NAIA-DFA Mussel Sector Workshop

Transcription

1 NAIA-DFA Mussel Sector Workshop March 30 th, 2011 Albatross Hotel Gander, NL

2 Workshop On March 30, 2011 NAIA, in partnership with the NL Department of Fisheries and Aquaculture, hosted a workshop to refresh and further educate Newfoundland s mussel growers and producers, as well as regulators about the recent changes within the Canadian Shellfish Sanitation Program. The workshop was held at the Albatross Hotel in Gander and featured representatives from Environment, the Canadian Food Inspection Agency, Fisheries and Oceans and Department of Fisheries and Aquaculture. NAIA recognizes the importance of such a workshop because of our commitment to helping the mussel aquaculture industry provide quality products while maintaining a healthy sustainable environment. The seminar looked at many of the recent changes in how the CSSP is administered. These include changes in water quality sampling frequency, and changes to classifications. In addition, updates on USFDA and EU Audits of the CSSP were given. Approaches to managing areas adjacent to Waste Water Treatment Plants and requirements for waste containments on harvest vessels were also presented. The representatives from each governmental organization also went over their role in the administration of the CSSP. The workshop also gave the growers a chance to network with members of the other organizations attending including regional representatives from Environment and Canadian Food Inspection Agency. NAIA would like to thank the presenters of the CSSP workshop: Gerry Dawe Canadian Food Inspection Agency, Rick Payne Department of Fisheries and Aquaculture, Ian Burford Department of Fisheries and Aquaculture, Dave Curtis Environment and Chris Hendry Fisheries and Oceans. Special thanks to presenters Chris Roberts, Atlantic Regional Head of Marine Water Quality Monitoring with Environment and John White, Fish Policy Officer with the Canadian Food Inspection Agency. Also, thank you to DFA for helping arrange and fund the workshop and, of course, many thanks to everyone who attended for making it a successful workshop. Written by : Samantha Lodge, Communications Assistant, NAIA

3 Agenda Gerry Dawe - CFIA The History and Organization of the (CSSP) Rick Payne - DFA DFA Aquaculture Licensing Division Responsibilities Shellfish Aquaculture Application Process Regulations and Requirements Related to CSSP Dave Curtis EC Environment Responsibilities CSSP Mandate - Federal and Provincial Government Collaboration Harvest Area Classification Process - Marine Water Quality Monitoring Gerry Dawe - CFIA Canadian Food Inspection Agency Responsibilities Molluscan Shellfish Monitoring Program - Sampling Strategies, Marine Biotoxins, Relaying, Wet Storage, and Depuration Foreign Export Lists Chris Hendry - DFO DFO Responsibilities Enforcement, Licensing and Notification Process Ian Burford - DFA Chris Roberts EC & John White - CFIA DFA Licensing & Quality Assurance Division Responsibilities Foreign Audits, Program Enhancements and Related Issues Human Waste Containment on Shellfish Harvest Vessels Annual Sampling Water Quality Provincial Processing Plant Regulations Classification of Harvest Areas Adjacent to Waste Water Treatment Plants Viruses Severe Rainfall Events Chris Hendry - DFO When Something Goes Wrong Facilitated Panel Discussion Options for harvesting plans affected by classification and status changes

4 NAIA-DFA Mussel Sector Workshop

5 History and Organization of CSSP NAIA-DFA Mussel Sector Workshop Gander, NL March 30, 2011

6 History of the CSSP : 150 deaths in US attributed to contaminated oysters 1948: & United States sign agreement for sanitary practices 1976: Department of Fisheries and the Environment (Fisheries and Marine Service) responsible for CSSP 1979: Creation of Department of Fisheries and Oceans and Environment Responsibilities for the CSSP divided between DFO and EC Page 6

7 History of the CSSP : 3 deaths, 100 illnesses due to domoic acid from PEI mussels 1988: DFO assumes full responsibility for marine biotoxin testing - Responsibilities for bioassay of PSP transferred from Health and Welfare to DFO 1992: CSSP Manual of Operations released 1997: Creation of Canadian Food Inspection Agency 2003: EU Audit 2004: USA Audit 2005: CSSP Re-Design 2009: EU and USA Audit Page 7

8 OBJECTIVES: Provide reasonable assurance that molluscan shellfish are safe for consumption, by controlling the harvesting of all molluscs within the tidal waters of, as well as of shellfish imported to ; and Fulfill s international obligations to meet the terms of bilateral agreements (e.g. USA, EU, etc.) for molluscan shellfish Page 8

9 CSSP- Federal Organization ADMINISTRATION: Canadian Food Inspection Agency (CFIA) Environment (EC), and Department of Fisheries and Oceans (DFO) LEGISLATION: the legal authority is provided by the Fisheries Act, the Management of Contaminated Fisheries Regulations, the Fish Inspection Act, Fish Inspection Regulations of, and the - United States Bilateral Agreement on Shellfish Governance: A comprehensive CSSP Manual of Operations; and A Memorandum of Understanding (that describes the roles and responsibilities of the three federal partners) Page 9

10 Departmental Responsibilities CANADIAN FOOD INSPECTION AGENCY responsible for the handling, processing, import and export of shellfish product; the Marine Biotoxin Monitoring Program; and are the lead agency for liaison with foreign governments ENVIRONMENT CANADA responsible for the monitoring and classification of shellfish growing areas on the basis of sanitary and bacteriological water quality surveys; and promoting pollution prevention, remediation and restoration of shellfish growing areas DEPARTMENT OF FISHERIES AND OCEANS responsible for the harvesting of shellfish including enforcement of closure orders and enacting the opening and closing of shellfish growing areas Page 10

11 CSSP Coordination ADM Steering Committee with a CSSP Secretariat in CFIA, HQ National Interdepartmental Shellfish Committee representatives from DFO, EC and CFIA Regional Interdepartmental Shellfish Committee representatives from all Atlantic provinces including Federal & Provincial governments, First Nations and Industry NL Molluscan Shellfish Working Group representatives from DFO, EC, CFIA, DFA, DOEC and NAIA Page 11

12 NAIA-DFA Mussel Sector Workshop

13 The Aquaculture Licencing Process Aquaculture Licencing & Inspection Division March 30, 2011

14 Overview Mandate of Licencing and Inspection Division Licencing-Application Process

15 Licencing and Inspection Division Mandate Responsible for licencing of aquaculture sites and to apply the Aquaculture Act and Aquaculture Regulations. Memorandum of Understanding (MOU) Legislation One-Stop Shopping

