed guidelines:
1. Scientifically questionable and unlikely to improve food safety
The mechanisms used to control food safety hazards in a HACCP system – critical control points or CCPs – must be based, by regulation, on sound scientific research. Increased in-plant testing of a CCP will not increase the validity of the CCP. Instead, FSIS should increase efforts to help plants make sure they have correctly identified and are meeting the key operational parameters of a CCP as documented by the scientific research supporting that CCP.
For example, a plant making a fully cooked product such a ham or a hot dog that is otherwise meeting the cooking time and temperature parameters of FSIS’ lethality performance standards (as described in “Appendix A”) should not be required to perform in-plant microbial testing to “validate” that cooking to the prescribed temperatures kills pathogens in their particular plant.
In addition, the FSIS appears to be taking two contradictory positions regarding laboratory versus in-plant conditions. On the one hand, FSIS states that new in-plant testing requirements are required “because often laboratory conditions may be different than actual conditions in the establishment” (Guidance, p. 5). At the same time, the new guidelines mandate the use of “indicator organisms” to validate in-plant pathogen reduction based upon laboratory demonstrations of the relationships between such “indicator organisms” and their associated pathogens (Guidance, pp. 7-9). We do not doubt that sound laboratory results will predict in-plant results if key operational parameters are met, but we disagree with the Agency’s decision to treat some laboratory results as more transferable to in-plant conditions than others.
2. Likely to reduce farmer and consumer access to appropriate-scale processing
Recent USDA initiatives – notably “Know Your Farmer, Know Your Food” and the recent partnership with the Department of Justice to examine consolidation in the meatpacking industry – suggests that the Department understands and supports the critical role played by small, independent meat processors as demand for local and other niche meats rises around the country. Yet as proposed, the new validation testing requirements would be extremely burdensome on small and very small plants. Such plants typically produce a wide variety of products, and the proposal would require separate testing for the production of all products that are “substantially different” (Guidance, page 9). Many small establishments around the country have stated that they will either stop processing under inspection or close entirely if this proposal were to be adopted due to the cost estimates for compliance.
3. Lacking clear justification
In your March 19th letter, you write, “there has been a demonstrated failure to adequately address validation for certain RTE products. FSIS has had more than one finding of Salmonella in its routine verification testing of.... These findings resulted in recalls.” These incidents – and the desire to make such incidents never happen again – appear to have motivated the new proposal.
We request that you release the incident data used as the basis of the proposed guidance so that stakeholders can properly evaluate the information. What if the data actually indicate that these are “key parameter” problems? If so, that won’t be fixed by testing outcomes. If not, this likely indicates either an inadequate hazard analysis or inconsistent circumstances that defy sampling and predictability, such as operator error, and neither of these will be solved by in-plant validation as proposed. We reiterate that FSIS should instead increase efforts to help plants make sure they have correctly identified and are meeting the key operational parameters of a Critical Control Point supported by scientific research.
Thank you for this opportunity to comment. Again, we wish to reiterate that we fully support FSIS’ staff and mission. We hope the Agency will revise its proposal to address these concerns.
1) Lauren Gwin, Ph.D., Oregon State University (Oregon), NMPAN Co-Coordinator
2) Arion Thiboumery, Ph.D., Iowa State University (Iowa), NMPAN Co-Coordinator
3) Bruce Dunlop, Lopez Island Farm (Washington)
4) Pam Saunders, Organic Prairie (Wisconsin)
5) Jeff Schahczenski, National Center for Appropriate Technology (NCAT) (Montana)
6) Cory Carman, Carman Ranch (Oregon)
7) David Schafer, Featherman Equipment Co. (Missouri)
