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method entitled ‘‘Analysis for Esch- ess or its delivery is identified), the erichia coli in Citrus Juices—Modifica- processor shall take corrective action tion of AOAC Official Method 992.30’’ or as set forth in § 120.10. another method that is at least equiva- (e) If two samples in a series of seven lent to this method in terms of accu- tests are positive for E. coli, the control racy, precision, and sensitivity in de- measures to attain the 5-log reduction tecting E. coli. This method is designed standard shall be deemed to be inad- to detect the presence or absence of E. equate and the processor shall imme- coli in a 20 mL sample of juice (con- diately: sisting of two 10 mL subsamples). The (1) Until corrective actions are com- method is as follows: pleted, use an alternative process or (1) Sample size. Total-20 mL of juice; processes that achieve the 5-log reduc- perform analysis using two 10 mL tion after the juice has been expressed; aliquots. (2) Perform a review of the moni- (2) Media. Universal Preenrichment toring records for control measures to Broth (Difco, Detroit, MI), EC Broth attain the 5-log reduction standard. (various manufacturers). The review shall be sufficiently exten- (3) Method. ColiComplete (AOAC Offi- sive to determine that there are no cial Method 992.30—modified). trends towards loss of control; (4) Procedure. Perform the following (i) If the conditions and practices are procedure two times: not being met, correct those that do (i) Aseptically inoculate 10 mL of not conform to the HACCP plan; or juice into 90 mL of Universal (ii) If the conditions and practices Preenrichment Broth (Difco) and incu- are being met, the processor shall vali- bate at 35 °C for 18 to 24 hours. date the HACCP plan in relation to the (ii) Next day, transfer 1 mL of 5-log reduction standard; and preenriched sample into 10 mL of EC (3) Take corrective action as set Broth, without durham gas vials. After forth in § 120.10. Corrective actions inoculation, aseptically add a shall include ensuring no product en- ColiComplete SSD disc into each tube. ters commerce that is injurious to (iii) Incubate at 44.5 °C for 18 to 24 health as set forth in § 120.10(a)(1). hours. (iv) Examine the tubes under PART 121—MITIGATION STRATEGIES longwave ultra violet light (366 nm). Fluorescent tubes indicate presence of TO PROTECT FOOD AGAINST IN- E. coli. TENTIONAL ADULTERATION (v) MUG positive and negative con- trols should be used as reference in in- Subpart A—General Provisions terpreting fluorescence reactions. Use Sec. an E. coli for positive control and 2 neg- 121.1 Applicability. ative controls—a MUG negative strain 121.3 Definitions. and an uninoculated tube media. 121.4 Qualifications of individuals who per- (d) If either 10 mL subsample is posi- form activities under subpart C of this tive for E. coli, the 20 mL sample is re- part. corded as positive and the processor 121.5 Exemptions. shall: (1) Review monitoring records for the Subpart B [Reserved] control measures to attain the 5-log re- Subpart C—Food Defense Measures duction standard and correct those conditions and practices that are not 121.126 Food defense plan. met. In addition, the processor may 121.130 Vulnerability assessment to identify choose to test the sample for the pres- significant vulnerabilities and actionable ence of pathogens of concern. process steps. (2) If the review of monitoring 121.135 Mitigation strategies for actionable process steps. records or the additional testing indi- 121.138 Mitigation strategies management cates that the 5-log reduction standard components. was not achieved (e.g., a sample is 121.140 Food defense monitoring. found to be positive for the presence of 121.145 Food defense corrective actions. a pathogen or a deviation in the proc- 121.150 Food defense verification.

