current fda food requirements and the new food safety modernization act€¦ · ·...

Current FDA Food Requirements

and the New Food Safety Modernization Act

Presented by Registrar Corp January 21st, 2016

About Registrar Corp Registrar Corp is a consulting firm providing regulatory compliance services for companies regulated by the U.S. Food and Drug Administration. The company is made up of 140 people worldwide, with 85 staff based in the U.S., including former U.S. FDA employees, scientists, and Regulatory Specialists. Registrar Corp assists each year over 18,000 companies in more than 160 countries around the world. The company serves all sectors regulated by U.S. FDA, including Food & Beverages, Cosmetics, Medical Devices, Drugs, and Radition-emitting Electronic Devices. More information may be found at http://www.registrarcorp.com

Quick Review: Top Ten Requirements for Manufacturers and Exporters of Food and Beverages to the United States (presented by David Lennarz)

DWPE: the “Dreaded Red” (presented by Mark Prinz) FSMA: New Rules (presented by Edwin VelezRivera) Questions & Answers

Webinar Overview

About our Speaker David Lennarz is a Vice-President at Registrar Corp. Mr. Lennarz is a graduate of the University of Virginia, and has worked for nearly 22 years in FDA-regulated industries in the U.S. and Europe. Mr. Lennarz has conducted seminars on U.S. Food and Drug Administration regulations for Food & Beverages, Drugs, Medical Devices, and Cosmetics for trade associations, trade shows, and governments in more than 30 countries around the world. He served as a Technical Expert for the U.S. Food and Drug Administration’s Foreign Facility Registration Verification Program operated by FDA’s Division of Field Investigations. He co-founded Registrar Corp in 2003 and is based in Registrar Corp’s head office in Hampton, Virginia.

Top 10 FDA Regulations for Food & Beverage Manufacturers and Exporters

#10: Good Manufacturing Practices (aka “GMPs”)

Presenter

Presentation Notes

1. Guidelines and conditions which must be met by every food facility to ensure production of safe and wholesome foods. GMPs required for all food and beverages are found in 21 CFR Part 110 and Part 111 for dietary supplements Failure to establish or follow GMPs is the top reason companies encounter difficulty with FDA. Since FDA doesn’t inspect every food factory in the world, one way they determine if a company is following GMPs is through inspections of products in our ports of entry. Many of you as customs brokers have seen Notices of Action that state a shipment has been detained because of “adulteration” (things like Salmonela, e-coli, or listeria) or filth. So if your client is importing food products from overseas, making sure their suppliers are following GMPs is critical.

#9: Food Safety

HACCP and Preventative Controls • Focuses on the prevention of hazards • HACCP required for Seafood and Juice product

Presenter

Presentation Notes

Part of following Good Manufacturing Practices means adhering to food safety systems. HACCP and following Preventative Controls is a current requirement for Seafood and Juice manufacturers. And FDA will occasionally detain shipments because the Importer does not have evidence that the manufacturing is operating under a HACCP Plan.

#8: Low-Acid Canned Food (“LACF”) Requirements

Presenter

Presentation Notes

Products that are low-acid, acidified, or thermally processed in a bottle, can, jar, flexible pouch or Tetra-pak The foreign manufacturer of the products must have a 5 digit Food Canning Establishment registration and submit Process Filings to FDA Process Filings (aka “SIDs”) required for each and every product & package size. A good example of an Acid Food is canned tuna. A good example of an Acidified Food is canned peaches.

#7: Labeling Requirements

Presenter

Presentation Notes

Complying with FDA labeling requirements Label is not just the label: website, brochures, marketing materials are also considered by FDA English (additional languages OK if fully translated) Specific requirements for front and side panels, including Fact Chart, Ingredients List, etc

#7: Future Changes to Labeling

Presenter

Presentation Notes

Be on the look out for a new rule for Nutrition Facts due in March 2016: The new rules will effectively mean every label for food sold in the U.S. will have to be changed to conform to the new requirements. There will be a “phase in” period for compliance, so there is no reason for panic, but the new rule will require changes.

