China 2013 Audit Poultry Processing Inspection System 151D

User Manual: 151D

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United States

Department

of

Agriculture

Li

Chunfeng

Food Safety

and Inspection

Service

Deputy Director General

Washington, D.C.

20250

General Administration

of

Quality Supervision,

Inspection and Quarantine (AQSIQ)

AUG

3 0

2013

Beijing, People's Republic

of

China

Dear Dr. Li:

The Food Safety and Inspection Service (FSIS)

of

the United States Department

of

Agriculture

(USDA) conducted an on-site verification audit

ofthe

People's Republic

of

China (PRC)

poultry processing inspection system from March 4-19, 2013. FSIS submitted the draft audit

report on June 28, 2013 and PRC responded on August 29, 2013 with a few minor suggestions.

The draft audit report was update with your suggestions. Enclosed is a copy

of

the final audit

report for poultry processing inspection system. This report was published

on

the FSIS website

(http://wvvw.fsis.usda.gov)

on

August 30

,2

013.

As all outstanding issues have been resolved, the PRC may proceed with certifying a list

of

poultry processing establishments as meeting the FSIS requirements. These certified

establishments may then begin exporting processed (heat-treated/cooked) poultry products to

the United States under the conditions established in FSIS' April 2006 final rule; i.e. only

processed poultry products produced from poultry slaughtered under FSIS inspection in the

United States or in a country eligible to export slaughtered poultry to the United States.

If

you have any questions, please contact me at telephone number 202-720-6400, facsimile

number 202-720-7990,

or

by e-mail at internationalequivalence@fsis.usda.gov.

9;ls~:V

-

Andreas Keller

{:;

~

Director

International Equivalence Staff

Office

of

Policy Program Development

Enclosure

Dr. Li Chunfeng

Scott SiridelaT, US Embassy, Beijing, China

Ralph Bean, Acting minister Counselor for Agriculture Affairs

Michael Riedel

,-

Senior Attache

Ryan

R.

Scott, Agricultural Attache

Morgan Perkins, F AS, North Asia Area Director

Casey Bean, OASA, F AS

Catherine Fulton, OASA, F AS

Cecilia

S.

Choi, EB, State Department

AI

Almanza, Administrator, FSlS

Carmen Rottenberg, Acting

Chief

of

Staff, OA

William C. Smith, Asst. Administrator,

OlEA

Jane Roth, Deputy Asst. Administrator, OlEA

Vincent Fayne, Director, MCAD, OlEA

Dee Dee Fumey, FSlS, OA

Daniel Engeljolm, Asst. Administrator, OFO

Rachel Edelstein, Assistant Administrator, OPPD

Soumaya Tohamy, Deputy Asst. Administrator, OPPD

Mary Stanley, Director, IPD, OPPD

Ronald

K.

Jones, Deputy Asst. Administrator, OFO

Andreas Keller, Director, IES, OPPD

Rick Hanies, Director, EPS, OPPD

Rita Kishore, Deputy Director, EPS, OPPD

Linda Chittum, Acting Director,

liD

, OFO

Shaukat Syed, Director, lAS,

OlEA

Francisco Gonzalez, lAS, OlEA

Cham1aine McGee, EPS, OPPD

Priya Kadam, IES, OPPD

FSIS:OIA:lES:PKadam: ChinaPoultryProcessingFinalAuditReportLetter08-30-2013.docx

2

FINAL

REPORT

OF

AN

AUDIT

CONDUCTED

IN

TI-IE

PEOPLE'S

REPUBLIC OF

CHINA

March 4 through 19, 2013

FSIS

AUDIT

OF

THE

FOOD

SAFETY

SYSTEM

GOVERNING

THE

PRODUCTION

OF PROCESSED

POULTRY

INTENDED

FOR

EXPORT

TO

THE

UNITED STATES OF

AMERICA

1

Food Safety and Inspection Service

United States Department

of

Agriculture

Executive

Summmy

This audit report describes the outcome

of

an on-site corrective action verification audit

conducted by the U.S. Department

of

Agriculture's (USDA) Food Safety and Inspection Service

(FSIS) on March 4-19, 2013, to determine whether the People's Republic

of

China's (PRC) food

safety system governing poulh·y processing remains equivalent to that

of

the United States

(U.S.), with the ability to produce products that are safe, wholesome, unadulterated, and properly

labeled. This audit was necessary to assess the effectiveness

of

the corrective actions the PRC

submitted

in

response to the December 1-21, 2010, verification audit. The March 2013 poultry

processing audit was conducted concunetitly with an equivalence audit

of

the PRC

's

poultry

slaughter inspection system, for which the observed findings are included in a separate report.

Representatives from the Certification and Accreditation Administration (CNCA), China

Inspection and Quarantine (CIQ) Shandong province, and USDA

's

Foreign Agricultural Service

(F AS) accompanied the FSIS auditors during the audit.

The audit focused

on

the ability

of

the Central Competent Authority (CCA), the General

Administration for Quality and Safety Inspection and Quarantine (AQSIQ), to regulate processed

poultry production. FSIS audited four poultry processing establishments, the CCA headquarters,

and the CIQ Shandong province govenunent offices. Detenninations concerning the

effectiveness

of

the

PRC's

food safety program focused on perfom1ance within the

fo

llowing six

equivalence components: (1) Govenunent Oversight, (2) Statutory Authority and Food Safety

Regulations, (3) Sanitation, (4) Hazard Analysis and Critical Control Point Systems, (5)

Chemical Residue Programs, and (6) Microbiological Testing Programs.

Based on

th

e analysis

of

the corrective actions submitted by the PRC in response to the 2010

audit and the results

of

the 2013 audit, FSIS concludes that the CCA has adequately addressed all

previously identified concems. Therefore, the

PRC's

processed poultry inspection system meets

the equivalence components for FSIS equivalence criteria. Because all outstanding issues have

been resolved, the PRC may proceed with certifying a list

of

establishments eligible

to

expo

rt

processed (heat-treated/cooked) poultry products to the United States, as long as the raw poultry

is sourced from countries that FSIS determined to have a poultry slaughter inspection system

equivalent to the U.S. system.

FSIS submitted the draft audit report to PRC on July

1,

2013 and PRC responded on August 29,

2013 with

no

substantive issues with the report.

2

TABLE OF CONTENTS

1. INTRODUCT-ION

2.

AUDIT OBJECTIVE, SCOPE, AND METHODOLOGY

3.

LEGAL BASIS FOR THE AUDIT

4. BACKGROUND

5.

GOVERNMENT OVERSIGHT

6.

STATUTORY AUTHORITY AND FOOD SAFETY REGULATIONS

7.

SANITATION

8.

HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEMS

9.

CHEMICAL RESIDUE PROGRAMS

10. MICROBIOLOGICAL TESTING PROGRAMS

11. EXIT MEETING

12.

CONCLUSIONS

13. ATTACHMENTS TO

THE

AUDIT REPORT

3

ABBREVIATIONS AND SPECIAL TERMS USED IN THE REPORT

AI-IVB

AQSIQ

CCA

CFR

CIQ

CNAS

CNCA

E.

coli

FSB

FSL

FSIS

GB

HACCP

Lm

MOA

MOI-l

PPIA

PRC

RTE

Salmonella spp.

SSOP

u.s

.c.

Animal Husbandry and Veterinary Bureau

Administration

of

Quality and Supervision and Inspection Quarantine

Central Competent Authority (AQSIQ)

Code

ofFederal

Regulations

China Inspection and Quarantine Authority (Branch and Provincial)

China National Accreditation Service for Conformity Assessment

Certification and Accreditation Administration

Escherichia coli

Entry-Exit Food Safety Bureau

PRC Food Safety Law

Food Safety and Inspection Service

Guobiao

Hazard Analysis and Critical Control Point

Listeria monocytogenes

Ministry

of

Agriculture

M.inish-y

of

Health

Poultry Products Inspection Act

People's Republic

of

China

Ready-to-Eat

Salmonella species

Sanitation Standard Operating Procedures

United States Code

4

USDA

VIC

United States Department

of

Agriculture

Veterinarian-in-Charge

5

1. INTRODUCTION

The Food Safety and Inspection Service (FSIS)

of

the United States Department

of

Agriculture

(USDA) conducted an on-site corrective action verification audit

of

the People's Republic

of

China's (PRC) poultry processing inspection system on March 4-19, 2013. This audit was

conducted simultaneously with an FSIS on-site equivalency verification audit

of

the

PRC's

poultry slaughter inspection system, for which the observed findings are included in a separate

report.

