COMPLIANCE REPORTS

This information was released under the Freedom of Information Act .

USDA
United States Food Safety Field Technical Service Center
Department of Agriculture And Inspection Operations Suite 300, Landmark Center
Service 1299 Farnam Street
Omaha, NE 68102


P515 INSPECTION SYSTEMS TEAM AUDIT: REPORT ON NEW ZEALAND’S MEAT INSPECTION PROGRAM
(March 17- March 30, 1999)

FINAL

INTRODUCTION
Background
This report contains information obtained during an on-site audit of New Zealand’s Ministry of Agriculture and Forestry (MM), Meat Inspection System from March 17 through March 30, 1999. The systems audit is an evaluation methodology for verification to confirm that New Zealand is providing adequate oversight to ensure that only wholesome, unadulterated and properly labeled products are exported to the United States.

New Zealand is the third largest exporter of meat products to the United States. New Zealand has certified 92 slaughter and processing establishments to the United States. Currently, 79 establishments are active exporters of fresh beef, mutton, lamb, veal, and canned meat products to the United States. Eighty-eight cold store/freezer facilities store/re-pack and export product to the United States. In 1998, New Zealand exported 477,162,848 pounds of meat products, of which 1,891,203 pounds (0.39%) were rejected on reinspection at the ports of entry. The causes for rejection were transportation damage, missing shipping marks, contamination, pathological conditions, and defects for labeling, net weights and processing.

During the last audit of New Zealand’s meat inspection system in 1996, 29 of 85 US-certified establishments were audited. The team concluded that:

· The new National Compliance Program (implemented in April 1996) requires detailed evaluation Qf New Zealand’s inspection system, however there was a tendency to pay less attention to incidentally observed problems by the individual Regional Review Officers.
· The MAF National Assessors (Compliance Staff) were thorough, but occasionally inconsistent.
· Compliance with zero-tolerance requirements for ingesta, feces and milk contamination, proper lighting at the inspection stations, cross-contamination prevention, and security of fetal calf blood needed to be improved.

There was no follow-up Food Safety and Inspection Service (ESIS) audit during 1997 and 1998. During this time, the International Policy Division (IPD) continued to consult with MAF to seek clarification of the equivalence issues.

Methodology
The inspection system audit was conducted in collaboration with MAF meat inspection officials. The team focused on scientific and technical relationships, current or developing program changes impacting food safety, and verification of the systems’ effectiveness. System verification was verified through document audit and on-site observation of the responses of the inspection service and establishments to variations noticed during the conduct of their routine operations.

The first three days were spent at MAF’s headquarters in Wellington. These days were occupied by discussions on various sanitary measures that provide the appropriate level of product safety and assurances needed from New Zealand on maintaining an appropriate level of health protection. Specific subjects discussed included the following:

Legal system - MAF Regulatory Authority, Meat Act 1981, Meat Regulations 1996, Slaughter Stock, Game and Poultry Regulations 1969, MAF Regulatory Authority (Meat and Seafood) Manuals, Industry Agreed Standards, and Industry Agreed Implementation Standards, Technical Directives, and Circulars
Management system - organization, fiunding, staff and training
Functional Relationship between MAF Verification Agency (MAFVA), and New Zealand Limited (ASURE) - a government agency controlled by the Minister of State Owned Enterprises (SOB)
· Slaughter and processed product inspection system - establishment approval and licensing, operations and procedures, process control
· Chemical residues and microbiological programs - monitoring, testing and control
· Food safety and public health initiatives (technical development and risk analysis) -generic Escherichia coli (E. coli) and Salmonella testing, microbiological database, Sanitation Standard Operating Procedures (SSOP), and Hazard Analysis and Critical Control Points (HACCP)
· Animal health system - animal identification, zoonoses and food-borne disease status
· Compliance enforcement system

Centrally located MAF Compliance Group (MAFCG) audit records of 28 establishments were audited to identify and determine the effectiveness of New Zealand’s inspection system in enforcing compliance of domestic and US inspection system requirements.

Six days were then spent conducting on-site audits of 11 establishments, one chemical residues testing laboratory, two accredited microbiological testing contract laboratories, and two in-plant microbiological testing laboratories. The official records of these facilities were also audited. Discussions were held with responsible officials in these facilities on scientific and technical aspects, the PRIHACCP rule and FSIS’ zero tolerance policy.

The PR/HACCP systems rule require establishments to take immediate preventive and corrective measures to control food safety hazards that are reasonably likely to occur in the food production process. Therefore based on the results of the on-site audit of in-plant inspection documents and operational performance, the team considered the compliance status of individual establishments as ‘Acceptable,’ ‘Acceptable with Variance,’ or ‘Unacceptable.’

· Acceptable: When non-compliance with components of PR/HACCP and other regulatory requirements was not identified, and/or if the variance was identified by the establishment representative(s) and an immediate or further planned action was taken to assure product safety.
· Acceptable with Variance: When the establishment failed to meet one or more components of PR/HACCP and other regulatory requirements, but took immediate or further planned corrective action to assure product safety subsequent to notification of non-compliance by New Zealand’s inspection service.
· Unacceptable: When the establishment failed to meet one or more components of PR/HACCP and other regulatory requirements, and subsequent to notification of non-compliance by the inspection service, failed to take immediate or further planned action to assure product safety.

On March 17, 1999, an introductory meeting was held with MAF officials in Wellington. Present were Dr. Tony Zobrab, Chief Meat Veterinary Officer; Ms. Dilky Wickaramasinghe, Executive Assistant; Dr. Geoffrey Allen, National Manager Compliance; Ms. Judy Barker,
Program Manager Meat and Game; Dr. Phil Ward, National Manager - Generic (approvals/registration, engineering, management support, technical communication, market access, and residues); Dr. John Lee, Market Access Counselor (North America); Ms. Karen
Armitage, Residue Manager; and Mr. Peter Fairless, National Manager Engineering.

