fsma: a foreign suppliers guide webinar slides.pdf · processing, packing, or holding of “food”...

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FSMA: A Foreign Suppliers GuideApril 27, 2016

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Presenters

Melvin S. DrozenPartnerWashington, [email protected]

David J. EttingerPartnerShanghai, [email protected]

Natalie E. RainerAssociateSan Francisco, [email protected]

Alissa D. JijonAssociateWashington, [email protected]

Jenny LiLegal ConsultantShanghai, [email protected]


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Agenda

Provide a high-level overview of three major rulesto implement the FDA Food Safety ModernizationAct (FSMA)• Hazard Analysis and Risk-Based Preventive

Controls (HARPC)• Produce Safety Standards• Foreign Supplier Verification (FSVP)

Together, these rules represent significant newcompliance obligations for the food industry, fromfarms to ingredient suppliers to finished foodprocessors

All three rules affect both domestic and foreignsuppliers to the U.S. market


FSMA Background

Enacted in 2011, the FDA Food Safety ModernizationAct (FSMA) has been the most sweeping reform of theU.S. food regulatory framework in over 70 years

Shifts regulatory focus from responding tocontamination to preventing it; new requirementsrelated to:

• Record inspection

• HARPC

• Intentional adulteration

• Sanitary transportation of food

• Imports


OVERVIEW OF FINAL HUMANHARPC/GMP RULE


Final Human HARPC/GMP Rule

Published on September 17, 2015• 80 Fed. Reg. 55908

Failure to comply with HARPC requirements is a

prohibited act (FD&C Act § 301(uu))

Failure to comply with GMP requirements may result in

food becoming adulterated or misbranded

Applies (with few exceptions) to registered food

facilities

Animal HARPC/GMP rule also exists, with provisions

substantially similar to those in the Human HARPC

rule covered here


Who really needs to comply?

Trigger for HARPC and GMP complianceis FDA facility registration under Section415

• Facilities that handle only food-contactsubstances thus are exempt from HARPC

Certain registered facilities are exemptfrom HARPC compliance or are subjectto modified requirements


Who is exempt?

Qualified facilities• Defined with respect to food sales volume and type of sales• Subject to modified requirements

Activities subject to seafood, juice, and LACF HACCP requirements• For LACF facilities, exemption applies only with respect to

microbiological hazards

GMP-compliant dietary supplement facilities Farms Low risk activity/food combinations performed by farm mixed-type

facilities that are small or very small businesses Alcohol beverage facilities Facilities solely storing non-fruit & vegetable raw agricultural

commodities for further distribution/processing Facilities storing packaged food not exposed to the environment

• Modified requirements related to storage of food that requiresrefrigeration


Registration Refresher

The trigger for registration is manufacturing,processing, packing, or holding of “food”

Raw materials and ingredients are “food”• According to FDA’s historical policy and statements, if a

company “reasonably believes that a substance is reasonablyexpected to be directed to a food use,” such a substance isregulated as food.

– 68 Fed. Reg. 58894, 58910-58911 (Oct. 10, 2003)

Even “secondary direct” additives may triggerregistration – depends on whether or not theymeet the “food-contact substance” definition


HARPC Elements

Written food safety plan

Hazard analysis

Preventive controls

Recall plan

Monitoring

Corrective actions

Verification activities

Supply-chain program

Records


Written Food Safety Plan

Must be written

Keep supporting recordsfor at least 2 years

Plan and records mustbe made available toFDA

Reanalysis required atleast every 3 years

Must be prepared by apreventive controlsqualified individual


Hazard Analysis

Consider known orreasonably foreseeablehazards that occurnaturally, as well as thosethat are introducedunintentionally orintentionally for economicgain

Biological

Parasites

EnvironmentalPathogens

Microorganisms ofpublic healthsignificance

Chemical

Pesticides

Drug residues

Natural toxins

Decomposition

Unapproved foodand color additives

Allergens

Radiological

Physical

Contamination byfragments (stone,metal, glass, etc.)