16 Licencing Application Process Aquaculture Development Officer (ADO) is first point of contact Species specific application form Application is submitted to the Licencing and Inspection Division with relevant supporting documentation

17 Site Holding Policy introduced in 2008 Allows for company to hold sites Proponent meet with ADO Application written request Milestones to be met Restrictions on use

18 The Initial Assessment Application is forwarded to ADO for initial assessment to ensure submission is complete Technical ability Financial capability Fish Health concerns Conduct site evaluation Return application to Registrar for registration

19 Application is Accepted Data in the application form is entered into the Aquaculture Licencing Information System (ALIS) Application is referred to various Provincial and Federal Government Depts / agencies and advertised in print media

20 The Referral Process Department of Fisheries and Aquaculture (DFA) Regional Services Division Conducts a Pre-licence inspection Dept of Environment and Conservation Crown Lands Branch Issues Lands Tenure Water Resources Management Division Issues Water Use Licence

21 The Referral Process Dept of Tourism, Culture and Recreation Historic Resources Division Provincial Archaeological Office Dept of Municipal Affairs Municipal Engineering Services Division Urban and Rural Planning Division

22 The Referral Process Transport Navigable Waters Protection Act (NWPA) Fisheries and Oceans Regional Aquaculture Coordinator Refers applications internally Recommendation back to DFA

23 The Referral Process Canadian Food Inspection Agency Regional Shellfish Specialist Environment Science and Technology Branch

24 Aquaculture Licencing Committee (ALC) Responses received and summarized ALC review - Recommendation to minister Reject Approve Approve pending... Licence Issued

25 NAIA-DFA Mussel Sector Workshop

26 Canadian Shellfish Sanitation Program Mussel Sector Workshop Newfoundland and Labrador March 30, 2011

27 Environment Environnement Newfoundland and Labrador Environment Marine Water Quality Monitoring 27

28 Environment Environnement Newfoundland and Labrador Marine Water Quality Monitoring Goal: to fulfill the requirements of the Canadian Shellfish Sanitation Program and the -United States Bilateral Agreement on Shellfish by: Classifying coastal waters as to their suitability for the harvesting of bivalve molluscan shellfish based on the sanitary and bacteriological water quality conditions in the area and by, Promoting pollution prevention, remediation and restoration of shellfish growing areas 28

29 Environment Environnement Newfoundland and Labrador Shellfish Growing Area Classification It is the first line of defense in the sanitary control of shellfish harvesting It is designed to identify and evaluate all sources of pollution to shellfish harvesting waters It is meant to limit harvesting in unsuitable areas and permit harvesting in approved growing waters It is meant to monitor and maintain knowledge of the water quality of shellfish growing areas 29

30 Environment Environnement Newfoundland and Labrador Shellfish Growing Area Classification Surveys Two Components Shoreline Sanitary Water Quality Annual Annual 30

31 Environment Purpose: Environnement Newfoundland and Labrador To identify all actual and potential sources of pollution which may affect an area, including: all point and non-point sources of pollution all freshwater discharges into the growing area To identify other sources such as boats and wildlife To identify Shoreline Sanitary Surveys meteorological effects, hydrographic effects, and geographic differences 31

32 Environment Purpose: Environnement Newfoundland and Labrador Water Quality Surveys To evaluate all sources of pollution to shellfish growing waters because: these waters are the pathways by which pathogenic micro-organisms and other contaminants are introduced to molluscan shellfish there is a clearly demonstrated relationship between sewage pollution and disease sewage deposited on land can release pathogens into waters via runoff most freshwater eventually reaches the marine environment shellfish pump large quantities of water through their bodies during normal feeding shellfish concentrate microorganisms which may include pathogens shellfish are eaten whole and often raw or only partially cooked 32

33 Environment Environnement What are we looking for? Newfoundland and Labrador Water Quality Surveys There are simply too many bacteria, viruses and other pathogens to examine everything Need an indication of the level of fecal pollution What meets this need is the Fecal Coliform bacteria *Illustration utilized from Water Microbiology Laboratory and Field Procedures, Millipore Corporation,

34 Environment Environnement Newfoundland and Labrador Water Quality Surveys Requirements: Each survey shall include the collection of water samples for bacteriological analysis as follows: a minimum of 15 samples per station per site for initial classification 5 sample visits per site annually samples should be taken from the surface (20cm) sample collection should be timed to coincide with major pollution impacts samples preferably delivered to the laboratory within 6 hours samples must be analyzed within 24 hours of collection 34

35 Environment Environnement Newfoundland and Labrador Survey Results Analysis of shoreline sanitary and water quality survey data allows Environment to make a Classification recommendation to DFO at the NL Molluscan Shellfish Working Group Recommendation is reviewed by the Atlantic Regional Interdepartmental Shellfish Committee DFO will post and enforce closures accepted by the Atlantic Regional Interdepartmental Shellfish Committee 35

36 Environment Environnement Newfoundland and Labrador Changes to Classification Terminology Old Terminology Approved areas Conditionally Approved Closed areas Prohibited areas New* Terminology Approved Conditionally Approved Restricted Conditionally Restricted* Prohibited areas New for CSSP? Harvesting Status Open Status Closed Status 36

37 Environment Environnement CSSP Growing Area Classification FC values refer to MPN FC/100ml concentrations Newfoundland and Labrador RESTRICTED AREA Sanitary concerns or monitored WQ does not meet 14/43 (EC) Prohibition Order issued under MCFR (DFO) Includes Prohibited, Relay and Depuration Zones APPROVED AREA Monitored WQ meets 14/43 (EC) Harvesting permitted at any time, subject to management by DFO PROHIBITED ZONE Minimum 300 metres from WWTP outfall Grossly contaminated area or known chemical source or WQ modelled on known plant conditions (EC) No harvesting except for seed or spat (DFO permit) DEPURATION ZONE Monitored WQ meets 88/260 (EC) Harvesting managed by permit (DFO) Shellfish depurated in registered plant per Depuration Plan (CFIA) Sanitary Survey Sites WWTP RELAY ZONE Harvesting managed by permit (DFO) Harvesting for relay to designated approved area for natural depuration Short-term relay: days natural depuration (w/ shellstock testing - CFIA) Long-term relay: >30 days natural depuration (no shellstock testing) Harvest from anywhere in restricted area other than prohibited zone CONDITIONALLY APPROVED AREA Monitored WQ meets 14/43 Approved area standard under specified conditions (e.g. Rainfall, season, upstream WWTP operation) (EC) Conditional Area Management Plan [CMP] (DFO administers CMP; all CSSP agencies + stakeholders are signatories) Unrestricted harvesting permitted when CMP conditions are met; restricted otherwise UNCLASSIFIED WATERS Unsurveyed waters; not tested and approved (EC) No commercial harvesting (DFO) 37

