us fda food safety modernization act-future impact on asia

The U.S. Food and Drug

Administration’s Food Safety

Modernization Act:

Future Impact on Asia

David Lennarz

Vice President, Registrar Corp

April 2014

1 14/04/2014

2

Current & Future Requirements

Background

Motivation and Concept

Proposed Rules

Effects on Foreign Manufacturers

Questions & Answers

3

FDA Food Safety Modernization Act: Facts

2011

1938

4

FDA Food Safety Modernization Act: Facts

5

U.S. Regulation Overview

6

Federal Register Citation

7

Code of Federal Regulations

The Food, Drug, and

Cosmetic Act is detailed

in what we call the Code

of Federal Regulations or

“CFR”

The CFR is a codification

of the general and

permanent rules published

in the “Federal Register”

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Code of Federal Regulations

9

Motivators for FSMA: Facts

48,000,000 Americans get sick

128,000 are hospitalized

3,000 die

High Profile Cases

Imports in the spotlight over past decade:

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United States Imports

12

Import Statistics

Medical Devices Drugs

Foods

13

Burden on Importers

and Foreign Manufacturers

FSMA makes importers more responsible for quality of

products from foreign manufacturers

14

Vision of FSMA: Prevention

15

Key Components

Prevention

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

• Proposed Rule Released January 4, 2013

• Comment period ended on November 22, 2013

Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption

• Proposed Rule Released January 4, 2013

• Comment period until November 22, 2013

Prevention

Mandatory Preventative

Controls for Food

• Two parts –

• New provisions requiring Hazard Analysis and Risk-based

Preventative Controls

• Revises existing CGMPs in 21 CFR part 110 and places

both new requirements into a new Part 117

• Affects all firms required to register under the

Bioterrorism Act, with exemptions

Prevention

16

Hazard Analysis and Risk-

based Preventative Controls

• Science and risk-based to prevent hazards to public

health

• Flexible in that firms develop these to fit their products

and operations in order to significantly minimize or

prevent all food safety hazards reasonably likely to

occur

• Similar to HACCP currently required by FDA for

seafood and juice and is common practice in many

companies worldwide

Prevention

17

How does this differ from

HACCP?

Differs from HACCP in that preventative controls may be required at points other than at critical control points and critical limits would not be required for all preventative controls.

A written Food Safety Plan must be developed and implemented

Prevention

18

What is a Food Safety Plan?

Conduct a Hazard Analysis

Establish Preventative Controls

Monitoring

Corrective Actions

Verification Activities

Recordkeeping

Prevention

19

Components of a

Food Safety Plan

• Must be prepared by a “Qualified Individual”

• “Qualified Individual” has training in standardized curriculum, or be otherwise qualified through job experience to develop and apply a food safety system

• Prepares plan, develops hazard analysis,

validates preventative controls, reviews

records, and conducts reanalysis of food

safety plan

Prevention

20

Mandatory Produce Safety

Standards –Proposed Rule

Establishes science-based standards for growing,

harvesting, packing, and holding produce on domestic

and foreign farms

Identifies routes of microbial contamination

• Agricultural water;

• biological soil amendments of animal origin;

• health and hygiene;

• animals in the growing area;

• equipment, tools, and buildings

Prevention

21


Standards – What’s Covered? Prevention

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• Covers fruits and vegetables in raw or

natural (unprocessed) state

• Exemptions include agricultural

commodities rarely consumed raw and

products that will be commercially

processed (such as canned)


Standards – When?

Of all FSMA rules, Produce Safety is most contentious

Public meetings with farmers has shed light on practical

problems

FDA itself has publically stated final rule will likely look very

different than proposed rule

Prevention

23

Vision of FSMA: Inspections,

Compliance and Response

24

Key Components

Inspections, Compliance, and Response

• Mandated Inspection Frequency - Immediate

• Records Access – Immediate

• Registration Renewal: Each food facility must renew its U.S. FDA registration every two years -- October 2012 – December 2012 (extended until January 31, 2013)

• Mandatory Recall - Immediate

• Expanded Administrative Detention - Effective July 2011

• Suspension of Registration - Effective June 2011

Inspections, Compliance, & Response

25

Mandated Inspection

Frequency Based on Risk, numbers to increase

Foreign facilities: within one year of the bill’s signing,

FDA is to increase inspections of foreign facilities, and

then increase that number every year for five years.