Hazard Analysis Factors

When evaluating hazards consider:• Severity of the illness or injury if hazard were to occur

and probability that hazard will occur without preventivecontrol

• Evaluation of environmental pathogens when ready-to-eat food is exposed to the environment prior topackaging where there is no treatment or other controlmeasure that would minimize the pathogen

• Specific factors such as formulation of food, facility &equipment, raw materials, transportation, processingconditions, intended use, sanitation, natural toxin levels

Goal is to determine whether any hazardsrequire the development of preventivecontrols


Preventive Controls

Purpose: To provide assurance that hazards will besignificantly minimized or prevented

Measures may include:• Process controls• Food allergen controls• Sanitation controls• Supply-chain controls• Recall plan

In some cases, an aspect of GMP compliance mayserve as a preventive control for a hazard. Wherethis is the case, the GMP becomes part of theHARPC plan, and associated requirements such asmonitoring, corrective actions, etc. attach toimplementation of that requirement.


Preventive Controls – Examples

Facility identifies raw materials thatcould be contaminated with Salmonella• Potential preventive control = a process

control, such as heat processing (e.g.,pasteurization)

Facility identifies metal fragmentationas a physical hazard due to the use ofmetal cutters and slicers duringprocessing• Potential preventive control = periodic

equipment checks to evaluate and addresswear and tear


PCs Not Required…

Facility exempt from implementing a preventive controlwhere:• Food cannot be consumed without downstream control (e.g.,

coffee beans, grains)

• Customer or subsequent entity in distribution chain will ensurethat the hazard is significantly minimized or prevented

– Must note on documents that food is "not processed to control[identified hazard]" and

– Obtain annual written assurance from customer

These exemptions are particularly important foringredient suppliers, who may be able to “delegate”implementation of preventive controls to customers.


Recall Plan

Recall plan required for all foods that have a hazardrequiring a preventive control

Plan must be written and must include the proceduresand persons responsible for performing the followingtasks:• Notifying direct consignee

• Notifying public

• Conducting effectiveness checks

• Disposing of recalled food


Monitoring

Written procedures to monitor thepreventive control (including frequency)

Monitor the preventive controls withadequate frequency to ensure they areconsistently performed

Document monitoring in records (subjectto verification)


Monitoring – Examples

Monitoring of pasteurization processcontrol to mitigate Salmonellacontamination = checkingtime/temperature records to ensureprocess met parameters necessary toeliminate pathogens

Monitoring of equipment check controlsto prevent metal fragment contamination= use of appropriately sensitive metaldetector on production line


Corrective Actions

Corrective action taken when preventive control is notproperly implemented

Corrective actions are written and specific to thehazard and preventive control

Example: Establish procedures for dealing with apathogen or indicator organism in ready-to-eat productfound by product testing


Verification/Validation

Verification activities must be appropriate topreventive control and documented inrecords Include verification of monitoring and corrective

actions

Product testing and/or environmental monitoring

Checking/calibrating process monitoring andverification instruments to ensure effectiveness

Preventive controls qualified individual mustvalidate or oversee validation of preventivecontrols


Validation Not Required…

Some PCs do not require validation:

• Food allergen controls (human food)

• Sanitation controls

• Recall plan

• Supply-chain program

• Other preventive controls where thepreventive controls qualified personprepares written justification for whyunnecessary


Supply-Chain Program

Receiving facility must establish andimplement a risk-based supply-chainprogram for raw materials and otheringredients that they have identified as ahazard that requires a “supply-chainapplied control”


Supply-Chain Program Elements

Use of approved suppliers (limited exception for temporary useof unapproved suppliers)

Determining appropriate supplier verification activities

• Onsite audits;

• Sampling and testing of raw material or other ingredient;

• Review of supplier’s relevant food safety records;

• Other appropriate activities based on supplier performance and therisk associated with the raw material/ingredient

Conducting/documenting supplier verification activities

Where applicable, verifying supply-chain control applied by anentity other than receiving facility’s supplier


GMP Revisions for Human Food

Deletion of nonbinding provisions

Conversion of previously nonbinding provisionsto binding requirements• Education: all employees must receive training

consistent with their duties

• Training: employees must receive training in foodhygiene and food safety principles (and suchtraining must be associated with recordkeeping)

Addition of provisions regarding allergen cross-contact

Note: Animal HARPC/GMP rule implementsGMPs for animal food for the first time


OVERVIEW OF PRODUCESAFETY RULE


Final Produce Safety Rule

Effective January 26, 2016.