The audit began with an entrance meeting

on

March 4, 2013,

in

Beijing with the participation

of

representatives from the General Administration

of

Quality Supervision, Inspection and

Quarantine's (AQSIQ) Central Competent Authority (CCA); the Certification and Accreditation

Administration (CNCA); Inspection and Quarantine (CIQ) from the Shandong province;

representatives from

USDA's

Foreign Agriculhiral Service (FAS) at the United States Embassy-

Beijing; and the FSIS audit team. The F AS provided assistance with translations and travel

logistics.

2.

AUDIT OBJECTIVE, SCOPE, AND

METHODOLOGY

FSIS' objective for the audit was to verify that the

PRC's

food safety system governing poultry

processing is equivalent to that

of

the United States (U.S.), with the ability to produce and export

products that are safe, wholesome, unadulterated, and properly labeled. In pursuit

of

this

objective and prior to the on-site verification audit, FSIS reviewed and analyzed the proffered

corrective actions and accompanying references submitted by the

CCA

to address findings FSIS

identified in the 2010 audit as not being equivalent for each

of

the components

of

the poultry

processing inspection system.

Representatives from the CNCA, CIQ-Shandong, and PAS-Beijing accompanied the FSIS

auditors throughout the audit. Determinations concerning program effectiveness focused on

performance within the following six equivalence components upon which system equivalence is

based: (1) Government Oversight, (2) Statutory Authority and Food Safety Regulations, (3)

Sanitation, (4) Hazard Analysis and Critical Control Point (HACCP) Systems, (5) Chemical

Residue Programs, and (6) Microbiological Testing Programs.

FSIS auditors evaluated the implementation

of

management control systems developed

by

the

PRC to ensure that poultry inspection verification and enforcement activities are standardized.

The govemment offices audited included the CCA headquarters in Beijing, and the CIQ

Shandong Provincial office along with interviews

of

representatives from tlu·ee CIQ local offices

in the Shandong province.

To verify the

CCA's

ability to provide consistent government oversight, FSIS visited four

poultry processing establislunents identified by the CCA as eligible to export poultry products to

the United States. During establislm1ent visits, FSIS placed its emphasis on the

CCA's

ability to

provide oversight

of

inspection personnel through supervisory reviews conducted in accordance

6

with Title 9 U.S. Code ofFederal Regulations (CFR), Part 381.196 and the in-plant inspectors'

ability to verify industry compliance with the associated laws and regulations.

This 2013 verification audit did not include visits to the analytical laboratories because the

auditors did not report systemic deficiencies with the teclmical support

of

the poultry processing

inspection system in the 2010 audit report. A copy

of

the 2010 report can be viewed on the

FSIS Web site at

www..f~is

.u

sd

a

.go

v/

O

P

P

DE

IFA

R/

C

hina

!C

hina

20

10

_Poult1y _Processin

g.

pdf

Audit

Scope

Summary

Sectors

Audited

No. Locations

Central Authority 1 AQSIQ, Beijing

Competent Authority Provincial Office Shandong Entry-Exit Inspection and

Offices 1 Quarantine Bureau, Qingdao

Local Offices 3 Qingdao, Weifang, Dezhou

• Qingdao 9-Alliance Group, Ltd

• Zhucheng Waimao Co., Ltd

• Weifang Legang Food Co., Ltd

• Zhong' AO Holdings Group Co., Ltd

Poultry Processing Establishments 4

3.

LEGAL

BASIS

FOR

THE

AUDIT

AND

AUDIT

STANDARDS

The audit was conducted under the specific provisions

ofthe

United States' and the

PRC's

laws

and regulations, specifically:

U.S. Poultry Products Inspection Act, Title

21

United States Code (U.S.C.)

451

, et seq.)

U.S Poultry Products Inspection Regulations regarding eligibility to import to the United States

(9 CFR 381.196)

PRC Food Safety Law (FSL), 2009

PRC Administrative Rules

on

Quarantine

of

Animal (Decree

No.6)

, January

21,2010

While the audit standards include applicable legislation and procedures submitted to FSIS by the

PRC, this audit included a review

of

the proffered corrective actions submitted to FSIS by the

PRC in response to the 20 I 0 audit findings as part

of

the

of

the document review and the

equivalence determination process.

7

4. BACKGROUND .

The PRC first requested an initial equivalence determination

of

its poultry processing inspec

ti

on

system in May 2004, for which FSIS conducted on-site audits in 2004.

In

2006, FSIS

determined that the

PRC's

poultry processing inspection system was equivalent to that

of

the

U.S. The PRC was added to the list

of

countries eligible to export processed poultry to the

United States with the following stipulation: processed heat-treated poultry products must be

derived from flocks slaughtered under (1) the U.S. inspection system or (2) the inspection system

of

another country eligible to export slaughtered poultry products to the United States. Only such

poultry would be permitted to be imported into the United States

in

accordance with 9 CFR §

94.6 (b), 9 CFR 381, and the Poultry Products Inspection Act (PPIA). This restriction is in place

because USDA's Animal and Plant Health Inspection Service (APHIS) does not consider the

PRC to be free

of

Highly Pathogenic Avian Influenza (HPAI) and Exotic Newcastle Disease

(END). As a result

of

this APHIS animal disease status designation, exports to the United States

ofraw

poultry from AI and END affected regions

of

the PRC are prohibited.

After conducting a comprehensive analysis

of

the PRC's Food Safety Law 2009 and all relevant

legislation supporting the

PRC's

poultry processing inspection system, FSIS conducted a

verification audit in 2010 to reaffirm the ongoing equivalence status

of

the

PRC's

processed

poultry inspection system, which is required to reinstate their export eligibility. However, there

were several findings that needed corrective actions, which are detailed in the 2010 audit report

(wwwfsis. usda.gov/

OP

P

DE

IF AR/China/China201 0

_P

oult1y _Processing.pdj).

The PRC submitted corrective actions in response to

th~

2010 findings. In July 2011, the PRC

submitted two manuals, Inspection Quarantine Manual

for

Pou

lt1y Exported to America

(IQMPES) and Microorganism Monitoring Program

for

Export Poult1y Products

(Jv!MEP

P).

FSIS reviewed and analyzed the corrective actions and these manuals as a precursor to

conducting the 2013 verification audit. During the 2013 audit,

tl1e

PRC submitted revisions to

the manuals, changing the name, content, and version numbers of both manuals, while improving

many sections from earlier versions. The inspection manual has been changed to Inspection

Quarantine

and

Supervision Work

for

Poultry Products Exported to the

US.

Handboo!C'

(IQSWPPEUH version 1.1). The microbe manual has been changed to Monitoring

Programfor

Microbes in Export Poult1y Products (MPMEPP version 1.0).

FSIS auditors verified the adequacy

of

the coiTective actions that the CCA had

prof

fered in

response to the 2010 audit findings and then reassessed FSIS' prior determination

of

equi

va

lence

for the PRC's poultry processing inspection system.

5. GOVERNMENT OVERSIGHT

The first

of

the six components that the FSIS auditors reviewed was Government Oversight. The

evaluation included a review and analysis

of

corrective actions the CCA submitted in response to

the 2010 audit findings. Based

on

the analysis

of

the corrective actions the PRC submitted in

response to the 2010 audit and the results

ofthe

verification activities conducted in the 2013

8

audit, FSIS concludes

that

the

CCA

has adequately addressed the identified concerns reported for

this equivalence component. Therefore, the

PRC's

poultry processing inspection system

continues

to

meet-FSIS equivalence criteria for this component.

