Report of the Canadian Audit of the United States National Shellfish Sanitation Program – 2018

On this page

• Abbreviations and special terms used in the report
• Executive summary
• 1. Introduction
• 2. Audit objective, scope, and methodology
• 3. Legal basis for the assessment
• 4. Background
• 5. Findings
• 6. Closing meeting
• 7. Conclusions and recommendations
• Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of the U.S. Bivalve Mollusc Sanitation Program Report – 2018

Abbreviations and special terms used in the report

Abbreviation	Definition
APC	Adverse Pollution Condition
ASP	Amnesic Shellfish Poisoning
CAMP	Conditional Area Management Plan
CFIA	Canadian Food Inspection Agency
CFR	Code of Federal Regulations
CFSAN	Centre for Food Safety and Applied Nutrition
CSSP	Canadian Shellfish Sanitation Program
FDA	Food and Drug Administration
HACCP	Hazard Analysis Critical Control Points
ISSC	Interstate Shellfish Sanitation Conference
LEO	Laboratory Evaluation Officer
MO	Model Ordinance
MOU	Memorandum of Understanding
MSC	Male-Specific Coliphage
NSSP	National Shellfish Sanitation Program
ODA	Oregon Department of Agriculture
OR	Oregon State
OSP	Oregon State Police
OSCP	Office of State Cooperative Programs
PEER	Program Element Evaluation Report
PSP	Paralytic Shellfish Poison
QAP	Quality Assurance Plan
QMP	Quality Management Program
SAPB	Shellfish and Aquaculture Policy Branch
SRS	Systematic Random Sampling
SSCA	State Shellfish Control Authority
SSI	Shellfish Standardization Inspectors
SSO	Shellfish Standardization Officer
U.S.	United States of America
WA	Washington State
Vp	Vibrio parahaemolyticus
WADOH	Washington Department of Health
WDFW	Washington Department of Fish and Wildlife
WWTP	Waste Water Treatment Plant

Executive summary

This report describes the outcome of an audit of the United States of America (U.S.) National Shellfish Sanitation Program (NSSP) conducted by the Government of Canada from September 10 to 21, 2018 in the states of Washington (WA) and Oregon (OR).

The main objective of the audit was to determine if the NSSP provides an equivalent level of health protection to that provided by the Canadian Shellfish Sanitation Program (CSSP) and the Quality Management Program (QMP). The audit also evaluated whether the NSSP was implemented as documented and, whether there were any significant differences between the NSSP and Canadian systems in the areas of: growing area classification and monitoring, harvesting controls, laboratories, and inspection systems for vessels, conveyances and processing establishments. The audit included site visits to/meetings with:

• 2 state shellfish control authority offices/meeting locations
• 4 state/regional authorities
• 4 harvesting areas
• 2 waste water treatment facilities
• 6 shellfish processing establishments
• 2 water sampling runs
• 1 state patrol
• 2 laboratories

Overall, the audit determined that the NSSP is being supported by a well-trained and dedicated team of professionals at both the state and federal level. Establishment inspections and oversight of NSSP activities at the national and regional level are being conducted as required. Furthermore, the NSSP is generally implemented as intended, and is effective at managing food safety risks associated with bivalve shellfish. Recommendations for consideration to enhance the NSSP/its implementation were noted in the following areas:

Growing area classification and monitoring

• emergency closures and water and/or shellstock testing of areas impacted by a widespread highly elevated fecal coliform contamination
• inclusion of waste water system discharges that represent a reduction of effluent quality in conditional management plans and associated prohibited areas
• re-opening criteria for closures resulting from unplanned discharge events

Harvesting controls

• state authority awareness of all compliance requirements for onboard human waste containment on harvest vessels
• state authority's processes to effectively determine whether aquaculture products have been harvested from a conditional area during a closed period and, during emergency closures

Processing establishment controls

• awareness by exporters of Canadian requirements
• controls for unexpected, sporadic contamination events at the harvest site and knowledge of processors about emergency closures enacted
• documentation and enforcement of the NSSP model ordinance (MO) standards

Laboratories

• knowledge and record gaps
• evaluation cycle for laboratories

1. Introduction

The Government of Canada conducted an on-site audit of the NSSP from September 10 to 21, 2018 in the states of WA and OR. The audit was led by the Canadian Food Inspection Agency (CFIA) and included team members from Fisheries and Oceans Canada and Environment and Climate Change Canada. Harvest area controls and harvest area classification elements were assessed by specialists from Fisheries and Oceans Canada and Environment and Climate Change Canada respectively. The remaining shellfish program elements were assessed by CFIA specialists.

The audit began with an opening meeting held in Bothell, WA on September 10, 2018, with participation of representatives from the U.S. competent authority, including the Food and Drug Administration (FDA) Centre for Food Safety and Applied Nutrition (CFSAN)'s Office of Food Safety – Shellfish and Aquaculture Policy Branch, International Affairs Staff, the Office of Regulatory Affairs (ORA) Office of State Cooperative Programs (OSCP) , and the auditors from the Government of Canada. The field portion of the audit was conducted in various locations in WA and OR which were representative of the export industry in these states, including growing areas, and processing establishments.

This was the first known Canadian audit of the NSSP.

2. Audit objective, scope and methodology

The objective of this audit was to determine if the U.S. bivalve mollusc sanitation program provides an equivalent level of health protection to that provided by the CSSP and the QMP. The scope of the audit included the whole bivalve mollusc production chain for products intended to be exported to Canada, in particular:

• growing area classification
• harvesting controls
• vessel controls
• conveyances
• landing areas
• processing establishments
• laboratories

The process included a review of relevant regulations, methods of implementation, site visits, observations of establishment conditions, verification activities conducted by each state visited, general level of operator compliance with the NSSP MO and/or State requirements, and subsequent corrective and follow-up actions.

The audit was conducted by assessing the implementation of the NSSP as described in the MO. In addition, the auditors noted any areas where the U.S. program differed from the CSSP and the QMP. Any significant differences were assessed to determine if the NSSP provides the same level of public health protection as that provided by the CSSP and the QMP. The audit was conducted using standard audit techniques of document review, interview and observation. The NSSP Guide for the Control of Molluscan Shellfish, 2015 – PDF (5.86MB) was the primary reference used to conduct the audit, taking into consideration revisions made in 2017.

Table 1: Audit scope summary

Meetings and site visits	No.	Locations and/or comments
Competent authorities National	2	Bothell, WA and Portland, OR
Competent authorities State/regional	4	WA Department of Health (State Shellfish Control Authority) WA Department of Fish and Wildlife Oregon Department of Agriculture (ODA) (State Shellfish Control Authority) Oregon State Police (OSP)
Harvest areas	4	Various locations in WA and OR
Waste water treatment facilities	2	Shelton, WA and North Bend, OR
Processing establishments	6	Various locations in WA and OR
Laboratories	2	Shoreline, WA and Portland, OR
Water sampling runs	2	McNeil and Anderson Islands, Drayton Passage and Oro Bay, WA and Coos Bay and South Slough, OR
State patrol	1	Hood Canal, WA

3. Legal basis for the audit

The audit was conducted under the authority of the:

• Canadian Fish Inspection Act and Regulations, specifically the requirements in section 6(1) (b) of the Regulations, which states:
  • "No person shall import, export or process for export or attempt to import, export or process for export live oysters, clams, mussels or other molluscs (except scallops) or raw products derived therefrom, 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."
• the Canadian Food and Drugs Act section 4(1) which prohibits the sale of food that:
  • "(a) has in or on it any poisonous or harmful substance;
  • (b) is unfit for human consumption;
  • (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
  • (d) is adulterated; or
  • (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions."

4. Background

4.1 Program design

The U.S. has established a comprehensive national program for the sanitary control of molluscan shellfish that is shipped interstate (the NSSP) and, a minimum set of requirements which are outlined in the MO. The program is implemented by States which are involved in the interstate harvest and/or trade of molluscan shellfish, and oversight is conducted by the FDA.

The FDA recognizes the Interstate Shellfish Sanitation Conference (ISSC) as the primary voluntary national organization of state shellfish regulatory officials that provides guidance and counsel on matters for the sanitary control and safety of shellfish. Membership includes representatives of federal organizations with a role in shellfish sanitation, state partners of states that ship shellfish interstate, as well as industry, academia, and other interested parties such as key trading countries with which the U.S. has an agreement.

Although only state partners can vote on matters pertaining to the program during biennial meetings of the ISSC, the active participation of other stakeholders promotes discussion, education, and innovation in realistic policy-making and the development of programs/tools that support the delivery of the NSSP. While the FDA does not vote on matters at the biennial meetings, FDA does review all actions taken by the ISSC at the meetings and may provide concurrence or non-concurrence, with public health justification, of any proposed changes to the NSSP.

A fundamental feature of this structure is the requirement for participating states to adopt the NSSP requirements by incorporating them into state regulations. This gives states the authority to deliver and enforce the NSSP MO within their borders.

Recognizing the diversity in the industry, geography, governments involved, and resourcing of ISSC states, the FDA has developed a system of oversight to ensure consistent delivery of the program by the states. This includes:

• a process by which both state inspectors and state laboratory evaluation officers (LEOs) are 'standardized' to ensure consistent delivery of NSSP requirements and laboratory evaluations, shellfish standardization officers (SSOs), shellfish standardization inspectors (SSIs), and LEOs
• a systematic process through which the FDA audits state programs: annual Program Element Evaluation Report (PEER) reviews of the key elements of the NSSP:
  • growing area (harvest)
  • control of harvest (enforcement)
  • plant processing and shipping
  • vibrio management
  • laboratory

ISSC states identify operators that are eligible to ship interstate through their process of oversight and evaluation. The names of these operators are submitted to FDA for posting on the Interstate Certified Shellfish Shippers List in near real time by the states (and can also be removed in near real time).

The FDA routinely evaluates the shellfish programs of the participating states and, those of foreign governments with which it has a shellfish trade agreement.