38 Environment Environnement Newfoundland and Labrador Classified Molluscan Shellfish Growing Areas 38

39 Environment Environnement Newfoundland and Labrador Classification Summary Approved Restricted Sq Km Km Shoreline Sq Km Km Shoreline 554 1, ,212 Total Area Classified (up to Nov 2010) Total Shoreline Newfoundland Total Shoreline Province of NL 970 Sq Km 2,654 Km Shoreline 11,548 Km 28,956 Km Total Molluscan Aquaculture Licenses (up to Jan 11) 52 39

40 Marine Water Quality Monitoring Environment DAVID CURTIS Project Biologist 6 Bruce St. Mt. Pearl, NL A1N 4T3 Tel: Fax: Dave.curtis@ec.gc.ca Web:

41 Canadian Shellfish Sanitation Program Newfoundland and Labrador

42 NAIA-DFA Mussel Sector Workshop

43 Newfoundland and Labrador Region Canadian Shellfish Sanitation Program Mussel Sector Workshop Newfoundland and Labrador March 30,

44 Newfoundland and Labrador Region Canadian Food Inspection Agency Food Safety Molluscan Shellfish Monitoring Program 44

45 Newfoundland and Labrador Region CFIA Responsibilities Responsible for the handling, processing, import and export of shellfish product; the Marine Biotoxin Monitoring Program; and are the lead agency for liaison with foreign governments Fish Inspection Regulations Section 6. (1) No person shall import, export or process for export or attempt to import, export or process for export (b) live oysters, clams, mussels or other molluscs (except scallops) or raw products derived there from, whether frozen or unfrozen, unless the President of the Agency is satisfied on the basis of information submitted to him that the waters from which such shellfish are taken and the premises in which they are handled and processed are of such a nature as will ensure that the shellfish are wholesome 45

46 Newfoundland and Labrador Region Molluscan Shellfish Monitoring Program In NL commercial harvest sampling is done at the processing plant Mussel product destined for export (ie. inter-provincial &/or international trade) must be produced in CFIA registered fish processing establishments Establishments must have a Quality Management Program (QMP) which includes prerequisites, regulatory, and HACCP control elements Sentinel site sampling is an extension of commercial harvest sampling conducted at the processing plants. It also allows for the monitoring of recreational harvesting activity thus providing an overall representation of the state of the shellstock in NL 46

47 Newfoundland and Labrador Region Registered Mussel Processing Establishment Listings 2011 Newfoundland & Labrador No. of Facilities Registered for Mussel Processing No. of Mussel Facilities on US ICSSL No. of Mussel Facilities on EU Bivalve Molluscs List

48 Newfoundland and Labrador Region Registered Mussel Processing Establishments NL

49 Newfoundland and Labrador Region Commercial Harvest Sampling Sampling frequency for commercial lots from all sites is once per week for ASP and PSP at the plant when in production. Limited DSP sampling is done every 2 weeks during the November to April period. A lot is defined as no more than one day harvest from a single site by one or more harvesters If any sample yields a positive result then all subsequent lots from that site must be sampled until it has been determined that the toxin event is over and that toxin levels have returned to below detection level If limits have been exceeded then the site will be closed and sampling shall continue until three consecutive lots over a 14 day period indicate levels below actionable limits and there is reasonable assurance the toxin episode is over For each site, it is imperative that samples be collected from the first lot of the year, and also from the first lot following a break in commercial activity at the site of one or more weeks The sampling frequency for mussels held in wet holding systems is similar to that for commercial lots stated above. 49

50 Newfoundland and Labrador Region Molluscan Shellfish Sentinel Sites NL

51 Newfoundland and Labrador Region Sentinel Site Sampling The sampling frequency for sentinel monitoring sites is every two weeks or once per month from May to November depending on the site location and sampling history Sites are sampled for ASP and PSP. Limited DSP sampling is conducted at select sentinel sites every 2 weeks. Mussels are the indicator species in all cases. If a sample yields a positive result that does not exceed actionable levels for a marine biotoxin, additional samples will be required from that site on a weekly basis until a decreasing or increasing trend has been determined If limits have been exceeded then CFIA recommends closure to DFO - Sampling will continue until three consecutive samples over a 14 day period indicate levels below actionable limits and there is reasonable assurance that the toxin episode is over The extent of a recommended closure and/or opening of an area to DFO is evaluated on a case by case basis CFIA field staff provide laboratory staff with at least one week s notice of the commencement of sampling at sentinel monitoring sites. Laboratory staff are also advised when sampling at any site concludes for the year 51

52 Newfoundland and Labrador Region Marine Biotoxin Analysis (Mussels) by Fiscal Year NL Region No. of Sampling Sites No. of Mussel Samples PSP Analysis ASP Analysis DSP Analysis Fiscal Year Fiscal Year

53 Newfoundland and Labrador Region Impact of Mussel Shellfish Poisoning Human Health Molluscan Shellfish Industry Tourism Economic costs to government / taxpayers 53

54 Newfoundland and Labrador Region Molluscan Shellfish Toxins in NL Paralytic Shellfish Poisoning (PSP) Amnesic Shellfish Poisoning (ASP; domoic acid) Diarrhetic Shellfish Poisoning (DSP) 54

55 Newfoundland and Labrador Region Molluscan Shellfish Toxins in NL Alexandrium, Pseudonitzschia, Dinophysis and Prorocentrum are components of the ocean planktonic community Usually they exist in very low numbers in the water column Under suitable conditions, blooms occur The toxic organisms are fed upon by filter-feeding bivalves which thereby acquire toxicity The shellfish themselves are not affected by the toxins Toxic shellfish cannot be distinguished from non-toxic shellfish by sensory means Eventually the bloom subsides and the shellfish gradually rid themselves of toxin 55