In the 2010 audit, the FSIS auditors confirmed that the State Council

of

the

PRC

delegates to

AQSIQ the authority to administer the poultry processing inspection system for exports.

AQSIQ serves as the

CCA

responsible for the safety

offood

products, promulgation

of

regulations on food inspection, and the sole authority to enforce the laws and regulations

governing the export system. Registration and certification

of

import/export food enterprises is

conducted by two major bureaus

of

the CCA: the Certification and Accreditation Administration

(CNCA) and the Entry-Exit Food Safety Bureau (FSB). These bureaus verify that establishments

fulfill official requirements before they grant the establishments' certification to export. Funding

for CCA operations is provided by the central government and supplemented by fees assessed by

the goverrunent on exported products.

The auditors also determined that the PRC Ministry

of

Agriculture (MOA) and the Ministry

of

Health (MOH) interact with the

CCA

to maintain appropriate regulation

of

the production

of

poultry products for export.

Under

tllis arrangement, the China National Accreditation Service

for Conformity Assessment (CNAS) and the CCA, have promulgated the national standard that

provides the general requirements for laboratory quality systems. FSIS auditors observed that

the CCA delegates to inspection and quarantine bureaus (CIQ) located throughout the country

the responsibility to implement inspection

of

animals and animal products and to regulate poultry

processing activities at establislunents producing products for export. The organizational

structure for the delegation

of

authority has not changed since the 2010 audit.

In the 2010 audit,

tl1e

auditors reported that the

CCA

allowed establishment-paid inspectors to

conduct regular pre-operational sanitation verification at processing establishments. The use

of

establislm1ent-paid inspectors conducting inspection activities could result

in

biased decisions

leading to the export

of

unsafe poultry products to the United States. This arrangement

constituted a conflict

of

interest and did not meet the requirements for ultimate control and

supervision over the official activities

of

all employees

of

the system, as articulated by FSIS

import regulations (9

CFR

381.196). As a corrective action, AQSIQ proposed to employ

goverrunent officials to conduct all official sanitation verification.

During the 2013 audit, FSIS auditors verified

tl1at

the CCA has implemented measures to ensure

that employees

of

the

PRC

govermnent perform official enforcement

of

regulatory requirements

tlu-ough cross referencing the ID badges and names

of

the CIQ inspectors observed performing

inspection work with the following: the CIQ office employment database; an employee pay

stub; training records; and a list

of

nan1es

of

CIQ employees, including tl1ose interviewed.

The employment records demonstrated that personnel conducting inspection activities were

employees

of

the

PRC

government.

The

CCA

hires and utilizes official employees to conduct

inspection duties, including sanitation. The CIQs hire official

staff

assigned to work at

establislunents producing cooked poultry products destined for the United States and retain

employee records.

PRC

employees are issued ID cards, with

or

without photos, and assigned

specific numbers that correlate to the respective CIQ Bureau database. Based

on

review

of

the

9

documentation, FSIS auditors determined that inspection personnel who are performing

governn1ent oversight are employees

of

CIQ.

In the 2010 audit, the auditors found that the provincial CIQs oversaw the inspection system by

designing and implementing inspection procedures as per PRC

's

national standards. The

PRC's

standards are in addition to those standards imposed by other importing countries. Auditors also

found that CIQ procedures were not consistently applied throughout the country. FSIS

concluded that this autonomy created significant variation in the application

ofthese

standards

among provinces. FSIS auditors reported that a recurring finding in the

PRC

's system was the

lack

of

standardized inspection procedures and thus the lack

of

govenm1ent oversight

of

its

inspection personnel. ·

In July 2011, the PRC submitted its response to this finding with two manuals, Inspection

Quarantine Manual

for

Poult1y Exported to America (IQMPES) and Microorganism Monitoring

Program

for

Export Poult1y Products (MMEPP). The purpose

of

the manuals is to implement

consistent inspection and verification activities

of

the systems across provinces that have

establishments identified as eligible to export poultry products to the United States. To maintain

consistency in the implementation

of

inspection procedures across all the provinces, the CCA

trained inspectors assigned to eligible establislunents on these manuals.

In the 2013 audit, the

CCA

identified one province (Shandong) with

tiu-ee

branch CIQ Offices as

having four eligible establishments to export poultry products to the United States. The auditors

noted that the CCA revised the manuals it had provided to FSIS in the 2011 response, creating

ti1e

new

ti1e

Inspection

and

Quarantine

and

Monitoring Manual

for

PoultJy Exported to America

(IQMMPEA), and the Microorganism Monitoring Program

for

Export Pou!tJy Products

(MMEP

P). The auditors confirmed that the

CCA

had disseminated the two newly revised

manuals, IQMMP EA and MMEP

P,

to the CIQ offices and establislm1ents and reviewed training

records for inspection persmmel at

ti1e

provincial CIQ, and local CIQ offices. FSIS auditors

confirmed consistent application

of

inspection procedures in all establislunents.

During the 2013 audit, the

PRC

submitted revisions to the previous manuals, changing the name,

content, and versions numbers

of

both manuals while improving many sections from earlier

versions. The inspection manual was changed to Inspection Quarantine

and

Supervision Work

for

Poult1y products Exported to the

U.S.

Handbook (IQSWPPEUH version

1.1

). The mic

ro

be

manual was changed to Monitoring Program

for

Microbes in Expqrted Poultty Products

(MPMEPP version 1.0). Based

on

analysis

of

the current revised manuals, the auditors

concluded that the

CCA

had standardized inspection procedures across

ti1e

CIQ offices and the

four establislunents within the Shandong province.

In the 2010 audit, the auditors observed that the CCA provided training to the newly hired

inspection personnel and developed provisions for ongoing training. However, the auditors

observed that the CIQ inspectors did not demonsh·ate an ability to verify that implementation

of

Hazard Analysis and Critical Control Point (HACCP) and microbiological testing programs was

consistent with PRC requirements. In response, AQSIQ provided training

on

HACCP,

Sanitation Standard Operating Procedures (SSOP), Listeria monocytogenes (Lm), and sanitation

in 2012.

10

In the 2013 audit, the auditors interviewed

CCA

officials and CIQ supervisory and in-plant

officials on the contents

of

the two manuals, inspection procedures, HACCP, sanitation,

microbiological hazards for Ready-to-Eat (RTE) products, and microbiological sampling and

testing procedures and practices. The FSIS auditors confirmed that inspection personnel were

trained on the fundamentals

ofthe

aforementioned inspection activities. The inspection

persmmel were able to identify all components

of

the written HACCP progran1s maintained by

the establishments, including microbiological hazards for RTE products. To :further assess

inspection personnel's lrnowledge

ofHACCP

, RTE programs, and supervisory assessment, the

auditors developed mock scenarios seeking projected actions expected for each scenario. CIQ

personnel were able to successfully demonstrate the knowledge required to make decisions and

take actions in accordance with the regulations

of

the system.

Also during the verification activities, FSIS confirmed that CIQ supervisory personnel conducted

and documented periodic evaluations

of

employee performance. Supervisors were interviewed

and asked to describe: (1) their preparation work/method prior to conducting subordinate

evaluation; (2) the types

of

questions asked

of

an employee during the evaluation regarding

inspection duties and knowledge

ofHACCP

principles; (3) whether or not the evaluation

included onsite observation in the performance

of

inspection activities and any sample questions

that are asked during the observation; (4) whether or not establishment written programs and

testing results are reviewed with the employee; and (5) the type

of

feedback (oral

or

written)

provided to an employee. The auditors detem1ined that the supervisors were lrnowledgeable on

these five items.

Auditors reviewed and discussed with the supervisors a sample

of

a completed evaluation form,

Official Patrolling Supervision Record. The auditor noted that the form did not contain the

employee's nan1e, but instead contained the establishment number. The auditors asked how one

would know which employee

was

evaluated. CIQ supervisor explained that the employee's

nan1e appears in the body

of

the document.