#6: Product Claims

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Presentation Notes

Claims on labeling FDA Regulates four types of claims Nutrient, relative, structure/function, health Unapproved new drug or dietary supplement? Does a product claim to “diagnose, cure, or mitigate?” FDA may rule product is a drug. Exporters of dietary supplements often encounter claim-related detentions

#5: Facility Registration

Presenter

Presentation Notes

Registration of facility with FDA First required under the Bioterrorism Act starting in 2003 Registration of location that manufactures, processes, packs, or warehouses food for human or animal consumption 11-digit number issued by FDA Must be updated within 60 days of any change. You should not register a facility without their explicit permission to do on their behalf. Part of the registration process requires a registrants to consent to FDA inspection.

#4: Facility Registration Renewal

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Presentation Notes

Food facilities have to renew by December 31,�2016. If they don’t, they will be required to re-register Renewal must be done between October 1st and December 31 of every even-numbered year Almost always, FDA is asking for new data It is highly likely that FDA will start asking for DUNs numbers, as already required for drug registrations.

#3: US Agent for FDA Communications

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Presentation Notes

Foreign facilities must designate a U.S. Agent for FDA communications The U.S. Agent acts as a communications link between FDA and your company The U.S. Agent receives important communications from FDA on your behalf (i.e. notices of inspection) The U.S. Agent must be physically located in the U.S. and available for FDA calls 24/7 Under the Food Safety Modernization Act, FDA is authorized to charge the U.S. Agent listed in Section 7 of a foreign food facilities registration “Re-Inspection” Fees, which could be the thousands of dollars. So you probably don’t want to serve as U.S. Agent unless you have a way to mitigate that risk.

#2: Prior Notice

Presenter

Presentation Notes

FDA Prior Notice Required before each and every shipment to the United States Typically performed by the customs broker with the entry submission However, if a shipment is coming in by express mail, such as FedEx, DHL, or UPS, it can be done through FDA’s Prior Notice System Interface Confirmation number issued by FDA Even if someone is just sending samples to buyers that will be consumed, or if serving food at a trade show, file a Prior Notice otherwise samples may not arrive

#1: New Rules of the FSMA

Presenter

Presentation Notes

Food Safety Modernization Act Signed into law in January 2011 – new burdens to be placed on US Importers and foreign manufacturers Grants FDA increased enforcement powers and mandates an increase in foreign inspections Various new requirements with different implementation dates: Preventative Controls, FSVP, VQIP, and 3rd Party Accreditation

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U.S. FDA Import Alerts

Mark Prinz, M.S. Senior Regulatory Specialist Thursday, January 21, 2016

Mark Prinz Senior Regulatory Specialist, Import Alerts

Mark Prinz holds a Master of Science degree in Biology from Old Dominion University in Norfolk, Virginia and has experience in both field and analytical research. Mr. Prinz began his career with Registrar Corp in 2010 reviewing the labeling and formulation of hundreds of products for FDA compliance. Since 2013, he has been heading Registrar Corp's Import Alerts department assisting international companies to develop the petitions required for removal or exemption from detention under various FDA Import Alerts.

An Issue of Resource Management

25-30 million entries per year Food, drugs, medical devices, and cosmetics

Over 300 possible ports of entry

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Import Refusals vs. Import Alerts

• Import Refusals result from a

single detention.

• Import Refusals occur when FDA inspects a shipment at its port of entry and determines it is non-compliant. That one specific non-compliant shipment is refused entry into the United States. Once a shipment is refused, it cannot be undone, so companies should carefully monitor their suppliers and the quality of products they ship.

• Import Alerts result in continuous detentions.

• Import Alerts occur when FDA notices a pattern of non-compliance from a particular company, country, or product type. All shipments of products listed on an Import Alert are subject to Detention Without Physical Examination (DWPE). Companies on Import Alert can petition for removal.

What is an Import Alert?

