Handbook Fishmeal For Use As Animal Feed

Part 6 - NOAA Handbook: Fishmeal and Fishery By-products for use as animal
feed and industrial treatments, not intended for human consumption.
Chapter 1 - Introduction ............................................................................................................................. 2

Chapter 2 - Normative References ............................................................................................................. 3
Chapter 3 - Terms and Definitions ............................................................................................................. 3
Chapter 4 - Program Requirements ........................................................................................................... 3
System Compliance Rating Criteria for By-product (not human consumption) facilities. ................ 3
1.0 Management Controls and Responsibilities ............................................................................. 3
Systems Criteria Rating..................................................................................................................... 32
Feed Audit Template ......................................................................................................................... 34
Chapter 6 -Certification............................................................................................................................... 39
Chapter 7 -Destination Specific Requirements ....................................................................................... 39
Canada .................................................................................................................................................... 41
Chile ........................................................................................................................................................ 43
China ....................................................................................................................................................... 43
Japan ....................................................................................................................................................... 46
Peru ........................................................................................................................................................ 47
Chapter 8 - Sample Collection and Submission of Aquatic Animal By-products (not intended for
human consumption) to NSIL for Laboratory Analysis.......................................................................... 47
Sample Numbers and Sample Sizes ..................................................................................................... 49
Sample Collection .................................................................................................................................. 49
Labeling Sample Containers ................................................................................................................. 50
Information Form .................................................................................................................................. 50
Packing Samples and Shipping Containers ......................................................................................... 52
ADDITIONAL RESOURCES ........................................................................................................................ 52
ATTACHMENTS ......................................................................................................................................... 52
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Chapter 1 - Introduction
The National Marine Fisheries Service (NMFS) Seafood Inspection Program (SIP), under the National
Oceanic and Atmospheric Administration (NOAA) of the USDC, conducts inspections, audits, and
certification of fisheries by-products. The SIP offers several types of inspection and product certification
services on a fee-for-service basis for fishery by-products that are not intended for human consumption.
Initially SIP performed fishery by-product inspection services to assist the U.S. fishmeal industry in
controlling Salmonella. However, due to industry & regulatory changes, the SIP has expanded its services
to include assistance in the control of additional hazards associated with products such as fishmeal, krill
meal, bone meal, fish oil, frozen fish by-products, hydrolyzed fish proteins and fish solubles.
Additional information regarding U.S. regulatory requirements for animal food and feed can be found at:
https://www.fda.gov/animal-veterinary/products/animal-food-feeds
Below is a tree designed to aid industry in identifying the fishery product certification scope of the various
U.S government agencies.
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Chapter 2 - Normative References
Fish and Fisheries Product Hazards and Controls Guidance 4th Edition April 2011
21 CFR part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Human Food
21 CFR part 123 Fish and Fishery Products
21 CFR 507 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls
for Food for Animals
21 CFR 509 Unavoidable Contaminants in Animal Food and Food Packaging Material
NOAA Manual 25 Seafood Inspection Program
Chapter 3 - Terms and Definitions
Fishmeal is heat processed, ground, dried fish used as animal feed or fertilizer.
Fish oil is oil derived from the tissues of oily fish.
Fish Solubles is the water soluble by-product pressed from the meal during the production of fish meal.
Bone Meal is a mixture of finely and coarsely ground marine animal bones (other than marine mammals)
and processed by - products. It is used as a nutritional supplement for animals.
Krill Meal is a specialty feed ingredient made of small shrimp- like crustacean.
Hydrolyzed fish proteins - products made from fish material by the method of protein hydrolysate
(breakage of proteins from which fish tissues are constructed into smaller parts—peptides and finally
into amino acids)
Chapter 4 - Program Requirements

Facilities wishing to obtain export health certification for fishmeal, fish oil, and other aquatic animal by-
products not intended for human consumption must participate in the SIP Fisheries By-product Approved
Establishment program. The minimum requirements to become a SIP Fisheries By-Products Approved
Establishment are system audits including the collection of samples conducted two times a year or within
an operation season. Facilities wishing to obtain export health certification for fish oil, or other aquatic
animal by-products intended for human consumption must follow the Approved Establishment/QMP
frequencies for fishery products for human consumption. The facilities management controls and
responsibilities; feed safety programs; sanitation and prerequisite programs; and quality systems will be
audited according to the following criteria.
System Compliance Rating Criteria for By-product (not human consumption)

facilities.
1.0 Management Controls and Responsibilities
The elements of this section apply to all participants in the USDC Seafood Inspection Program in the
evaluation of facilities, processes and systems.
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1.1.0 Management Responsibilities
1.1.1 Management commitment not properly implemented or communicated.
Top management shall provide evidence of its commitment to the development and implementation of
the food safety management system and to continually improving its effectiveness by: a) showing feed
safety is supported by the business objectives of the organization, b) communicating to the organization
the importance of meeting feed safety standards, statutory and regulatory requirements, as well as
customer requirements relating to feed safety, c) establishing a feed safety policy, d) conducting
management reviews, and e) ensuring the availability of resources.
Deficiency: Critical
1.1.2 Feed safety policy not prepared or properly implemented.
Top management shall define, document and communicate its feed safety policy. Top management shall
ensure that the feed safety policy a) is appropriate to the role of the organization in the feed chain, b)
conforms with both statutory and regulatory requirements and with mutually agreed feed safety
requirements of customers, c) is communicated, implemented, and maintained at all levels of the
organization, d) is reviewed for continued suitability, e) adequately addresses communication, and f) is
supported by measurable objectives.
Deficiency: Serious
1.1.3 Feed safety management system planning not properly performed.
Top management shall ensure that a) planning of the feed safety management system is properly carried
out to meet all applicable requirements, and b) the integrity of the feed safety management system is
maintained when changes to the feed safety management system are planned and implemented.
Deficiency: Serious
1.1.4 Responsibility and authority not properly defined or communicated.
Top management shall ensure that responsibilities and authorities are defined and communicated within
the organization to ensure the effective operation and maintenance of the feed safety management
system. All personnel shall have responsibility to report problems with the feed safety management
system to identified person(s). Designated personnel shall have defined responsibility and authority to
initiate and record actions.
Deficiency: Serious
1.2.0 Feed Safety Team
1.2.1 Feed safety team leader not appointed.
Top management shall appoint a feed safety team leader who, irrespective of other duties, shall have the
responsibility and authority to: a) manage a feed safety team and organize its work, b) ensure relative
training and education of the team members, and c) ensure that the feed safety management system is
established, implemented, maintained and updated.
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Deficiency: Serious
1.2.2 Feed safety team leader does not report to top management.
The feed safety team leader must report to the organization’s top management and will inform them on
the effectiveness and suitability of the feed safety management system.
Deficiency: Major
1.2.3 Feed safety team is not interdisciplinary as applicable.
The feed safety team shall have a combination of multi-disciplinary knowledge and experience in
developing and implementing the feed safety management system. This includes, but need not be limited
to, the organization’s products, processes, equipment and feed safety hazards within the scope of the
feed safety management system. Records shall be maintained that demonstrate that the feed safety team
has the required knowledge and experience.
Deficiency: Major
1.3.0 Communication
1.3.1 Effective external communication not established, implemented, or maintained.
To ensure that sufficient information on issues concerning feed safety is available throughout the feed
chain, the organization shall establish, implement, and maintain effective arrangements for
communicating with: a) suppliers and contractors, b) customers or consumers, in particular in relation to
product information (including instructions regarding intended use, specific storage requirements, and as
appropriate, shelf life), enquiries, contracts or order handling including amendments, and customer
feedback including customer complaints, c) statutory and regulatory authorities, and d) other
organizations that have an impact on or will be affected by the effectiveness or updating of the feed safety
system.
The communication shall provide information on feed safety aspects of the organization’s products that
may be relevant to other organizations in the feed chain. This applies especially to known feed safety
hazards that need to be controlled by other organizations in the feed chain. Records of communications
shall be maintained. Feed safety requirements from statutory and regulatory authorities and customers
shall be available. Designated personnel shall have defined responsibility and authority to communicate
information concerning feed safety externally. Information obtained through external communication
shall be included as input to all system updating and management reviews.
Deficiency: Serious
1.3.2 Effective internal communication not established, implemented, or maintained.
The organization shall establish, implement, and maintain effective arrangements for communicating with
personnel on issues having an impact on food safety. In order to maintain the effectiveness of the feed
safety management system, the organization shall ensure that the feed safety team is informed in a timely
manner of changes, including but not limited to the following: a) products or new products, b) raw
materials, ingredients and services, c) production systems and equipment, d) production premises,
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location of equipment, surrounding environment, e) cleaning and sanitation programs, f) packaging,

