Top Banner
The U.S. Food Safety System and Equivalence: Perspectives from Two U.S. Agencies WTO SPS Committee Thematic Session on Equivalence – Part 2 18 March 2019 1
38

d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Oct 09, 2020

Download

Documents

dariahiddleston
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Page 1: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

The U.S. Food Safety System and Equivalence: Perspectivesfrom Two U.S. Agencies

WTO SPS Committee Thematic Session on Equivalence – Part 2

18 March 2019

1

Page 2: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOverview of the U.S. Food Safety System

• Department of Health and Human Service- Food and Drug Administration (FDA)- Centers for Disease Control and Prevention

• United States Department of Agriculture- Food Safety and Inspection Service- Animal and Plant Health Inspection Service

• Environmental Protection Agency (EPA)• Department of Commerce - NOAA/NMFS• Bureau of Customs and Border Protection (CBP)• Alcohol and Tobacco Tax and Trade Bureau (TTB)• State and Local Health and Agriculture Agencies

2

Page 3: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOverview of the U.S. Food Safety System

Two perspectives in today’s presentation:

• Department of Agriculture– Food Safety and Inspection Service (FSIS)

• Department of Health and Human Services– Food and Drug Administration (FDA)

3

Page 4: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:Why is This Important?

• World Trade Organization (WTO)/Sanitary and Phytosanitary (SPS) Measures Agreement

• Equivalence determinations of an exporting country’s regulatory food safety inspection system for meat, poultry, or egg products is a prerequisite for trade with the United States

Importance Of Equivalence

• Protects public health

• Ensures compliance with safety policies of imported food

• Facilitates trade

4

Equivalence:Why is This Important?

Page 5: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceWhat is Equivalence?

Equivalence—the process of determining whether a country’s food safety system achieves the appropriate level of protection for public health as applied domestically in the United States

5

Page 6: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceWhat is Equivalence?

The equivalence process requires the exporting country to objectively demonstrate how its food safety system, including laws, regulations, policies, and food safety procedures achieve comparable results as the US food safety system

6

Page 7: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Food Safety and Inspection ServiceU.S. Laws and Regulations

• Federal Meat Inspection Act (FMIA)• Poultry Products Inspection Act (PPIA)• Egg Products Inspection Act (EPIA)• Humane Methods of Slaughtering Act

Title 9 of the Code of Federal Regulations • Parts 300 – 500 Meat (Siluriformes)• Parts 362, 381 Poultry• Parts 590, 592 Egg Products

Page 8: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceFSIS Requirements

• FSIS statutes require foreign meat, poultry, and egg products food regulatory systems to be ‘‘equivalent to’’ US requirements

• Regulatory requirements for equivalence and eligible foreign countries listed in: • § 327.2 for meat products• § 381.196 for poultry products• § 590.910 for egg products.

8

Page 9: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Food Safety and Inspection Service:Imported Meat and Poultry Products

Imported

4.2 Billion lbs. of meat/poultry

Consisting of

85%Fresh red

meat

From

39Eligible

countries

In CY 2017, the U.S…

11% Processed meat/

poultry

Canada, 41%

Australia, 18%

New Zealand,

12%

Mexico, 11 %

Other 18%

4% Raw poultry

Page 10: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Food Safety and Inspection Service:Imported Egg Products

Imported

10.4 Million lbs. of egg products

From

Canada and the

Netherlands

In CY 2017, the U.S…

Note: Canada and the Netherlands are the only countries approved to export egg products to the U.S. at this time.

Page 11: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:FSIS Risk-Based Equivalence Determinations

Types of FSIS equivalence reviews:

• Initial equivalence

• Ongoing equivalence

• Reinstatement of equivalence determination

• Individual sanitary measure equivalence

11

FSIS evaluates exporting country’s

inspection system for equivalence through

document review, on-site audits, and point-of-entry reinspection of product at the time

of importation

Page 12: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceInitial Equivalence

Steps for Initial Equivalence Process:1. Country Submits Written Request to FSIS2. Document Submission through Self-Reporting Tool3. Document Review 4. On-Site Verification Audit5. Public Notification-Proposed Rule in Federal Register6. Final Determination of Equivalence- Final Rule in Federal Register; 7. Country provides a sample health certificate, list of eligible

certified establishments approved by the central competent authority (CCA) to export to the US

Initial equivalence is undertaken when a country wants to export meat, poultry, or egg products to the United States for the first time