On March 18 and 19, other MAF officials joined the technical presentations and discussions on the MAF inspection system. These officials were: Mr. Neil Kiddey, Deputy Manager Compliance; Mr. Keith Willett, Executive Officer Compliance; Dr. Judi Lee, National Manager
HACCP; Mr. Neil Armitage, National Manager Approvals and Registration; Dr. Roger Cook, National Advisor Microbiology; and Dr. Jos Goebbels, General Manager MAF Verification Agency (MAF VA).

The United States Department of Agriculture (USDA), Food Safety and Inspection Service (ESIS) participants were: Mr. Donald Smart, Director, Review Staff (Inspection Systems Coordinator); Dr. Hussain Magsi, International Audit Staff Officer (Audit Team Leader); Dr.
Douglas Nrks, International Audit Staff Officer (Team Member); and Dr. Ann Marie McNamara, Director, Microbiology Division (Team Member). Mr. Gary Meyer, Agricultural Attache, U. S. Embassy was also present.

The MAFCG’s (central audit) documents of 28 establishments were audited, of which a set of 17 establishments was selected for on-site audit. The itinerary was finalized, and audit procedures were discussed. The following MAFCG auditors were designated to participate in document and on-site audits: Mr. Neil Kiddy, Dr. Ziggy Bojarski, Mr. Dudley Morrison, Dr. Patrick Poletti, and Dr. Jack Pociecha. Dr. Goeffrey Allen served as the audit coordinator for MAF.


Centralized Establishment Records Audit
The purpose of examining establishment records was to correlate document findings with on-site establishment performance and inspection controls to determine the effectiveness of New Zealand’s in-plant inspection system.

Under the ESIS audit-sampling plan, of the 92 establishments that New Zealand certified to export to the United States, 25 were randomly selected for centralized records audit. The randomly selected establishments were ME 9, ME 15, ME 16, ME 18, ME 21, ME 23, ME 32, ME 34, ME 37, ME 39, ME 43, ME 58, ME 60, ME 66, ME 78, ME 84, ME 100, ME 101, ME 102, ME 103, PH 31, PH 134, PH 173, PH 353 and PH 450. The following establishments were replaced with alternates: ME 51 (company closed), ME 54 (currently processes pork for local market), ME 75 (currently not operating), ME 85 (company closed), and ME 120 (MAF withdrew export inspection license; currently processes game meat).

In addition, of 88 cold stores/freezers, three establishments 5 53, 5105 and S 181 were selected for document audit.

On-site Audit of Establishments
The on-site audit emphasized evaluation of actual or potential hazards associated with public health and safety, such as, contamination of meat products, including zero tolerance for feces, ingesta and milk; animal diseases transmissible to humans and wholesomeness of the edible tissue; composition standards and procedures for processed products; compliance activities including prevention of economic fraud; and the detection of chemicals and drugs in meat products.

Following the document audit of 28 establishments, a set of 17 meat slaughter and processed products establishments was selected for on-site audit. Of these, a subset of nine was selected for the initial on-site team audit. These establishments conducted the following operations:
ME 9 Slaughter beef
ME 15 Slaughter beef
ME 34 Slaughter veal, mutton and lamb
ME 37 Slaughter veal, mutton and lamb
ME 39 Slaughter beef, veal, mutton and lamb
ME 78 Slaughter mutton and lamb
ME 84 Slaughter beef
ME 100 Slaughter beef, mutton and lamb
PH 134 Canned corn beef, mutton and lamb

The remaining eight establishments (of the original 17) were selected for extended audit, in case the initial audit resulted in an in-plant system failure. These establishments were ME 101, ME 102, ME 103, ME 58, ME 60, ME 42, ME 28, and ME 18. Establishments 5 105 and 5 181 were selected for on-site verification for SSOP implementation and other requirements. The selection of establishments was based on documented performance, process and inspection controls, and a port of entry rejection profile.

Establishment representatives were given the opportunity to identify and correct any deficiencies that might be found. The MAF auditor(s) were requested to conduct an audit of the ‘in-plant inspection system.’ The ‘in-plant inspection system’ encompasses an environment that maintains and operates a facility which complies with domestic and US requirements for acceptable premises, facilities, equipment, operations, and performance standards and procedures assuring preparation and distribution of wholesome, unadulterated and safe food products. FSIS team auditors made independent observations without intervention, except when product integrity was jeopardized without the establishment’s knowledge, and/or MAFVA and MAFCG auditors.

Establishment records and MAF inspection documents were also audited. The auditors discussed inspection standards and procedures, and process control programs, specifically food safety initiatives, with establishment management, and MAFCG and MAFVA Technical Supervisors. The in-plant record audit concentrated primarily on food safety hazards that included:
· Required sampling for microbiological (E. ccli, Salmonella and Listeria) and residue testing
· Slaughter and processing inspection standards and procedures
· Control of restricted meats, such as carcasses determined to have tuberculosis, cysticercosis, etc., and control of condemned or inedible product
· Water and ice supply; rodent and pest control; and the use of chemicals in the establishments
· Quality assurance and other food safety initiatives - SSOP and HACCP plans including AQL programs to monitor net weights; and carcass/boneless meat reinspection; wholesomeness of additives and packaging materials; labels and security device control; and export product certification and integrity control
· Risk and performance-based MAFVA verification audits, and MAFCG periodic risk based audit records
· ASURE inspector’s performance, training, and relationship with MAFVA Technical Superyisors and MAFCG auditors.

Laboratory Audit
The national chemical residue testing laboratories providing service to MAF include the National Chemical Residue Laboratory (Agri. Quality NZ in Upper Hutt), which tests all chemical residues (except chemical elements) and species verification samples, and the Institute for environmental and Scientific Research in Lower Hutt, which analyses chemical elements.