Supervisors were asked

to

describe the procedures to handle employees who demonstrate an

inability to perform inspection duties

at

a satisfactory level.

It

was explained that for an

employee deemed unfit for duty, CIQ provides additional training and the employee's

weaknesses are discussed.

If

the employee continues to be w1able to perform inspection duties

adequately, the person is transferred to another agency. The auditors concluded that supervisors

had the ability to effectively assess a subordinate's knowledge, skills, and ability in the

performance

of

inspection activities and had a process to remove

an

employee who is not able to

satisfactorily perform inspection duties.

Based on the analysis

of

the conective actions the PRC. submitted in response to the 2010 audit

and the results

of

the current verification activities conducted in the 2013 audit, FSIS concludes

that that the

CCA

has adequately addressed previously identified concerns. The

CCA

has hired

government inspectors to conduct verification activities and trained those employees to perform

the work. The

CCA

has also created and disseminated two manuals that can

be

uniformly

implemented across all establishments exporting processed poultry

to

the United States. FSIS

also detem1ined that supervisory

staff

demonstrated the ability to effectively assess a

11

subordinate's knowledge, skills, and ability in the performance

of

inspection activities and had a

process to remove an employee who was not able to satisfactorily

perfonn

official duties.

Therefore, the

PRC's

poultry process inspection system meets FSIS equivalence criteria for this

component.

6. STATUTORY AUTHOIUTY AND FOOD SAFETY REGULATIONS

The second

of

the six equivalence components that FSIS auditors reviewed was Statutory

Authority and Food Safety Regulations. This component pertains to the legal authority and the

regulatory framework utilized by the CCA to impose requirements equivalent to those governing

the system

of

processed poultry inspection organized and maintained in the United States. Based

on

analysis

of

the corrective action submitted by the PRC in response to the 2010 audit and the

results

of

the current verification activities conducted in the 2013 audit, FSIS concludes that the

CCA has adequately addressed previously identified concerns reported with this equivalence

component. Therefore, the

PRC's

poultry processing inspection system meets FSIS equivalence

criteria for this component.

In 2010, FSIS auditors reported that the

PRC's

inspection system

of

processed poultry provided

requirements for processed poultry inspection activities; establislunent construction; control over

inedible and condemned materials; and daily inspection and periodic supervisory reviews

of

official establislm1ents. In the 2013 audit, FSIS auditors confirn1ed that these requirements had

not changed.

In the 2010 audit, the auditors reported that establishment-paid inspectors were conducting

official pre-operational sanitation verification at processing establislm1ents. This finding was

presented to the

CCA

as an issue that constituted a potential conflict

of

interest. As a corrective

action, AQSIQ proposed to employ government officials to conduct all official sanitation

verification activities.

In 2013, FSIS auditors verified that the CCA has implemented measures to ensure that

employees

of

the PRC perform official enforcement

of

regulatory requirements through cross

referencing the ID badges and names

of

the CIQ inspectors observed performing inspection work

with CIQ office employment database, an employee pay stub, training records and a list

of

names

of

CIQ employees, including those interviewed. The employment records demonstrated

that personnel conducting inspection were PRC employees. The CCA hires and utilizes official

employees to conduct inspection duties, including sanitation. The CIQs hire official

staff

assigned to work at establislunents producing cooked poultry products destined for the United

States and retain employee records. PRC employees are issued ID cards, with

or

without photos

and assigned specific numbers that con-elate to the respective CIQ Bureau database. This

potential conflict

of

interest involving establishment-paid officials conducting inspection

activities has apparently been resolved.

In the 2013 audit, FSIS auditors interviewed supervisory and in-plant CIQ persom1el to verify

their knowledge

of

U.S. requirements,

CCA

regulations, and the two manuals, as well as to

determine their ability to conduct supervisory reviews.

The

auditors also observed and

12

interviewed in-plant CIQ inspectors as they performed their assigned duties related to the

verification

of

the adequacy

of

the establislunents' HACCP and operational sanitation programs.

During an observation assessment

of

inspection activities, an auditor discussed the operational

cooking records with the CIQ inspectors and asked the inspectors to describe specific features

within the record that aid in determining compliance and accuracy

of

the records. Inspectors

were asked to provide the critical control point (CCP) process step, the critical limit and

frequency

of

monitoring for each CCP

of

the records reviewed, and the number

of

CCPs within

the HACCP plan. Upon returning to the establishment's conference room, the auditors reviewed

with the inspectors the HACCP plan for each

of

the CCPs against the records reviewed during

the plant tour. The inspectors were also asked to describe the components

of

a HACCP program

and the type

of

training received. FSIS auditors found that supervisory and in-plant inspectors

were knowledgeable about their responsibilities and had the competency to perform their duties.

A minor one-time observation occurred at one establishment regarding a design flaw

of

the

establishment's recordkeeping form; the fonn did not account for additional temperature

verification checks being conducted

by

the establislm1ent Quality Control personnel. These

additional temperature verification checks were not described in the HACCP plan. During the

discussions with the inspector, he articulated measures expected to be taken by both the plant and

himself regarding compliance

of

critical limits and product safety, which would correct the

recordkeeping form and the HACCP plan to account for the additional temperature verification

checks. He was able to demonstrate through the additional temperature verification checks that

the product had met the critical limit and was safe. However, he failed to say he would

document the noncompliance though he had earlier described as part

of

his training the need for

documentation

of

the noncompliance along with the name

of

the noncompliance fonn to be used.

It

is unclear why he did not list tilis activity during the discussion; however, the inspector

eventually stated he would document the noncompliance. A noncompliance record was

produced for this incident.

The auditors also reviewed and discussed the revised form Pre-Operational Inspection Official

Onsite Verification

of

Cooked Plants, which deals with sanitation and is generated and

maintained by the CIQ officials, and verified that officials prepared detailed documentation

of

observed findings, which includes preventive measures by the establishment and verification

notation for corrective actions and signatures

of

the CIQ inspectors. The CCA introduced this

revised official form for-completion by

ti1e

CIQ inspectors conducting pre-operational sanitation

inspections and verification. The establishment must complete the form Pre-Operational Record

of

Cooked Plants to document pre-operational facility reviews. During an observation

assessment

of

sanitation activities, the inspectors were asked to describe tile specific sanitation

reviews conducted before and during operations, as well as specifics regarding the establishment

procedures. The auditors were able to observe, in one plant, scheduled hand washlng and

sanitizing via a portable cart wheeled into each room by two Quality Assurance (QA) employees.

Employees washed their hands at the cart, and the QA employee sprayed a sanitizer on their

gloved hands before they returned to work. This activity occurred every 30 minutes. The

inspector stated that poultry meat, wllich falls on the floor, is placed inside plastic lined inedible

trash cans and only designated plant employees discard.the trash into a locked chamber

compartment at the end

of

the day.

13

In accordance with the analysis

of

the cm

Te

ctive action submitted by the PRC in response to the

2010 audit and the results

of

the verification activities conducted in the 2013 audit, FSIS

concludes that the CCA has adequately addressed previously identified concerns reported with

this equivalence component. Therefore, the

PRC's

poultry processing inspection system meets

FSIS equivalence criteria for this component.

7.

SANITATION

The third

of

the six equivalence components that the FSIS auditors reviewed was sanitation.

FSIS requires that the inspection system provide requirements for sanitation, for sanitary

handling

of

products, and for the development and implementation

of

sanitation standard

operating procedures. In the 2010 audit, there were no major findings with this component and

FSIS had concluded that the CCA had effectively implemented its requirements for sanitation

and sanitary handling

of

poultry products intended for export to the United States. As a result,

the PRC had met the requirements for this equivalence component.

In

the 2013 audit, the auditors verified this observation and concluded that there were no

concerns. Therefore, the

PRC's

poultry processing inspection system meets FSIS equivalence

criteria for this component.

