Canadian Audit of the Mexican Shellfish Sanitation Program Final Audit Report - 2016
5. Findings

5.1 Regulatory foundation

The MSSP regulatory foundation is based on Mexico's General Health Law and the Fisheries General Law. The Health Secretariat COFEPRIS regulatory authority comes from the Sanitary Control Regulation of Products and Services. Specific details on food safety requirements are found in Mexican Official Standards 128 (Hazard Analysis Critical Control Point - HACCP), 251 (sanitary conditions), and 242 (seafood safety).

Application of Mexican requirements is further described in the MSSP technical guide, the associated technical annexes and risk management documents.

5.2 Government oversight

5.2.1 Organizational structure

The MSSP is delivered by multiple federal and state agencies within Mexico. At the federal level the Health Secretariat (COFEPRIS), Secretariat of Agriculture, Livestock Rural Development, Fisheries and Food (SAGARPA), Secretariat of Environment and Natural Resources and the Navy Secretariat have entered into an agreement which outlines the various roles and responsibilities of each secretariat. The main functions of each are as follows:

COFEPRIS

• Overall co-ordination of the MSSP at the state, federal and international level
• Enforcement of the MSSP requirements for harvesting and processing
• Certification of processing establishments and classification of growing areas
• Ongoing inspection of certified shellfish processing establishments
• Oversight of marine biotoxin monitoring and vibrio risk management
• Making recommendations to close shellfish areas when necessary
• Development and maintenance of the MSSP technical guide, operational manuals and other guidance
• Co-ordination of supporting laboratory analytical procedures including training

SAGARPA through CONAPESCA

• Patrol of shellfish harvesting areas
• Issues aquaculture licenses
• Issues shellfish harvesting licenses
• Oversight of aquaculture site construction and remodelling drawings
• Monthly operational planning document with the Navy Secretariat on enforcement activities
• Provide monthly patrol summary data to COFEPRIS

Secretariat of Environment and Natural Resources

• Pollution prevention
• Provide scientific advice to COFEPRIS on matters related water quality when available
• Provide advice on the environmental impact by harvesting and/or growing shellfish

Navy Secretariat

• Contribute to surveillance of shellfish growing areas when necessary at the request of SAGARPA
• Co-ordinate with other institutions in maritime research

In addition to the federal institutions that participate in the MSSP in Mexico, each state has responsibility to deliver some aspects of the program. This may include collection of water and/or shellstock samples for: classification of the growing areas, monitoring of bacteriological indicators or pathogens such as E. coli, Vibrio, Salmonella, and monitoring of marine biotoxins or phytoplankton levels. State officials may also be involved in inspection of processing establishments and in classifying shellfish growing areas.

State inspectors are extensively involved in MSSP functions in Baja California. They conduct all of the official sampling, participate in growing area classification and, participate in processing establishment inspection activities with COFEPRIS standardized inspectors most of the time.

5.2.2 Program resources

COFEPRIS is the organization within the Health Secretariat that has sole responsibility for oversight and delivery of the MSSP in international export areas. The current staff complement consists of 10 operational staff that are identified as specialist inspectors, project managers or liaison officers. Operational staff report through a management hierarchy that includes a program manager, an executive director and a commissionaire.

Analytical support for the MSSP is delivered by CCAYAC and by the state laboratories. At CCAYAC there are currently 18 technicians, analysts, method developers, supervisors/managers and other staff working in the central reference laboratory. Laboratory staff report through a management hierarchy that includes a manager, 2 executive directors and a commissionaire.

At the state laboratory in Mexicali there are 13 technicians, analysts, supervisors and support staff that are providing analytical support to the MSSP. The operations of the laboratory are overseen by a 4 person management team.

At the state operational level in Baja California there are 7 inspectors that assist in the delivery of the MSSP. They perform various duties such as sampling from growing areas for microbiological testing, chemical or marine biotoxins analysis, classification of growing areas and, inspection of processing establishments. There are also 20 state level control-of-harvest inspectors. They are responsible for completing monthly inspections for all fisheries, including shellfish. Duties include verifying each harvester for valid aquaculture licences, species under production, and any change in harvest area classification.