Approved contract laboratories perform the microbiological testing. There are 51 laboratojes approved to conduct specific tests, such as, water microbiology and chemistry, meat microbiology and chemistry, food composition, food additives and contaminants, environmental tests, and tests for tallow, fats and oils. Certified trainers train the sample takers.

Dr. McNamara visited microbiological testing laboratories in one ovine (ME 34) and one bovine (ME 15) slaughter establishment, the National Chemical Residue Laboratory in Upper Hutt, and two microbiological testing laboratories in Auckland. Dr. McNamara conducted technical discussions, examined technical documents, and audited New Zealand’s National Microbiological Database (NMD) program.


RESULTS AND DISCUSSION
Summary
During the period March 17 - March 30, 1999, the FSIS Inspection Systems Audit Team performed an on-site audit of New Zealand’s inspection system. Establishment records, MAF inspection and systems management and resource documents, 11 establishments, and three laboratories were audited. At the conclusion of the audit, a number of variances from the US inspection system were noted, as detailed below:

Organization and Resource Management
· The organizational structure of the meat inspection program is not vertically integrated.
· Some inspectors are leased for extended periods (up to 12 months) to work for the establishments to perform quality assurance and other discretionary services. Continuous (daily) inspection coverage is not provided in canned product establishments. Export certification of canned products (PH 134) in transit was authorized before completion of incubation (heat penetration) test.
· Trainee inspectors (not certified as competent) perform on-line postmortem inspection.

SSOP Implementation
· The inspection service (MAFV) does not monitor implementation and determine the effectiveness of SSOP requirements on a continuing basis. Unlike daily monitoring in FSIS’ ‘Performance Based Inspection System (PBIS)’, New Zealand’s ‘Performance Based Verification (PBV)’ system provides for auditing once every week to every three months.
· In establishments ME 15, ME 34, ME 37, ME 39, ME 78, ME 84, ME 100 and PH 134, the corrective and/or preventive actions for pre-operational and/or operational sanitation were not taken or not completely documented.
· In establishments ME 39 and ME 84 product contamination with ingesta and hair was observed by an FSIS auditor. In these establishments, the establishment’s management took~ the actions to protect or prevent product contamination upon notification by the auditors.
· SSOPs were not implemented in two warehouse/freezer facilities (S 105 and 5 181) audited.

HACCP Implementation
· There is no continuous HACCP implementation monitoring, and non-performance evaluation/control system in place. The MAFVA Technical Leaders monitor the implementation of HACCP during their FSIS-required monthly audits The in-plant MAFVA Technical Supervisor’s frequency of HACCP monitoring is performed according to New Zealand’s PBV audit system, which is triggered by the outcome of the audit. Verification can be reduced to weekly, monthly or even quarterly. These Technical Supervisors are not trained in HACCP.
In establishment ME 39, at ‘Y-cut’ and ‘neck-skin roller’ stations (CCP’s), repetitive product contamination and corrective actions were recorded, but no re-validation or reassessment was done.
· The pre-shipment review of associated records is not performed on products intended for export.

Microbiological Testing
There is no formal MAF-directed Salmonella Testing Program as mandated by the PR/HACCP rule. There is a voluntary Salmonella Testing Program, which may be utilized at the option of each establishment. However, establishments may discontinue testing at their discretion.

A number of deviations or deficiencies were observed in the E. col, and informal Salmonella testing programs. These deficiencies included (I) sampling procedures (dissimilar size and sites), (2) sampling techniques (variability between swabbing procedures and technicians), (3) lack of trend data utilization (not used to identify fecal contamination), (4) reporting of results (significant delays), (5) reliance on verbal communication, and (6) training of laboratory technicians (uncertified).

Residue Testing
Imported meat products were not tested or included in the National Residue Monitoring Program.


Organization and Management Resources
In November 1998, the former MAF Quality Management Team, which included the Inspector-in-Charge and the meat inspectors, was divided into two separate organizations: MAF Verification Agency (MAFVA), and New Zealand Limited (ASURE), a government agency controlled by the Minister of State Owned Enterprises.

The ASURE Inspectors (700 full time and 200 part time) constitute the front-line inspection service performing antemortem and postmortem inspection. There is also a group of four Quality Assurance Auditors who supervise and administer the activities of ASURE inspectors and also conduct planned audits to verify the performance of the establishments.

The MAFVA employs 90 Technical Supervisors who verify establishment programs, ASURE inspector’s performance, and procedures and standards controls at a variable frequency of once a week to quarterly. The frequency of establishment performance monitoring is based on the audit rating of ‘Acceptable,’ ‘Marginal,’ and ‘Fail’, which slides up and down as the performance rating changes. Nine MAFVA Team Leaders supervise and audit the activities of the Technical Supervisors. ASURE employees perform on-line inspection, while the Technical Supervisors audit the activities of the ASURE inspectors as well as the establishment activities.

The MAF organizational structure is not vertically integrated. Two Ministries (MAF and SOE), which are responsible for oversight and verification of establishments’ programs, their operational performance, and in-plant inspection controls verification lack binding functional collaboration and technical relationships. For example, in establishment ME 84, the MAFVA Technical Supervisor recorded and notified the ASURE supervisor of the negligence of on-line postmortem inspectors on several occasions, but no actions were taken or recorded by ASURE supervisory officials. Also, in establishment ME 100, MAFVA Technical Supervisors learned about one half hour’s slaughter operations being conducted without inspection. Allegedly, one or more carcasses were allowed to pass by with no inspector on the postmortem inspection line. The Technical Supervisor withheld 308 cartons of suspect product, and notified the ASURE supervisor in writing, but no action was taken or recorded by the ASURE officials.

