Foreign Material Manual - Agricultural Marketing Service

1 Marketing and Regulatory Programs Agricultural Marketing Service Fruit and Vegetable Program Specialty Crops Inspection Division Foreign Material Manual July 2013 Fore ign Material Manual Table of Contents FDA and SCI Division Guidelines .. 2 Classification and Segregation .. 2 SCI Division Guidelines .. 3 Methods of Analysis .. 3 Classification .. 4 Acceptance C riteria .. 6 TABLE I - A ccept anc e C riteria - Foreign Material (No FDA or SCI Division Gui de lines) .. 8 TABLE II - A cceptanc e Criteria (Off Flavor) .. 9 Sampling Rates .. 9 Segregation - Failing Lot s .. 10 SCI Division Foreign Material G ui delines ( for certain products NOT c overed by an FDA DAL).

2 12 Processed Raisins .. 13 Recording R esults .. 14 Agreement with Food & Drug A dministration .. 16 Completion and Maintenance o f Forms .. 17 Drosophila Egg and Larva Determination Tomato Products .. 22 Light F ilth .. 27 General Proc edures: .. 28 Wildman E xtraction for Canned and F rozen Berries .. 30 Rapid Jar Method .. 32 Macroscopic E xamination .. 34 Maggot s in Canned Mus hrooms .. 36 Mol d Count .. 39 Howard Mol d Counting Method .. 43 Sampl ing/Ins pection Procedures .. 48 Acceptance C riteria .. 50 Certification .. 52 Commodity S pecific Procedures .. 52 Mol d Analysis - C anned and Frozen Fruit and Berries.

3 52 i Mol d Analysis - Fruit N ectars, Purees, and Pastes .. 55 Mol d Analysis - P ineapple and Citrus P roducts .. 57 Mol d Analysis Canned T omatoe s and Tomato Products .. 59 Technical Ins pection Procedures for Microanalysis of P rocessed Raisins .. 61 Atta chments .. 66 ii SCI Division Inspection Series Foreign Material Manual Effective Date: July 2013 Page 1 of 66 INTRODUCTION This Manual is designe d for Specialty Crops Inspection (SCI) Division e mployees of the Department of Agriculture ( USDA). Its purpose is to assist in the uniform eva luation of f oreign Material in processed fruit a nd vegetable c ommodities.

4 This involves application of F ood and Drug (FDA) guidelines and procedures, which form an integral part of Division services . If needed, contact your i mmediate supervisor f or a ny situation not addressed in this Manual . This Manual contains links to various interna l and externa l sources of information. For inspection personnel without interne t or intrane t access, please contact your immediate supervisor to obtain hard c opies of documents as needed. GUIDE FOR ELECTRONIC USAGE The Administrative, Inspection, and Mana gement (AIM) S ystem of instruc tional manuals is ava ila ble e lectronically in Adobe A crobat Por tabl e Document For mat ( PDF) a t the f ollowing intrane t a ddress: http://agnis/sites/FV/PPB/ Whe n accessed electronically, AIM materials have h yperlinks and hypertext ( visible as underlined blue t ext) a va ila ble to the P DF user.

5 Clicking on a h yperlink takes the r eade r to a web site with infor mation relating to the subject. Hypertext will link the reade r to a different pa ge within the c ur rent Manual - or e ven a different Manual - with infor mation relating to the subject. For example, the h ypertext in the T able of C ontents allows a reader to go directly to the section of interest in the Manual by clic king on the s ection title within the Table of C ontents. PDF offers a v ariety of t ools depe nding on the A dobe version the r eader h as. The newer the version, the more tools ava ila ble. To learn about the variety of P DF s earch options ava ila ble: Clic k on the Help t ab on the top of this page, Then clic k on the Adobe A crobat Help b ar, Type t he word Search i n the Search box, a nd clic k on the Search button, A series of options will become a vaila ble, Clic k on the Access Search Features link and fol low the instruc tions for the t ype of search you are interested in.

6 This document for mat a llows a P DF user to easily s earch for c ontent within a document, or within multiple documents. SCI Division Inspection Series Foreign Material Manual Effective Date: July 2013 Page 2 of 66 FDA AND SCI DIVISION GUIDELINES Title 21, Code of Federal Regulations (CFR), Part which may be f ound at the f ollowing interne t a ddress: ys/ allows the F ood and Drug Administration (FDA) to establish maximum leve ls of natural or unavoidable defects in foods for human use that present no inherent hazards to health. The F DA publication "Defect Leve ls Handbook The F ood Defect Action Levels," contains the action leve ls for n atural or unavoidable defects that may be p resent in certain processed fruits, ve getables, and related pr oducts intended for human use.

7 This publication may also be f ound on the F DA website a t the f ollowing interne t a ddress: Poor manufacturing pr actices and/or products that are harmful to consumers may result in enf or cement or r egulatory a ction without regard to the e nd product defect leve l. Likewise, the mixing or blending of f ood with a defect a t or a bove the c ur rent defect action leve l with another lot of the s ame or a nother f ood is not permitted. Suc h a practice would render the f inal f ood unlawful regardless of t he defect leve l of the f inished food. FDA has set a defect action leve l ( DAL) for certain defects which pose no inherent hazard to health.

8 These limits have been established because it is economically impractical to grow, harve st, or process raw products that are totally free of non-hazardous, naturally occur ring, unavoidable de fects. The action leve ls are not intended to cover poor manufacturing pr actices. The D AL represents a s pecific number a t which FDA will regard the f ood pr oduct a s being adulterated and subject to enf or cement action to ensure that c ontaminated pr oduct does not reach the c onsumer. Classification and Segregation The limits established for f oreign Material in this guide are b ased upon the nature of the Material , the impact upon the c onsumer, the capability of t he industry to remove such Material under good (acceptable) c ommercial practices, and the possible harmful effect of such Material .

9 The F DA recognizes that three factor s must be t ake n into account in eva luating the presenc e o f an adulterant in food: 1. Significance to public health; 2. Origin ( , field pest vs. stored product pest); a nd 3. Concentration (how many or how much was found in a known amount of food). Products that are n ot covered b y the FDA DALs that c ontain Foreign Material a re subject to regulatory action if a lot fails the criteria in Table I, and it is not maintained under A gricultural Marke ting Service ( AMS) c ontrol. For products with Foreign Material which poses no inherent ha zard to health, use C lasses 1, 2, and 3 in Table I.

10 For products containing ha rmful Material , use C lass 4 and Grade N ot Certif ied (GNC) in Table I SCI Division Inspection Series Foreign Material Manual Effective Date: July 2013 Page 3 of 66 SCI Division Guidelines Guidelines have been established by SCI f or certain defects that are not covered by an FDA DAL, a nd the t able is shown on page 12 ((SCI Division Guideline). No grade w ill be assigne d to a commodity that fails a SCI guideline. Additionally, a ll items bearing Official Marks as described in the r egulations must be e xamined for wholesomene ss according to the applicable table in this instruc tion.)