Regulatory Requirements under the Federal Meat Inspection Act and the Poultry Products Inspection Act (9 CFR 412.1-500.8)

615 SUBCHAPTER E—REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT PART 412—LABEL APPROVAL Sec. 412.1 Label approval. 412.2 Approval of generic labels. AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. SOURCE: 78 FR 66838, Nov. 7, 2013, unless otherwise noted. § 412.1 Label approval. (a) No final label may be used on any product unless the label has been sub mitted for approval to the FSIS Label ing and Program Delivery Staff, ac companied by FSIS Form 7234–1, Appli cation for Approval of Labels, Marking, and Devices, and approved by such staff, except for generically approved labels authorized for use in § 412.2. The management of the official establish ment or establishment certified under a foreign inspection system, in accord ance with parts 327 and 381, subpart T, must maintain a copy of all labels used, in accordance with parts 320 and 381, subpart Q, of this chapter. Such records must be made available to any duly authorized representative of the Secretary upon request. (b) All labels required to be sub mitted for approval as set forth in paragraph (a) of this section will be submitted to the FSIS Labeling and Program Delivery Staff. A parent com pany for a corporation may submit only one label application for a product produced in other establishments that are owned by the corporation. (c) The Food Safety and Inspection Service requires the submission of la beling applications for the following: (1) Sketch labels as defined in para graph (d) of this section for products which are produced under a religious exemption; (2) Sketch labels for products for for eign commerce whose labels deviate from FSIS regulations, with the excep tion of printing labels in foreign lan guage or printing labels that bear a statement of the quantity of contents in accordance with the usage of the country to which exported as described in § 317.7 and part 381, subpart M of this chapter. (3) Special statements and claims as defined in paragraph (e) of this section and presented in the context of a final label. (4) Requests for the temporary use of final labels as prescribed in paragraph (f) of this section. (d) A ‘‘sketch’’ label is the concept of a label. It may be a printer’s proof or equivalent that is sufficiently legible to clearly show all labeling features, size, and location. The Food Safety and Inspection Service will accept sketches that are hand drawn or computer gen erated, or other reasonable facsimiles that clearly reflect and project the final version of the label. (e) ‘‘Special statements and claims’’ are claims, logos, trademarks, and other symbols on labels that are not defined in the Federal meat and poul try products inspection regulations or the Food Standards and Labeling Pol icy Book, (except for ‘‘natural’’ and negative claims (e.g., ‘‘gluten free’’)), health claims, ingredient and proc essing method claims (e.g., high-pres sure processing), structure-function claims, claims regarding the raising of animals, organic claims, and instruc tional or disclaimer statements con cerning pathogens (e.g., ‘‘for cooking only’’ or ‘‘not tested for E. coli O157:H7’’). Examples of logos and sym bols include graphic representations of hearts and geographic landmarks. Spe cial statements and claims do not in clude allergen statements (e.g., ‘‘con tains soy’’) applied in accordance with the Food Allergen Labeling and Con sumer Protection Act. (f)(1) Temporary approval for the use of a final label that may be deemed de ficient in some particular may be granted by the FSIS Labeling and Pro gram Delivery Staff. Temporary ap provals may be granted for a period not to exceed 180 calendar days, under the following conditions: VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00625 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 616 9 CFR Ch. III (1–1–18 Edition) § 412.2 1 See 9 CFR 317.8(b)(40) and 381.129(f). (i) The proposed label would not mis represent the product; (ii) The use of the label would not present any potential health, safety, or dietary problems to the consumer; (iii) Denial of the request would cre ate undue economic hardship; and (iv) An unfair competitive advantage would not result from the granting of the temporary approval. (2) Extensions of temporary approv als may also be granted by the FSIS Labeling and Program Delivery Staff provided that the applicant dem onstrates that new circumstances, meeting the above criteria, have devel oped since the original temporary ap proval was granted. § 412.2 Approval of generic labels. (a)(1) An official establishment, or an establishment certified under a foreign inspection system in accordance with part 327, or part 381, subpart T of this chapter, is authorized to use generi cally approved labels, as defined in paragraph (b) of this section, and thus is free to use such labels without sub mitting them to the Food Safety and Inspection Service for approval, pro vided the label, in accordance with this section, displays all mandatory fea tures in a prominent manner in compli ance with part 317 or part 381, and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service will select samples of generi cally approved labels from the records maintained by official establishments and establishments certified under for eign inspection systems, in accordance with part 327 or part 381, subpart T, to determine compliance with label re quirements. If the Agency finds that an establishment is using a false or mis leading label, it will institute the pro ceedings prescribed in § 500.8 of this chapter to revoke the approval for the label. (b) Generically approved labels are labels that bear all applicable manda tory labeling features (i.e., product name, safe handling statement, ingre dients statement, the name and place of business of the manufacturer, packer or distributor, net weight, legend, safe handling instructions, and nutrition la beling) in accordance with Federal reg ulations. Labels that bear claims and statements that are defined in FSIS’s regulations or the Food Standards and Labeling Policy Book (except for nat ural and negative claims), such as a statement that characterizes a prod uct’s nutrient content, such as ‘‘low fat,’’ has geographical significance, such as ‘‘German Brand,’’ or makes a country of origin statement on the label of any meat or poultry product ‘‘covered commodity’’,1 and that com ply with those regulations are also deemed to be generically approved by the Agency without being submitted for evaluation and approval. Allergen statements (e.g., ‘‘contains soy’’) ap plied in accordance with the Food Al lergen Labeling and Consumer Protec tion Act are also deemed generically approved. PART 416—SANITATION Sec. 416.1 General rules. 416.2 Establishment grounds and facilities. 416.3 Equipment and utensils. 416.4 Sanitary operations. 416.5 Employee hygiene. 416.6 Tagging insanitary equipment, uten sils, rooms or compartments. 416.11 General rules. 416.12 Development of sanitation SOP’s. 416.13 Implementation of SOP’s. 416.14 Maintenance of Sanitation SOP’s. 416.15 Corrective Actions. 416.16 Recordkeeping requirements. 416.17 Agency verification. AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53. SOURCE: 61 FR 38868, July 25, 1996, unless otherwise noted. § 416.1 General rules. Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of in sanitary conditions and to ensure that product is not adulterated. [64 FR 56417, Oct. 20, 1999] § 416.2 Establishment grounds and fa cilities. (a) Grounds and pest control. The grounds about an establishment must be maintained to prevent conditions VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00626 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 617 Food Safety and Inspection Service, USDA § 416.2 that could lead to insanitary condi tions, adulteration of product, or inter fere with inspection by FSIS program employees. Establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within estab lishment facilities. Pest control sub stances used must be safe and effective under the conditions of use and not be applied or stored in a manner that will result in the adulteration of product or the creation of insanitary conditions. (b) Construction. (1) Establishment buildings, including their structures, rooms, and compartments must be of sound construction, be kept in good re pair, and be of sufficient size to allow for processing, handling, and storage of product in a manner that does not re sult in product adulteration or the cre ation of insanitary conditions. (2) Walls, floors, and ceilings within establishments must be built of dura ble materials impervious to moisture and be cleaned and sanitized as nec essary to prevent adulteration of prod uct or the creation of insanitary condi tions. (3) Walls, floors, ceilings, doors, win dows, and other outside openings must be constructed and maintained to pre vent the entrance of vermin, such as flies, rats, and mice. (4) Rooms or compartments in which edible product is processed, handled, or stored must be separate and distinct from rooms or compartments in which inedible product is processed, handled, or stored, to the extent necessary to prevent product adulteration and the creation of insanitary conditions. (c) Light. Lighting of good quality and sufficient intensity to ensure that sanitary conditions are maintained and that product is not adulterated must be provided in areas where food is proc essed, handled, stored, or examined; where equipment and utensils are cleaned; and in hand-washing areas, dressing and locker rooms, and toilets. (d) Ventilation. Ventilation adequate to control odors, vapors, and condensa tion to the extent necessary to prevent adulteration of product and the cre ation of insanitary conditions must be provided. (e) Plumbing. Plumbing systems must be installed and maintained to: (1) Carry sufficient quantities of water to required locations throughout the establishment; (2) Properly convey sewage and liquid disposable waste from the establish ment; (3) Prevent adulteration of product, water supplies, equipment, and utensils and prevent the creation of insanitary conditions throughout the establish ment; (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; (5) Prevent back-flow conditions in and cross-connection between piping systems that discharge waste water or sewage and piping systems that carry water for product manufacturing; and (6) Prevent the backup of sewer gases. (f) Sewage disposal. Sewage must be disposed into a sewage system separate from all other drainage lines or dis posed of through other means suffi cient to prevent backup of sewage into areas where product is processed, han dled, or stored. When the sewage dis posal system is a private system re quiring approval by a State or local health authority, the establishment must furnish FSIS with the letter of approval from that authority upon re quest. (g) Water supply and water, ice, and so lution reuse. (1) A supply of running water that complies with the National Primary Drinking Water regulations (40 CFR part 141), at a suitable tem perature and under pressure as needed, must be provided in all areas where re quired (for processing product, for cleaning rooms and equipment, uten sils, and packaging materials, for em ployee sanitary facilities, etc.). If an establishment uses a municipal water supply, it must make available to FSIS, upon request, a water report, issued under the authority of the State or local health agency, certifying or at testing to the potability of the water supply. If an establishment uses a pri vate well for its water supply, it must make available to FSIS, upon request, documentation certifying the pota bility of the water supply that has been renewed at least semi-annually. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00627 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 618 9 CFR Ch. III (1–1–18 Edition) § 416.3 (2) Water, ice, and solutions (such as brine, liquid smoke, or propylene gly col) used to chill or cook ready-to-eat product may be reused for the same purpose, provided that they are main tained free of pathogenic organisms and fecal coliform organisms and that other physical, chemical, and micro biological contamination have been re duced to prevent adulteration of prod uct. (3) Water, ice, and solutions used to chill or wash raw product may be re used for the same purpose provided that measures are taken to reduce physical, chemical, and micro biological contamination so as to pre vent contamination or adulteration of product. Reuse that which has come into contact with raw product may not be used on ready-to-eat product. (4) Reconditioned water that has never contained human waste and that has been treated by an onsite advanced wastewater treatment facility may be used on raw product, except in product formulation, and throughout the facil ity in edible and inedible production areas, provided that measures are taken to ensure that this water meets the criteria prescribed in paragraph (g)(1) of this section. Product, facili ties, equipment, and utensils coming in contact with this water must undergo a separate final rinse with non-recondi tioned water that meets the criteria prescribed in paragraph (g)(1) of this section. (5) Any water that has never con tained human waste and that is free of pathogenic organisms may be used in edible and inedible product areas, pro vided it does not contact edible prod uct. For example, such reuse water may be used to move heavy solids, to flush the bottom of open evisceration troughs, or to wash antemortem areas, livestock pens, trucks, poultry cages, picker aprons, picking room floors, and similar areas within the establishment. (6) Water that does not meet the use conditions of paragraphs (g)(1) through (g)(5) of this section may not be used in areas where edible product is handled or prepared or in any manner that would allow it to adulterate edible product or create insanitary condi tions. (h) Dressing rooms, lavatories, and toi lets. (1) Dressing rooms, toilet rooms, and urinals must be sufficient in num ber, ample in size, conveniently lo cated, and maintained in a sanitary condition and in good repair at all times to ensure cleanliness of all per sons handling any product. They must be separate from the rooms and com partments in which products are proc essed, stored, or handled. (2) Lavatories with running hot and cold water, soap, and towels, must be placed in or near toilet and urinal rooms and at such other places in the establishment as necessary to ensure cleanliness of all persons handling any product. (3) Refuse receptacles must be con structed and maintained in a manner that protects against the creation of insanitary conditions and the adultera tion of product. [64 FR 56417, Oct. 20, 1999] § 416.3 Equipment and utensils. (a) Equipment and utensils used for processing or otherwise handling edible product or ingredients must be of such material and construction to facilitate thorough cleaning and to ensure that their use will not cause the adultera tion of product during processing, han dling, or storage. Equipment and uten sils must be maintained in sanitary condition so as not to adulterate prod uct. (b) Equipment and utensils must not be constructed, located, or operated in a manner that prevents FSIS inspec tion program employees from inspect ing the equipment or utensils to deter mine whether they are in sanitary con dition. (c) Receptacles used for storing ined ible material must be of such material and construction that their use will not result in the adulteration of any edible product or in the creation of in sanitary conditions. Such receptacles must not be used for storing any edible product and must bear conspicuous and distinctive marking to identify per mitted uses. [64 FR 56417, Oct. 20, 1999] VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00628 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 619 Food Safety and Inspection Service, USDA § 416.12 § 416.4 Sanitary operations. (a) All food-contact surfaces, includ ing food-contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary con ditions and the adulteration of prod uct. (b) Non-food-contact surfaces of fa cilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as fre quently as necessary to prevent the creation of insanitary conditions and the adulteration of product. (c) Cleaning compounds, sanitizing agents, processing aids, and other chemicals used by an establishment must be safe and effective under the conditions of use. Such chemicals must be used, handled, and stored in a man ner that will not adulterate product or create insanitary conditions. Docu mentation substantiating the safety of a chemical’s use in a food processing environment must be available to FSIS inspection program employees for re view. (d) Product must be protected from adulteration during processing, han dling, storage, loading, and unloading at and during transportation from offi cial establishments. [64 FR 56417, Oct. 20, 1999] § 416.5 Employee hygiene. (a) Cleanliness. All persons working in contact with product, food-contact sur faces, and product-packaging materials must adhere to hygienic practices while on duty to prevent adulteration of product and the creation of insani tary conditions. (b) Clothing. Aprons, frocks, and other outer clothing worn by persons who handle product must be of mate rial that is disposable or readily cleaned. Clean garments must be worn at the start of each working day and garments must be changed during the day as often as necessary to prevent adulteration of product and the cre ation of insanitary conditions. (c) Disease control. Any person who has or appears to have an infectious disease, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contami nation, must be excluded from any op erations which could result in product adulteration and the creation of insani tary conditions until the condition is corrected. [64 FR 56417, Oct. 20, 1999] § 416.6 Tagging insanitary equipment, utensils, rooms or compartments. When an FSIS program employee finds that any equipment, utensil, room, or compartment at an official es tablishment is insanitary or that its use could cause the adulteration of product, he will attach to it a ‘‘U.S. Rejected’’ tag. Equipment, utensils, rooms, or compartments so tagged can not be used until made acceptable. Only an FSIS program employee may remove a ‘‘U.S. Rejected’’ tag. [64 FR 56417, Oct. 20, 1999] § 416.11 General rules. Each official establishment shall de velop, implement, and maintain writ ten standard operating procedures for sanitation (Sanitation SOP’s) in ac cordance with the requirements of this part. § 416.12 Development of Sanitation SOP’s. (a) The Sanitation SOP’s shall de scribe all procedures an official estab lishment will conduct daily, before and during operations, sufficient to prevent direct contamination or adulteration of product(s). (b) The Sanitation SOP’s shall be signed and dated by the individual with overall authority on-site or a higher level official of the establishment. This signature shall signify that the estab lishment will implement the Sanita tion SOP’s as specified and will main tain the Sanitation SOP’s in accord ance with the requirements of this part. The Sanitation SOP’s shall be signed and dated upon initially imple menting the Sanitation SOP’s and upon any modification to the Sanita tion SOP’s. (c) Procedures in the Sanitation SOP’s that are to be conducted prior to operations shall be identified as such, and shall address, at a minimum, the cleaning of food contact surfaces of fa cilities, equipment, and utensils. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00629 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 620 9 CFR Ch. III (1–1–18 Edition) § 416.13 (d) The Sanitation SOP’s shall speci fy the frequency with which each pro cedure in the Sanitation SOP’s is to be conducted and identify the establish ment employee(s) responsible for the implementation and maintenance of such procedure(s). § 416.13 Implementation of SOP’s. (a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations. (b) Each official establishment shall conduct all other procedures in the Sanitation SOP’s at the frequencies specified. (c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s. § 416.14 Maintenance of Sanitation SOP’s. Each official establishment shall rou tinely evaluate the effectiveness of the Sanitation SOP’s and the procedures therein in preventing direct contami nation or adulteration of product(s) and shall revise both as necessary to keep them effective and current with respect to changes in facilities, equip ment, utensils, operations, or per sonnel. § 416.15 Corrective Actions. (a) Each official establishment shall take appropriate corrective action(s) when either the establishment or FSIS determines that the establishment’s Sanitation SOP’s or the procedures specified therein, or the implementa tion or maintenance of the Sanitation SOP’s, may have failed to prevent di rect contamination or adulteration of product(s). (b) Corrective actions include proce dures to ensure appropriate disposition of product(s) that may be contami nated, restore sanitary conditions, and prevent the recurrence of direct con tamination or adulteration of prod uct(s), including appropriate reevalua tion and modification of the Sanitation SOP’s and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP’s or the procedures specified therein. [61 FR 38868, July 25, 1996, as amended at 62 FR 26219, May 13, 1997] § 416.16 Recordkeeping requirements. (a) Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being respon sible for the implementation and moni toring of the procedure(s) specified in the Sanitation SOP’s shall authen ticate these records with his or her ini tials and the date. (b) Records required by this part may be maintained on computers provided the establishment implements appro priate controls to ensure the integrity of the electronic data. (c) Records required by this part shall be maintained for at least 6 months and made available to FSIS. All such records shall be maintained at the official establishment for 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request. § 416.17 Agency verification. FSIS shall verify the adequacy and effectiveness of the Sanitation SOP’s and the procedures specified therein by determining that they meet the re quirements of this part. Such verification may include: (a) Reviewing the Sanitation SOP’s; (b) Reviewing the daily records docu menting the implementation of the Sanitation SOP’s and the procedures specified therein and any corrective ac tions taken or required to be taken; (c) Direct observation of the imple mentation of the Sanitation SOP’s and the procedures specified therein and any corrective actions taken or re quired to be taken; and (d) Direct observation or testing to assess the sanitary conditions in the establishment. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00630 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 621 Food Safety and Inspection Service, USDA § 417.2 PART 417—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Sec. 417.1 Definitions. 417.2 Hazard Analysis and HACCP plan. 417.3 Corrective actions. 417.4 Validation, Verification, Reassess ment. 417.5 Records. 417.6 Inadequate HACCP Systems. 417.7 Training. 417.8 Agency verification. AUTHORITY: 7 U.S.C. 450; 21 U.S.C. 451–470, 601–695; 7 U.S.C. 1901–1906; 7 CFR 2.18, 2.53. SOURCE: 61 FR 38868, July 25, 1996, unless otherwise noted. § 417.1 Definitions. For purposes of this part, the fol lowing definitions shall apply: Corrective action. Procedures to be fol lowed when a deviation occurs. Critical control point. A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. Critical limit. The maximum or min imum value to which a physical, bio logical, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an ac ceptable level the occurrence of the identified food safety hazard. Food safety hazard. Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption. HACCP System. The HACCP plan in operation, including the HACCP plan itself. Hazard. SEE Food Safety Hazard. Preventive measure. Physical, chem ical, or other means that can be used to control an identified food safety haz ard. Process-monitoring instrument. An in strument or device used to indicate conditions during processing at a crit ical control point. Responsible establishment official. The individual with overall authority on site or a higher level official of the es tablishment. § 417.2 Hazard Analysis and HACCP Plan. (a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards rea sonably likely to occur in the produc tion process and identify the preven tive measures the establishment can apply to control those hazards. The hazard analysis shall include food safe ty hazards that can occur before, dur ing, and after entry into the establish ment. A food safety hazard that is rea sonably likely to occur is one for which a prudent establishment would estab lish controls because it historically has occurred, or because there is a reason able possibility that it will occur in the particular type of product being proc essed, in the absence of those controls. (2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified. (3) Food safety hazards might be ex pected to arise from the following: (i) Natural toxins; (ii) Microbiological contamination; (iii) Chemical contamination; (iv) Pesticides; (v) Drug residues; (vi) Zoonotic diseases; (vii) Decomposition; (viii) Parasites; (ix) Unapproved use of direct or indi rect food or color additives; and (x) Physical hazards. (b) The HACCP plan. (1) Every estab lishment shall develop and implement a written HACCP plan covering each product produced by that establish ment whenever a hazard analysis re veals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories: (i) Slaughter—all species. (ii) Raw product—ground. (iii) Raw product—not ground. (iv) Thermally processed—commer cially sterile. (v) Not heat treated—shelf stable. (vi) Heat treated—shelf stable. (vii) Fully cooked—not shelf stable. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00631 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 622 9 CFR Ch. III (1–1–18 Edition) § 417.3 (viii) Heat treated but not fully cooked—not shelf stable. (ix) Product with secondary inhibi tors—not shelf stable. (2) A single HACCP plan may encom pass multiple products within a single processing category identified in this paragraph, if the food safety hazards, critical control points, critical limits, and procedures required to be identi fied and performed in paragraph (c) of this section are essentially the same, provided that any required features of the plan that are unique to a specific product are clearly delineated in the plan and are observed in practice. (3) HACCP plans for thermally proc essed/commercially sterile products do not have to address the food safety haz ards associated with microbiological contamination if the product is pro duced in accordance with the require ments of part 318, subpart G, or part 381, subpart X, of this chapter. (c) The contents of the HACCP plan. The HACCP plan shall, at a minimum: (1) List the food safety hazards iden tified in accordance with paragraph (a) of this section, which must be con trolled for each process. (2) List the critical control points for each of the identified food safety haz ards, including, as appropriate: (i) Critical control points designed to control food safety hazards that could be introduced in the establishment, and (ii) Critical control points designed to control food safety hazards intro duced outside the establishment, in cluding food safety hazards that occur before, during, and after entry into the establishment; (3) List the critical limits that must be met at each of the critical control points. Critical limits shall, at a min imum, be designed to ensure that appli cable targets or performance standards established by FSIS, and any other re quirement set forth in this chapter per taining to the specific process or prod uct, are met; (4) List the procedures, and the fre quency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits; (5) Include all corrective actions that have been developed in accordance with § 417.3(a) of this part, to be fol lowed in response to any deviation from a critical limit at a critical con trol point; and (6) Provide for a recordkeeping sys tem that documents the monitoring of the critical control points. The records shall contain the actual values and ob servations obtained during monitoring. (7) List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with § 417.4 of this part. (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and dated by the responsible es tablishment individual. This signature shall signify that the establishment ac cepts and will implement the HACCP plan. (2) The HACCP plan shall be dated and signed: (i) Upon initial acceptance; (ii) Upon any modification; and (iii) At least annually, upon reassess ment, as required under § 417.4(a)(3) of this part. (e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an establishment to develop and implement a HACCP plan that complies with this section, or to operate in accordance with the re quirements of this part, may render the products produced under those con ditions adulterated. [61 FR 38868, July 25, 1996, as amended at 62 FR 61009, Nov. 14, 1997] § 417.3 Corrective actions. (a) The written HACCP plan shall identify the corrective action to be fol lowed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure: (1) The cause of the deviation is iden tified and eliminated; (2) The CCP will be under control after the corrective action is taken; (3) Measures to prevent recurrence are established; and (4) No product that is injurious to health or otherwise adulterated as a re sult of the deviation enters commerce. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00632 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 623 Food Safety and Inspection Service, USDA § 417.4 (b) If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall: (1) Segregate and hold the affected product, at least until the require ments of paragraphs (b)(2) and (b)(3) of this section are met; (2) Perform a review to determine the acceptability of the affected product for distribution; (3) Take action, when necessary, with respect to the affected product to en sure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters com merce; (4) Perform or obtain reassessment by an individual trained in accordance with § 417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan. (c) All corrective actions taken in ac cordance with this section shall be doc umented in records that are subject to verification in accordance with § 417.4(a)(2)(iii) and the recordkeeping requirements of § 417.5 of this part. § 417.4 Validation, Verification, Reas sessment. (a) Every establishment shall vali date the HACCP plan’s adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented. (1) Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to de termine that the HACCP plan is func tioning as intended. During this HACCP plan validation period, the es tablishment shall repeatedly test the adequacy of the CCP’s, critical limits, monitoring and recordkeeping proce dures, and corrective actions set forth in the HACCP plan. Validation also en compasses reviews of the records them selves, routinely generated by the HACCP system, in the context of other validation activities. (2) Ongoing verification activities. On going verification activities include, but are not limited to: (i) The calibration of process-moni toring instruments; (ii) Direct observations of monitoring activities and corrective actions; and (iii) The review of records generated and maintained in accordance with § 417.5(a)(3) of this part. (3)(i) Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard anal ysis or alter the HACCP plan. Such changes may include, but are not lim ited to, changes in: raw materials or source of raw materials; product for mulation; slaughter or processing methods or systems; production vol ume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the fin ished product. The reassessment shall be performed by an individual trained in accordance with § 417.7 of this part. The HACCP plan shall be modified im mediately whenever a reassessment re veals that the plan no longer meets the requirements of § 417.2(c) of this part. (ii) Each establishment must make a record of each reassessment required by paragraph (a)(3)(i) of this section and must document the reasons for any changes to the HACCP plan based on the reassessment, or the reasons for not changing the HACCP plan based on the reassessment. For annual reassess ments, if the establishment determines that no changes are needed to its HACCP plan, it is not required to docu ment the basis for this determination. (b) Reassessment of the hazard anal ysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food safety hazard exists. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product for mulation; slaughter or processing methods or systems; production vol ume; packaging; finished product dis tribution systems; or, the intended use or consumers of the finished product. [61 FR 38868, July 25, 1996, as amended at 77 FR 26936, May 8, 2012] VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00633 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 624 9 CFR Ch. III (1–1–18 Edition) § 417.5 § 417.5 Records. (a) The establishment shall maintain the following records documenting the establishment’s HACCP plan: (1) The written hazard analysis pre scribed in § 417.2(a) of this part, includ ing all supporting documentation; (2) The written HACCP plan, includ ing decisionmaking documents associ ated with the selection and develop ment of CCP’s and critical limits, and documents supporting both the moni toring and verification procedures se lected and the frequency of those pro cedures. (3) Records documenting the moni toring of CCP’s and their critical lim its, including the recording of actual times, temperatures, or other quantifi able values, as prescribed in the estab lishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all ac tions taken in response to a deviation; verification procedures and results; product code(s), product name or iden tity, or slaughter production lot. Each of these records shall include the date the record was made. (b) Each entry on a record main tained under the HACCP plan shall be made at the time the specific event oc curs and include the date and time re corded, and shall be signed or initialed by the establishment employee making the entry. (c) Prior to shipping product, the es tablishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure complete ness, including the determination that all critical limits were met and, if ap propriate, corrective actions were taken, including the proper disposition of product. Where practicable, this re view shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with § 417.7 of this part, or the responsible establishment official. (d) Records maintained on computers. The use of records maintained on com puters is acceptable, provided that ap propriate controls are implemented to ensure the integrity of the electronic data and signatures. (e) Record retention. (1) Establish ments shall retain all records required by paragraph (a)(3) of this section as follows: for slaughter activities for at least one year; for refrigerated product, for at least one year; for frozen, pre served, or shelf-stable products, for at least two years. (2) Off-site storage of records re quired by paragraph (a)(3) of this sec tion is permitted after six months, if such records can be retrieved and pro vided, on-site, within 24 hours of an FSIS employee’s request. (f) Official review. All records required by this part and all plans and proce dures required by this part shall be available for official review and copy ing. § 417.6 Inadequate HACCP Systems. A HACCP system may be found to be inadequate if: (a) The HACCP plan in operation does not meet the requirements set forth in this part; (b) Establishment personnel are not performing tasks specified in the HACCP plan; (c) The establishment fails to take corrective actions, as required by § 417.3 of this part; (d) HACCP records are not being maintained as required in § 417.5 of this part; or (e) Adulterated product is produced or shipped. § 417.7 Training. (a) Only an individual who has met the requirements of paragraph (b) of this section, but who need not be an employee of the establishment, shall be permitted to perform the following functions: (1) Development of the HACCP plan, in accordance with § 417.2(b) of this part, which could include adapting a generic model that is appropriate for the specific product; and (2) Reassessment and modification of the HACCP plan, in accordance with § 417.3 of this part. (b) The individual performing the functions listed in paragraph (a) of this VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00634 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 625 Food Safety and Inspection Service, USDA § 424.1 section shall have successfully com pleted a course of instruction in the ap plication of the seven HACCP prin ciples to meat or poultry product proc essing, including a segment on the de velopment of a HACCP plan for a spe cific product and on record review. § 417.8 Agency verification. FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the require ments of this part and all other appli cable regulations. Such verification may include: (a) Reviewing the HACCP plan; (b) Reviewing the CCP records; (c) Reviewing and determining the adequacy of corrective actions taken when a deviation occurs; (d) Reviewing the critical limits; (e) Reviewing other records per taining to the HACCP plan or system; (f) Direct observation or measure ment at a CCP; (g) Sample collection and analysis to determine the product meets all safety standards; and (h) On-site observations and record review. PART 418—RECALLS Sec. 418.1 [Reserved] 418.2 Notification. 418.3 Preparation and maintenance of writ ten recall procedures. 418.4 Records. AUTHORITY: 7 U.S.C. 450; 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. SOURCE: 77 FR 26936, May 8, 2012, unless otherwise noted. § 418.1 [Reserved] § 418.2 Notification. Each official establishment must promptly notify the local FSIS District Office within 24 hours of learning or de termining that an adulterated or mis branded meat, meat food, poultry, or poultry product received by or origi nating from the official establishment has entered commerce, if the official establishment believes or has reason to believe that this has happened. The of ficial establishment must inform the District Office of the type, amount, ori gin, and destination of the adulterated or misbranded product. § 418.3 Preparation and maintenance of written recall procedures. Each official establishment must pre pare and maintain written procedures for the recall of any meat, meat food, poultry, or poultry product produced and shipped by the official establish ment. These written procedures must specify how the official establishment will decide whether to conduct a prod uct recall, and how the establishment will effect the recall, should it decide that one is necessary. § 418.4 Records. All records, including records docu menting procedures required by this part, must be available for official re view and copying. PART 424—PREPARATION AND PROCESSING OPERATIONS Subpart A—General Sec. 424.1 Purpose and scope. Subpart C—Food Ingredients and Sources of Radiation 424.21 Use of food ingredients and sources of radiation. 424.22 Certain other permitted uses. 424.23 Prohibited uses. AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. SOURCE: 64 FR 72175, Dec. 23, 1999, unless otherwise noted. Subpart A—General § 424.1 Purpose and scope. This part of the regulations pre scribes rules for the preparation of meat and the processing of poultry products. The rules in this part further the purposes of the Federal Meat In spection Act (FMIA) and the Poultry Products Inspection Act (PPIA) by, among other things, preventing the adulteration or misbranding of meat and poultry products at official estab lishments. 9 CFR Chapter III, Sub chapter A, Parts 318 and 319, Subpart C of this part, and 21 CFR Chapter I, Sub chapter A or Subchapter B, specify VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00635 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 626 9 CFR Ch. III (1–1–18 Edition) § 424.21 rules for the use of certain food ingre dients (e.g., food additives and color additives) and sources of radiation that may render meat or poultry products adulterated or misbranded. Subpart C—Food Ingredients and Sources of Radiation § 424.21 Use of food ingredients and sources of radiation. (a)(1) General. No meat or poultry product shall bear or contain any food ingredient that would render it adul terated or misbranded, or which is not approved in this part, part 318 or part 319 of this chapter, or by the Adminis trator in specific cases. (2)(i) Poultry products and poultry broth used in the processing of poultry products shall have been processed in the United States only in an official es tablishment or imported from a foreign country listed in § 381.196(b), and have been inspected and passed in accord ance with the regulations. Detached ova and offal shall not be used in the processing of any poultry products, ex cept that poultry feet may be processed for use as human food in a manner ap proved by the Administrator in specific cases and detached ova may be used in the processing of poultry products if the processor demonstrates that such ova comply with the requirements of the Federal Food, Drug, and Cosmetic Act. (ii) Liquid, frozen, and dried egg products used in the processing of any poultry product shall have been pre pared under inspection and be so marked in accordance with the Egg Products Inspection Act. (3)(i) Carcasses, parts thereof, and products of cattle, sheep, swine, goats, or equines may be used in the proc essing of poultry products only if they were prepared in the United States in an official meat packing establishment or imported from a foreign country listed in § 327.2(b), were inspected and passed in accordance with the Federal Meat Inspection Act and the regula tions under such Act (subchapter A of this chapter), and are so marked. (ii) Pork from carcasses or carcass parts used as an ingredient in poultry products that has been found free of trichinae, as described under § 318.10 (a)(2), (e) and (f) of the Federal meat inspection regulations (9 CFR 318.10 (a)(2), (e) and (f)), is not required to be treated for the destruction of trichinae. (iii) Poultry products containing pork muscle tissue which the Adminis trator determines at the time the la beling for the product is submitted for approval in accordance with part 381 of the regulations in subchapter A or upon subsequent reevaluation of the product would be prepared in such a manner that the product might be eaten rare or without thorough cook ing because of the appearance of the finished product or otherwise, shall be effectively heated, refrigerated, or cured to destroy any possible live trichinae, as prescribed in § 318.10(c) of this chapter, at the official establish ment where such products are pre pared. In lieu of such treatment of poultry products containing pork, the pork ingredient may be so treated. (b)(1) Food ingredients and sources of radiation. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR chapter I, sub chapter A or subchapter B, shall be listed for such use under this chapter, subject to declaration requirements in parts 316 and 317, or subparts M and N, of part 381 of this chapter, unless pre cluded from such use or further re stricted in parts 318 or 319, or subparts O and P, of part 381 of this chapter, or unless such use otherwise results in the adulteration or misbranding of meat or poultry products. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR Chapter I, subchapter A or subchapter B, may be listed or approved for such use under this chapter by the Administrator in § 424.21, subject to declaration require ments in parts 316 and 317, or subparts M and N, of part 381 of this chapter. (2) No food ingredients or sources of radiation may be used in the prepara tion of any meat or poultry product, for any purpose, unless the use is listed or approved in 21 CFR chapter I as a di rect food additive (21 CFR part 172), a secondary direct food additive (21 CFR part 173), indirect food additive (21 CFR parts 174–178), radiation source (21 CFR VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00636 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 627 Food Safety and Inspection Service, USDA § 424.21 part 179), an interim-listed direct food additive (21 CFR part 180), a prior-sanc tioned substance (21 CFR part 181), a Generally Recognized As Safe (GRAS) substance (21 CFR parts 182 or 184), or by a regulation in this chapter. Part 319 of this chapter also specifies other food ingredients that are acceptable in preparing specified products. (3) No food ingredient, the intended use of which is to impart color in any meat or poultry product, shall be used unless such use is approved in 21 CFR chapter I as a color additive (21 CFR Parts 73, 74, 81, and 82) or in a regula tion in this chapter. (4) Petitions to amend 21 CFR chap ter I to provide for uses of food addi tives, or other substances or sources of radiation necessary in the preparation of meat or poultry products, or food in gredients used to impart color to prod uct, should be sent to the Food and Drug Administration, in accordance with the provisions of 21 CFR parts 71 or 171, as appropriate. (5) Inquiries concerning the regu latory status under the Federal Food, Drug, and Cosmetic Act of any articles intended for use as components of, or in contact with, meat or poultry prod ucts, may be addressed to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 200 C Street, SW, Washington, DC 20204, or the Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development and Evaluation, Washington, DC 20250–3700. (6) Inquiries concerning the use in specific meat or poultry products of substances that are not affirmed by the Food and Drug Administration as Gen erally Recognized as Safe (GRAS) or otherwise listed in 21 CFR part 182 or part 184, or of food or color additives listed in 21 CFR regulations for general use in foods or for use in meat, or poul try products, generally, including mix tures of such substances or additives, should be addressed to the Department of Agriculture, Food Safety and Inspec tion Service, Office of Policy, Program Development and Evaluation, Wash ington, DC 20250–3700. (c) The food ingredients specified in the following chart are approved for use in the preparation of meat prod ucts, provided they are used for the purposes indicated, within the limit of the amounts stated, and under other conditions specified in this part and Part 317 of this chapter. Part 319 of this chapter specifies other food ingredients that are acceptable in preparing speci fied meat products. This chart also contains food ingredients that are ac ceptable for use in poultry products, provided they are used for the purpose indicated, within the limits of the amounts stated and under other condi tions specified in this part. No meat or poultry product shall bear or contain any food ingredient that would render it adulterated or misbranded, or which is not approved in this part, or by the Administrator in specific cases. Class of substance Substance Purpose Products Amount Acidifiers ................... Acetic acid .............. To adjust acidity ..... Various meat and poultry products 2. Sufficient for purpose. 3 Citric acid ................ ......do ...................... ......do .................................. Do. Glucono delta-lac tone. ......do ...................... ......do .................................. Do. Lactic acid .............. ......do ...................... ......do .................................. Do. Phosphoric acid ...... ......do ...................... ......do .................................. Do. Tartaric acid ............ ......do ...................... ......do .................................. Do. Anti-coagulants ........ Citric acid ................ To prevent clotting .. Fresh blood of livestock ...... 0.2 percent with or without water. When water is used to make a solution of citric acid added to the blood of livestock, not more than 2 parts of water to 1 part of citric acid shall be used. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00637 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 628 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Sodium citrate ........ ......do ...................... ......do .................................. Not to exceed 0.5 percent based on the ingoing weight of the product. When water is used to make a solution of so dium citrate added to live stock blood, not more than 2 parts of water to 1 part of sodium citrate shall be used. Antifoaming agent .... Methyl polysilicone To retard foaming ... Soups (meat and poultry) ... 10 ppm. ......do ...................... Rendered fats (meat and poultry). Do. ......do ...................... Curing pickle (meat and poultry). 50 ppm. Antimicrobial Agents Potassium lactate ... To inhibit microbial growth. Various meat and poultry products, except infant formulas and infant food. 4.8% by weight of total for mulation. Sodium diacetate .... ......do ...................... ......do .................................. 0.25% by weight of total for mulation. Sodium lactate ........ ......do ...................... ......do .................................. 4.8% by weight of total for mulation. Trisodium phos phate. To reduce microbial levels. Raw, chilled poultry car casses. 