It was learned that a Memorandum of Understanding (MOU) was drafted between MAF and ASURE to clearly define their functional relationships. The auditors received two different MOU’s. Dr. Peter McKenzie, ASURE Technical Manager, presented one draft during the audit, and another (undated) was received at the Technical Service Center after the audit. The contents of the MOU’s are not consistent.

Inspection Coverage and Supervision
The on-site audit of establishment PH 134 revealed that the MAF VA inspector visited the establishment on a weekly basis under the newly implemented PBV audit system. With the compliance and rating status of PBV, on-site visits to processing establishments can be as infrequent as once every six months. MAFVA was advised that daily visits are required at the US-certified establishments. It was stated during the exit meeting that daily coverage had been reinstated. The lack of daily coverage was attributed to an administrative error on the part of MAFVA supervisory personnel.

Official Inspector’s Services Leased to the Industry
At establishment ME 84, it was observed that an official meat inspector was working for and under the authority of a QA establishment manager conducting HACCP monitoring and performing other duties for the establishment. The ASURE supervisor reported that the inspector had been ‘leased’ to the establishment for 12 months to conduct QA activities at the request of the establishment. The auditor deemed it as a conflict or appearance of a conflict of interest. In establishment ME 78, the inspector monitored HACCP activities for the establishment in addition to his on-line duties.

Under the leasing program, inspectors may be required to conduct discretionary services, such as trimming, etc., for the industry during their spare time periods, and/or in addition to his/her on-line duties depending on the line speed.

MAF requires meat inspectors to be suitably qualified, appropriately trained; maintain their skills; use statutozy powers appropriately to the prescribed duties; and be capable of carrying out assigned duties. To conduct antemortem and postmortem duties, the inspector must be qualified, and not a trainee. However, in establishment ME 9, the audit of training records indicated that two inspectors had not completed their training. Dr. Peter McKenzie, ASURE Technical Manager, confirmed that, of seven trainees who had completed initial training steps, two were not certified as competent to conduct inspection activities, and that the trainees would be replaced immediately.

It was learned that the training of the meat inspectors had gradually been reduced from training in all aspects of meat inspection to segmented inspection for species-specific heads, viscera or carcasses over a period of about 15 years. Around the 1980’s, MAF-hired inspectors were educated and trained in an authorized college. Later in the 1990’s, the inspectors were on-the-job trained for specific species inspection, such as only bovine or ovine postmortem inspection. Currently, the inspectors are trained and authorized for inspection of the heads, viscera or carcasses of sheep, cattle, swine or poultry.

Establishment Performance Evaluation
A staff of eight National Compliance Assessors (MAFCG auditors) performs periodic in-depth audits of export licensed or federally registered establishments. Of eight auditors, five audit meat and seafood establishments. The MAFCG auditors conduct periodic audits of about 16 domestic slaughterhouses, 63 export slaughter establishments, 83 processed products establishments, 88 cold storage facilities, 48 pet food establishments, 14 deer slaughter and processing establishments, and several other operations including rendering, opossum, fish and poultry product establishments.

The MAFCG auditors examine the documents and evaluate on-site performance and compliance of the establishment, on-line inspectors, and the MAFVA verifiers. These audits are risk and performance-based, and the establishments are given ratings of ‘Acceptable,’ ‘Marginal,’ ‘Fail,’ or ‘Incomplete’. All ‘Fail’ rated establishments are re-audited within nine months. Others, which are delisted by importing country au4itors, or determined by MAFCG auditors as having the likelihood of endangering public health are audited within 30 days. Special audits are conducted when necessary. All establishments are audited within three to five years. Each audit normally lasts two to three days.

A - pass (acceptable standard of compliance)
M - pass (marginal standard of compliance; one or more serious deviations from MAF regulations specifications noted; MAFVA control not as good as expected)
F - fail (MAFVA verification and control is deficient; MAFCG intervention may be needed)
Z - incomplete audit (does not reflect ongoing status)

The audit team verified the implementation and effectiveness of the PR/HACCP rule using FSIS Directives 5000.1 (Enforcement of Regulatory Requirements in Establishments Subject to the HACCP System Regulations), and 5400.5 (Inspection System Activities). The applicable HACCP component ‘activities,’ ‘elements,’ and ‘procedures’ were taken into account before final determinations were made on the establishment’s process control, and the effectiveness of the inspection system. In addition, the team audited the ‘non-compliance records’ generated by MAFVA or MAFCG verifiers and provided to the non-conforming establishments.

SSOP Implementation
The inspection service (MAFV) did not monitor implementation and determine the effectiveness of SSOP requirements on a continuing basis. Unlike daily monitoring in FSIS’ PBIS, the New Zealand’s PBV’ audit system provides for auditing as infrequent as once every three months. In establishments ME 15, ME 34, ME 37, ME 39, ME 78, ME 84, ME 100 and PH 134 the corrective actions for pre-operational and/or operational sanitation were not taken or completely documented, and the preventive actions were seldom addressed.

In establishments ME 39 and ME 84 product cont.unination with feces, ingesta and hair was observed by an FSIS auditor. In these establishments, the management took the actions to protect or prevent product contamination, when notified by the auditors.

SSOPs were not implemented in two warehouse/freezer facilities (5 105 and 5 181) audited.

HACCP Implementation
Continuous monitoring for HACCP implementation and non-performance evaluation was not performed by MAFVA. The MAFVA Technical Leaders, it was stated, monitor and verify the effectiveness of HACCP during their FSIS required monthly audits. However, there was no documentation made available to verify their monitoring activities. The frequency of verification of the HACCP systems is according to the New Zealand’s PBV audit system, which is triggered by the PBV audit’s outcome. Ideally when the systems are working well, the monitoring of HACCP compliance or verification may be at intervals of up to three months in slaughterhouses, and up to six months in export warehouses and byproduct facilities.

The MAFVA Technical Supervisors are not trained in HACCP. The nine Team Leaders (supervisors of TS) are trained, and visit US certified establishments about once every two to three months.