26

Foreign Facility

Inspection Schedule


0

5000

10000

15000

20000

25000

2011 2012 2013 2014 2015 2016

Insp

ec

tio

ns

Year

27

Registration Renewal

Required for both domestic and foreign facilities

“Facility” is a location that manufactures, processes, packs, or

warehouses food or beverages for human or animal

consumption

Required between October 1st and December 31st of

every even year starting in 2012


28

Registration Statistics


0

50000

100000

150000

200000

250000

300000

Foreign Facility Domestic Facility

Reg

istr

ati

on

s

Facility Type

Registrations prior to December 31, 2012

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Registration Statistics 2/19/14

FDA purged database of those that failed to renew in

early 2013

New February 19, 2014 statistics now show:

81,575 US Facilities

115,753 Non-U.S. Facilities

TOTAL: 197,328 versus +/- 430,000 in 2012

Approximately 50% of all registrations were deleted


30

Registration Statistics 2/19/14

China: 10,180 USA: 81,575

Japan: 13,296 France: 9,952

Korea: 3,805 Italy: 9,243

India: 3,133 Mexico: 8,465

Taiwan: 1,874 Canada: 6,533

Thailand: 1,555 Spain: 4,426

Vietnam: 1,385 Chile: 2,603

Indonesia: 970 Germany: 2,287

Malaysia: 903 Singapore: 743 (2009)


31

Registration Renewal

Facilities that failed to renew must now re-register

A new number is issued

Failure to renew will prevent issuance of a Prior Notice

Confirmation Number, therefore preventing the

submission (the FFRM and PNSI are now linked)


32

Suspension of Registration

FDA may by order suspend the

registration of a facility

reasonable probability of causing

serious adverse health consequences

or death to humans or animals

If the registration of a facility

is suspended

no person can import or export food

into the United States from that

facility


33

Vision of FSMA: Import Safety

34

Key Components

Import Safety

• Voluntary Qualified Importer Program

• Guidance Document Not Yet Released

• Foreign Supplier Verification Program

• Proposed Rule Released July 26, 2013

• Comment Period ended on January 27, 2014

Import Safety

35

Voluntary Qualified Importer

Program (VQIP)

FDA to establish a Voluntary Qualified Importer Program

(VQIP) to expedite entry into the United States of

imported food from eligible, qualified importers.

FDA will qualify eligible importers to participate in

VQIP based on risk considerations.

Import Safety

36

Voluntary Qualified

Importer Program

FDA will charge a User Fee for importers wishing to

enroll in the program

Guidance document has not yet been issued

Similar to C-TPAT?

Will large importers and retailers embrace VQIP?

Will small importers be excluded by cost or complexities

of the program?

Import Safety

37

Foreign Supplier Verification

Program for Importers of Food Import Safety

All importers must

establish, maintain, and

follow a FSVP

38


Program for Importers of Food

Proposed regulations vary based on type of food

(processed, produce, dietary supplements)

Important: the obligations are placed on the importer,

which in turn will place some obligations on the foreign

manufacturer

Import Safety

39


Program for Importers of Food

Key components:

Importer to maintain list of foreign suppliers

Perform supplier compliance status review

Conduct hazard analysis through verification activities

Conduct investigative & corrective actions (as needed)

Reassess FSVP periodically

Supply importer identification (DUNs Number)

Maintain Records

Import Safety

40

Conduct Compliance Status

Review

Importers required to review compliance status of the

food and foreign supplier before importing.

FDA Warning Letters

Import Alerts

Certification requirements

What does this mean for

you? Importers will be

watching you more closely.

Import Safety

41

Periodic Reassessment of the

FSVP

Importers required to reassess their FSVP within three

years of establishing the plan

Sooner if they become aware of new information about potential

hazards associated with the food

How does that affect you? Importers will look to you for

updated information on hazards

Import Safety

42

Modified FSVP Requirements

Proposed rule defines “very small importer” and “very

small foreign supplier” as having annual food sales of no

more than $500,000

Eligibility would have to be documented annually and

importers would have to obtain written assurances every 2

years that their suppliers are complying

Import Safety

43

Modified FSVP

Requirements

Food from a foreign supplier in good compliance

standing with a food safety system that FDA has officially recognized as comparable or equivalent

New Zealand has been recognized

Perhaps the European Union and Canada next?