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121.157 Reanalysis. Contaminant means, for purposes of this part, any biological, chemical, Subpart D—Requirements Applying to physical, or radiological agent that Records That Must Be Established and may be added to food to intentionally Maintained cause illness, injury, or death. 121.301 Records subject to the requirements Facility means a domestic facility or of this subpart. a foreign facility that is required to 121.305 General requirements applying to register under section 415 of the Fed- records. 121.310 Additional requirements applying to eral Food, Drug, and Cosmetic Act, in the food defense plan. accordance with the requirements of 121.315 Requirements for record retention. part 1, subpart H of this chapter. 121.320 Requirements for official review. Farm means farm as defined in § 1.227 121.325 Public disclosure. of this chapter. 121.330 Use of existing records. FDA means the Food and Drug Ad- Subpart E—Compliance ministration. Food means food as defined in section 121.401 Compliance. 201(f) of the Federal Food, Drug, and AUTHORITY: 21 U.S.C. 331, 342, 350g, 350(i), Cosmetic Act and includes raw mate- 371, 374. rials and ingredients. SOURCE: 81 FR 34219, May 27, 2016, unless Food defense means, for purposes of otherwise noted. this part, the effort to protect food from intentional acts of adulteration Subpart A—General Provisions where there is an intent to cause wide scale public health harm. § 121.1 Applicability. Food defense monitoring means to con- This part applies to the owner, oper- duct a planned sequence of observa- ator or agent in charge of a domestic tions or measurements to assess or foreign food facility that manufac- whether mitigation strategies are oper- tures/processes, packs, or holds food for ating as intended. consumption in the United States and is required to register under section 415 Food defense verification means the of the Federal Food, Drug, and Cos- application of methods, procedures, metic Act, unless one of the exemp- and other evaluations, in addition to tions in § 121.5 applies. food defense monitoring, to determine whether a mitigation strategy or com- § 121.3 Definitions. bination of mitigation strategies is or The definitions and interpretations has been operating as intended accord- of terms in section 201 of the Federal ing to the food defense plan. Food, Drug, and Cosmetic Act are ap- Full-time equivalent employee is a term plicable to such terms when used in used to represent the number of em- this part. The following definitions ployees of a business entity for the pur- also apply: pose of determining whether the busi- Actionable process step means a point, ness qualifies as a small business. The step, or procedure in a food process number of full-time equivalent employ- where a significant vulnerability exists ees is determined by dividing the total and at which mitigation strategies can number of hours of salary or wages be applied and are essential to signifi- paid directly to employees of the busi- cantly minimize or prevent the signifi- ness entity and of all of its affiliates cant vulnerability. and subsidiaries by the number of Adequate means that which is needed hours of work in 1 year, 2,080 hours to accomplish the intended purpose in (i.e., 40 hours × 52 weeks). If the result keeping with good public health prac- is not a whole number, round down to tices. Affiliate means any facility that con- the next lowest whole number. trols, is controlled by, or is under com- Holding means storage of food and mon control with another facility. also includes activities performed inci- Calendar day means every day as dental to storage of food (e.g., activi- shown on the calendar. ties performed for the safe or effective

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storage of that food, such as fumigat- registered. An example of such a facil- ing food during storage, and drying/de- ity is a ‘‘farm mixed-type facility,’’ hydrating raw agricultural commod- which is an establishment that is a ities when the drying/dehydrating does farm, but also conducts activities out- not create a distinct commodity (such side the farm definition that require as drying/dehydrating hay or alfalfa)). the establishment to be registered. Holding also includes activities per- Packing means placing food into a formed as a practical necessity for the container other than packaging the distribution of that food (such as food and also includes re-packing and blending of the same raw agricultural activities performed incidental to commodity and breaking down pallets), packing or re-packing a food (e.g., ac- but does not include activities that tivities performed for the safe or effec- transform a raw agricultural com- tive packing or re-packing of that food modity into a processed food as defined (such as sorting, culling, grading, and in section 201(gg) of the Federal Food, weighing or conveying incidental to Drug, and Cosmetic Act. Holding facili- packing or re-packing)), but does not ties could include warehouses, cold include activities that transform a raw storage facilities, storage silos, grain agricultural commodity into a proc- elevators, and liquid storage tanks. essed food as defined in section 201(gg) Manufacturing/processing means mak- of the Federal Food, Drug, and Cos- ing food from one or more ingredients, metic Act. or synthesizing, preparing, treating, Qualified individual means a person modifying or manipulating food, in- who has the education, training, or ex- cluding food crops or ingredients. Ex- perience (or a combination thereof) amples of manufacturing/processing ac- necessary to perform an activity re- tivities include: Baking, boiling, bot- quired under subpart C of this part, as tling, canning, cooking, cooling, cut- appropriate to the individual’s assigned ting, distilling, drying/dehydrating raw duties. A qualified individual may be, agricultural commodities to create a but is not required to be, an employee distinct commodity (such as drying/de- of the establishment. hydrating