• Covered farms generally have two years tocomply; smaller farms have more time

• One year to comply with uniquerequirements for sprouts; more time forsmaller farms


Final Produce Safety Rule (con’t)

Standards for agricultural water,biological soil amendments, sprouts,domesticated and wild animals, workertraining/health/hygiene, equipment, tools,and more


Applicability

Apply to “primary production farms,”which includes physical locations wherecrops are grown/harvested and livestockis raised (aquaculture included)

• Also apply to packing sheds

Apply to “secondary activities farms” notlocated at primary production farm butdevoted to harvesting (e.g., hulling,shelling), packing


Exemptions

Produce not normally consumed raw:potatoes, various shell beans (e.g.,garbanzo and black), asparagus, pumpkins,and others

Food grains (e.g., barley, oats, rice, wheat)


Exemptions (con’t)

Produce for personal or on-farmconsumption

Farms whose annual value of producesold in previous three years is $25,000 orless

Produce that is not a raw agriculturalcommodity (RAC)


Exemptions (con’t)

Produce that ultimately undergoessufficient processing to adequatelyreduce microorganisms of public healthsignificance; examples:

• Foods subject to Low acid canned foodsregulations

• Acidified foods

• Juice HACCP

• Refining/Distilling/Other processing toproduce sugar, oil, spirits, beer, etc.


Are frozen fruits and vegetables exempt?

Only exempt if processing(e.g., blanching, freezing) adequatelyreduces presence of pathogens

• Processes must be validated


Agricultural Water

Water intended to (or likely to) contactharvestable portion of covered product orfood-contact surfaces.

• Must be safe and of adequate sanitary quality(e.g., microbial quality, E. coli)

• Requirements for inspection, maintenance,testing of water, water sources, anddistribution systems

• Record keeping required forwater test results, etc.


Biological Soil Amendments of Animal Origin

Material of animal origin, including manure,intentionally added to soil to• improve chemical or physical condition for growing

plants or

• improve soil’s capacity to hold water

Different requirements for treated versusuntreated• Untreated may not contact covered produce

during application, and there must be minimalpotential for contact with produce after application

• Recordkeeping requirements apply


Biological Soil Amendments of Animal Origin (con’t)

Treated amendments/Stabilized compostsubject to limits on pathogenic organisms:• L. monocytogenes: ND using LOD of one CFU

per 5 g (or mL)

• E. coli 0157:H7: ND using LOD of 0.3 mostprobable numbers (MPN) per 1 g (or mL)

• Salmonella: ND using LOD of 3 MPN per 4 g(or mL)

Must be handled so that untreated soilamendments do not contaminate treatedmaterial.


Sprouts

The growing conditions of sprouts raiseunique safety concerns• Special sprout rules do not apply to soil- or

substrate-grown sprouts harvested without theirroots

Produce safety regulations include hazardanalysis, facility, sanitation, testing,sampling, and recordkeeping requirementsfor both• Farms producing seeds/beans

for sprouts and• Sprout growers


Domesticated and Wild Animals

Animal-related requirements apply whenthere is a reasonable probability thatanimals will contaminate coveredproduce• Section 112.112 applies immediately prior to

and during harvest; Section 112.83 appliesduring growing season

• FDA specifies that these regulationsdo not require exclusion of animals,destruction of animal habitats, andsimilar activities


Worker Training and Health and Hygiene

Personnel handling produce or food contactsurfaces (and supervisors) must receivetraining upon hiring and at least once annuallythat includes

• Principles of food hygiene and safety

• Importance of health and personal hygiene

• Standards established in Produce Safety Ruleapplicable to the staff’s duties


Equipment and Tools

Must be installed to permit propercleaning of equipment and adjacentspaces

Must be stored and maintained so as toprevent contamination of produce andprevent attracting/harboring pests


Buildings

Requirements apply to

• Fully or partially enclosed buildings used forcovered activities (e.g., packing houses),

• Storage sheds/structures used to store foodcontact surfaces (e.g., harvest contains andfood packing material)


OVERVIEW OF FINALFOREIGN SUPPLIER

VERIFICATION PROGRAM(FSVP) RULE


Final FSVP Rule

Published on November 27, 2015

• 80 Fed. Reg. 74226

Importation of food without implementing

FSVP is a prohibited act

(FD&C Act § 301(zz))

Alignment with FSMA preventive controls

(PC) supply-chain provisions


Who needs to comply?

FSVP rule applies to all importers of food

• Importer: U.S. owner or consignee of a foodat time of U.S. entry;

– where there is no such entity at the time of entry,the importer is the U.S. agent or representative ofthe foreign owner or consignee

• Food defined broadly to include rawmaterials, ingredients, finished food andfood-contact substances


Exemptions from FSVP

Food subject to seafood, juice, and LACF HACCPrequirements

Food imported for R&D purposes or for personal use

Alcoholic beverages imported from certain foreignsuppliers

Food transshipped or imported for processing andexport

Food returned to the U.S. without further processingin a foreign country

Certain meat, poultry, and egg products under USDAjurisdiction


Exemptions from FSVP (cont.)

