1 Food Safety and Inspection Service Descriptive Designations

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Food Safety and Inspection Service: Descriptive Designations for Mechanically Tenderized Beef and Added Solutions Mark Wheeler & Janice Fabina Labeling and Program Delivery Staff (LPDS) Food Safety and Inspection Service (FSIS), USDA September 2016 2

Food Safety and Inspection Service: Agenda • LPDS Overview • MTB Rule – – – Background Application Requirements Label Examples Validated Cooking Instructions Q/A’s • Added Solution Rule – – – Background Application Requirements Label Examples Q/A’s • Resources • Contact Information • Questions 3

Food Safety and Inspection Service: LPDS Mission Statement • The Labeling and Program Delivery Staff (LPDS) develops policies and inspection verification methods and administers programs to protect consumers from misbranded and economically adulterated meat, poultry, and egg products such that all labels are truthful and not misleading. 4

Mechanically Tenderized Beef 5

Food Safety and Inspection Service: Background – Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products (MTB) • Since 2003 and prior to the proposed rule, the CDC received reports of six outbreaks attributable to needle- or blade- tenderized beef products prepared in restaurants and consumers’ homes. • Among these outbreaks, there were a total of 157 E. coli O 157: H 7 cases that resulted in 27 hospitalizations and 4 cases of hemolytic uremic syndrome (HUS). • FSIS received petitions from Safe Food Coalition and Conference of Food Protection Ø to require labels of mechanically tenderized beef products to specify that the products were mechanically tenderized. 6

Food Safety and Inspection Service: Background – MTB Products, continued Benefit of having a rule • Estimate of illness from public health surveillance – 63, 153 (annual illnesses) x 0. 394 (beef attributable) × 0. 079 (non-intact) = 1, 965 • Consider effect of changing cooking behavior Decreases illnesses by 1887 to 78 7

Food Safety and Inspection Service: Background – MTB Products, continued • A Proposed Rule was published on June 10, 2013 – FSIS received 122 comments on the proposed rule –(approx. 75 comments were form letters ); nearly 100 comments in support of the rule requiring the descriptive designation and cooking instructions. – Those opposed stated that the SHI already inform the consumer to cook the product thoroughly; cooking instruction will not be effective; and the descriptive designation is inaccurate 8

Food Safety and Inspection Service: Background – MTB Products, continued Milestones • June 10, 2013 - Proposed Rule published • August 9 2013 - Extended comment period • December 4 reopened until Dec 24, 2013 • May 18, 2015 - Final Rule published – 9 CFR 317. 2(e)(3) – Effective May 17, 2016 • FSIS Compliance Guideline for Validated Cooking Instructions; issued 2015 • FSIS Notice 37 -16; issued June 6, 2016 9

Food Safety and Inspection Service: Application of MTB regulation, 9 CFR 317. 2(e)(3) • Products covered: – Needle- or blade-tenderized raw beef products product destined for household consumers, hotels, restaurants, or similar institutions • Products not covered: – MTB Products destined to be fully cooked at an official establishment – Other tenderization methods, such as pounding and cubing, change the appearance of the product, putting consumers on notice that the product is not intact – Corned Beef – Raw or partially cooked beef products that are less than 1/8” thick e. g. , beef bacon or carne asada 10

Food Safety and Inspection Service: Descriptive Designation of MTB Products The label must bear: 1. The descriptive designation “mechanically tenderized, ” “blade tenderized, ” or “needle tenderized” and an accurate description of the beef component in the product name; and 2. In close proximity; w/o intervening text or graphics 3. All words in the descriptive designation be in the same style, color, and on a single-color contrasting background 4. Upper and lower case allowed; however, smallest letter must be at least 1/3 the size of the largest letter 5. Validated cooking instructions for subject products destined for household consumers, hotels, restaurants, or similar institutions. 11

Food Safety and Inspection Service: Descriptive Designation of MTB Products, continued Example label Validated cooking instructions need to include: • a cooking method • that these products need to be cooked to a specified minimum internal temperature, • whether these products need to be held at that minimum temperature or higher for a specified time before consumption, i. e. , dwell time or rest time, to ensure that potential pathogens are destroyed, • and that the internal temperature should be measured by a thermometer. 12