grapes to produce raisins), evaporating, eviscerating, extracting Significant vulnerability means a vul- juice, formulating, freezing, grinding, nerability that, if exploited, could rea- homogenizing, irradiating, labeling, sonably be expected to cause wide scale milling, mixing, packaging (including public health harm. A significant vul- modified atmosphere packaging), pas- nerability is identified by a vulner- teurizing, peeling, rendering, treating ability assessment conducted by a to manipulate ripening, trimming, qualified individual, that includes con- washing, or waxing. For farms and sideration of the following: (1) Poten- farm mixed-type facilities, manufac- tial public health impact (e.g., severity turing/processing does not include ac- and scale) if a contaminant were added, tivities that are part of harvesting, (2) degree of physical access to the packing, or holding. product, and (3) ability of an attacker Mitigation strategies mean those risk- to successfully contaminate the prod- based, reasonably appropriate meas- uct. The assessment must consider the ures that a person knowledgeable possibility of an inside attacker. about food defense would employ to Significantly minimize means to reduce significantly minimize or prevent sig- to an acceptable level, including to nificant vulnerabilities identified at eliminate. actionable process steps, and that are Small business means, for purposes of consistent with the current scientific this part, a business (including any understanding of food defense at the subsidiaries and affiliates) employing time of the analysis. fewer than 500 full-time equivalent em- Mixed-type facility means an estab- ployees. lishment that engages in both activi- Subsidiary means any company which ties that are exempt from registration is owned or controlled directly or indi- under section 415 of the Federal Food, rectly by another company. Drug, and Cosmetic Act and activities Very small business means, for pur- that require the establishment to be poses of this part, a business (including

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any subsidiaries and affiliates) aver- these functions if such experience has aging less than $10,000,000, adjusted for provided an individual with knowledge inflation, per year, during the 3-year at least equivalent to that provided period preceding the applicable cal- through the standardized curriculum. endar year in sales of human food plus This individual may be, but is not re- the market value of human food manu- quired to be, an employee of the facil- factured, processed, packed, or held ity. without sale (e.g., held for a fee). (3) One or more qualified individuals Vulnerability means the susceptibility must do or oversee: of a point, step, or procedure in a fa- (i) The preparation of the food de- cility’s food process to intentional fense plan as required in § 121.126; adulteration. (ii) The conduct of a vulnerability as- You means, for purposes of this part, sessment as required in § 121.130; the owner, operator, or agent in charge (iii) The identification and expla- of a facility. nation of the mitigation strategies as required in § 121.135; and § 121.4 Qualifications of individuals (iv) Reanalysis as required in who perform activities under sub- § 121.157. part C of this part. (d) Additional qualifications of super- (a) Applicability. You must ensure visory personnel. Responsibility for en- that each individual who performs ac- suring compliance by individuals with tivities required under subpart C of the requirements of this part must be this part is a qualified individual as clearly assigned to supervisory per- that term is defined in § 121.3. sonnel with a combination of edu- (b) Qualifications of individuals as- cation, training, and experience nec- signed to an actionable process step. Each essary to supervise the activities under individual assigned to an actionable this subpart. process step (including temporary and (e) Records. Training required by seasonal personnel) or in the super- paragraphs (b)(2) and (c)(2) of this sec- vision thereof must: tion must be documented in records, (1) Be a qualified individual as that and must: term is defined in § 121.3—i.e., have the (1) Include the date of training, the appropriate education, training, or ex- type of training, and the persons perience (or a combination thereof) trained; and necessary to properly implement the (2) Be established and maintained in mitigation strategy or combination of accordance with the requirements of mitigation strategies at the actionable subpart D of this part. process step; and (2) Receive training in food defense § 121.5 Exemptions. awareness. (a) This part does not apply to a very (c) Qualifications of individuals for cer- small business, except that a very tain activities described in paragraph small business must, upon request, pro- (c)(3) of this section. Each individual as- vide for official review documentation signed to certain activities described in sufficient to show that the facility paragraph (c)(3) of this section must: meets this exemption. Such docu- (1) Be a qualified individual as that mentation must be retained for 2 years. term is defined in § 121.3—i.e., have the (b) This part does not apply to the appropriate education, training, or ex- holding of food, except the holding of perience (or a combination thereof) food in liquid storage tanks. necessary to properly perform the ac- (c) This part does not apply to the tivities; and packing, re-packing, labeling, or re-la- (2) Have successfully completed beling of food where the container that training for the specific function at directly contacts the food remains in- least equivalent to that received under tact. a standardized curriculum recognized (d) This part does not apply to activi- as adequate by FDA or be otherwise ties of a farm that are subject to sec- qualified through job experience to tion 419 of the Federal Food, Drug, and conduct the activities. Job experience Cosmetic Act (Standards for Produce may qualify an individual to perform Safety).

