Dietary supplements that present a significant or unreasonable risk (21 CFR 119.1)

350 21 CFR Ch. I (4–1–15 Edition) Pt. 119 a material issue, and must include a recommended decision, with a state ment of reasons. (iv) Written appeal. If the appellant appeals the detention order but does not request a hearing, the Regional Food and Drug Director must render a decision on the appeal affirming or re voking the detention order within 5 working days after the receipt of the appeal. (v) Regional Food and Drug Director decision. If, based on the evidence pre sented at the hearing or by the appel lant in a written appeal, the Regional Food and Drug Director finds that the shell eggs were produced or held in vio lation of this section, he must affirm the order that they be diverted, under the supervision of an officer or em ployee of FDA for processing under the EPIA or by a treatment that achieves at least a 5-log destruction of SE or de stroyed by or under the supervision of an officer or employee of FDA; other wise, the Regional Food and Drug Di rector must issue a written notice that the prior order is withdrawn. If the Re gional Food and Drug Director affirms the order, he must order that the diver sion or destruction be accomplished within 10-working days from the date of the issuance of his decision. The Re gional Food and Drug Director’s deci sion must be accompanied by a state ment of the reasons for the decision. The decision of the Regional Food and Drug Director constitutes final agency action, subject to judicial review. (vi) No appeal. If there is no appeal of the order and the person in possession of the shell eggs that are subject to the order fails to divert or destroy them within 10-working days, or if the de mand is affirmed by the Regional Food and Drug Director after an appeal and the person in possession of such eggs fails to divert or destroy them within 10-working days, FDA’s district office or, if applicable, the State or local rep resentative may designate an officer or employee to divert or destroy such eggs. It shall be unlawful to prevent or to attempt to prevent such diversion or destruction of the shell eggs by the designated officer or employee. (b) Inspection. Persons engaged in production of shell eggs must permit authorized representatives of FDA to make, at any reasonable time, an in spection of the egg production estab lishment in which shell eggs are being produced. Such inspection includes the inspection and sampling of shell eggs and the environment, the equipment related to production of shell eggs, the equipment in which shell eggs are held, and examination and copying of any records relating to such equipment or eggs, as may be necessary in the judg ment of such representatives to deter mine compliance with the provisions of this section. Inspections may be made with or without notice and will ordi narily be made during regular business hours. (c) State and local cooperation. Under sections 311 and 361 of the Public Health Service Act, any State or local ity that is willing and able to assist the agency in the enforcement of §§ 118.4 through 118.10, and is authorized to inspect or regulate egg production establishments, may, in its own juris diction, enforce §§ 118.4 through 118.10 through inspections under paragraph (b) of this section and through adminis trative enforcement remedies specified in paragraph (a) of this section unless FDA notifies the State or locality in writing that such assistance is no longer needed. A state or locality may substitute, where necessary, appro priate State or local officials for des ignated FDA officials in this section. When providing assistance under para graph (a) of this section, a State or lo cality may follow the hearing proce dures set out in paragraphs (a)(2)(iii) through (a)(2)(v) of this section, or may utilize comparable State or local hear ing procedures if such procedures sat isfy due process. (d) Preemption. No State or local gov erning entity shall establish, or con tinue in effect any law, rule, regula tion, or other requirement regarding prevention of SE in shell eggs during production, storage, or transportation that is less stringent than those re quired by this part. PART 119—DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK AUTHORITY: 21 U.S.C. 321, 342, 343, 371. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00360 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 351 Food and Drug Administration, HHS § 120.3 § 119.1 Dietary supplements con taining ephedrine alkaloids. Dietary supplements containing ephedrine alkaloids present an unrea sonable risk of illness or injury under conditions of use recommended or sug gested in the labeling, or if no condi tions of use are recommended or sug gested in the labeling, under ordinary conditions of use. Therefore, dietary supplements containing ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act. [69 FR 6853, Feb. 11, 2004] PART 120—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Subpart A—General Provisions Sec. 120.1 Applicability. 120.3 Definitions. 120.5 Current good manufacturing practice. 120.6 Sanitation standard operating proce dures. 120.7 Hazard analysis. 120.8 Hazard Analysis and Critical Control Point (HACCP) plan. 120.9 Legal basis. 120.10 Corrective actions. 120.11 Verification and validation. 120.12 Records. 120.13 Training. 120.14 Application of requirements to im ported products. Subpart B—Pathogen Reduction 120.20 General. 120.24 Process controls. 120.25 Process verification for certain proc essors. AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 242l, 264. SOURCE: 66 FR 6197, Jan. 19, 2001, unless otherwise noted. Subpart A—General Provisions § 120.1 Applicability. (a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the re quirements of this part. Juice means the aqueous liquid expressed or ex tracted from one or more fruits or vegetables, purees of the edible por tions of one or more fruits or vegeta bles, or any concentrates of such liquid or puree. The requirements of this part shall apply to any juice regardless of whether the juice, or any of its ingredi ents, is or has been shipped in inter state commerce (as defined in section 201(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(b)). Raw ag ricultural ingredients of juice are not subject to the requirements of this part. Processors should apply existing agency guidance to minimize microbial food safety hazards for fresh fruits and vegetables in handling raw agricultural products. (b) The regulations in this part shall be effective January 22, 2002. However, by its terms, this part is not binding on small and very small businesses until the dates listed in paragraphs (b)(1) and (b)(2) of this section. (1) For small businesses employing fewer than 500 persons the regulations in this part are binding on January 21, 2003. (2) For very small businesses that have either total annual sales of less than $500,000, or if their total annual sales are greater than $500,000 but their total food sales are less than $50,000; or the person claiming this exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of juice were sold in the United States, the regula tions are binding on January 20, 2004. § 120.3 Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cos metic Act, § 101.9(j)(18)(vi), and part 110 of this chapter are applicable to such terms when used in this part, except where redefined in this part. The fol lowing definitions shall also apply: (a) Cleaned means washed with water of adequate sanitary quality. (b) Control means to prevent, elimi nate, or reduce. (c) Control measure means any action or activity to prevent, reduce to ac ceptable levels, or eliminate a hazard. (d) Critical control point means a point, step, or procedure in a food proc ess at which a control measure can be applied and at which control is essen tial to reduce an identified food hazard to an acceptable level. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00361 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B