Food Safety and Inspection Service: Cooking Instruction (Example) • For Food Safety and Quality Follow These Cooking Instructions: Gas Grill: 1) Heat gas grill on Medium-High. 2) Cook for 6 minutes to an internal temperature of 145°F as measured with a food thermometer. Flip steak over at least twice during cooking. 3) After removing from the gas grill, for safety, allow meat to rest at or above 145° F internal temperature for at least three minutes before serving. * Please note that the above instructions are an example of cooking instructions. Your instructions may not be the same as these; however, your instructions should provide the preparer with clear instructions to get to the necessary end point temperature. 13

Food Safety and Inspection Service: Validating Cooking Instructions • FSIS Compliance Guideline for Validating Cooking Instructions for Mechanically Tenderized Beef Products is available here: http: //www. fsis. usda. gov/w ps/wcm/connect/606919 b 65192 -40 bd-a 32 b 99 a 41 c 75 eeb 6/Comp_Guide _MTB. pdf? MOD=AJPERES. 14

Food Safety and Inspection Service: MTB Generic Approval • If label already has sketch approval, adding the MTB descriptive designation can be done through generic approval • For new labels, "generic" approval may be used for products requiring the MTB descriptive designation as long as there are: – no unapproved special statements or claims on the label, and – as long the label is in compliance with all of the other labeling regulations (refer to 9 CFR 412. 2). NOTE: FSIS Inspectors do not generically approve labels. Establishments do not generically approve labels. FSIS approves labels through generic labeling regulations. 15

Questions & Answers for Mechanically Tenderized Beef 16

Food Safety and Inspection Service: MTB Questions and Answers • Question: Do the new labeling requirements apply to mechanically tenderized beef products labeled or prepared at retail stores? • Answer: Yes, The new labeling requirements would apply to raw or partially cooked mechanically tenderized beef products produced, packaged, and labeled at a retail store. 17

Food Safety and Inspection Service: MTB Questions and Answers, continued • Question: Is beef cubed steak is subject to the new labeling requirements? • Answer: No, this regulation will not apply to raw or partially cooked beef products that have been cubed. The regulation is specific to needle and blade tenderized beef products. FSIS stated in the final rule: Below is the text from the regulation. The descriptive designation will only apply to raw or partially cooked beef products that have been needle tenderized or blade-tenderized, including beef products injected with marinade or solution. Other tenderization methods, such as pounding and cubing, change the appearance of the product, putting consumers on notice that the product is not intact. Moreover, most establishments already label cubed products as such. (80 FR 28157) 18

Food Safety and Inspection Service: MTB Questions and Answers, continued • Question: Must the label of a raw or partially cooked mechanically tenderized beef product that contains added solution also declare the percentage of added solution? • Answer: Yes. However, there are different options for declaring the total amount of solution added. See 9 CFR 317. 2(e)(2). 19

Food Safety and Inspection Service: MTB Questions and Answers, continued • Question: What must be included in the validated cooking instructions • for mechanically tenderized beef ? Answer: The labels of raw and partially cooked needle- or bladetenderized beef products destined for household consumers, hotels, restaurants, or similar institutions will have to bear validated cooking instructions, including: – The cooking method; – that these products need to be cooked to a specified minimum internal temperature; – whether the product needs to be held for a specified time at that temperature or higher before consumption to ensure that potential pathogens are destroyed throughout the product; and – a statement that the internal temperature should be measured by a thermometer (9 CFR 317. 2(e)(3)(iii)). 20

Food Safety and Inspection Service: MTB Questions and Answers, continued • Question: To meet requirements for validated cooking instructions on the labels of mechanically tenderized raw beef products, can producers use a grid or table format to display cooking times and temperatures based on product thickness? See the example below. • Answer: Yes. Below is an example of how a chart could be used on labels of mechanically tenderized product to meet these requirements. Cook the following size steaks on a grill for the time indicated until the cooked steak reaches 145° F as measured with a meat thermometer. Then allow the product to rest for 3 minutes. Size (Thickness) 0. 5" 1. 0" 1. 5" 2. 0" 2. 5" 3. 0" 3. 5" Cooking time 1 ½ min, flip and cook for 2 min, flip and cook for 2 min 2 ½ min, flip and cook for 3 min, flip and cook for 4 min 21

Raw Meat & Poultry Products with Added Solutions 22

Food Safety and Inspection Service: Background – Added Solutions Regulation • July 2007, Truthful Labeling Coalition (TLC), Petition – Consumers were often unaware of added solutions – Requested labeling to clearly disclose added solutions • March 2009, the California Agricultural Commissioners and Sealers Association, Petition – Consumers were often unable to compare the value of products with added solution to those without. • 2006 public meeting & a 2009 ANPR on the use of “natural” claims – FSIS received >12, 000 comments related to the labeling of poultry with added solutions – Most also requested clear and prominent labeling • FSIS compared poultry and meat labeling regulations and guidance – Similar but not the same 23

