Acidified foods (21 CFR 114.3-114.100)

331 Food and Drug Administration, HHS § 114.5 processes, shall be retained at the proc essing plant for a period of not less than 1 year from the date of manufac ture, and at the processing plant or other reasonably accessible location for an additional 2 years. If, during the first year of the 3-year record-retention period, the processing plant is closed for a prolonged period between sea sonal packs, the records may be trans ferred to some other reasonably acces sible location at the end of the sea sonal pack. (h) Records of this part may be main tained electronically, provided they are in compliance with part 11 of this chapter. [44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11923, Mar. 3, 2011] PART 114—ACIDIFIED FOODS Subpart A—General Provisions Sec. 114.3 Definitions. 114.5 Current good manufacturing practices. 114.10 Personnel. Subparts B–D [Reserved] Subpart E—Production and Process Controls 114.80 Processes and controls. 114.83 Establishing scheduled processes. 114.89 Deviations from scheduled proce dures. 114.90 Methodology. Subpart F—Records and Reports 114.100 Records. AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264. SOURCE: 44 FR 16235, Mar. 16, 1979, unless otherwise noted. Subpart A—General Provisions § 114.3 Definitions. For the purposes of this part, the fol lowing definitions apply. (a) Acid foods means foods that have a natural pH of 4.6 or below. (b) Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cab bage, artichokes, cauliflower, pud dings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, ‘‘pickles’’ or ‘‘pickled lll.’’ Carbonated bev erages, jams, jellies, preserves, acid foods (including such foods as stand ardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not signifi cantly differ from that of the predomi nant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this part. (c) Lot means the product produced during a period indicated by a specific code. (d) Low-acid foods means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. Tomatoes and tomato prod ucts having a finished equilibrium pH less than 4.7 are not classed as low-acid foods. (e) Scheduled process means the proc ess selected by a processor as adequate for use under the conditions of manu facture for a food in achieving and maintaining a food that will not per mit the growth of microorganisms hav ing public health significance. It in cludes control of pH and other critical factors equivalent to the process estab lished by a competent processing au thority. (f) Shall is used to state mandatory requirements. (g) Should is used to state rec ommended or advisory procedures or to identify recommended equipment. (h) Water activity (aw) is a measure of the free moisture in a product and is the quotient of the water vapor pres sure of the substance divided by the vapor pressure of pure water at the same temperature. [44 FR 16235, Mar. 16, 1979, as amended at 61 FR 14245, Apr. 1, 1996] § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the cri teria in part 110 of this chapter, apply VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00341 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 332 21 CFR Ch. I (4–1–15 Edition) § 114.10 in determining whether an article of acidified food is adulterated (1) within the meaning of section 402(a)(3) of the act (21 U.S.C. 342(a)(3)) in that it has been manufactured under such condi tions that it is unfit for food, or (2) within the meaning of section 402(a)(4) of the act (21 U.S.C. 342(a)(4)) in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been ren dered injurious to health. § 114.10 Personnel. All operators of processing and pack aging systems shall be under the oper ating supervisions of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food-protec tion principles, personal hygiene and plant sanitation practices, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily com pleted the prescribed course of instruc tion. The Commissioner will consider students who have satisfactorily com pleted the required portions of the courses presented under § 108.35 and part 113 of this chapter before March 16, 1979, to be in compliance with the requirement of this section. Subparts B–D [Reserved] Subpart E—Production and Process Controls § 114.80 Processes and controls. (a) Processing operations. The manu facturer shall employ appropriate qual ity control procedures to ensure that finished foods do not present a health hazard. (1) Acidified foods shall be so manu factured, processed, and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manu facturing shall be in accordance with the scheduled process. Acidified foods shall be thermally processed to an ex tent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of re producing in the food under the condi tions in which the food is stored, dis tributed, retailed and held by the user. Permitted preservatives may be used to inhibit reproduction of microorga nisms of nonhealth significance (in lieu of thermal processing). (2) Sufficient control, including fre quent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Measure ment of acidity of foods in-process may be made by potentiometric methods, titratable acidity, or colorimetric methods. If the finished equilibrium pH of the food is above 4.0, the measure ment of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by ti tration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suit able method. Special care should