Notice to all entry ports that certain products from specific areas or manufacturers may be violative

Created whenever FDA discovers a pattern of violation that creates a reason to believe that future shipments may be similarly violative

Instructs FDA compliance officers to detain these products

More than 250 active Import Alerts

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Example: 36 Seafood-specific Import Alerts

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Additional Import Alerts Related to Seafood & Other Products

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99-19 (Salmonella) 99-22 (Allergen Labeling) 99-30 (Mislabeling) Etc…

Types of Import Alerts

List Import Alerts: Subject to the alert unless you’re on the Green List

List Import Alerts: Only subject to the alert if you are on the Red List

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List Import Alerts: Inherently risky products from anywhere in the world

• 16-20 – Puffer Fish (Tetrodotoxin)

Violations common or widespread in certain regions

• 16-07 – Dried or Pickled Finfish from Thailand (Filth) • 16-35 – Raw and Cooked Shrimp from India (Filth/Decomp/Salmonella)

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List Import Alerts: Based on the nature of the violation or history of the company

16-04 – Misbranded Seafood

16-120 – Foreign Processors Not in Compliance with Seafood HACCP

99-19 – Food Products due to Salmonella

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Detention Without Physical Examination (DWPE)

Shipment will be detained without inspector even looking at it

Works under the premise that the products appear violative based on a history of violation

NOT an automatic refusal The importer must present evidence to FDA that the product is

NOT violative in order to get a shipment released from detention

This process will repeat for ALL shipments for as long as the Import Alert is in effect

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16-35 Raw and Cooked Shrimp from India

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Importers Affected Too

Import Alert # 16-119 “Detention Without Physical Examination of Fish and Fishery Products For Importer And Foreign Processor

(Manuf) Combinations”

Failure to Comply with Seafood HACCP Verification Requirements

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FDA Import Alerts

What can be done if a company finds

themselves subject to DWPE?

PETITION!

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Removal from DWPE

A firm will remain subject to DWPE unless it provides evidence to FDA that it is no longer at risk

Petition sent to Division of Import Operations (DIO) to request removal May be 100+ pages in length Requires extensive documentary evidence

DIO reviews petition, which can take months before a decision is made

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Petition Requirements

Documentary evidence that the problem has been corrected or prevented Will vary depending upon the circumstances (e.g. a revised HACCP plan,

change of suppliers, label revisions, lab analyses of every lot, etc.)

A series of non-violative shipments to verify that the corrective or preventive actions are sufficient Minimum of 5-12 shipments Submission of shipping documents

• US Customs Form 3461 or 7501 • Commercial Invoice • Packing List • Bill of Lading

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Food Safety Modernization Act

(FSMA)

Presented by Edwin VelezRivera Thursday, January 21, 2016

Edwin Velezrivera Director of Food Safety

Edwin VelezRivera holds a Master of Science degree in Food Science and Technology from Kansas State University. Mr. VelezRivera has over 21 years of experience in the Food Safety, Auditing, and Food Defense profession. He has taken numerous FDA training courses, including "Good Manufacturing Practices (GMP)," "Food Code," "Inspection Techniques and Evidence Development,” and more. Mr. VelezRivera has been with Registrar Corp since 2012. His team performs mock FDA food facility inspections around the world, reviews and develops HACCP, Food Safety, and Food Defense plans, and executes other food safety related services.

Rules Having Direct Impact on Imports

Preventive Control Rule for Human and Animal Foods Foreign Supplier Verification Program (FSVP) Voluntary Qualified Importer Program (VQIP) Two Additional Rules we will NOT cover today are: Produce Safety Third Party Accreditation

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• Current Good Manufacturing Practice (GMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food • Originally proposed: January 16, 2013 • Supplemental proposal: September 29, 2014 • Public comments: More than 8,000 for the original

proposal; more than 1,300 for the supplemental proposal

• Final rule was published September 17th, 2015 • Implementation starts September 2016

Background: Preventive Control Rule for Human and Animal Foods

Who is Covered? • Facilities that manufacture, process, pack or

hold human food • In general, facilities required to register with

FDA under sec. 415 of the FD&C Act • Not farms or retail food establishments

• Applies to domestic and imported food • Some exemptions and modified requirements

apply

Other Exemptions

• Activities subject to Hazard Analysis & Critical Control Points (HACCP) regulations (i.e., seafood and juice)