The states of Baja California, Baja California Sur and Sonora are the only states that have shellfish growing areas and processing establishments that are certified for export to the United States. Within those states there are 7 establishments and 9 growing areas that are certified and eligible for export. Based on the relative size of the export program and the number of staff dedicated to the program the MSSP is adequately resourced to deliver the required elements of a shellfish sanitation program.

5.2.3 Training

Every COFEPRIS staff member that works in the MSSP is required, as a minimum, to have a university degree in a relevant scientific field. Additional knowledge and training in good manufacturing practices and HACCP food safety systems is required for specialized inspectors who are assessing compliance of shellfish processing establishments to MSSP requirements.

The MSSP also participates in United States Food and Drug Administration's (USFDA) inspector standardization training program. There are currently 3 inspectors at COFEPRIS that are certified by the USFDA to conduct official inspections of processing establishments. Three additional inspectors are undergoing standardization training. Mexico is working towards recognition to conduct standardization training by COFEPRIS staff instead of being standardized by USFDA.

COFEPRIS provided initial training to SAGARPA personnel in 2003. Since that time, the SAGARPA is responsible for ensuring inspectors receive adequate training in basic law enforcement, shellfish control regulations and creation and maintenance of a patrol policy document. SAGARPA officials demonstrated the online training module of their annual inspection and surveillance course for state control-of-harvest inspectors. All new staff receives the comprehensive training, including topics such as general legislation and regulations on fisheries and aquaculture, Mexican shellfish harvest standards, handling procedures and legal authorities of staff. All staff are required to take two annual mandatory courses, the first on inspection & surveillance techniques and the second on technical aspects of the fisheries.

Select members of the CCAYAC laboratory have received Laboratory Evaluation Officer training from the USFDA, and use this training to conduct audits of state laboratories. State laboratory staff receives internal task-specific training as well as both program and technical training from CCAYAC staff. This training is demonstrated to be effective through regular supervision and annual proficiency testing of individual laboratory analysts.

5.2.4 Program assessment/audit

The MSSP is routinely audited by the USFDA (2007/08 and 2013) and has been audited by the European Union. The 2013 USFDA audit included an assessment of laboratories performing analytical analysis used to support the MSSP. COFEPRIS and USFDA have signed a Memorandum of Understanding pertaining to shellfish matters which was last updated in 2012.

The state laboratories are audited for compliance with MSSP procedures by the CCAYAC laboratory. The technical performance of the state laboratories is also assessed through routine international and CCAYAC proficiency test exercises.

5.2.5 Industry, community, and international relations

Mexico is a regular participant in the Interstate Shellfish Sanitation Conference (ISSC). The ISSC's primary function is to foster and promote shellfish sanitation through the cooperation of state and federal control agencies, the shellfish industry, and the academic community. New Zealand, Korea and Canada also participate in biennial ISSC meetings.

Mexico also sends delegates to the biennial International Conference on Molluscan Shellfish Safety. International Conference on Molluscan Shellfish Safety is the premier global forum for the exchange of the latest emerging bivalve shellfish public health issues and risk management tools.

Mexico as a Codex Alimentarius Commission of the United Nations Food and Agriculture Organization (CODEX) member, participates in the CODEX Committee on Fish and Fishery Products. The committee is responsible for the maintenance and updating of the Standard for Live and Raw Bivalve Molluscs (CODEX STAN 292-2008).

COFEPRIS has begun to host a regular conference on shellfish sanitation matters bringing together federal, state, academia and industry stakeholders within Mexico. The main purpose is to raise awareness of shellfish sanitation issues and work in a collaborative environment to improve the MSSP. The second conference was held in March of 2016.

5.3 Shellfish inspection and control program

5.3.1 Risk assessment and risk management

The most recent risk assessment for Vibrio parahaemolyticus (Vp) by COFEPRIS was completed in July of 2014. The risk assessment concluded that even though illnesses are not reasonably likely to occur on an annual basis a comprehensive Vp management plan was developed which includes regular testing at harvest areas, strict time/temperature controls for harvesters, and HACCP controls for establishments. HACCP plans include final product testing for verification that controls are functioning as intended. Time/temperature control records by processing establishments demonstrated compliance to the Vp management plan requirements. All final product verification results were in compliance to the Mexican standard of 104 Most Probable Number (MPN)/g.