In establishment ME 39, at ‘Y-cut’ and ‘neck-skin roller’ stations (CCP’s), repetitive product contamination and corrective actions were recorded, but no re-validation or reassessment was done.
Microbiological Testing Program
Variations or deficiencies of New Zealand’s testing programs in comparison to the PR/HACCP rule or Good Laboratory Practices were found in the following areas:

E. coli Testing
Observations of the actual carcass sampling technique in-plant showed that the actual number of times the surface was swabbed with both dry and wet swabs was highly variable between samples taken by the same sample collector and between sample collectors. The US instructions to the inspectors for carcass sample collection state that the area is to be swabbed 10 times in each direction to reduce variability in sampling technique.

· Smaller sampling sizes on carcasses are routinely being used for microbiological sampling as compared to the size of sites required in the PR/HACCP rule. The PR/HACCP rule mandates a sample size of 300 cm2 (100cm2 x 3 sites per carcass) for cattle (including bobby calves). MAF has directed establishments to comply with the 300cm2 sample size for cattle, but the bobby calf program only requires a sample size of 15cm2 per carcass (5 cm2 x 3 sites).

In similar fashion, the site of the carcass sites being sampled for ovine microbiological testing programs is much smaller (15 cm2 total; 5 cm2 x 3 carcass sites). Although technical amendments clarifying the requirements of an ovine testing program are not being projected until late 1999, the New Zealand program tests a carcass size which is 10-fold smaller than in the US. The ovine sampling sites used in the New Zealand program (outerleg, flank, v-cut) also differ from the US sites (rump, flank, and brisket). The bobby calf sampling sites are not the same sites used for sampling cattle in the PR/HACCP rule. The cattle sites are rump, flank, and brisket. The New Zealand program samples the rump, flank, and foreleg.

· There appeared to be a lack of the use of trend data by establishment personnel to monitor potential problems with fecal contamination. Reporting E. coli data in a graphic format similar to aerobic plate count data would make upward trends more readily visible to the establishment personnel and show the history of E. ccli testing in an establishment over time.

· There were significant delays in the written reporting of laboratory results to establishment managers responsible for process control activities in-plant. The turn-around times for E. ccl: results (a 48-hour test, maximum) often took 7-9 days to be reported. This time period is too long for effective process control activities to take place. There was a reliance on verbal instructions from laboratories to the establishments or MAF to laboratories, which could not be substantiated by written documentation.

· In one microbiological laboratory, current training records for one person signing laboratory reports did not exist. The supervisor verified this omission and the person involved.

Salmonella testing is required under the New Zealand National Microbiological Database program for both adult cattle and calves but differs in scope and technical detail to the PR/HACCP rule.

Other Risk Areas
Contamination
In establishments ME 39 and ME 84 product was contaminated with ingesta, feces and hair. Corrective actions was taken, when notified by the auditor. Other sanitation related deviations have been described under the SSOP Implementation narrative.

Disease
·Antemortem and postmortem inspection findings
On antemortem and postmortem inspection, commonly observed conditions are:

Cattle - actinomycosis, actinobacillosis, cysticercosis, tuberculosis, arthritis, neoplams, pleurisy, pneumonia, pyogenic lesions, septicemia-toxemia, emaciation, ocular squamous cell carcinoma, retained placenta, xanthosis, facial eczema, hydatidosis, wounds and bruises, and contamination.

Calves - arthritis, navel ill, pleurisy, pneumonia, wounds and bruises.

Sheep and lambs - arthritis, caseous lymphadenitis (cornebacteriosis), cysticercosis, neoplasms, pleurisy, pyogenic lesions, sarcosporidiosis, hydatidosis, wounds and bruises.

Epidemiology and Food-borne Disease Status
Animal diseases existing in the country are leptospirosis (multiple species), bovine tuberculosis, infectious bovine rhinotracheitis, Johne’s disease, equine rhinopneumonitis, Marek’s disease, and viral hemmorhagic diseases of rabbits.

Significant animal diseases communicable to humans in New Zealand are leptospirosis (multiple species), tuberculosis, cysticercosis, sarcosporidiosis, hydatidosis and cornebacteriosis. The incidence of human cases of cryptosporidiosis, leptospirosis and tuberculosis have increased significantly during the last two years. In the first 11 months of 1998, there were 835 cases of cryptosporidiosis, compared with 350 for the same months in 1997. Spring peaks occur predominantly in rural areas and are probably due to the presence of ovines, which excrete C,yptosporidium Qocysts in huge numbers. Similarly the cases of leptospirosis (multiple species) have increased, and the cases of human tuberculosis have increased (Source- New Zealand Public health Report, Vol. 6, No. 1: Jan. 1999, page 6; provided by MAF).

Tuberculosis in cattle is a serious concern of national importance. An eradication plan has been in force for some time. In June 1998, the incidence was 8.4%, and a target is to reduce infected herds to 6.1% by June 2001. There is a large population of opossums, which are carriers of the organism, and are hard to eradicate.

Processing
Canned products are authorized for export before the end of the 10-day incubation period or heat penetration test as a gas forming or other microbial contamination indicator (PH 134). Export certificates are issued for in- transit product when incubation has successfully been completed.

During a MAFCG audit, the auditor reported that product was shipped to the US before the end of the incubation cycfe. The establishment manager stated that this was an approved practice. At the request of the establishment, MAF ruled that according to FSIS regulation section 3 18.309(dXl)(viii), which states, “Shipping. No product shall be shipped from the establishment before the end of the required incubation period except as provided in this paragraph or paragraph (b) or (c) of this section. An establishment wishing to ship product prior to the completion of the required incubation period shall submit a written proposal to the area supervisor. Such a proposal shall include provisions that will assure that shipped product will not reach the retail level of distribution before sample incubation is completed...” However, this regulation applies only to US domestically produced product.