Food Safety and Inspection Service: Background – Added Solutions Regulation, continued Considering the petitions, comments, and labeling policies for raw poultry and meat products with added solutions: Regulations needed to be updated to be more meaningful to consumers. To provide uniform requirements for raw meat and poultry with added solutions. To ensure fair competition in marketplace to benefit consumers and producers. 24

Food Safety and Inspection Service: Background – Added Solutions Regulation, continued Milestones: • Proposed rule published July 27, 2011 • Comments were accepted from July 27, 2011 through January 7, 2012 • Final rule was published December 31, 2014 – Red meat 9 CFR 317. 2(e)(2) – Poultry 9 CFR 381. 117(h) • FSIS Notice 28 -16; issued May 3, 2016 25

Food Safety and Inspection Service: Background – Added Solutions Regulation, continued • Effective Dates – January 1, 2016: raw poultry, pork, and other red meat (excluding beef) with added solutions to comply except the descriptive designation may use 1/4 sizing. – May 17, 2016: raw MTB with added solutions to comply except that the solution designation may use 1/4 sizing. – January 1, 2018: All covered products must comply with 1/3 size requirement. 26

Food Safety and Inspection Service: Application of the Final Rule, 317. 2(e)(2) & 381. 117(h) • Affects the following entities: – Domestic establishments; – Foreign establishments that export to the US; – Retailers. 27

Food Safety and Inspection Service: Application of the Final Rule, 317. 2(e)(2) & 381. 117(h), continued • Applies to raw meat and poultry products with added solutions that: – do not meet a standard of identity; – are sold for: retail sale, institutional/HRI use, or further processing; – are produced in retail facilities, such as grocery stores • Products that Are subject to the rule, for example: – Whole muscle or ground products with added solutions. – Breaded raw (not heat treated) whole muscle or ground products with added solutions. – Raw meat or poultry with added solution that is coated with seasoning, sauce, glaze, ice glaze, and similar coatings. – Corned beef products that exceed regulatory limitation of added solution 28

Food Safety and Inspection Service: Application of the Final Rule, 317. 2(e)(2) & 381. 117(h), continued Products that are Not subject to the final rule, for example: – Raw products in compliance with and labeled according to a standard of identity. • Corned Beef (9 CFR 319. 100 -. 102). • Cured pork (9 CFR 319. 104 & 319. 105) – Heat-treated, breaded, whole muscle products with added solutions. – Descriptively labeled raw products. • e. g. , (Uncooked) Beef Water and Binder Product – Cooked products with added solution. • Red meat with solution subject to Policy Memo 084 A. 29

Food Safety and Inspection Service: Requirements for the Descriptive Designation for Raw Meat and Poultry Products Containing Added Solutions 1. Product name must include a “descriptive designation. ” 2. Descriptive designation includes: a. the % of added solution. (lb solution / lb raw meat/poultry) x 100 a. all ingredients (single or multi-ingredient) in descending order of predominance. 3. Percent solution must be a number with the percent symbol “%” e. g. , “ 10%” (not, ten percent). a. Product name and descriptive designation must be in a single easy-to-read font style, the same color, and on the same singlecolor contrasting background without intervening text or graphics. 30

Food Safety and Inspection Service: Requirements for the Descriptive Designation for Raw Meat and Poultry Products Containing Added Solutions , continued 5. All lettering in product name and descriptive designation will need to meet 1/3 sizing: a. Shortest letter compared to tallest letter b. exception, 1/4 size applicable for 2 additional years (Jan 1, 2018) 6. Separate ingredients statement is required if the descriptive designation does not sub-list all multi-ingredient components. • “Enhanced” may not be used in the product name or in the descriptive designation which is part of the product name. a. “Contains” may be used in the descriptive designation. 31

Food Safety and Inspection Service: Descriptive Designation for Raw Meat and Poultry Products Containing Added Solutions Example Label: • Meat Cut Name: “Pork Tenderloin” • Descriptive Designation: “ 15% Added Solution of Water and Teriyaki Sauce” • Ingredients Statement: required in this example because teriyaki sauce needs to be sub-listed. 32