4.2 Production and trade information

Between 2014 and 2017, 12,531,758 kg of shellfish was exported from the U.S. to Canada. Exports included oysters, clams, scallops, abalone and geoduck, in shell-off and shell-on.

A list of dealers who were eligible to export bivalve molluscan shellfish to Canada as of September 10, 2018 (including live, raw and processed shellfish products) is available on the FDA's Interstate Certified Shellfish Shippers List website.

5. Findings

5.1 Regulatory foundation

The FDA recognizes the ISSC as the primary voluntary national organization of state shellfish regulatory officials that provides guidance and counsel on matters for the sanitary control and safety of shellfish.

Authorities for the implementation of the NSSP include instruments enforced by both the FDA and, by ISSC states. For instance, the FDA enforces the following regulatory instruments:

• U.S. Public Health Service Act
• Food Drug and Cosmetic Act
• The Lacey Act
• Fair Packaging and Labeling Act
• Portions of the Public Health Service Act
• FDA's Seafood Hazard Analysis Critical Control Points (HACCP) Regulation
• FDA regulations Title 21 of the Code of Federal Regulation (CFR) Parts 1 – 1299

The 42 U.S code § 243: General Grant of Authority for Cooperation and the 21 U.S. Code § 372 – Examinations and Investigations give the FDA the authorization to accept assistance from state and local authorities in the enforcement of laws. This provides a legal mechanism for the NSSP model which depends on the states for implementation. The relationship between the FDA and ISSC is formalized in Memorandum of Understanding (MOU) 225-84-2003. The memorandum states that the FDA has administrative oversight of the NSSP while each State Shellfish Control Authority (SSCA) is responsible for the day-to-day implementation, management, and enforcement of NSSP controls.

State laws or regulations must provide an adequate legal basis for sanitary control from the growing area, during harvesting, processing, distribution, and shipping. This legal authority must enable 1 or more departments or agencies of the State to regulate and supervise the classification of growing areas, harvest, relaying and transport of shellstock at its source; the shipment, tagging and storage of shellstock; the operation of depuration plants; and the shucking, packing, labelling and repacking of shellfish.

A unique situation exists in WA where indigenous Tribes also have a role in the management of the shellfish industry. In 1994, judge Edward Rafeedie reaffirmed WA's Tribes treaty rights to harvest shellfish. The Tribal Consent Decree was also signed in 1994, and while Tribes did not give up the right to be their own shellfish control authority, the agreement recognized the Washington Department of Health (WADOH) as the state shellfish control authority managing sanitation issues for raw molluscan shellfish.

Each ISSC state is directly responsible for the effective regulation of all production and handling of shellfish within its confines, not merely for the protection of its own citizens, but equally for safeguarding such of its product as goes to other States (or, internationally).

Each ISSC state adopts laws and regulations providing the necessary legal authority to carry out and enforce requirements of the NSSP. State laws and regulations are reviewed by the FDA during their routine evaluation programs. For example, the Oregon Administrative Rule 603-100-0010 adopts the NSSP as the rules governing Sanitation of Shellfish Growing Areas and Harvesting, Processing and Distribution of Shellfish. The Washington State Administrative Code part 246-282-005 minimum performance standards stipulate that "Any person engaged in a shellfish operation or possessing a commercial quantity of shellfish or any quantity of shellfish for sale for human consumption must comply with and is subject to the requirement of the FDA and NSSP".

When 2 or more state or tribal agencies regulate the sanitary control of the shellfish industry within a state, a clear statement of each agency's responsibilities to regulate and enforce the NSSP must be developed in the form of a memorandum of understanding. Likewise, when shellfish is harvested in 1 state and landed in another state, a MOU is also developed. This is the case of WA and OR, where an agreement recognizing that oysters harvested in WA are shipped to facilities in OR for packing/processing exists to deal with harvested product shipped before cooling.

In general, federal and state laws and regulations provide an appropriate legal basis for the sanitary control of shellfish from the growing area to harvesting, processing, distribution and shipping.

5.2 Government oversight

5.2.1 Organizational structure

The FDA is a federal agency of the United States Department of Health and Human Services. It regulates foods that are not regulated by the U.S. Department of Agriculture. In conjunction with FDA field staff, the FDA's CFSAN carries out the FDA's mandate to ensure the nation's food supply is safe, sanitary, wholesome, and honestly labelled.

The FDA's Office of the Commissioner houses the Office of Regulatory Affairs (ORA) which is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts analyses of regulated products, reviews products offered for import into the U.S., and works with state, local, tribal, territorial and foreign counterparts to fulfill its mission.

CFSAN's Shellfish and Aquaculture Policy Branch (SAPB) develops policies, guidelines and model regulations pertaining to shellfish and aquaculture safety, provides oversight, training, technical assistance, expert advice to government and industry.

The ORA's OSCP standardizes/trains the SSO's and then the SSO's train the SSI's.

The OSCP also works with the SAPB to evaluate and provide guidance to help resolve non conformities identified at the state level.

The FDA's Office of International Programs and CFSAN's International Affairs staff work with the competent authorities of other countries to lead, coordinate, and manage international activities in collaboration with relevant FDA Centers and Offices, to advance the overall mission of the FDA.

As outlined above, each SSCA is responsible for the effective regulation of the program within its borders. Given the diversity and complexity of the NSSP elements, this typically requires the service of several state competent authorities. For instance:

• in WA:
  • the WADOH is responsible for the implementation of the NSSP (growing areas, processing plants, laboratories, and illness investigations)
  • the Washington Department of Ecology is responsible for the permitting and regulating of WWTPs
  • Washington Department of Fish and Wildlife (WDFW) police are responsible for patrolling the growing areas
  • tribal authorities implement NSSP program requirements and actively participate in the ISSC, but rely on the state authority to conduct oversight activities due to limited internal resources
• in OR:
  • the ODA is responsible for implementing the NSSP (growing areas, processing plants, laboratories, and illness investigations)
  • the Oregon Department of Environmental Quality is responsible for permitting and regulating of WWTPs
  • the OSP is responsible for patrolling growing areas

5.2.2 Oversight program

To ensure uniformity in the administration and implementation of the requirements of the NSSP MO at the State and Tribal level, the FDA reviews the state public health control programs on an annual basis. Conducted by the FDA's shellfish specialists using the procedures and requirements outlined in the FDA Compliance Program Manual 7318.004: Chapter 18 – Technical Assistance – PDF (918 kb), the compliance program focuses on 5 specific program elements which are evaluated at the frequencies outlined in Table 2: Vibrio control and management, growing area classification, plant processing and shipping, control of harvest, and laboratory evaluation. A random evaluation of the growing area occurs annually, plant processing and shipping occurs every 2 years, the control of harvest review is undertaken every 1 or 2 years, the vibrio control plan review is performed every year, and laboratory evaluation is conducted at least once every 3 years.

Table 2: NSSP program elements and frequency of their evaluation

No.	Program element	Frequency of evaluation
1	Vibrio control and management	Annually
2	Growing area classification	Annually
3	Plant processing and shipping	Every 2 years
4	Control of harvest	Every 1 or 2 years
5	Laboratory evaluation	Minimum of once every 3 years

Establishments to be assessed for the plant processing element are generally selected on a random basis, but may be targeted to make sure previous non-compliances have been properly addressed. Attachment E of Chapter 18 – Technical Assistance is used to determine the representative number of plants.

The FDA shellfish specialist summarizes their evaluations in a PEER. They promptly notify the OSCP branch director of any non-conformance with the NSSP. The OSCP branch director and specialist consults with the SAPB to determine appropriate action and, communicates those actions to the SSCA. States are required to investigate the program element deficiency(ies) and provide a written response (corrective actions plan) to the shellfish specialist within 30 calendar days of receipt of the PEER.

Any new state or tribal regulatory program proposing to operate under the NSSP must have their proposed program reviewed by the FDA prior to its initiation to ensure that any shellstock produced under the state or tribal program for movement in interstate commerce meets the requirements of the MO.

States must keep records in a central file to facilitate the FDA review of their shellfish sanitation programs, and must assist the FDA in conducting such reviews. States must maintain data and files that will provide evidence and demonstrate the effective administrative management of the shellfish sanitary control program as part of their participation in the NSSP.

5.2.3 Training

The FDA Office of Training Education and Development sends an Annual Training Needs Survey to the SSCAs and the OSCP branch director in the second quarter each year. The FDA shellfish specialist assists the states in determining training needs and priorities. Near the end of the 3rd Quarter, the Office of Training Education and Development conducts an annual planning meeting for all training courses for the next fiscal year. Training includes seminars, meetings and national conferences which provide information about food safety, good manufacturing practices, growing area management/science and MO interpretation.

The NSSP requires state/tribal program regulatory staff to be trained with appropriate knowledge, skills, and abilities to administer their program. States/tribal authorities are responsible for determining specific job qualifications and requirements for hiring.

State/Tribes are responsible for employee training and maintenance of employee training records including:

• job descriptions and duties for personnel
• minimum education or other qualifications for personnel
• minimum training requirements for staff

5.2.3.1 Inspectors

Under the NSSP model, personnel involved in the oversight of the program are "standardized" to ensure national consistency in the delivery of the program. In this scheme, the FDA national standardization officer (FDA's National Shellfish Standard) standardizes the FDA shellfish specialists who in turn standardize the State SSO(s). The SSO(s) then standardizes State SSI.

All FDA shellfish specialists are standardized by the FDA National Plant Standard, CFSAN, Office of Food Safety. Specialists must have the appropriate education and job experience as defined by their job description, as well as training which includes 2 to 3 days of Basic Seafood HACCP and the FD245 Shellfish Plant Standardization Course.

State personnel must be nominated by their supervisor to be a candidate for standardization by submitting a standardization nomination form, which is kept on file at the appropriate FDA office. As described in Section IV of Chapter III of the NSSP, state candidates must have job experience as a senior inspector with experience and responsibility in the shellfish program, including at least 1 year of full time experience performing shellfish plant inspection, within the last 3 years. Prior to field standardization, the candidate must successfully complete 2 to 3 days of Basic Seafood HACCP and the FD245 Shellfish Plant Standardization Course. The candidate must also have at least 20 hours of training in the application of food science and related studies in microbiology and/or epidemiology, HACCP principles/plan review and state regulations.