This policy could also be construed as contraly to FMIA section 17, and MPI regulation, section 322.4, which do not allow products to be exported to a foreign country from any port in the United States, until an official export certificate has been issued and delivered.

Residues
No deviations were noted in MAF’s national chemical compounds/element, drugs and antibiotic residue monitoring program. However, imported meat products are not tested for residues contrary to US requirements.

Compliance - - Economic Fraud/Enforcement
New Zealand’s Meat Act of 1981 contains authorities comparable to the Federal Meat Inspection
Act, and MAF personnel are effectively preventing the export of meat products to the United
States that do not meet US requirements.

The MAF Compliance Group and MAF Verification Agency are responsible for auditing activities at official establishments, and also for the movement of inedible/condemned material to pet food licensees. MAFCG and MAFVA check inventory controls, sealing of containers, cargo seals, and MAF seals, in addition to determining the source of raw materials.

The MAFReg Enforcement Unit, comprised mostly of former police officers, is responsible for investigating and prosecuting the individuals/companies that have violated the Meat Act or Health Regulations. Documentation is similar to that used by FSIS, in that it would contain evidence/exhibits/statements to prove the offense. A chart summarizing enforcement activities for the past few years was provided to the audit team.

There is no authority in the Meat Act of 1981, or in the regulations or manual, to initiate an action to cancel the registration of an establishment or suspend the license to operate a registered establishment based upon a conviction. The existing law contains only a reference to “individuals of upright standing.” The Animal Products Act, expected to be passed into law later this year, is much stronger and more specific as to the ability of convicted individuals to operate within the meat industry.

For details on Compliance/Enforcement standards see Attachment 1.

Exit Meeting
On March 29, 1999, an exit conference was held with Dr. Andrew McKenzie, MAF Regulatory Authority, Chief Meat Inspection, Dr. Tony Zohrab, Dr. Geoff Allen, Mr. Neil Kiddey, Ms Judy Barker, Dr. Phil Ward, Dr. John Lee, Mr. Keith Willett, Dr. Judi Lee, Dr. Roger Cook, and Dr.
Jos Goebbels.

The Team Leader summarized the observations and results highlighting the variations described below:
· Regulatory changes and structure, and resource management system

· Vertical integration of inspection program and relationships between MAF Compliance Group, MAF Verification Authority and ASURE NZL Ltd. is needed. Dr. McKenzie agreed with the observations, and stated there was room for improvement.
· Leasing set-vices of official inspectors to work for the industry present a conflict of interest situation. Dr. Zohrab stated that ‘leasing of inspectors to the industry,’ in his opinion, was not a conflict or an appearance of a conflict interest.
· Training and inspection by unqualified trainees is permitted by New Zealand. Dr. Phil Ward provided a copy of Technical Directive 98/133 on Training. N: crrniments were made on the subject.
· On the subject of Technical Supervisors not being trained in PR/HACCP, it was stated that Team Leaders supervising the Technical Supervisors were trained, and that Technical Supervisors would be trained in the near future.

· In-plant inspection system
Export product certification without completion of incubation period - section 319.308 of the MPI regulations was cited, which authorizes distribution prior to incubation if approved by Area Supervisor/District Manager versus FMIA section 17, and section 322 4 prohibiting shipment for export without proper documentation. Dr. Zohrab stated that it was a different interpretation; product is on the water for a long time and could be controlled if the incubation test failed.

· Dr. ZoIu-ab dismissed the need to monitor residues in meats being imported in to US-certified establishments from US certified establishments. He stated that meat coming from certified countries (Australia) was already tested by Australia.
· Daily inspection coverage in canning establishments needs to be reinstituted. Dr. Zobrab said that it would be done.
· Dr. Zobrab stated MAF did not believe that SSOPs must be implemented in cold stores/freezers. He stated that SSOPs would be implemented in these facilities in the future.
· In response to an inquiry in regards to HACCP on the definition of ‘non-compliant product’, and ‘how it was controlled,’ Dr. Judi Lee, National Manager (HACCP) provided a written response.
· There was lack of documentation (SSOP and HACCP) and recording of corrective and preventive actions taken. Dr. Zobrab agreed to look into it.

· Residue control, and microbiological testing system
It was reiterated that the microbiological and residue testing audit was continuing, and one additional visit to the facilities was needed for Dr. McNamara to complete the audit. Dr. McNamara briefly remarked on her preliminary findings.

At the conclusion of the audit on March 30, Dr. McNamara summarized her findings with Drs. Tony Zohrab and Roger Cook. She identified significant variances from those of the FSIS. She told them that the significance of her findings could only be ascertained by [PD.
They were aware of the deficiencies noted. It was apparent, however, that MAF would like to maintain the status quo.

Dr. Andrew McKenzie appreciated the FSIS team’s visit. He stated that too frequent visits are not necessary, and that too few visits are not productive. He remarked if foreign auditors had not shown up, then a deficiency like SSOP implementation would have not been identified. He stated that a major food safety policy shift in New Zealand would become effective July 1, 1999, wherein all food control activities, currently under the Health Minister, would be transferred to MAF. He said that the Animal Products Act of 1999 is before the Parliament for final approval.

CONCLUSION AND RECOMMENDATIONS
Based on overall inspection system performance, the team determined that New Zealand’s meat inspection system varies considerably from the US inspection system. There are significant variations in the application of and compliance with the PR/HACCP rule and other FSIS regulatory requirements. A summary follows:

· The organizational structure is not vertically integrated to control the inspection system. Two Ministries (Ministry of Agriculture and Forestry, and Ministry of State Owned Enterprises) manage the program. In the Ministry of Agriculture and Fisheries two independent sister agencies (MAF Regulatory Authority and MAF Verification Authority) are involved. These agencies lack binding functional relationship with ASURE NZL Ltd. (a government agency controlled by the Minister of State Owned Enterprises (SOE)).