In the 20 I 0 audit, the FSIS auditors reviewed legislation, regulations, and official instructions

and confirmed that the CCA exercised its legal authority to require establislunents

to

develop and

implement sanitation programs and ensure sanitary handling

of

products. The auditors found

that the establislunents were maintaining sanitary conditions in accordance with AQSIQ

Directive No. 20, 2002, Regulation on Administration

of

Sanitary Registration

and

Enrollment

for

Establishments

of

Food

for

Export, and GB/T 20094-2006, AQSIQ National Standard, Code

of

Hygienic Practice

for

Registration on Abaltoir

and

Meat Processing Establishments.

In 20 I

0,

the auditors observed that the CCA required establislunents to conduct biannual

sanitation audits, as required by the PRC regulation. During review

of

the biannual sanitation

audit records, FSIS suggested improvements for in-depth reviews of these audits.

During the 2013 audit, FSIS auditors found no systemic issues with this component.

Establishments identified, documented, and corrected sanitation deficiencies noted during pre-

operational and operational inspection. The updated versions

of

the inspection manual had been

distributed

to

the goverrunent offices and establishments. CIQ officials effectively verified the

adequacy

of

the implementation

of

the sanitation progran1, documented their findings, and

verified adequacy

of

the conective actions. The FSIS auditors conducted onsite observations

of

the facilities and operational activities and concluded that, overall, the establislm1ent's facilities

were well maintained and in good repair, and sanitary controls were effectively implemented to

prevent the development

of

insanitary conditions.

FSIS concludes that the CCA effectively implements its requirements for sanitation and sanitary

handling

of

poultry products intended for export to the United States.

As

a result, the PRC meets

the requirements for this equivalence component.

14

8. HAZARD ANALYSIS AND

CRITICAL

CONTROL

POINT

(HACCP) SYSTEMS

The fourth

of

the six equivalence components reviewed by FSIS was HACCP systems. The

inspection system must require that each official establishment develop, implement, and

maintain a HACCP plan. Based on the analysis

of

the corrective action submitted by the PRC in

response to the 2010 audit and the results

of

the verification activities conducted in the 20

13

audit, FS

IS

concludes that the CCA has adequately addressed the previously identified concerns

reported with regard to this equivalence component. Therefore, the

PRC's

poultry processing

inspection system meets FSIS equivalence criteria for this component.

In the 2013 audit, the FSIS verified that the CCA had issued regulations that require each official

establishment develop, implement, and maintain a HACCP system. The auditors evaluated the

design and implementation

ofHACCP

programs at four certified processing establishments. The

auditors observed that the CCA exerts its legal authority by requiring operators to comply with

HACCP system mles.

In the 2010 audit, FSIS conducted an onsite audit and reported to the CCA the following findings

related to this component

of

the system:

Establishments failed to specifically identify Listeria monocytogenes (Lm) in their hazard

analysis as a potential biological

ha

zard reasonably likely to occur in the post-lethality

processing envirom11ent. However, establislunents did have sanitary controls in place

controlling the post-lethality environment.

The stabilization step for heat-treated products was not identified in the hazard analysis in

some establishments.

Establislunents omitted processing steps in the product flowchart, thus the hazard analysis

of

the entire process was incomplete.

CIQ officials did not recognize inadequacies

of

the HACCP plans that included omitted

processing steps in the flow chart, identifying missing stabilization steps, and identi

fy

ing Lm

as a potential biological hazard.

The national standard outlining requirements for HACCP systems (GB/T 19538-2004) does

not require preventive measures as part

of

the corrective actions to deviations from critical

limits.

In response, the CCA proposed that as cmTective actions, it would develop and distribute

manuals containing inspection procedures to ensure the uniform implementation

of

regulatory

requirements at establislunen

ts

that produce cooked poultry products for export to the United

States. The CCA also indicated that it would train CIQ persollilel on the contents

of

the manuals

and would require that establislunents comply with the HACCP regulations

of

the system.

15

In the 2013 audit, the auditor verified that the corrective actions proffered by the CCA to address

the 2010 audit findings had been adequately implemented. Specifically, the

CCA

had provided

to CIQ officials and establislunents a copy

of

the updated inspection manual requiring that

establislunents recognize

Lm

as a biological haz

ar

d likely to occur in the post-lethality

processing environment. The auditors verified that the establislunent's HACCP plan did include

Lm

as a biological hazard. In the Inspection Quarantine and Supervision Work

for

Poult1y

products Exported to the US. Handbook version 1.1, (IQSWPPEUH) manual Section 3.4.2.2.2,

the CCA has referenced 9

CFR

381.150 for lethality

of

Salmonella and stabilization for

Clostridium perfi·ingens

in

cooked poultry products as well as FSIS Appendix B for additional

controls

of

Clostridium perfi·ingens. Furthermore, the inspection manual requires that

establishments identify, in their Sanitation Standard Operating Procedures (SSOP) or in their

pre-requisite program, Clostridium perfi'ingens as a pathogen to be controlled during

stabilization

of

cooked poultry product destined for the United States. FSIS auditors conducted

on-site observations and verified that recordkeeping maintained

by

the establislunents adequately

documented monitoring

of

cooking and cooling temperatures

of

products.

The

auditors reviewed

establislunents'

HACCP

programs and detennined that all steps were included in the flow chart

to permit analysis

of

each step in the process.

In addition, the

CCA

updated the inspection manual with a requirement for establishments to

provide preventive measures

when

a deviation occurs. The auditors reviewed records for

documented deficiencies and found

that

the establislm1ents' stated preventive measure for the

deviations was noted. These records included verification statements and the signature

ofthe

CIQ inspector verifying acceptability

of

the corrective action. FSIS auditors also verified that

the establislunents received a copy

of

the inspection manual.

The auditors interviewed inspection officials and reviewed records maintained

by

these officials

assigned to provide inspection

at

the audited establislunents. FSIS auditors found that a series

of

controls was

in

place

to

ensure that only raw poultry products that arrive from eligible poultry

slaughter establislunents are accepted

by

further processing establislm1ents. Authorized

establislunents are poultry slaughter plants th

at

have implemented systems

to

ensure that

slaughtered flocks meet regulatory requirements regarding health management, husbandry

practices, and compliance with drug withdrawal protocols. CIQ officials

at

the slaughter

establislunents verify during ante mortem inspection that the aforementioned requirements are

met by reviewing the Record

of

Veterinmy Ante-lvlortem Inspection

of

Export Poulfly

Processing Plant

and

Quarantine Certificate. The processing establislunents include a

"receiving

of

raw materials" step in their hazard analysis and receive the Quarantine Certificate

as pro

of of

raw material originating from an approved source plant. Additionally, CIQ officials

conduct verification activities associated with the receipt

of

raw products.

Based

on

the above analysis, FSIS concluded that the

PRC's

inspection system meets the

requirement for this equivalence component.

16

9. CHEMICAL RESIDUE PROGRAMS

The fifth

of

the six equivalence components reviewed by FSIS was Chemical Residues. The

inspection system

must

have a chemical residue control program that is organized and

administered

by

the national government. This includes random sampling

of

internal organs and

fat

of

carcasses for chemical residues as identified

by

the exporting country's meat and poultry

inspection authorities or by FSIS as potential contaminants, as well as methods to deter

recmrence

of

chemical residue violations.

CIQ officials verify that the raw poultry received

at

the poultry establishments comes from

an

approved source and meets the residue control program requirements. FSIS auditors verified that

raw products utilized

by

the poultry processing establishments are derived from authorized

poultry slaughter establishments that comply with the AQSIQ residue control progran1 for

exported poultry products.

This component will be further discussed in the draft audit report for initial equivalence for

poultry slaughter inspection.