be taken when food ingredients have been subjected to lye, lime, or similar high pH materials. (3) Procedures for acidification to at tain acceptable equilibrium pH levels in the final food include, but are not limited to, the following: (i) Blanching of the food ingredients in acidified aqueous solutions. (ii) Immersion of the blanched food in acid solutions. Although immersion of food in an acid solution is a satisfac tory method for acidification, care must be taken to ensure that the acid concentration is properly maintained. (iii) Direct batch acidification, which can be achieved by adding a known amount of an acid solution to a speci fied amount of food during acidifica tion. (iv) Direct addition of a predeter mined amount of acid to individual containers during production. Liquid acids are generally more effective than solid or pelleted acids. Care must be taken to ensure that the proper amount of acid is added to each con tainer. (v) Addition of acid foods to low-acid foods in controlled proportions to con form to specific formulations. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00342 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 333 Food and Drug Administration, HHS § 114.90 (4) Testing and examinations of con tainers shall occur often enough to en sure that the container suitably pro tects the food from leakage or con tamination. (b) Coding. Each container or product shall be marked with an identifying code permanently visible to the naked eye. If the container does not permit the code to be embossed or inked, the label may be legibly perforated or oth erwise marked, as long as the label is securely affixed to the product con tainer. The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed. The packing period code shall be changed often enough to en able ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers con stituting the batch do not represent those processed during more than one personnel shift. § 114.83 Establishing scheduled proc esses. The scheduled process shall be estab lished by a qualified person who has ex pert knowledge acquired through ap propriate training and experience in the acidification and processing of acidified foods. § 114.89 Deviations from scheduled processes. Whenever any process operation devi ates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the commercial processor of the acidified food shall either: (a) Fully reprocess that portion of the food by a process established by a competent processing authority as adequate to en sure a safe product; (b) thermally proc ess it as a low-acid food under part 113 of this chapter; or (c) set aside that portion of the food involved for further evaluation as to any potential public health significance. The evaluation shall be made by a competent proc essing authority and shall be in accord ance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Unless the evaluation demonstrates that the food has undergone a process that has ren dered it safe, the food set aside shall ei ther be fully reprocessed to render it safe, or be destroyed. A record shall be made of the procedures used in the evaluation and the results. Either upon completion of full reprocessing and the attainment of a safe food, or after the determination that no significant po tential for public health hazard exists, that portion of the food involved may be shipped in normal distribution. Oth erwise, the portion of the food involved shall be destroyed. § 114.90 Methodology. Methods that may be used to deter mine pH or acidity for acidified foods include, but are not limited to, the fol lowing: (a) Potentiometric method for the deter mination of pH—(1) Principles. The term ‘‘pH’’ is used to designate the intensity or degree of acidity. The value of pH, the logarithm of the reciprocal of the hydrogen ion concentration in solu tion, is determined by measuring the difference in potential between two electrodes immersed in a sample solu tion. A suitable system consists of a potentiometer, a glass electrode, and a reference electrode. A precise pH deter mination can be made by making an electromotive force (emf) measurement of a standard buffer solution whose pH is known, and then comparing that measurement to an emf measurement of a sample of the solution to be tested. (2) Instruments. The primary instru ment for use in pH determination is the pH meter or potentiometer. For most work, an instrument with a di rect-reading pH scale is necessary. Bat tery and line-operated instruments are available commercially. If the line voltage is unstable, line-operated in struments should be fitted with voltage regulators to eliminate drifting of meter-scale readings. Batteries should be checked frequently to ensure proper operation of battery operated instru ments. An instrument using an ex panded unit scale or a digital readout system is preferred since it allows more precise measurements. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00343 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 334 21 CFR Ch. I (4–1–15 Edition) § 114.90 (3) Electrodes. The typical pH meter is equipped with a glass membrane elec trode and a reference electrode or a single probe combination electrode. Various types of electrodes designed for specific uses are available. The most commonly used reference elec trode is the calomel electrode, which incorporates a salt bridge filled with saturated potassium chloride solution. (i) Care and use of electrodes. Calomel electrodes should be kept filled with saturated potassium chloride solution or other solution specified by the man ufacturer because they may become damaged if they are allowed to dry out. For best results, electrodes should be soaked in buffer solution, distilled or deionized water, or other liquid speci fied by the manufacturer for several hours before using and kept ready by storing with tips immersed in distilled water or in buffer solution used for standardization. Electrodes should be rinsed with water before immersing in the standard buffers and rinsed with water or the solution to be measured next between sample determinations. A lag in meter response may indicate aging effects or fouling of the elec trodes, and cleaning and rejuvenation of the electrodes may be necessary and may be accomplished by placing the electrodes in 0.1 molar sodium hydrox ide solution for 1 minute and then transferring them to 0.1 molar hydro chloric acid solution for 1 minute. The cycle should be repeated two times, ending with the electrodes in the acid solution. The electrodes should then be thoroughly rinsed with water and blot ted with soft tissue before proceeding with the standardization. (ii) Temperature. To obtain accurate results, a uniform temperature should be maintained for the electrodes, the standard buffer solutions, and the sam ples. Tests should be made at a tem perature between 20° and 30 °C, the op timum being 25 °C. Any temperature determinations made without meter compensation may affect pH values. An automatic temperature compensator may be used. (iii) Accuracy. The accuracy of most pH meters is stated to be approxi mately 0.1 pH unit, and reproducibility is usually ±0.05 pH unit or less. Some meters permit the expansion of any pH unit range to cover the entire scale and have an accuracy of approximately ±0.01 pH unit and a reproducibility of ±0.005 pH units. (4) General procedure for determining pH. When operating an instrument, the operator should use the manufacturer’s instructions and should observe the fol lowing techniques for pH determina tions: (i) Switch the instrument on and allow the electronic components to warm up and stabilize before pro ceeding. (ii) Standardize the instrument and electrodes with commercially prepared standard 4.0 pH buffer or with freshly prepared 0.05 molar potassium acid phthalate buffer solution prepared as outlined in ‘‘Official Methods of Anal ysis of the Association of Official Ana lytical Chemists’’ (AOAC), 13th Ed. (1980), section 50.007(c), under ‘‘Buffer Solutions for Calibration of pH Equip ment—Official Final Action,’’ which is incorporated by reference. Copies may be obtained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. Note the tempera ture of the buffer solution and set the temperature compensator control at the observed temperature (room tem perature is near 25 °C). (iii) Rinse the electrodes with water and blot, but do not wipe, with soft tis sue. (iv) Immerse the tips in the buffer so lution and take the pH reading, allow ing about 1 minute for the meter to stabilize. Adjust the standardization control so that the meter reading cor responds to the pH of the known buffer (for example, 4.0) for the temperature observed. Rinse the electrodes with water and blot with soft tissue. Repeat procedure with fresh portions of buffer solution until the instrument remains in balance on two successive trials. To check the operation of the pH meter, check the pH reading using another standard buffer such as one having a VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00344 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 335 Food and Drug Administration, HHS § 114.90 pH of 7.0, or check it with freshly pre pared 0.025 molar phosphate solution prepared as outlined in the AOAC, 13th Ed. (1980), section 50.007(e), which is in corporated by reference. The avail ability of this incorporation by ref erence is given in paragraph (a)(4)(ii) of this section. Expanded scale pH meters may be checked with pH 3.0 or pH 5.0 standard buffers. Buffers and instru ments can be further checked by com parison with values obtained with a second properly standardized instru ment. (v) Indicating electrodes may be checked for proper operation by first using an acid buffer and then a base buffer. First standardize the electrodes using a pH 4.0 buffer at or near 25 °C. Standardization control should be ad justed so that the meter reads exactly 4.0. Electrodes should be rinsed with water, then blotted and immersed in a pH 9.18 borax buffer prepared as out lined in the AOAC, 13th Ed. (1980), sec tion 50.007(f), which is incorporated by reference. The availability of this in corporation by reference is given in paragraph (a)(4)(ii) of this section. The pH reading should be within ±0.3 units of the 9.18 value. (vi) The pH meter can be tested for proper operation by shorting the glass and reference electrode inputs, thereby reducing the voltage to zero. In some meters this shorting is done by switch ing the instrument to standby, and in other instruments by use of a shorting strap. With the instrument shorted out, standardization control should be turned from one extreme to another. This operation should produce a deflec tion greater than ±1.5 pH unit from center scale. (5) Determining pH on samples. (i) Ad just the temperature of the sample to room temperature (25 °C), and set the temperature compensator control to the observed temperature. With some expanded scale instruments, the sam ple