storage, and distribution systems, g) personnel qualification level and/or allocation of responsibilities and
authorizations, h) statutory and regulatory requirements, i) knowledge regarding feed safety hazards and
control measures, j) customer, sector, and other requirements which the organization observes, k)
relevant enquiries from external interested parties, l) complaints indicating feed safety hazards associated
with the product, and m) other conditions which have an impact on feed safety.
The feed safety team shall ensure that this information is included in the updating of the feed safety
management system. Top management shall ensure that relevant information is included as input to
management review.
Deficiency: Serious
1.4.0 Emergency Preparedness and Response
1.4.1 Emergency response procedures not established, implemented or maintained.
Top management shall establish, implement and maintain procedures to manage potential emergency
situations and accidents that can impact feed safety relevant to the role of the organization in the food
chain.
1.5.0 Management Review
1.5.1 Management review not properly performed or documented.
Top management shall review the organization’s feed safety management system at planned intervals to
ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing
opportunities for improvement and the need for change to the system, including the feed safety and
quality policy. Records from management reviews shall be maintained.
The input to management review shall include, but is not limited to information on: a) follow-up actions
from previous management reviews, b) analysis of results of verification activities, c) changing
circumstances that can affect feed safety or quality, d) emergency situations, accidents, and withdrawals,
e) reviewing results of system updating activities, f) review of communication activities including customer
feed-back, and g) external audits or inspections. The data shall be presented in a manner that enables
top management to relate the information to stated objectives of the feed safety system.
The output from the management review shall include decisions and actions related to: a) assurance of
feed safety, b) improvement of the effectiveness of the feed safety management system, c) resource
needs, and d) revisions of the organization’s feed safety policy and objectives.
Deficiency: Serious
1.6.0 Resource Management
The organization shall provide adequate resources for the establishment, implementation, maintenance
and updating of the feed safety management system.
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1.6.1 Necessary human resource competencies not identified.
The feed safety team and the other personnel carrying out activities having an impact on feed safety shall
be competent and shall have appropriate education, training skills and experience. Where the assistance
of external experts is required for the development, implementation, operation, or assessment of the
feed safety management system, records of agreement or contracts defining the responsibility and
authority of external experts shall be available.
Deficiency: Serious
1.6.2 Personnel have not received documented training necessary for the proper function of the feed
system.
The organization shall: a) identify the necessary competencies for personnel whose activities have an
impact on feed safety, b) provide training or take other action to ensure personnel have the necessary
competencies, c) ensure that personnel responsible for monitoring, corrections, and corrective actions of
the management system are trained, d) evaluate the implementation and the effectiveness of a), b), and
c), e) ensure that the personnel are aware of the relevance and importance of their individual activities in
contributing to feed safety, f) ensure that the requirement for effective communication is understood by
all personnel whose activities have an impact on feed safety, and g) maintain appropriate records of
training and action as described above.
Training must include the areas of HACCP, good manufacturing practices, and allergens to appropriate
personnel. Each firm must have available a person who has met the training requirement by NOAA for
this program. The training requirement 1) fulfills the 21 CFR part 123.10 training requirement and, 2)
personnel must pass the NOAA HACCP Exam with an 80% or better. In addition, copies of all trained
personnel’s certificates must on file with the firm. Per 21 CFR part 123, these duties are assigned only to
properly trained personnel. However, failure of this element will not likely cause an immediate hazard or
defect. Therefore it is rated as a Serious deficiency. Per 21 CFR part 123, these duties are assigned to only
properly trained personnel. Failure of this element could lead to an immediate hazard or defect.
At a minimum, the following functions shall be performed by an individual who has successfully completed
training in the application of HACCP principles to fish and fishery product processing at least equivalent
to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug
Administration or who is otherwise qualified through job experience to perform these functions. Job
experience will qualify an individual to perform these functions if it has provided knowledge at least
equivalent to that provided through the standardized curriculum.
Developing a HACCP plan, which could include adapting a model or generic-type HACCP plan,
that is appropriate for a specific processor, in order to meet the requirements of Sec. 123.6(b);
Reassessing and modifying the HACCP plan in accordance with the corrective action procedures
specified in Sec. 123.7(c)(5), the HACCP plan in accordance with the verification activities specified
in Sec. 123.8(a)(1), and the hazard analysis in accordance with the verification activities specified
in Sec. 123.8(c); and
Performing the record review required by Sec. 123.8(a) (3). The trained individual need not be an
employee of the processor.
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Deficiency: Serious/Critical
1.6.3 Insufficient infrastructure to implement and maintain the feed safety system.
The organization shall provide the resources for the establishment and maintenance of the infrastructure
needed to implement a proper feed safety system.
Deficiency: Serious
1.6.4 Work environment is not properly established, managed, or maintained relative to feed safety.
The organization shall provide the resources for the establishment, management, and maintenance of the
work environment needed to implement a proper feed safety management system.
Deficiency: Serious
1.7.0 Continual Improvement
1.7.1 Continuous improvement activities not performed.
Top management shall ensure that the organization continually improves the effectiveness of the feed
safety management system through the use of communication, management review, internal audit,
evaluation of individual verification results, analysis of results of verification activities, validation of
control measure combinations, and corrective actions.
Deficiency: Serious
b. 2.0 Feed Safety
The organization shall plan and develop the processes needed for the realization of safe products. The
organization shall implement, operate, and ensure the effectiveness of the planned activities and any
changes to those activities. This includes pre-requisite programs as well as the HACCP plan.
2.1.0 Operational Prerequisite Programs
2.1.1 Operational prerequisite programs not present or not effective.
Each processor shall have and implement a written operational prerequisite procedures or similar
document that is specific to each location where fish and fishery products are produced. The operational
prerequisite programs shall be documented and shall include the following information for each program:
a) feed safety hazard(s) to be controlled by the program, b) control measure(s), c) monitoring procedures
that demonstrate that the prerequisite programs are implemented; d) corrections and corrective actions
to be taken if monitoring shows that the operational prerequisite programs are not in control; e)
responsibilities and authorities; f) record(s) of monitoring.
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Deficiency: Serious
2.1.2 Operational prerequisite procedures not followed.
This deficiency will be assessed if it is determined that the firm did not follow their written procedures,
whether or not specific s deficiencies were observed.
Deficiency: Serious
2.2.0 Hazard Analysis
2.2.1 Description of products, processes or control measures not properly performed.
All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated
and documented. Records shall be maintained.
All raw materials, ingredients and product-contact materials shall be described in documents to the extent
needed to conduct the hazard analysis, including the following, as appropriate: a) biological, chemical,
and physical characteristics; b) composition of formulated ingredients, including additives and processing
aids; c) origin; d) method of production; e) packaging and delivery methods; f) storage conditions and
shelf life; g) preparation and/or handling before use or processing; h) feed safety-related acceptance
criteria or specifications of purchased materials and ingredients appropriate to their intended uses. The
organization shall identify statutory and regulatory feed safety requirements related to the above.
The characteristics of end products shall be described in documents to the extent needed to conduct the
hazard analysis, including information on the following, as appropriate: a) product name or similar
identification; b) composition; c) biological, chemical and physical characteristics relevant for feed safety;
d) intended shelf life and storage conditions; e) packaging; f) labeling relating to feed safety and/or
instructions for handling, preparation and usage; g) method(s) of distribution. The organization shall
identify statutory and regulatory feed safety requirements related to the above.
The intended use, the reasonably expected handling of the end product, and any unintended but
reasonably expected mishandling and misuse of the end product shall be considered and shall be
described in documents to the extent needed to conduct the hazard analysis. Groups of users and, where
appropriate, groups of consumers shall be identified for each product, and consumer groups known to be
especially vulnerable to specific feed safety hazards shall be considered.
Flow diagrams shall be prepared for the products or process categories covered by the feed safety
management system. Flow diagrams shall provide a basis for evaluating the possible occurrence, increase
or introduction of feed safety hazards. Flow diagrams shall be clear, accurate and sufficiently detailed.
Flow diagrams shall, as appropriate, include the following: a) the sequence and interaction of all steps in
the operation; b) any outsourced processes and subcontracted work; c) where raw materials, ingredients
and intermediate products enter the flow; d) where reworking and recycling take place; e) where end
products, intermediate products, by-products and waste are released or removed. The feed safety team
shall verify the accuracy of the flow diagrams by on-site checking. Verified flow diagrams shall be
maintained as records.
All information described above shall be updated as necessary.