8 to 12 percent; solution to be maintained at 45 °F. to 55 °F. and applied by spraying or dipping car casses for up to 15 sec onds when used in ac cordance with 21 CFR 182.1778. Antioxidants and oxy gen interceptors. Ascorbyl palmitate .. To retard rancidity .. Margarine or oleomargarine 0.02 percent (by wt. of fin ished product) individually or in combination with other antioxidants ap proved for use in mar garine. Ascorbyl stearate. BHA (butylated hy droxyanisole). .............................. ......do ...................... Dry sausage ........... 0.003 based on total weight 0.006 percent in combina tion with other anti oxidants for use in meat. ......do ...................... Rendered animal fat or a combination of such fat and vegetable fat. 0.01 percent ........................ 0.02 percent in combination with other anti-oxidants for use in meat. ......do ...................... Fresh pork, sau sage, brown and serve sausages, fresh Italian sau sage products, pregrilled beef patties, fresh sau sage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs. 0.01 percent based on fat content. 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content. ......do ...................... Dried meats ............ 0.01 percent based on total weight. 0.01 percent in combination with other anti-oxidants for use in meat. ......do ...................... Margarine or oleo margarine. 0.02 percent (by wt. of the finished product) individ ually or in combination with other antioxidants approved for use in mar garine.. ......do ...................... Various poultry products. 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00638 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 629 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount BHT (butylated hy droxytoluene). ......do ...................... Dry sausage ........................ 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat. ......do ...................... Rendered animal fat or a combination of such fat and vegetable fat. 0.01 percent ........................ 0.02 percent in combination with other anti-oxidants for use in meat. ......do ...................... Fresh pork, sau sage, brown and serve sausages, fresh Italian sau sage products, pregrilled beef patties, fresh sau sage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs. 0.01 percent based on fat content. 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content. ......do ...................... Dried meats ............ 0.01 percent based on total weight. 0.01 percent in combination with other anti-oxidants for use in meat. ......do ...................... Margarine or oleo margarine. 0.02 percent (by wt. of the finished product) individ ually or in combination with other antioxidants approved for use in mar garine.. ......do ...................... Various poultry products. 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.. Dodecyl gallate ....... ......do ...................... Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individ ually or in combination with other antioxidants approved for use in mar garine. Glycine .................... ......do ...................... Rendered animal fat or a combination of such fat and vegetable fat. 0.01 percent 0.02 percent in combination with other anti-oxidants for use in meat. Octyl gallate ............ ......do ...................... Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individ ually or in combination with other antioxidants approved for use in mar garine. Propyl gallate .......... ......do ...................... Dry sausage ........................ 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat. ......do ...................... Rendered animal fat or a combination of such fat and vegetable fat. 0.01 percent ........................ 0.02 percent in combination with other anti-oxidants for use in meat. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00639 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 630 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount ......do ...................... Fresh pork, sau sage, brown and serve sausages, fresh Italian sau sage products, pregrilled beef patties, fresh sau sage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs. 0.01 percent based on fat content. 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content. ......do ...................... Dried meats ............ 0.01 percent based on total weight. 0.01 percent in combination with other anti-oxidants for use in meat. ......do ...................... Margarine or oleo margarine. 0.02 percent (by wt. of the finished product) individ ually or in combination with other antioxidants approved for use in mar garine.. ......do ...................... Various poultry products. 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content).. Resin guaiac ........... ......do ...................... Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent. 0.02 percent in combination with other antioxidants for use in meat. TBHQ (tertiary butylhydroquinon e). ......do ...................... Dry sausage 0.003 percent based on weight. 0.006 percent in combina tion only with BHA and/or BHT. ......do ...................... Rendered animal fat or a combination of such fat and vegetable fat. 0.01 percent ........................ 0.02 percent in combina tion only with BHA or BHT. ......do ...................... Fresh pork, sau sage, brown and serve sausages, fresh Italian sau sage products, pregrilled beef patties, fresh sau sage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs. 0.01 percent based on fat content. 0.02 percent in combin ation only with BHA and/ or BHT, based on fat con tent. ......do ...................... Dried meats ............ 0.01 percent based on total weight. 0.01 percent in combina tion only with BHA and/or BHT. ......do ...................... Margarine or oleo-mar garine. 0.02 percent alone or in combination only with BHA and/or BHT, based on oil or fat content. ......do ...................... Various poultry products ..... 0.01 percent based on fat content (0.02 percent in combination only with BHA and/or BHT, based on fat content). Tocopherols ............ ......do ...................... Rendered animal fat or a combination of such fat and vegetable fat. 0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as ‘‘lard’’ or ‘‘rendered pork fat.’’ VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00640 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 631 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount ......do ...................... Dry sausage, semidry sau sage, dried meats, uncooked or cooked fresh sausage made with beef and/or pork, uncooked or cooked Italian sausage products, uncooked or cooked meatballs, uncooked or cooked meat pizza toppings, brown and serve sausages, pregrilled beef patties, and restructured meats. Not to exceed 0.03 percent based on fat content. Not used in combination with other antioxidants. ......do ...................... Various poultry products ..... 0.03 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content). Artificial Sweeteners Saccharin ................ To sweeten product Bacon .................................. 0.01 percent. Binders and Extend ers. Agar-agar ................ To stabilize and thicken. Thermally processed canned and jellied meat food products. 0.25 percent of finished product. Algin ........................ To extend and sta bilize product. Breading mix; sauces (meat only) and various poultry products. Sufficient for purpose in ac cordance with 21 CFR 172.5. A mixture of sodium alginate, calcium carbonate and calcium lactate/ lactic acid (or glucono delta lac tone). To bind meat pieces Restructured meat food products. Sodium alginate not to ex ceed 1.0 percent; calcium carbonate not to exceed 0.2 percent; and lactic acid/calcium lactate (or glucono delta-lactone) not to exceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 percent of product at formulation. Mixture ingredients must be added dry. A mixture of sodium alginate, calcium carbonate, lactic acid, and calcium lactate. To bind poultry pieces. Ground and formed raw or cooked poultry pieces. Sodium alginate not more than 0.8 percent, calcium carbonate not more than 0.15 percent; lactic acid and calcium lactate, in combination, not more than 0.6 percent of prod uct formulation. Added mixture may not exceed 1.55 percent of product at formulation. The mixture must be added in dry form. Bread ...................... To bind and extend product. Bockwurst ............................ 3.5 percent individually or collectively with other binders for use in meat. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers for use in meat. ......do ...................... Spaghetti with meat balls and sauce, spaghetti with meat and sauce and simi lar products. 12 percent individually or collectively with other binders for use in meat. Carboxymethyl cel lulose (cellulose gum). To extend and sta bilize product. Baked pies (meat only) and various poultry products. Sufficient for purpose in ac cordance with 21 CFR 172.5. Carrageenan ........... To extend and sta bilize product. Breading mix; sauces (meat only) and various poultry products. Sufficient for purpose in ac cordance with 21 CFR 172.5. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00641 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 632 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount To prevent purging of brine solution. Cured pork products as pro vided in 9 CFR 319.104(d). Not to exceed 1.5 percent of product formulation; permitted in combination only with soy protein con centrate, combination not to exceed 1.5 percent of product formulation; in ac cordance with 21 CFR 172.620, 172.623, and 172.626. Carrageenan, Lo cust bean gum, and Xanthan gum blend. ......do ...................... ......do .................................. In combination, not to ex ceed 0.5 percent of for mulation; not permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.620, 172.623, 172.626, 184.1343, and 172.695. Cereal ..................... To bind and extend product. Sausages as provided in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders for use in meat. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers for use in meat. Dried milk ............... ......do ...................... Sausages as provided for in 9 CFR Part 319. 3.5 percent individually or collectively with other binders for use in meat Dried skim milk, cal cium reduced. ......do ...................... Sausages as provided in 9 CFR 9 CFR Part 319. Do. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers for use in meat. Enzyme (rennet) treated with cal cium reduced dried skim milk and calcium lac tate. ......do ...................... Sausages as provided for in 9 CFR Part 319. 3.5 percent total finished product (calcium lactate required at rate of 10 per cent of binder.) ......do ...................... Imitation sausages; nonspe cific loaves; soups, stews (meat only) and various poultry products. Sufficient for purpose in ac cordance with 21 CFR 172.5 (calcium lactate re quired at a rate of 10 per cent of binder). Enzyme (rennet) treated with so dium caseinate and calcium lac tate. ......do ...................... Imitation sausages; nonspe cific loaves; soups, stews (meat only) and various poultry products. Sufficient for purpose in ac cordance with 21 CFR 172.5 (calcium lactate re quired at a rate of 25 per cent of binder). Food starch modi fied. To prevent purging of brine solution. Cured pork products as pro vided for in 9 CFR 319.104(d). Not to exceed 2 percent of product formulation in ‘‘Ham Water Added’’ and ‘‘Ham with Natural Juices’’ products; not to exceed 3.5 percent of product formulation in ‘‘Ham and Water Prod uct—X percent of Weight is Added Ingredients’’ products; permitted in combination only with soy protein concentrate, with combination of modified food starch at 3 percent of product formulation and soy protein con centrate at 0.5 percent of product formulation; in ac cordance with 21 CFR 172.892. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00642 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 633 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount Gelatin .................... To bind and extend product. Various poultry products ..... Sufficient for purpose in ac cordance with 21 CFR 172.5. Gums, vegetable .... ......do ...................... Egg roll (meat only) and various poultry products. Sufficient for purpose in ac cordance with 21 CFR 172.5. Isolated soy protein ......do ...................... Sausage as provided for in 9 CFR Part 319, bockwurst. 2 percent. ......do ...................... Imitation sausages; nonspe cific loaves; soups; stews (meat only) and various poultry products. Sufficient for purpose in ac cordance with 21 CFR 172.5. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers for use in meat. ......do ...................... Spaghetti with meatballs and sauce, spaghetti with meat and sauce and simi lar products. 12 percent individually or collectively with other binders and extenders for use in meat. To prevent purging of brine solution. Cured pork products as pro vided for in 9 CFR 319.104(d). Not to exceed 2 percent of product formulation, not permitted in combination with other binders ap proved for use in cured pork products. Methyl cellulose ...... To extend and sta bilize product (also carrier). Meat and vegetable patties; various poultry products. 0.15 percent. Sodium caseinate ... To bind and extend product. Imitation sausages, nonspe cific loaves, soups, stews (meat only). Sufficient for purpose in ac cordance with 21 CFR 182.1748 and 21 CFR 172.5. ......do ...................... Sausages as provided for in 9 CFR Part 319. 2 percent in accordance with 21 CFR 182.1748. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers and extenders for use in meat in accordance with 21 CFR 182.1748. ......do ...................... Spaghetti with meatballs and sauce, spaghetti with meat and sauce and simi lar products. 12 percent individually or collectively with other binders and extenders for use in meat in accord ance with 21 CFR 182.1748. To prevent purging of brine solution. Cured pork products as pro vided for in 9 CFR 319.104(d). Not to exceed 2 percent of product formulation; not permitted in combination with other binders ap proved for use in cured pork products, in accord ance with 21 CFR 182.1748. To bind and extend product. Various poultry products ..... 3 percent in cooked prod uct, 2 percent in raw product, in accordance with 21 CFR 172.5 and 182.1748. Soy flour ................. ......do ...................... Sausages as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers and extenders for use in meat. ......do ...................... Spaghetti with meatballs and sauce, spaghetti with meat and sauce and simi lar products. 12 percent individually or collectively with other binders and extenders for use in meat. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00643 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 634 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Soy protein con centrate. ......do ...................... Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers and extenders for use in meat. ......do ...................... Spaghetti with meatballs and sauce, spaghetti with meat and sauce and simi lar products. 12 percent individually or collectively with other binders and extenders for use in meat. To prevent purging of brine solution. Cured pork products as pro vided for in 9 CFR 319.104(d). Not to exceed 3.5 percent of product formulation; permitted in combination only with modified food starch, with combination of modified food starch at 3 percent of product for mulation and soy protein concentrate at 0.5 per cent of product formula tion; in combination only with carrageenan, com bination not to exceed 1.5 percent of product formu lation. Starchy vegetable flour. To bind and extend product. Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers and extenders for use in meat. Tapioca dextrin ....... ......do ...................... Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat, in accord ance with 21 CFR 184.1277. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers and extenders for use in meat, in accordance with 21 CFR 184.1277. ......do ...................... Spaghetti with meatballs and sauce, spaghetti with meat and sauce and simi lar products. 12 individually or collectively with other binders and ex tenders for use in meat, in accordance with 21 CFR 184.1277. ......do ...................... Various poultry products ..... Sufficient for purpose in ac cordance with 21 CFR 184.1277. Vegetable starch .... ......do ...................... Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers and extenders for use in meat. Wheat gluten .......... To bind and extend product. Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat, in accord ance with 21 CFR 184.1322. ......do ...................... Chili con carne, chili con carne with beans. 8 percent individually or col lectively with other bind ers for use in meat, in ac cordance with 21 CFR 184.1322. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00644 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 635 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount ......do ...................... Spaghetti with meatballs and sauce, spaghetti with meat and sauce and simi lar products. 12 percent individually or collectively with other binders and extenders for use in meat, in accord ance with 21 CFR 184.1322. ......do ...................... Various poultry products ..... Sufficient for purpose in ac cordance with 21 CFR 184.1322. Whey, Dry or dried To bind or thicken .. Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat. ......do ...................... Imitation sausages, nonspe cific loaves, soups, stews (meat only). 8 percent individually or col lectively with other bind ers and extenders for use in meat. ......do ...................... Chili con carne, chili con carne with beans, pork or beef with barbecue sauce. 8 percent individually or col lectively with other bind ers and extenders for use in meat. ......do ...................... Various poultry products ..... Sufficient for purpose in ac cordance with 21 CFR 184.1322. Whey, Reduced lac tose. To bind or thicken .. Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat. ......do ...................... Imitation sausages, nonspe cific loaves, soups, stews (meat only). Sufficient for purpose in ac cordance with 21 CFR 172.5. ......do ...................... Chili con carne, chili con carne with beans, pork or beef with barbecue sauce. 8 percent individually or col lectively with other bind ers and extenders for use in meat. Whey, Reduced minerals. ......do ...................... Sausage as provided for in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat. ......do ...................... Imitation sausages, nonspe cific loaves, soups, stews (meat only). Sufficient for purpose in ac cordance with 21 CFR 172.5. ......do ...................... Chili con carne, chili con carne with beans, pork or beef with barbecue sauce. 8 percent individually or col lectively with other bind ers and extenders for use in meat. Whey protein con centrate. ......do ...................... Sausage as provided in 9 CFR Part 319, bockwurst. 3.5 percent individually or collectively with other binders and extenders for use in meat, in accord ance with 21 CFR 184.1979c. ......do ...................... Imitation sausages, nonspe cific loaves, soups, stews. Sufficient for purpose in ac cordance with 21 CFR 184.1979c. ......do ...................... Chili con carne, chili con carne with beans, pork or beef with barbecue sauce. 8 percent individually or col lectively with other bind ers and extenders for use in meat, in accordance with 21 CFR 184.1979c To bind meat pieces Restructured meat food products, whole muscle meat cuts. 3.5 percent individually or collectively with other binders and extenders for use in meat, in accord ance with 21 CFR 184.1979c. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00645 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 636 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Xanthan gum .......... To maintain: uniform viscosity; suspen sion of particulate matter, emulsion stability; freeze thaw stability. Meat sauces, gravies or sauces and meats, canned or frozen and/or refrigerated meat salads, canned or frozen meat stews, canned chili or chili with beans, pizza topping mixes and batter or breading mixes. Sufficient for purpose in ac cordance with 21 CFR 172.5. ......do ...................... Various poultry products, except uncooked prod ucts or sausages or other products with a moisture limitation established by Subpart P of Part 381. Sufficient for purpose Bleaching Agent ....... Hydrogen peroxide To remove color ..... Tripe (substance must be removed from product by rinsing with clear water). Sufficient for purpose. Catalysts (sub stances must be eliminated during process). Nickel ...................... To accelerate chem ical reaction. Rendered animal fats or a combination of such fats and vegetable fats. Do. Sodium amide ........ Rearrangement of fatty acid radicals. ......do .................................. Do. Sodium methoxide .. ......do ...................... ......do. Chilling Media .......... Salt (NaCl) .............. To aid in chilling ..... Raw poultry products .......... 700 lbs. to 10,000 gallons of water. Coloring Agents (arti ficial). Coal tar dyes (FD&C certified). To color products ... Various poultry products ..... Sufficient for purpose. Color additives list ed in 21 CFR Part 74, Subpart A of Part 82, Subpart B (operator must furnish evidence to inspector in charge that color additive has been certified for use in connection with foods by the Food and Drug Admin istration). To color casings or rendered fats; marking and branding product. Sausage casings, oleo margarine, shortening, marking or branding ink on product (meat only). Sufficient for purpose (may be mixed with approved natural coloring matters or harmless inert material such as common salt and sugar). Titanium oxide ........ To whiten ................ Canned ham salad spread and creamed-type canned meat products. Poultry salads and poultry spreads. 0.5 percent. Coloring Agents (nat ural). Alkanet, annatto, carotene, cochi neal, green chlo rophyll, saffron and tumeric. To color casings or rendered fats; marking and branding product. Sausage casings, oleo margarine, shortening, marking or branding ink on product (meat only). Sufficient for purpose (may be mixed with approved artificial dyes or harmless inert material such as common salt and sugar). Annatto, carotene ... To color products ... Various poultry products ..... Sufficient for purpose. Curing accelerators (must be used only in combination with curing agents). Ascorbic acid .......... To accelerate color fixing or preserve color during stor age. Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products. 75 oz to 100 gal pickle at 10 percent pump level; 3⁄4 oz to 100 lb meat, meat byproduct or poultry prod uct; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product). VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00646 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 637 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount Citric acid or sodium citrate. To accelerate color fixing or preserve color during stor age. Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products. May be used in cured meat products or in 10 percent solution used to spray surfaces of cured meat cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used. May be used in cured poultry products to re place 50 percent of the ascorbic acid or sodium ascorbate that is used. Erythorbic acid ........ To accelerate color fixing or preserve color during stor age. Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products. 75 oz to 100 gal pickle at 10 percent pump level; 3⁄4 oz to 100 lb meat, meat byproduct or poultry prod uct; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product). Fumaric acid ........... ......do ...................... Cured, comminuted meat, poultry or meat and poul try products. 0.065 percent (or 1 oz to 100 lb) of the weight of the meat, poultry or the meat or poultry byprod ucts before processing. Glucono delta lac tone. ......do ...................... Cured, comminuted meat or meat food product. 8 oz to each 100 lb of meat or meat byproduct. ......do ...................... Genoa salami ...................... 16 oz to 100 lb of meat (1.0 percent). Sodium acid pyrophosphate. ......do ...................... Frankfurters, wieners, vi enna, bologna, garlic bo logna, knockwurst and similar products. Not to exceed alone or in combination with other curing accelerators for use in meat the following: 8 oz in 100 lb of meat, or meat and meat byprod ucts, content of the for mula; nor 0.5 percent in the finished product. Sodium ascorbate .. To accelerate color fixing or preserve color during stor age. Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products. 87.5 oz to 100 gal pickle at 10 percent pump level; 7⁄8 oz to 100 lb meat, meat byproduct or poultry prod uct; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product). Sodium erythorbate To accelerate color fixing or preserve color during stor age. Cured pork and beef cuts, cured comminuted meat food products, cured comminuted poultry or poultry products. 87.5 oz to 100 gal pickle at 10 percent pump level; 7⁄8 oz to 100 lb meat, meat byproduct or poultry prod uct; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.) VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00647 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 638 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Curing Agents .......... Sodium or potas sium nitrate. Source of nitrite ...... Cured meat products other than bacon. Nitrates may not be used in baby, jun ior, and toddler foods. Cured, comminuted poul try or poultry products. 7 lb to 100 gal pickle; 31⁄2 oz to 100 lb meat or poul try product (dry cure); 23⁄4 oz to 100 lb chopped meat or poultry. Sodium or potas sium nitrite (sup plies of sodium ni trite and potas sium nitrite and mixtures con taining them must be kept under the care of a respon sible employee of the establishment. The specific nitrite content of such supplies must be known and clearly marked accord ingly). To fix color .............. Cured meat and poultry products. Nitrites may not be used in baby, junior, or toddler foods. 2 lb to 100 gal pickle at 10 percent pump level; 1 oz to 100 lb meat or poultry product (dry cure); 1⁄4 oz to 100 lb chopped meat, meat byproduct or poultry product. The use of nitrites, nitrates or com bination shall not result in more than 200 ppm of ni trite, calculated as sodium nitrite in finished product, except that nitrites may be used in bacon only in accordance with para graph (b) of this section. Denuding Agents (may be used in combination. Must be removed from tripe by rinsing with potable water.). Lime (calcium oxide, calcium hydrox ide). To denude mucous membranes. Tripe .................................... Sufficient for purpose. Sodium carbonate .. ......do ...................... ......do .................................. Do. Sodium citrate ........ ......do ...................... ......do .................................. Do. Sodium gluconate ... ......do ...................... ......do .................................. Do. Sodium hydroxide ... ......do ...................... ......do .................................. Do. Sodium persulfate .. ......do ...................... ......do .................................. Do. Sodium silicates (ortho, meta, and sesqui). ......do ...................... ......do .................................. Do. Trisodium phos phate. ......do ...................... ......do .................................. Do. Emulsifying Agents .. Actylated monoglycerides. To emulsify product Shortening and various poultry products. Sufficient for purpose. Diacetyl tartaric acid esters of mono and diglycerides. ......do ...................... ......do .................................. Do. Glycerol-lacto stea rate, oleate, or palmitate. ......do ...................... ......do .................................. Do. Lecithin ................... To emulsify product (also as an anti oxidant). Oleomargarine, shortening, various meat and poultry products. 0.5 percent in oleo margarine, use in other products—sufficient amount for emulsification. Mono and diglycerides (glyc erol palmitate, etc.). To emulsify product Rendered animal fat or a combination of such fat with vegetable fat; oleo margarine. Sufficient for purpose in lard and shortening; 0.5 per cent in oleomargarine. ......do ...................... Various poultry products ..... Sufficient for purpose. Mono and diglycerides of fatty acids esterified with any of the following acids: acetic, acetyltartaric, cit ric, lactic, tartaric, and their sodium and calcium salts; the sodium sulfoacetate de rivatives of these mono and diglycerides. ......do ...................... Margarine or oleomargarine 0.5 percent. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00648 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 639 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount Polyglycerol esters of fatty acids (polyglycerol esters of fatty acids are re stricted to those up to and includ ing the decaglycerol esters and other wise meeting the requirements of § 172.854(a) of the Food Additive Regulations). ......do ...................... Rendered animal fat or a combination of such fat with vegetable fat when use is not precluded by standards of identity of composition; oleo margarine. Sufficient for purpose for rendered animal fat or combination with vege table fat; 0.5 percent for oleomargarine. Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate). ......do ...................... Shortening for use in non standardized baked goods, baking mixes, icings, fillings, and top pings and in the frying of foods (meat only). Ren dered poultry fat or a combination of such fat with vegetable fat. 1 percent when used alone. If used with polysorbate 80 the combined total shall not exceed 1 per cent. Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate). ......do ...................... Shortening for use in non standardized baked goods, baking mixes, icings, fillings, and top pings and in the frying of foods (meat only). Var ious poultry products. 1 percent when used alone. If used with polysorbate 60 the combined total shall not exceed 1 per cent. 1,2-propylene glycol esters of fatty acids. ......do ...................... Margarine or oleomargarine 2.0 percent. Propylene glycol mono and diesters of fats and fatty acids. ......do ...................... Rendered animal or poultry fat or a combination of such fat with vegetable fat. Sufficient for purpose. Stearyl-2-lactylic acid. ......do ...................... Shortening to be used for cake icings and fillings (meat only). 3.0 percent. Stearyl monoglyceridyl citrate. ......do ...................... Shortening ........................... Sufficient for purpose Film Forming Agents A mixture consisting of water, sodium alginate, calcium chloride, sodium carboxymethyl cellulose, and corn syrup solids. To reduce cooler shrinkage and help protect sur face. Freshly dressed meat car casses. Such carcasses must bear a statement ‘‘Protected with a film of water, corn syrup solids, sodium alginate, calcium chloride and sodium carboxymethyl-cellulose.’’. Formulation may not ex ceed 1.5 percent of hot carcass weight when ap plied. Chilled weight may not exceed hot weight. Flavoring Agents; Protectors and De velopers. Artificial smoke fla voring. To flavor product .... Various (meat and poultry) 2 Sufficient for purpose. Autolyzed yeast ex tract. ......do ...................... ......do .................................. Do. Benzoic acid (so dium, potassium and calcium salts). To retard flavor re version. Margarine or oleomargarine 0.1 percent individually, or if used in combination with other flavoring agents for use in meat or with sorbic acid and its salts, 0.2 per cent (expressed as the acids in the wt. of the fin ished foods). Calcium lactate ....... To protect flavor ..... Cooked semi-dry and dry products including sau sage, imitation sausage, and nonspecific meat food sticks. 0.6 percent in product for mulation. Citric acid ................ ......do ...................... Various poultry products ..... Sufficient for purpose. Flavoring ................. Chili con carne .................... Do. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00649 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 640 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Corn syrup solids; corn syrup; glu cose syrup. To flavor product .... Various poultry products, sausage, hamburger, meat loaf, luncheon meat, chopped or pressed ham. Do. Dextrose ................. ......do ...................... Sausage, ham and cured products. Do. Diacetyl ................... ......do ...................... Oleomargarine .................... Do. Disodium guanylate ......do ...................... Various meat and poultry products. 2 Disodium inosinate ......do ...................... ......do .................................. Do. Harmless bacteria starters of the aci dophilus type, lac tic acid starter or culture of Pediococcus cerevisiae. To develop flavor .... Dry sausage, pork roll, thuringer, lebanon bolo gna, cervelat, and salami. 0.5 percent. Harmless lactic acid producing bacteria. To prevent the growth of Clos tridium botulinum. Bacon .................................. Sufficient for purpose. Hydrolyzed plant protein. To flavor product .... Various meat and poultry products. 2 Do. Isopropyl citrate ...... To protect flavor ..... Oleomargarine .................... 0.02 percent. Malt syrup ............... To flavor product .... Cured meat products .......... 2.5 percent. ......do ...................... Various poultry products ..... Sufficient for purpose. Milk protein hydroly sate. ......do ...................... Various meat and poultry products. 2 Do. Monoammonium glutamate. ......do ...................... ......do .................................. Do. Monosodium glu tamate. ......do ...................... ......do .................................. Do. Potassium lactate ... ......do ...................... Various meat and meat food products, poultry and poultry food products, ex cept infant formula and infant food. 2 Not to exceed 2 percent of formulation; in accord ance with 21 CFR 184.1639. Smoke flavoring ...... To flavor product .... Various meat and poultry products. Sufficient for purpose. Sodium acetate ...... To flavor products .. Various meat and poultry products. Not to exceed 0.25% of for mulate in accordance with 21 CFR 184.1721. Sodium diacetate .... ......do ...................... ......do .................................. Not to exceed 0.25% of for mulate in accordance with 21 CFR 184.1754. Sodium lactate ........ ......do ...................... Various meat and meat food products, poultry and poultry food products, ex cept infant formula and infant food. 2 Not to exceed 2 percent of formulation in accordance with 21 CFR 184.1768. Sodium sulfoacetate derivative of mono and diglycerids. ......do ...................... Various meat and poultry products. 2 0.5 percent. Sodium tripolyphosphate. To help protect fla vor. ‘‘Fresh Beef,’’ 2 ‘‘Beef for further cooking, ‘‘Cooked Beef,’’ Beef Patties, Meat Loaves, Meat Toppings, and similar products de rived from pork, lamb, veal, mutton, and goat meat which are cooked or frozen after processing. 0.5 percent of total product. Sodium tripolyphosphate and sodium mix tures, metaphosphate, insoluble; and so dium polyphosphates, glassy. ......do ...................... ......do .................................. Do. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00650 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 641 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount Sorbitol ................... To flavor, to facili tate the removal of casings from product, and to reduce caramelization and charring. Cooked sausage labeled frankfurter, frank, furter, wiener, and knockwurst; cured pork and pork prod ucts, as provided for in 9 CFR Part 319. Not to exceed 2 percent of the weight of the formula excluding the formula weight of water or ice, when used in accordance with 21 CFR 184.1835. Starter distillate ....... To help protect fla vor. Oleomargarine .................... Sufficient for purpose. Stearyl citrate ......... ......do ...................... ......do .................................. 0.15 percent. Sugars (sucrose and dextrose). To flavor product .... Various meat and poultry products. Sufficient for purpose. Gases ....................... Carbon dioxide liq uid. Contact freezing ..... Various poultry products ..... Do. Carbon dioxide solid (dry ice). To cool product ...... Chopping of meat, packing of product. Sufficient for purpose. To cool product or facilitate chopping or packaging. Various poultry products ..... Do. Nitrogen .................. To exclude oxygen from sealed con tainers. Various meat and poultry products. Do. Nitrogen, liquid ....... Contact freezant ..... ......do .................................. Do. Hog Scald Agents (must be removed by subsequent cleaning oper ations). Caustic soda ........... To remove hair ....... Hog carcasses .................... Sufficient for purpose. Dicotyl sodium sulfosuccinate. ......do ...................... ......do .................................. Do. Dimethylpolysiloxan e. ......do ...................... ......do .................................. Do. Disodium-calcium ethylenediaminet etra-acetate. ......do ...................... ......do .................................. Do. Disodium phosphate ......do ...................... ......do .................................. Do. Ethylenediaminetetr a-acetic acid (so dium salts). ......do ...................... ......do .................................. Do. Lime (calcium oxide, calcium hydrox ide). ......do ...................... ......do .................................. Do. Potassium hydrox ide. Do. Propylene glycol ..... ......do ...................... ......do .................................. Do. Soap (prepared by the reaction of calcium, potas sium, or sodium with rosin or fatty acids of natural fats and oils). ......do ...................... ......do .................................. Do. Sodium acid pyrophosphate. ......do ...................... ......do .................................. Do. Sodium carbonate .. ......do ...................... ......do .................................. Do. Sodium dodecylbenzene sulfonate. ......do ...................... ......do .................................. Do. Sodium gluconate ... ......do ...................... ......do .................................. Do. Sodium hexametaphosph ate. ......do ...................... ......do .................................. Do. Sodium lauryl sul fate. ......do ...................... ......do .................................. Do. Sodium mono and dimethylnaphthal ene sulfonate (molecular weight 245–260). ......do ...................... ......do .................................. Do. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00651 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 642 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Sodium n alkylbenzene sulfonate (alkyl group predomi nantly C12 and C13 and not less than 95 percent C10 and C16). ......do ...................... ......do .................................. Do. Sodium pyrophosphate. ......do ...................... ......do .................................. Do. Sodium silicates (ortho, meta, and sesqui). ......do ...................... ......do .................................. Do. Sodium sulfate ........ ......do ...................... ......do .................................. Do. Sodium tripolyphosphate. ......do ...................... ......do .................................. Do. Sucrose .................. ......do ...................... ......do .................................. Do. Triethanolamine dodecylbenzene sulfonate. ......do ...................... ......do .................................. Do. Trisodium phos phate. ......do ...................... ......do .................................. Do. Miscellaneous .......... Adipic acid .............. To acidify ................ Margarine or oleomargarine Sufficient for purpose. Ascorbic acid, erythorbic acid, citric acid, sodium ascorbate and so dium citrate, sin gly or in combina tion. To delay discolora tion. Fresh beef cuts, fresh lamb cuts, and fresh pork cuts. Not to exceed, singly or in combination, 500 ppm or 1.8 mg/sq inch of product surface of ascorbic acid (in accordance with 21 CFR 182.3013), erythorbic acid (in accord ance with 21 CFR 182.3041), or sodium ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, sin gly or in combination, 250 ppm or 0.9 mg/sq inch of product surface of citric acid (in accordance with 21 CFR 182.6033), or so dium citrate (in accord ance with 21 CFR 182.6751). Calcium disodium, EDTA (calcium di sodium ethylene diaminetetra acetate. To preserve product and to protect fla vor. Margarine or oleomargarine 75 ppm by weight of the fin ished oleomargarine or margarine. Calcium propionate To retard mold growth. Pizza crust .......................... 0.32 percent alone or in combination based on weight of the flour brace used. ......do ...................... Fresh pie dough (poultry only). 0.3 percent of calcium pro pionate or sodium propio nate alone, or in com bination, based on weight of flour used. Citric acid ................ To preserve cured color during stor age. Cured pork cuts .................. Not to exceed 30 percent in water solution used to spray surfaces of cured cuts, prior to packaging, in accordance with 21 CFR 184.1033. (The use of such solution shall not result in the addition of a significant amount of moisture to the product and shall be applied only once to product). Citric acid (sodium and potassium salts). To acidify ................ Margarine and oleo margarine. Sufficient for purpose. d- and dl-alpha-to copherol. To inhibit nitrosa mine formation. Pump-cured bacon ............. 500 ppm; by injection or surface application. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00652 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 643 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount Dipotassium phos phate. To decrease the amount of cooked out juices. Meat food products except where otherwise prohib ited by the meat inspec tion regulations and poul try food products except where otherwise prohib ited by the poultry prod ucts inspection regula tions.. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phos phate in meat food prod uct (only clear solution may be injected into meat food product). For poultry food products, 0.5 per cent of total product. Disodium phosphate ......do ...................... ......do .................................. Do. Glycerine ................ Humectant .............. Shelf stable meat snacks ... Not to exceed 2 percent of the formulation weight of the product in accordance with 21 CFR 182.1320. Hydrochloric acid .... To acidify ................ Margarine or oleomargarine Sufficient for purpose. Lactic acid (sodium and potassium salts). ......do ...................... ......do .................................. Do. L-Tartaric acid (so dium and sodium potassium salts). ......do ...................... ......do .................................. Do. Monopotassium phosphate. To decrease the amount of cooked out juices. Meat food products except where otherwise prohib ited by the meat inspec tion regulations and poul try food products except where otherwise prohib ited by the poultry prod ucts inspection regula tions.. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phos phate in meat food prod uct (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. Monosodium phos phate. ......do ...................... ......do .................................. Do. Phosphoric acid ...... To acidify ................ Margarine or oleomargarine Sufficient for purpose. Potassium bicarbon ate. To alkalize .............. Margarine or oleomargarine Sufficient for purpose. Potassium car bonate. ......do ...................... ......do .................................. Do. Potassium pyrophosphate. To decrease the amount of cooked out juices. Meat food products except where otherwise prohib ited by the meat inspec tion regulations and poul try food products except where otherwise prohib ited by the poultry prod ucts inspection regula tions.. 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phos phate in meat food prod uct (only clear solution may be injected into meat food product). For poultry food products, 0.5 per cent of total product. Potassium sorbate .. To retard mold growth. Dry sausage ........................ 10 percent in water solution may be applied to cas ings after stuffing or cas ings may be dipped in so lution prior to stuffing. Potassium tripolyphosphate. To decrease the amount of cooked out juices. Meat food products except where otherwise prohib ited by the meat inspec tion regulations and poul try food products except where otherwise prohib ited by the poultry prod ucts inspection regula tions. 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phos phate in meat food prod uct (only clear solution may be injected into meat food product). For poultry food products, 0.5 per cent of total product. Propyl paraben (propyl p-hydroxy benzoate). To retard mold growth. Dry sausage ........................ 3.5 percent in water solution may be applied to cas ings after stuffing or cas ings may be dipped in so lution prior to stuffing. Silicon dioxide ........ Processing aid/dis persant. Tocopherol containing bacon curing mixes. At level not to exceed 4.0 percent in the dry mix. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00653 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 644 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Sodium acid pyrophosphate. To decrease the amount of cooked out juices. Meat food products except where other prohibited by the meat inspection regu lations and poultry food products except where otherwise prohibited by the poultry products in spection regulations.. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phos phate in meat food prod uct (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. Sodium bicarbonate To neutralize excess acidity, cleaning vegetables. Rendered fats, soups, cur ing pickle (meat and poul try). Sufficient for purpose. To alkalize .............. Margarine or oleomargarine Do. Sodium carbonate .. ......do ...................... ......do .................................. Do. Sodium citrate buffered with citric acid to a pH of 5.6. To inhibit the growth of micro-orga nisms and retain product flavor dur ing storage. Cured and uncured, proc essed whole muscle meat and poultry food products, e.g., ham, chicken breasts. Not to exceed 1.3 percent of the formulation weight of the product in accord ance with 21 CFR 184.1751. Sodium hydroxide ... To alkalize .............. Margarine or oleomargarine Sufficient for purpose. To decrease the amount of cooked out juices. Poultry food products con taining phosphates. May be used only in com bination with phosphate in a ratio not to exceed one part sodium hydroxide to four parts phosphate. ......do ...................... Meat food products con taining phosphates. May be used only in com bination with phosphates in a ratio not to exceed one part sodium hydrox ide to four parts phos phate; the combination shall not exceed 5 per cent in pickle at 10 per cent pump level; 0.5 per cent in product. Sodium metaphosphate, insoluble. ......do ...................... Meat food products except where other prohibited by the meat inspection regu lations, and poultry food products except where otherwise prohibited by the poultry products in spection regulations. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phos phate in meat food prod uct (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. Sodium polyphosphate, glassy. ......do ...................... ......do .................................. Do. Sodium proprionate To retard mold growth. Pizza crust .......................... 0.32 percent alone or in combination based on weight of the flour brace used. ......do ...................... Fresh pie dough (poultry only). 0.3 percent of calcium proprionate or sodium proprionate alone, or in combination, based on weight of flour used. Sodium pryophosphate. To decrease the amount of cooked out juices. Meat food products except where otherwise prohib ited by the meat inspec tion regulations and poul try food products except where otherwise prohib ited by the poultry prod ucts inspection regula tions. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phos phate in meat food prod uct (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product. Sodium tripolyphosphate. ......do ...................... ......do .................................. Do. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00654 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 645 Food Safety and Inspection Service, USDA § 424.21 Class of substance Substance Purpose Products Amount Sorbic acid (sodium, potassium, and calcium salts). To preserve product and to retard mold growth. Margarine or oleomargarine 0.1 percent individually, or if used in combination or with benzoic acid or its salts, 0.2 percent (ex pressed as the acids in the wt. of the finished foods). Tricalcium phos phate. To preserve product color during dehy dration process. Mechanically deboned chicken to be dehydrated. Not to exceed 2 percent of the weight of the me chanically deboned chick en prior to dehydration, in accordance with 21 CFR 182.1217. Poultry scald agents (must be removed by subsequent cleaning oper ations). Alpha-hydro-omega hydroxy-poly (oxy ethylene) poly (oxypropylene) (minimum 15 moles) poly (oxy ethylene) block copolymer (poloxamer). To remove feathers Poultry carcasses ................ Not to exceed 0.05 percent by weight in scald water. Dimethylpolysiloxan e. ......do ...................... ......do .................................. Sufficient for purpose. Dioctyl sodium sulfosuccinate. ......do ...................... ......do .................................. Do. Dipotassium phos phate. ......do ...................... ......do .................................. Do. Ethylenediaminetetr a-acetic acid (so dium salts). ......do ...................... ......do .................................. Do. Lime (calcium oxide, calcium hydrox ide). ......do ...................... ......do .................................. Do. Polyoxyethylene (20) sorbitan monooleate. ......do ...................... ......do .................................. Not to exceed 0.0175 per cent in scald water. Potassium hydrox ide. ......do ...................... ......do .................................. Sufficient for purpose. Propylene glycol ..... ......do ...................... ......do .................................. Do. Sodium acid phos phate. ......do ...................... ......do .................................. Do. Sodium acid pyrophosphate. ......do ...................... ......do .................................. Do. Sodium bicarbonate ......do ...................... ......do .................................. Do. Sodium carbonate .. ......do ...................... ......do .................................. Do. Sodium dodecylbenzene sulfonate. ......do ...................... ......do .................................. Do. Sodium-2-ethylhexyl sulfate. ......do ...................... ......do .................................. Do. Sodium hexametaphosph ate. ......do ...................... ......do .................................. Do. Sodium hydroxide ... ......do ...................... ......do .................................. Do. Sodium lauryl sul fate. ......do ...................... ......do .................................. Do. Sodium phosphate (mono-, di-, tribasic). ......do ...................... ......do .................................. Do. Sodium pyrophosphate. ......do ...................... ......do .................................. Do. Sodium sesquicarbonate. ......do ...................... ......do .................................. Do. Sodium sulfate ........ ......do ...................... ......do .................................. Do. Sodium tripolyphosphate. ......do ...................... ......do .................................. Do. Tetrasodium pyrophosphate. ......do ...................... ......do .................................. Do. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00655 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 646 9 CFR Ch. III (1–1–18 Edition) § 424.21 Class of substance Substance Purpose Products Amount Proteolytic Enzymes Aspergillus flavus oryzae group. To soften tissue ...... Raw poultry muscle tissue of hen, cock, mature tur key, mature duck, mature goose, and mature guin ea, and raw meat cuts. Solutions consisting of water and approved proteolytic enzyme ap plied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus oryzae .. ......do ...................... ......do .................................. Do. Bromelin ................. ......do ...................... ......do .................................. Do. Ficin ........................ ......do ...................... ......do .................................. Do. Papain .................... ......do ...................... ......do .................................. Do. Refining Agents (must be elimi nated during proc ess of manufac turing). Acetic acid .............. To separate fatty acids and glycerol. Rendered fats (meat only) .. Sufficient for purpose. Bicarbonate of soda ......do ...................... ......do .................................. Do. Carbon (purified charcoal). To aid in refining of animal fats. ......do .................................. Do. Caustic soda (so dium hydroxide). To refine fats .......... ......do .................................. Do. Diatomaceous earth; Fuller’s earth. ......do ...................... ......do .................................. Do. Sodium carbonate .. ......do ...................... ......do .................................. Do. Tannic acid ............. ......do ...................... ......do .................................. Do. Rendering agents ..... Tricalcium phos phate. To aid rendering ..... Animal fats .......................... Do. Trisodium phos phate. ......do ...................... ......do .................................. Do. Synergists (used in combination with antioxidants). Citric acid ................ To increase effec tiveness of anti oxidants. Any meat product permitted to contain antioxidants as provided for in this part. Not to exceed 0.01 percent based on fat content. ......do ...................... Poultry fats .......................... 0.01 percent alone or in combination with anti oxidants in poultry fats. Malic acid ............... ......do ...................... Lard and shortening ............ 0.01 percent based on total weight in combination with antioxidants for use in meat products only. ......do ...................... Poultry fats .......................... 0.01 percent alone or in combination with anti oxidants in poultry fats. Monoglyceride cit rate. ......do ...................... Lard, shortening, fresh pork sausage, dried meats and poultry fats. 0.02 percent. Monoisopropyl cit rate. ......do ...................... Lard, shortening, oleo margarine, fresh pork sausage, dried meats. Do. ......do ...................... Poultry fats .......................... 0.01 percent poultry fats. Phosphoric acid ...... ......do ...................... Lard, shortening, and poul try fats. 0.01 percent. Tenderizing agents .. Aspergillus flavus oryzae group. To soften tissue ...... Raw poultry muscle tissue of hen, cock, mature tur key, mature duck, mature goose, and mature guin ea, and raw meat cuts. Solutions consisting of water and approved proteolytic enzyme ap plied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus oryzae .. ......do ...................... ......do .................................. Not more than 3 percent of a 0.8 molar solution. Bromelin ................. ......do ...................... ......do .................................. Do. Calcium chloride ..... ......do ...................... ......do .................................. Do. Magnesium chloride ......do ...................... ......do .................................. Do. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00656 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 647 Food Safety and Inspection Service, USDA § 424.22 Class of substance Substance Purpose Products Amount Papain .................... To soften tissue ...... Raw poultry muscle tissue of hen, cock, mature tur key, mature duck, mature goose, and mature guin ea, and raw meat cuts. Solutions consisting of water and approved proteolytic enzyme ap plied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. Potassium chloride ......do ...................... ......do .................................. Not more than 3 percent of a 2.0 molar solution. Potassium, magne sium or calcium chloride. ......do ...................... ......do .................................. A solution of approved inor ganic chlorides injected into or applied to raw meats or poultry cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. 1 [Reserved] 2 Information as to the specific products for which use of this additive is approved may be obtained upon inquiry addressed to the Labeling and Additives Policy Division, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. 3 Provided that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to ac complish the desired technical effect as determined in specific cases prior to label approval under part 412 of this chapter. 4 Special labeling requirements are prescribed in 381.120 for raw poultry chilled in a medium with more than 70 lbs. of salt to 10,000 gals. of water. [64 FR 72175, Dec. 23, 1999, as amended at 65 FR 3123, Jan. 20, 2000; 65 FR 34391, May 30, 2000; 78 FR 66839, Nov. 7, 2013] § 424.22 Certain other permitted uses. (a) Under appropriate declaration as required in parts 316 and 317 of this chapter, the following substances may be added to meat: (1) General. Common salt, approved sugars (sucrose, cane or beet sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids (corn syrup, glucose syrup and fructose), wood smoke, vinegar, flavorings, spices, so dium nitrate, sodium nitrite, potas sium nitrate, potassium nitrite, and other food and color additives specified in the chart in paragraph (c) of this section may be added to meat under conditions, if any, specified in this part or in part 317 of this chapter. (2) Artificial flavorings. Other harm less artificial flavorings may be added to meat, with the approval of the Ad ministrator in specific cases. (3) Coloring matter and dyes. Coloring matter and dyes, other than those specified in a regulation permitting that use in this chapter or in 21 CFR Chapter I, Subchapter A and Sub chapter B, may be applied to meat mixed with rendered fat, applied to natural and artificial casings, and ap plied to such casings enclosing prod ucts, if approved by the Administrator in specific cases. When any coloring matter or dye is applied to casings, there shall be no penetration of color ing into the product. (b) Use of nitrite and sodium ascorbate or sodium erythorbate (isoascorbate) in bacon—(1) Pumped bacon. With respect to bacon injected with curing ingredi ents and massaged bacon, sodium ni trite shall be used at 120 parts per mil lion (ppm) ingoing or an equivalent amount of potassium nitrite shall be used (148 ppm ingoing); and 550 ppm of sodium ascorbate or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or sodium erythorbate have a molecular weight of approximately 198. Hydrated forms of these substances shall be adjusted to attain the equivalent of 550 ppm of so dium ascorbate or sodium erythorbate. (i) The Department shall collect sam ples of pumped bacon from producing plants and analyze them for the level of nitrosamines by the Thermal Energy Analyzer (TEA). In the event that a TEA analysis indicates that a confirm able level of nitrosamines might be present, additional samples shall be collected and analyzed by gas chroma tography. Presumptive positive results VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00657 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 648 9 CFR Ch. III (1–1–18 Edition) § 424.22 must be confirmed by mass spectrom etry before being considered positive. If during the interval required for the De partment to analyze the confirmatory samples by gas chromatography and mass spectrometry, changes are made in processing procedures which are ex pected to result in no confirmable lev els of nitrosamines in pumped bacon produced by these new procedures, an establishment may submit samples to USDA for analysis upon prior notifica tion and arrangements with USDA. If, however, an establishment furnishes USDA with laboratory results from testing five consecutive lots of pumped bacon produced under the new proce dures and the testing is performed by the USDA methodology and proce dures, those results will be utilized in making the determination concerning the product produced under the new procedures. Should the results of these tests reveal that confirmable levels of nitrosamines are not indicated in any of the five consecutive lots, the con firmation analysis by USDA shall be terminated and the establishment shall revert to normal monitoring status. In the event the test results continue to indicate nitrosamines, however, USDA shall proceed in its confirmation anal ysis on the original samples taken for confirmation. If any one of the original samples collected by USDA for con firmation is found to contain confirm able levels of nitrosamines, all pumped bacon in the producing establishment and all future production will be re tained. The Department shall sample and analyze such retained pumped bacon for nitrosamines on a lot by lot basis. A production lot shall be that pumped bacon produced by the estab lishment in any single shift. Samples from any lot of pumped bacon under re tention found to contain nitrosamines at a confirmable level shall cause the lot of pumped bacon to be disposed of in a manner to ensure it will not form nitrosamines when cooked. Such dis posal may include incorporation of the uncooked pumped bacon as an ingre dient of another meat provided it is processed for eating without further preparation in a manner to preclude the formation of nitrosamines. Bacon subsequently produced shall not be re tained because of nitrosamines if the operator of the establishment makes adjustments in the processing of the product and laboratory results ob tained by TEA analysis of samples from five consecutive normal sized lots of pumped bacon indicates that the product being produced contains no confirmable levels of nitrosamines. These tests from five consecutive nor mal sized lots of pumped bacon shall be conducted by the Department. How ever, if the establishment furnishes the Department with the results of tests conducted under the methodology and procedures used by the Department, such test results will be utilized in making the determination concerning the nitrosamine content of the prod uct. All tests of pumped bacon for nitrosamines under this paragraph (b)(1)(i) shall be made on pumped bacon cooked at 340 degrees F. for 3 minutes on each side. In order to determine that no confirmable levels of nitrosamines are present in a sample tested, the testing must be performed by methodology and procedures that would detect the presence of any nitrosamines at 10 ppb. (ii) Notwithstanding the provisions of paragraph (b)(1)(i) of this section, so dium nitrite may be used at: (A) 100 ppm ingoing (potassium ni trite at 123 ppm ingoing); and 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; or (B) A predetermined level between 40 and 80 ppm (potassium nitrite at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate); and addi tional sucrose or other similar fer mentable carbohydrate at a minimum of 0.7 percent and an inoculum of lactic acid producing bacteria such as Pediococcus acetolactii or other bacteria demonstrated to be equally effective in preventing the production of botu linum toxin at a level sufficient for the purpose of preventing the production of botulinum toxin. (C) The Department shall collect samples of bacon from establishments producing under paragraph (b)(1)(ii) of this section and analyze them for the level of nitrosamines. Samples shall be randomly selected throughout the pro duction of a lot. The actual sampling VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00658 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 649 Food Safety and Inspection Service, USDA § 424.22 plans and methods of analysis that are used will result in approximately the same likelihood as under paragraph (b)(1)(i) of this section of having a pre sumptive positive result when the true mean level of nitrosamines in a produc tion lot is 10 ppb. In the event of a pre sumptive positive result, the establish ment shall become subject to the pro visions of paragraph (b)(1)(i) of this section. (2) Immersion cured bacon. Immersion cured bacon may be placed in a brine solution containing salt, nitrite and flavoring material or in a container with salt, nitrite and flavoring mate rial. Sodium nitrite shall not exceed 120 ppm ingoing or an equivalent amount of potassium nitrite (148 ppm ingoing) based on the actual or esti mated skin-free green weight of the bacon bellies. (3) Bacon made with dry curing mate rials. With respect to bacon made with dry curing materials, the product shall be cured by applying a premeasured amount of cure mixture to the bacon belly surfaces, completely covering the surfaces. Sodium nitrite shall not ex ceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly. (c) Irradiation of meat food and poul try products. (1) General requirements. Meat food and poultry products may be treated to reduce foodborne pathogens and to ex tend product shelf-life by the use of sources of ionizing radiation as identi fied in 21 CFR 179.26(a). Official estab lishments must irradiate meat food and poultry products in accordance with 21 CFR 179.26(b), the Hazard Anal ysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, and the provisions of this section. (2) Dosimetry. Official establishments that irradiate meat food and poultry products must have the following pro cedures in place: (i) Laboratory operation procedures for determining the absorbed dose value from the dosimeter. (ii) Calibration criteria for verifying the accuracy and consistency of any means of measurement (e.g., time clocks and weight scales). (iii) Calibration and accountability criteria for verifying the traceability and accuracy of dosimeters for the in tended purpose, and the verification of calibration at least every 12 months. To confirm traceability, establish ments must relate, through docu mentation, the end point measurement of a dosimeter to recognized standards. (iv) Procedures for ensuring that the product unit is dose mapped to identify the regions of minimum and maximum absorbed dose and such regions are con sistent from one product unit to an other of like product. (v) Procedures for accounting for the total absorbed dose received by the product unit (e.g., partial applications of the absorbed dose within one produc tion lot). (vi) Procedures for verifying routine dosimetry, i.e., assuring each produc tion lot receives the total absorbed dose. Establishments may either posi tion one dosimeter at the regions of minimum and maximum absorbed dose (or at one region verified to represent such) on at least the first, middle, and last product unit in each production lot or use statistically based validation and dose mapping to determine the number and placement of dosimeters in each production lot. (vii) Procedures for verifying the re lationship of absorbed dose as meas ured by the dosimeter to time exposure of the product unit to the radiation source. (viii) Procedures for verifying the in tegrity of the radiation source and processing procedure. Aside from ex pected and verified radiation source ac tivity decay for radionuclide sources, the radiation source or processing pro cedure must not be altered, modified, replenished, or adjusted without re peating dose mapping of product units to redefine the regions of minimum and maximum absorbed dose. (3) Documentation. Official establish ments that irradiate meat food or poul try products must have the following documentation on premises, available to FSIS: (i) Documentation that the irradia tion facility is licensed or possesses gamma radiation sources registered VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00659 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 650 9 CFR Ch. III (1–1–18 Edition) § 424.23 with the Nuclear Regulatory Commis sion (NRC) or the appropriate State government acting under authority granted by the NRC. (ii) Documentation that the machine radiation source irradiation facility is registered with the appropriate State government, if applicable. (iii) Documentation that a worker safety program addressing OSHA regu lations (29 CFR chapter XVII) is in place. (iv) Citations or other documents that relate to incidences in which the establishment was found not to comply with Federal or State agency require ments for irradiation facilities. (v) A certification by the operator that the irradiation facility personnel will only operate under supervision of a person who has successfully completed a course of instruction for operators of food irradiation facilities. (vi) A certification by the operator that the key irradiation personnel, who monitor or control daily operations, have been trained in food technology, irradiation processing, and radiation health and safety. (vii) Guarantees from the suppliers of all food-contact packaging materials that may be subject to irradiation that those materials comply with the Fed eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (4) Labeling. (i) The labels on pack ages of meat food and poultry products irradiated in their entirety, in con formance with this section and with 21 CFR 179.26(a) and (b), must bear the logo shown at the end of this para graph. Unless the word ‘‘Irradiated’’ is part of the product name, labels also must bear a statement such as ‘‘Treat ed with radiation’’ or ‘‘Treated by irra diation.’’ The logo must be placed in conjunction with the required state ment, if the statement is used. The statement is not required to be more prominent than the declaration of in gredients required under § 317.2(c)(2) of this chapter. (ii) For meat food or poultry prod ucts that have been irradiated in their entirety, but that are not sold in pack ages, the required logo must be dis played to the purchaser with either the labeling of the bulk container plainly in view or a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. In either case, the information must be prominently and conspicuously displayed to pur chasers. Unless the word ‘‘Irradiated’’ is part of the product name, the label ing counter sign, card, or other device also must bear a statement such as ‘‘Treated with radiation’’ or ‘‘Treated by irradiation.’’ The logo must be placed in conjunction with the required statement, if the statement is used. (iii) The inclusion of an irradiated meat food or poultry product ingre dient in any multi-ingredient meat food or poultry product must be re flected in the ingredient statement on the finished product labeling. (iv) Optional labeling statements about the purpose for radiation proc essing may be included on the product label in addition to the stated require ments elsewhere in this section, pro vided that such statements are not false or misleading. Statements that there has been a specific reduction in microbial pathogens must be substan tiated by processing documentation. [64 FR 72175, Dec. 23, 1999, as amended at 64 FR 72165, Dec. 23, 1999; 65 FR 34391, May 30, 2000; 78 FR 66839, Nov. 7, 2013] § 424.23 Prohibited uses. (a) Substances that conceal damage or inferiority or make products appear better or of greater value. No substance may be used in or on any meat if it conceals damage or inferiority or makes the VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00660 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31 ER 2 3 D E 9 9 .0 0 0 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 651 Food Safety and Inspection Service, USDA § 430.1 product appear to be better or of great er value than it is. Therefore: (1) Paprika or oleoresin paprika may not be used in or on fresh meat, such as steaks, or comminuted fresh meat, such as chopped and formed steaks or patties; or in any other meat con sisting of fresh meat (with or without seasoning). (2) Paprika or oleoresin paprika may be used in or on chorizo sausage and other meat in which paprika or oleo resin paprika is permitted as an ingre dient in a standard of identity or com position in part 319 of this subchapter. (3) Sorbic acid, calcium sorbate, so dium sorbate, and other salts of sorbic acid shall not be used in cooked sau sages or any other meat; sulfurous acid and salts of sulfurous acid shall not be used in or on any meat; and niacin or nicotinamide shall not be used in or on fresh meat product; except that potas sium sorbate, propylparaben (propyl p hydroxybenzoate), and calcium propio nate, may be used in or on any product, only as provided in 9 CFR Chapter III. (b) Nitrates. Nitrates shall not be used in curing bacon. [64 FR 72175, Dec. 23, 1999, as amended at 78 FR 14640, Mar. 7, 2013] PART 430—REQUIREMENTS FOR SPECIFIC CLASSES OF PRODUCT Sec. 430.1 Definitions. 