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(e)(1) This part does not apply with Subpart C—Food Defense respect to alcoholic beverages at a fa- Measures cility that meets the following two conditions: § 121.126 Food defense plan. (i) Under the Federal Alcohol Admin- (a) Requirement for a food defense plan. istration Act (27 U.S.C. 201 et seq.) or You must prepare, or have prepared, chapter 51 of subtitle E of the Internal and implement a written food defense Revenue Code of 1986 (26 U.S.C. 5001 et plan. seq.) the facility is required to obtain a (b) Contents of a food defense plan. The permit from, register with, or obtain written food defense plan must include: approval of a notice or application (1) The written vulnerability assess- from the Secretary of the Treasury as ment, including required explanations, a condition of doing business in the to identify significant vulnerabilities United States, or is a foreign facility of and actionable process steps as re- a type that would require such a per- quired by § 121.130(c); mit, registration, or approval if it were (2) The written mitigation strategies, a domestic facility; and including required explanations, as re- (ii) Under section 415 of the Federal quired by § 121.135(b); Food, Drug, and Cosmetic Act the fa- (3) The written procedures for the cility is required to register as a facil- food defense monitoring of the imple- ity because it is engaged in manufac- mentation of the mitigation strategies turing, processing, packing, or holding as required by § 121.140(a); one or more alcoholic beverages. (4) The written procedures for food (2) This part does not apply with re- defense corrective actions as required spect to food that is not an alcoholic by § 121.145(a)(1); and beverage at a facility described in (5) The written procedures for food defense verification as required by paragraph (e)(1) of this section, pro- § 121.150(b). vided such food: (c) Records. The food defense plan re- (i) Is in prepackaged form that pre- quired by this section is a record that vents any direct human contact with is subject to the requirements of sub- such food; and part D of this part. (ii) Constitutes not more than 5 per- cent of the overall sales of the facility, § 121.130 Vulnerability assessment to as determined by the Secretary of the identify significant vulnerabilities Treasury. and actionable process steps. (f) This part does not apply to the (a) Requirement for a vulnerability as- manufacturing, processing, packing, or sessment. You must conduct or have holding of food for animals other than conducted a vulnerability assessment man. for each type of food manufactured, (g) This part does not apply to on- processed, packed, or held at your fa- farm manufacturing, processing, pack- cility using appropriate methods to ing, or holding of the following foods evaluate each point, step, or procedure on a farm mixed-type facility, when in your food operation to identify sig- conducted by a small or very small nificant vulnerabilities and actionable business if such activities are the only process steps. Appropriate methods must include, at a minimum, an eval- activities conducted by the business uation of: subject to section 418 of the Federal (1) The potential public health im- Food, Drug, and Cosmetic Act. pact (e.g., severity and scale) if a con- (1) Eggs (in-shell, other than raw ag- taminant were added; ricultural commodities, e.g., pasteur- (2) The degree of physical access to ized); and the product; and (2) Game meats (whole or cut, not (3) The ability of an attacker to suc- ground or shredded, without secondary cessfully contaminate the product. ingredients). (b) Inside attacker. The assessment must consider the possibility of an in- Subpart B—Reserved side attacker. 448

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(c) Written vulnerability assessment. (b) Food defense monitoring. You must Regardless of the outcome, the vulner- monitor the mitigation strategies with ability assessment must be written and adequate frequency to provide assur- must include an explanation as to why ances that they are consistently per- each point, step, or procedure either formed. was or was not identified as an action- (c) Records—(1) Requirement to docu- able process step. ment food defense monitoring. You must document the monitoring of mitigation § 121.135 Mitigation strategies for ac- strategies in accordance with this sec- tionable process steps. tion in records that are subject to (a) You must identify and implement verification in accordance with mitigation strategies at each action- § 121.150(a)(1) and records review in ac- able process step to provide assurances cordance with § 121.150(a)(3)(i). that the significant vulnerability at (2) Exception records. Records may be each step