Food Safety and Inspection Service: Application of the Final Rule, 317. 2(e)(2) & 381. 117(h) • When both the MTB and added solution descriptive designations are required: – they are considered equal – may be placed in any order relative to the product name. For example : • “Beef Mechanically Tenderized Contains 12% solution of water, spices, and salt”, or • “Beef Contains 12% solution of water, spices, and salt, Mechanically Tenderized”, or • “Mechanically Tenderized Beef Contains 12% solution of water, spices, and salt” 33

Food Safety and Inspection Service: Label Example with Both MTB & Added Solution Descriptive Designations 34

Food Safety and Inspection Service: Corned Beef Products For Corned Beef Products: – Keep in mind, corned beef products do not need the MTB designation but they may need one for added solution – 9 CFR 319. 100, “corned beef” & 319. 102 “corned beef round” and other beef cuts (but Not brisket) • if added solution is = or< 10%; No designation needed • if solution is > X% Yes, added solution designation required – 9 CFR 319. 101, “corned beef brisket” • If added solution is = or <20%; No designation needed • If solution is >20%, Yes, added solution designation required 35

Questions & Answers for Raw Meat & Poultry with Added Solution 36

Food Safety and Inspection Service: Added Solution Questions and Answers • Question: If we find that any of our labels need correcting based on the recently published final rule for raw products with added solutions, can we do this with a generic approval? • Answer: Yes, provided that the label complies with 9 CFR 412. 2. Modifying or adding a descriptive designation is not considered a special claim. 37

Food Safety and Inspection Service: Added Solution Questions and Answers, continued • Question: Can we use "contains x% solution" as an identifier on box end labels on a shipping container that holds fully labeled packages inside the box? • Answer: The labeling for a shipping container that holds fully labeled immediate containers is not required to bear a product name, but when the container voluntarily bears the product name, the name must be complete to accurately reflect the nature of the product inside. The product name for raw products with added solution subject to this rule must include the solution descriptive designation. However, FSIS has made an exception to allow a shortened version of the descriptive designation on the shipping container. For example, if the retail label inside the shipping container declares “pork with 10% solution of water, salt, and sodium phosphate, ” the shipping container label may repeat the same information or use an abbreviated format such as “Pork w/10% Solution” or “PRK w/10% SLN”. The immediate containers inside the shipping container may not bear a shortened version of the descriptive designation. 38

Food Safety and Inspection Service: Added Solution Questions and Answers, continued • Question: Under this final rule, does the ingredients statement need to be on the Principal Display Panel (PDP)? • Answer: No. The regulations in 9 CFR 317. 2(c)(2) and (f) and 381. 118 continue to allow the ingredients statement to be placed on the information panel or on the 20% panel for cylinders. 39

Food Safety and Inspection Service: Added Solution Questions and Answers, continued • Question: Does the rule apply to product containing added solution, regardless of the method of incorporating the solution (for example, marinating, basting, injection, vacuum tumbling)? • Answer: Yes. The rule applies to products where solution has been incorporated into raw meat or poultry through any method, for example, marinating, basting, injection, vacuum tumbling. 40

Food Safety and Inspection Service: Added Solution Questions and Answers, continued • Question: Do statements, such as "colored with annatto" and “coated with seasonings, ” need to be in the same type style, height, and color as the rest of the product name? • Answer: No. Statements that further describe the product name, for example, “colored with annatto” and “coated with seasonings, ” are not part of the descriptive designation and do not need to comply with the formatting requirements. 41

Resources 42

Food Safety and Inspection Service: Available Resources for MTB Final Rule: http: //www. fsis. usda. gov/wps/wcm/connect/ea 5 a 6 c 2 e-a 3 d 0 -4990 -9479 -755 e 82 f 5 ceb 2/20080017 F. pdf? MOD=AJPERES FSIS Compliance Guideline for Validating Cooking Instructions for MTB Products: http: //www. fsis. usda. gov/wps/wcm/connect/606919 b 6 -5192 -40 bd-a 32 b 99 a 41 c 75 eeb 6/Comp_Guide_MTB. pdf? MOD=AJPERES FSIS Notice 37 -16: http: //www. fsis. usda. gov/wps/wcm/connect/c 7 e 4 e 5 fa-07 af-401 d-81 c 8 -df 297 c 6 ff 4 c 4/3716. pdf? MOD=AJPERES&CONVERT_TO=url&CACHEID=c 7 e 4 e 5 fa-07 af-401 d-81 c 8 -df 297 c 6 ff 4 c 4 MTB Questions and Answers: http: //www. fsis. usda. gov/wps/wcm/connect/e 42698 a 1 -1949 -4828 -9909 -5 ff 919 f 275 c 6/FAQs 2008 -0017. pdf? MOD=AJPERES MTB Proposed Rule: http: //www. fsis. usda. gov/wps/wcm/connect/741 a 8 b 94 -85 b 0 -4800 -963 e-ad 0517838 a 02/20080017. pdf? MOD=AJPERES 43