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Deficiency: Major
2.2.2 Hazard analysis not properly performed.
The feed safety team shall conduct a hazard analysis to determine which hazards need to be controlled,
the degree of control required to ensure feed safety, and which combination of control measures is
required. A feed safety hazard that is reasonably likely to occur is one for which a prudent processor
would establish controls because experience, illness data, scientific reports, or other information provide
a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or
fishery product being processed in the absence of those controls.
All feed safety hazards that are reasonably expected to occur in relation to the type of product, type of
process and actual processing facilities shall be identified and recorded. Such hazard analysis must also
consider any products, including ingredients or additives that may contain allergens as a significant
hazard. Allergen assessment must also consider unintentional inclusion of an allergenic ingredient or
additive. (21CFR123.6a)
The identification shall be based on a) the preliminary information and data collected according to the
previous section, b) experience, c) external information including, to the extent possible, epidemiological
and other historical data, and d) information from the feed chain on feed safety hazards that may be of
relevance for the safety of the end products, intermediate products and the feed at end use. The step(s)
(from raw materials, processing and distribution) at which each feed safety hazard may be introduced
shall be indicated.
When identifying the hazards, consideration shall be given to a) the steps preceding and following the
specified operation, b) the process equipment, utilities/services and surroundings, and c) the preceding
and following links in the feed chain.
For each of the feed safety hazards identified, the acceptable level of the feed safety hazard in the end
product shall be determined whenever possible. The determined level shall take into account established
statutory and regulatory requirements, customer feed safety requirements, the intended use by the
customer and other relevant data. The justification for, and the result of, the determination shall be
recorded.
A hazard assessment shall be conducted to determine, for each feed safety hazard identified, whether its
elimination or reduction to acceptable levels is essential to the production of a safe feed, and whether its
control is needed to enable the defined acceptable levels to be met. Each feed safety hazard shall be
evaluated according to the possible severity of adverse health effects and the likelihood of their
occurrence. The methodology used shall be described, and the results of the feed safety hazard
assessment shall be recorded.
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Based on the hazard assessment, an appropriate combination of control measures shall be selected which
is capable of preventing, eliminating or reducing these feed safety hazards to defined acceptable levels.
In this selection, each of the control measures as determined shall be reviewed with respect to its
effectiveness against the identified feed safety hazards. The control measures selected shall be
categorized as to whether they need to be managed through operational prerequisite programs or by the
HACCP plan.
The existing control measures, process parameters and/or the rigorousness with which they are applied,
or procedures that may influence feed safety, shall be described to the extent needed to conduct the
hazard analysis. External requirements (e.g., from regulatory authorities or customers) that may impact
the choice and the rigorousness of the control measures shall also be described.
The selection and categorization shall be carried out using a logical approach that includes assessments
with regard to the following: a) its effect on identified feed safety hazards relative to the strictness applied;
b) its feasibility for monitoring (e.g., ability to be monitored in a timely manner to enable immediate
corrections); c) its place within the system relative to other control measures; d) the likelihood of failure
in the functioning of a control measure or significant processing variability; e) the severity of the
consequence(s) in the case of failure in its functioning; f) whether the control measure is specifically
established and applied to eliminate or significantly reduce the level of hazard(s); g) synergistic effects
(i.e., interaction that occurs between two or more measures resulting in their combined effect being
higher than the sum of their individual effects).
Control measure categorized as belonging to the HACCP plan shall be implemented as such. The
methodology and parameters used for this categorization shall be described in documents, and the results
of the assessment shall be recorded.
2.2.3 Hazard analysis not available.
The hazard and defect analysis is the foundation of the HACCP plan. If the analysis is not performed, the
entire plan and its efficacy is suspect. Firms must provide this analysis to the requesting Consumer Safety
Officer in writing. If it is not provided and evidence suggests that it was performed but a written document
is not available, a Serious deficiency will be assessed. Otherwise, a Critical deficiency will be assessed.
2.3.0 HACCP Plan
2.3.1 No written HACCP plan when one is required.
Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one
or more feed safety hazards that are reasonably likely to occur. (21CFR123.6b)Firms must provide this
plan to the requesting Consumer Safety Officer.
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Deficiency: Serious
2.3.2 Plan is not location and/or fish species specific.
A HACCP plan shall be specific to:
1. Each location where fish and fishery products are processed by that processor; and
2. Each kind of fish and fishery product processed by the processor. The plan may group kinds
of fish and fishery products together, or group kinds of production methods together, if the
feed safety hazards, critical control points, critical limits, and procedures required to be
identified and performed are identical for all fish and fishery products so grouped or for all
production methods so grouped.
Deficiency: Major
2.3.3 Hazard(s) is not listed in the plan.
The HACCP plan shall, at a minimum list the feed safety hazards that are reasonably likely to occur and
that thus must be controlled for each fish and fishery product. Consideration should be given to whether
any food safety hazards are reasonably likely to occur as a result of the following:
1. Natural toxins;
2. Microbiological contamination;
3. Chemical contamination;
4. Pesticides;
5. Drug residues;
6. Decomposition in scombroid toxin-forming species or in any other species where a feed safety
hazard has been associated with decomposition;
7. Parasites, where the processor has knowledge or has reason to know that the parasite-
containing fish or fishery product will be consumed without a process sufficient to kill the
parasites, or where the processor represents, labels, or intends for the product to be so
consumed;
8. Unapproved use of direct or indirect feed or color additives or allergens; and
9. Physical hazards
In the event that one or more hazards are not identified, a deficiency will be assessed.
Deficiency: Serious
2.3.4 Hazard(s) is not controlled.
Firms may not have met the requirements of performing the hazard analysis or writing a required HACCP
plan. However, controls may still be in place for the hazards identified by the Consumer Safety Officer. If
it is determined that the controls are not in place, a Critical deficiency will be assessed.
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2.3.5 CCPs are not properly identified in the plan.
The HACCP plan shall, at a minimum list the critical control points for each of the identified food safety
hazards, including as appropriate:
1. Critical control points designed to control feed safety hazards that could be introduced in the
processing plant environment; and
2. Critical control points designed to control feed safety hazards introduced outside the
processing plant environment, including feed safety hazards that occur before, during, and
after harvest. (21CFR123.6c.2)
Deficiency: Serious
2.3.6 Appropriate critical limit(s) is not listed in the plan.
Critical limits shall be determined for the monitoring established for each critical control point. Critical
limits shall be established to ensure that the identified acceptable level of the feed safety hazard in the
end product is not exceeded. Critical limits shall be measurable. The rationale for the chosen critical
limits shall be documented. Critical limits that are evaluated by observation (e.g., visually or by sensory
evaluation) shall be supported by instructions or specifications and/or education and training. If evidence
is present that the critical limits were improperly identified but those identified were followed, the
deficiency will be assessed here. (21CFR123.6c.3)
Deficiency: Serious
2.3.7 Critical limits not followed.
Self-explanatory.
2.3.8 Monitoring procedure stated in the plan is inadequate.
Monitoring procedures shall be established for each critical limit. (21CFR123.6c.4) The results of
monitoring will indicate whether the CCP is in or out of control. The system shall include all scheduled
measurements or observations relative to the critical limit(s). The monitoring system shall consist of
relevant procedures, instructions and records that cover the following: a) measurements or observations
that provide results within an adequate time frame; b) monitoring devices used; c) applicable calibration
methods; d) monitoring frequency; e) responsibility and authority related to monitoring and evaluation
of monitoring results; f) record requirements and methods. The monitoring methods and frequency shall
be capable of determining when the critical limits have been exceeded in time for the product to be
isolated before it is used or consumed. Where allergen controls are not sufficient or proper or identified
allergens are not declared on product labels where appropriate, a critical deficiency will be assessed.
2.3.9 Monitoring procedures not followed:
Monitoring procedures must be followed to maintain control of the process. If any monitoring procedure
has not been followed the firm is not in compliance with this item
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Deficiency: Serious
2.3.10 Corrective action listed in plan is not appropriate or adequate.
Planned corrections and corrective actions to be taken when critical limits are exceeded shall be specified
in the HACCP plan. The actions shall ensure that the cause of nonconformity is identified, that the
parameter(s) controlled at the CCP is (are) brought back under control, and that recurrence is prevented.
Documented procedures shall be established and maintained for the appropriate handling of potentially
unsafe products to ensure that they are not released until they have been evaluated and the cause of the
deviation is corrected (e.g., not injurious to health or adulterated).
A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be
taken and assigns responsibility for taking those steps, to ensure that:
1. No product enters commerce that is either injurious to health, is otherwise adulterated as a

result of the deviation, or does not meet Program requirements; and
2. The cause of the deviation is corrected. (21CFR123.7)
Deficiency: Serious
2.3.11 Corrective action not taken
Whenever a deviation from a critical limit, sanitation, monitoring or verification procedures occurs, a
processor shall take corrective action. Processors shall develop written corrective action plans, which
become part of their plans by which they predetermine the corrective actions that they will take whenever
there is a deviation from a critical limit.
A firm is provided room for error in their plan through a system of corrective actions. If an error or problem
arises in the conduct of the feed safety management plan, the firm must file a corrective action report.
All other deficiencies may possibly be averted in this checklist if corrective action reports are filed for each
problem or situation. Failure to file a corrective action report will be considered a failure to take a
corrective action and the firm will then not be in compliance with this item.
When a deviation from the plan occurs and the processor does not have a corrective action plan that is
appropriate for that deviation, the processor shall:
1. Segregate and hold the affected product.