Each state generally sponsors an adequate number of SSO candidates to ensure that each certified shellfish dealer is routinely inspected for compliance with the MO plant processing requirements, and enough SSI candidates to ensure that each shellfish firm receives uniform routine inspections.

Performance criteria and procedures for candidates can be found in the NSSP, Section IV, Chapter III, .02, Chapters IV through VIII.

The audit team observed that the WADOH was in a phase of rebuilding their team to ensure appropriate coverage for WA after recent staff turnover. WADOH had 4 SSI's (3 inspectors plus the supervisor), and 1 SSO. The 3 inspectors and the inspection supervisor were currently undertaking SSO training. In OR, there was 1 SSO, and 5 to 6 SSI's. The SSI's are also responsible for inspections of other food commodities such as dairy, juice and other seafood products. Because of their diverse responsibilities, OR inspectors must also be professional Sanitarians.

The audit team observed that State SSI and State SSO training followed the procedures laid out in the NSSP MO. Inspections were being delivered at the frequency required by the MO, despite some resource challenges.

The team was impressed by the level of knowledge of employees and, the maturity of the control systems at several of the processors we visited. Although we did note several challenges with implementation, we found the inspectors in both states to be very knowledgeable about the program requirements. Inspectors communicated the program requirements and discussed their recommendations skillfully, demonstrating a strong working relationship with their processors. It was clear that industry looks to their inspectors for support and guidance. Similarly, we observed a strong collaborative relationship between the FDA SSO and state inspectors as well as the processors.

5.2.3.2 Authorized samplers

The SSCA is responsible for the training and coordination of marine water sample collection. No specific requirements were noted in the NSSP as to who may conduct marine water quality sampling, however specific requirements are outlined for the proper collection, transportation, and examination of marine water samples.

In WA, annual water quality sampling in previously classified areas is mostly conducted by the WADOH staff who operate the collection vessel and coordinate sampling, frequently with a non-WADOH volunteer or Tribe. In unclassified areas where shellfish industry stakeholders wish to classify a new area, an agreement is established whereby the shellfish industry stakeholder may conduct up to 50% of the initial sampling required to establish classification. The WADOH completes the remaining sampling. Once the area is classified, WADOH fulfills all ongoing sampling requirements to maintain classification.

In OR, water quality sample collection may be completed by the ODA, shellfish industry stakeholders, or a combination thereof. Shellfish industry members or the ODA may operate the collection vessel and/or conduct the sampling. In circumstances where shellfish industry stakeholders conduct sampling, annual training is conducted by the ODA.

In WA, biotoxin samples are collected by a combination of WADOH, WDFW, Department of Natural Resources (DNR), local health authorities, Tribes, shellfish industry stakeholders and citizen volunteers. Samplers are trained by the WADOH at a yearly workshop, prior to performing any sampling activities. Additionally, the WADOH meets with any seasonal samplers at or before the start of any high biotoxin risk periods. In OR, biotoxin samples are collected by ODA staff in conjunction with the Department of Fish and Wildlife. An MOU is in place between the 2 departments, which covers sampling.

5.2.3.3 Patrol officers

Both the WDFW Police and the OSP employ professionally-trained law enforcement officers that are designated as state police. In addition to extensive basic law enforcement officer training at state police academies, officers receive specialized training in natural resource policing, including shellfish sanitation. New officers also complete a field training program, with mentorship and coaching by experienced field training officers before being able to work independently. There are regular meetings and communications between the enforcement agencies and the respective SSCA (WADOH or ODA) to identify training needs. Each police agency employs a senior officer as a "NSSP Coordinator" to oversee NSSP related activities, including ongoing in-service training needs.

5.2.3.4 Laboratory staff

According to Chapter III.01 Quality Assurance, laboratories supporting the NSSP are required to develop a written quality assurance plan (QAP) that includes describing the laboratory staff training program to ensure that personnel are qualified, properly trained and supervised. Both laboratories visited had a training program that includes requirements for staff qualifications, training and supervision. On-site, the laboratories provided policies, procedures and records to support their compliance to these program requirements.

5.2.3.5 Harvesters

Harvesters training requirements are defined by each state/tribe, including harvest, handling, and transportation practice. At a minimum, 1 individual involved in the shellfish operation must receive the required training. The interval between training sessions is not to exceed 5 years. A harvester shall be allowed 90 days following initial licensing to obtain the required education.

In WA, training or education of harvesters is provided for NSSP requirements. In both WA and OR, outreach and information is available for harvesters and the general public with regards to shellfish sanitation and control of harvest laws.

5.2.3.6 Shellstock shippers

In order to receive and renew dealer certification, the MO requires all personnel who manufacture, process, pack, or hold foods to be trained in accordance with 21 CFR 117.4. Once an employee is hired, the dealer is allowed 30 days to provide the required education. All dealers, including shellstock shippers must obtain the required education.

5.2.3.7 Shucker packers

In order to receive and renew dealer certification, the MO requires all personnel who manufacture, process, pack, or hold foods to be trained in accordance with 21 CFR 117.4. Once an employee is hired, the dealer is allowed 30 days to provide the required education. All dealers, including shucker packers must obtain the required education.

5.2.4 Program assessment/audit

The NSSP MO is routinely reviewed and updated through the ISSC, whose membership includes representatives of federal organizations with a role in shellfish sanitation, state partners of states that ship shellfish interstate, as well as industry, academia, and other interested parties such as key trading countries with which the U.S. has an agreement.

An internal mechanism for NSSP member states/tribes to conduct a program self-assessment utilizing national standards is encouraged, but not required.

The NSSP was assessed by the European Union from March 17 to 27, 2015.

5.2.5 Industry, community, and international relations

The U.S. is an active member of the Codex Alimentarius Commission and its subsidiary bodies. Representatives of several the FDA serve as members of policy and technical committees, delegates to Codex meetings, or as committee chairs.

The U.S. is an active participant in the World Trade Organization Sanitary and Phytosanitary Measures and Technical Barriers to Trade committees.

As mentioned in sections 4.1 and 5.2.1, the FDA routinely evaluates the shellfish programs of foreign governments with which it has a shellfish trade agreement.

The FDA is a participant in the ISSC. The ISSC is composed of state shellfish regulatory officials, industry officials, FDA, and other Federal agencies, and provides the forum for state regulatory officials to establish uniform national guidelines and to exchange information regarding sources of safe shellfish. Every 2 years, the ISSC holds a face-to-face conference where representatives of federal organizations with a role in shellfish sanitation, state partners of states who ship shellfish interstate, as well as industry, academia, and other interested parties such as key trading countries with which the U.S. has an agreement to share current information, discuss challenges, and, to take decisions that impact the structure and/or implementation of the NSSP.

Regional meetings are held to discuss regional issues. As example is the Pacific Rim Shellfish Sanitation Conference. The Pacific Rim Shellfish Sanitation Conference is the annual meeting of the Pacific Rim Shellfish Sanitation Association, whose mandate is to provide a forum for discussion of food safety issues related to shellfish. The Pacific Rim Shellfish Sanitation Association is a non-profit group consisting of representatives from various federal and state governments, industry, and tribal groups along the Pacific coast. It includes jurisdictions which produce shellfish (Alaska, BC, WA, OR, California, Hawaii, and Mexico) as well as shellfish receiving states within the Pacific region (Montana, Idaho, Nevada, Arizona).

Regular meetings and communications occur between the state enforcement agencies and their respective SSCA (WADOH or ODA) to ensure operational effectiveness and for training needs.

5.3 Shellfish inspection and control program

5.3.1 Growing area classification

Under the NSSP, growing areas are classified as approved, conditionally approved, restricted, conditionally restricted and prohibited as outlined in Section II of the MO, Chapter IV (Shellstock Growing Areas), @.03 (Growing Area Classification).

The audit team reviewed 4 growing areas in WA (Oakland Bay, North Bay, Hood Canal 8 and Annas Bay) and 2 growing areas in OR (Tillamook and Coos Bays) through a combination of on-site observations and interviews, and, document reviews of Annual, Sanitary and PEER reports. Additional growing areas in each state were discussed and/or visited during the audit however reporting requirements were only reviewed for the areas noted above.

The classifications of the growing areas reviewed included: approved, conditionally approved, restricted and prohibited. The SSCAs explained that the restricted classification is not widely employed in WA and OR while the conditionally restricted classification is not used at all. The characteristics of the growing areas and rationale for the identified classifications were assessed and were determined to be consistent with the NSSP requirements.

Field visits by ground of the growing areas included a visual assessment of classification boundaries, pollution source identification and station placement. Field visits by water of other growing areas in WA (McNeil and Anderson Islands, Drayton Passage and Oro Bay) and in OR (Coos Bay and South Slough) confirmed sampling techniques, marine station placement and pollution source identification in relation to classification boundaries.

The team generally found the SSCA's approach to assigning classification reasonable where boundaries were appropriately delineated based on identified pollution sources, marine station placement and water quality meeting the prescribed standard. This approach was clear although within the Upper Coos Bay growing area in OR, an extension of the foreshore prohibited area eastward from the Highway 101 (Coos Bay Bridge) south to encompass the main shipping channel along the North Bend foreshore may be considered to account for potential pollution sources along the immediate foreshore and within the shipping channel.

Of particular note in both states was the use of Conditional Area Management Plans (CAMPs) for rainfall, river level and, in WA, marinas, that were used in defined areas were water quality may be compromised under predictable environmental conditions for specific periods of time. Supported by a robust dataset collected under various environmental conditions, closure triggers have been established where marine water contamination has been identified during sampling. Defined conditional areas and closure periods are outlined in the CAMP. Several CAMPs were reviewed, found to be up-to-date, met the criteria outlined in the NSSP and are a reasonable approach to maintaining access to shellfish growing waters where water quality maybe compromised under predictable environmental conditions.