Importers that are HARPC-compliantfacilities (more on this later)

Importers of fruits and vegetablessubject to Produce Safety rule

Importers of dietary supplementssubject to (and compliant with) certainsupplement GMP requirements

Very small importers and importers offood from certain small foreignsuppliers (more on this later)

Food imported from a country with anofficially recognized U.S.-equivalentsafety system

…


More on Preventive Controls (PC)

Importers are deemed to be incompliance with most of FSVP if they

• Comply with PC supply-chain provisions

• Implement preventive controls under PCregulation for hazards in imported food

• Are not required to implement a preventivecontrol under certain PC provisions


Very Small Importers and Food from CertainSmall Suppliers

Very small importers (VSI)

• Less than $1 million/year in human food sales

• Less than $2.5 million/year in animal food sales

Food from certain small suppliers

• Qualified facility

• Produce from certain small suppliers that arenot covered farms

• Shell egg producers with < 3,000 laying hens


FSVP Elements

The importers shall

Conduct analysis of hazards

• Will the imported food reasonably likely causeillness or injury?

Evaluate and approve foreign suppliers basedon hazard analysis

Conduct supplier verification activities

Take corrective actions when appropriate

Maintain records of FSVP activities


Use of Qualified Individuals

Must use a qualifiedindividual to perform allrequired FSVP tasks

Qualified individualsmust have the training,education, or experience

Qualified individualsmust not have anyfinancial conflicts ofinterest


Hazard Analysis

Similar to HARPC framework

Goal: to determine whether it is necessaryto implement any measures to controlhazards

To implement, importers must documentand conduct a hazard analysis for all knownor reasonably foreseeable hazards

An importer may assess another entity’shazard analysis


Foreign Supplier Evaluation

Food must be imported from foreignsuppliers that have been evaluated andapproved

Evaluation must take into account:• Hazard analysis

• Entities responsible for controlling hazards

• Foreign supplier’s food safety performance

• Foreign supplier’s compliance status underFDA or foreign regulations

Importers must reevaluate their foreignsuppliers at least once every three years


Foreign Supplier Verification

Establish and follow written procedures thatverify• food is only imported from approved suppliers, and

• hazards identified in imported food are appropriatelycontrolled

Appropriate verification activities include:• Onsite audits of foreign suppliers

• Sampling and testing of food

• Review of foreign supplier’s relevant food safety records

May rely on another entity’s determination


Other FSVP Requirements

Corrective actions must be documented

Importers must maintain related recordsfor at least two years and provide recordsto FDA on request


FSVP Implications for Imported FCS

FSVP rule applies to Food-ContactSubstance (FCS) importers

• This includes finished packaging articles(e.g. bottles and closures), as well as resinsand preforms

• All the aforementioned FSVP requirementswill likely apply to FCS importers

– unless an applicable exemption to the rule can beidentified by the importer (e.g. the importerdetermines there are no hazards associated withthe imported FCS)


FSVP Implications for Imported FCS

Unexpected decision by FDA to subjectFCS importers to FSVP rule

Keller and Heckman LLP leading industryinitiative to obtain better understanding

Will have better clarity on complianceobligations for FCS importers under theFSVP rule in near future


What does compliance mean? Compliance is likely to mean different things to

different entities in the supply chain

There is no “one size fits all” approach to complyingwith HARPC, GMPs, Produce Safety, or FSVP

Compliance must be tailored to individual foods andfacilities

Common element = qualified individuals mustimplement compliance strategies across facilities


Compliance Deadlines

Revised GMPs & HARPC: September 19, 2016

Produce Safety: January 26, 2018

• January 26, 2017 for covered activities related tosprouts

FSVP: the latest of

• 18 months after final rule (May 29, 2017)

• If supplier is subject to the PC or produce safetyregulations, 6 months after the food foreign supplier isrequired to comply with the relevant regulations


Questions & Answers


Washington, DC • Brussels • San Francisco • Shanghai • Paris

Keller and Heckman LLP

THANK YOU!

Melvin [email protected]

David [email protected]

Natalie [email protected]

Alissa [email protected]

Jenny [email protected]

fsma: a foreign suppliers guide webinar slides.pdf · processing, packing, or holding of “food”...

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