12

Page 13: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:Initial Equivalence Document Submission

The Self-Reporting Tool (SRT) is a questionnaire that provides an organized means for the country’s government to document how its inspection system achieves an equivalent level of protection

Six Equivalence Components:

• Government Oversight (e.g., Organization and Administration)

• Government Statutory Authority and Food Safety and Other Consumer Protection Regulations (e.g., Inspection System Operation, Product Standards and Labeling, and Humane Handling)

• Government Sanitation• Government Hazard Analysis and Critical Control

Point (HACCP) System• Government Chemical Residues Testing

Programs• Government Microbiological Testing Programs

13

Page 14: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:Initial Equivalence On-Site Verification Audit

On-site verification is a system audit with the goal to verify through objective evidence that the foreign country ’s inspection system meets US levels of protection

When the document review process shows the country’s system to be satisfactory, a technical team will visit the country for an on-site verification audit

Audit Objectives• To verify that the country possesses an equivalent

inspection system that attains US levels of protectionThe Scope Of The Audit• Includes all aspects of the inspection system under

consideration for equivalence (e.g. meat, poultry, and/or egg products)

14

Page 15: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:Initial Equivalence On-Site Verification Audit

Technical team identifies appropriate locations to conduct the system audit within these sectors:

• Government offices (central, regional, local)

• Establishments (slaughter, processing, and cold storage)

• Laboratories

After the audit…

• FSIS sends the draft audit report to the country

• FSIS reviews and incorporates the country’s comments

• FSIS issues the final audit report

15

Page 16: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

• The Central Competent Authority (CCA) shows through documentation that the design of its inspection system achieves the appropriate level of public health protection (Complete SRT responses with supporting documentation)

• The CCA demonstrates during the course of an on-site verification audit that it can implement the inspection system (e.g., laws, regulations, inspection procedures, and enforcement protocols) documented in the SRT (Acceptable audit results)

16

Equivalence:Initial Equivalence Determination

Page 17: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:Initial Equivalence Rulemaking

Public Notification through Rulemaking: FSIS initiates a proposed rule after the document review and the on-site audit steps have been satisfactorily completed.

• FSIS publishes a proposed rule in the Federal Register to add the country to the list of countries eligible to export meat, poultry, or egg products to the US

• Proposed rule is notified to the WTO SPS Committee• In general, a 60-day period is provided for public comment on

the proposed rule• FSIS reviews and analyzes all comments received• Based on its review, FSIS makes a final determination about the

equivalence application. If positive, FSIS publishes a final rule in the Federal Register along with its responses to the publiccomments 17

Page 18: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOngoing Equivalence

Ongoing equivalence applies to countries currently eligible to export meat, poultry or egg products to the United States

18

On-SiteAudits

Point-of-Entry

Reinspection

DocumentAnalysis

Page 19: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Food Safety and Inspection Service:Public Health Information System (PHIS)

How FSIS prevents foodborne illnessPublic Health Information System

Centralized database that

generates Type of Inspection

(TOI) and stores reinspection

results

Tracks results from each

country

Tracks results from each

foreign establishment

Links ports of entry

Upon verification of

proper documentation,

inspector enters data into

PHIS

Page 20: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Food Safety and Inspection Service:POE Reinspection Types of Inspection (TOI)

• Product Exams• Public health and food safety standards

• Condition of Container

• Net Weight Verification

• Pink Juice Test (cooked beef)

Ensure that the products that FSIS regulates are safe, wholesome,

and properly labeled

FSIS Inspection Personnel perform

several type of Physical

Examinations

Page 21: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOngoing Equivalence

Ongoing equivalence applies to countries currently eligible to export meat, poultry or egg products to the United States

• Routine audits of the country’s inspection system by FSIS• Annual update of information by exporting country

• Updated SRT responses OR verification current SRT responses are up-to-date

• Up-to-date list of certified establishments eligible to export to US• Updated government residue control program and microbiological

sampling and testing program, including previous year’s test results and reactions to residue findings

• Reinspection of product at point-of-entry (POE)• Responses to US POE violations

21

Page 22: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:Reinstatement of Equivalence Determination

Reinstatement of equivalence is undertaken when a country wants to resume exporting meat, poultry, or egg products to the United States

Reinstatement of Equivalence Process:

1. Country submits written request to FSIS2. Document submission through Self-Reporting Tool3. Document review4. On-site Verification Audit may or may not be needed5. FSIS notifies the country of the reinstatement equivalence

determination through a formal written letter

NOTE: Rulemaking is not needed for reinstatement of equivalence determinations22

Page 23: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Equivalence:Individual Sanitary Measure Equivalence Determination

An individual sanitary measure is undertaken when a country wants to change a specific food safety procedure in its equivalent food safety inspection system

Individual Sanitary Measure Equivalence Process:

1. Country submits written request to FSIS2. Document submission through self-reporting tool3. Document Review4. An equivalence assessment may or may not be needed5. FSIS notifies country of its individual sanitary measure equivalence

determination through a formal written letter

NOTE: Rulemaking is not needed for individual sanitary measure equivalence determinations

23

Page 24: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceNotifications to WTO SPS Committee

24

Country Product Category Rulemaking WTO Notifications Comments

Slovenia and Croatia

Meat Proposed - April 29, 1992 (57 FR 18079) Final - Aug. 17, 1992 (57 FR 36889)

None

Czech Republic Meat Direct final - April 12, 1995 (60 FR 18540) None Changed Czechslovakia to Czech republic (former listed since 1948).1

Mexico Poultry (processed only from U.S. or other approved country)

Proposed - Nov. 28, 1997 (62 FR 63284) Final - Sept. 14, 1999 (64 FR 49640)

G/SPS/N/USA/104 (12/8/97) (proposed)

Slovakia Proposed - Aug. 13, 2001 (66 FR 42472) Final - Feb. 8, 2005 (70 FR 6554)

G/SPS/N/USA/490 (8/17/01) G/SPS/N/USA/1035 (2/23/05)

New Zealand and Australia

Poultry (ratites only)

Direct Final - June 23, 2003 (68 FR 37069) None

San Marino Meat products Proposed - Aug. 13, 2004 (69 FR 50086) Final - Oct. 4, 2005 (70 FR 57725)

G/SPS/N/USA/950 (8/20/04) G/SPS/N/USA/950/Add.1 (10/17/05)

Chile Meat Proposed - May 10, 2005 (70 FR 24485) Final – Nov. 21, 2005 (70 FR 70033)

SPS/N/USA/1072 (5/13/2005)* SPS/N/USA/1072/A1 (11/28/2005)*

*Approximate dates from STAR

China Poultry (processed only from US or other approved country)

Proposed - Nov. 23, 2005 (70 FR 70746) Final - April 24, 2006 (71 FR 20867)

G/SPS/N/USA/1168 (11/30/05) G/SPS/N/USA/1168/Add.1 (5/11/06)

Chile Poultry Proposed - Feb. 26, 2007 (72 FR 8293) Proposed - May 10, 2007 (72 FR 26567) (supplemental information). Final - Nov. 1, 2007 (72 FR 61793)

SPS/N/USA/1520 (4/16/2007) SPS/N/USA/1520/A1 (5/23/2007) SPS/N/USA/1520/A2 (11/21/2007)

Australia Equivalence of Australia’s, Meat Safety Enhancement Program (MSEP), an alternative to the conventional meat inspection system

Notice – March 3, 2011 (76 FR 11752) G/SPS/N/USA/2173 (3/8/11) Individual sanitary measure

Korea Poultry Proposed - Nov. 27, 2012 (77 FR 70724) Final - March 26, 2014 (79 FR 16656)

No

Lithuania Meat Proposed - Dec. 17, 2014 (79 FR 75073) G/SPS/N/USA/2724 (1/13/15)

1 Before 1948, the Bureau of Animal Industry (an FSIS forerunner) did not publish equivalence determinations. In 1938, the relevant regulation, 9 CFR 27.2, stated that the Secretary may refuse products from countries found not to be equivalent.

Page 25: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceUSDA, FSIS Contact Information

Contact Information:

US Department of AgricultureFood Safety and Inspection ServiceOffice of International Coordination

Room 3143, South Building 1400 Independence Ave SWWashington D.C. 20250-3700

Phone: 202-708-9543Fax: (202) 690-3856

E-mail: [email protected]

Page 26: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOverview of the U.S. Food Safety System

The second U.S. perspective:

• Department of Health and Human Services– Food and Drug Administration (FDA)

– Center for Food Safety and Applied Nutrition (CFSAN)

26

Page 27: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceTrade and Economic Overview

• 25 cents of every consumer dollar is spent on FDA-regulated products. Of that amount, approximately 75% is spent on food.