5.3.2 Growing area classification

In accordance with the MSSP Technical Guide, all shellfish growing areas require a sanitary survey in order to be appropriately classified by the state authority. COFEPRIS evaluates and approves each growing area classification and periodically reviews the sanitary conditions in such areas.

Specific components that must be evaluate in a growing area, and the performance standards which must be achieved during the initial survey and during subsequent annual and re-evaluation surveys, are outlined in Chapter IV and Annex 1 of the MSSP Technical Guide.

During this audit, field visits were conducted of 2 shellfish harvesting areas. Sanitary survey reports (Triennial Reevaluations and Annual Updates) for 3 growing areas were also reviewed. The growing areas audited during this mission were Rincon de Ballenas, Bahia de San Quintin and San Felipe-Puertecitos, all of which are located in Baja California.

Annual Sanitary and Triennial Sanitary Reevaluation reports for all 3 growing areas were reviewed. Field visits were limited to the growing areas at Rincon de Ballenas and Bahia de San Quintin.

The field audit component served to verify that pollution sources were accurately assessed and that marine water quality monitoring sites were appropriately placed in order to assess impacts of actual and potential pollution sources in the approved classified area.

It was also noted from the field visit component, that the prohibited classification has not been established at sewage treatment plant discharge locations, at sewage pump stations, at marinas, or at other pollution points reported to be of potential public health significance. The MSSP requires establishment of a prohibited classification where the sanitary survey determines that the growing area is adjacent to a sewage treatment plant outfall or other points of public health significance. Marinas (including docks or structures for mooring vessels and harbours) which are located within or adjacent to a shellstock growing area should be classified as conditional or prohibited according to the Technical Guide. Meeting this requirement will also bring the MSSP more in line with the CSSP.

Overall, all the reports (Rincon de Ballenas triennial 2009-2011, annual 2012, annual 2014-2015; Bahia de San Quintin triennial 2009-2011, annual 2012, annual 2014-2015; and San Felipe Puertecitos annual 2012, annual 2014-2015) were well written and well organized. The reports incorporated most, but not all, of the minimum reporting requirements outlined in Annex 1 of the MSSP Technical Guide. Specifically, the following components outlined in Annex 1 of the MSSP Technical Guide were found to be missing, and/or require closer attention:

Section II. Description of harvesting area

• Include all classification changes that occurred since the last reporting period (no mention was made of the 2013 closure)
• Report unusual events such as hurricanes, tropical storms or flooding events and what actions were taken in response to these.

Section III. Study of pollution sources

• Include evaluation (such as through dye or computer modelling) of sewage discharges occurring in or adjacent to a growing area
• Information about impacts of marinas and/or docks including closure lines
• distance between pollution sources and the water body and/or harvest area
• georeferenced coordinates of relevant pollution sources
• accurately differentiation of point and non-point pollution sources
• ensure consistency in pollution sources listings between maps, tables and text

Section IV. Hydrographic and meteorological characteristics

• Rainfall quantity and occurrence (particularly during the sampling periods and all major occurrences)

Section V. Studies of water quality

• Rationale for established location of monitoring sites
• Sampling plan schedule
• Results of required bacteriological and physical-chemical parameters- some are not presented, or are not presented consistently. Indicate what action was taken where the required limits were exceeded

A significant discrepancy in the statistics used to classify growing areas was raised with COFEPRIS during the audit. It was noted that the estimated 90^th percentile statistic was the referenced statistic to classify growing areas reported to be monitored under the Adverse Pollution Sampling strategy. The CSSP and NSSP require the use of the percentage greater than 43 FC/100ml MPN (for a five tube decimal dilution test) statistic for Adverse Pollution Sampling. The estimated 90^th percentile is applied only in growing areas under the Systematic Random Sampling strategy.

The following examples from the audited growing areas illustrate the different classification outcome based on the estimated 90^th percentile statistic (Systematic Random Sampling standard) and when using the percentage >43 FC statistic (Adverse Sampling Condition standard).

It was suggested by COFEPRIS that some confusion may have occurred when the applicable sections of the NSSP were translated into sections E, F and G in Chapter IV of the MSSP Technical Guide.