2. Perform or obtain a review to determine the acceptability of the affected product for
distribution. The review shall be performed by an individual or individuals who have adequate
training or experience to perform such a review.
3. Take corrective action, when necessary, with respect to the affected product to ensure that
no product enters commerce that is either injurious to health or is otherwise adulterated as
a result of the deviation or does not meet other program requirements;
4. Take corrective action, when necessary, to correct the cause of the deviation;
5. Perform or obtain timely reassessment of the system by an individual or individuals who have
been properly trained to do so, to determine whether the plan needs to be modified to reduce
the risk of recurrence of the deviation, and modify the plan as necessary.
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In addition, the organization shall assess the validity of the previous measurement results when the
equipment or process is found not to conform to requirements. If the measuring equipment is
nonconforming, the organization shall take action appropriate for the equipment and any product
affected. Records of such assessment and resulting action shall be maintained.
2.3.12 Verification procedure stated in plan is inadequate.
The HACCP plan shall list the verification procedures, and frequency thereof, that the processor will use.
Every processor shall verify that the HACCP plan is adequate to control feed safety hazards that are
reasonably likely to occur, and that the plan is being effectively implemented.
Verification shall include, at a minimum:
1. Reassessment of the feed safety management system. A reassessment of the adequacy of the
plan whenever any changes occur that could affect the hazard analysis or alter the plan in any
way or at least annually. (21CFR123.8a.1) Such changes may include changes in the following:
Raw materials or source of raw materials, product formulation, processing methods or
systems, finished product distribution systems, or the intended use or consumers of the
finished product. The reassessment shall be performed by an individual or individuals who
have been trained in accordance with Sec. 123.10 of 21 CFR Part 123.
The system shall be modified immediately whenever a reassessment reveals that the plan is no longer
adequate to fully meet the requirements.
2. Ongoing verification activities. Ongoing verification activities including:

a. A review of any consumer complaints that have been received by the processor to
determine whether they relate to the performance of critical control points or reveal
the existence of unidentified critical control points;
b. The calibration of process-monitoring instruments; and,
c. At the option of the processor, the performing of periodic end-product or in-process
testing. (Note: Some end item testing is required as part of the HACCP QMP system.
See Program requirements.) (21CFR123.8a.2)
3. Records review. (21CFR123.8a.3) A review, including signing and dating, by an individual who
has been trained in accordance with Sec. 123.10, of the records that document:
a. The monitoring of critical control points. The purpose of this review shall be, at a
minimum, to ensure that the records are complete and to verify that they document
values that are within the critical limits. This review shall occur within 1 week of the
day that the records are made;
b. The taking of corrective actions. The purpose of this review shall be, at a minimum,
to ensure that the records are complete and to verify that appropriate corrective
actions were taken in accordance with Sec. 123.7. This review shall occur within 1
week of the day that the records are made; and
c. The calibrating of any process control instruments used at critical control points and
the performing of any periodic end-product or in-process testing that is part of the
processor's verification activities. The purpose of these reviews shall be, at a
minimum, to ensure that the records are complete, and that these activities occurred
in accordance with the processor's written procedures. These reviews shall occur
within 1 week of the day that the records are made.
16
4. Processors shall immediately follow corrective action procedures whenever any verification
procedure, including the review of a consumer complaint, reveals the need to take a
corrective action. (21CFR123.8b)(See Corrective Action sections listed above.)
5. Reassessment of the hazard analysis. (21CFR123.8c) Whenever a processor does not have a
HACCP plan because a hazard analysis has revealed no feed safety hazards that are reasonably
likely to occur, the processor shall reassess the adequacy of that hazard analysis whenever
there are any changes that could reasonably affect whether a feed safety hazard now exists.
Such changes may include, but are not limited to changes in: Raw materials or source of raw
materials, product formulation, processing methods or systems, finished product distribution
systems, or the intended use or consumers of the finished product. The reassessment shall
be performed by an individual or individuals who have been properly trained in accordance
with 21 CFR 123.10. (See 1.6.2)
6. Recordkeeping. (21CFR123.8d) All verification activities, including the calibration of process-
monitoring instruments and the performing of any periodic end-product and in-process
testing, shall be documented and recorded and is subject to the recordkeeping requirements
listed below. The organization shall provide evidence that the specified monitoring and
measuring methods and equipment are adequate to ensure the performance of the
monitoring and measuring procedures. Where necessary to ensure valid results, the
measuring equipment and methods used a) shall be calibrated or verified at specified
intervals, or prior to use, against measurement standards traceable to international or
national measurement standards, where no such standards exist, the basis used for
calibration or verification shall be recorded, b) shall be adjusted or re-adjusted as necessary,
c) shall be identified to enable the calibration status to be determined, d) shall be safeguarded
from adjustments that would invalidate the measurements results, and e) shall be protected
from damage and deterioration. When used in the monitoring and measurement of specified
requirements, the ability of computer software to satisfy the intended application shall be
confirmed. This shall be undertaken prior to initial use and shall be reconfirmed as necessary.
The output of this activity shall be in a form suitable for the organization’s method of operations.
Verification results shall be recorded and shall be communicated to the feed safety team. Verification
results shall be provided to enable the analysis of the results of the verification activities. If system
verification is based on testing of end product samples, and where such test samples show nonconformity
with the acceptable level of the feed safety hazard, the affected lots of product shall be handled as
potentially unsafe.
The organization shall conduct internal audits at planned intervals to determine whether the feed safety
management system a) conforms to the planned arrangements, to the feed safety management system
requirements established by the organization, and b) is effectively implemented and updated. An audit
program shall be planned, taking into consideration the importance of the processes and areas to be
audited, as well as any actions resulting from previous audits. The audit criteria, scope, frequency and
methods shall be defined and documented. Selection of auditors and the conduct of audits shall ensure
the objectivity and impartiality of the audit process. Auditors shall not audit their own work. The
management responsible for the area being audited shall ensure that actions are taken without undue
delay to eliminate nonconformities and their causes.
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The feed safety team shall systematically evaluate the individual results of planned verification. If
verification does not demonstrate conformity with the planned arrangements, the organization shall take
action to achieve the required conformity. The feed safety team shall analyze the results of verification
activities, including the results of the internal and external audits. The results of the analyses and the
resulting activities shall be recorded and shall be reported, in an appropriate manner, to top management
as input to the management review.
The monitoring system shall consist of relevant procedures, instructions and records that cover the
following: a) measurements or observations that provide results within an adequate time frame; b)
monitoring devices used; c) applicable calibration methods; d) monitoring frequency; e) responsibility and
authority related to monitoring and evaluation of monitoring results; f) record requirements and
methods.
Deficiency: Serious
2.3.13 Verification procedures not followed.
Verification procedures are those that provide for management to determine the overall effectiveness of
the plan. Not following these procedures could ultimately cause the plan to fail or misidentify a hazard,
defect, or control procedure. Since failure of these procedures will likely not immediately cause the plan
to fail, it is rated at a Serious level. This item should be checked on a trend basis, not based on isolated
incidences unless they are of such severity to warrant action. Firms must reassess their hazard analyses
when information or other evidence indicates the need and at least yearly. The plan must be signed and
dated by a management official responsible for the operation of the facility. The plan must be signed
upon implementation and at least once each year.
Deficiency: Serious
2.4.0 Control of Nonconformity
2.4.1 Traceability system inadequate.
The organization shall establish and apply a traceability system that enables the identification of product
lots and their relation to batches of raw materials, processing and delivery records. The traceability
system shall be able to identify incoming material from the immediate suppliers and the initial distribution
route of the end product. Traceability records shall be maintained for a defined period for system
assessment to enable the handling of potentially unsafe products and in the event of product withdrawal.
Records shall be in accordance with statutory and regulatory requirements (including those for firm
registration and traceability relative to the Bioterrorism Act) and customer requirements and may, for
example, be based on the end product lot identification.
Deficiency: Serious
2.4.2 Improper handling of potentially unsafe products
The organization shall handle nonconforming products by taking action(s) to prevent the nonconforming
product from entering the feed chain unless it is possible to ensure that a) the feed safety hazard(s) of
concern has(ve) been reduced to the defined acceptable levels, b) the feed safety hazard(s) of concern
will be reduced to identified acceptable levels prior to entering the feed chain, or c) the product still meets
the defined acceptable level(s) of the feed safety hazard(s) of concern despite the nonconformity.
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All lots of product that may have been affected by a nonconforming situation shall be held under control
of the organization until they have been evaluated. If products that have left the control of the
organization are subsequently determined to be unsafe, the organization shall notify relevant interested
parties and initiate a withdrawal or recall. The controls and related responses and authorization for
dealing with potentially unsafe products shall be documented.
Each lot of product affected by the nonconformity shall only be released as safe when any of the following
conditions apply: a) evidence other than the monitoring system demonstrates that the control measure
have been effective; b) evidence shows that the combined effect of the control measures for that
particular product complies with the performance intended; c) the results of sampling, analysis and/or
other verification activities demonstrate that the affected lot of product complies with the identified
acceptable levels for the feed safety hazard(s) concerned.
Following evaluation, if the lot of product is not acceptable for release it shall be handled by one of the
following activities: a) reprocessing or further processing within or outside the organization to ensure that
the feed safety hazard is eliminated or reduced to acceptable levels; b) destruction and/or disposal as
waste.
Deficiency: Serious
2.4.3 Withdrawals and recalls not designed or implemented properly.
To enable and facilitate the complete and timely withdrawal of lots of end products which have been
identified as unsafe a) top management shall appoint personnel having the authority to initiate a
withdrawal and personnel responsible for executing the withdrawal, and b) the organization shall
establish and maintain a documented procedure for
1. notification to relevant interested parties (e.g. statutory and regulatory authorities,