56 Properties of the Agent: Newfoundland and Labrador Region PSP PSP occurs worldwide Toxin produced by Alexandrium species Mussels become toxic by feeding on Alexandrium Other species become toxic by feeding on toxic mussels Toxins involved are collectively known as saxitoxins (STX, GTX, etc.) Toxins are relatively heat stable Courtesy C. McKenzie Courtesy C. McKenzie 56

57 Newfoundland and Labrador Region PSP Re-Suspended Cysts Throughout most of its life cycle, Alexandrium exists as dormant cysts resting in sediments The cysts are toxic Turbulent water conditions may cause certain types of sediments to be stirred up High numbers of toxic cysts may be re-suspended Mussels may acquire toxicity by feeding on the cysts 57

58 PSP Assay and Reported units: Newfoundland and Labrador Region PSP levels are determined by High Performance Liquid Chromatography (HPLC) more specifically Post Column Oxidation (PCOX) 24 hours processing and analysis testing is conducted every working day results reported as micrograms of saxitoxin equivalents per 100g of whole tissue (µg/100g) analysis done by Chemistry Lab in St. John s, NL Action Level: PSP > 80ug/ 100g - product action - closure of molluscan shellfish area 58

59 Newfoundland and Labrador Region PSP Symptoms of PSP Intoxication: beginning with 5-30 minutes after ingestion of toxin tingling sensation or numbness around lips tingling/numbness spreads to face and neck prickly sensation in fingers and toes headache and dizziness difficulty speaking prickly sensation spreads to limbs stiffness and lack of coordination general weakness 59

60 Newfoundland and Labrador Region PSP Symptoms of PSP Intoxication, Cont d: respiratory difficulty rapid pulse less common symptoms include sensation of lightness, salivation, thirst, temporary blindness and gastrointestinal symptoms victims remain calm and conscious paralysis of respiratory muscles may lead to death no known antidote artificial respiration may be required 60

61 Newfoundland and Labrador Region Distribution of Existing PSP Closures NL 61

62 Newfoundland and Labrador Region ASP Properties of the Agent: Known to occur in Atlantic, Pacific coast of North America, Argentina, Europe, South Africa, Australia and New Zealand Mussels become toxic by feeding on Pseudonitzschia Toxin involved is domoic acid Courtesy C. McKenzie 62

63 Newfoundland and Labrador Region ASP Assay and Reported Units: ASP levels are determined by High Performance Liquid Chromatography (HPLC) 48 hours or longer processing and analysis testing is conducted 1-2 days per week results reported as micrograms per gram of whole tissue (µg/g) analysis done by Chemistry Lab in St. John s, NL Action Level: ASP > 20 µg/g - product action - closure of molluscan shellfish area 63

64 Newfoundland and Labrador Region ASP Symptoms of ASP Intoxication: nausea, vomiting and diarrhea within 1/2 hour to 6 hours after ingestion of the toxin if poisoning is not severe, victim recovers in a few days if poisoning is severe or victim has other health problems (e.g. kidney problems) and cannot excrete toxin readily, temporary or permanent brain damage may occur most notable symptom is loss of short term memory deaths have occurred in severe cases 64

65 Newfoundland and Labrador Region DSP Properties of the Agent: Known to occur in North and South America, Europe, Japan and South East Asia Courtesy C. McKenzie Mussels become toxic by feeding on Dinophysis and Prorocentrum Okadaic acid and DTX-1 most commonly associated with DSP outbreaks Toxins produce gastrointestinal symptoms and are known to be tumor promoters 65

66 Newfoundland and Labrador Region DSP Assay and Reported Units: DSP levels are determined by Liquid Chromatography - Mass Spectrometry (LC-MS) 48 hours or longer processing and analysis testing is conducted 1-2 days per week results are reported as micrograms per gram of whole tissue (µg/g) analysis done by Chemistry Lab in Dartmouth, NS Action Level: DSP > 0.2 µg/g (DTX-1 and/or Okadaic acid) or (Pectenotoxins PTX-1, PTX-2, PTX-3, PTX- 4, PTX-6, PTX-11) - product action - closure of molluscan shellfish area Courtesy C. McKenzie Courtesy National Research Council 66

67 Newfoundland and Labrador Region DSP - Lipophilic Toxins Monitor for OA, DTX-1, DTX-2, DTX-3, AZA-1, AZA-2, AZA-3, PTX-1, PTX-2, PTX-3, PTX-4, PTX-6, PTX-11, YTX, GYM Courtesy C. McKenzie There are no DSP suspect harvesting areas in NL The DSP sampling strategy changed focus in 2010 from EU export only requirements to being incorporated into limited routine testing No EU product certification if equal to or greater than 0.16 ug/g of whole tissue 67

68 Newfoundland and Labrador Region DSP Symptoms of DSP Intoxication: nausea, vomiting and diarrhea within 1/2 hour to 6 hours after ingestion of the toxin victims usually recover within 3 days no deaths have been attributed to DSP 68

69 Newfoundland and Labrador Region DSP - Lipophilic Toxins Okadaic Acid Group Tumor promoters Nausea, Vomiting, Diarrhea Pectenotoxins More potent than Okadaic Acid Liver No Nausea, Vomiting, Diarrhea Azaspiracids Attacks internal organs Induce tumors Nausea, Vomiting, Diarrhea Gymnodimine GYM Toxic to mice Yessotoxins YTX, 45-OH-YTX, Homo-YTX, 45-OH-homo-YTX Attacks cardiac muscle Swelling cells Spirolides Toxic to mice 69

70 Newfoundland and Labrador Region Biotoxin Tolerances Toxins United States European Union New Zealand Paralytic Shellfish Poison (PSP) 80 microgram saxitoxin equivalent/100 gram 80 microgram saxitoxin equivalent/100 gram 80 microgram saxitoxin equivalent/100 gram 80 microgram saxitoxin equivalent/100 gram Amnesic Shellfish Poison (ASP) 20 microgram/gram 20 microgram/gram 20 microgram/gram 20 microgram/gram Diarrhetic Shellfish Poison (DSP) Okadaic Acid and/or DTX-1 singly or combination 0.2 microgram/g of digestive gland (20 microgram/100g whole shellfish flesh) No standard maximum level of okadaic acid, DTX and PTX singly or combination 0.8 microgram/g of digestive gland (16 microgram/100 g whole shellfish flesh) maximum level of okadaic acid, DTX and PTX singly or combination 0.8 microgram/g of digestive gland (16 microgram/100 g whole shellfish flesh) Neurotoxic Shellfish Poison (NSP) No standard NSSP Non-detectable No standard No standard 70