Mexico's coastal zone, including Baja California, is susceptible to tropical storms and hurricanes and their frequency has been on the increase. A number of these storms have made landfall in or near shellfish growing areas in Baja California and in other parts along this portion of the Pacific. The growing area reports reviewed during the audit did not mention if sanitary conditions in the growing areas were affected during such events or if closure action was taken during the 2009-2012 and 2014-2015 period. It is widely recognized that storms, and intense rainfall and flooding in particular, can adversely impacts marine water quality. Such conditions therefore represent a significant risk to consumers of shellfish that are harvested from affected waters.

According to Section @.03 in Chapter IV of the MSSP Technical Guide, growing areas shall be placed in the closed status when pollution conditions exist which were not included in the database used to classify the area. It further states that when it is determined that an emergency condition or situation exists, then the growing area will be placed within 24 hours in the closed status.

COFEPRIS indicated that efforts are made most times to sample the growing areas immediately following tropical storms or hurricanes, but that is not always possible. Furthermore, while emergency closure action has been taken on some occasions, no evidence could be provided that such precautionary measures are consistently applied in all growing areas.

5.3.3 Harvest area controls

Patrol policy

CONAPESCA, the enforcement body within the SAGARPA, provided the audit team with a copy of the 2011 patrol policy document. Officials acknowledged that the document has not been updated annually and that some of the legislation and regulations have since changed and are not reflected in the current version. It was also observed that the patrol frequencies as dictated by the growing area risk categories are not being met. All growing areas were determined to be low risk, necessitating four patrols per 30 growing days. However, CONAPESCA conducts only one official monthly patrol of each area. If an area required more visits (e.g. due to emergency closures), state officials would adjust their schedule accordingly but might not capture this effort in official reporting on the MSSP to COFEPRIS. It was noted that an additional level of protection is afforded due to the nature of the military checkpoints on the coastal highway. At the beginning of monthly troop rotations, CONAPESCA inspectors brief military personnel on proper shellfish transportation procedures. Anyone transporting quantities of shellfish without a CONAPESCA-issued harvest certificate would result in the military contacting CONAPESCA officials for confirmation and/or follow up. With the additional coverage provided by the military checkpoints, the audit team was satisfied with the harvest area controls program element.

Shellfish aquaculture

The competent authority responsible for the control of aquaculture activities is SAGARPA. Through CONAPESCA, they are required to maintain records that include the construction drawings, operational plans and any permits, franchises and/or licences for all aquaculture activities. During interviews with state authorities, the audit team reviewed the records at the CONAPESCA office in Ensenada. The team confirmed retention of construction and remodelling drawings, operational plans, the associated aquaculture licences as well as harvest certificates for aquaculturists operating in waters around Baja California. The record retention protocols met the MSSP program requirements.

Inspection

The MSSP requires CONAPESCA to inspect land-based and open water aquaculture sites on a regular basis. There are 20 inspection personnel in Baja California and 25 in Baja California South who perform monthly patrol inspections for all fisheries, including shellfish aquaculture. Upon completion of the monthly patrol, officers provide a summary report to COFEPRIS in Mexico City which includes a breakdown by area, harvester, species, month and status of inspection. The audit team was given an electronic copy of the monthly report and an explanation of improvements implemented in 2013 to better represent the overall status of a particular growing area. The audit team noticed that there was some redundancy in the creation of these summary reports in that inspectors were required to re-copy multiple area descriptions for each harvester inspected. In discussions with COFEPRIS, SAGARPA and CONAPESCA staff in Ensenada, it was noted that it would be possible to reduce the administrative burden on staff and still provide quality summary information to COFEPRIS.

During interviews with CONAPESCA personnel, it was determined that no local personnel are examining the occurrence data for larger trends. Inspectors told the auditors that the CONAPESCA legal group is responsible for this function, highlighting larger trends by species as well as suggesting adaptations of enforcement strategies. The audit team was unable to verify the effectiveness of this function. Additional information would have been useful to validate this claim. Further, inclusion of this function in the patrol policy document would increase the ability of the MSSP to deter illegal shellstock harvesting and mitigate any potential risks to human health.

On board waste containment

The MSSP requires that human sewage shall not be discharged from a vessel used in the harvesting of shellstock, or from vessels which buy shellstock while the vessels are in growing areas. However, there is currently no legislative or regulatory requirement for vessels to be equipped with on board waste containment devices. Larger vessels are usually equipped with on board waste containment devices but in the majority of classified areas, the processing establishment is located a short distance from the growing areas and smaller working vessels can return to land as required. The audit team was informed that the environmental agency (SEMARAT) has control of how and where marine vessels can discharge waste but that there is not a dedicated policy concerning shellfish areas. COFEPRIS does have promotional materials targeting industry that explain the importance of reducing any point or non-point source contamination from entering classified areas. However, during document review and interviews with program officials it was determined that there is no single agency responsible for overseeing onboard human waste containment requirements of the MSSP.