customers and/or consumers),
2. handling of withdrawn products as well as affected lots of the products still in stock, and
3. the sequence of actions to be taken.
Withdrawn products shall be secured or held under supervision until they are destroyed, used for
purposes other than originally intended, determined to be safe for the same (or other) intended use, or
reprocessed in a manner to ensure they become safe. The cause, extent and result of a withdrawal shall
be recorded and reported to top management as input to the management review. The organization shall
verify and record the effectiveness of the withdrawal program through the use of appropriate techniques
(e.g. mock or practice withdrawal).
Deficiency: Serious
2.5.0 Validation
2.5.1 Validation activities improperly performed
The feed safety team shall plan and implement the processes needed to validate control measures and/or
control measure combinations. Prior to implementation of control measures to be included in operational
prerequisite programs and the HACCP plan and after any change therein, the organization shall validate
that a) the selected control measures are capable of achieving the intended control of the feed safety
hazard(s) for which they are designated, and b) the control measures are effective and capable of, in
combination, ensuring control of the identified feed safety hazard(s) to obtain end products that meet
the defined acceptable levels.
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If the result of the validation shows that one or both of the above elements cannot be confirmed, the
control measure and/or combinations thereof shall be modified and re-assessed. Modifications may
include changes in control measures (i.e. process parameters, rigorousness and/or their combination)
and/or change(s) in the raw materials, manufacturing technologies, end-product characteristics, methods
of distribution and/or intended use of the end product.
Deficiency: Serious
2.6.0 Records
2.6.1 Inadequate information on records (Facility name and location, etc.)
Based on the required information stated in 21 CFR Part 123.9a.
All records required by this part shall include:
1. The name and location of the processor or importer;

2. The date and time of the activity that the record reflects;
3. The signature or initials of the person performing the operation; and
4. Where appropriate, the identity of the product and the production code, if any.
Deficiency: Major
2.6.2 Record data is missing.
All records must be kept up-to-date. Entries must be made as they are measured. The records shall contain
the actual values and observations obtained during monitoring or measurement. All time schedules
outlined in the QMP plan must be maintained. Examples of non-compliance include: measurement
observed to be taken but not entered on record; partial entry of information from monitoring procedures;
initials for QA verification not recorded in a timely manner; etc. If record data is missing, a Major deficiency
will be assessed.
All labels must be up-to-date. All labels must be kept on file by the firm. If labels are not up-to-date, a
Serious deficiency will be assessed.
The maintenance of records on computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and signatures.
Deficiency: Major (Serious for Labels)
2.6.3 Records are inaccurate.
All entries must be accurate or the record is meaningless. If calculations, time test measured, etc., are not
correct, the box for this deficiency should be checked. Further, as the use of correction fluid and
obliterating a record entry are not proper in the keeping of records, their routine use should be considered
an inaccurate reading and the serious deficiency assigned. This deficiency will also be used for the
compliance of product leaving the firm.
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2.6.4 Records are not available for inspection.
If the firm is unable to supply the requested record(s) in a reasonable amount of time for inspector review,
they are not in compliance with this item. If portions of a record are not available, the firm is not in
compliance with this item. All required records shall be retained at the processing facility or importer's
place of business in the United States for at least 1 year after the date they were prepared in the case of
refrigerated products and for at least 2 years after the date they were prepared in the case of frozen,
preserved, or shelf-stable products.
Records that relate to the general adequacy of equipment or processes being used by a processor,
including the results of scientific studies and evaluations, shall be retained at the processing facility or the
importer's place of business in the United States for at least 2 years after their applicability to the product
being produced at the facility.
If the processing facility is closed for a prolonged period between seasonal packs, or if record storage
capacity is limited on a processing vessel or at a remote processing site, the records may be transferred
to some other reasonably accessible location at the end of the seasonal pack but shall be immediately
returned for official review upon demand.
2.6.5 Documents or records are falsified.
This item is self-explanatory. However, intent on the part of the firm or its representatives must be shown.
For example, if an item on a record was shown to be corrected with correction fluid or other means of
obliteration, the inspector must show that someone with, full knowledge, changed the entry to reflect a
value that was not the value measured or observed. Otherwise, this will be considered an inaccurate
entry.
3.0 Sanitation and Prerequisite Programs
References: 21 CFR Part 507; 21 CFR Part 123.11(b); 50 CFR Parts 260.96-260.104
3.1.0 Sanitation Standard Operating Procedures and Prerequisite Programs
3.1.1 Sanitation standard operating procedures or prerequisite programs not present or not effective.
Each processor shall have and implement a written sanitation standard operating procedure (SSOP) or
similar document that is specific to each location where fish and fishery products are produced. The SSOP
shall specify how the processor would meet those sanitation conditions and practices that are to be
monitored.
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Deficiency: Serious
3.1.2 Sanitation standard operating procedures not followed.
This deficiency will be assessed if it is determined that the firm did not follow their written SSOPs, whether
or not specific sanitation deficiencies were observed.
Deficiency: Serious
3.1.3 Sanitation not monitored.
Each processor shall monitor the conditions and practices during processing with sufficient frequency to
ensure, at a minimum, conformance with those conditions and practices specified in 21 CFR Part 570 and
123 that are both appropriate to the plant and the feed being processed and relate to the following:
1. Safety of the water that comes into contact with feed or feed contact surfaces, or is used in
the manufacture of ice;
2. Condition and cleanliness of feed contact surfaces, including utensils, gloves, and outer
garments;
3. Prevention of cross-contamination from unsanitary objects to feed, feed packaging material,
and other feed contact surfaces, including utensils, gloves, and outer garments, and from raw
product to cooked product;
4. Maintenance of hand washing, hand sanitizing, and toilet facilities;
5. Protection of feed, feed packaging material, and feed contact surfaces from adulteration with
lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other
chemical, physical, and biological contaminants;
6. Proper labeling, storage, and use of toxic compounds;
7. Control of employee health conditions that could result in the microbiological contamination
of feed, feed packaging materials, and feed contact surfaces; and
8. Exclusion of pests from the feed plant.
The firm shall define the applicable frequencies of monitoring in their sanitation standard operating
procedures and must adhere to these frequencies.
Deficiency: Serious
3.2.0 Safety of Process Water
Process water must be of suitable quality as it directly interfaces or becomes part of the product being
manufactured. Therefore, no filth, deleterious chemicals, bacteria, or other contaminants may be present
in solution as it will directly affect the safety or wholesomeness of the product. Available water must pass
potability standards established by federal, state, and local authorities. Water that is supplied to the plant
must meet certain minimum standards. However, processing water must also be reasonably protected in
the facility. Conditions that allow contamination to occur cannot be allowed. These may include cross-
connection of plumbing, back-siphonage, or back flow from a contaminated source to the supply system
or open vessels of water.
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3.2.1 Unsafe or unsanitary water supply.

