Fowler, Mark

K-State Research Exchange

Food Safety Modernization ActStill time for public comment, but be prepared to comply with new rules. On Jan. 16, 2013, the proposed rule outlining the requirements of the Food and Drug Administration’s (FDA) Food Safety Mod-ernization Act (FSMA) was published for public comment. So,the milling industry needs to take note, because the countdown has begun, and the period for public comment will end on May 16, 2013.The proposed FSMA rule focuses on preventive controls for human food that can cause foodborne illnesses. The rule applies to domestic and foreign companies that manufacture, process, pack, or hold food.Under the proposed rule, firms would be required to implement written plans that identify hazards, specify steps to prevent those hazards, identify and record monitoring results, and specify actions taken to correct prob-lems.The FDA will continue to inspect facilities to confirm the plans are implemented and evaluated properly. Under the proposed rule, the first compliance date would be one year after the final rule is published in the Federal Register for most companies.The FDA is proposing to allow two years for small businesses (e.g., fewer than 500 employees) and three years for very small businesses to comply. The definition of a very small business would be comprised of the following three different levels based on total annual sales and adjusted for inflation: less than $250,000, less than $500,000, and less than $1 million.The FDA also will hold public meetings to explain the proposal and provide additional opportunity for input.Background on FSMAThe FSMA was signed into law in January 2011, “to better protect public health by helping to ensure the safety and security of the food supply.” FSMA is significant to the grain c 28  First Quarter 2013 MILLING  JOURNALManagementMark FowlerResponse No. 28128_30_32_Fowler_Column.indd   2 2/15/2013   2:29:42 PMBased on FSMA changes, preventive controls may be required at points other than at critical control points, and criti-cal limits would not be required for all preventive controls. This is an important difference, because FSMA allows some subjectivity into the system by allowing companies to develop controls that fit their products and operations. At a minimum, facilities will be re-quired to write and implement a food safety plan to include the following:• Hazard analysis that identifies and evaluates known or reasonably foresee-able hazards.• Preventive controls implemented to minimize or prevent identified hazards significantly including:– Processing risks.– Food allergens.– Sanitation.– Recall plan.• Monitoring procedures to ensure preventive controls are performed and documented. • Corrective actions for when pre-ventive controls are not implemented properly.• Verification activities to ensure c fied CGMPs will be a new 21 CFR part 117 titled “Current Good Manufactur-ing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”Hazard Analysis, Risk-Based Controls FSMA hazard analysis and risk-based preventive control requirements are similar to HACCP systems but with some subtle differences.Although both FSMA and HACCP preventive controls are science-based, HACCP has developed standards that are defined and widely accepted across the food industry.milling industry, because it mandates facilities to implement a HACCP pro-gram or similar plan to:• Evaluate hazards.• Identify preventive controls.• Implement actions to minimize or prevent these hazards.• Verify that preventive controls are adequate.• Take corrective action when needed.• Maintain a written plan and docu-mentation.HACCP plans or similar programs no longer will be voluntary to provide a safe, reliable ingredient to customers but required by law and enforced by the FDA.The proposed rule will apply to all fa-cilities that are required to register under FDA’s current food facility registration regulations.FMSA has two main parts:1. It includes provisions requiring hazard analysis and risk-based preven-tive controls.2. It revises the Current Good Manu-facturing Practice (CGMP) require-ments found in 21 Code of Federal Regulations (CFR) part 110. The modi-30  First Quarter 2013 MILLING  JOURNALResponse No. 301____________________________________HACCP plans or similar pro-grams  no longer will  be voluntary to provide a safe, reliable ingredient to custom-ers but required by law and enforced by the FDA.  - Mark Fowler, associate director,IGP, KSU____________________________________28_30_32_Fowler_Column.indd   4 2/15/2013   2:29:54 PMComment ProceduresThe process for comment of this pro-posed rule is set by the Administrative Procedure Act. Final rules issued by FDA under this process have the force of law. There are three steps in the comment process.Step 1: FDA proposes a rule and requests comments.Step 2: FDA considers your com-ments and issues a final rule.Step 3: Companies comply with the rule based on the “effective date.”FDA is proposing the effective date of this law to be 60 days after the final rule is published, which could be July or August 2013, with compliance dates depending on size of the company.Again, small businesses would have two years to comply, and very small busi-nesses would have three years, while all other businesses would have to comply within one year after publication of the final rule.The full text of proposed rule, “Cur-rent Good Manufacturing Practice and Hazard Analysis and Risk-Based Preven-tive Controls for Human Food,” is in the Federal Register for public review and comments.The proposed and final rules, with supporting documents, can be found on the FDA’s official website www.regulations.gov, as well as on the FSMA website: www.fda.gov/Food/FoodSafety/FSMA/default.htm.FSMA is the most extensive change of FDA’s food safety regulations in more than 70 years. Change is inevitable and expected, but forced change is often uncomfortable and difficult to accept.I encourage everyone to read the full text of the FSMA rule and make your support and concerns known, as our industry enters into the next era of FDA regulation.Mark Fowler is associate director of the International Grains Program (IGP), Department of Grain Science and Industry, Kansas State University, Manhattan.be required to complete training success-fully, in accordance with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. The CGMP regulation would be revised and changed to offer more details about meeting existing requirements for protect-ing against food contamination, as well as cross-contamination of food allergens.The FDA also is requesting comments on mandating training for employees and supervisors, including a requirement for records that document that training.32  First Quarter 2013 MILLING  JOURNAL____________________________________FDA is proposing the effective date of this law to be 60 days after the final rule is published, which could be July or August 2013. . .  - Mark Fowler_____________________________________Response No. 321FANGED HEADElevator BoltFLAT COUNTERSUNKHEAD (NO. 1 NORWAY)Elevator BoltELEVATOR BUCKETS - ELEVATOR BOLTS*Tapco’s style CC-XD elevator bucket is made with 35-50% more resin than Tapco’s classic style CC-HD. The color blue, when used in connection with elevator buckets, is a U.S. registered trademark owned by Tapco Inc.© 2011 Tapco Inc.®  All rights reserved.FDA-Compliant ResinWill not leach into or affectthe integrity of ingredi-ents used for foodproducts. FDA-com-pliant Nylon andUrethane resins availableby special request.  Anatomy of a Tapco CC-XD(Xtreme Duty) Elevator BucketTested and ProvenUniform profile shapeassures consistent discharge characteristicsover the entire bucketrange.Tough and FlexiblePrime virgin resins“give” or “yield” tobypass obstructions in your elevator,allowing the bucket to return to itsoriginal shape. Thick walls provideexceptional strength.Straight DischargeUntapered sides providedirect and compact discharge pattern.STYLE CC-XD (XTREME DUTY)High-Density Polyethylene Elevator BucketUnequaled StrengthMolded with 35-50% more resin through-out the entire bucket* – not just at criticalwear points – for superior strength andlong life.Accurate Capacity RatingsEqual or greater carrying capacity of equivalent size steel buckets. Smooth,rounded front lip aids in filling of bucket. ••••••The Ultimate Bucket for Xtreme Throughputnew SIZE15"x 7"Available in severe-duty urethane for extreme abrasion resistance, impact-modifiednylon for rough and abrasive applications and high-density polyethylene for free flowing product applications. 900,000 elevator buckets in 93 sizes, 12 styles, 6 materials in stock.PLUS 15 million elevator bolts in 54 sizes, 6 styles, 3 grades. +1 800 288 2726  • +1 314 739 9191   www.tapcoinc.com®AnatXD2c_4_75x7_312_MJ_island  6/2/11  1:22 PM  Page 1       preventive controls are consistently implemented and effective.• Recordkeeping where facilities are required to keep a written food safety plan and records of preventive controls, monitoring, corrective actions, and verification.A qualified individual would be re-quired to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records, and conduct a reanalysis of the food safety plan or oversee these activities.To be qualified, an individual would 28_30_32_Fowler_Column.indd   6 2/19/2013   1:41:43 PM

Food Safety Modernization Act

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Food Safety Modernization Act

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