5.3.4 Processing establishment controls (HACCP)

The MSSP technical guide and technical annexes contain policies and procedures for processing establishments who wish to be eligible to export shellfish from Mexico. This includes:

• establishment certification
• minimum inspection frequencies
• technical requirements
• recertification
• enforcement actions
• criteria for performance based inspection programs

Specifically, Chapter X of the MSSP includes the general requirements for all establishments with regards to:

• HACCP
• Sanitation
• Shellstock identification
• Shipping documents
• Corrective action documentation.

Chapter XII provides additional specific minimum requirements for establishments designated as shellfish shippers (SS). Currently, all establishments in Mexico are certified as shellstock shippers.

The minimum inspection frequency for establishments designated as shellstock shippers (SS) is twice per annum. Inspections are to be conducted by qualified COFEPRIS Standardized officers using the MSSP Standardized 30 item Plant inspection form. State inspectors also participate in most of these official inspections. The MSSP requires COFEPRIS to maintain inspection records for each establishment in a central file. Inspection findings are categorized by COFEPRIS as critical (C), key (K) or other (O) depending on severity and consequence. Assessment criteria is in place that prompts COFEPRIS to take actions including revising the existing compliance schedule for that establishment, suspension of activities or other administrative actions should unacceptable levels of compliance be encountered. The MSSP requires written corrective actions be provided by the establishment to address identified deficiencies and includes measures to be taken by COFEPRIS should the establishment fail to adhere to the negotiated timeframe for correction or repeated non-compliance.

During this audit, the central files for 2014 and 2015 were reviewed for the 4 establishments visited. The audit team found the files to contain extensive documentation to support the inspections. A variety of inspection findings with negotiated correction timeframes were found to be documented on the 30 point inspection form. Correction actions and associated correspondence were also reviewed. It was determined through interviews with COFEPRIS staff that each corrective action plan is followed up on at the next inspection, or earlier if deemed necessary. Inspection files were available at COFEPRIS for each establishment which supported the required minimum visitation frequency of twice per annum.

Shellfish processing activities were observed at only 1 of the 4 establishments visited. No critical HACCP or establishment deficiencies were identified during the audit and the establishments were found to be in good overall structural and sanitary condition. COFEPRIS staff demonstrated a good understanding of the MSSP dealer requirements during walkthroughs and record reviews. It was noted in one establishment with a recirculating salt water treatment system that the MSSP turbidity requirement was not being evaluated by COFEPRIS or monitored by the establishment. When requested, COFEPRIS staff assigned the appropriate level of compliance, as described in the MSSP, to any specific on-site deficiencies noted by the audit team.

It was noted that COFEPRIS does not sample end product for microbial analysis during their inspections and also that the MSSP does not require COFEPRIS to document corrective action plan implementation assessments. It was observed that 1 of the 4 establishments has not conducted end product microbial analysis and that 2 of the 4 establishments were applying an incorrect E. coli standard to their results. These observations and differences from the Canadian system are not considered significant.

The authority has a comprehensive establishment inspection and certification system in place to evaluate compliance to the requirements of the MSSP and to take enforcement actions when required.

5.3.5 Microbiological testing programs

The MSSP conducts routine shellfish sampling from export growing areas for Salmonella, Vp and Vibrio cholera (Vc) testing in addition to the water sampling conducted for classification of shellfish growing areas. Shellfish samples have been analyzed for E. coli as well but not since 2013. According to Chapter IV of the Technical Guide, determinations of E. coli in shellfish shall be made to enforce the classification. In most cases shellfish samples are analyzed for Salmonella and Vp on a monthly basis and for Vc on a bimonthly basis. All results are included in the classification reports of each growing area.

During this audit microbiological data for 2014 and 2105 was reviewed from 3 growing areas in Baja California: San Felipe-Puertecitos, Rincon de Ballenas, and Bahia San Quintin.