10. MICROBIOLOGICAL TESTING PROGRAMS

The last

of

the six equivalence components that the FSIS auditors reviewed was Microbiological

Testing Programs. This component pertains to regulatory requirement for the inspection system

to have a microbiological testing progran1, organized and administered

by

the national

government. Both the

CCA

and the establishments certified for export to the United States are to

employ control measures to prevent adulteration

of

both post-lethality exposed and non-exposed

Ready-to-Eat (RTE) products by

Lm

and Salmonella spp. Furthennore, the

CCA

must conduct

verification sampling and testing for Lm, and Salmonella spp

in

post-lethality exposed RTE

products, product contact surfaces, and environmental surface samples, to verify that an

establishment's control measures are effective in controlling these pathogens. Based

on

the

analysis

ofthe

corrective actions submitted by the

PRC

in response to the 2010 audit and the

results

of

the current verification activities conducted in the 2013 audit, FSIS concludes that the

CCA

has adequately addressed previously identified concerns reported with this equivalence

component. Therefore, the

PRC's

China's

processed poultry inspection system meets FSIS

equivalence criteria for this equivalence component. The following analysis explains this

decision.

In 2010 audit, FSIS conducted an audit and reported to the

CCA

the following findings related to

this component

of

the system:

• The

CCA

needed to provide clear direction concerning the FSIS definition

ofRTE

products as outlined

in

9

CFR

430.1.

• Among the provinces audited, CIQ officials had not uniformly implemented sampling

protocols to assess effective establishment control measures for

Lm

in the post-lethality

17

processing envirmm1ent. CIQ officials did not verify that the methods used by the

establislm1ents to test the product and the environmental samples were adequate for the

intended analysis

of

Lm. During the audit, the PRC discussed a zero tolerance policy for Lm

and Salmonella spp. in RTE products. However, the auditors were unable to identify any

specific legislation

or

written procedures describing a zero tolerance policy. The auditors

observed that a 25g test portion was used for Salmonella, though FSIS requires

a minimum

of

325g test portion.

In response to the 2010 audit findings, the CCA proffered corrective actions to address each

of

the findings reported. The CCA indicated that it would develop a Microorganism Monitoring

Program for Export Poultry Products (MMPEPP), which would specifically describe the method

required to monitor microorganisms, including

Lm

in products and in the processing

environment.

The CCA also indicated that in the newly issued regulations, Listeria and Salmonella were

specifically mentioned as pathogens

of

concern to be controlled in the production

of

cooked

products. Furthermore, the CCA stated that the MMPEPP would include the requirement for

Lm and Salmonella, testing and would clearly state that there is a zero tolerance for Lm and

Salmonella in cooked poultry products and require uniforn1 monitoring

of

pathogen controls for

Lm in products and the processing envirmm1ent. The manual was revised to require a 325g

san1p

le for detecting Salmonella

in

cooked poultry products for export. Finally, the CCA

indicated in its response that it would implement training

of

officials on each

of

the items

included in the proffered corrective action.

During the 2013 audit, the auditors verified that the CCA had included the FSIS definition

of

RTE,

as

written verbatim in 9

CFR

430.1, in its Inspection, Quarantine

and

Supervision Work

for Poullly Products Exported to the US. Handbook (IPSWPPEH) version 1.1, and that the CIQ

inspectors were knowledgeable

ofthis

definition. The CCA developed the Monitoring Program

for

Microbes in Export Poultry Products (MPMEPP) version 1.0 which includes provisions for

mandatory testing for

Lm

and Salmonella and states that there is zero tolerance for these

pathogens

in

RTE products in Appendices 2 and

4.

The auditors also verified that the CCA has

updated the manual to include 325g test portion for Salmonella testing.

FSIS auditors, interviewed CIQ inspectors and found that they conduct product testing for Lm

and Salmonella

on

a monthly basis.

If

a positive sample is found, either by govenm1ent testing

or by establishment testing, the CCA will initiate additional testing

of

food contact and

environmental surfaces. The auditors verified that this is consistent with the official instructions

contained in Appendix 2, Section 3

.1.1.1

of

the MPMEPP version 1.0. Product that is positive is

either destroyed or reheated to destroy the pathogens and retested in a manner consistent with the

instructions contained in Section 3.1.6

ofthe

MPMEPP version 1.0. The CCA will also conduct

an in-depth verification assessment

of

an establishment that produced product that tested positive

for Lm or Salmonella. In addition, the establishments are required to initiate enhanced cleaning

and sanitizing

of

the enviromnent and food contact surfaces.

After analysis

of

the MPMEPP version 1.0 manual, FSIS determined that the CCA developed

requirements and responsibilities for both regulatory verification and establishment

18

implementation

of

microbiological controls. Specifically, in Section 3, Jvfonitoring Pro

cedures,

of

the MPMEPP version 1.0, the CCA references the 10,000 series

of

FSIS directives covering

RTE products,

Lm

testing, and intensified verification sampling, as well as 9

CFR

430.4, and

PRC's

GB 16869. In MPMEPP version 1.0, Appendix 2 and Appendix 4, the CCA provides

instructions for control and verification

of

Lm

testing

of

product, food contact surfaces and the

environment for the

CCA

and establishments.

The CCA conducts three types

of

sampling as described in Appendix

2:

regular, enhanced, and

conventional. In the MPMEPP version 1.0, Section 3 .1.1.1, the CCA provides instructions to

inspection personnel to conduct regular product sampling on a monthly basis. When a positive

result occurs from either regular product sampling

or

conventional sampling, the CCA initiates

en

hanced monitoring once every 2 weeks (Section 3.1.7.

1)

, collecting samples from

10

FCS, 5

environment, 3 product, and 1 brine sample

(if

needed) while citing FSIS Directive 10,300.1

(Section 3.1.7.2).

In conventional sampling, all plants are sampled once every 4 years similar to FSIS sampling

described in Directive 10,240.5. MPMEPP version 1.0, Section 3.2.3, describes the conventional

frequency at which the CCA will sample food contact surfaces and processing environn1ent.

MPMEPP, Section 3.1.7.3 provides enhanced monitoring and comprehensive testing for seasonal

facilities that have not undergone continuous regular sampling.

For the establishments, the

CCA

provides instructions in MPMEPP version 1.0, Appendix 4,

regarding sampling and testing for Lm.

In

Section 2, the CCA mandates sampling

of

product,

food contact surfaces, and envirorunental surfaces. Fwthermore,

Sect~on

4.1 mandates that

establishments control Lm hazards through HAACP, SSOP,

or

prerequisite programs. The rest

of

Appendix 4 provides mandates for what to do when a positive sample is detected: sampling

size, frequency, sampling method, recordkeeping, and enhanced procedures. The CCA is

responsible for evaluating the establishment's

Lm

control plans and verifies the adequacy

of

its

implementation.

Based on the above analysis, FSIS concluded that the PRC's inspection system meets the

requirement for this equivalence component.

11. EXIT MEETING

An exit meeting was held on March 19,2013, in Beijing with AQSIQ.

At

this meeting, the FSIS

auditors presented their observations made during the audit.

12. CONCLUSIONS

In the 2013 audit, FSIS analyzed and verified the

PRC's

proffered corrective actions to previous

findings

of

systemic impact that were identified in the 2010 audit. This audit involved the

following equivalence components: (1) Governn1ent Oversight; (2) Statutory Authority and

Food Safety Regulations; (4) Hazard Analysis and Criti.cal Control Point (HACCP) Systems; and

(6) Microbiological Testing Programs. FSIS found that the PRC adequately addressed each

of

19

the findings. Component 5, Chemical Residue Progranis, is discussed in the draft audit report for

initial equivalence for poultry slaughter inspection.

Based on the analysis

of

the

conective

actions submitted

by

the

PRC

in response to the 20 I 0

audit and the results

of

the verification activities conducted in the 20

13

audit, FSIS concludes

that the CCA has adequately addressed all previously identified concerns reported. Therefore,

the

PRC's

poultry processing inspection system meets FSIS equivalence criteria for all system

components. With all outstanding issues resolved, the

PRC

may certify a list

of

establishments

eligib

le

to

export processed (heat-treated/cooked) poultry products to the United States, as long as

the raw poultry is sourced from countries that have been determined by FSIS to have an

equivalent poultry slaughter inspection system.