· Unqualified (trainee) inspectors are permitted to perform on-line postmortem inspection. Other inspectors are trained to conduct in inspection only in specific disciplines, such as species, head, viscera, carcass inspection.
· Inspectors are leased up to 12 months to work for the establishments. They may also be required to conduct some discretionary services, such as trimming, etc. for the industry during their spare time periods.
· Inspection coverage of processed products, and cutting, boning facilities is provided according to ‘Performance Based Verification’ audits results. Inspection coverage may occur at weekly, monthly, or even as infrequently as six-month intervals.
· SSOP and HACCP implementation and effectiveness is, at best-monitored monthly by the MAF Verification Authority. Corrective or preventive actions taken are not documented or are poorly addressed. Non-compliance procedures are not well defined or understood by MAF staff Pre-shipment verification of the product before distribution is not done. SSOPs in warehouse facilities were not implemented.
· Shipment of product without export certification or completion of incubation cycle of shelf-stable canned product was being authorized.
· E. coli sampling, process control trends and training programs were not comparable to PR/HACCP rule requirements.
· Salmonella testing is required under the New Zealand National Microbiological Database program for both adult cattle and calves but differs in scope and technical detail to the PR/HACCP rule.
· Imported meats intended for further processing and export to the US were not tested for residues. However, imported meats intended for further processing in New Zealand and subsequent export to the U.S. must come from certified establishments in the country of origin.

It is recommended that:

1. MAF should be informed that FSIS must be consulted and kept abreast of any actual or proposed changes in policy or regulations prior to implementation.
2. A follow-up inspection system audit, in a timely manner, to verify compliance with FSIS requirements would be useful in assuring confidence in food safety.

Dr. Hussain Magsi Mr Donald C Smart
International Audit Staff Officer Director, Review Staff
Technical Service Center Technical Service Center



Dr M. Douglas Parks
International Audit Staff Officer
Technical Service Center

COMPLIANCE/ENFORCEMENT PROGRAM
Country Reviewed: New Zealand Date of Review: March 17-29. 1999

Reviewer: Donald C. Smart, Director, Review Staff Technical Service Center

Agency responsible for Country Compliance/Enforcement Program: MAFReg Enforcement Unit (MAFReg = Ministry of Agriculture and Forestry Regulatory Authority)

A. Legal Authority

1. Does the country’s law contain authorities at least equivalent to United States for enforcement
meat and poultry acts? (x) Yes ( ) No

Remarks:
The Meat Act of 1981 contains authorities comparable to the Federal Meat Inspection Act. Currently, poultry is only produced for the domestic market and is ineligible for export. Poultry is covered by Food Hygiene Regulations.

A new law, the Animal Products Act, has been proposed to the country legislature and is due for the second reading. The Act is due to be passed into law in September. Andrew McKenzie, Chief of MAFReg, stated that there should be no problems with the law passing the legislature. After the passage of the Animal Products Act, the provisions of the Meat Act of 1981 will be phased out over a 3-year period At the end of this 3-year period all food products from animals will be covered under the same law. The new law also provides additional enforcement authorities.

Resources

1. Number of full time Compliance/Enforcement Officers:

The Enforcement Unit is currently comprised of Investigators originating predominately from an enforcement or legal background The Unit is controlled by a National Manager who is supported by 2 Senior Investigating Supervisors (Legal and Operational). The remainder of the Enforcement team consists of 6 investigators, 9 supporting Enforcement Officers, I Support Officer (Word Processing) and 1 Support Officer (Intel Analysis/Clerical).

2. Current country population approximately: 3.6 million

3. Volume of production

Exported to the United States - 479,089,307 pounds during CY 1998
Exported to other countnes - approx. 1,089,000,000 pounds during CY 1998
Domestic consumption - Unable to determine

Compliance Programs

1. Does the country impose controls on product believed to be adulterated of misbranded? (x)Yes ( )No
a. Detentions (x)Yes ( )No
b. Recalls (x)Yes ( )No
c. Seizures (x)Yes ( )No
d. Other similar actions (x) Yes ( ) No

Remarks:

a. Detentions are referred to as “impounding” in the Meat Act of 1981.
b. Recall authority is availabk for product in domestic distribution under the Meat Act of 1981, product in international channels is not specifically covered, but would be returned to NZ if problems with product were discovered after it had been shippedfrom the country. All NZ products will be covered under the new Animal Products Act, when passed into law.
c. The Biosecurity Act provides for compensation to the owner of the product seized
d. The Meat Act of 1981 provides for condemnation and destruction of adulterated or misbranded products.

2. Does the country impose the enforcement of record keeping requirement and the access, examination, copying and sampling privileges?
(x ) Yes ( ) No

Remarks:

The Meat Act of 1981 provides for entry, inspection, samples, and records and includes language similar to the FMJA to include “any person/firm/corporation “. The Animal Products Act will contain the same provisions.

3. Does the country make systematic reviews of all classes of persons, firms and corporations dealing in meat or poultry product intended for either human consumption or other use?
(x)Yes ( )No

Remarks:

For the next 6 months all export premises will continue to be reviewed under a risk-based system. After 6 months, MAF will reorganize and have all current health responsibilities for retail and restaurant operations. Pet food and inedible operations are included in their responsibilities. The Enforcement Unit does not have systematic reviews, but bases their work in response to leads, information, direction, and requests.
4. Do these reviews extend to storage locations of both edible and inedible/condemned and 4-D meat and poultry products?

. Are inedible/condemned products examined for labeling and decharacterization to preclude use as human food? (x ) Yes ( ) No
·Are systems in place to preclude diversion of inedible/condemned products into human food channels? (x) Yes ( ) No

Remarks:

The Compliance Group and the MAF Verification Agency conduct examination of product and records relating to inedible/condemned material. A vet food license is required of all individuals dealing in pet food The CG and MAF Verification check inventory controls, sealing ot containers, cargo seals. and MAF seals, in addition to determining source of raw materials.