71 Newfoundland and Labrador Region Toxins United States European Union New Zealand Pectenotoxins (PTX) 0.2 microgram/g of digestive gland (20 microgram/100g whole shellfish flesh) No standard See DSP above See DSP above Yessotoxins No standard No standard Maximum level of YTX equivalent 5 microgram/g of digestive gland (100 microgram/100g whole shellfish flesh) Azaspiracids No standard No standard Maximum level of AZA 0.8 microgram/g of digestive gland (16 microgram/100g whole shellfish flesh) Phytoplankton No regulatory monitoring Biotoxin Tolerances No regulatory monitoring Regulatory monitoring Maximum level of YTX, 45 OH YTX, homo YTX, and 45 OH homo YTX shall 5 microgram YTX equivalent/g of digestive gland (100 microgram/100g whole shellfish flesh) Maximum level of AZA 1, AZA 2, & AZA3 equivalent 0.8 microgram/g of digestive gland (16 microgram/100g whole shellfish flesh) Regulatory monitoring since

72 Newfoundland and Labrador Region Laboratory Services Standards for Biotoxins High Priority Samples: Consumer complaints Rising biotoxin levels Imminent closures These samples are dealt with immediately Receive highest priority from the laboratory staff All CFIA laboratories are ISO accredited 72

73 Newfoundland and Labrador Region Biotoxins Closure (Re-Opening) Recommendation Procedure CFIA staff reviews all data Extent of the area to be closed (re-opened) is determined CFIA recommends harvest prohibition (harvest reopening) to DFO CFIA sends s or faxes to other government agencies, processors, industry associations and partners in the monitoring program 73

74 Mercury (Hg) Using Cold Vapor AA Spectrometry Cadmium (Cd) Using Inductively Coupled Plasma (ICP) Mass Spectrometry Lead (Pb) Newfoundland and Labrador Region Elemental Analyses Mussels to EU Using Inductively Coupled Plasma (ICP) Mass Spectrometry 74

75 Newfoundland and Labrador Region Bacteriological Analyses The bacterial group of interest is known as Enterobacteriaceae They are generally associated with sewage contamination Those of interest are: E. coli Salmonella 75

76 Newfoundland and Labrador Region E. coli Analysis Methodology: Health MF HPB 19 - Enumeration of Coliforms, Fecal Coliforms and of E. coli in Foods using the MPN method E. coli - processing and analysis: 3-6 days 76

77 Newfoundland and Labrador Region Salmonella Analysis MF LP 29 Qualicon BAX System Method for Detection of Salmonella in a Variety of Food MF LP 29 processing and analysis: 3 days 77

78 Newfoundland and Labrador Region Bacterial Analysis Mussel samples for bacterial analysis must be received fresh in the laboratory as freezing will cause die-off of the resident bacterial flora Mussels are scrubbed using sterile brushes and potable water prior to shucking, only live animals are to be used Bacterial analysis of mussel samples starts within 24 hours of sample collection 78

79 Newfoundland and Labrador Region Bacteriological Guidelines For Raw Molluscan Shellfish If a mussel sample collected at a CFIA registered shellfish processing establishment fails to meet a bacteriological guideline, and provided the establishment s QMP is verified to be in control, then 5 sample units are collected at the implicated harvest area E. coli 5 sample units reject if any two samples exceed 230mpn/100g or any one sample exceeds 330mpn/100g Salmonella 5 sample units reject if Salmonella is detected in individual or pooled sample 79

80 Newfoundland and Labrador Region Other CSSP Topics of Interest to Mussel Growers and Processors DFA Developmental, Expansion and Upgrade Applications Conditional Management Plan (non-wwtp) Wet Storage in Processing Plants Relaying Depuration Facilities 80

81 Newfoundland and Labrador Region DFA Developmental, Expansion and Upgrade Applications Applications are referred to CFIA Requests are vetted through ARISC CFIA cost shares sampling effort with growers CFIA s response based upon marine biotoxin results CFIA tests for elemental analyses and reports any noteworthy findings to DFA as a courtesy only 81

82 Newfoundland and Labrador Region Conditional Management Plan (non-wwtp) To operate in a conditional area (approved or restricted) based on the effects of, e.g. rainfall events, stormwater runoff, seasonal variations, etc. Development of a CMP is supported by: a harvesting plan (proponent) background information (EC classification report) methods & procedures shellstock sampling and testing regime (CFIA) methods & procedures water quality sampling and testing regime (EC) enforcement, surveillance & control mechanisms (DFO) Once approved, the CSSP partners will manage the area in accordance with the CMP. Non-compliance with the CMP may mean immediate closure 82

83 Newfoundland and Labrador Region Wet Storage in Processing Plants Wet holding of mussels may only be conducted in CFIA registered facilities as per the Fish Inspection Regulations Here are a few components to consider/incorporate in the QMP: Water from approved areas only to be used in wet storage tanks. This is not permitted when a biotoxin closure is in effect unless approved controls are in place to filter water supply If water is drawn from non-approved sources then it must be treated with UV system, chlorination/dechlorination or ozonation/deozonation When using UV treatment, water turbidity must not exceed specified limits otherwise sand filters or equivalent may be used as a pretreatment Each storage facility must meet Schedules I and II of FIR Mussels from different harvest lots shall not be comingled in tanks 83

84 Newfoundland and Labrador Region Controlled Relaying and Depuration Relay systems and land-based depuration facilities are efficient methods of achieving microbiologically safe mussels that are harvested from areas classified as restricted or conditionally restricted in the open status DFO may issue a licence to harvest mussels for food purposes in an area that is contaminated, following approval of a decontamination plan CFIA advises on these decontamination plans 84