Import Safety

44

Modified FSVP

Requirements Modified FSVP requirements for Juice and seafood from facilities compliant with HACCP

Alcoholic beverages

Food imported for research or evaluation purposes;

Food imported for personal consumption; and

Food that is transshipped or imported for further processing and export.

Import Safety

45

46

Vision of FSMA: Enhanced Partnerships

Key Components

Enhanced Partnerships

• Third Party Audits / Certification

• Proposed Rule Released July 26, 2013

• Comment Period ended January 27, 2014

• Capacity Building

• Outreach through training

• Establishment of overseas offices

• China offices of FDA established


47

Third Party Audit Concept

Allows FDA to leverage industry audits

A credible third-party program will help to facilitate entry

of certain imported foods under VQIP

A comprehensive third-party program will create a new

path for working with foreign governments


48

Third-Party Audits

Proposed Rule covers development of a program to establish Accreditation Bodies and Third Party Auditors seeking recognition by the FDA. Encompasses:

The monitoring and oversight of participating accreditation bodies and auditors

The auditing and certification of foreign food facilities

Notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health.


49

Capacity Building

FSMA directs FDA to develop a comprehensive plan to

expand the technical, scientific, and regulatory food

safety capacity of foreign governments and their

respective food industries


50

New User Fees under

FSMA

New FDA User Fees: October 1, 2011

FDA Hourly Rates for Fiscal Year 2014:

$237 per hour, domestic

$302 per hour, foreign activities

Charged for:

DWPE Petition Review

Reconditioning

Re-Inspections

VQIP


51

New User Fees under

FSMA

Re-inspection Fees are calculated for:

Traveling to and from the facility

Preparing reports

Analyzing samples

Examining labels

Thus far, FDA has not issued re-inspection fees

Guidance document pending


52

New User Fees under FSMA

Re-inspection Fees Will be charged to the facility’s U.S. Agent listed in Section 7 of

the food facility registration module

An importer who was listed as the U.S. Agent in a foreign registration may be liable even if they were listed in 2003 and no longer conduct business with the foreign facility


53

U.S. Agent Responsibilities

US Agent is designated in

Section 7, FFRM

US Agent must:

Reside in USA

Be available 24/7

Answer questions as

though they are

answering for registrant

Should know how to

deal with FDA.


54

Takeaways…

FSMA phased in over years

New rules will have a great impact on Asian and firms

worldwide

Final Rules likely to be different than proposed rules,

especially for Produce

Smaller manufacturers who ignore rules will likely face

greater risk of Import Alert

55

In Summary…

U.S. remains a market of volume and high value

Dedicate resources now to food safety to avoid expensive

problems later

FSMA is phased in over time, final rules yet to be

announced.

Once final rules are released, Registrar Corp will offer a

range of services to help foreign manufacturers comply

with FSMA.

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About Us

Registration & US Agent Service

FDA Prior Notice Submissions

Labeling and Ingredient Reviews

LACF Registration & Process Filing Submissions

Detention Assistance & Removal from DWPE

Mock FDA Inspections

HACCP and Food Safety Plan Development

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Contact Us: USA Office

Registrar Corp Headquarters

144 Research Drive

Hampton, Virginia

USA 23666

P: +757-224-0177

F: +757-224-0179

E: [email protected]

www.registrarcorp.com

16/10/2013 59

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Registrar Corp Office in China

Registrar Corp's Office in China

(美国FDA REGISTRAR公司深圳代表处隶属于Registrar Corp公司,负责其在中国境内相关业务。)

Room 606-608, Block A, Rongchao Binhai Building,

No. 5 Xinghua 1st Road, Bao'an CBD

Shenzhen City

People's Republic of China 518101

Phone: 400-860-0210 / +86-755-82070649

Fax: +86-755-82070866

Mobile: +86-18926783540 / 13794462358

Email: [email protected] www.registrarcorp.com

mailto:[email protected]

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Questions?

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