Audit Team:

Francisco Gonzalez,

DVM

Senior Program Auditor

(On-site auditor)

Charmaine McGee,

DVM

Export Program

Staff

(On-site auditor)

~

~

Priya Kadam, Ph.D

~),)

·-{s: (l

f:,/

Senior Microbiologist/Senior Equivalence Officer

13. ATTACHMENTS

TO

THE AUDIT REPORT

None

at

this time.

20

22. Records documenting: the written HACCP plan, monitoring of the

critical control points, dates and times of specific event occurrences.

Hazard Analysis and Critical Control Point

(HACCP) Systems - Ongoing Requirements

Part D - Continued

Economic Sampling

27. Written Procedures

10. Implementation of SSOP's, including monitoring of implementation.

8. Records documenting implementation.

United States Department of Agriculture

Food Safety and Inspection Service

Foreign Establishment Audit Checklist

1. ESTABLISHMENT NAME AND LOCATION 2. AUDIT DATE 3. ESTABLISHMENT NO. 4. NAME OF COUNTRY

Place an X in the Audit Results block to indicate noncompliance with requirements. Use O if not applicable.

Part A - Sanitation Standard Operating Procedures (SSOP)

Basic Requirements

7. Written SSOP

5. NAME OF AUDITOR(S)

Audit

Results

9. Signed and dated SSOP, by on-site or overall authority.

11. Maintenance and evaluation of the effectiveness of SSOP's.

12. Corrective action when the SSOP's have failed to prevent direct

product contamination or adulteration.

13. Daily records document item 10, 11 and 12 above.

Part B - Hazard Analysis and Critical Control

Point (HACCP) Systems - Basic Requirements

Sanitation Standard Operating Procedures (SSOP)

Ongoing Requirements

14. Developed and implemented a written HACCP plan .

15. Contents of the HACCP list the food safety hazards,

critical control points, critical limits, procedures, corrective actions.

16. Records documenting implementation and monitoring of the

HACCP plan.

17. The HACCP plan is signed and dated by the responsible

establishment individual.

18. Monitoring of HACCP plan.

19. Verification and validation of HACCP plan.

20. Corrective action written in HACCP plan.

21. Reassessed adequacy of the HACCP plan.

Part C - Economic / Wholesomeness

23. Labeling - Product Standards

24. Labeling - Net Weights

25. General Labeling

26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)

28. Sample Collection/Analysis

29. Records

Audit

Results

Salmonella Performance Standards - Basic Requirements

Part E - Other Requirements

36. Export

38. Establishment Grounds and Pest Control

39. Establishment Construction/Maintenance

40. Light

41. Ventilation

42. Plumbing and Sewage

43. Water Supply

44. Dressing Rooms/Lavatories

45. Equipment and Utensils

46. Sanitary Operations

47. Employee Hygiene

Part D - Sampling

Generic E. coli Testing

Part F - Inspection Requirements

Part G - Other Regulatory Oversight Requirements

56. European Community Directives

57. Monthly Review

FSIS- 5000-6 (04/04/2002)

58.

ON-SITE AUDIT

6. TYPE OF AUDIT

DOCUMENT AUDIT

30. Corrective Actions

31. Reassessment

32. Written Assurance

33. Scheduled Sample

34. Species Testing

35. Residue

37. Import

48. Condemned Product Control

49. Government Staffing

50. Daily Inspection Coverage

51. Enforcement

52. Humane Handling

53. Animal Identification

54. Ante Mortem Inspection

59.

55. Post Mortem Inspection

Zhucheng Waimao Co., LTD/Shandong Delicate Food

Co., Ltd.

East end of Mizhou Road

Zhucheng, Shandong, PRC

3700/03409

People’s Republic of China

Drs. Gonzalez and McGee

X

X

March 8, 2013

FSIS 5000-6 (04/04/2002)

60. Observation of the Establishment

Page 2 of 2

61. NAME OF AUDITOR 62. AUDITOR SIGNATURE AND DATE

Processing Establishment No. 3700/03409

FSIS auditors observed electrical cords bundled on top of several workstations’ lamps, one overhead electrical outlet with

exposed wires and frayed conduit that had been rendered difficult to clean.

FSIS auditors received copies of documented corrective actions and official verification prior to the completion of the audit. The

evidence provided demonstrated an effective corrective action and adequate official verification.

Drs. Gonzalez and McGee

22. Records documenting: the written HACCP plan, monitoring of the

critical control points, dates and times of specific event occurrences.

Hazard Analysis and Critical Control Point

(HACCP) Systems - Ongoing Requirements

Part D - Continued

Economic Sampling

27. Written Procedures

10. Implementation of SSOP's, including monitoring of implementation.

8. Records documenting implementation.

United States Department of Agriculture

Food Safety and Inspection Service

Foreign Establishment Audit Checklist

1. ESTABLISHMENT NAME AND LOCATION 2. AUDIT DATE 3. ESTABLISHMENT NO. 4. NAME OF COUNTRY

Place an X in the Audit Results block to indicate noncompliance with requirements. Use O if not applicable.

Part A - Sanitation Standard Operating Procedures (SSOP)

Basic Requirements

7. Written SSOP

5. NAME OF AUDITOR(S)

Audit

Results

9. Signed and dated SSOP, by on-site or overall authority.

11. Maintenance and evaluation of the effectiveness of SSOP's.

12. Corrective action when the SSOP's have failed to prevent direct

product contamination or adulteration.

13. Daily records document item 10, 11 and 12 above.

Part B - Hazard Analysis and Critical Control

Point (HACCP) Systems - Basic Requirements

Sanitation Standard Operating Procedures (SSOP)

Ongoing Requirements

14. Developed and implemented a written HACCP plan .

15. Contents of the HACCP list the food safety hazards,

critical control points, critical limits, procedures, corrective actions.

16. Records documenting implementation and monitoring of the

HACCP plan.

17. The HACCP plan is signed and dated by the responsible

establishment individual.

18. Monitoring of HACCP plan.

19. Verification and validation of HACCP plan.

20. Corrective action written in HACCP plan.

21. Reassessed adequacy of the HACCP plan.

Part C - Economic / Wholesomeness

23. Labeling - Product Standards

24. Labeling - Net Weights

25. General Labeling

26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)

28. Sample Collection/Analysis

29. Records

Audit

Results

Salmonella Performance Standards - Basic Requirements

Part E - Other Requirements

36. Export

38. Establishment Grounds and Pest Control

39. Establishment Construction/Maintenance

40. Light

41. Ventilation

42. Plumbing and Sewage

43. Water Supply

44. Dressing Rooms/Lavatories

45. Equipment and Utensils

46. Sanitary Operations

47. Employee Hygiene

Part D - Sampling

Generic E. coli Testing

Part F - Inspection Requirements

Part G - Other Regulatory Oversight Requirements

56. European Community Directives

57. Monthly Review

FSIS- 5000-6 (04/04/2002)

58.

ON-SITE AUDIT

6. TYPE OF AUDIT

DOCUMENT AUDIT

30. Corrective Actions

31. Reassessment

32. Written Assurance

33. Scheduled Sample

34. Species Testing

35. Residue

37. Import

48. Condemned Product Control

49. Government Staffing

50. Daily Inspection Coverage

51. Enforcement

52. Humane Handling

53. Animal Identification

54. Ante Mortem Inspection

59.

55. Post Mortem Inspection

Weifang Legang Food Co., Ltd.

Honghe Town of Changle County

Shandong, PRC

3700/03435

People’s Republic of China

Drs. Gonzalez and McGee

X

X

March/12/2013

FSIS 5000-6 (04/04/2002)

60. Observation of the Establishment

Page 2 of 2

61. NAME OF AUDITOR 62. AUDITOR SIGNATURE AND DATE

Processing Establishment No. 3700/03435

39. FSIS auditors identified structural deficiencies that included accumulation of residue on the outer surfaces of a tumbler in

the raw product area and coils of electrical cords on workstation lamps in the cooked product area.