5. Does the country have a planned compliance review system in effect that identifies assigned follow up and reviews based on risk of operation and/or individuals? (x)Yes ( )No

Remarks:

The existing law, the Meat Act of 1981, is admittedly weak in its reference to individuals as it talks only of “individuals of upright standing.” The new law, The Animal Products Act, is much stronger and more specific as to the ability of convicted individuals to operate within the meat industry.
6. Is there an enforcement (police type) agency to investigate and prosecute people suspected of illegal activities? (x)Yes ( )No

Documentation Used:

The MAFReg Enforcement Unit, comprised mostly of former police officers, is responsible for investigating and prosecuting individuals/companies that have violated the Meat Act or Health Regulations. Documentation would be similar to  that used by FSIS, in that it would contain evidence/exhibits/statements to prove the offense. (SEE ATTACHMENT FOR DETAILS OF RECENT ENFORCEMENT ACTIVITIES.)
7. Does the Country document alleged violations and does this documentation provide pertinent details? (x) Yes ( ) No

Remarks:

All necessary documentation is collected that would add to criminal prosecution. Prosecutory efforts are carried out through the Crown Prosecutor, the equivalent of our United States Attorney.

8. Is proper action taken for disposition of reports of violations (identifying minor or serious violations)? (x) Yes ( ) No

Remarks:

Reports of violations are disposed of in a similar manner as we have in FSIS. Minor infractions are closed with a Letter of Warning, and the more serious offenses are prosecuted by the Crown Prosecutor.

9. Does the Country’s program have access to legal resources for prosecuting cases? (x)Yes ( )No

Remarks:

MAFReg has a national manager responsible for legal actions (similar to our General Counsel),
who serves as attorney advisor for prosecutions. There is a legal section at M4FReg
Headquarters (Wellington) that functions like our Office of General Counsel. The Crown
Prosecutor (similar to our US. Attorney) handles all cases that are referred for prosecution.

10. Describe the species-testing program.
a. How many samples are taken?
b. Who takes the samples?
c. Where are they taken?
d. What techniques are used in selecting and collecting the samples?
e. Describe the laboratory support (locations, methodology, source of reagents).
f. How is the test information used? Example - product is not exported until satisfactory results are received, recall procedures.

Remarks:

a. Species sampling is conducted on a random basis.
b. Species samples are collected by employees of the MAF Verification Agency.
c. Species samples are taken at the producing establishment, prior to shipment.
d Random section of samples, which are then maintained under security until shipment to the national laboratory in Wallaceville.
e. The national laboratory is in Wallaceville, approximately 45 minutes north of downtown Wellington. Species kits are obtained from a company in Australia and have been repeatedly proven to be accurate to the 1-percent level. Check samples are analyzed monthly
f MAFReg has not documented a problem with species substitution or misuse. The meat export market is a huge part of their economy and the government and companies would not want to jeopardize that market. Sample results are not required prior to export of product, but if questionable results were obtained, the product in question would be immediately returned to NZ.

The sampling plan for CY 1999 and the results of CY 1998 sampling have been submitted to Washington for review.

11. Is there a separate compliance/enforcement staff to monitor product integrity outside normal inspection control? (x ) Yes ( ) No


Remarks:
The MAFReg Enforcement Unit, the MAFReg Compliance Group, the Ministry of Health, and Territorial Health Protection Officers (monitored by the Compliance Group), all play roles in the monitoring of meat products in distribution channels.

Administrative Record keeping:

1. Does the country prepare and maintain records over compliance activities?
2. Name of official responsible for country’s compliance activities.
3. Do the country’s compliance/enforcement officers complete daily activity reports?

Remarks:

1. Records are prepared and maintained and are supplied to the Minister of Agriculture. (SEE
ATTACHMENT FOR SUMMARY OF ENFORCEMENT ACTIVITIES.)
2. Mr. Jockey Jensen is the National Manager for Enforcement and is based at MAFReg National Headquarters in Wellington. Dr. Geoff Allen is the National Manager for the Compliance Group (official premise audits) and splits his time between the National
Headquarters and his home office in Dunedin (South Island).
3. Enforcement Officers complete activity reports each day; members of the Compliance Group complete activity reports when on audit visits.

Enforcement of Administrative Sanctions:

1. Does the Country have regulatory requirements for and authority to withhold, suspend or withdraw inspection services for:

a. Insanitary conditions / inadequate SSOP’s
b. Inadequate HACCP systems
c. Failure to test and record for E. coli
d. Failure to meet performance standard for Salmonella
e. Unfitness - (Felony convictions or two misdemeanors involving transactions with food)
i. Are convicted individuals operationally and financially divested from official establishments?
ii. Are there ways to prevent certifying to the U.S. any plant where the owners have been convicted of a criminal act?
f Inhumane slaughter
g. Assaults or threats of assaults, intimidation, interference with government officials
h. Failure to destroy condemned meat or poultry products

Remarks:

a. yes
b. yes
c. yes
d yes
e. yes

i. The existing law, the Meat Act of 1981, is admittedly weak in its reference to individuals as it talks only of “individuals of upright standing.” The new law, The Animal Products Act, is much stronger and more specific as to the ability of convicted individuals to operate within the meat industry.

ii. It would be difficult under the current law, but MAFReg officials stated that they would devote resources to assure that appropriate oversight was provided

All authorities for administrative sanctions are contained within the Meat Act of 1981. The Animal Products Act, when passed, will contain the same provisions and authorities but will strengthen MAF ‘s ability to take administrative action against convicted individuals.

2. Does the Country have compliance/enforcement protocols in place to enforce the above, i.e.,
withhold, suspend, withdraw? (x) Yes ( ) No