cfsan food gmps

8/8/2019 Cfsan Food Gmps

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Food GMPFood GMPModernizationModernization

Don L. Zink, Ph.D.Don L. Zink, Ph.D.

U. S. Food and Drug AdministrationU. S. Food and Drug Administration

Center for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition



Why Modernize Food CGMPs?Why Modernize Food CGMPs? Originally written in 1969, last revised in 1986Originally written in 1969, last revised in 1986

Revolutionary new understanding of the causesRevolutionary new understanding of the causesof foodborne illness compared to 20 years agoof foodborne illness compared to 20 years ago

Evolutionary changes in the food industry andEvolutionary changes in the food industry and

farm practices since 1986farm practices since 1986 Increased sales and consumption of fresh produceIncreased sales and consumption of fresh produce

itemsitems

More refrigerated readyMore refrigerated ready--toto--eat foodseat foods

More meals consumed outside the homeMore meals consumed outside the home

Fewer meals prepared from “scratch” Fewer meals prepared from “scratch”



Revolutionary Changes in OurRevolutionary Changes in Our

Understanding of Food SafetyUnderstanding of Food Safety

Listeria monocytogenes Listeria monocytogenes is now recognized asis now recognized as

a significant hazard that can becomea significant hazard that can becomeestablished in the food manufacturingestablished in the food manufacturingenvironmentenvironment

Expanded view of food safetyExpanded view of food safety Food allergens are now recognized as a hazardFood allergens are now recognized as a hazard

We now have a FarmWe now have a Farm--toto--Table view of foodTable view of foodsafetysafety Salmonella Salmonella control in fresh eggscontrol in fresh eggs

Fresh produce as a source of Fresh produce as a source of Salmonella, E. coli Salmonella, E. coli O157:H7,O157:H7, Cyclospora, and Cyclospora, and HAVHAV



Approach to CGMP ModernizationApproach to CGMP Modernization

How can we amend the regulation toHow can we amend the regulation to

make it “risk make it “risk --based” based”

Involve stakeholders early in the processInvolve stakeholders early in the process

Keep what has worked well in the pastKeep what has worked well in the past Modernize the regulation in “phases” if Modernize the regulation in “phases” if

necessarynecessary



GMP ResearchGMP Research

Literature reviewLiterature review

Examined other approaches to GMPsExamined other approaches to GMPs

Expert ElicitationExpert Elicitation

Identified the most significant problems andIdentified the most significant problems andmost needed preventive controlsmost needed preventive controls

Class I and II recall analysisClass I and II recall analysis

Characterized the causes of processingCharacterized the causes of processingfailures that led to recallsfailures that led to recalls



Expert ElicitationExpert Elicitation

Most significant food safety problems:Most significant food safety problems:

Deficient employee trainingDeficient employee training

Contamination of raw materialsContamination of raw materials

Poor plant and equipment sanitationPoor plant and equipment sanitation

Poor plant design and constructionPoor plant design and construction



Research ResultsResearch Results

Expert Elicitation:Expert Elicitation: Need for GMP requirements for:Need for GMP requirements for:

TrainingTraining – – Ongoing and targeted trainingOngoing and targeted training

Audits Audits – – Periodic inspections by inPeriodic inspections by in--house orhouse or

external auditorsexternal auditors SOPs/SSOPsSOPs/SSOPs

Documentation of sanitation and key controlsDocumentation of sanitation and key controls

Validation/Evaluation Validation/Evaluation – – prove the effectiveness of prove the effectiveness of

controls, sanitation and trainingcontrols, sanitation and training



Recall AnalysisRecall Analysis

Reviewed class I and class II recalls forReviewed class I and class II recalls for

19991999 – – 20032003

Determined which recalls could have beenDetermined which recalls could have been

prevented by a GMPprevented by a GMP--type preventivetype preventivecontrolcontrol

Two food scientists examined each recallTwo food scientists examined each recall

file to identify the likely root causefile to identify the likely root cause



Recall AnalysisRecall Analysis

1,307 recalls were class I or II during the1,307 recalls were class I or II during the

5 year period5 year period

684 (50%) were class I and 649 (50%)684 (50%) were class I and 649 (50%)

were class IIwere class II 1,146 recalls (88%) occurred because of a1,146 recalls (88%) occurred because of a