temperature must be the same as the temperature of the buffer solution used for the standardization. (ii) Rinse and blot the electrodes. Im merse the electrodes in the sample and take the pH reading, allowing 1 minute for the meter to stabilize. Rinse and blot the electrodes and repeat on a fresh portion of sample. Oil and grease from the samples may coat the elec trodes; therefore, it is advisable to clean and standardize the instrument frequently. When oily samples cause fouling problems, it may become nec essary to rinse the electrodes with ethyl ether. (iii) Determine two pH values on the well-mixed sample. These readings should agree with one another to indi cate that the sample is homogeneous. Report values to the nearest 0.05 pH unit. (6) Preparation of samples. Some food products may consist of a mixture of liquid and solid components that differ in acidity. Other food products may be semisolid in character. The following are examples of preparation procedures for pH testing for each of these cat egories: (i) Liquid and solid component mix tures. Drain the contents of the con tainer for 2 minutes on a U.S. standard No. 8 sieve (preferably stainless steel) inclined at a 17- to 20-degree angle. Record weight of the liquid and solid portions and retain each portion sepa rately. (a) If the liquid contains sufficient oil to cause electrode fouling, separate the layers with a separatory funnel and retain the aqueous layer. The oil layer may be discarded. Adjust the tempera ture of the aqueous layer to 25 °C and determine its pH. (b) Remove the drained solids from the sieve, blend to a uniform paste, ad just the temperature of the paste to 25 °C and determine its pH. (c) Mix aliquots of solid and liquid fractions in the same ratio as found in the original container and blend to a uniform consistency. Adjust the tem perature of the blend to 25 °C and de termine the equilibriated pH. Alter natively, blend the entire contents of the container to a uniform paste, ad just the temperature of the paste to 25 °C, and determine the equilibriated pH. (ii) Marinated oil products. Separate the oil from the solid product. Blend the solid in a blender to a paste con sistency; it may become necessary to add a small amount of distilled water to some samples to facilitate the blending. A small amount of added water will not alter the pH of most VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00345 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 336 21 CFR Ch. I (4–1–15 Edition) § 114.100 food products, but caution must be ex ercised concerning poorly buffered foods. No more than 20 milliliters of distilled water should be added to each 100 grams of product. Determine the pH by immersing electrodes in the pre pared paste after adjusting the tem perature to 25 °C. (iii) Semisolid products. Food products of a semisolid consistency, such as pud dings, potato salad, etc., may be blend ed to a paste consistency, and the pH may be determined on the prepared paste. If more fluidity is required, 10 to 20 milliliters of distilled water may be added to 100 grams of product. Adjust the temperature of the prepared paste to 25 °C and determine its pH. (iv) Special product mixtures. For spe cial product mixtures such as anti pasto, pour off the oil, blend the re maining product to a paste, and deter mine the pH of the blended paste. If more fluidity is required, add 10 to 20 milliliters of distilled water to each 100 grams of product and blend. Adjust the temperature of the prepared paste to 25 °C and determine its pH. (7) Process pH determination. Obtain sample portions of material for pH de termination. (i) For process liquids, adjust the temperature of the liquid to 25 °C and determine the pH by immersing the electrodes in the liquid. (ii) Drain solid materials on a sieve and blend to a workable paste. Adjust the temperature of the prepared paste to 25 °C and determine its pH. (iii) If enough solid materials are available to make a paste, blend rep resentative aliquots of liquid and solid materials to a workable paste. Adjust the temperature of the prepared paste to 25 °C and determine the equilibrated pH. Alternatively, blend the entire con tents of the container to a uniform paste, adjust the temperature of the paste to 25 °C, and determine the equilibrated pH. (b) Colorimetric methods for the deter mination of pH. This method may be used in lieu of the potentiometric method if the pH is 4.0 or lower. (1) Principle. The colorimetric method for pH involves the use of indicator dyes in solutions that gradually change color over limited pH ranges. An indi cator that has the greatest color change at approximately the pH of the sample being tested is selected. The pH is determined by the color of the indi cator when exposed to the sample under test. (2) Indicator solutions. Most indicator solutions are prepared as a 0.04 percent solution of the indicator dye in alco hol. In testing, a few drops of indicator solution are added to 10-milliliter por tions of the sample solution. Colors should be compared using a bright background. Approximate determina tions can be made on white porcelain spot plates, the test colors being com pared thereon with a set of color stand ards. More accurate colorimetric tests can be made using a comparator block fitted with sets of tubes of standard in dicator solutions of known pH. (3) Indicator paper. A paper tape treated with indicator dye is dipped into the sample solution. Depending upon the pH of the