In San Felipe-Puertecitos there were 100 geoduck clam samples taken from 4 zones within the area. There were no Salmonella or Vc detected in any of those samples. The highest Vp level detected was 3.6 MPN/g. In addition, 16 clam samples were tested and no Salmonella or Vp were detected and the highest Vp level was 14 MPN/g. In Rincon de Ballenas there were 53 mussel samples tested and no salmonella or Vc were detected. The highest Vp level recorded was 9.3MPN/g. In Bahia San Quintin there were a total of 101 samples of various species of oysters and clams analyzed. Salmonella was not detected in any samples, 2 were positive for Vc and the highest Vp level observed was 23 MPN/g in manila clams. One of the samples that tested positive for Vc was confirmed to be a non-toxigenic strain.

There were 205 samples analyzed for E. coli from San Felipe-Puertecitos, Rincon de Ballenas and Bahia San Quintin from 2011 to 2013. Only 2% of those samples exceeded 230 MPN/100g with the highest result being 490 MPN/100g.

The MSSP has a comprehensive shellstock testing program for many of the bacterial pathogens associated with shellfish and primary bacterial indicator used in shellfish sanitation programs. Based on the data reviewed it appears that these bacteria do not pose a significant health risk in shellfish harvested from the export growing areas.

5.3.6 Marine biotoxin and chemical testing programs

Marine biotoxins

Mexico's marine biotoxin monitoring program policies and procedures are described in the following documents:

• MSSP technical guide - Chapter IV Section .04 - Marine Biotoxin Control
• MSSP Technical Annex 7 - Work instruction for the sanitary control of shellfish exposed to a harmful algae bloom
• MSSP Technical Annex 8 - Work instruction for the Sampling of Phytoplankton and Detection of Marine Biotoxins
• Contingency Plan for the Control of Marine Biotoxins

The program is based on a combination of phytoplankton monitoring and shellfish toxin testing. Phytoplankton sampling is done either on a weekly qualitative or a biweekly quantitative basis while shellfish is tested on a monthly basis. Sampling and testing is increased in response to a harmful algae event which is defined by either exceeding toxic phytoplankton limits for various species or by exceeding toxin standards in shellfish. The contingency plan states that phytoplankton sampling is increased to every 3^rd day while shellfish testing is increased to every 4^th day. The MSSP toxin standards for shellfish are 0.8mg/kg for paralytic shellfish poisoning (PSP), 20mg/kg for amnesic shellfish poisoning (ASP) and 0.16mg/kg for DSP while the maximum allowable limits of toxic phytoplankton in seawater are:

Shellfish is tested using screening methods by state laboratories. Methods currently in use include the Scotia Rapid Tests for PSP and ASP and the Abraxis PP2A test for DSP. Any positive screening tests result in a precautionary closure and are sent to the CCAYAC lab in Mexico City for confirmation testing by mouse bioassay or by chemical methods.

The contingency plan states that all species must be analyzed using the reference method and must be shown to be toxin-free or below the regulatory limits in order to re-open an area. However, results from screening methods were used to lift precautionary closures initiated from elevated phytoplankton counts. The risk of false negative results must be considered when using screening tests in situations with increased potential and probability of elevated toxin levels.

The sampling frequency in response to a harmful algal bloom is listed differently in the English version of two different documents. Table 2 of the Contingency Plan for the Control of Marine Biotoxins states that quantitative phytoplankton monitoring is completed every third day, but Table 1 of the Work Instruction for Sanitary Control of Shellfish Exposed to Harmful Algal Bloom states that quantitative phytoplankton monitoring is completed every other day. Both documents state that shellfish product samples are collected and analyzed at a minimum of every four days. These sampling requirements should be clarified and listed the same in all relevant documents. In follow up correspondence, MSSP officials have clarified that the official Spanish documents have the same sampling frequency and the English versions have been corrected.

Phytoplankton and marine biotoxin data for 2014 and 2105 was reviewed from 3 growing areas in Baja California; San Felipe-Puertecitos, Rincon de Ballenas, and Bahia San Quintin.

In San-Felipe-Puertecitos phytoplankton sampling was not conducted on a regular basis. In 2014 there was no sampling in March or December and sampling was only conducted for 1 week in May and July. There was no response (i.e. precautionary closure and increased sampling) to increased phytoplankton counts in area in November of 2015. Marine biotoxin testing was, for the most part, conducted on a monthly basis although testing for DSP did not commence until May of 2014. Additional sampling was initiated upon receiving reports of dead birds and marine mammals in the area. The area was closed from Jan 13, 2015 to July 16, 2015 due to elevated levels of PSP.