GMPGMP--related problem (including labelingrelated problem (including labeling

problems)problems)



Recall AnalysisRecall AnalysisFigure 1: Recall actions by specific processor-level problems*

(N=1146)

4%

68%

8%

9%

32%

26%

8%

0% 10% 20% 30% 40% 50% 60% 70% 80%

Incorrect packaging/labeling

Ineffective employee training

Failure to follow processing SOP

Contamination of raw materials

Excess/mistaken addition of chemicals/ingredients

Ineffective use of sanitation principles

Unknown



Public CommentsPublic Comments

Most common themes in comments:Most common themes in comments:

The need to maintain flexibilityThe need to maintain flexibility

The need for guidanceThe need for guidance

TrainingTraining Food allergen controlsFood allergen controls

Environmental monitoringEnvironmental monitoring

Written sanitation proceduresWritten sanitation procedures Temperature controlsTemperature controls



Modernization OpportunitiesModernization Opportunities

Training for supervisors and workers toTraining for supervisors and workers to

ensure that they have the necessaryensure that they have the necessaryknowledge and expertise in food hygiene,knowledge and expertise in food hygiene,

food protection, employee health andfood protection, employee health and

personal hygiene to produce safe foodpersonal hygiene to produce safe food

products.products.




Allergen control plans for food processing Allergen control plans for food processing

establishments that produce foodsestablishments that produce foodscontaining allergens.containing allergens.




Written environmental pathogen controlWritten environmental pathogen control

program for food processors that produceprogram for food processors that producereadyready--toto--eat foods that support theeat foods that support the

growth of growth of Listeria monocytogenes Listeria monocytogenes ..




Written sanitation procedures that defineWritten sanitation procedures that define

the scope, sanitation objective,the scope, sanitation objective,management responsibility, monitoring,management responsibility, monitoring,

corrective action and record keepingcorrective action and record keeping

associated with the sanitation procedure.associated with the sanitation procedure.



Modernization OpportunitiesModernization Opportunities 21 CFR Part 110.19(a) excludes “establishments21 CFR Part 110.19(a) excludes “establishments

engaged solely in the harvesting, storage, orengaged solely in the harvesting, storage, ordistribution of one or more ‘raw agriculturaldistribution of one or more ‘raw agricultural

commodities,’ ... which are ordinarily cleaned,commodities,’ ... which are ordinarily cleaned,

prepared, treated, or otherwise processedprepared, treated, or otherwise processedbefore being marketed to the consuming public” before being marketed to the consuming public”

from compliance with the regulations in Partfrom compliance with the regulations in Part

110. Part 110.19(b) states “FDA, however, will110. Part 110.19(b) states “FDA, however, willissue special regulations if it is necessary toissue special regulations if it is necessary to

cover these excluded operations.” cover these excluded operations.”



Modernization OpportunitiesModernization Opportunities “…manufacturers must keep certain types of “…manufacturers must keep certain types of

processing records to document that controlsprocessing records to document that controlsand systems that ensure food safety are beingand systems that ensure food safety are beingcarried out properly, and that the agency needscarried out properly, and that the agency needsto be able to review these records in order toto be able to review these records in order to

verify that a food establishment is in complianceverify that a food establishment is in compliancewith the regulations.” with the regulations.” TrainingTraining

Allergen Control Plan Allergen Control Plan Listeria monocytogenes Listeria monocytogenes control plancontrol plan

Sanitation proceduresSanitation procedures




Amend 21 CFR 110.80(b)(3) which lists Amend 21 CFR 110.80(b)(3) which lists

specific temperature requirements for hotspecific temperature requirements for hotand cold storage of foods, and insteadand cold storage of foods, and instead

issue guidance for temperature controlissue guidance for temperature control



Current StatusCurrent Status During the past year, staff resources have beenDuring the past year, staff resources have been

devoted to fresh produce issues and the citizen’sdevoted to fresh produce issues and the citizen’spetition on a “tolerance” forpetition on a “tolerance” for Listeria Listeria

monocytogenes monocytogenes in foods that do not supportin foods that do not support

growthgrowth We are now putting some staff resources back We are now putting some staff resources back

into the CGMP Modernization effort and we areinto the CGMP Modernization effort and we are

in the early stages of drafting a proposed rulein the early stages of drafting a proposed rule GMP research questionnaireGMP research questionnaire

cfsan food gmps

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