In the growing areas reviewed, emergency situations such as excessive rainfall, flooding or spill events may have pre-established triggers for implementing larger, wide-scale growing area emergency closures. These closures typically extend beyond the boundaries of pre-existing conditional areas into adjacent Approved classified waters. Based on environmental data, established protocols were noted for excessive rainfall thresholds typically >2 to 3 inches over 24 hours, rainfall thresholds over consecutive days or in the case of river levels, exceeding pre-established river gauge heights. Growing areas would be closed for periods of time typically ranging from 5 to 7 days or in the case of OR, 5 days or 10 tidal cycles.

In WA it was noted that emergency closure action may not be triggered if excessive widespread contamination is detected during the course of a water quality sampling. However, for the growing area emergency closures reviewed that were implemented based on the exceedance of a specific environmental condition, the approach seemed reasonable and supported by environmental data. Spills of waste water will be discussed in further detail in Section 5.3.1.2 under Waste water systems.

Marinas

MO Section II, Chapter IV (Shellstock Growing Areas), @.05 (Marinas) outlines the requirements for classification adjacent to marinas under the NSSP. Upon initial review, it was noted that a marina assessment was not completed for the Port of Garibaldi in the prohibited area near Bay City in the Tillamook growing area in OR. However, upon further review, a marina assessment had been completed within the most recent sanitary assessment. In both states, marinas observed within growing areas had marina assessments completed as required. In some growing areas in WA such as Twanoh State Park, a CAMP has been developed around the seasonal use of the dock and moorage area allowing for harvest during pre-established time periods.

Sanitary surveys

MO Section II, Chapter IV (Shellstock Growing Areas), @.01 (Sanitary Survey) outlines the minimum requirements for Sanitary Surveys. In WA, the WADOH produces standalone pollution source assessment reports that are completed in tandem with the Sanitary Survey growing area reports whereas in OR, the ODA incorporates pollution source information directly into the Shellfish Growing Area Water Quality and Shoreline Survey report equivalent to the Sanitary Survey report.

In WA, all Sanitary, Triennial and Annual Review Reports provided to the team were up-to-date. Although not noted as a requirement, in circumstances where classification changes were made after the most recent Sanitary Survey Report, an addendum to the Sanitary Survey Report was written. In cases where a recent Sanitary Survey Report was not recently completed, a Triennial Review Report was provided. All reviewed reports were found to be well-written and to contain sufficient detail to fulfill the minimum reporting requirements outlined under the NSSP. All other requirements of the Sanitary Survey were found to be complete and up-to-date.

In OR, all Sanitary and Annual Review Reports provided were up-to-date. Although it was communicated during the course of the audit that Triennial Review Reports are written, none were provided and therefore, could not be evaluated. All other reviewed reports were found to be well-written and to contain sufficient detail to fulfill the minimum reporting requirements outlined under the NSSP. All other requirements of the Sanitary Survey were found to be complete and up-to-date.

Microbiological standards

MO Section II, Chapter IV (Shellstock Growing Areas), @.02 (Microbiological Standards) outlines the requirements for the 2 NSSP sample collection strategy options: Adverse Pollution Condition (APC) and Systematic Random Sampling (SRS). Under the NSSP, either regime is an acceptable sampling approach for assessing growing area water quality taking into consideration the presence of point and non-point pollution sources. WA assesses the growing areas examined using the SRS strategy, but the SSCA indicated that 2 growing areas in WA are monitored under the APC strategy. In OR, the growing areas reviewed are assessed utilizing APC, SRS or a combination thereof. Under the selected sampling regimes, both states were found to meet or exceed annual sampling frequency requirements which typically ranged from 6 to 12 samples per year in the growing areas reviewed. Water quality standards are assessed utilizing the last 30 samples for SRS or the last 15 samples for APC. For the data sets reviewed, the bacteriological standards for all growing areas evaluated except a single marine station in Tillamook Bay, OR (identified in the most recent Annual Review Report), were found to meet the appropriate classification standard while in open status.

5.3.1.1 Authorized samplers and sampling methodology

MO Section III, Chapter III (Laboratory), @.01 (Quality Assurance) outlines the requirements for the collection, transportation, and examination of marine water. Marine water samples in both states are collected in a similar way. In WA, the collection of samples is mostly conducted by the WADOH where as in OR, sample collection may be completed by the ODA, shellfish industry stakeholders, or a combination thereof. Observations in the field during sampling activities in WA indicate samples are collected approximately 6 inches below the surface whereas in OR, they are collected approximately 12 to 24 inches below the surface. The water sample is aseptically placed in 120 ml sterile plastic bottles and immediately put under ice in an insulated cooler. During sampling, staff records the time, tidal phase, surface water temperature, salinity and any pollution source observations at each sampling station.

Samples utilized to classify growing areas for regulatory purposes are processed by the state laboratories: in WA, the WADOH Laboratory in Shoreline, and in OR, the ODA Laboratory in Portland. Sample analysis begins within 30 hours of collection. The NSSP MO, provides SSCAs the flexibility to test marine water for either total coliforms or fecal coliforms and apply the appropriate identified standard. Both states utilize the fecal coliform standard where water samples are processed using the American Public Health Association A-1 Modified (5-tube, 3-dilution) method as described in the Microbiological standards, above.

The procedures followed for the collection, transportation, and examination of marine water were found to be consistent with the requirements specified in the NSSP to follow the American Public Health Association's Recommended Procedures for the Examination of Seawater and Shellfish.

5.3.1.2 Waste water systems

The risk of contamination of bivalve shellfish from enteric viruses in human sewage is a significant food safety concern. Common sources of contamination include untreated sanitary discharges from vessels, non-existent or failing on-site septic systems of shoreline residences, and municipal waste water treatment and collection systems. To gain familiarity with the nature of urban waste water systems that discharge to marine areas, the audit team visited local waste water treatment plants (WWTPs) serving Shelton, WA and North Bend, OR.

Section II of the MO, Chapter IV (Shellstock Growing Areas), @.03 (Growing Area Classification) outlines the requirements for classifying waters adjacent to waste water discharges. The team reviewed the waste water technology in place and the management of operations influencing the classification of receiving waters adjacent to the outfall of both WWTPs. Staff at both WWTPs were found to be knowledgeable. They were very aware of the shellfish classification adjacent to the plant and management strategies used to limit impacts to the adjacent shellfish harvesting areas.

Sanitary surveys, annual reviews of treatment plants and associated dye studies were reviewed. In WA, these included an assessment of dilution available and potential disruptions that can occur at the WWTPs to define prohibited areas adjacent to WWTP discharges.

WADOH uses a limited number of CAMPs for areas potentially impacted by WWTPs. The plans identified use time of travel considerations to define the extent of the conditional areas. The SSCA's approach for classifying the areas adjacent to the WWTP was found to be reasonable and consistent with NSSP requirements.

In OR, water quality and shoreline surveys, annual reviews and dye studies for Coos Bay were reviewed. The dye study conducted in Coos bay was limited to dye discharges from 2 of the 3 WWTPs in the bay and therefore may overestimate the cumulative dilution available. Areas identified by dye studies as not achieving 1000:1 dilution were not consistently classified as prohibited as recommended in MO Section IV 19. Determining Appropriately sized Prohibited Areas Associated with Waste water Treatment Plants the "FDA recommends a minimum of 1000:1 dilution around a WWTP outfall to mitigate the impact of viruses on shellfish growing areas".

The Coos Bay estuary has considerable pressure resulting from 3 waste water system discharges that experience significant wet weather flow variations. Plants discharging to the Bay include Coos Bay #1 which splits flow and bypasses secondary treatment elements for portions of flow received during high flow events with some regularity. This results in a blending of secondary and primary treated effluents prior to chlorination. The bay has rainfall-based conditional management plans but a conditional plan identifying closures for split flow sewage events is not in place. Previous conditional management plans did include closures for split flow sewage events but the split flow condition is no longer maintained as a trigger for invoking closures. A comparison of effluent quality data during normal operations and split flow events demonstrating that split flow events do not represent a reduction in effluent quality was not provided. Although the area is often closed by rainfall while split flow events are occurring, there exists potential for a re-opening of the Conditional areas while a split flow event is ongoing.

The audit team did not observe a consistent approach for emergency closures resulting from the unplanned discharge of raw sewage or partially-treated sewage in WA and OR. Discussions and documentation received indicated closures are implemented in response to unplanned discharge events. However, a consistent process to confirm that the situation or condition has returned to normal and that sufficient time has elapsed to allow the shell stock to eliminate pathogens, particularly viruses, that may be present in shell stock to pre-closure levels was not observed. The duration of emergency closures ranged from as little as 4 days to 7 days in general following discharge events. OR also utilizes a 5-day or 10-tide cycle approach as re-opening criteria.

Although not a requirement, as an option to better address viral concerns the SSCA may utilize male-specific coliphage (MSC) in growing areas affected by waste water discharges to establish criteria for reopening after an unplanned discharge event. Studies establishing and documenting the interval necessary for reduction of contaminant levels in shellstock to pre-closure levels were not presented by either state. The use of viral presence indicators such as MSC analysis following 7 day closures for re-opening purposes for unplanned waste water system discharges or closures remaining in place for 21 days was not observed. Following unplanned sewage discharges, the process for re-opening observed in both states focused on fecal coliform reductions only, without consideration to viral reduction targets.

5.3.2 Harvest area controls

5.3.2.1 Licensing and regulatory compliance

Licensing of harvesters

Licensing of all recreational fishers, wild commercial harvesters and aquaculture operators is required in both WA and OR. Licences are issued annually and maintained by SCAs and records are maintained. The WADOH and the OR ODA are the main licensing authorities with respect to aquaculture and commercial fisheries while fish and wildlife management agencies are involved in the management of wild bivalve shellfish resources, and are the licensing authority for recreational harvest. Tribal usual and accustomed fishing areas, as defined in treaties, in WA are co-managed with the state for natural resource allocations and harvest. Although tribal lands and bivalve fisheries involve some sovereign lands, the WADOH conduct NSSP regulatory activities on behalf of the tribal governments under the Consent Decree agreement. In addition, dealers and processing plants that purchase and sell bivalve shellfish are also licensed, and compulsory inspections are required. Compliance with licences and regulations is checked by patrol officers and WADOH and the ODA. There is no depuration fishery in WA, but relay is licenced. There are no depuration or relay fisheries in OR.