8) Amy Sipes, John's Custom Meats, LLC. (Kentucky)
9) John Bingham, Wild Orchard Farm (New York)
10) Bob Filbrandt, Bob's Processing (Michigan)
11) Henry Ahern, Bonnie Brae Farms (New York)
12) Fred Griffen, High Lonesome Farm (New York)
13) Debra Farrara Ball, Eagle Bridge Custom Meat and Smokehouse (New York)
14) Chris Bailey, Vermont Smoke and Cure (Vermont)
15) Ginger S. Myers, Maryland Rural Enterprise Development Center, University of Maryland (Maryland)
16) Joe Cloud, True & Essential Meats (Virginia)
17) Kamyar Enshayan, Ph.D., Center for Energy & Environmental Education, University of Northern Iowa (Iowa)
18) Joe and Karen Schueller, Scio Poultry Processing (Oregon)
19) Barth Anderson, Fair Food Fight (Minnesota)
20) Judith McGeary, Farm and Ranch Freedom Alliance (Texas)
21) Mark Kastel, Cornucopia Institute (Wisconsin)
22) Ulla Kjarval, Spring Lake Farm (New York)
23) Richard Needham, Needham, Inc. (Nebraska)
24) Mary K. Gloster, Rocky Top Farm (New York)
25) Lisa Dawson, Northeast Oregon Economic Development District (Oregon)
26) Patricia S. Girard, consumer (New Hampshire)
27) David Dadekian, consumer (Connecticut)
28) Northwest Meat Processors Association (Oregon, Idaho, Washington)
29) Lucia Stout Huebner, Beechtree Farm (New Jersey)
30) Palmer Uhl, consumer (New Jersey)
31) Jo Robinson, www.eatwild.com (Washington)
32) Andy Cloud, Cloud's Meats, Inc. (Missouri)
33) Missouri Association of Meat Processors (Missouri)
34) Rob Lorentz, Lorentz Meats (Minnesota)
35) Pat Klinger, consumer (Washington)
36) Frances Graziano, Graziano Brothers, Inc. (Iowa)
37) Kimberly Henricks, consumer (Missouri)
38) Renee Burton, consumer (Maryland)
39) Jace Iversen, consumer (Washington)
40) Tracy Kukkonen, consumer (Massachusetts)
41) Minnesota Association of Meat Processors (Minnesota)
42) Meg Martin, consumer (Wyoming)
43) Roger Ingram, University of California Cooperative Extension (California)
44) Erich von Gehren, prospective meat plant owner (Virginia)
45) Dezra Helgeson, consumer (Minnesota)
46) Barbara and Henrik Bull, consumers (California)
47) Joe Martinez, Wyoming Dep't of Agriculture Consumer Health Services (Wyoming)
48) Jenny Bickford, consumer (Pennsylvania)
49) Cathy Thienes, consumer (Oregon)
50) Terry H. Anderson, consumer (Oregon)
51) Keith Rowand, Laughing Duck Gardens and Cookery (Virginia)
52) Matt Swain, consumer (California)
53) John Muenchow, consumer (Oregon)
54) Kristina Thorpe, consumer (Washington)
55) Audrie Court, consumer (California)
56) Connie Blattner, consumer (Oregon)
57) Alana Schwamberger, consumer (New Jersey)
58) Audrey Wagner, consumer (Illinois)
59) Mimi Smith, Port Angeles Community Market (Washington)
60) Daniel Rosmann, Rosmann Family Farms (Iowa)
61) Gail Dickinson, M.D., consumer (Connecticut)
62) Anne Taliaferro, consumer (Oregon)
64) Donna Prizgintas, chef (Iowa)
65) Richard Jones, Valley Vista Testing (Kansas)
66) Frederick Kirschenmann, Kirschenmann Family Farms, Inc. (North Dakota)
67) Fred Hunt, El Dorado County & Georgetown Divide RCD (California)
68) Kolan and Janet Parsons, KGL Green Pasture Farm LLC (North Carolina)
69) Kelly Scott, consumer (Maryland)
70) Megan Barbour, consumer (Texas)
71) William Crowley, consumer (California)
72) Josh McClary, consumer (Indiana)
73) James Purcell, consumer (Oregon)
74) Jay Dickason, consumer (California)
75) Heather Buechler, consumer (Wisconsin)
76) Tim Sanders, consumer (California)
77) Jeremy & Beth Floyd, consumers (Tennessee)
78) Deborah Evans, Bagaduce Farms (Maine)
79) Bob Stent, Tomkat Ranch (California)
80) Sissy Muirhead, consumer (New Hampshire)
81) William Muenchow, Laurel Health Care Co. (Ohio)
82) Michael Koob, Beech Meadow Farm (Ohio)
83) Christi Mitchell Twain, Cold Arse Farm (Maine(
84) Keith DeHaan, Ph.D., Food and Livestock Planning, Inc. (Missouri)
85) Peter Reynolds and Caroline McGee, McRey Farm (New York)
86) Lori Fischer, Nebraska Prairie Harvest Project (Nebraska)
87) Deborah Hunsberger, Nebraska Environmental Action Coalition (Nebraska)
88) Robert O'Dell, Nebraska Environmental Action Coalition (Nebraska)
89) Ted Thieman, Nebraska Environmental Action Coalition (Nebraska)
90) Kate Allen, Nebraska Environmental Action Coalition (Nebraska)
91) Verley Family, LLC (Nebraska and Virginia)
92) Pati Martinson & Terrie Bad Hand, Taos County Economic Development Corporation (New Mexico)
93) Carol Schooley, North Star Neighbors (Nebraska)
94) Elizabeth Baker, consumer (Michigan)