solution, the tape will change color and an approximate pH can be determined by comparison with a standard color chart. (c) Titratable acidity. Acceptable methods for determining titratable acidity are described in the AOAC, 13th Ed. (1980), section 22.060, under ‘‘Ti tratable Acidity—Official Final Ac tion,’’ for ‘‘Indicator Method,’’ and sec tion 22.061 for ‘‘Glass Electrode Meth od—Official Final Action,’’ which is in corporated by reference. The avail ability of this incorporation by ref erence is given in paragraph (a)(4)(ii) of this section. The procedure for pre paring and standardizing the sodium hydroxide solution is described in the AOAC, 13th Ed. (1980), sections 50.032– 50.035, under ‘‘Sodium Hydroxide—Offi cial Final Action’’ by the ‘‘Standard Potassium Hydroxide Phthalate Meth od,’’ which is also incorporated by ref erence and available as set forth in paragraph (a)(4)(ii) of this section. [44 FR 16235, Mar. 16, 1979, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 5609, Feb. 14, 1984; 54 FR 24892, June 12, 1989; 63 FR 14035, Mar. 24, 1998] Subpart F—Records and Reports § 114.100 Records. (a) Records shall be maintained of ex aminations of raw materials, pack aging materials, and finished products, VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00346 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 337 Food and Drug Administration, HHS § 115.50 and of suppliers’ guarantees or certifi cations that verify compliance with Food and Drug Administration regula tions and guidance documents or ac tion levels. (b) Processing and production records showing adherence to scheduled proc esses, including records of pH measure ments and other critical factors in tended to ensure a safe product, shall be maintained and shall contain suffi cient additional information such as product code, date, container size, and product, to permit a public health haz ard evaluation of the processes applied to each lot, batch, or other portion of production. (c) All departures from scheduled processes having a possible bearing on public health or the safety of the food shall be noted and the affected portion of the product identified; these depar tures shall be recorded and made the subject of a separate file (or log identi fying the appropriate data) delineating them, the action taken to rectify them, and the disposition of the portion of the product involved. (d) Records shall be maintained iden tifying initial distribution of the fin ished product to facilitate, when nec essary, the segregation of specific food lots that may have become contami nated or otherwise unfit for their in tended use. (e) Copies of all records provided for in paragraphs (b), (c), and (d) of this section shall be retained at the proc essing plant or other reasonably acces sible location for a period of 3 years from the date of manufacture. [44 FR 16235, Mar. 16, 1979, as amended at 65 FR 56479, Sept. 19, 2000] PART 115—SHELL EGGS AUTHORITY: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271. § 115.50 Refrigeration of shell eggs held for retail distribution. (a) For purposes of this section a ‘‘retail establishment’’ is an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption directly to con sumers. (b) Except as provided in paragraph (c) of this section, all shell eggs, whether in intrastate or interstate commerce, held for retail distribution: (1) Shall promptly be placed under re frigeration as specified in paragraph (b)(2) of this section upon receipt at a retail establishment, except that, when short delays are unavoidable, the eggs shall be placed under refrigeration, as soon as reasonably possible; and (2) Shall be stored and displayed under refrigeration at an ambient tem perature not greater than 7.2 °C (45 °F) while held at a retail establishment. (c) Shell eggs that have been specifi cally processed to destroy all viable Salmonella shall be exempt from the re quirements of paragraph (b) of this sec tion. (d) Under sections 311 and 361 of the Public Health Service Act (PHS Act), any State or locality that is willing and able to assist the agency in the en forcement of paragraph (b) of this sec tion, and is authorized to inspect or regulate retail establishments, may, in its own jurisdiction, enforce paragraph (b) of this section through inspections under paragraph (f) of this section and through administrative enforcement remedies identified in paragraph (e) of this section until FDA notifies the State or locality in writing that such assistance is no longer needed. When providing assistance under paragraph (e) of this section, a State or locality may follow the hearing procedures set out in paragraphs (e)(2)(iii) through (e)(2)(iv) of this section, substituting, where necessary, appropriate State or local officials for designated FDA offi cials or may utilize State or local hear ing procedures if such procedures sat isfy due process. (e) This section is established under authority of both the Federal Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under the act, the agency can enforce the food adulteration pro visions under 21 U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the issuance of implementing enforce ment regulations; therefore, FDA has established the following administra tive enforcement procedures for the di version or destruction of shell eggs and for informal hearings under the PHS Act: VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00347 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