85 Newfoundland and Labrador Region Relaying Mussels for relay must be placed in or on a shellfish lease in an area clearly marked off to identify the relay site The defined lots of relayed mussels are separated by at least 10 metres to avoid cross contamination with other mussels and to maintain identity Lots of mussels destined for relay must remain in water for a minimum of 14 days Lots of mussels relayed from 14 to 21 days must be analysed for faecal coliforms with a minimum of 1 sample. Lots of mussels relayed in excess of 21 days may be exempted from testing at the discretion of CFIA Any CFIA registered plant processing this product must verify as part of their Critical Control Point (CCP) for incoming product that appropriate procedures have been followed Mussel processor/grower records and bacteriological analysis results must be made available upon request All analyses are to be performed by an approved lab 85

86 Newfoundland and Labrador Region Depuration Facilities Faster process than natural/container relaying Must be CFIA registered and conform to requirements of the QMP One time only fee of $7500 (>300 sq.m) and $6000 (<300 sq.m) plus all other annual fees All buildings must conform to CFIA s FIR Applicant must submit proposal to CFIA 86

87 Newfoundland and Labrador Region Depuration Facilities (cont d) Proposal to CFIA should include: Facility design and location Process water source Equipment design including provisions for lab facilities Utilisation of any product during evaluation period Description of the controls to ensure that labelling, harvesting, transport, operational and pre- and post-depuration storage requirements are met 87

88 Newfoundland and Labrador Region Depuration facilities (cont d) Process Verification - facility must prove with a minimum 20 lots that the depuration process is consistently cleansing the mussels Routine QMP Monitoring (Post-Verification) Requirements Mussel samples for bacteriological analysis must be taken from every lot at zero hour and at the final hour of depuration End Product Standards for Each Process Process Deviations 88

89 Newfoundland and Labrador Region Conclusion The Molluscan Shellfish Monitoring Program does not limit itself to crisis; rather it provides sustained support to all stakeholders involved in the growing, processing and regulation of mussels 89

90 Newfoundland and Labrador Region Websites for Additional Information SpecificInformation/Seafood/FederalStatePrograms/ NationalShellfishSanitationProgram/UCM SpecificInformation/Seafood/FederalStatePrograms/I nterstateshellfishshipperslist/default.htm PerCountry_en.htm 90

91 Newfoundland and Labrador Region Contact Information Gerry Dawe A/RPO Aquaculture 10 Barter s Hill, St. John s, NL A1C 5K4 Tel: Fax: Gerry.Dawe@inspection.gc.ca Web: 91

92 Newfoundland and Labrador Region 92

93 NAIA-DFA Mussel Sector Workshop

94 Fisheries and Oceans NL Region Fisheries & Oceans (DFO) Managing the resource and risks to human health

95 Fisheries and Oceans NL Region DFO & CSSP CSSP Delivery Primary responsibility within DFO resides with the Fisheries and Aquaculture Management (FAM) Sector Other sectors indirectly involved or impacted Science Oceans Policy & Economics FAM NL Region 3 divisions Aquaculture Management Resource Management Conservation & Protection 95

96 Fisheries and Oceans NL Region DFO Responsibilities DFO, under the authority of the Fisheries Act and pursuant regulations: Administers openings and closures of molluscan shellfish growing areas Notifies the public of these openings and closures Patrols and enforces molluscan shellfish closures Controls harvesting of molluscan shellfish from classified areas (e.g. issuing licences where required) 96

97 Fisheries and Oceans NL Region Legislation Acts & Regulations The legal authority for delivery of DFO s mandate is provided primarily by: the Fisheries Act Management of Contaminated Fisheries Regulations (MCFRs) MCFRs Section 3(1) Prohibition Orders Section 4(1) Authorizes the issuance of a licence Section 4(2) Decontamination Plans 97

98 Fisheries and Oceans NL Region Variation Order vs. Prohibition Order Variation Order The purpose of a variation order is to vary (change) regulations that pertain to: A close time A fishing quota or A limit on size or weight of fish A variation order can be made only if the close time, fishing quota or limit on the size or weight of fish to be varied has been fixed in regulations and has been fixed in regulations in respect of an area 98

99 Fisheries and Oceans NL Region Openings and Closures - Process Recommendation from EC/ CFIA Prohibition Order Request by AM to C&P (Regulations Unit) RDG Approval Authority as per Sec. 3(1) MCFRs Public Notice Monitoring, Control & Surveillance Notify media, external contacts & internal staff Signs posted, database maintained, enforce and patrol closures 99

100 Fisheries and Oceans NL Region Program Delivery Regional Headquarters Policy development & program administration Shared responsibility of AM and C&P Staff Officers Area/ Detachment/ Satellite Offices Posts signs Patrols and enforces shellfish closures Primarily - Fishery Officers 100

101 Fisheries and Oceans NL Region 101

102 Fisheries and Oceans NL Region DFO Offices 102

103 Fisheries and Oceans NL Region Environment Stakeholders Existing Closures Aquaculture (Shellfish) 51 Sites Commercial Fishers Scallops, Clams Recreational Fishers Scallops (3,000+ licences), mussels, etc. Aboriginals closures (Widely distributed around the island) 103

104 Fisheries and Oceans NL Region Integrated Multi-Trophic Aquaculture First Steps Aquaculture License and Land Tenure IMTA Management Plan (IMTAMP) location and dimensions of the tenure details of the species to be cultivated and harvested process flow diagram for all cultivation and harvesting detailed hazard analysis for all flow steps identified controls for sanitation and pests verification/audit system to ensure compliance to MP description of the responsibilities/duties of involved parties statement that all shellfish be processed in a federally registered fish processing establishment as per the Fish Inspection Regulations. 104

105 Fisheries and Oceans NL Region Integrated Multi-Trophic Aquaculture cont d Supporting Documentation Next Steps CFIA food safety EC sampling regime DFO licenses and/or orders Review by RISC If approved: DFO revise orders / authorize harvest CFIA verify plant QMP Annual reporting (prop) and auditing (3 rd party) RISC can recommend closure if IMTAMP not adhered to 105

106 Fisheries and Oceans NL Region New Species Fisheries Emerging Fisheries Policy Three Stages Requirements and procedures for new fisheries new fishery : - Fisheries involving new species and/or stocks that are not utilized or not fully utilized, and not currently covered by a management plan. Stage I Feasibility Stage II Exploratory Stage III - Commercial Application Review Includes detailed plans, biology, stock assessment Review Committee - governments (federal, provincial, territorial), Aboriginal groups, industry, public 106