Regulatory compliance

Laws, regulations and associated regulatory instruments appear to be comprehensive and allow for the effective management and oversight by the state authorities of all activities relating to the control of harvest areas. State laws and regulations are similar to Canadian ones for managing fisheries and aquaculture. Regulatory compliance activities have comparable compliance and management outcomes to fisheries and aquaculture management in Canada.

The WADOH and the ODA are the primary agencies responsible for the NSSP program delivery, along with Tribes in WA (as per section 5.1). While the WA WDFW and the OR OSP, Fish and Wildlife Division are responsible for law enforcement activities and patrol of shellfish sanitation areas. Both agencies have well-trained professional inspectors and enforcement officers. Enforcement agencies had well-equipped uniformed officers with training and designation as state police officers, in addition to specialized training for shellfish and the NSSP. Patrols and operations can be carried out at all times, day or night and may include joint patrols, the ability to conduct special operations, large scale investigations or inspections, and the use of aircraft to support operations.

Patrol policy

Both the WDFW and OSP have detailed patrol policy documents, memorandums of understanding and agreements with their respective partner agencies, WADOH and ODA. Coverage includes delegation of responsibilities, training, communications, joint patrols and operations.

Maintaining records

The WA and OR SCAs maintain records of shellfish sanitation activities, including patrol activity reports, compliance records, prosecutions, and the results of prosecutions. All agencies use mobile technology to allow for the entry and use of compliance data in the field and during inspections. The OSP had just started using a new and innovative smartphone mobile application that was developed to capture trooper time and patrol effort, including patrol frequency results. Of special note was the WDFW Regional Electronic Shellfish Patrol Calculation Tool data system used to record and report officer shellfish sanitation patrols and effort. The system was relatively new but was demonstrated in the field to be easy and quick for officers to use, tracked progress of meeting minimum patrol frequency in patrol areas and was able to produce reports. The OSP troopers utilize a relatively new smartphone application that captures (among other information) patrol frequency data and reporting on patrols, which is very innovative and also of interest.

Identification of prohibited and restricted areas

WA and OR SCAs utilize websites, maps, email distribution lists, phone calls and other methods to ensure that commercial harvesters are informed of the conditional areas, emergency closures, biotoxin closures and the location of classified areas. In the event that an emergency closure occurs or a conditional area closes, harvesters and aquacultures operators are notified quickly. Posting of signs or notices may occur depending on various factors in each state and may be posted by officers or by state agency partners, as necessary (that is, state parks, wildlife/fisheries management agencies, etc.). It should be noted that in OR, notification of emergency closures goes to harvesters and the OSP, but not to dealers directly.

Prevention of illegal harvesting and sales

The WADOH and ODA conduct field inspections of harvest and aquaculture operations, dealers and processing plants to verify compliance with NSSP requirements. The WDFW and OSP, Fish and Wildlife Division, have the responsibility for conducting law enforcement activities, investigations and patrols of the growing areas to apprehend and deter people from harvesting in prohibited, restricted, closed conditional areas and emergency closures. Inspections of commercial, aquaculture, recreational and tribal fisheries may be conducted to ensure compliance with regulations and patrols are conducted to meet the patrol frequency established by the NSSP. In addition to general patrol activities, special operations such as undercover or plainclothes may be utilized. Inspection blitzes are conducted of retail and restaurant establishments, often in conjunction with inspectors from the WADOH or ODA. Joint patrols between law enforcement officers and the Inspectors of growing areas or inspections of retail/wholesale establishments may be undertaken as required. The WADOH and ODA may also refer violations of law that are found by Inspectors to the respective state's enforcement agency for further investigation or prosecution.

Both states have established patrol frequency requirements for patrol areas as per the NSSP. Minimum patrol frequency requirements are being met and often exceeded. In OR, the FDA had identified a deficiency with OSP meeting patrol frequency in 2017 (PEER 2017). This was due to a budget shortfall. A funding arrangement between the OSP and the ODA is now in place to prevent this from occurring again.

In both WA and OR, recreational harvesters may harvest bivalves in unclassified areas, although biotoxin monitoring is in place. Unlawful harvest may also occur in prohibited or restricted areas. Enforcement is conducted for recreational harvest, prohibited areas and inspections and undercover special operations are conducted at retail and restaurant establishments to detect and deter illegal sales of bivalves harvested. As a result of these patrol activities, in conjunction with the inspections done by WADOH and ODA Inspectors, there is a robust system in place for detecting, disrupting and deterring illegal bivalve shellfish harvest and sales activities. Overall, there is an effective enforcement program that minimizes the potential for unlawful bivalve shellfish from entering the export market.

Summary of findings

All aspects of WA's control of harvest and patrol program appear to be effective. Based on PEER reports and discussion with FDA representatives, the FDA exercises effective oversight of the control of harvest and patrol elements of the NSSP for both states. OR has a good control of harvest/patrol program with the exception of 2 issues identified:

1. The OSP does not check for compliance with onboard human waste containment/marine sanitation devices on harvest vessels as required by Section II, Chapter VIII, .02, D of the NSSP MO. Although ODA inspectors may incidentally check for compliance when harvest vessels are encountered in the field or at a processing plant, OSP troopers are in the field often and are likely better able to conduct effective compliance inspections. Furthermore, OSP was not aware of the requirement for vessels to have onboard waste containment and have not been mandated by ODA to conduct inspections for this purpose. This appears to be a gap in the compliance program that needs to be addressed.
2. The other issue of concern was that OSP has difficulty in effectively determining whether or not aquaculture oysters have been harvested during a closed time in a conditional area. Although an area may be in closed status and harvest is prohibited, aquaculture operators frequently take product from the water and transport it to another area to conduct maintenance or sorting/grading of the oysters. Troopers are unable to determine whether or not legitimate aquaculture activities are occurring or if the oysters are being harvested and sold unlawfully. The audit team was advised that it is theoretically possible that oysters could be harvested during a closure of the conditional area and then enter a processing plant without detection. This issue may also be relevant to emergency closures. This also appears to be a gap in the compliance program that needs to be addressed.

5.3.2.2 Traceability

In both WA and OR, only licensed harvesters (wild and aquaculture) may harvest bivalve shellfish for commercial purposes. Harvesters are required to affix tags that meet NSSP requirements to each bivalve container (including allowances for bulk containers). Tags must remain affixed to containers until emptied and then tags must be retained for a period of time by the receiver of the containers. Harvesters must also keep records of the harvested product. Verification of tags and records is carried out during field inspections or inspections at a processing facility.

Only licensed shellstock shippers or shucker/packers may purchase and process bivalve shellfish from licensed harvesters. And, licensed harvesters can only sell in state to licensed dealers.

5.3.2.3 Sanitary and chemical containment on vessels and work platforms

Both WA and OR have enforceable requirements in place for the use of sanitary human waste containment devices on board harvest vessels. There are also laws in place to prevent pollution from vessels in entering the environment and contaminating shellfish growing areas. Harvest and transport vessels must meet strict sanitary requirements to prevent contamination of harvested bivalves and are subject to periodic inspections as a result of annual relicensing requirements, field inspections, or both. As examples of special efforts to prevent sewage pollution to growing waters, Puget Sound WA has special regulations in place to prevent any sewage discharge by all boaters; floating platforms with toilet facilities were observed in Tillamook Bay OR, for use by all boaters.

5.3.3 Processing establishment controls (HACCP)

The WADOH and the ODA are the key agencies responsible for the delivery of the NSSP in processing establishments in WA and OR.

Section III Chapter X of the NSSP specifies that inspections of certified shellfish dealers should be conducted at such frequency as is necessary to assure compliance with NSSP requirements. The recommended frequency of inspection of certified shucker packers and repackers is at least quarterly.

In WA an annual plan is established and inspection frequency is monitored during the record review portion of each inspection. In OR the software used develops the inspection plan based on the classification of each establishment, an automatic email notification is sent if inspections are missed. Inspectors in OR also have the option of modifying the plan based on priorities.

Inspection records in WA and OR are maintained in electronic databases. Records reviewed at each establishment visited during the audit showed that inspections were being conducted at the recommended frequency.

Vibrio parahaemolyticus (Vp) control requirements

Each state from which oysters or hard shell clams are harvested is required to conduct a Vp risk evaluation annually. If the risk of Vp infection is reasonably likely to occur in hard shell clams or oysters are harvested from a given area, a control plan is required.

Risk assessments and control plan development for the 2 states visited during the audit appear to be in compliance with the criteria set out in the NSSP MO. There are however, some differences between the MO requirements, and Canadian requirements for Vp control. For example:

• as listed in the FDA's Fish and Fisheries Products Hazards and Controls Guidance, the standard for Vp in ready-to-eat fishery products (minimal cooking by consumer) is >= 10,000 /g
  • the Canadian guideline for Vp is in 5 subunits, no sample may exceed 100/g
• Vp control programs for oysters rely only on temperature reduction to prevent pathogen growth
  • control programs do not take into consideration the initial load of Vp at time of harvest
• Vp controls (in dealer plans or in state control plans) are not validated to ensure that Vp levels in final product have been reduced to an acceptable level
• the team was informed that state Vp programs rely on illness data as a main tool to verify that controls are effective
  • with the exception of Vp indicator site samples taken by OR, final product testing is not conducted to verify that the process is effective in reducing Vp levels in product
  • states do undertake a risk assessment each year, using temperature and illness data
  • it should also be noted that WA and OR will close growing areas should the in-season associated illnesses exceed a threshold

Note

One (1) processor visited that ships oysters for raw consumption to Canada is implementing controls to ensure each lot meets the Canadian guidelines for Vp. Products from 2 of the 3 companies visited who ship shucked oysters to Canada were labelled with a minimum time/internal cook temperature as required by Canada.