will be significantly mini- affirmative records demonstrating the mized or prevented and the food manu- mitigation strategy is functioning as factured, processed, packed, or held by intended. Exception records dem- your facility will not be adulterated onstrating the mitigation strategy is under section 402 of the Federal Food, not functioning as intended may be Drug, and Cosmetic Act. For each miti- adequate in some circumstances. gation strategy implemented at each actionable process step, you must in- § 121.145 Food defense corrective ac- clude a written explanation of how the tions. mitigation strategy sufficiently mini- mizes or prevents the significant vul- (a) Food defense corrective action proce- nerability associated with the action- dures. As appropriate to the nature of able process step. the actionable process step and the na- ture of the mitigation strategy: (b) Mitigation strategies and accom- panying explanations must be written. (1) You must establish and imple- ment written food defense corrective § 121.138 Mitigation strategies man- action procedures that must be taken agement components. if mitigation strategies are not prop- Mitigation strategies required erly implemented. under§ 121.135 are subject to the fol- (2) The food defense corrective action lowing mitigation strategies manage- procedures must describe the steps to ment components as appropriate to en- be taken to ensure that: sure the proper implementation of the (i) Appropriate action is taken to mitigation strategies, taking into ac- identify and correct a problem that has count the nature of each such mitiga- occurred with implementation of a tion strategy and its role in the facili- mitigation strategy; and ty’s food defense system: (ii) Appropriate action is taken, when (a) Food defense monitoring in ac- necessary, to reduce the likelihood cordance with § 121.140; that the problem will recur. (b) Food defense corrective actions in (b) Records. All food defense correc- accordance with § 121.145; and tive actions taken in accordance with (c) Food defense verification in ac- this section must be documented in cordance with § 121.150. records that are subject to food defense verification in accordance with § 121.140 Food defense monitoring. § 121.150(a)(2) and records review in ac- As appropriate to the nature of the cordance with § 121.150(a)(3)(i). mitigation strategy and its role in the facility’s food defense system: § 121.150 Food defense verification. (a) Written procedures. You must es- (a) Food defense verification activities. tablish and implement written proce- Food defense verification activities dures, including the frequency with must include, as appropriate to the na- which they are to be performed, for ture of the mitigation strategy and its food defense monitoring of the mitiga- role in the facility’s food defense sys- tion strategies. tem:

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(1) Verification that food defense nificant increase in a previously identi- monitoring is being conducted as re- fied vulnerability; quired by § 121.138 (and in accordance (2) Whenever you become aware of with § 121.140); new information about potential (2) Verification that appropriate de- vulnerabilities associated with the food cisions about food defense corrective operation or facility; actions are being made as required by (3) Whenever you find that a mitiga- § 121.138 (and in accordance with tion strategy, a combination of mitiga- § 121.145); tion strategies, or the food defense plan (3) Verification that mitigation as a whole is not properly imple- strategies are properly implemented mented; and and are significantly minimizing or (4) Whenever FDA requires reanalysis preventing the significant to respond to new vulnerabilities, cred- vulnerabilities. To do so, you must ible threats to the food supply, and de- conduct activities that include the fol- velopments in scientific understanding lowing, as appropriate to the facility, including, as appropriate, results from the food, and the nature of the mitiga- the Department of Homeland Security tion strategy and its role in the facili- biological, chemical, radiological, or ty’s food defense system: other terrorism risk assessment. (i) Review of the food defense moni- (c) You must complete such reanaly- toring and food defense corrective ac- sis required by paragraphs (a) and (b) of tions records within appropriate time- this section and implement any addi- frames to ensure that the records are tional mitigation strategies needed to complete, the activities reflected in address the significant vulnerabilities the records occurred in accordance identified, if any: with the food defense plan, the mitiga- (1) Before any change in activities tion strategies are properly imple- (including any change