107 Fisheries and Oceans NL Region Introductions and Transfers National Code on I&T of Aquatic Organisms All FW and marine aquatic organisms protect aquatic ecosystems while encouraging responsible use of aquatic resources Regional I&T Committee DFO, CFIA, DFA, DOEC Risk Assessment Establishment (probability, consequence) Genetic, ecological, disease 107

108 Fisheries and Oceans NL Region NL Commercially Harvested Molluscan Shellfish Mussels Blue Mussel, c Scallops Sea Scallop, w/c Iceland Scallop, w Whelk Common Northern Whelk, w Clams Softshell Clam, w Propellor Clam, w Arctic Surf Clam/Stimpson s Surf Clam, w Greenland Cockle, w (w = wild, c = cultured) 108

109 Fisheries and Oceans NL Region Distribution of Existing Closures 109

110 Chris Hendry Regional Aquaculture Coordinator Fisheries and Oceans Fisheries and Oceans NL Region PO Box 5667, 80 East White Hills Road St. John s, NL A1C 5X Contact Informatiom 110

111 NAIA-DFA Mussel Sector Workshop

112 Newfoundland Aquaculture Industry Association Mussel Sector Workshop March 30, 2011 DFA Licensing and Quality Assurance Division Responsibilities

113 Jurisdictional Responsibilities License buyers and processors Issue license conditions Grant exemptions Perform raw material inspections Complement the role of the Canadian Food Inspection Agency (CFIA)

114 Licensed Mussel Processing Facilities 2010 Primary Processor In-Province Retail Processor

115 Fish Inspection Administrative Regulations License required (Section 3) License not required (Section 4) Classes of licenses (Section 7)

116 Fish Inspection Operations Regulations Establishment requirements (Section 3) Duties of a processor (Section 15) Marketing of bi-valve molluscs (Section 19)

117 Section 19 A person shall not market bi-valve molluscs unless: the molluscs have been harvested from an area approved for that purpose by the Minister of Fisheries and Oceans () the molluscs, when transported for sale to a processing facility or sales outlet, are in closed containers or bags that are tagged to indicate the type of species, harvesting site, date harvested and name of harvester that person maintains a record of all tags referred to in the above bullet which record is available for inspection by an inspector; and the molluscs have been sampled and analyzed to monitor toxin levels in accordance with the protocols established and administered by the Canadian Food Inspection Agency.

118 Information Licensing Legislation Ian Burford Director of Licensing and Quality Assurance Tel: (709)

119 NAIA-DFA Mussel Sector Workshop

120 Classification Adjacent to Wastewater Systems Significant Rainfall Events Mussel Sector Workshop Gander, NL March 30, 2011

121 Wastewater Page 121

122 Wastewater Includes sanitary sewage (grey and blackwater), industrial process waste (e.g. chemicals, nutrients) Untreated wastewater effluent poses the highest risk of waterborne pathogens and other harmful bacteria contaminating bivalve molluscan shellfish Evaluation primarily based on bacterial contamination as indicator of pathogens, but virus concerns are increasing Page 122

123 Wastewater wastewater treatment systems across 328 identified that discharge to shellfish growing areas in BC, Quebec and Atlantic 144 in Atlantic adjacent to shellfish areas 110 wastewater systems in NL (excl. Labrador): 34 secondary-level treatment (lagoons, ext. aeration, etc.) 76 primary-level treatment (majority communal septic tanks) To date, only 3 have been identified with potential to impact shellfish areas: Pilley s Island Roberts Arm Trinity Page 123

124 Wastewater System Assessment Collection of technical and operational information about the plant and collection system to identify most likely failure scenario (bypass, loss of disinfection, etc.) Conduct drogue studies in receiving waters to determine currents and tidal effects Sample influent and effluent under different conditions to obtain representative fecal coliform concentrations Page 124

125 Hydrodynamic Modelling Use various internationally-accepted computer models to predict effluent plume travel and impact area Use actual measured data from wastewater system Current and tidal data from drogue studies Wind and bathymetric data Adjust for temperature, salinity, bacterial decay rates Model for most common failure scenario; i.e. not catastrophic Limit of predicted impact area under all conditions represents the outer boundary of the area that requires conditional management Prohibited area based on dilution of effluent under all operating conditions to address virus concerns Page 125

126 Hydrodynamic Modelling Video Not Available Page 126

127 CSSP Growing Area Classification 101 Emergency Closures APPROVED Meets WQ criteria for unrestricted harvesting at all times PROHIBITED Minimum 300m from WWTP or LS outfalls No harvesting except under licence for seed or spat RESTRICTED CLOSED STATUS Meets No harvesting WQ criteria of any for kind depuration following harvesting WWTP or LS failure Suitable Minimum for 7 day relay closure harvesting (max. 21 days) LS LS WWTP LS Page 127 UNCLASSIFIED WATERS Unsurveyed waters; not tested and not approved for harvesting

128 CSSP Growing Area Classification Conditional Management Open Status APPROVED Meets WQ criteria for unrestricted harvesting at all times PROHIBITED Minimum 300m from WWTP or LS outfalls No harvesting except under licence for seed or spat Monitored 14 FC Boundary where FC concentration is reduced to 14 FC/100mL based on routine WQ monitoring under normal conditions at WWTP and LS LS LS WWTP LS CONDITIONALLY RESTRICTED Restricted harvesting under licence when in Open Status Meets restricted harvesting WQ criteria based on routine WQ monitoring during normal operations at the WWTP and LS CONDITIONALLY APPROVED Approved harvesting when in Open Status Meets approved harvesting WQ criteria based on routine WQ monitoring during normal operations at the WWTP and LS Page 128 UNCLASSIFIED WATERS Unsurveyed waters; not tested and not approved for harvesting

129 CSSP Growing Area Classification Conditional Management Closed Status (WWTP or LS failure) APPROVED Meets WQ criteria for unrestricted harvesting at all times PROHIBITED Minimum 300m from WWTP or LS outfalls No harvesting except under licence for seed or spat CONDITIONALLY- MANAGED ZONE LS LS WWTP LS CONDITIONALLY RESTRICTED NO harvesting when in Closed Status CONDITIONALLY APPROVED NO harvesting when in Closed Status Possibility for restricted harvesting below modelled 88 FC/100mL Modelled 14 FC Modelled line where FC concentration is reduced to 14 FC/100mL Page 129 UNCLASSIFIED WATERS Unsurveyed waters; not tested and not approved for harvesting