Approach to HACCP

Minimum critical control points and critical limits are outlined in the NSSP MO. States/dealers will often implement those controls as written. This differs from the Canadian approach to HACCP. For example:

• during inspections, states described reviewing the HACCP plan table only to determine if required controls set out in the NSSP MO and/or in the state control program are adopted
  • the underlying hazard analysis is not routinely reviewed to ensure that all significant hazards are identified, and that an appropriate CCP determination has been made
• critical limit validation which is specific to the process and to the harvest site is not routinely performed by processors, or reviewed by regulators (for example, Vp controls)
• we did not observe any routine monitoring or verification processes for sporadic contamination events at the harvest site (for example, contamination due to animal life, on-board waste containment, harvest practices, etc.)
  • see Appendix H to the QMP Reference Standard and Compliance Guidelines for more information

In OR, harvesters and the OSP are notified of commercial harvest area closures in conditionally managed areas, or during emergency events. Processing facilities receive the same information as harvesters regarding closures through an email distribution list.

Prerequisite programs

General construction, equipment and sanitation requirements are outlined in the NSSP:

• Section II Model Ordinance:
  • Chapter X.02 General Sanitation Requirements
  • Chapter XI, XII, XIII and XIV.02 Sanitation Requirements
  • Chapter XV.02 Sanitation
• Section IV Guidance Documents:
  • Chapter III.01 Shellfish Industry Equipment Construction Guide

Some requirements for construction and equipment or employee hygiene and plant sanitation were observed to differ from the requirements of the Canadian Facility Inspection Program and/or the CSSP Manual of Operations. For example:

• 1 nearshore wet storage facility was:
  • located adjacent to an area that receives discharge from the plant floor drains (grey water)
  • immediately adjacent to the wharf
    • the CSSP states that the area within a minimum 125 metre radius around wharves is classified as prohibited
  • described by the state as being classified as conditionally approved
• protective outer clothing that covers all street clothing and footwear is not required by the NSSP MO
• the MO requires hand jewellery that cannot be sanitized, secured or removed to be covered with finger cots or gloves, but does not make mention of other types of jewellery (for example, watches, necklaces, etc.)
• direct entry to the processing area from the outdoors is allowed by the NSSP MO
• 1 dealer did not have a hand washing sink located in the processing area, or in direct line of site of the processing area (shucking room), as required by the Canadian Facility Inspection Program
  • the NSSP requires hand washing sinks to be present in packing rooms, and "convenient to work areas" for other parts of the plant
• hand washing sinks are not required to be hands-free
• wood pallets were observed to be used throughout plant operations, including for worker stands, stacked in packing areas, to store bins of oysters waiting to be shucked, and for storing hoses (that is, used for more than just dry storage or loading packaged product to be shipped)

Note

It was explained that oysters are not considered to become "food" until they are being shucked. In Canada, registered processors must treat the shellstock as food as soon as it comes under their control, and they are required to provide oversight to ensure sanitary handling from harvest onwards. This may account for some of the discrepancies between Canadian and U.S. standards.

A future Canadian audit could further explore the potential impact of these differences on the effectiveness of the Canadian and U.S. approaches at achieving common food safety outcomes.

State implementation of NSSP MO or NSSP Guidance Document requirements

General construction, equipment and sanitation requirements are outlined in the NSSP:

• Section II Model Ordinance:
  • Chapter X.02 General Sanitation Requirements
  • Chapter XI, XII, XIII and XIV.02 Sanitation Requirements
  • Chapter XV.02 Sanitation
• Section IV Guidance Documents:
  • Chapter III.01 Shellfish Industry Equipment Construction Guide

On several occasions during processor inspections, team members observed construction/equipment and sanitation/hygiene issues that were out of compliance with MO or the Guidance Document requirements. State inspectors did not record these issues as debits in their inspections and/or note them as issues when queried. In addition, it was not clear under what circumstances enforcement action would be taken during an inspection. For example:

• in 1 outdoor land-based wet storage facility visited, there were no tank covers or roof over the tanks/totes to prevent entry and contamination by birds, animals or vermin
• dripping condensate was observed, in 1 case on shellstock waiting to be shucked
  • in 1 case, product was moved, but no further corrective action was requested (see above comment about when shellstock becomes food)
  • in another case, product was not moved
• construction/building issues that could lead to pest control issues were observed in each plant visited.
  For example:
  • product conveyors carried shellstock in from the outside for shucking, and by doing so, created gaps in wall
  • gaps between the walls or floors and exterior doors were observed in every location visited
  • exterior doors to processing areas were observed to be left open during processing, with no air curtains or anterooms
• use of wooden worker stands was observed
• wooden handled shovels and rakes, wooden pallets were observed in use at processing facilities
• beams and cross members were observed to be constructed of wood in 1 plant
• 1 plant had beams constructed of rusting metal
• employees were observed to be using their boots or street clothes pockets to store their spare shucking knives while working on the line
• aprons and boots were observed being washed at the end of a processing line immediately adjacent to product
  • the same brush was used to scrub aprons as to scrub boots (splash not observed, but there was potential for splash onto product)

The team also reviewed previous inspection reports from all 6 processors visited. We did not see many (if any) building-related issues on the reports, despite observing multiple debits at each facility.

Authorities

The team noted a gap in OR's legal authorities. Their legislation currently adopts a specific version of the NSSP. Because their legislature only sits every 2 years, the version of the NSSP that is incorporated into their legislation is often outdated. This leads to non-compliance with the requirements of the NSSP (as documented in the 2017 OR Peer Report for Processing). Although they implement the newest version when it is available, it is possible that they could be challenged by industry should there ever be discrepancy between versions which would influence their action/inaction.

5.3.4 Microbiological testing programs

5.3.4.1 Harvesting areas

Shellfish growing area classification is based on water quality monitoring (see 5.3.1). There is no required harvest area sampling of shellfish meat, either from the harvest area or post processing.

Responsive programs are in place for testing of shellfish from the harvest area as a response to illness outbreaks, as outlined in Section IV, Chapter V of the NSSP Guidance Documents.

As noted in section 5.3.3 above and 5.3.4.2 below, there are no routine verification samples collected of either post-harvest, or post-processed product and correspondingly no harvest area actions outlined to respond to unsatisfactory test results.

5.3.4.2 Processing establishments

Microbiological standards/guidelines are summarized in the Fish and Fishery Products Hazards and Controls Guidance (Fourth Ed.), Appendix 5, table A-5. With the exception of the allowable level of Vp, the microbiological "food safety levels" are equivalent to those of Canada.

The auditors interviewed state inspectors, FDA officials and processing plant representatives. With 1 exception, processing plants visited did not utilize final product testing to periodically verify that control measures were effective, or that control programs were valid (see notes about HACCP approach in section 5.3.3 above).

ODA did take periodic final product samples (1 subunit) during Vp "season", but did not use the results to inform final product actions, or to judge the effectiveness of the Vp control program (although reported levels have been very low, normally <20 per g).

Neither processors nor shellfish control authorities take periodic verification samples of shellfish to confirm routine monitoring or verification processes for sporadic contamination events at the harvest site (for example: contamination due to animal life, on-board waste containment, and harvest practices). This is a fundamental difference from the Canadian approach where HACCP includes routine verification (for example, by microbiological testing), to ensure that control measures are effective in producing a safe final product.

5.3.5 Marine biotoxin and chemical testing programs

5.3.5.1 Marine biotoxins

Biotoxin control requirements are set out in Chapter IV of the NSSP MO. Monitoring frequency is not specified in the MO, but is left up to the state to determine the appropriate interval. A harvest site must be placed in closed status if the growing waters and/or the level of biotoxin present, exceeds the criteria listed in the MO. Closures must be maintained until the control authority has data to show that the toxin content of the shellfish in the growing area is below the standard.

Both WA and OR have documented and implemented biotoxin control programs which appear to meet the standards in the MO.

WA monitors paralytic shellfish poison (PSP), amnesic shellfish poison (ASP/domoic acid) and diarrheic shellfish poison levels. OR monitors for PSP and ASP. Both states monitor for these biotoxins year-round. Additionally, both states partner with 3rd parties to implement a phytoplankton monitoring program, as an "early warning" system.

Mussels are mainly used as the sentinel species, but in both states, target species are used for monitoring and also re-opening samples. Samples are collected by WADOH, shellfish operations, and by volunteers. Samples are collected in OR by ODA, the Oregon Department of Fish and Wildlife, plus other 2nd and 3rd party samplers.

WA collects samples once per week in high risk months (May to October) and once every 2 weeks November to April. Once an area is closed, it stays closed until 2 consecutive samples collected between 7 and 10 days apart are below the closure limit per biotoxin.

OR collects samples at least twice per month from 12 sites. Sampling frequency can be increased when levels start to rise. Once an area is closed, it remains closed for at least 2 consecutive sample sets, after toxin levels decline below the standard.

Both WA and OR post biotoxin status on their websites.

Biotoxin standards meet Canadian requirements. There are no recommendations for the biotoxin monitoring program. Implementation appears to be effective and meet both NSSP MO and CSSP requirements.

5.3.5.2 Chemical testing

The FDA has established action levels, tolerances, and guidance levels for poisonous or deleterious substances to control the levels of contaminants in human food, including seafood (FDA Federal Register 1977; FDA, 2002). As described in the NSSP Section IV, Chapter II, action levels are established and revised according to criteria specified in the Code of Federal Regulations (21 CFR 109 and 509), and are revoked when a regulation establishing a tolerance for the same substance and use becomes effective. However, the Fish and Fishery Products Hazards and Controls Guidance – Fourth Edition, is published by the FDA and used for products in interstate commerce. In the Guidance, Table 3-3 and related chapters enumerate the different hazards related to the different invertebrate species. In the case of molluscan shellfish, shellfish control authorities are to consider the degree of chemical contamination as part of their classification of harvesting waters.