• FDA’s Center for Food Safety and Applied Nutrition (CFSAN)

• The American food industry accounts for 20% of U.S. Gross National Product and employees 14 million.

27

Page 28: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceFDA, CFSAN Food Safety Mission

CFSAN, in conjunction with the Agency’s field staff, is responsible for promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, wholesome and honestly labeled, and that cosmetic products are safe and properly labeled.

28

Page 29: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

Products Regulated by CFSAN

* containing <2% poultry or beef

Page 30: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceFDA, CFSAN Requirements

– Equivalence is NOT REQUIRED as a condition of market access for U.S. imported foods regulated by FDA

– FDA requires exporting countries to meet premarket conditions for two types of products

– FDA uses the PREDICT system, scoring each entry line on the basis of risk factors and surveillance requirements

– FDA does NOT REQUIRE certification or listing requirements attesting to food safety

– FDA does NOT REQUIRE food safety questionnaires 30

Page 31: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceEquivalence Determinations

• Can apply to individual measures, groups of measures, or controlsystems for particular commodities.

• FDA and FSIS use the same risk-based approach to an equivalenceassessment, both review a Member's legal controls followed by an on-site audit to observe how the Member implements controls.

• FDA requires exporters or exporting countries to meet premarket conditions only for raw shellfish and Grade A dairy products. Equivalence can be used to facilitate trade in these two areas.

• FDA reviews information from the exporting Member, to determine whether the exporting Member objectively demonstrates that its measures achieve the appropriate level of sanitary or phytosanitary protection. 31

Page 32: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceFramework for Equivalence Determinations

FDA developed its equivalency determination process based on Codex Guidance: See CAC/GL-53-2003, Guidelines on the judgement of equivalence of sanitary measures associated with food inspection and certification systems.

1. Formal request for equivalence.

2. Agreement reached to undertake equivalency determination.

3. FDA works with its counterpart competent authority in Exporting Member country to exchange information on its systems.

4. Commitment of time and resources on the part of both FDA and its counterpart competent authority in the Exporting Member country.

32

Page 33: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceProcess for Determining Equivalence

Paper Review – Audit – ReportScope – Article 4 of the SPS Agreement

– Specific measures (HACCP, testing methods, inspectionfrequencies)

– Specific areas (labs, inspections, pathogens)– Facilities (processors, importers, warehouses)– Partial systems (e.g., shellfish and Grade “A”, seafood, supplements)

Approaches– Quantitative (log reductions, performance standards, public health

metrics, temperatures)

– Qualitative (training, oversight, authority, resources, etc.)

– Broad food safety goals and public health purposes

Experts – Subject Matter Expert Conclusions

33

Page 34: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceGrade “A” Dairy –Regulatory Approach

• Grade "A" milk products (including fluid milks and creams, yogurts, cottage cheese) are regulated by FDA in co-operation with the states (and Puerto Rico).

• We regulate via standards and procedures that have been agreed upon under the aegis of the National Conference on Interstate Milk Shipments (NCIMS).

34

Page 35: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOptions to Facilitate Trade in Grade “A” Dairy

There are four options for exporting Grade “A” dairy products to the United States:

1. Equivalence determination upon request of an Exporting Member for Grade "A" milk and Milk products.

2. Membership in the NCIMS - country or a subdivision (e.g.a province or state).

3. 3rd Party Certification - A firm in an Exporting Member may opt to have its milkshed approved as Grade "A" so that the firm can be IMS-listed.

4. A participant in the NCIMS (e.g. a state) can determine that a firm and its milkshed can be approved as Grade A and thus the firm can be IMS-listed.

35

Page 36: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOptions to Facilitate Trade in Raw Shellfish

• Raw Molluscan shellfish include bivalves such as oysters, clams, mussels and scallops.

• The Interstate Shellfish Shippers Conference (ISSC) fosters and promotes shellfish sanitation under direct oversight of FDA.

• Foreign entities must demonstrate that the controls they use to ensure the safety of raw molluscan shellfish provide the same level of protection as the controls in the NSSP.

• Assessment includes review of exporting Member’s written submission, on-site audit, audit report, proposed determination, final determination.

36

Page 37: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceFDA, CFSAN Contact Information

Contact Information:

Food and Drug AdministrationCenter for Food Safety and Applied Nutrition

5001 Campus DriveCollege Park, MD 20740

[email protected]

37

Page 38: d Z h X^ X & } } ^ ( Ç ^ Ç u v µ ] À o v W W ] À ( } u d Á } h X ......v U ð í 9 µ o ] U í ô 9 E Á o v U í î 9 D Æ ] } U í í 9 K Z í ô 9 5DZ SRXOWU\)RRG 6DIHW\ DQG

EquivalenceOverview of the U.S. Food Safety System

QUESTIONS?