The water supply, including seawater, will be in compliance when by certification or direct testing the
supply is found to meet the federal standards set forth by the Environmental Protection Agency or the
World Health Organization as applicable. Water used for washing, rinsing, or conveying feed shall be safe
and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying feed if it does
not increase the level of contamination of the feed.
3.2.2 Water potability certificate not current
Private supplies shall have testing performed at a minimum of every six (6) months. Certification of
municipal or community systems should be secured at a minimum of once per year. Where used, seawater
must meet processing use requirements and potability must be tested at a frequency sufficient to ensure
the acceptability of the water source from that geographic area.
Deficiency: Serious
3.2.3 Self water treatment performed improperly.
Where water supply is treated (such as chlorinated, ozone, UV) on premises, equipment must be properly
maintained and/or residual must be within acceptable limits based upon statutory, regulatory, and
requirements of the end-user.
Deficiency: Serious
3.2.4 No protection against backflow, back-siphonage, or other sources of contamination.
A facility will be in compliance when all cross-connections are eliminated, backflow prevention devices
are installed wherever backflow or siphonage may occur, or where other possible forms of contamination
may be present. A diagram or chart of all such devices will be on file for review.
Deficiency: Serious
3.2.5 Inadequate supply of water and hot water.
The water supply shall be sufficient for the operation intended. Plumbing shall be of adequate size and
design and adequately installed and maintained to carry sufficient quantities of water to required
locations throughout the plant. Water shall be sufficient to properly convey sewage and liquid disposable
waste from the plant. Running water at a suitable temperature and under pressure as needed, shall be
provided in all areas where required for processing of feed, for the cleaning of equipment, utensils and
food packaging, or for employee sanitary facilities.
Hot water is necessary for many cleaning techniques. In addition, a hot water supply is necessary to
provide a comfortable means for employees to wash their hands. If the tap is on and a luke-warm supply
of water is present in sufficient quantities for the tasks it will perform in the facility, the plant is in
compliance. The supply must also be easily accessible for its proper use.
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Deficiency: Minor (Lack of hot water)/Major (Lack of sufficient water supply)

3.2.6 Ice not manufactured, handled, or used in a sanitary manner.
A facility will be in compliance when potable water is used for manufacturing ice, when the manufacturing
equipment is clean, and the ice only contacts impervious surfaces; the ice holding containers are clean
and made of appropriate impervious material; handling equipment is clean and appropriate for feed
contact; and ice is properly used. For facilities receiving ice from an outside supply, a certificate of
conformance will be necessary to ensure that the ice being received meets the standards set forth in this
document. In addition, potability checks must be made at a minimum of every six (6) months on ice
received.
Deficiency: Major/Critical
3.2.7 Other areas covered by the CGMPs.
Deficiency: Minor
3.3.0 Feed Contact Surfaces
3.3.1 Equipment and utensils' design, construction, location, or materials cannot be readily cleaned or
sanitized; does not preclude product adulteration or contamination.
Any equipment used in the manufacturing or handling of the feed product must be designed or
constructed so that it can be properly cleaned and inspected. Failure to do so will cause the facility to be
out of compliance. In addition, if the materials used are not of a material suitable for its intended purpose
or there is reuse of single-service items, then the facility is also out of compliance.
Seams on product-contact surfaces shall be smoothly bonded or maintained so as to minimize
accumulation of feed particles, dirt, and organic matter and thus minimize the opportunity for growth of
microorganisms.
All plant equipment and utensils shall be so designed and of such material and workmanship as to be
adequately cleanable, and shall be properly maintained. All equipment should be so installed and
maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Product-contact
surfaces shall be corrosion-resistant when in contact with feed. They shall be made of nontoxic materials
and designed to withstand the environment of their intended use and the action of feed and, if applicable,
cleaning compounds and sanitizing agents. Feed containers and feed-packaging materials that are safe
and suitable are to be used. Product-contact surfaces shall be maintained to protect feed from being
contaminated by any source, including unlawful indirect feed additives.
3.3.2 Equipment and utensils not maintained in proper repair or removed when necessary. (Feed contact
surfaces)
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All feed contact surfaces must be kept in good repair. If the contact surface cannot be repaired, then the
piece of equipment or utensil should be removed so as not to allow for its use. Failure to provide these
conditions will result in non-compliance. Assessment of this deficiency will be made relative to the risk of
the product at that stage of production. For example, if the equipment under consideration is being used
for handling product after a kill step in the process, this product is higher risk and therefore the deviation
is more significant.
Deficiency: Major (Serious for products at a high risk stage of processing)
3.3.3 Feed contact surfaces not cleaned or sanitized before use, after interruptions, or as necessary.
Feed contact surfaces and feed containers must be adequately cleaned using proper techniques to
remove dirt and debris and must be adequately sanitized. Sanitizers must be used before product contacts
the surface. Sanitizing without cleaning is insufficient. Any violation will be considered non-compliance.
Risk should be considered when assessing this deficiency. Product leaving a cooker to be packaged and
frozen will have a higher level of risk than a raw fish at receiving.
3.3.4 Concentrations of cleaners and sanitizers are not effective, safe, or routinely checked.
All sanitizing agents (e.g., hand sanitizers, equipment sanitizers, etc) must be used in the proper
concentration and in the manner prescribed in the usage instructions to be effective.
Deficiency: Major
Deficiency: Minor
3.4.0 Prevention of Cross Contamination
3.4.1 Grounds condition can permit contaminants to enter the facility.
There shall be no conditions on the grounds such as dusty roads or parking lots, standing or ponding water,
chemical spills, etc., that can cause contamination to be carried into the plant through such means as wind
drafts, personnel foot traffic, adherence to personnel clothing, flooding, etc.
Deficiency: Minor/Major
3.4.2 Facility
3.4.2.1 Design, layout of materials used cannot be readily cleaned and sanitized; does not preclude
product contamination. Insufficient lighting for the applicable operation.
25
Design of the facility structure should be such that access is easily obtained to all areas. This is necessary
for proper cleaning and sanitizing of floors, walls and ceilings, as well as for visual inspections. If the rooms
(including restrooms and employee break rooms) in the facility are laid out or designed in such a way that
they cannot be readily cleaned or sanitized, then the facility is not in compliance. This would include
insufficient lighting, improper materials for walls, ceilings, etc., as well as hard-to-reach rooms or corners
even when the equipment is removed from the room.
Deficiency: Major
3.4.2.2 Insufficient separation by space or other means allows product to be adulterated or contaminated.
There must be sufficient separation between different activities in the processing, packaging and handling
of feed products such as 1) separation between activities, 2) layout of facility (employee traffic) 3) product
sequencing and 4) product display. This includes the complete separation of living/sleeping quarters or
heavy maintenance areas from feed-handling areas. The feed product should flow easily from one stage
to another and not be allowed to come into contact with non-feed contact surfaces if exposed. In addition,
the layout of the facility should not be such that product contamination/adulteration is likely due to issues
such as heavy employee traffic through work areas. Production is not organized and scheduled in a
manner which precludes cross-contamination or cross-contact of product by allergens. Adequate
separation can be by physical barrier, time, space, etc. Sanitary handling procedures and processing
methods during operations are to be in place to protect feed against contamination to include physical
protection from airborne contamination.
Feed manufacturing areas and equipment used for manufacturing feed should not be used to
manufacture food products unless there is no reasonable possibility for the contamination of human food.
3.4.3 Condition of roof, ceilings, walls, floors, or lighting not maintained; lights not protected.
3.4.3.1 Areas directly affecting product or packaging material.
For those areas that will directly affect product or primary packaging materials, (packaging immediately
surrounding product), the roof, ceiling, walls, floors, the storage of ingredients or materials that permits
cross-contamination or cross-contact by allergens or ingredients, and lighting fixtures must be maintained
as designed and lights must be protected. Failure to do so causes the facility to be out of compliance.
Deficiency: Serious
3.4.3.2 Other.
For areas in the facility other than in 3.4.3.1 above, the roof, ceilings, walls, floors, or lighting fixtures must
also be maintained as designed. This does not include those areas designated as offices and in which feed
products or primary packaging materials in any stage of production will not be handled or stored.
Deficiency: Major
3.4.4 Cleaning methods permit adulteration or contamination.
26
Employees must take care to use methods that will not adulterate or contaminate the product. Any
cleaning or sanitizing procedures or techniques that may cause the product to become adulterated or
contaminated will cause the facility to be in non-compliance. Examples of non-compliance include but are
not limited to inadvertent touching of product or product surfaces with wash water, detergent, sanitizers,
etc., during production.
Deficiency: Serious (Critical for products at a high risk stage of production)
3.4.5 Finished product/primary packaging material not properly covered or protected.
Finished product must be packaged, covered or protected so as to not permit contamination or
adulteration prior to shipment and during transportation. Primary packaging materials should be
adequately covered when stored or not in use. Failure to provide these conditions will result in non-
compliance.
Deficiency: Major/Serious
3.4.6 Equipment and utensils not maintained in proper repair or removed when necessary. (Non-feed
contact surfaces)
All non-feed contact surfaces should also be maintained in good repair. The facility is in non-compliance
when the maintenance of all additional equipment or areas of equipment and utensils not referred to in
item 3.4.3.1 above is insufficient and may allow indirect product contamination.
Deficiency: Minor (Major for products at a high risk stage of production)
3.4.7 Non-feed contact surfaces, equipment, or areas not cleaned before use.
Non-feed contact areas must also be cleaned prior to use. Areas such as walls, ceilings, floors, as well as
equipment must also be cleaned prior to use. However, sanitizing is not required.
Deficiency: Major
3.4.8 Processing or feed handling personnel do not maintain a high degree of personal cleanliness.
All persons, while in feed preparation or handling areas, shall wear clean outer garments and conform to
hygienic practices while on duty to the extent necessary to prevent contamination or adulteration of feed.
This includes occasional workers or visitors to the area.
3.4.9 Processing or feed handling personnel do not take necessary precautions to prevent adulteration
or contamination of feed.
All persons, while in a feed preparation or handling area, shall:
1. Wash their hands thoroughly to prevent contamination by undesirable microorganisms