FSIS auditors received copies of documented corrective actions and official verification prior to the completion of the audit. The

evidence provided demonstrated an effective corrective action and adequate official verification.

Drs. Gonzalez and McGee

22. Records documenting: the written HACCP plan, monitoring of the

critical control points, dates and times of specific event occurrences.

Hazard Analysis and Critical Control Point

(HACCP) Systems - Ongoing Requirements

Part D - Continued

Economic Sampling

27. Written Procedures

10. Implementation of SSOP's, including monitoring of implementation.

8. Records documenting implementation.

United States Department of Agriculture

Food Safety and Inspection Service

Foreign Establishment Audit Checklist

1. ESTABLISHMENT NAME AND LOCATION 2. AUDIT DATE 3. ESTABLISHMENT NO. 4. NAME OF COUNTRY

Place an X in the Audit Results block to indicate noncompliance with requirements. Use O if not applicable.

Part A - Sanitation Standard Operating Procedures (SSOP)

Basic Requirements

7. Written SSOP

5. NAME OF AUDITOR(S)

Audit

Results

9. Signed and dated SSOP, by on-site or overall authority.

11. Maintenance and evaluation of the effectiveness of SSOP's.

12. Corrective action when the SSOP's have failed to prevent direct

product contamination or adulteration.

13. Daily records document item 10, 11 and 12 above.

Part B - Hazard Analysis and Critical Control

Point (HACCP) Systems - Basic Requirements

Sanitation Standard Operating Procedures (SSOP)

Ongoing Requirements

14. Developed and implemented a written HACCP plan .

15. Contents of the HACCP list the food safety hazards,

critical control points, critical limits, procedures, corrective actions.

16. Records documenting implementation and monitoring of the

HACCP plan.

17. The HACCP plan is signed and dated by the responsible

establishment individual.

18. Monitoring of HACCP plan.

19. Verification and validation of HACCP plan.

20. Corrective action written in HACCP plan.

21. Reassessed adequacy of the HACCP plan.

Part C - Economic / Wholesomeness

23. Labeling - Product Standards

24. Labeling - Net Weights

25. General Labeling

26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)

28. Sample Collection/Analysis

29. Records

Audit

Results

Salmonella Performance Standards - Basic Requirements

Part E - Other Requirements

36. Export

38. Establishment Grounds and Pest Control

39. Establishment Construction/Maintenance

40. Light

41. Ventilation

42. Plumbing and Sewage

43. Water Supply

44. Dressing Rooms/Lavatories

45. Equipment and Utensils

46. Sanitary Operations

47. Employee Hygiene

Part D - Sampling

Generic E. coli Testing

Part F - Inspection Requirements

Part G - Other Regulatory Oversight Requirements

56. European Community Directives

57. Monthly Review

FSIS- 5000-6 (04/04/2002)

58.

ON-SITE AUDIT

6. TYPE OF AUDIT

DOCUMENT AUDIT

30. Corrective Actions

31. Reassessment

32. Written Assurance

33. Scheduled Sample

34. Species Testing

35. Residue

37. Import

48. Condemned Product Control

49. Government Staffing

50. Daily Inspection Coverage

51. Enforcement

52. Humane Handling

53. Animal Identification

54. Ante Mortem Inspection

59.

55. Post Mortem Inspection

Zhongao Holdings Group Co., Ltd

No. 1999 Central Street

Qingyun County

Shandong, PRC

3700/03439

People’s Republic of China

Drs. Gonzalez and McGee

X

March/14/2013

FSIS 5000-6 (04/04/2002)

60. Observation of the Establishment

Page 2 of 2

61. NAME OF AUDITOR 62. AUDITOR SIGNATURE AND DATE

Processing Establishment No. 3700/03439

The sanitary conditions and general operations of the establishment currently meet FSIS’s requirements and appear to comply

with the PRC requirements.

Drs. Gonzalez and McGee

22. Records documenting: the written HACCP plan, monitoring of the

critical control points, dates and times of specific event occurrences.

Hazard Analysis and Critical Control Point

(HACCP) Systems - Ongoing Requirements

Part D - Continued

Economic Sampling

27. Written Procedures

10. Implementation of SSOP's, including monitoring of implementation.

8. Records documenting implementation.

United States Department of Agriculture

Food Safety and Inspection Service

Foreign Establishment Audit Checklist

1. ESTABLISHMENT NAME AND LOCATION 2. AUDIT DATE 3. ESTABLISHMENT NO. 4. NAME OF COUNTRY

Place an X in the Audit Results block to indicate noncompliance with requirements. Use O if not applicable.

Part A - Sanitation Standard Operating Procedures (SSOP)

Basic Requirements

7. Written SSOP

5. NAME OF AUDITOR(S)

Audit

Results

9. Signed and dated SSOP, by on-site or overall authority.

11. Maintenance and evaluation of the effectiveness of SSOP's.

12. Corrective action when the SSOP's have failed to prevent direct

product contamination or adulteration.

13. Daily records document item 10, 11 and 12 above.

Part B - Hazard Analysis and Critical Control

Point (HACCP) Systems - Basic Requirements

Sanitation Standard Operating Procedures (SSOP)

Ongoing Requirements

14. Developed and implemented a written HACCP plan .

15. Contents of the HACCP list the food safety hazards,

critical control points, critical limits, procedures, corrective actions.

16. Records documenting implementation and monitoring of the

HACCP plan.

17. The HACCP plan is signed and dated by the responsible

establishment individual.

18. Monitoring of HACCP plan.

19. Verification and validation of HACCP plan.

20. Corrective action written in HACCP plan.

21. Reassessed adequacy of the HACCP plan.

Part C - Economic / Wholesomeness

23. Labeling - Product Standards

24. Labeling - Net Weights

25. General Labeling

26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)

28. Sample Collection/Analysis

29. Records

Audit

Results

Salmonella Performance Standards - Basic Requirements

Part E - Other Requirements

36. Export

38. Establishment Grounds and Pest Control

39. Establishment Construction/Maintenance

40. Light

41. Ventilation

42. Plumbing and Sewage

43. Water Supply

44. Dressing Rooms/Lavatories

45. Equipment and Utensils

46. Sanitary Operations

47. Employee Hygiene

Part D - Sampling

Generic E. coli Testing

Part F - Inspection Requirements

Part G - Other Regulatory Oversight Requirements

56. European Community Directives

57. Monthly Review

FSIS- 5000-6 (04/04/2002)

58.

ON-SITE AUDIT

6. TYPE OF AUDIT

DOCUMENT AUDIT

30. Corrective Actions

31. Reassessment

32. Written Assurance

33. Scheduled Sample

34. Species Testing

35. Residue

37. Import

48. Condemned Product Control

49. Government Staffing

50. Daily Inspection Coverage

51. Enforcement

52. Humane Handling

53. Animal Identification

54. Ante Mortem Inspection

59.

55. Post Mortem Inspection

Qingdao Nine-Alliance Group Co., Ltd.

Weihai West Road

Laixi, Qingdao

Shandong, PRC

3700/03447

People’s Republic of China

Drs. Gonzalez and McGee

X

x

March 7, 2013

FSIS 5000-6 (04/04/2002)

60. Observation of the Establishment

Page 2 of 2

61. NAME OF AUDITOR 62. AUDITOR SIGNATURE AND DATE

Processing Establishment No. 3700/03447

39. Establishment Construction/Maintenance

FSIS auditors observed several long electrical cords bundled with pieces of wire and repaired with

electrical tape that rendered them difficult to clean. There was also one frayed electrical cord near exposed

frozen RTE products. CIQ officials documented these structural deficiencies and ensured implementation

of adequate corrective action within 48 hours.

An air-line water trap was not adequately closed and sealed causing its contents to spray in the

surrounding area.

FSIS auditors received copies of documented corrective actions and official verification prior to the

completion of the audit. The evidence provided demonstrated an effective corrective action and adequate

official verification.

Drs. Gonzalez and McGee