• Manufacturing, processing, packing, and holding of dietary supplements

• Alcoholic beverages at certain facilities • Activities subject to low-acid canned food

regulations (microbiological hazards only)

New Food Safety Plan Requirement

• Hazard analysis • Preventive Controls • Monitoring Procedures • Corrective Actions • Verification Procedures • Recordkeeping

New Supply Chain Program Requirement

Manufacturing/processing facilities must have a risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt (“supply-chain applied control”).

New Supplier Verification Activities

• Onsite audits (default for serious hazards) • Sampling and testing • Review of relevant food safety records • Review and Monitoring of FDA Compliance

Status of manufacturers

Activity and frequency based on nature of hazard, where it is controlled and supplier

performance.

• Very small businesses and Businesses subject to Pasteurized Milk Ordinance • Less than $1 million in annual food sales • Three years (September 17, 2018)

• Small businesses • Businesses with fewer than 500

full-time employees • Two years (September 17, 2017)

• All other businesses • One year (September 17, 2016)

Compliance Dates for Businesses

Planned Guidance

• Hazard analysis and preventive controls • Environmental monitoring • Food allergen controls • Validation of process controls • A Small Entity Compliance Guide that explains

the actions a small or very small business must take to comply with the rule

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Final Rule on Foreign Supplier

Verification Programs

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Background: Foreign Supplier Verification Program

Foreign Supplier Verification Rule (“FSVP”) Proposed rule: July 29, 2013 Supplemental proposal: Sept. 29, 2014 Public comments: 300+ for proposed rule and 100+

for supplemental Final rule issued: Nov. 13, 2015 Implementation Date starting May 2017

2

Presenter

Presentation Notes

Key Principles of FSVP Rule

Requires importers to share responsibility for ensuring safety of imported food

Risk-based (according to types of hazards, importers, and suppliers)

Flexibility in meeting requirements (assessing activities conducted by others)

Alignment with PC supply-chain provisions

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Purpose of FSVPs

To provide adequate assurances that: Foreign suppliers produce food using processes and

procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions

Food is not adulterated or misbranded (as to allergen labeling)

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Who Must Comply?

“Importer” is U.S. owner or consignee of a food at time of U.S. entry.

If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent.

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Exemptions from FSVP Firms subject to juice or seafood HACCP regulations Food for research or evaluation Food for personal consumption Alcoholic beverages and ingredients (when importer

uses them to make an alcoholic beverage)

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FSVP Exemptions (cont.)

Food transshipped through U.S. Food imported for processing and export “U.S. food returned” Meat, poultry, and egg products subject to USDA

regulation at time of importation

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Importers in Compliance with Preventive Controls

Importers are deemed in compliance with most of FSVP when they: Comply with PC supply-chain provisions Implement preventive controls under PC regulation

for hazards in food they import Are not required to implement a preventive control

under certain PC provisions

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Use of Qualified Individuals

Must use a qualified individual to perform all required FSVP tasks Must have education, training, or experience (or combination

thereof) necessary to perform the activity Must be able to read and understand the language of any

records reviewed in performing an activity A company may outsource this expertise

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Hazard Analysis Evaluate known or reasonably foreseeable hazards to

determine if they require a control Biological, chemical (including radiological), and physical

hazards Naturally occurring, unintentionally introduced, or

intentionally introduced for economic gain May assess another’s hazard analysis

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Evaluation of Food and Foreign Supplier

Must “approve” suppliers and determine appropriate supplier verification activities (may use unapproved suppliers on temporary basis when subject food to verification)

Considerations include: Risk posed by the food (hazard analysis) Entities controlling hazards or verifying control Supplier characteristics (procedures, processes, and practices) FDA compliance status and food safety history

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Verification Activities (cont.)