In Rincon de Ballenas phytoplankton sampling was not conducted on a regular basis. There was no phytoplankton sampling for June and July of 2014 and from August to December of 2015. It was noted that there were multiple instances where phytoplankton levels exceeded MSSP limits and no responsive action was taken. Marine biotoxin testing was monthly except for the months of April 2014 and December 2015. DSP sampling did not commence until May of 2014.

In Bahia San Quintin phytoplankton sampling was conducted on a regular basis with the exception of December 2014. Sampling in 2015 was, for the most part, twice a week even though the phytoplankton levels remained low throughout the year. Marine biotoxin testing was monthly except for February and December of 2015. DSP sampling did not commence until May of 2014.

The MSSP emphasis on managing biotoxin risk mainly by phytoplankton monitoring highlights the importance of strict adherence to planned sampling and reacting to those results in a timely manner. In was noted on several occasions that samples were not collected on a regular minimum basis or there was no response to phytoplankton levels above the limit. These actions substantially increase the chances of missing a harmful algae event or having shellfish harvested with toxin levels above the MSSP standards.

Chemical testing

The last MSSP survey for heavy metals in growing areas destined for export was between 2011 and 2013. During that survey 45 samples were analyzed for mercury, cadmium and lead in 9 growing areas. One sample was analyzed for arsenic. Mercury values reported ranged from <0.016 to 0.30mg/kg. Cadmium values ranged from not detected to 2.86mg/kg with most being below 1mg/kg. Lead values ranged from not detected to 0.66mg/kg. There was no arsenic detected in the one sample that was analyzed.

All of the mercury results are below the Canadian guideline of 0.5mg/kg. Although there is no Canadian or CODEX standard for cadmium and lead in shellfish, the values reported are within the values typically found in Canadian shellfish.

5.4 Food related illness and outbreak investigation

Chapter II of the MSSP describes the procedures to be followed by the authority in the event of a shellfish-related illness outbreak. This includes an investigation at the processing and harvest area levels to determine the source of the illness and to implement appropriate control measures to prevent further illness from occurring. Product sampling from the establishment or harvest area may occur in support of these activities. The outcome of this investigation determines actions which may be taken with respect to products still on the market and/or it may result in action at the harvest area. Continued presence of a pathogen in the harvest area following the outbreak may result in a sanitary survey being conducted by the authority, continued closure and/or, reclassification of the area.

COFEPRIS staff stated that there have been no outbreaks as defined in the MSSP linked to exported product. During interviews, COFEPRIS inspectors demonstrated a good understanding of the procedures they would be required to follow in an outbreak situation. The authority has received occasional isolated reports of illness in which shellfish originating from certified Mexican establishments had been consumed. A review of two reports from 2015 identified that COFEPRIS gathered appropriate and adequate information from the complainant and completed timely investigations of the establishment controls associated with the potentially implicated lots. In the cases reviewed, it was found that the COFEPRIS investigation concluded that the establishment was implementing controls for the potentially implicated lots in accordance with MSSP HACCP requirements.

It was noted that the COFEPRIS investigations are not captured in a searchable central database but rather are maintained in isolation on the lead investigator's computer. As COFEPRIS standardization officers are involved in the investigations and are all located in the same office, the food safety investigations appeared to the audit team to be well executed and coordinated appropriately between COFEPRIS staff.

5.5 Laboratory controls

The laboratory component of the MSSP is described in the following documents:

• MSSP technical guide - Chapter III
• Laboratory Guide for the Analysis of Seawater and Shellfish
• Individual quality assurance handbooks and detailed procedures in each laboratory

The laboratory duties in support of the MSSP are divided between state laboratories and a federal laboratory under the responsibility of CCAYAC. The state laboratories:

• perform microbiological testing on shellfish and seawater samples
• perform marine toxin testing on shellfish using screening methods

The CCAYAC laboratory:

• provides training and supervision to state laboratories
• performs confirmatory marine biotoxin testing
• maintains the Laboratory Guide for the Analysis of Seawater and Shellfish
• provides additional surge capacity for both microbiological and marine toxin testing in the event that state laboratories cannot handle increased sample volumes during harmful algal blooms or investigations
• audits state laboratories

The screening method used for ASP is the Scotia Rapid Test. This test kit has not been recognized by any international bodies or subjected to collaborative interlaboratory validation studies. Since this is not an official, or reference method it must be validated for use in each laboratory. Data provided by the manufacturer included several examples of false negative results. Studies to characterize the risk of false negative results within the MSSP have not been conducted, nor were any validation data presented for use of the Scotia Rapid Test for ASP within the Baja California state laboratory.