The Guidance requires "environmental chemical contaminants and pesticides" to be identified as a significant hazard, and the control measure is said to be checking that shellstock was appropriately tagged, from approved harvest waters, and harvested by licensed harvesters. The team interviewed processors, and found that these controls were being implemented.

Processors of shellfish may choose to control environmental chemical contaminants and pesticides at receipt (for example, by screening raw materials). The processors could reject the product or choose to implement refining steps that reduce the contaminants to acceptable levels in the finished product, if unacceptable levels were found. The team interviewed processor representatives, but did not find that any additional testing was being performed on shellstock upon receipt.

State competent authorities did describe testing of geoduck for arsenic in order to meet requirements of countries to which geoduck is exported. They did not describe any other chemical testing being performed.

No particular recommendations for chemical testing were noted.

5.4 Food related illness and outbreak investigation

Section II – Chapter II, Section III-Chapter II, and Section IV-Chapter V of the NSSP describe the procedures to be followed by the authority in the event of a shellfish-related illness outbreak. Investigations at the harvest area and processing facility, possibly including product sampling, are done to determine the source of the illness. Based on the findings, actions may include recall of product still on the market or closure of the harvest area.

Staff in WA and OR were interviewed and found to have a good understanding of the procedures to be followed in case of an illness outbreak.

WADOH staff described the process for investigating a shellfish illness complaint to determine the source, collect information for epidemiological investigation, locate and manage the harvest area, and monitor a recall. WA has a dedicated staff member in the role of shellfish illness prevention coordinator.

Staff in OR described the process from receiving an illness complaint, through gathering information for the epidemiological investigation. This is done by the Department of Health in the case of a restaurant complaint and picked up by the Department of Agriculture if the product is linked to a licensed facility. OR staff see 5 to 6 single source complaints per year for microbiological caused illness and have not seen a confirmed bio-toxin illness.

A review of recall plans at 1 licensed facility in each of WA and OR indicated that the facilities were capable of identifying the first point of distribution for a given lot of product.

The procedures implemented by WA and OR for dealing with illness out breaks and recalls appear to be in accordance with the NSSP.

5.5 Laboratory controls

The NSSP Guide for the Control of Molluscan Shellfish, 2015 – PDF (5.86MB) revision describes the program requirements related to Laboratories. The relevant sections found in the guide that cover laboratory requirements include:

• Chapter I. Shellfish Sanitation Program Requirements for the Authority. @.03 Evaluation of Shellfish Sanitation Program Elements Section B
• Chapter III. Laboratory
• Section IV Guidance Documents, Chapter II, .14 Approved NSSP Laboratory Tests, .15 Evaluation of Laboratories by State Shellfish LEOs Including Laboratory Evaluation Checklists
• Laboratory Evaluation Checklists:
  • NSSP Laboratory Evaluation Checklist for Microbiology
  • Mouse Bioassay and Scotia Rapid Test for Paralytic Shellfish Poisoning (PSP)
  • Paralytic Shellfish Poisoning (PSP) HPLC-PCOX Method Evaluation Checklist
  • Laboratory Evaluation Checklist – Analysis for NSP (Mouse Bioassay)
• Domoic Acid (Amnesic Shellfish Poisoning: ASP) HPLC-UV

These chapters, sections and checklists were used as a guide to obtain evidence of adherence to the program's requirements and the competent authority's oversight of laboratories. Two (2) laboratories, 1 each from WA and OR were visited. Staff interviews were conducted and direct observation of laboratory technique was performed to assess implementation.

The presence and content of the following written QAP elements were verified:

• the organizational structure
• the lab staff training program
• descriptions of analytical methods
• proficiency testing program participations,
• corrective action for Laboratory QAP, operations and performance deficiencies
• participation in the lab evaluation process
• records of analytical performance and quality control
• records of equipment maintenance and calibrations

Observations

One (1) of the laboratory's QAPs (manual) generally covered the required elements of Chapter III of the program with some deficiencies in the following areas:

Staff training and knowledge
Certain staff training records were all signed on the same day; however the numerous components contained in the training records did not allow one to determine the date the actual training was actually accomplished and/or authorized. In addition, when directly questioned, laboratory staff could not reference information in the quality management plan (manual) required for the performance of a specific aspect of their duties.

Equipment calibrations
The evaluation/verification of calibration certificates (thermometers, pipettes) was not performed in a consistent manner and did not allow one to determine the fitness for purpose of the equipment in use. More specifically, the temperature is measured without consistent application of a correction factor that impacts the temperature reading.

The other laboratory's QAP covered the required elements of Chapter III of the program and no gaps were detected.

Previously completed microbiology, mouse bioassay (PSP) and domoic acid (ASP) evaluation checklists were verified onsite at both laboratories. Only versions of the latest completed verification visits were available for audit. There were no records or completed checklists of previous visits since visits had not been conducted at the minimum frequency of once every 3 years as stated in Chapter III.01 C.

The following 2 new laboratory evaluation checklists were provided by the competent authority during the laboratory visits. They serve as an indicator of continued program enhancement:

• Laboratory QAP
• Probe Microbiology (Vibrio) – Proposal 17-110

These checklists are in the process of being implemented. For the purpose of this visit, the laboratories were not assessed against these new checklists.

Recommendations were made to:

• implement the Laboratory QAP checklist to further help minimize knowledge and record gaps at the laboratory level
• continue evaluating laboratories that generate data for the NSSP, at least once every 3 years, as required in Chapter III.01C

6. Closing meeting

The closing meeting was held in Portland, OR on September 21, 2018. It was attended by the Canadian audit team, the Domestic and Food Import and Export Divisions of the CFIA, Environment and Climate Change Canada representatives, and FDA representatives responsible for the NSSP from OSCP, ORA, and the Office of Food Safety. The audit team thanked The FDA for their commitment to the logistical planning of the audit, as well as for their professionalism and responsiveness to the audit teams' questions and requests, and their openness and transparency throughout the audit process. The audit team presented their observations and recommendations, and re-iterated the expectation to share a draft report with the FDA within 60 working days of the conclusion of the audit.

7. Conclusions and recommendations

The audit determined that the NSSP is generally implemented as intended, and is effective at managing food safety risks associated with bivalve shellfish. A summary of the conclusions drawn from the team's observations as well as several recommendations are provided below.

Growing area classification

From the observation of the implementation of the growing area elements of the NSSP by WA and OR, the auditors believe the NSSP classification program provides an equivalent level of food safety assurance to the CSSP for shellfish harvested from growing areas.

All information in the survey reports provided to the Canadian audit team was well-documented and prepared in a consistent and methodical fashion. WADOH and ODA staff demonstrated complete expertise in the requirements of the NSSP and its application. All questions related to the growing area component of the program were answered completely, consistently and confidently. Some observations made in WA during the audit triggered the following recommended enhancement that Canada has found to be effective in mitigating environmental risks in harvest areas:

• although the auditors recognized that WA has protocols for implementing emergency closures (greater than 3 inches of precipitation in a 24 hour period), under circumstances where a widespread highly-elevated fecal coliform contamination event is detected over multiple stations through routine sampling, they suggest that an emergency closure of the impacted area(s) be considered even if the previously established criteria for an emergency closure are not met
  • although it may be an infrequent occurrence, this action will serve to protect human health under situations that may not normally trigger an emergency closure or perhaps close a conditional area
  • under such circumstances, to validate if contamination persists, verification water and / or shellstock testing following the event may be utilized to assess if waters have returned to safe harvesting conditions

With respect to OR, observations from documentation provided and observations in the field prompted the following considerations:

• within Upper Coos Bay, consider 2 additional sample sites along the northern boundary of Haynes Inlet just outside the prohibited area to determine if contamination may be extending beyond the northern prohibited area boundary into the Haynes Inlet Conditionally approved area
• within Upper Coos Bay, consider extending the foreshore prohibited area eastward from the Highway 101 (Coos Bay Bridge) south to encompass the main shipping channel along the North Bend foreshore

Waste water systems

Dye study documentation provided for Coos Bay suggests that achieving 1000:1 dilution to mitigate the risk of viruses is a challenge in the Bay. Predictable disruptions such as wet-weather split-flow events are not considered in conditional management plans. It is recommended that the higher persistence of viral pathogens should be considered when assessing the need for waste water system conditional management plans and associated prohibited areas.

It is recommended that the re-opening criteria for closures resulting from unplanned discharge events be adjusted to better address the greater persistence of viral components of sewage discharges out of the normal course of events.

The auditors recognize WA's efforts in identifying areas for remediation through the establishment of "Shellfish Protection Districts" and, in establishing their internal Geographic Information System which supports the rapid assessment of water quality, leading to responsive changes in classification.

OR is meeting the requirements for the growing area elements of the NSSP in highly-complex growing areas despite their limited resources. Staff demonstrated a high level of expertise across a wide variety of program elements which are often managed by multiple staff and programs in other SSCAs.

Finally, both states diligently collect water quality samples under varied environmental conditions that supports the use of conditional area management to maintain and or expand shellfish harvest area access. In addition, comprehensive shoreline surveys are conducted in both states. Where investigations of on-site septic systems have identified failing systems, closures are quickly implemented, relevant authorities are contacted and corrective action is taken.

Control of harvest and patrol

Since no field assessment was possible in OR due to an OSP policy that prevents non-state personnel from being aboard OSP vessels and aircraft, it was not possible to fully assess the control of harvest/patrol element. As a general recommendation for future audits, it would be beneficial for the FDA to confirm, in advance, state policies for non-state personnel to accompany officers in boats, aircraft or vehicles. Issues of liability and planning may then be resolved prior to the audit mission.