Determine appropriate verification activities (and frequency) based on food and supplier evaluation Activities may include: onsite auditing; sampling and testing;

review of supplier records; other appropriate measures Annual onsite auditing is default approach when a

food has a SAHCODHA hazard.

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Reliance on Verification Activities Conducted by Others

May rely on another entity’s determination or performance of appropriate verification activities (e.g., farm audits conducted by produce distributor)

Must review and assess results of verification activities (importer’s own or others on which it relies)

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Verification Activities (cont.)

Onsite audits: Must be conducted by “qualified auditor”; may be

government employee Consider applicable FDA food safety regulations (or

laws and regulations of country with comparable or equivalent food safety system)

Substitute results of inspection by FDA or food safety authority in comparable or equivalent food safety system

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Requirements for Special Circumstances

The food cannot be consumed without application of control (e.g., coffee beans).

Hazard controlled by importer’s customer or subsequent entity in US distribution. Disclosure statement Written assurance Other system to ensure control of hazard at subsequent

distribution step

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Other FSVP Requirements

Corrective actions Importer identification at entry Recordkeeping

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Dietary Supplements

Most standard requirements do not apply when an imported dietary supplement component or packaging meets specifications established in accordance with dietary supplement CGMPs.

Other dietary supplements (including finished supplements): hazard analysis not required; verification standard is compliance with CGMPs.

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Very Small Importers and Food from Certain Small Suppliers

Very small importer (VSI) Less than $1 million/yr. in human food sales Less than $2.5 million/yr. in animal food sales

Food from certain small suppliers Qualified facility Produce from certain small suppliers that are not covered

farms Shell egg producers with < 3,000 laying hens

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VSIs and Importers of Food from Small Suppliers (cont.)

Annually document eligibility Verification: Written assurances from suppliers Additional requirements for food from small

suppliers: Evaluate and monitor supplier compliance history Approve suppliers Ensure food is from approved suppliers

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Countries with Comparable or Equivalent Safety Systems

Most FSVP requirements would not apply when importing certain food from supplier in country whose food safety system FDA has officially recognized as comparable or determined to be equivalent. New Zealand! As of now.

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FDA Guidance and Outreach

Developing FSVP draft guidance for industry Food Safety Preventive Controls Alliance will develop

course materials for FSVP. Webinars and meetings

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Voluntary Qualified Importer Program (“VQIP”)

Fast Lane for Food Imports

• Expedited Entry • Expedited Lab Analysis • Dedicated Help Desk

• Not the Same as C-TPAT, but a similar concept.

VQIP

Who Can Participate? “VQIP Importer” term • May be different than Importer of Record and FSVP Importer • May be foreign entity • Three year shipping history is reviewed • Annual Audit by FDA Accredited Auditor • No ongoing FDA proceedings (Import Alerts or other actions) Annual Fee: Estimated First Year Fee = $16,400.00

VQIP

When? • Importers May Apply Annually January – March • VQIP Year Runs From October to September • First Year Anticipated to be 2018

VQIP

Which Foods? • Nothing on Import Alert or Recall • Must be From Supplier Certified by FDA Accredited Auditor • Must Be Identified on VQIP Application

•No Additions During the Year

Summary and Solutions

Key Requirements: GMPs, registration, labeling, FCE, Prior Notice

Import Alerts and DWPE FSMA Main takeaway: Number of existing rules, and more

on the way. Prudent path for importers: Select suppliers carefully,

and be sure to monitor them for FDA issues which may in turn cause detentions or delays at the port

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FDA Compliance Monitor

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Summary and Solutions

Registrar Corp provides a full range of fixed-fee compliance services: Registration & U.S. Agent Service Prior Notice Filings Label, Ingredient, and Product Review LACF and Food Safety Services (Mock FDA Inspections, etc) Detention Assistance DWPE Petition Submissions

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Questions?

Web Site: www.registrarcorp.com Email: [email protected]

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Registrar Corp Worldwide Offices

Contact Us

Registrar Corp Headquarters 144 Research Drive Hampton, Virginia

USA 23666 P: +757-224-0177 F: +757-224-0179

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