before starting work, after each absence from the work station, and at any other time when
the hands may have become soiled or contaminated. After washing, the hands must be
sanitized.
27
2. Remove all insecure jewelry, and when feed is being manipulated by hand, remove from
hands any jewelry that cannot be adequately sanitized or properly covered.
3. If gloves are used in feed handling, maintain them in an intact, clean, and sanitary condition.
Such gloves shall be of an impermeable material except where their usage would be
inappropriate or incompatible with the work involved. If gloves are used they will be washed
and sanitized at the same frequency as employees’ hands as described in number one of this
list.
4. Wear hair nets, caps, masks, or other effective hair restraint. Other persons that may
incidentally enter the processing areas shall comply with this requirement.
5. Not expectorate; nor store clothing or other personal belongings; not eat food or drink
beverages; nor use tobacco in any form in areas where feed or feed ingredients are exposed,
or in areas used for feed processing, storage of feed ingredients and/or packaging materials,
washing of equipment and utensils, or in production areas.
6. Take other necessary precautions to prevent contamination of feeds with microorganisms or
foreign substances including, but not limited to perspiration, hair, cosmetics, tobacco,
chemicals, and medicants.
7. Using sanitary handling procedures during operations to protect feed against contamination,
e.g., picking up dropped feed from the floor.
Deficiency: Minor
3.5.0 Handwashing, Hand Sanitizing, and Toilet Facilities
3.5.1 Hand washing and hand sanitizing stations not present or conveniently located.
Hand washing and hand sanitizing stations must be present and located properly and in sufficient numbers
to provide employees ease of their use. Devices or fixtures, such as water control valves, shall be so
designed and constructed to protect against recontamination of clean, sanitized hands.
Deficiency: Serious (Critical for products at a high risk stage of production)
3.5.2 Improper disposal of toilet waste or sewage.
A facility is in compliance when sewage systems drain properly, are vented to the outside, and are
connected to an approved private septic system or a public septic and/or sewage system.
3.5.3 Inadequate supplies/signs for employees.
28
The restrooms and hand-washing stations must provide supplies such as toilet paper, soap, waste
containers, running water (see 3.2.5), sanitary towel service or suitable drying devices, etc., sufficient to
meet employees’ needs. Readily understandable signs directing employees handling unprotected feed,
feed packaging materials, or feed contact surfaces to wash and sanitize their hands at the proper
frequency. Refuse receptacles shall be constructed and maintained in a manner that protects against
contamination of feed.
3.5.4 Insufficient number of functional toilets.
The facility must have one operable, clean, in good repair, conveniently accessible toilet per fifteen (15)
employees, per gender. For men, urinals may be substituted for toilet bowls, but only to the extent of
one-third (1/3) of the total number of bowls required. Facilities shall be maintained in a sanitary condition
with self-closing doors that do not open directly into areas where feed is exposed to airborne
contamination, except where alternate means of protection have been implemented.
Deficiency: Minor
3.6.0 Protection from Adulteration
3.6.1 Condensation or other deleterious sources present.
Adequate physical protection of feed from adulterants that may drip, drain, or be drawn into the feed
must be in place. Provide adequate physical protection or separation of feed during processing (filling,
packaging, assembling, etc.) to protect from contamination. If any condensation, overhead leaks, water
splash or other conditions occur that may result in the adulteration of product or primary packaging
material, the facility is in non-compliance for this item.
3.6.2 Adequate air exchange does not exist.
A facility is in compliance when adequate air exchange exists to preclude the development of foul odors
or contamination of product.
Deficiency: Minor (Only for products at a high risk stage of production)
Deficiency : Minor
3.7.0 Proper Labeling, Use, and Storage of Toxic Compounds
Plant chemicals are cleaners, sanitizers, rodenticides, insecticides, feed grade machine lubricants, etc.
They must be used according to manufacturer's instructions, have proper labeling, and be stored in a safe
manner or they may pose a risk of contaminating the feed product that the establishment is handling or
manufacturing.
29
A facility will be in compliance when the chemicals are used according to manufacturer's instructions and
recommendations and stored in an area of limited access away from feed handling or manufacturing. All
chemicals must be labeled to show the name of the manufacturer, instructions for use, and the
appropriate EPA approval.
Only the following toxic materials may be used or stored in a plant where feed is processed or exposed:
a) those required to maintain clean and sanitary equipment and surfaces, b) those necessary for use in
laboratory testing procedures, c) those necessary for plant and equipment maintenance and operation,
and d) those necessary for use in the plant’s operations.
3.7.1 Chemical(s) improperly used or handled.
3.7.2 Chemical(s) improperly stored.
Deficiency: Serious
3.7.3 Chemical(s) improperly labeled.
Deficiency: Major
3.7.4 Material Safety Data Sheets (MSDS) not available for all chemicals in use at the facility.
Deficiency: Serious
Deficiency: Minor
3.8.0 Control of Employee Health Conditions
3.8.1 Facility management does not have in effect measures to restrict people with known disease from
contaminating the product.
No person affected by disease in a communicable form, or while a carrier of such disease, or while affected
with boils, sores, infected wounds, or other abnormal sources of microbiological contamination, shall
work in a feed plant in any capacity in which there is a reasonable possibility of feed or feed ingredients
becoming contaminated by such person. Plant management shall require employees to report illness or
injury to supervisors.
Deficiency: Serious
Deficiency: Minor
3.9.0 Exclusion of Pests
The presence of rodents, insects, and other animals in the facility must not be allowed because they are
sources for the contamination of feed with foreign material, filth, and bacteria, etc.
30
3.9.1 Harborage and attractant areas present.

The facility and grounds are free of harborage areas. These include but are not limited to: uncut weeds,
brush or tall grass; improper storage of unused equipment or materials; presence of litter, waste and
refuse; or standing or stagnant water. All garbage and refuse containers are rodent/insect-resistant and
outside storage areas are to be properly constructed. If the plant grounds are bordered by grounds not
under the operator’s control and these grounds are not maintained in a proper manner with regard to
this element, care shall be exercised in the facility to exclude pests that may be a source of contamination
by the means outlined in the other areas of this element.
Deficiency: Major
3.9.2 Pest control measures not effective.
3.9.2.1 Exclusion
Openings to the outside of or within the facility may allow vermin or other pests to enter. Openings and
cracks should be screened or otherwise sealed. Screens must be of a mesh not larger than 1/16th of an
inch in order to exclude insects. Cracks or holes should be sealed and doors and windows should close
tightly (no opening larger than 1/4 ") to exclude rodents or other animals. Air curtains and strip curtains
must be effective. Air curtains shall comply with National Sanitation Standard Number 37 for Air Curtains
for entranceways in feed establishments. Strip curtains must run the entire opening with sufficient overlap
between flaps (1/2 inch). In addition, every effort should be made to keep birds from areas of the plant
where feed is transferred or processed.
Deficiency: Major
3.9.2.2 Extermination
Birds--Nesting areas must be eliminated.
Insects – There should not be a significant number of insects present in the facility. Insect electrocution
devices, when used, must be located near the entranceway. Approved insecticides should be used
whenever insect populations become noticeable.
Rodents – There should not be evidence of rodent activity. Evidence of rodents includes, but is not limited
to: fecal droppings present; urine stains on bags or walls; slide marks along rodent runways; or feeding
areas around stored dry goods bags that may be excessive. The facility should have appropriate rodent
control measures in place. If not, the facility is not in compliance.
3.9.3 Improper disposal of processing waste.
A facility is in compliance with regard to processing wastes when they are placed in proper containers,
placed at appropriate locations throughout the plant, and removed frequently.
31
Deficiency: Serious
3.9.4 Inadequate housekeeping.
Any excess clutter in production areas, employee areas, or other areas of the facility will cause the facility
to be in non-compliance. This does not include those areas designated as office areas.
Deficiency: Minor
3.9.5 No written pest control program.
Self-explanatory. Diagrams of bait station locations at the facility shall be maintained and kept available
for review.
Deficiency: Serious
3.9.6 Pesticides not applied by a licensed individual.
Self-explanatory. However, in some locations, particularly outside the United States, licensing is not
performed. In such instances the application shall be performed by a trained individual.
Deficiency: Serious
Deficiency: Minor
32
Systems Criteria Rating

