2 chapter United States Government Regulations and International Standards Related to Food Analysis S.Suzanne Nielsen 2.2.1.1.3 Other FDA Regulations 18 2.2.1.2 Food Definitions and Standards 18 2.2.1.3 Inspection and Enforcement 18 2.2.1 United States Food and Drug Administration 2.2.2 United States Department of Agriculture 21 (FDA)17 2.2.2.1 Standards of Identity for Mea 2.2.1.1 Legislative History 17 Cosmetic Acto 21 2.2.1.12 ns to 2.2.3.1 Seafood Inspection Service 22
16 PartI.General Information 2.3 Regulations 2.2.4 United St and Rec mme ndations for Milk 26 26 ns,and Explosives 22 e 2.2.4.1 Regulatory Responsibility for Alcoholio 2.4 Regulations and Recom,nendations for Shellfish 27 2.2.4.2 Standards and Composition of Beer 24 1 State and Federal Shellfish Santation Wine,and Distilled Beverage Spirits 22 Programs 27 2.2.5 United States Environmental Protection 2.4.2 Natural and Environmental Agency 23 Toxic Substances in Shellfish 27 2.2.5.1 Pesticide Registration and 2.5 Voluntary Federal Recommenions Arecting Food ater Standards and 23 .Food Purchase,and nta nts nt Ac 2.2.5.3 Effluent Co ition from Food 2.5.2 Nation Processing Plants 24 State Food Pa hts and Measures ns 28 2.2.6 United States Customs Service 24 2.6 Intemational Standards and Policies 2 2.2.6.1 Harmonized Tariff Schedule of 261 Codex Alimentarius 29 the United States(TSUSA)25 2.6.2 ISO Standards 29 2.2.6.2 Food Composition and the TSUSA 25 2.6.3 Other Standards 30 2.2.7 United States Federal Trade Commission 25 2.7 Summary 30 2272o88A025 2.8 Study Questions 30 tion,and 3
Chapter 2.United States Goverment Regulaticns 17 2.1 INTRODUCTION relevant to food analysis is the section that authorizes food definitions and standards of identity,as further Knowledge of government regulations relevant to the described below. chemical alysis of foods is extremely important to y and reg ndus y to pro some fo ds,tointformco The Miller ticide Ar in 1954 to ingredients a food must contain,what must be testcd table amount of pesticide residues on and the procedures used to analyze foods for safety fac- tors and quality attributes.This chapter describes the they enter the marketplace. under the authority of the FDA,is now administered sition of foods.The reader is re by the Environmental Protection Agency(EPA). The Food d Additives Amendment enacted in 1958 an was mg a ive to prover fore ad R115) on ractices established by The antr internet addresses arc given at the end of this chap a rider to this an ndment its the rDa fro for many of the goverment agencs and documents discussed. known to be carcinogenic. The Color Additives Amendment of 1960 defines coior additives,sets rules for both certified and uncerti- 22 UNITED STATES FEDERAL tieicolors,Drovid es for the approval of color additives REGULATIONS AFFECTING FOOD hat mi r npt from certifica COMPOSITION on, D 2.2.1 Unlted States Food and cod Additi qu dm h Color Additives ant c Drug AdminIstration(FDA) The nutrition laheling at d education act of 1990 nent agency within the (NLEA),described further in Chapter 3,made nutrition and Huma Services(DHHS) labeling mandatory on most food products under FDA or regt aing,among oth urisdiction,and established definitions for health and nutrient claims The NLEA emphasized the relation monitor the affected industries and ensure the con to c sumer of the safety of such products.A comprehensive ent Health and Education collection of federal laws,guidelines,and r gulations lem relevant to foods and drugs has been published by the ulations for dietary om those in Food and Drug Law Institute(2). ED&C Act and in acts vant to dietary supple passed prior to 1994.The DSHEA defined sup 2.2.1.1 Legislative History as"dietary ingredients"(defined in specific but broad terms),set criteria to regulate claims and labeling,and Cosm hed government agencies to handle regulation. of 1938 ssified ow as etary ing ents rat er than by d t assure he previously us tary nde f th nd Tg.A4卫 This law.which broadened the pe of the foc and od for raditio Drug Act of 1906,further defined and set regulations mlation of dietar o ents have been separated on adulterated and misbranded foods.The FDA was rom those for traditiona food given power to seize illegal products and to imprison The Food Quality Protection Act(1996)amended and fine violators.An important part of the 1938 Act both the FD&C Act and the Federal Insecticide