The screening method used for diarrhetic shellfish poisoning (DSP) does not address the risk associated with other lipophilic shellfish toxins that have been detected in Mexico. A recent journal article by Garcia-Mendoza et al^{Footnote 4} documented two significant classes of lipophilic shellfish toxins in Mexican shellfish, notably, azaspiracid shellfish toxins and pectenotoxin shellfish toxins. The CCAYAC laboratory has recently validated a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that can detect lipophilic shellfish toxins (including azaspiracid shellfish toxins and pectenotoxin shellfish toxins) and plan to analyse all shellfish samples using this new method after they are screened for DSP toxins. This plan will create a database which can be used to determine the risk associated with lipophilic shellfish toxins throughout Mexico. This data should be analysed carefully to determine appropriate risk management procedures to address DSP toxins as well as other lipophilic shellfish toxins. The CCAYAC laboratory is also encouraged to continue improving their LC-MS/MS method so that it can meet performance criteria established in CODEX guideline 292-2008 (2015 revision). This guideline specifies a limit of quantitation of 0.02 mg/kg for both okadaic acid and azaspiracid-1 (AZA1); the validation data generated in the CCAYAC laboratory only demonstrate a limit of quantitation of 0.05 mg/kg for both okadaic acid and AZA1. It was observed through review of the validation data that the CODEX guidelines should be achievable.

The Laboratory Guide for the Analysis of Seawater and Shellfish contains many procedures to be followed by all laboratories. There were a number of instances when observed practices did not reflect the procedures listed in the guide:

For the CCAYAC laboratory:

• A list of qualified analysts was not sent to the FDA as required by section 2.2.1

For the Baja California state laboratory:

• The method of recording signatures on the sample information sheets does not demonstrate which toxin analysis has been performed by which qualified analyst. Traceability is a critical concept in ISO 17025, upon which section 1.3 requires laboratory quality management systems to be based.
• The balance used for biotoxin work only had a sensitivity of 0.1g and not 0.01g as required in section 3.1.6
• The mechanical micropipette used for DSP analysis on March 03, 2016 did not have records of verification as required in section 3.1.8.B.
• In the months of May and September no determination of chlorine was carried out, contrary to section 3.4. Although evidence of the corrective actions was presented for both findings, when recurrent it is advisable to analyze the effectiveness of the actions taken.

The Baja California State Laboratory Quality Plan contains procedures specific to the implementation of a quality management system for MSSP work. There were a number of instances when observed practices did not reflect the procedures listed in the guide:

• Section 17.B requires the report of analysis to include a record of the time elapsed between sampling and analysis. Records for two different samples (1602281055 and 1602081034) were examined to verify correct information was accurately recorded on the report of analysis. Small discrepancies were observed between the times recorded on the sample worksheet and the reports of analyses for both samples.
• End times for 35°C incubation of seawater samples are not recorded as required in section 20.1.3.

A number of positive observations were also made during the two laboratory visits, which reflected excellent practices and cooperation. The MSSP is commended in the following areas:

• There is strong communication between federal and state laboratories. This includes undocumented use of online chat groups to relay information about significant toxin results quickly and efficiently.
• The CCAYAC laboratory has a very clear and organized chart (known as the mind map) describing various program requirements and documentation. The chart hyperlinks to all of the relevant program requirements.
• The CCAYAC laboratory has begun adding English translations of key documents as annexes to key documents.
• The Baja California State Laboratory demonstrated an extraordinary level of detail and attention paid to all technical work.
• The Baja California State Laboratory demonstrated effective real-time training and coaching of technical staff through a high level of supervision.
• All laboratory staff were cooperative, patient, and willing to engage in professional discussions to clarify and improve processes.