in mitigation mented, and appropriate decisions were strategy) at the facility is operative; made about food defense corrective ac- (2) When necessary within 90-cal- tions; and endar days after production; and (ii) Other activities appropriate for verification of proper implementation (3) Within a reasonable timeframe, of mitigation strategies; and providing a written justification is pre- pared for a timeframe that exceeds 90 (4) Verification of reanalysis in ac- days after production of the applicable cordance with § 121.157. food first begins. (b) Written procedures. You must es- (d) You must revise the written food tablish and implement written proce- defense plan if a significant change in dures, including the frequency for which they are to be performed, for the activities conducted at your facil- verification activities conducted ac- ity creates a reasonable potential for a cording to § 121.150(a)(3)(ii). new vulnerability or a significant in- crease in a previously identified vul- (c) Documentation. All verification ac- nerability or document the basis for tivities conducted in accordance with the conclusion that no revisions are this section must be documented in needed. records.

§ 121.157 Reanalysis. Subpart D—Requirements Apply- (a) You must conduct a reanalysis of ing to Records That Must Be the food defense plan, as a whole at Established and Maintained least once every 3 years; (b) You must conduct a reanalysis of § 121.301 Records subject to the re- the food defense plan as a whole, or the quirements of this subpart. applicable portion of the food defense (a) Except as provided by paragraph plan: (b) of this section, all records required (1) Whenever a significant change by subpart C of this part are subject to made in the activities conducted at all requirements of this subpart. your facility creates a reasonable po- (b) The requirements of § 121.310 apply tential for a new vulnerability or a sig- only to the written food defense plan.

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§ 121.305 General requirements apply- of a facility as a very small business ing to records. during the applicable calendar year. Records must: (b) The food defense plan must be re- (a) Be kept as original records, true tained for at least 2 years after its use copies (such as photocopies, pictures, is discontinued. scanned copies, microfilm, microfiche, (c) Except for the food defense plan, or other accurate reproductions of the offsite storage of records is permitted original records), or electronic records; if such records can be retrieved and (b) Contain the actual values and ob- provided onsite within 24 hours of re- servations obtained during food defense quest for official review. The food de- monitoring; fense plan must remain onsite. Elec- (c) Be accurate, indelible, and legible; tronic records are considered to be on- (d) Be created concurrently with per- site if they are accessible from an on- formance of the activity documented; site location. (e) Be as detailed as necessary to pro- (d) If the facility is closed for a pro- vide history of work performed; and longed period, the food defense plan (f) Include: may be transferred to some other rea- (1) Information adequate to identify sonably accessible location but must be the facility (e.g., the name, and when returned to the facility within 24 hours necessary, the location of the facility); for official review upon request. (2) The date and, when appropriate, the time of the activity documented; § 121.320 Requirements for official re- (3) The signature or initials of the view. person performing the activity; and All records required by this part (4) Where appropriate, the identity of must be made promptly available to a the product and the lot code, if any. duly authorized representative of the (g) Records that are established or maintained to satisfy the requirements Secretary of Health and Human Serv- of this part and that meet the defini- ices for official review and copying tion of electronic records in § 11.3(b)(6) upon oral or written request. of this chapter are exempt from the re- quirements of part 11 of this chapter. § 121.325 Public disclosure. Records that satisfy the requirements Records required by this part will be of this part, but that also are required protected from public disclosure to the under other applicable statutory provi- extent allowable under part 20 of this sions or regulations, remain subject to chapter. part 11 of this chapter. § 121.330 Use of existing records. § 121.310 Additional requirements ap- plying to the food defense plan. (a) Existing records (e.g., records that are kept to comply with other Federal, The owner, operator, or agent in State, or local regulations, or for any charge of the facility must sign and other reason) do not