PartI.General Inormation Fungicide program has the following components: 1.Determine potential hazards in each process. 2.Identify critical control points. 2.2.1.1.3 Other FDA Regulations TheFDAhas devel 3.Establish control limits for each critical control tior levels in ddition to the egulations des point t the EDaC Act of 1938 Most of them 45 n pro cedures to monit to imple Establis are published in Title 21 of the CFR.They include the Good Manufacturing Practice (GMP)regulations(21 atam of record keeping CFR 110),regulations r ing food labe ing(21 CFR guidelines 7.Estabis prog gram to verify efficacy of program 101),recal CFR104) ing re While GMPs and HACCP programs are based largely be on microbiological concerns,certain chemical anc healt and physical tests (e.g.inactivation of toxic constituents ive claims(discuss ed presence of extraneous m atter met ection)are in Cha or 3) often necessary to ensure the safety of foods With increasing responsibility being placed on food processors and regulatory agencies to ensure the safety 2.2.1.2 Food Definitions and Standards of foods eaten by consum ners,FDA has placed consi erable emphasis on GMI egula on Hazarc The food definitions and standards established by the FDA are published in 21 CFR 100-169 and include stan- A Critical Control Point (HA sys interag dards of identity,quality,and fill.The standards of identity,which have been set for a wide variety of and the Centers tood pro cts,are most relevant to l ana ol(CDC)(6)Both GMPand ysis of foods the chen ally est phasize the importance of preventing hazards, nts a to avoid problems associated with detecting hazards in permit foods. n set,and max The GMP regulations,legally based on the FD& els for ine ensive ingredients are sometimes Act,but not established t.The kind and amount of certain vitamins and min marke erals that must be present in foods labeled "enriched TL foo fe are specified.The standards of identity for some foods and include a list of optional ingre h 121 ant to food r no cream (2 Fig.2- th sta 1.General provisions that define and interpret the d an include ctations for maintaining ded analytical method for determining 3.go for design, con Although standards of quality and fill are less struction and mainte related to the chemical analysis of foods than are stan ocess con- dards of identity,they are important for economic and trols;and lerations.Standards of quality 5.Defect action levels (DALs)for natural and ed by the FDA for ecanned fruits and veg unavoidable defects t such as ten to eral GMPs (21 CFR 110), and vegetables foods (21 CFR 113),acidified foods (21 CFR 114),and tomato products,and seafood state how full a container bottled drinking water(21 CFR 129). must be to avoid consumer deception. Unlike GMP regulations,HACCP is a system developed and implemented by a food processor,orig inally designed to produce zero defect (no hazard)foo 2.2.1.3 Inspection and Enforcement ghts(9).The FD nos ave opted th heir inspection programs An HACCP eggs;
Chapter 2 United States Government Regulations S131160 Sour cream Methods of Analysis of the Association of Official (a)Description.Sour cream results from the souring,by Analytical Chemists,"13th Ed.(1980),which is incor- cing bacteria,of pasteurized cream. porated by reference Copies may be obtained from lactic acid produ our cream cont hen the food than tion of 18 percent the Asso al Analytica -nemists Inter hatio 4 7-25 Frederic Ave.,su pt th utr Capitol Stree btained by subtracting the m the weight of (1)Milkfat content "Fat Official Final Action." the food;but in no case does the food contain less than section 16.172. 14.4 percent milkfat.Sour cream has a titratable acidity (2)Titratable acidity-"Acidity-Official Final of not less than 0.5 percent,calculated as la ctic acid Action, section 16.023. (b)Optional ingredients.(1)Safe and suitable ingredi (d)Nomenclature.The name of the food is prevent syneresis,or extenc cre r alterna vely "Culture ur cream name of th appea he pr (2)Sodiun ze ent may be am The ad h ring a orecurso a declaration indicating the p that characterizes ther (3)Renne (4)Safe and suitable nutritive sweeteners. this chapter.If nutritive sweetener in an amount suffi- cient to characterize the food is added without addition (5)Salt. of character (6)Flavoring ingredients,with or without safe and rizing flavoring,the name of the food shall be pre by the wor swe ened su and f it juice (including concentrated fruit () he by th and suitable natural and artificial food fla- 01and130。i9 42FR14360,Mar.15,1977,a 2股8RoeR2网 nded at 47 FR 11824, vorin (c)Methods of analysis.Referenced methods in para graph(c)(1)and (2 of this section are from"ffcia 1une12.1989:58FR2891.1an.6.19931 2-1■ Standard of identity for sour cream.From 21 CFR 131.160(2002 gur。 FDA shares responsibilities with other regulator ples of how eDa interacts with other cies for certain foods.as described in later sections g the safety and analysis of foods follow work- this chapter.The FDA has responsibility for enforc- ing with the National Marine Fisheries Service toensure ing the 1938 FD&C Act as amended,which prohibits seafood safety,the FDA sets and enforces allowable adulteratton and misbranding of food products.Rele evels of contamin and pathogenic microorgan- ted foods,the sm in seafood.The FDA has jurisdiction o er som proc com ng wI The EDA and the standards of identity,standards of quality the EPA are enforced by the FDA.Imported food prod- dards of fill.nutrition labeling.and other labeling ucts regulated by the EDa are subiect to inspection regulations.It regulates color additives and the use of food additives for all foods e FDA work The FDA together with other federal agencies Depar described inth wihindividualstatesandtheUnitedstate s chapter and with state and ment of Agricu ensure th is refer to as the fd of dar the FDA mD