430.4 Control of Listeria monocytogenes in post-lethality exposed ready-to-eat prod ucts. AUTHORITY: 7 U.S.C. 450; 7 U.S.C. 1901–1906; 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. SOURCE: 68 FR 34224, June 6, 2003, unless otherwise noted. § 430.1 Definitions. Antimicrobial agent. A substance in or added to an RTE product that has the effect of reducing or eliminating a microorganism, including a pathogen such as L. monocytogenes, or that has the effect of suppressing or limiting growth of L. monocytogenes in the prod uct throughout the shelf life of the product. Examples of antimicrobial agents added to RTE products are po tassium lactate and sodium diacetate. Antimicrobial process. An operation, such as freezing, applied to an RTE product that has the effect of sup pressing or limiting the growth of a microorganism, such as L. monocytogenes, in the product through out the shelf life of the product. Deli product. A ready-to-eat meat or poultry product that typically is sliced, either in an official establish ment or after distribution from an offi cial establishment, and typically is as sembled in a sandwich for consump tion. Hotdog product. A ready-to-eat meat or poultry frank, frankfurter, or wie ner, such as a product defined in 9 CFR 319.180 and 319.181. Lethality treatment. A process, includ ing the application of an antimicrobial agent, that eliminates or reduces the number of pathogenic microorganisms on or in a product to make the product safe for human consumption. Examples of lethality treatments are cooking or the application of an antimicrobial agent or process that eliminates or re duces pathogenic microorganisms. Post-lethality exposed product. Ready to-eat product that comes into direct contact with a food contact surface after the lethality treatment in a post lethality processing environment. Post-lethality processing environment. The area of an establishment into which product is routed after having been subjected to an initial lethality treatment. The product may be ex posed to the environment in this area as a result of slicing, peeling, re-bag ging, cooling semi-permeable encased product with a brine solution, or other procedures. Post-lethality treatment. A lethality treatment that is applied or is effective after post-lethality exposure. It is ap plied to the final product or sealed package of product in order to reduce or eliminate the level of pathogens re sulting from contamination from post lethality exposure. Prerequisite program. A procedure or set of procedures that is designed to provide basic environmental or oper ating conditions necessary for the pro duction of safe, wholesome food. It is called ‘‘prerequisite’’ because it is con sidered by scientific experts to be pre requisite to a HACCP plan. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00661 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 652 9 CFR Ch. III (1–1–18 Edition) § 430.4 Ready-to-eat (RTE) product. A meat or poultry product that is in a form that is edible without additional prepara tion to achieve food safety and may re ceive additional preparation for palat ability or aesthetic, epicurean, gastro nomic, or culinary purposes. RTE prod uct is not required to bear a safe-han dling instruction (as required for non RTE products by 9 CFR 317.2(l) and 381.125(b)) or other labeling that directs that the product must be cooked or otherwise treated for safety, and can include frozen meat and poultry prod ucts. § 430.4 Control of Listeria monocytogenes in post-lethality ex posed ready-to-eat products. (a) Listeria monocytogenes can con taminate RTE products that are ex posed to the environment after they have undergone a lethality treatment. L. monocytogenes is a hazard that an es tablishment producing post-lethality exposed RTE products must control through its HACCP plan or prevent in the processing environment through a Sanitation SOP or other prerequisite program. RTE product is adulterated if it contains L. monocytogenes, or if it comes into direct contact with a food contact surface that is contaminated with L. monocytogenes. Establishments must not release into commerce prod uct that contains L. monocytogenes or that has been in contact with a food contact surface contaminated with L. monocytogenes without first reworking the product using a process that is de structive of L. monocytogenes. (b) In order to maintain the sanitary conditions necessary to meet this re quirement, an establishment producing post-lethality exposed RTE product must comply with the requirements in cluded in one of the three following al ternatives: (1) Alternative 1. Use of a post lethality treatment (which may be an antimicrobial agent) that reduces or eliminates microorganisms on the product and an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes. If an estab lishment chooses this alternative: (i) The post-lethality treatment must be included in the establishment’s HACCP plan. The antimicrobial agent or process used to suppress or limit the growth of the pathogen must be in cluded in either the establishment’s HACCP plan or its Sanitation SOP or other prerequisite program. (ii) The establishment must validate the effectiveness of the post-lethality treatment incorporated in its HACCP plan in accordance with § 417.4. The es tablishment must document, either in its HACCP plan or in its Sanitation SOP or other prerequisite program, that the antimicrobial agent or proc ess, as used, is effective in suppressing or limiting growth of L. monocytogenes. (2) Alternative 2. Use of either a post lethality treatment (which may be an antimicrobial agent) that reduces or eliminates microorganisms on the product or an antimicrobial agent or process that suppresses or limits growth of L. monocytogenes. If an estab lishment chooses this alternative: (i) The post-lethality treatment must be included in the establishment’s HACCP plan. The antimicrobial agent or process used to suppress or limit growth of the pathogen must be in cluded in either the establishment’s HACCP plan or its Sanitation SOP or other prerequisite program. (ii) The establishment must validate the effectiveness of a post-lethality treatment incorporated in its HACCP plan in accordance with § 417.4. The es tablishment must document in its HACCP plan or in its Sanitation SOP or other prerequisite program that the antimicrobial agent or process, as used, is effective in suppressing or limiting growth of L. monocytogenes. (iii) If an establishment chooses this alternative and chooses to use only an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes, its sanitation program must: (A) Provide for testing of food con tact surfaces in the post-lethality proc essing environment to ensure that the surfaces are sanitary and free of L. monocytogenes or of an indicator orga nism; (B) Identify the conditions under which the establishment will imple ment hold-and-test procedures fol lowing a positive test of a food-contact surface for an indicator organism; VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00662 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 653 Food Safety and Inspection Service, USDA § 430.4 (C) State the frequency with which testing will be done; (D) Identify the size and location of the sites that will be sampled; and (E) Include an explanation of why the testing frequency is sufficient to en sure that effective control of L. monocytogenes or of indicator orga nisms is maintained. (iv) An establishment that chooses this alternative and uses a post lethality treatment of product will likely be subject to more frequent verification testing by FSIS than if it had chosen Alternative 1. An establish ment that chooses this alternative and uses an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes will likely be subject to more frequent FSIS verification testing than if it uses a post-lethality treatment. (3) Alternative 3. Use of sanitation measures only. (i) If an establishment chooses this alternative, its sanitation program must: (A) Provide for testing of food con tact surfaces in the post-lethality proc essing environment to ensure that the surfaces are sanitary and free of L. monocytogenes or of an indicator orga nism; (B) Identify the conditions under which the establishment will imple ment hold-and-test procedures fol lowing a positive test of a food-contact surface for an indicator organism; (C) State the frequency with which testing will be done; (D) Identify the size and location of the sites that will be sampled; and (E) Include an explanation of why the testing frequency is sufficient to en sure that effective control of L. monocytogenes or of indicator orga nisms is maintained. (ii) An establishment producing a deli product or a hotdog product, in ad dition to meeting the requirements of paragraph (b)(3)(i) of this section, must meet the following requirements: (A) The establishment must verify that the corrective actions that it takes with respect to sanitation after an initial positive test for L. monocytogenes or an indicator organism on a food contact surface in the post lethality processing environment are effective by conducting follow-up test ing that includes a targeted test of the specific site on the food contact sur face area that is the most likely source of contamination by the organism and such additional tests in the sur rounding food contact surface area as are necessary to ensure the effective ness of the corrective actions. (B) During this follow-up testing, if the establishment obtains a second positive test for an indicator organism, the establishment must hold lots of product that may have become con taminated by contact with the food contact surface until the establishment corrects the problem indicated by the test result. (C) In order to release into commerce product held under this section, the es tablishment must sample and test the lots for L. monocytogenes or an indi cator organism using a sampling meth od and frequency that will provide a level of statistical confidence that en sures that each lot is not adulterated with L. monocytogenes. The establish ment must document the results of this testing. Alternatively, the estab lishment may rework the held product using a process that is destructive of L. monocytogenes or the indicator orga nism. (iii) An establishment that chooses Alternative 3 is likely to be subject to more frequent verification testing by FSIS than an establishment that has chosen Alternative 1 or 2. An establish ment that chooses Alternative 3 and that produces deli meat or hotdog products is likely to be subject to more frequent verification testing than one that does not produce such products. (c) For all three alternatives in para graph (b): (1) Establishments may use verification testing that includes tests for L. monocytogenes or an indicator or ganism, such as Listeria species, to verify the effectiveness of their sanita tion procedures in the post-lethality processing environment. (2) Sanitation measures for control ling L. monocytogenes and procedures for antimicrobial agents or processes that suppress or limit the growth of the pathogen may be incorporated ei ther in the establishment’s HACCP plan or in its Sanitation SOP or other VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00663 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 654 9 CFR Ch. III (1–1–18 Edition) Pt. 439 prerequisite program. When these con trol procedures are incorporated into the Sanitation SOP or prerequisite pro gram, and not as a CCP in the HACCP plan, the establishment must have doc umentation that supports the decision in its hazard analysis that L. monocytogenes is not a hazard that is reasonably likely to occur. (3) The establishment must maintain sanitation in the post-lethality proc essing environment in accordance with part 416. (4) If L. monocytogenes control meas ures are included in the HACCP plan, the establishment must validate and verify the effectiveness of measures for controlling L. monocytogenes included in its HACCP plan in accordance with § 417.4. (5) If L. monocytogenes control meas ures are included in the Sanitation SOP, the effectiveness of the measures must be evaluated in accordance with § 416.14. (6) If the measures for addressing L. monocytogenes are addressed in a pre requisite program other than the Sani tation SOP, the establishment must in clude the program and the results pro duced by the program in the docu mentation that the establishment is required to maintain under 9 CFR 417.5. (7) The establishment must make the verification results that demonstrate the effectiveness of the measures it employs, whether under its HACCP plan or its Sanitation SOP or other prerequisite program, available upon request to FSIS inspection personnel. (d) [Reserved] (e) An establishment that controls L. monocytogenes by using a post-lethality treatment or an antimicrobial agent or process that eliminates or reduces, or suppresses or limits the growth of the organism may declare this fact on the product label provided that the estab lishment has validated the claim. [68 FR 34224, June 6, 2003, as amended at 80 FR 35188, June 19, 2015] PART 439—ACCREDITATION OF NON-FEDERAL CHEMISTRY LAB ORATORIES Sec. 439.1 Definitions. 439.5 Applications for accreditation. 439.10 Criteria for obtaining accreditation. 439.20 Criteria for maintaining accredita tion. 439.50 Refusal of accreditation. 439.51 Probation of accreditation. 439.52 Suspension of accreditation. 439.53 Revocation of accreditation. 439.60 Notifications and hearings. AUTHORITY: 7 U.S.C. 138f, 450, 1901–1906; 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. SOURCE: 73 FR 52196, Sept. 9, 2008, unless otherwise noted. § 439.1 Definitions. (a) Accreditation—Determination by FSIS that a laboratory is qualified to analyze official samples of raw or proc essed meat and poultry products, be cause it has met the requirements for accreditation specified in this part, for the presence and amount of all four food chemistry analytes (protein, mois ture, fat, and salt); or a determination by FSIS that a laboratory is qualified to analyze official samples of raw or processed meat and poultry products, because it has met the requirements for accreditation in this part, for the presence and amount of a specified chemical residue of any one of several classes of chemical residues. A labora tory may hold more than one accredi tation. (b) Accredited laboratory—A non-Fed eral analytical laboratory that has met the requirements for accreditation specified in this Part and, therefore, at an establishment’s discretion, may be used in lieu of an FSIS laboratory for analyzing official regulatory samples. Payment for the analysis of official samples is to be made by the establish ment using the accredited laboratory. (c) Accredited Laboratory Program (ALP)—The FSIS program in which non-Federal laboratories are accredited as eligible to perform analyses on offi cial regulatory samples of raw or proc essed meat and poultry products, and through which a check sample program for quality assurance is conducted. (d) Chemical residue misidentification— see ‘‘Correct chemical residue identi fication’’ definition. (e) Coefficient of variation (CV)—The standard deviation of a distribution of analytical values multiplied by 100 and divided by the mean of those values. (f) Comparison mean—The average re sult, for a sample, obtained from all VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00664 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 655 Food Safety and Inspection Service, USDA § 439.1 submitted results that have a large de viation measure of zero. When only two laboratories perform the analysis and the large deviation measure is not zero, alternative procedures for establishing a comparison mean may be employed by FSIS. For purposes of computing the comparison mean, a laboratory’s ‘‘result’’ for a food chemistry analyte is the obtained analytical value; a lab oratory’s ‘‘result’’ for a chemical res idue is the logarithmic transformation of the obtained analytical value. (g) Correct chemical residue identifica tion—Reporting by a laboratory of the presence and analytical value of a chemical residue that was included in the ALP check sample above the min imum reporting level. Failure of a lab oratory to report the presence of such a chemical residue is considered a misidentification. In addition, report ing the presence of and analytical value for a residue that was not in cluded in the ALP check sample above the minimum reporting level is consid ered a misidentification. (h) CUSUM—A class of statistical procedures for assessing whether or not a process is ‘‘in control.’’ Each CUSUM value is constructed by accumulating incremental values obtained from ob served results of the process, and then determined to either exceed or fall within acceptable limits for that proc ess. The initial CUSUM values for each laboratory whose application for ac creditation is accepted are set at zero. The CUSUM values are reset to zero at the beginning of each year; that is, the CUSUM values associated with the first maintenance check sample each year are set equal to the CUSUM incre ment for that sample. The four CUSUM procedures are: (1) Positive systematic laboratory difference CUSUM (CUSUM–P)—mon itors how consistently an accredited laboratory gets numerically greater re sults than the comparison mean; (2) Negative systematic laboratory difference CUSUM (CUSUM–N)—mon itors how consistently an accredited laboratory gets numerically smaller results than the comparison mean; (3) Variability CUSUM (CUSUM–V)— monitors the average ‘‘total deviation’’ (i.e., the combination of the random fluctuations and systematic dif ferences) between an accredited labora tory’s results and the comparison mean; and (4) Individual large deviation CUSUM (CUSUM–D)—monitors the magnitude and frequency of large differences be tween the results of an accredited lab oratory and the comparison mean. (i) Food chemistry—For the purposes of part 439, ‘‘food chemistry’’ will refer to analysis of raw or processed meat or poultry products for the analytes mois ture, protein, fat, and salt. All four analytes must be determined when a food chemistry analysis is conducted, unless otherwise advised by the ALP. (j) Individual large deviation—An ana lytical result that differs from the sample comparison mean by more than would be expected assuming normal laboratory variability. (k) Initial accreditation check sample— A sample provided by the ALP to a non-Federal laboratory to determine whether the laboratory’s analytical ca pability meets the standards for grant ing accreditation. (l) Inter-laboratory accreditation main tenance check sample—A sample pro vided by FSIS to an accredited labora tory to assist in determining whether the laboratory is maintaining accept able levels of analytical capability. (m) Large deviation measure—A meas ure that quantifies an unacceptably large difference between a laboratory’s analytical result and the sample com parison mean. (n) Minimum proficiency level (MPL)— The minimum concentration of a res idue at which an analytical result will be used to assess a laboratory’s quan tification capability. This concentra tion is an estimate of the smallest con centration for which the average coef ficient of variation (CV) for reproduc ibility (i.e., combined within and be tween laboratory variability) does not exceed 20 percent. (o) Minimum reporting level (MRL)— The number such that if any obtained analytical value for a residue in a check sample or official sample equals or exceeds this number, then the res idue is reported together with the ob tained analytical value. (p) Official sample—A sample selected by an inspector or inspection service VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00665 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 656 9 CFR Ch. III (1–1–18 Edition) § 439.1 employee in accordance with FSIS pro cedures for regulatory use. (q) Probation—The period com mencing with official notification to an accredited laboratory that its check sample results no longer satisfy the performance requirements specified in this rule, and ending with official noti fication that accreditation either is fully restored, is suspended, or is re voked. (r) QA (See Quality assurance recov ery). (s) QC (See Quality control recovery). (t) Quality assurance (QA) recovery— The ratio of a laboratory’s analytical value for a check sample residue to the established level of the analyte in the check sample, multiplied by 100. As dictated by the procedures for the analyte, the analytical value may be adjusted prior to the recovery com putation. (u) Quality control (QC) recovery—The ratio of a laboratory’s analytical value of a quality control standard to the es tablished level of the analyte in the standard, multiplied by 100. As dictated by the procedures for the analyte, the analytical value may be adjusted prior to the recovery computation. (v) Refusal of accreditation—An action taken by FSIS when a laboratory that is applying for accreditation is denied the accreditation. (w) Responsibly connected—Any indi vidual, or entity, that is a partner, offi cer, director, manager, or owner of 10 percent or more of the voting stock of the applicant or recipient of accredita tion or an employee in a managerial or executive capacity or any employee who conducts or supervises the chem ical analysis of FSIS official samples. (x) Revocation of accreditation—An ac tion taken by FSIS against a labora tory, removing the laboratory’s right to analyze official samples. (y) Standardizing constant—A number that results from a mathematical ad justment to the ‘‘standardizing value’’ and is used to compute the standard ized difference for a check sample re sult. The number takes into consider ation the expected variance of the dif ference between the accredited or ap plying laboratory’s result(s) and the comparison mean for a sample, the standardizing value, the correlation and number of repeated results by a laboratory on a sample, and the num ber of laboratories that analyzed a sample. (z) Standardized difference—The quotient of the difference between a laboratory’s result on a sample and the comparison mean of the sample divided by the standardizing constant. (aa) Standardizing value—A number representing the performance standard deviation of an individual result. The number is given, or computed by, the information provided in Tables 1 and 2 to this paragraph (aa). TABLE 1 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR FOOD CHEMISTRY [By product class and analyte] Product/class Moisture Protein 1 Fat 1 Salt 1 <12.5% ≥12.5% <1% 1–4% ≥4% 2 Cured Pork/ Canned Ham ..... 0.50 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22 Ground Beef .......... 0.71 0.060 (X 0.65) N/A 0.35 (X 0.25) 0.127 0.127 (X 0.25) 0.22 Other Meat Prod ucts .................... 0.57 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22 Poultry Products .... 0.57 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22 1 The standardizing value is either the value given in the table or is computed by the formula set forth in the table, where X is the comparison mean of the sample. Standardizing values are provided for different percentages of fat and salt as indicated in the table. 2 For dry salami and pepperoni products. TABLE 2 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR CHEMICAL RESIDUES Class of residues Standard-izing value 3 Chlorinated Hydrocarbons: 1 Aldrin .......................................................... 0.20 Benzene Hexachloride ............................... 0.20 TABLE 2 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR CHEMICAL RESIDUES—Continued Class of residues Standard-izing value 3 Chlordane ................................................... 0.20 Dieldrin ....................................................... 0.20 DDT ............................................................ 0.20 VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00666 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 657 Food Safety and Inspection Service, USDA § 439.10 TABLE 2 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR CHEMICAL RESIDUES—Continued Class of residues Standard-izing value 3 DDE ............................................................ 0.20 TDE ............................................................ 0.20 Endrin ......................................................... 0.20 Heptachlor .................................................. 0.20 Heptachlor Epoxide .................................... 0.20 Lindane ....................................................... 0.20 Methoxychlor .............................................. 0.20 Toxaphene .................................................. 0.20 Hexachlorobenzene .................................... 0.20 Mirex ........................................................... 0.20 Nonachlor ................................................... 0.20 Polychlorinated Biphenyls: 0.20 Arsenic 2 ..................................................... 0.25 Sulfonamides 2 ................................................... 0.25 Volatile Nitrosamine 2 ................................. 0.25 1 Laboratory statistics are computed over all results (exclud ing PCB results), and for specific chemical residues. 2 Laboratory statistics are only computed for specific chem ical residues. 