need to be dupli- date the food defense plan: cated if they contain all of the required (a) Upon initial completion; and information and satisfy the require- (b) Upon any modification. ments of this subpart. Existing records § 121.315 Requirements for record re- may be supplemented as necessary to tention. include all of the required information (a)(1) All records required by this and satisfy the requirements of this part must be retained at the facility subpart. for at least 2 years after the date they (b) The information required by this were prepared. part does not need to be kept in one set (2) Records that a facility relies on of records. If existing records contain during the 3-year period preceding the some of the required information, any applicable calendar year to support its new information required by this part status as exempt as a very small busi- may be kept either separately or com- ness must be retained at the facility as bined with the existing records. long as necessary to support the status

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Subpart E—Compliance are applicable to such terms when used in this part, except that the definitions § 121.401 Compliance. and terms in parts 110 and 117 do not (a) The operation of a facility that govern such terms where such terms manufactures, processes, packs, or are redefined in this part and except holds food for sale in the United States that the terms facility, hazard, and if the owner, operator, or agent in manufacturing/processing in parts 110 charge of such facility is required to and 117 do not govern such terms where comply with, and is not in compliance used in this part. The following defini- with, section 418 of the Federal Food, tions shall also apply: Drug, and Cosmetic Act or subparts C (a) Certification number means a or D of this part is a prohibited act unique combination of letters and under section 301(uu) of the Federal numbers assigned by a shellfish control Food, Drug, and Cosmetic Act. authority to a molluscan shellfish (b) The failure to comply with sec- processor. tion 420 of the Federal Food, Drug, and (b) Critical control point means a Cosmetic Act or subparts C or D of this point, step, or procedure in a food proc- part is a prohibited act under section ess at which control can be applied, 301(ww) of the Federal Food, Drug, and and a food safety hazard can as a result Cosmetic Act. be prevented, eliminated, or reduced to acceptable levels. PART 123—FISH AND FISHERY (c) Critical limit means the maximum PRODUCTS or minimum value to which a physical, biological, or chemical parameter must Subpart A—General Provisions be controlled at a critical control point to prevent, eliminate, or reduce to an Sec. acceptable level the occurrence of the 123.3 Definitions. 123.5 Current good manufacturing practice. identified food safety hazard. 123.6 Hazard analysis and Hazard Analysis (d) Fish means fresh or saltwater Critical Control Point (HACCP) plan. finfish, crustaceans, other forms of 123.7 Corrective actions. aquatic animal life (including, but not 123.8 Verification. limited to, alligator, frog, aquatic tur- 123.9 Records. tle, jellyfish, sea cucumber, and sea ur- 123.10 Training. 123.11 Sanitation control procedures. chin and the roe of such animals) other 123.12 Special requirements for imported than birds or mammals, and all mol- products. lusks, where such animal life is in- tended for human consumption. Subpart B—Smoked and Smoke-Flavored (e) Fishery product means any human Fishery Products food product in which fish is a charac- 123.15 General. terizing ingredient. 123.16 Process controls. (f) Food safety hazard means any bio- logical, chemical, or physical property Subpart C—Raw Molluscan Shellfish that may cause a food to be unsafe for human consumption. 123.20 General. 123.28 Source controls. (g) Importer means either the U.S. owner or consignee at the time of entry AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, into the United States, or the U.S. 371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264. agent or representative of the foreign SOURCE: 60 FR 65197, Dec. 18, 1995, unless owner or consignee at the time of entry otherwise noted. into the United States, who is respon- sible for ensuring that goods being of- Subpart A—General Provisions fered for entry into the United States are in compliance with all laws affect- § 123.3 Definitions. ing the importation. For the purposes The definitions and interpretations of this definition, ordinarily the im- of terms in section 201 of the Federal porter is not the custom house broker, Food, Drug, and Cosmetic Act (the act) the freight forwarder, the carrier, or and in parts 110 and 117 of this chapter the steamship representative.

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