Pt. 121 21 CFR Ch. I (4–1–17 Edition) 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. 444 VerDate Sep<11>2014 13:04 Jun 30, 2017 Jkt 241071 PO 00000 Frm 00454 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB Food and Drug Administration, HHS § 121.3 121.157 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 445 VerDate Sep<11>2014 13:04 Jun 30, 2017 Jkt 241071 PO 00000 Frm 00455 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB § 121.3 21 CFR Ch. I (4–1–17 Edition) 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.