130 Conditional Management Each conditionally-managed area must have a Conditional Management Plan (CMP) DFO develops and administers CMP CFIA, DFO, EC, wastewater system operator are the minimum required signatories (Provincial regulatory agency and harvester association are optional) Specifies the roles and responsibilities for each CSSP agency and the actions taken in the event of a discharge of untreated or partially-treated waste Operator must agree to maintain an adequate detection system for accidental spills, and agree to notify DFO within a specified time period Page 130

131 Conditional Management DFO will respond to discharge report and immediately close the area Area stays closed for a minimum of seven days After the discharge event, EC tests water, CFIA tests shellstock When both water and shellstock have returned to acceptable standards, CFIA and EC will recommend to DFO that the conditional area may return to open status The majority of time when the wastewater system is operating properly, the conditional area remains in open status Page 131

132 Conditional Management Detection Notification Response Key elements to a successful CMP Important to close the area in a timely manner and for processors to apply enhanced HACCP controls Page 132

133 Significant Weather Events Page 133

134 Significant Weather Events As filter feeders, bivalve shellfish are sensitive to changes in their environment, particularly from contaminants entering growing waters from overflowing WWTPs, stormwater, surface runoff following intense rainfall Recent extraordinary rainfall events in Atlantic prompted EC to recommend temporary closure of coastal waters in Maritime Provinces as a precaution to protect public health As predicted, shellfish waters in most areas were proven to be contaminated As expected, water quality (measured by EC) and shellfish meat quality (measured by CFIA) returned to acceptable standard after a number of days and areas were re-opened Page 134

135 Hurricane Igor Slightly different approach taken in response to Igor, but principles were the same CSSP contacted key industry members in Eastern and Central NL to ensure that product was not harvested Given lower level of wastewater treatment in most areas, WQ and sanitary classification accounts for discharges of higher-concentration effluent Harvesting activity had been low in advance of storm Page 135

136 Significant Weather Events By virtue of working in a marine environment, aquaculture operators have a greater awareness of marine weather forecasts and conditions Industry is encouraged to monitor forecasts and take appropriate actions in advance of a storm should conditions require a broad closure Elevated contamination levels in areas affected by either surface runoff or wastewater systems is proven and is a key principle of sanitary assessments under the CSSP Q&A factsheet is being developed and will be posted on the CFIA website soon Page 136

137 NAIA-DFA Mussel Sector Workshop

138 Canadian Shellfish Sanitation Program Mussel Sector Workshop Gander, NL March 30, 2011

139 Program Highlights Changes to the Program Foreign Audits USFDA 2004 and 2009 EU 2003 and 2009 Viruses in Shellfish Recent studies Norovirus and Outbreaks Page 139

140 Recent CSSP Program Changes 1. Requirement for human waste containment devices on harvesting vessels 2. Water quality monitoring frequency 3. Controls for managing the harvest of shellfish adjacent to wastewater treatment plants Page 140

141 1. Shellfish Harvesting and Handling Enhanced controls to prevent overboard discharge already prohibits the overboard discharge of human waste Program enhancements in 2008 now require on-board human waste containment on shellfish harvesting vessels applies to vessels where timely access to onshore facilities is not possible. Page 141

142 2. Water Quality Monitoring Frequency Historically, sampling was 5 times every 3 years target is to move to 5 times every year for nonremote areas. Program enhancements started in 2007, will increase s water quality monitoring frequency. All areas in NL are now sampled annually and will continue to be if resource levels are maintained. Page 142

143 3. Shellfish Harvesting in Areas Near WWTP Management utilizing a combination of; Collaboration with provinces to strengthen WWTP safety performance enhanced reporting of WWTP/collection system bypasses Revised classification; Conditional Management Plans Enhanced processor HACCP controls Education initiatives to improve awareness Page 143

144 3. Classification Former Categories Closed (included prohibited) Approved Conditionally Approved New Categories Prohibited Conditionally Restricted Restricted Conditionally Approved Approved Status of Harvest Areas (independent of classification) Open or Closed Page 144

145 3. Generic Classification Map Page 145

146 3. Classification WWTP assessments in NL Pilley s Island complete Roberts Arm inner harbour reclassified in 2010, Hammer and Bear Cove to be assessed in 2011 Trinity to be assessed in 2011 Page 146

147 Foreign Audits USFDA and Audit was focused on enhancements to the program since 2004 Final report has been received 2 components 1 on delivery on program and 1 on criteria used to establish the size of prohibited zones around WWTPs EU and 2009 Objective was to verify if the CSSP is equivalent to relevant European Community provisions Some focus on enhancements since 2003 audit Final report has been received has achieved equivalency with the EU Page 147

148 Viruses In Shellfish Concern with viral contamination in shellfish is increasing worldwide Norovirus Hepatitus A Health - Health Risk Assessment : Enteric Virus (Norovirus and Hepatitis A Virus) Contamination of Bivalve Molluscan Shellfish Viral risk is low, however data is lacking 2008 CFIA conducted 2 studies NB, PEI, BC Main purposes was to validate the lab methodology additional data gathered with respect to viruses in wastewater and shellfish in prohibited zones 2009/10/11 More extensive done in NB, NS, PE and BC Looking at virus and bacteria levels in wastewater, in shellfish growing area water, and in shellfish at different distances from WWTP effluent pipes Page 148

149 Norovirus Facts Formally known as Norwalk virus (winter vomiting disease in 1968 at an Elementary School in Norwalk, Ohio) Responsible for >90% of non bacterial infections Low infectious dose, as low as 10 virions Present in faeces and vomit of infected people Highly infectious nature > 100 strains Environmentally robust Short lived immunity - max 18 months Large human reservoir Many vectors of transmission food (handled by infected person) shellfish, swimming pools, water, Resistance to heat cooking does not inactivate the virus and shellfish are often eaten raw or slightly cooked. Page 149

150 Norovirus Page 150

151 Viruses Page 151

152 NAIA-DFA Mussel Sector Workshop

153 Fisheries and Oceans NL Region Fisheries & Oceans (DFO) Managing the resource and risks to human health When Something Goes Wrong