38


Related Documents
o v ] Ç o } } h&K> W€¦ · s } ] o ( ] Z v £ õ U í ì U í í U í î U í ï U í ð U í ñ í ò µ P o u v v ] } v o W } µ o ] µ µ Ç o } } U o v } µ À µ Æ } µ o

o v ] Ç o } } h&K> W€¦ · s } ] o ( ] Z v £ õ U í ì...

Category: Documents
Í U U U U U

Í U U U U U

Category: Documents
í í r í ï D ] o Z } U < Á o U t U ò í ì ñ E W ó ô í ó õ ô í ó ì õ ... · 2020. 8. 5. · í í r í ï D ] o Z } U < Á o U t U ò í ì ñ WK } Æ ó ì ï U t

í í r í ï D ] o Z } U < Á o U t U ò í ì ñ E W ó ô...

Category: Documents
Reporte Diciembre 2019Z } v u ] v } Z } ] ] u î ì í õ í î l í õ W 9

Reporte Diciembre 2019Z } v u ] v } Z } ] ] u î ì í õ í...

Category: Documents
P»¾ « ¤ P ±±¤Âö d « j±Í 9±Í¾  ÷ U Ý ¤±Í¾ Âx70qf2omd3j1myjzz16p9h6m-wpengine.netdna-ssl.com/... · Orange and White Infographic Resume Author: Molly McKendry

P»¾ « ¤ P ±±¤Âö d « j±Í 9±Í¾  ÷ U Ý...

Category: Documents
® í H u 0 ^ í ¤ ; Ä í Ä í ;í S ^ ¤ / j 0 j í ¤ ;í S j ... · H ^ í ¤ ; Ä Ä í ;í S u ¤ Å j P 5P j Å ¤ j ¤ í ; ^ ¤ 7 \ $ H ^ í ¤ ; Ä Ä í ;í S u ¤ Å

® í H u 0 ^ í ¤ ; Ä í Ä í ;í S ^ ¤ / j 0 j í ¤.....

Category: Documents
R ´ ê - Yokohama · Ì G4 ö 9× u20 8 M r U Y C ~ í í í í í í í í í í í í í í í í í ... 2 Ñ 0{ g B N4 ¦ Ñ ¥ È Ì"@'ö#. í4: G ì ¦ Ñ § º | G c r>0>0

R ´ ê - Yokohama · Ì G4 ö 9× u20 8 M r U Y C ~ í í....

Category: Documents
í F1 #Í a(Ì1azuminorekishi.sakura.ne.jp/discussion.pdf2 b K t ^ >P í F1 #Í a(Ì1 >R í F ^#Í @ R Æ ë ^ í F Æ [ L ~ [ P a í F Æ b 7 W \ a U ^ J Y1 #Í J R a S 9 >>4 a&u

í F1 #Í a(Ì1azuminorekishi.sakura.ne.jp/discussion.pdf2 b...

Category: Documents
Í u 0 Í À vÍ

Í u 0 Í À vÍ

Category: Documents
3Q19 CEB IR Final v2...0 & E Á } l W• ï ñ ] v ] } v •

3Q19 CEB IR Final v2...0 & E Á } l W• ï ñ ] v ] } v •

Category: Documents
î ^ u î ì í õ EdZ >E/ 'ZKhW W> ~ ^ v oE ] } ^ Z } u v Ç } ^ Z ' } µ · 2019-09-02 · ' } } ( ] ] v Ç í î ó 9 } ¨ í õ X ó u ~, í î ì í ô W ¨ ô X ó u i µ /d

î ^ u î ì í õ EdZ >E/ 'ZKhW W> ~ ^ v oE ] } ^ Z } u v.....

Category: Documents
5$-$67+$1 81,9(56,7< 2) +($/7+ 6&,(1&(6 -$,385 ......^ XE } X Z } o o E } X & } u E } X v ] E u & Z E u ' v P } Ç W, } u ] ] o ^ í î Z u } í ì Z 9 í î Z 9 D l ] v K v o ]

5$-$67+$1 81,9(56,7< 2) +($/7+ 6&,(1&(6 -$,385 ......^ XE }....

Category: Documents