Inconsistencies observed during the audit and recommendations to address them include:

• OSP troopers do not inspect harvest vessels for marine sanitation devices or other onboard waste containment and are not aware of the legal requirement
  • ensure that the state authorities are fully aware of all compliance requirements for onboard human waste containment on harvest vessels
• OSP troopers have difficulty in enforcing conditional area closures with oyster aquaculture
  • there is a possibility of unlawfully harvested or contaminated oysters entering a processing plant or being sold
  • ensure that state authorities examine this issue further and develop effective enforcement measures for aquaculture product during a conditional area closure or emergency closure

Processing and establishment controls (HACCP)

In general, the NSSP is implemented as intended, and is effective at managing food safety risks associated with bivalve shellfish. The audit team observed good communication and interaction between the FDA, SSCAs and industry, demonstrating a strong, collaborative working relationship between all parties.

That said, the team observed a number of differences in pre-requisite requirements between the NSSP and the Canadian program. A future Canadian audit could further explore the potential impact of these differences on the effectiveness of the U.S. and Canadian approaches at achieving common food safety outcomes.

The team also observed inconsistencies in how non-compliances to construction/equipment and sanitation/hygiene requirements from the MO or the Guidance Document requirements were addressed. State inspectors did not record these non-compliances as debits in their inspections and/or note them as issues when queried. In addition, it was not clear under what circumstances enforcement action would be taken during an inspection.

In summary, the FDA should consider the following recommendations to enhance the implementation of their program:

• with respect to the risks posed by Vp in oysters: ensure dealers who ship oysters to Canada are aware of Canadian product requirements (both guidelines and label requirements) and ensure that they are met for lots shipped
  • this also applies to other differences in Canadian labelling requirements. For instance, harvest date
• HACCP plans should consider and include controls for unexpected, sporadic contamination events at harvest sites
• with respect to the state implementation of NSSP MO requirements, and resulting enforcement actions
  • the CFIA understands that the FDA is aware of this issue, and supports the ongoing conversation with the states and, efforts to develop and deliver future training to ensure that the NSSP MO standards are properly documented and enforced
• OR should consider modifying the language in their state regulation to adopt "the most current" version of the NSSP MO, instead of a specific edition, in an effort to remove potential conflict between state and federal requirements and potential resulting industry challenges

Marine biotoxins and chemical testing program

Both WA and OR have documented and implemented biotoxin control programs. Implementation appears to be effective and meets both NSSP MO and CSSP requirements. There are no recommendations for the biotoxin monitoring program.

Laboratories

Based on the evidence collected and reviewed prior to and during the on-site visits, the following conclusions were made about the laboratory controls:

• the FDA currently provides program and laboratory oversight as described in the NSSP Guide for the Control of Molluscan Shellfish, however previous evaluation visits were not performed at the established frequency as required in Chapter III.01C
• the laboratories are following the program requirements to assure the quality of testing results although some training record and knowledge gaps were observed

These 2 observations prompted the recommendations presented in Annex 1.

A future Canadian team visit is suggested to verify implementation of the new Laboratory QAP and Probe Microbiology (Vibrio) checklists and, to verify continued laboratory evaluations are being performed as required in Chapter III.01C.

In addition, the following observations were also made during the laboratory visits:

• there appears to be good communication and interaction between the FDA and the authorized testing laboratories
• all FDA and state laboratory staff was very cooperative, patient and willing to engage in open discussion on program and laboratory requirements, processes and practices

Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of the U.S. Bivalve Mollusc Sanitation Program Report – 2018

Note

The NSSP is implemented by states with oversight by FDA. Many of the recommendations relate to areas/items that are the responsibility of states to implement. Where this is the case, it is so noted.

Growing (harvest) area classification

No.	CFIA recommendations	FDA action plans/comments
1.	Consider implementing an emergency closure of area(s) impacted by a widespread highly elevated fecal coliform contamination event detected over multiple stations through routine sampling, even if it does not meet the previously established criteria for an emergency closure for that area. Validate if contamination persists by conducting verification water and /or shellstock testing following the event to assess if waters have returned to safe harvesting conditions.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for possible implementation. Updates will be provided upon completion of the evaluation scheduled to occur in late summer 2019. This conversation is occurring at the national level and via two (2) proposals submitted to the 2019 ISSC Biennial Meeting. In addition, this was covered in the 2018 Growing Area Evaluation as a New and Emerging Concern for WA; and was covered during the 2018 Growing Area Evaluation in OR with a recommendation made for establishing criteria in the Netarts growing area.
2.	Consider adding 2 sample sites in Upper Coos Bay along the northern boundary of Haynes Inlet just outside the prohibited area to determine if contamination may be extending beyond the northern prohibited area boundary into the Haynes Inlet conditionally approved area.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for possible implementation. Updates will be provided upon completion of the evaluation. This will be communicated to the Oregon Department of Agriculture before the 2019 Growing Area PEER, currently scheduled to occur in late summer 2019. FDA will inform CFIA of the outcome of the discussion.
3.	Consider extending the foreshore prohibited area in Upper Coos Bay eastward from the Highway 101 (Coos Bay Bridge) south to encompass the main shipping channel along the North Bend foreshore.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for possible implementation. Updates will be provided upon completion of the evaluation. This recommendation will be communicated to the Oregon Department of Agriculture before the 2019 Growing Area PEER. FDA will inform CFIA of the outcome of the discussion.
4.	Consider higher persistence of viral pathogens when assessing the need for waste water system conditional management plans and associated prohibited areas.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for possible implementation. Updates will be provided upon completion of the evaluation. This will be communicated to the Oregon Department of Agriculture during the 2019 Growing Area PEER, currently scheduled to occur late summer. Specifically, it will be communicated that the state should consider the option provided under Chapter IV@.03C(2)iii to utilize MSC in growing areas adjacent to WWTPs to address the concerns noted in this report. FDA will inform CFIA of the outcome of the discussion.
5.	Adjust re-opening criteria for closures resulting from unplanned discharge events to better address the greater persistence of viral components of sewage discharges out of the normal course of events.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for possible implementation. Updates will be provided upon completion of the evaluation. FDA will communicate this concern with the state through the 2019 Growing Area PEER and recommend consideration of studies that establish criteria for reopening based on viral levels in the shellfish meats or the area must be in the closed status until the event is over and twenty-one (21) days have passed under Chapter IV@.03C(2)iii. FDA will inform CFIA of the outcome of the discussion.

Harvest area patrol (enforcement)

No.	CFIA recommendations	FDA action plans/comments
1.	Confirm and communicate to future lead auditors in advance, any state policies that may prevent non-state personnel to accompany officers in boats, aircraft or vehicles that may limit the auditors' ability to fully assess the control of harvest/patrol element.	FDA was not aware that this situation would arise during the audit and commits to communicating with state personnel in advance of any future audits to ensure that a complete evaluation of the harvest area patrol element, including in-field components, can be executed.
2.	Ensure that state authorities are fully aware of all compliance requirements for onboard human waste containment on harvest vessels.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for continued implementation. Updates will be provided upon completion of the evaluation. FDA communicated and discussed this item with the WA SSCA and the Patrol agency during the 2018 Control of Harvest PEER. This has not been noted as an issue in OR; however, this will be communicated to the Oregon Department of Agriculture during the 2019 Control of Harvest PEER scheduled for late summer 2019. FDA will inform CFIA of the outcome of the discussion.
3.	Ensure state authorities have a process in place to effectively determine whether aquaculture products have been harvested in a conditional area during a closed period and, during emergency closures.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for possible implementation. This has been communicated to the Oregon Department of Agriculture and will be followed up on during the 2019 Control of Harvest PEER. Updates will be provided upon completion of the evaluation scheduled for late summer 2019.

Processing and establishment controls (HACCP)

No.	CFIA recommendations	FDA action plans/comments
1.	Ensure dealers who ship oysters to Canada are aware of, and meet Canadian product requirements for: Vp (including guidelines and labelling) other differences in Canadian labelling requirements (for example, harvest dates)	FDA plans to communicate this recommendation to the ISSC and consider ways that they could facilitate distribution of information regarding the requirements for product being shipped to Canada. The FDA will work with the ISSC to notify industry of the requirements.
2.	HACCP plans should consider and include controls for unexpected, sporadic contamination events at the harvest site.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process to ensure full implementation of existing requirements. Updates will be provided upon completion of the evaluation. The NSSP covers this at the Receiving CCP for dealers: harvest from approved areas and conditionally approved areas in the open status. If the growing area(s) are in the closed status, states communicate the closure.
3.	Continue to work with SSCAs to ensure that the NSSP MO standards are properly and consistently documented and enforced during inspection activities.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process to ensure consistent implementation. Updates will be provided upon completion of the evaluation. For WA this specific recommendation was documented and discussed during the 2018 Plant and Shipping PEER. The state has developed an action plan that includes increased checks and balances within the program to ensure deficiencies are documented and are accurate. For OR this topic will be covered during the 2019 Plant and Shipping PEER Evaluation; FDA will inform CFIA of the outcome of the discussion.
4.	OR should consider modifying the language in their state regulation to adopt "the most current" version of the NSSP MO, instead of a specific edition, to remove potential conflict between state and federal requirements and subsequent challenges from industry.	This activity is a state responsibility. FDA will review this recommendation with the state(s) during the program element evaluation process for possible implementation; however, the FDA has communicated this recommendation to the state in the past. This is the choice of the state of Oregon. Updates will be provided upon completion of the evaluation.

Laboratory

No.	CFIA recommendations	FDA action plans/comments
1.	Continue to evaluate laboratories that generate data for the NSSP, at least once every 3 years, as required in Chapter III.01C.	FDA will continue to strive to meet the triennial frequency as currently required. As discussed during the audit, FDA laboratory evaluation officers were understaffed and unable to complete the evaluations. Recently, the group was able to complete the frequency of evaluations and is now looking at new and novel ways to accomplish this task and stay current. We look forward to continued discussions with Canadian counterparts.
2.	Implement the Laboratory QAP checklist to further minimize knowledge and record gaps at the laboratories.	FDA is working with laboratories to implement the new QAP. All labs are expected to be fully implementing the new QAP by their next evaluation visit. By 2021 all conforming NSSP laboratories will be compliant with the LQAP checklist.