3 The standardizing value of all initial accreditation and pro bationary check samples computations is 0.15. (bb) Suspension of accreditation—Ac tion taken by FSIS against a labora tory that temporarily removes the lab oratory’s right to analyze official sam ples. Suspension of accreditation ends when accreditation either is fully re stored or is revoked. (cc) Systematic laboratory difference— A comparison of one laboratory’s re sults with the comparison mean for samples that show, on average, a con sistent relationship. A laboratory that is reporting, on average, numerically greater results than the comparison mean has a positive systematic labora tory difference. Conversely, numeri cally smaller results indicate a nega tive systematic laboratory difference. (dd) Variability—Random fluctuations in a laboratory’s processes that cause its analytical results to deviate from a true value. (ee) Variance—The expected average of the squared differences of sample re sults from an expected sample mean. § 439.5 Applications for accreditation. (a) Application for accreditation shall be made on designated paper or electronic forms provided by FSIS, or otherwise in writing, by the owner or manager of a non-Federal analytical laboratory. The forms shall be sent to the ALP or may be submitted elec tronically when so provided for by FSIS. The application shall specify the kinds of accreditation that are wanted by the owner or manager of the labora tory. A laboratory whose accreditation has been refused or revoked may re apply for accreditation after 60 days from the effective date of that action, and must provide written documenta tion specifying what corrections were made. (b) At the time that an Application for Accreditation is filed with the ALP, the management of a laboratory shall, for each accreditation sought, submit a check, bank draft, or money order in the amount specified in 9 CFR 391.5, made payable to the U.S. Department of Agriculture, along with the com pleted application for the accredita tion(s). When so provided for by FSIS, electronic transfer of funds may be ac cepted. (c) Accreditation will not be granted or continued, without further proce dure, for failure to pay the accredita tion fee(s). The fee(s) paid will be non refundable and will be credited to the account from which the expenses of the laboratory accreditation program are paid. (d) Annually on the anniversary date of each accreditation, FSIS will issue a bill in the amount specified in 9 CFR 391.5 for each accreditation held. Bills are payable upon receipt by check, bank draft, or money order made pay able to the U.S. Department of Agri culture and become delinquent 30 days from the date of the bill. (e) Accreditation will be terminated without further procedure for having a delinquent account. The fee(s) paid will be nonrefundable and will be credited to the account from which the expenses of the ALP are paid. § 439.10 Criteria for obtaining accredi tation. (a) Analytical laboratories may be accredited for the analyses of food chemistry analytes, as defined in § 439.1 of this part, or a specific chemical res idue or a class of chemical residues in raw or processed meat and poultry products. (b) Accreditation will be given only if the applying laboratory successfully satisfies the requirements presented below. For food chemistry accredita tion, the requirements must be satis fied for all four analytes. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00667 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 658 9 CFR Ch. III (1–1–18 Edition) § 439.10 (c) This accreditation authorizes offi cial FSIS acceptance of the analytical test results provided by these labora tories on official samples. (d) To obtain FSIS accreditation, an analytical laboratory must: (1) Be supervised by a person holding, at a minimum, a bachelor’s degree in chemistry, food science, food tech nology, or a related field. (i) For food chemistry accreditation, the supervisor must also have one year’s experience in food chemistry analysis, or equivalent qualifications, as determined by the Administrator. (ii) For chemical residue accredita tion, either the supervisor or the ana lyst assigned to analyze the sample must also have three years’ experience determining analytes at or below part per million levels, or equivalent quali fications, as determined by the Admin istrator. (2) Demonstrate an ability to achieve quality assurance levels that are with in acceptable limits for systemic lab oratory difference, variability, and in dividual large deviations, in the analyte category for which accredita tion is sought, using analytical proce dures designated by the FSIS ALP as being acceptable. An applying labora tory will successfully demonstrate these capabilities for: (i) Food chemistry if its results from a 36 check sample accreditation study each satisfy the criteria presented in paragraph (e) of this section. (ii) Chemical residues if its analyt ical results for each specific chemical residue provided in a check sample ac creditation study containing a min imum of 14 check samples satisfy the criteria presented in paragraph (e) of this section, including criteria for QA and QC recovery and for residue identi fication. In addition, if the laboratory is requesting accreditation for the analysis of chlorinated hydrocarbons, all analytical results for the residue class must collectively satisfy the cri teria. [Conformance to criteria in para graph (e) of this section will only be de termined when six or more analytical results with associated comparison means at or above the logarithm of the minimum proficiency level are avail able.] (3) Round all check sample statis tical computations to the nearest tenth, except where otherwise noted. (4) Complete a second set of the req uisite number of check samples if the results of the first set of check samples do not meet the criteria for obtaining accreditation. (i) The second set of check samples will be provided within 30 days fol lowing the date of receipt by FSIS of a request from the applying laboratory. The second set of food chemistry check samples will be analyzed for only the analyte(s) for which unacceptable ini tial results had been obtained by the laboratory. (ii) If the results of the second set of check samples do not meet the criteria for obtaining accreditation, the labora tory may reapply after a 60-day wait ing period, commencing from the date of refusal of accreditation by FSIS. At that time, a new application, all fees, and all documentation of corrective ac tion required for accreditation must be submitted. (5) Allow inspection of the laboratory by FSIS officials prior to the deter mination of granting accredited status. (6) Pay the accreditation fee by the date required. (e) Quality assurance levels—(1) Sys tematic laboratory difference: The abso lute value of the average standardized difference must not exceed the fol lowing: (i) For food chemistry, 0.73 minus the product of 0.17 and the standard devi ation of the standardized differences; and (ii) For chemical residues, 1.67 (2.00 if there are less than 12 analytical re sults) minus the product of 0.29 and the standard deviation of the standardized differences. (2) Variability: The estimated stand ard deviation of the standardized dif ference must not exceed the following: (i) For food chemistry, 1.15; and (ii) For chemical residues, a com puted limit that is a function of the number of analytical results used in the computation of the standard devi ation, and of the amount of variability. (3) Individual large deviations: One hundred times the average of the large deviation measures of the individual samples must be less than 5.0. A result VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00668 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 659 Food Safety and Inspection Service, USDA § 439.20 will have a large deviation measure equal to zero when the absolute value of the result’s standardized difference, (d), is less than 2.5 and otherwise a measure equal to 1–(2.5/d). (4) For residue analyses, the fol lowing additional quality assurance re quirements must be met. (i) QA recovery: The average of the QA recoveries of the individual check sample analytical results must lie within ranges established by FSIS. (ii) QC recovery: All QC recoveries must lie within ranges established by FSIS. Supporting documentation must be made available to FSIS upon re quest. (iii) Correct identification: There must be correct identification of all chem ical residues in all samples. § 439.20 Criteria for maintaining ac creditation. (a) To maintain accreditation, an an alytical laboratory must fulfill the re quirements of paragraphs (b) through (i) of this section. (b) Official samples. (1) An accredited laboratory must expeditiously report analytical results, in the analyte cat egory for which accreditation was granted, of official samples on des ignated forms to the Data Center Staff, USDA/FSIS Eastern Laboratory, Rus sell Research Center, P.O. Box 6085, Athens, GA 30604 (for U.S. Postal Serv ice delivery), or Data Center Staff, USDA/FSIS Eastern Laboratory, Rus sell Research Center, 950 College Sta tion Road, Athens, GA 30605 (for com mercial carrier delivery). When so pro vided for by FSIS, analytical results may be reported to the Data Center Staff by facsimile at (706) 546–3589, or electronically. The Federal inspector at any establishment may assign the analysis of official samples to an FSIS laboratory if, in the inspector’s judg ment, there are delays in receiving test results on official samples from an ac credited laboratory. (2) Every QC recovery associated with reporting of official samples must lie within ranges established by FSIS. Supporting documentation must be made available to FSIS upon request. (c) Records. An accredited laboratory must: (1) Maintain laboratory quality con trol records for the most recent three years that samples have been analyzed under this Program. (2) Maintain complete records of the receipt, analysis, and disposition of of ficial samples for the most recent three years that samples have been analyzed under this Program. (3) Maintain in a secure electronic format or in a standards book, which is preferably a permanently bound book with sequentially numbered pages, all records, readings, and calculations for standard solutions. All entries are to be dated and signed by the analyst im mediately upon completion of the entry, and by the supervisor, or in the absence of the supervisor by the super visor’s designee, before use of the standard solution but no later than within one week. The standards book is to be retained for three years after the last recorded entry. (4) Maintain records and supervisor approvals of recoveries, and of instru ment maintenance and calibration. The records are to be retained for three years after the last recorded entry. (5) As provided in paragraph (f) of this section, records should be avail able for review by any duly authorized representative of the Secretary of Agri culture, including ALP personnel or their designees. (d) Check samples. (1) An accredited laboratory must analyze interlabora tory accreditation maintenance check samples and return the results to FSIS within three weeks of sample receipt. This must be done whenever requested by FSIS and at no cost to FSIS. (2) Results must be those of the ac credited laboratory. Analyses of main tenance check samples shall not be contracted out by the accredited lab oratory. (3) As provided by the requirements in paragraph (h) of this section, a check sample report will be considered complete only if laboratories report all analytes present in the check sample for the analyte category in which ac creditation was granted. (e) Corporate changes. The ALP must be informed within 30 days of any change of address or in the laboratory’s VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00669 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 660 9 CFR Ch. III (1–1–18 Edition) § 439.20 ownership, officers, directors, super visory personnel, or other responsibly connected individual or entity. (f) On-site review. An accredited lab oratory must permit any duly author ized representative of the Secretary to perform both announced and unan nounced on-site laboratory reviews of facilities and records, both hard copy and electronic, during normal business hours, and to copy any records per taining to the laboratory’s participa tion in the ALP. (g) Analytical procedures. An accred ited laboratory must use analytical procedures designated by the FSIS ALP as being acceptable. (h) Quality assurance levels. (1) An ac credited laboratory must demonstrate an ability to maintain quality assur ance levels that are within acceptable limits for systematic laboratory dif ference, variability, and individual large deviations in the analysis of interlaboratory check samples for the analyte category for which accredita tion was granted. An accredited labora tory will successfully demonstrate the maintenance of these capabilities if its analytical results from interlaboratory accreditation maintenance check sam ples satisfy the criteria presented in this paragraph (h). All statistical com putations are to be rounded to the nearest tenth, except where otherwise noted. (2) In addition, a laboratory accred ited for a specific chemical residue or a chemical residue class: (i) Must satisfy criteria presented in this paragraph for chemical residue re coveries and proper identification; (ii) Must demonstrate the mainte nance of its capabilities by reporting its analytical results for each specific chemical residue found above the min imum proficiency level; and (iii) Must, if accredited for the anal ysis of chlorinated hydrocarbons, ob tain analytical results that collec tively satisfy the criteria. (3) Systematic laboratory difference: The standardized difference between the accredited laboratory’s result and the comparison mean for each interlab oratory accreditation maintenance check sample is used to determine two CUSUM values, designated as CUSUM– P and CUSUM–N. (i) When determining compliance with this criterion for all chlorinated hydrocarbon results in a sample collec tively, the following statistical proce dure must be followed to account for the correlation of analytical results within a sample: The average of the standardized differences of the analyt ical results within the sample, divided by a constant, is used in place of a sin gle standardized difference to deter mine the CUSUM–P (or CUSUM–N) value for the sample. The constant is a function of the number of analytical results used to compute the average standardized difference. (ii) Positive systematic laboratory difference: This value is computed and evaluated as follows: (A) Determine the CUSUM–P incre ment for the sample. (1) The CUSUM–P increment for food chemistry, as defined in § 439.1 of this part, is set equal to: 2.0, if the standardized difference is greater than 2.4, ¥2.0, if the standardized difference is less than ¥1.6, or the standardized difference minus 0.4, if the standardized difference lies be tween ¥1.6 and 2.4, inclusive. (2) The CUSUM–P increment for chemical residues is set equal to: 2.0, if the standardized difference is greater than 2.5, ¥2.0, if the standardized difference is less than ¥1.5, or the standardized difference minus 0.5, if the standardized difference lies be tween ¥1.5 and 2.5, inclusive. (B) Compute the new CUSUM–P value. The new CUSUM–P value is ob tained by adding, algebraically, the CUSUM–P increment to the last pre viously computed CUSUM–P value. If this computation yields a value small er than 0, the new CUSUM–P value is set equal to 0. (C) Evaluate the new CUSUM–P value. The new CUSUM–P value must not exceed: (1) 5.2 for food chemistry. (2) 4.8 for chemical residues. (iii) Negative systematic laboratory difference: This value is computed and evaluated as follows: (A) Determine the CUSUM–N incre ment for the sample. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00670 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 661 Food Safety and Inspection Service, USDA § 439.20 (1) The CUSUM–N increment for food chemistry is set equal to: 2.0, if the standardized difference is greater than 1.6, ¥2.0, if the standardized difference is less than ¥2.4, or the standardized difference plus 0.4, if the standardized difference lies be tween ¥2.4 and 1.6, inclusive. (2) The CUSUM–N increment for chemical residues is set equal to: 2.0, if the standardized difference is greater than 1.5, ¥2.0, if the standardized difference is less than ¥2.5, or the standardized difference plus 0.5, if the standardized difference lies be tween ¥2.5 and 1.5, inclusive. (B) Compute the new CUSUM–N value. The new CUSUM–N value is ob tained by subtracting, algebraically, the CUSUM–N increment from the last previously computed CUSUM–N value. If this computation yields a value smaller than 0, the new CUSUM–N value is set equal to 0. (C) Evaluate the new CUSUM–N value. The new CUSUM–N value must not exceed: (1) 5.2 for food chemistry. (2) 4.8 for chemical residues. (4) Variability: The absolute value of the standardized difference between the accredited laboratory’s result and the comparison mean for each interlab oratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM– V. (i) When determining compliance with this criterion for all chlorinated hydrocarbon results in a sample collec tively, the following statistical proce dure must be followed to account for the correlation of analytical results within a sample: The square root of the sum of the within sample variance and the average standardized difference of the sample, divided by a constant, is used in place of the absolute value of the standardized difference to deter mine the CUSUM–V value for the sam ple. The constant is a function of the number of analytical results used to compute the average standardized dif ference. (ii) The variability value is computed and designated as follows: (A) Determine the CUSUM–V incre ment for the sample. The CUSUM in crement is set equal to the larger of ¥0.4 or the absolute value of the stand ardized difference minus 0.9. If this computation yields a value larger than 1.6, the increment is set equal to 1.6. (B) Compute the new CUSUM–V value. The new CUSUM–V value is ob tained by adding, algebraically, the CUSUM–V increment to the last pre viously computed CUSUM–V value. If this computation yields a value less than 0, the new CUSUM–V value is set equal to 0. (C) Evaluate the new CUSUM–V value. The new CUSUM–V value must not exceed 4.3. (5) Large deviations: The large devi ation measure of the accredited labora tory’s result for each interlaboratory accreditation maintenance check sam ple is used to determine a CUSUM value, designated as CUSUM–D. (i) A result will have a large devi ation measure equal to zero when the absolute value of the result’s standard ized difference, (d), is less than 2.5, and otherwise a measure equal to 1¥(2.5/d). (ii) The large deviation value is com puted and evaluated as follows: (A) Determine the CUSUM–D incre ment for the sample. The CUSUM in crement is set equal to the value of the large deviation measure minus 0.025. (B) Compute the new CUSUM–D value. The new CUSUM–D value is ob tained by adding, algebraically, the CUSUM–D increment to the last pre viously computed CUSUM–D value. If this computation yields a value less than 0, the new CUSUM–D value is set equal to 0. (C) Evaluate the new CUSUM–D value. The new CUSUM–D value must not exceed 1.0. (6) For chemical residues: (i) Each QC recovery must lie within ranges established by FSIS. Supporting documentation must be made available to FSIS upon request. (ii) Not more than one residue misidentification may be made in any two consecutive check samples. (iii) Not more than two residue misidentifications may be made in any eight consecutive check samples. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00671 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 662 9 CFR Ch. III (1–1–18 Edition) § 439.50 (i) Fees. An accredited laboratory must pay the required accreditation fee when it is due. (j) Probation. An accredited labora tory must meet the following require ments if placed on probation pursuant to § 439.51 of this part: (1) Send all official samples that have not been analyzed as of the date of written notification of probation to a specified FSIS laboratory by certified mail or private carrier or, as an alter native and as directed by FSIS, to a laboratory accredited by FSIS for the designated analyte(s). Mailing expenses will be paid by FSIS. (2) Analyze a set of check samples similar to those used for initial accred itation, and submit the analytical re sults to FSIS within three weeks of re ceipt of the samples. (3) Satisfy criteria for accreditation check samples specified in § 439.10 of this part. § 439.50 Refusal of accreditation. Upon a determination by the Admin istrator, a laboratory will be refused accreditation for the following reasons: (a) A laboratory will be refused ac creditation for failure to meet the re quirements of § 439.5 or § 439.10 of this part. (b) A laboratory will be refused sub sequent accreditation for failure to re turn to an FSIS laboratory, by cer tified mail or private carrier, or, as an alternative and as directed by FSIS, to a laboratory accredited by FSIS for the designated analytes, all official sam ples that have not been analyzed as of the notification of a loss of accredita tion. (c) A laboratory will be refused ac creditation if the laboratory or any in dividual or entity responsibly con nected with the laboratory has been convicted of, or is under indictment for, or has charges on an information brought against them in a Federal or State court concerning any of the fol lowing violations of law: (1) Any felony. (2) Any misdemeanor based upon ac quiring, handling, or distributing of unwholesome, misbranded, or decep tively packaged food or upon fraud in connection with transactions in food. (3) Any misdemeanor based upon a false statement to any governmental agency. (4) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity. § 439.51 Probation of accreditation. Upon a determination by the Admin istrator, a laboratory will be placed on probation for the following reasons: (a) If the laboratory fails to complete more than one interlaboratory accredi tation maintenance check sample anal ysis as required by § 439.20(d) of this part within 12 consecutive months, un less written permission is granted by the Administrator. (b) If the laboratory fails to meet any of the criteria set forth in §§ 439.20(d) and 439.20(h) of this part. § 439.52 Suspension of accreditation. The accreditation of a laboratory will be suspended if the laboratory or any individual or entity responsibly connected with the laboratory is in dicted or has charges on information brought against them in a Federal or State court for any of the following violations of law: (a) Any felony. (b) Any misdemeanor based upon ac quiring, handling, or distributing of unwholesome, misbranded, or decep tively packaged food or upon fraud in connection with transactions in food. (c) Any misdemeanor based upon a false statement to any governmental agency. (d) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity. § 439.53 Revocation of accreditation. The accreditation of a laboratory will be revoked for the following rea sons: (a) An accredited laboratory that is accredited to perform analysis under §§ 439.5, 439.10 and 439.20 of this part will have its accreditation revoked for fail ure to meet any of the requirements of § 439.20 of this part, except for the fol lowing circumstances. If the accredited laboratory fails to meet any of the cri teria set forth in §§ 439.20(d) and 439.20(h) of this part and it has not failed during the 12 months preceding VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00672 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 663 Food Safety and Inspection Service, USDA § 441.10 its failure to meet the criteria, it shall be placed on probation, but if it has failed at any time during those 12 months, its accreditation will be re voked. (b) An accredited laboratory will have its accreditation revoked if the Administrator determines that the lab oratory or any responsibly connected individual or any agent or employee has: (1) Altered any official sample or an alytical finding; or (2) Substituted any analytical result from any other laboratory and rep resented the result as its own. (c) An accredited laboratory will have its accreditation revoked if the laboratory or any individual or entity responsibly connected with the labora tory is convicted in a Federal or State court of any of the following violations of law: (a) Any felony. (b) Any misdemeanor based upon ac quiring, handling, or distributing of unwholesome, misbranded, or decep tively packaged food or upon fraud in connection with transactions in food. (c) Any misdemeanor based upon a false statement to any governmental agency. (d) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity. § 439.60 Notification and hearings. Accreditation of any laboratory will be refused, suspended, or revoked under the conditions previously described in this Part 439. The owner or operator of the laboratory will be sent written no tice of the refusal, suspension, or rev ocation of accreditation by the Admin istrator. In such cases, the laboratory owner or operator will be provided