Food Safety and Inspection Service: Available Resources for Raw Meat and Poultry Products with Added Solutions Added Solution Final Rule: http: //www. fsis. usda. gov/wps/wcm/connect/942 b 0716 -42 a 9 -4 d 0 e-8 e 5 f-3 ba 4 d 2 dfc 70 d/20100012. pdf? MOD=AJPERES Added Solution Questions and Answers: http: //www. fsis. usda. gov/wps/wcm/connect/70 c 4707 c-d 4 cf-4845 -b 97 f-ad 8 dc 23 e 4 c 46/Q-AAdded-Solutions-122415. pdf? MOD=AJPERES FSIS Notice 28 -16: http: //www. fsis. usda. gov/wps/wcm/connect/0 a 97 ba 4 c-b 3 cd-431 a-8 d 40 -91 cb 5539 c 83 b/2816. pdf? MOD=AJPERES&CONVERT_TO=url&CACHEID=0 a 97 ba 4 c-b 3 cd-431 a-8 d 40 -91 cb 5539 c 83 b Added Solution Proposed Rule: http: //www. fsis. usda. gov/wps/wcm/connect/534 b 2 d 6 d-7 ee 0 -4 a 2 f-8869 -01811 a 29 b 1 f 6/20100012 RO. pdf? MOD=AJPERES 44

Food Safety and Inspection Service: Available Resources on Labeling FSIS Main Labeling Website: http: //www. fsis. usda. gov/wps/portal/fsis/topics/regulatory-compliance/labeling Label Submission and Approval System (LSAS): http: //lsas. fsis. usda. gov Generic Labeling Resources: http: //www. fsis. usda. gov/wps/portal/fsis/topics/regulatory-compliance/labeling/Labeling. Policies FSIS Directives: http: //www. fsis. usda. gov/wps/portal/fsis/topics/regulations/directives 45

Food Safety and Inspection Service: Available Resources: ask. FSIS, MTB, Labeling For MTB Labeling Questions - ask. FSIS http: //askfsis. custhelp. com Use the “Submit A Question” tab, and enter the following: Subject Field: Enter Mechanically Tenderized Question Field: Enter your question with as much detail as possible. Product Field: Select Labeling from the drop-down menu. Category Field: Select Labeling Regulations, Policies and Claims from the drop-down menu • Policy Arena: Select Domestic (U. S. ) only from the drop-down menu • When all fields are complete, press Continue and at the next screen press Finish Submitting Question. • • • 46

Food Safety and Inspection Service: Available Resources: ask. FSIS, MTB, Cooking For Validation or Cooking Instructions Questions - ask. FSIS http: //askfsis. custhelp. com • Subject Field: Enter Topic Name (e. g. , Validation of cooking instructions) • Question Field: Enter question with as much detail as possible. • Product Field: Select General Inspection Policy from the dropdown menu. • Category Field: Select Sampling from the drop-down menu. • Policy Arena: Select Domestic (U. S. ) Only from the drop-down menu. 47

Food Safety and Inspection Service: Available Resources: ask. FSIS, Added Solution For Added Solution Questions - ask. FSIS http: //askfsis. custhelp. com Use the “Submit A Question” tab, and enter the following: Subject Field: Enter Raw Products with Added Solution Question Field: Enter your question with as much detail as possible. Product Field: Select Labeling from the drop-down menu. Category Field: Select Labeling Regulations, Policies and Claims from the drop-down menu • Policy Arena: Select Domestic (U. S. ) only from the drop-down menu • When all fields are complete, press Continue and at the next screen press Finish Submitting Question. • • • 48

Food Safety and Inspection Service: Contacting LPDS or RIMS by Phone • When leaving a phone message • • • LPDS general voice mail (301) 504 -0878 RIMS general voice mail (301) 504 -0890 Speak slowly and clearly Provide your name and phone number, repeat number Specify the topic of your question (not “labeling”) • Calls are distributed by topic to a staff member that specializes in that subject area – e. g. for LPDS: MTB, added solution, nutrition labeling, animal production raising claims, generically approved labeling, amenability, etc. 49

Food Safety and Inspection Service: Questions? 50