an opportunity to present, within 30 days of the date of the notification, a state ment challenging the merits or valid ity of such action and to request an oral hearing with respect to the denial, suspension, or revocation decision. An oral hearing will be granted if there is any dispute of material fact joined in such responsive statement. The pro ceeding will be conducted thereafter in accordance with the applicable rules of practice, which will be adopted for the proceeding. Any such refusal, suspen sion, or revocation will be effective upon the receipt by the laboratory of the notification and will continue in effect until final determination of the matter by the Administrator. PART 441—CONSUMER PROTEC TION STANDARDS: RAW PROD UCTS AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53. SOURCE: 66 FR 1771, Jan. 9, 2001, unless oth erwise noted. § 441.10 Retained water. (a) Raw livestock, poultry, and fish carcasses and parts will not be per mitted to retain water resulting from post-evisceration processing unless the establishment preparing those car casses and parts demonstrates to FSIS, with data collected in accordance with a written protocol, that any water re tained in the carcasses or parts is an unavoidable consequence of the process used to meet applicable food safety re quirements. (b) Raw livestock, poultry, and fish carcasses and parts that retain water from post-evisceration processing and that are sold, transported, offered for sale or transportation, or received for transportation, in commerce, must bear a statement on the label in promi nent letters and contiguous to the product name or elsewhere on the prin cipal display panel of the label stating the maximum percentage of water that may be retained (e.g., ‘‘up to X% re tained water,’’ ‘‘less than X% retained water,’’ ‘‘up to X% water added from processing’’). The percent water state ment need not accompany the product name on other parts of the label. Raw livestock and poultry carcasses and parts that retain no water may bear a statement that no water is retained. (c)(1) An establishment subject to paragraph (a) of this section must maintain on file and available to FSIS its written data-collection protocol. The protocol must explain how data will be collected and used to dem onstrate the amount of retained water in the product covered by the protocol that is an unavoidable consequence of VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00673 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 664 9 CFR Ch. III (1–1–18 Edition) § 441.10 the process used to meet specified food safety requirements. (2) The establishment must notify FSIS as soon as it has a new or revised protocol available for review by the Agency. Within 30 days after receipt of this notification, FSIS may object to or require the establishment to make changes in the protocol. (d) Expected elements of a protocol for gathering water retention data: (1) Purpose statement. The primary purpose of the protocol should be to de termine the amount or percentage of water absorption and retention that is unavoidable using a particular chilling system while achieving the regulatory pathogen reduction performance stand ard for Salmonella as set forth in the PR/HACCP regulations (9 CFR 310.25(b), 381.94(b)) and the time/temperature re quirements set forth in 9 CFR 381.66. Additional purposes that could be in cluded are determining chilling system efficiency and evaluating product qual ity. (2) Type of washing and chilling system used by the establishment. Any post-evis ceration washing or chilling processes that affect water retention levels in and microbial loads on raw products should be described. For poultry estab lishments, the main chiller types, iden tified by the mechanism used to trans port the birds through the chiller or to agitate the water in the chiller, are the drag-through, the screw type, and the rocker-arm type. (3) Configuration and any modifications of the chiller system components. A de scription of chiller-system configura tions and modifications should be pro vided. The description should include the number and type of chillers in a se ries and arrangements of chilling sys tem components, and the number of evisceration lines feeding into a chiller system. If there is a pre-chilling step in the process, its purpose and the type of equipment used should be accurately described. Any mechanical or design changes made to the chilling equip ment should be described. (4) Special features in the chilling proc ess. Any special features in the chilling process, such as antimicrobial treat ments, should be described. Also, the length and velocity of the dripping line should be described, as well as the total time allowed for dripping. Any special apparatus, such as a mechanism for squeezing excessive water from chilled birds, should be explained. (5) Description of variable factors in the chilling system. The protocol should de scribe variable factors that affect water absorption and retention. In poultry processing, such factors are typically considered to be the time in chiller water, the water temperature, and agitation. The protocol should con sider air agitation, where applicable. Additional factors that may affect water absorption and retention are scalding temperature and the pressure or amount of buffeting applied to birds by feather removal machinery, and the resultant loosening of the skin. An other factor that should be considered is the method used to open the bird for evisceration. (6) Standards to be met by the chilling system. For example, the chilling sys tem may be designed simply to achieve a reduction in temperature of ready-to cook poultry to less than 40 °F within the time limit specified by the regula tions, or in less time. As to the stand ard for pathogen minimization, the Sal monella pathogen reduction standards, as set forth in the PR/HACCP final rule, have been suggested. Although there is not yet an applicable Sal monella standard for turkeys, establish ments are free to adopt practicable cri teria for use in gathering data on tur keys under the protocols here sug gested. Additional microbiological tar gets, such as E. coli or Campylobacter levels, or reductions in numbers of other microorganisms, may also be used. (7) Testing methods to be employed. The protocol should detail the testing methods to be used both for measuring water absorption and retention and for sampling and testing product for pathogen reductions. The protocol should call for water retention and pathogen reduction tests at various chilling equipment settings and chilling time-and-temperature com binations. The method to be used in calculating water absorption and re tention should be reproducible and sta tistically verifiable. With respect to the pathogen-reduction aspect of the testing, FSIS recommends the methods VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00674 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 665 Food Safety and Inspection Service, USDA § 442.2 used for E. coli and Salmonella testing under the PR/HACCP regulations. The number of samples, the type of sam ples, the sampling time period, and the type of testing or measurement should be included in the protocol. (8) Reporting of data and evaluation of results. The protocol should explain how data obtained are to be reported and summarized. The criteria for eval uating the results and the basis for conclusions to be drawn should be ex plained. (9) Conclusions. The protocol should provide for a statement of what the data obtained demonstrate and what conclusions were reached. [66 FR 1771, Jan. 9, 2001, as amended at 80 FR 75616, Dec. 2, 2015] PART 442—QUANTITY OF CON TENTS LABELING AND PROCE DURES AND REQUIREMENTS FOR ACCURATE WEIGHTS Sec. 442.1 Quantity of contents labeling 442.2 Definitions and procedures for deter mining net weight compliance 442.3 Scale requirements for accurate weights, repairs, adjustments, and re placement after inspection 442.4 Testing of scales 442.5 Handling of failed product AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. SOURCE: 73 FR 52192, Sept. 9, 2008, unless otherwise noted. § 442.1 Quantity of contents labeling. This part prescribes the procedures to be followed for determining net weight compliance and prescribes the reasonable variations allowed from the declared net weight on the labels of im mediate containers of products in ac cordance with 9 CFR 317.2(c)(4), 317.2(h), and 381.121. § 442.2 Definitions and procedures for determining net weight compliance. (a) For the purpose of § 442.1 of this part, the reasonable variations al lowed, and the definitions and the pro cedures to be used, in determining net weight and net weight compliance are presented in the National Institute of Standards and Technology (NIST) Handbook 133, ‘‘Checking the Net Con tents of Packaged Goods,’’ Fourth Edi tion, January 2005, which is incor porated by reference. The Director of the Federal Register approves this in corporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of NIST Handbook 133 may be purchased from the Superintendent of Documents, U.S. Government Printing Office, 732 N. Capitol Street, NW., Washington, DC, 20401. You may con tact the Government Printing Office Toll-Free at 1–866–512–1800 or go to: http://bookstore.gpo.gov. You may in spect a copy of NIST Handbook 133 at the FSIS Docket Room, U.S. Depart ment of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue, SW., Room 2534, Washington, DC 20250. You can contact the FSIS Docket room by calling 202–720–0344 or 202–720–3813. The NIST Handbook 133 is also available for inspection at the Na tional Archives and Records Adminis tration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (b) The following NIST Handbook 133 requirements are not incorporated by reference. CHAPTER 2—BASIC TEST PROCEDURE— GRAVIMETRIC TESTING 2.3 Basic Test Procedure—Tare Proce dures—Wet Tare 2.3 Basic Test Procedure—Moisture Al lowances—What moisture allowance is used with wet tare when testing packages bearing a USDA seal of inspection? 2.4 Borax CHAPTER 3—TEST PROCEDURES—FOR PACKAGES LABELED BY VOLUME 3.5 Mayonnaise and Salad Dressing 3.7 Pressed and Blown Glass Tumblers and Stemware 3.8 Volumetric Test Procedures for Paint, Varnish, and Lacquers—Non Aerosol 3.9 Testing Viscous Materials—Such as Caulking Compounds and Pasters 3.10 Peat Moss 3.11 Mulch and Soils Labeled by Volume 3.12 Ice Cream Novelties 3.13 Fresh Oysters Labeled by Volume 3.14 Determining the Net Contents of Compressed Gas Cylinders 3.15 Volumetric Test Procedures for Pack aged Firewood with a Labeled Volume of 133 L (4 Cu Ft) or Less VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00675 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 666 9 CFR Ch. III (1–1–18 Edition) § 442.3 3.16 Boxed Firewood 3.17 Crosshatched Firewood 3.18 Bundles and Bags of Firewood CHAPTER 4—TEST PROCEDURES—PACKAGES LABELED BY COUNT, LINEAR MEASURE, AREA, THICKNESS, AND COMBINATIONS OF QUANTITIES 4.5 Paper Plates and Sanitary Paper Prod ucts 4.6 Special Test Requirements for Pack ages Labeled by Linear or Square Measure (Area) 4.7 Polyethylene sheeting 4.8 Packages Labeled by Linear or Square (Area) Measure 4.9 Bailer Twine—Test Procedure for Length 4.10 Procedure for Checking the Area Measurement of Chamois Appendix C Glos sary—wet tare § 442.3 Scale requirements for accu rate weights, repairs, adjustments, and replacements after inspection. (a) All scales used to determine the net weight of meat and poultry prod ucts sold or otherwise distributed in commerce in federally inspected meat and poultry establishments will be in stalled, maintained, and operated in a manner that ensures accurate weights. Such scales shall meet the applicable requirements contained in National In stitute of Standards and Technology (NIST) Handbook 44, ’’Specifications, Tolerances, and Other Technical Re quirements for Weighing and Meas uring Devices,’’ 1999 Edition, November 1988, which is incorporated by ref erence. This incorporation was ap proved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (These mate rials are incorporated as they exist on the date of approval.) A notice of any change in the Handbook cited here will be published in the FEDERAL REGISTER. Copies may be purchased from the Su perintendent of Documents, Govern ment Printing Office, Washington, DC 20402. The incorporation information also is available for inspection at the Office of the Federal Register Informa tion Center, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (b) All scales used to determine the net weight of meat or poultry products sold or otherwise distributed in com merce or in States designated under section 301(c) of the Federal Meat In spection Act and section 5(c) of the Poultry Products Inspection Act shall be of sufficient capacity to weigh the entire unit or package. (c) No scale will be used at a feder ally inspected establishment to deter mine the net weight of meat or poultry products unless it has been found upon test and inspection, as specified in NIST Handbook 44 to provide accurate weight. If a scale is inspected or tested and found to be inaccurate, or if any repairs, adjustments, or replacements are made to a scale, it shall not be used until it has been reinspected and re tested by a USDA official, or a State or local government weights and meas ures official, or a State registered or li censed scale repair firm or person, and it must meet all accuracy require ments as specified in NIST Handbook 44. If a USDA inspector has put a ’’Re tain’’ tag on a scale, the tag can only be removed by a USDA inspector. As long as the tag is on the scale, it shall not be used. § 442.4 Testing of scales. (a) The operator of each official es tablishment that weighs meat or poul try food products will cause such scales to be tested for accuracy in accordance with the technical requirements of NIST Handbook 44, at least once during the calendar year. In cases where the scales are found not to maintain accu racy between tests, more frequent tests may be required and verified by an au thorized USDA program official. (b) The operator of each official es tablishment shall display on or near each scale a valid certification of the scale’s accuracy from a State or local government’s weights and measures authority or from a State registered or licensed scale repair firm or person, or shall have alternative documented pro cedures showing that the scale has been tested for accuracy in accordance with the requirements of NIST Hand book 44. § 442.5 Handling of failed product. Any lot of product that is found to be out of compliance with net weight re quirements upon testing in accordance with the methods prescribed in § 442.2 of this subchapter shall be handled as follows: VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00676 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 667 Food Safety and Inspection Service, USDA § 500.3 (a) A lot tested in an official estab lishment and found not to comply with net weight requirements may be re processed and must be reweighed and remarked to satisfy the net weight re quirements of this section in accord ance with the requirements of this part. (b) A lot tested outside an official es tablishment and found not to comply with net weight requirements must be reweighed and remarked with a proper net weight statement, provided that such reweighing and remarking will not deface, cover, or destroy any other marking or labeling required under this subchapter, and the net quantity of contents is shown with the same prominence as the most conspicuous feature of a label. PART 500—RULES OF PRACTICE Sec. 500.1 Definitions. 500.2 Regulatory control action. 500.3 Withholding or suspension of inspec tion without prior notification. 500.4 Withholding action or suspension of inspection with prior notification. 500.5 Notification, appeals, and actions held in abeyance. 500.6 Withdrawal of inspection. 500.7 Refusal to grant inspection. 500.8 Procedures for rescinding or refusing approval of marks, labels, sizes, and con tainers. AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53. SOURCE: 64 FR 66546, Nov. 29, 1999, unless otherwise noted. § 500.1 Definitions. (a) A ‘‘regulatory control action’’ is the retention of product, rejection of equipment or facilities, slowing or stopping of lines, or refusal to allow the processing of specifically identified product. (b) A ‘‘withholding action’’ is the re fusal to allow the marks of inspection to be applied to products. A with holding action may affect all product in the establishment or product pro duced by a particular process. (c) A ‘‘suspension’’ is an interruption in the assignment of program employ ees to all or part of an establishment. § 500.2 Regulatory control action. (a) FSIS may take a regulatory con trol action because of: (1) Insanitary conditions or practices; (2) Product adulteration or mis branding; (3) Conditions that preclude FSIS from determining that product is not adulterated or misbranded; or (4) Inhumane handling or slaugh tering of livestock. (b) If a regulatory control action is taken, the program employee will im mediately notify the establishment orally or in writing of the action and the basis for the action. (c) An establishment may appeal a regulatory control action, as provided in §§ 306.5 and 381.35 of this chapter. § 500.3 Withholding action or suspen sion without prior notification. (a) FSIS may take a withholding ac tion or impose a suspension without providing the establishment prior noti fication because: (1) The establishment produced and shipped adulterated or misbranded product as defined in 21 U.S.C. 453 or 21 U.S.C. 602; (2) The establishment does not have a HACCP plan as specified in § 417.2 of this chapter; (3) The establishment does not have Sanitation Standard Operating Proce dures as specified in §§ 416.11–416.12 of this chapter; (4) Sanitary conditions are such that products in the establishment are or would be rendered adulterated; (5) The establishment violated the terms of a regulatory control action; (6) An establishment operator, offi cer, employee, or agent assaulted, threatened to assault, intimidated, or interfered with an FSIS employee; or (7) The establishment did not destroy a condemned meat or poultry carcass, or part or product thereof, in accord ance with part 314 or part 381, subpart L, of this chapter within three days of notification. (b) FSIS also may impose a suspen sion without providing the establish ment prior notification because the es tablishment is handling or slaugh tering animals inhumanely. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00677 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 668 9 CFR Ch. III (1–1–18 Edition) § 500.4 § 500.4 Withholding action or suspen sion with prior notification. FSIS may take a withholding action or impose a suspension after an estab lishment is provided prior notification and the opportunity to demonstrate or achieve compliance because: (a) The HACCP system is inadequate, as specified in § 417.6 of this chapter, due to multiple or recurring non compliances; (b) The Sanitation Standard Oper ating Procedures have not been prop erly implemented or maintained as specified in §§ 416.13 through 416.16 of this chapter; (c) The establishment has not main tained sanitary conditions as pre scribed in §§ 416.2–416.8 of this chapter due to multiple or recurring non compliances; (d) The establishment did not collect and analyze samples for Escherichia coli Biotype I and record results in accord ance with § 310.25(a) or § 381.94(a) of this chapter; (e) The establishment did not meet the Salmonella performance standard requirements prescribed in § 310.25(b) or § 381.94(b) of this chapter. § 500.5 Notification, appeals, and ac tions held in abeyance. (a) If FSIS takes a withholding ac tion or imposes a suspension, the es tablishment will be notified orally and, as promptly as circumstances permit, in writing. The written notification will: (1) State the effective date of the ac tion(s), (2) Describe the reasons for the ac tion(s), (3) Identify the products or processes affected by the action(s), (4) Provide the establishment an op portunity to present immediate and corrective action and further planned preventive action; and (5) Advise the establishment that it may appeal the action as provided in §§ 306.5 and 381.35 of this chapter. (b) The prior notification provided for in § 500.4 of this part will: (1) State the type of action that FSIS may take; (2) Describe the reason for the pro posed action; (3) Identify the products or processes affected by the proposed action; (4) Advise the establishment of its right to contact FSIS to contest the basis for the proposed action or to ex plain how compliance has been or will be achieved; and (5) Advise the establishment that it will have three business days from re ceipt of the written notification to re spond to FSIS unless the time period is extended by FSIS. (c) An establishment may appeal the withholding action or suspension, as provided in §§ 306.5 and 381.35 of this chapter. (d) If FSIS suspends inspection and does not hold the suspension action in abeyance as provided in paragraph (e) of this section, the establishment may request a hearing pursuant to the Uni form Rules of Practice, 7 CFR Subtitle A, part 1, subpart H. Upon such re quest, the Administrator will file a complaint that will include a request for an expedited hearing. (e) FSIS may hold a suspension in abeyance and allow the establishment to operate under the conditions agreed to by FSIS and the establishment. § 500.6 Withdrawal of inspection. The FSIS Administrator may file a complaint to withdraw a grant of Fed eral inspection in accordance with the Uniform Rules of Practice, 7 CFR sub title A, part 1, subpart H because: (a) An establishment produced and shipped adulterated product; (b) An establishment did not have or maintain a HACCP plan in accordance with part 417 of this chapter; (c) An establishment did not have or maintain Sanitation Standard Oper ating Procedures in accordance with part 416 of this chapter; (d) An establishment did not main tain sanitary conditions; (e) An establishment did not collect and analyze samples for Escherichia coli Biotype I and record results as pre scribed in § 310.25(a) or § 381.94(a) of this chapter; (f) [Reserved] (g) An establishment did not slaugh ter or handle livestock humanely; (h) An establishment operator, offi cer, employee, or agent assaulted, threatened to assault, intimidated, or VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00678 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 669 Food Safety and Inspection Service, USDA § 500.8 interfered with an FSIS program em ployee; or (i) A recipient of inspection or any one responsibly connected to the re cipient is unfit to engage in any busi ness requiring inspection as specified in section 401 of the FMIA or section 18(a) of the PPIA. [64 FR 66546, Nov. 29, 1999, as amended at 79 FR 49637, Aug. 21, 2014] § 500.7 Refusal to grant inspection. (a) The FSIS Administrator may refuse to grant Federal inspection be cause an applicant: (1) Does not have a HACCP plan as required by part 417 of this chapter; (2) Does not have Sanitation Stand ard Operating Procedures as required by part 416 of this chapter; (3) Has not demonstrated that ade quate sanitary conditions exist in the establishment as required by part 308 or part 381, subpart H, and part 416 of this chapter; (4) Has not demonstrated that live stock will be handled and slaughtered humanely; or (5) Is unfit to engage in any business requiring inspection as specified in sec tion 401 of the FMIA or section 18(a) of the PPIA. (b) If the Administrator refuses to grant inspection, the applicant will be provided the opportunity for a hearing in accordance with the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H. § 500.8 Procedures for rescinding or refusing approval of marks, labels, and containers. (a) FSIS may rescind or refuse ap proval of false or misleading marks, la bels, or sizes or forms of any container for use with any meat or poultry prod uct under section 7 of the FMIA or under section 8 of the PPIA. (b) FSIS will provide written notifi cation that: (1) Explains the reason for rescinding or refusing the approval; (2) Provides an opportunity for the establishment to modify the marking, labeling, or container so that it will no longer be false or misleading; and (3) Advises the establishment of its opportunity to submit a written state ment to respond to the notification and to request a hearing. (c) If FSIS rescinds or refuses ap proval of false or misleading marks, la bels, or sizes or forms of any container for use with any meat or poultry prod uct, an opportunity for a hearing will be provided in accordance with the Uniform Rules of Practice, 7 CFR sub title A, part 1, subpart H. VerDate Sep<11>2014 16:50 Jan 24, 2018 Jkt 244029 PO 00000 Frm 00679 Fmt 8010 Sfmt 8010 Q:\09\9V2.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B