33
34
Feed Audit Template
Audit Report
Facility
(Place the full legal business
name of the firm here.) (In this box of the template, place a picture of the front of the business or a
picture of the firm’s logo. Do not include any photos with personnel,
Site Visit Dates yourself, team members, or product in this area. If no appropriate photo
(List the range of the actual exists, leave the box blank.)
dates of the site.)
Lead Auditor
(Place the name of the lead
auditor, title, phone number
and email)
Purpose
To determine if the feed safety system meets U.S. Food and Drug Administration (FDA) requirements (21
CFR part 123 and 21 CFR 507) and if the system meets USDC NOAA Seafood Inspection Program Fishery
Byproducts (not for human consumption) requirements.
35
Scope
Surveillance Audit--All program requirements, documentation, records, work procedures, and facility
operations under the firm's financial and operational control and as referenced in their HACCP plan for
the applicable fishery products.
References
Applicable FDA regulations, including but not limited to:
• 21 CFR part 123 Fish and Fishery Products
• 21 CFR 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals.)
• 21 CFR part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Human Food
• 21 CFR 509 Unavoidable Contaminants in Animal Food and Food Packaging Material
• Fish and Fisheries Product Hazards and Controls Guidance 4th Edition April 2011
• NOAA Manual 25 Seafood Inspection Program
The audit team, consisting of employees of the Seafood Inspection Program of the United States
Department of Commerce, was requested to verify the accuracy, validity, and the implementation of the
feed safety plan at the [FACILITY NAME] facility in [STATE of COUNTRY]. The request was made and the
audit was performed on behalf of the Seafood Inspection Program.
(Example language. However keep the introduction simple. It is not necessary here to add operations
information on the facility.)
Methodology
Upon arrival at the firm, the opening meeting was performed by procedure and was attended by the audit
team and [LIST ATTENDEES]. The firm’s feed safety plan was received at the start of the site visit and an
audit was performed. The audit plan included evaluation of the firm’s hazard analysis, critical control
points (implementation, accuracy, efficacy), sanitation standard operating procedures, verification
procedures, and record keeping. Where possible, observations were verified by interviews, records,
photographs, or testing. After gaining all necessary objective evidence, findings were developed and are
listed below.
(This is template language and should be adapted to fit the audit. It is designed for a general description
of the methods of obtaining evidence of the audit only. In addition only include those tests and evaluations
actually performed such as NSIL lab samples.)
36
Findings
(listed in order of significance)
(In this section list out the findings providing sufficient information in which to lead a reader to understand
the scope of the issue, the evidence found, and the conclusions of the auditor, including why the decision
was made to assess a deficiency. An example of a write up is found below. Photographs can be placed in
a way to illustrate and define the issue. Be sure to caption the photograph and keep the statements to
fact. Justify paragraphs for the entire report to both sides and keep margins to a minimum of 1 inch.)
Finished product/primary packaging material not properly covered or protected.

The protective cover for the auger that transfers finished fishmeal from the press and the dryer has an
opening between two of its panels. Fishmeal traveling through this area have received a thermal process
and is now considered sterile. Openings of the nature described above may allow contaminants to come
into direct contact with the sterile fishmeal and thus become a source of post thermal contamination. All
openings should be eliminated in order to prevent product contamination. 3.4.5 Serious
Gap observed in the protective cover of the auger

37
Observations
Harborage and attractant areas present

Dry storage had all materials pushed up against the wall. This
not only prohibits effective sanitation control, but pests can find
harborage in the tight areas. 3.9.1 Major
Insufficient space between the wall

and packaging
Summary and Conclusions

(This is template language and should not be changed.)
The USDC Seafood Inspection Program conducted an audit on [FACILITY] located in [CITY, PROVINCE,
COUNTRY] from [DATES OF AUDIT]. This audit included an examination of the company’s feed safety plan
for the receipt, processing, and packaging of [PRODUCTS] and the operation of the plan, including
sanitation standard operating procedures, for compliance with the applicable sections of the U.S. Food
and Drug Administration (USFDA) regulations addressing “Procedures for the Safe and Sanitary Processing
and Importing of Fish and Fishery Products (21 CFR Parts 123 and 507). Based on this audit we have
concluded that:
● The firm has implemented a feed safety system that complies with the requirements of the U.S.
Food and Drug Administration (21 CFR part 123 and 21 CFR 507) and the USDC NOAA Seafood
Inspection Fishery Byproducts Program (not for human consumption).
● The firm produced product that meets the specifications of [FIRM NAME] as identified on [DATE].
(This statement should also reflect when the firm is out of compliance with the above stated
references. The auditor does not state a failure of the system )
The USDC Seafood Inspection Program can only provide such attestations on an audit-by-audit basis, as
an audit is a picture in time. It is believed that if the firm follows the HACCP plan as written, there is a
reasonable expectation that the products described above and produced by this firm will be acceptable
for export from the United States. This report, or any statements therein, is not a certification or approval
of a specific lot of product. It is only a report on the viability of the system and the processes in place.
38
Corrective Action Request

Corrective action is necessary to improve the process or to bring the system back into control. Even if the
firm does not desire to proceed with another audit or continue with the Program, it is still highly
recommended that management provide a written corrective action plan to this agency for inclusion in
the report. In this way, the firm's commitment to feed safety and its due diligence in correcting
deficiencies could be documented. As no findings exist, no corrective action is necessary. (This last
sentence is added only if true.)
Please provide a written corrective action to the findings listed above. Be certain to include both short-
term solutions as well as long term more permanent solutions to each issue.
With respect to continued improvement, we have also enclosed the Systems Compliance Rating to this
report, which contains information of observed sanitation deficiencies noted during the course of this
audit.
Supplemental Report
(In this section you are to give a general idea of the controls evaluated and found. The narrative below is
an example of the level of detail expected. Attempt to give statements of fact but you may also indicate
other issues, positive and negative, found during your audit.)
Management Controls and Responsibilities
The element of management controls and responsibilities was evaluated through interview,
documentation review, and records assessment. The firm takes reasonable care to place necessary
procedures in writing for consistency. Management commitment to feed safety is implemented or
communicated through posted memos and staff meetings. The feed safety policy has been prepared and
implementation was demonstrated. Responsibility or authority for feed safety is clearly defined and
communicated, and a feed safety team leader is in place which reports to top management. Effective
external and internal communication is established, implemented, and maintained. Emergency response
procedures have not yet been established. Management review is properly performed and documented
through memos to staff and meeting notes. The necessary human resource competencies have been
minimally identified. Personnel have received training necessary for the proper function of the feed
system and the training is documented. The infrastructure to implement and maintain the feed safety
system is sufficient. The work environment is properly established, managed, and maintained with regard
to feed safety. Continuous improvement activities are minimally performed.
Feed Safety Management
The firm’s feed safety plan was reviewed at the start of the site visit by the audit team. All elements of
the HACCP Plan were developed correctly and implemented properly and the firm’s plan was signed and
dated within the last year. Traceability is maintained sufficient to perform a mock recall. The firm’s record
keeping system is fully acceptable with the employees competent in their abilities and responsibilities.
39
Sanitation and Prerequisite Programs
Sanitation standard operating procedures (covering the eight areas of sanitation listed in 21CFR Part 123
and 21CFR Part 507) and acceptable prerequisite programs were in place. The auditor found that
sanitation monitoring occurs daily with observations recorded within the Fishmeal Sanitation Inspection
Log. The water used for processing within the facility is provided by the [NAME AND LOCATION OF FIRM,
MUNICIPALITY ETC.]. The city releases an annual report detailing the overall quality of the water. A review
of the most recent report found that water supplied by the city meets the requirements as set forth by
the Environmental Protection Agency.
Chapter 6 -Certification
Requests for export certification of aquatic animal by-products not intended for human consumption are
processed by the Seafood Inspection Program. Certificates are issued after verification that all U.S.
requirements are met along with any specific requirements of the importing country. Certification must
be issued prior to export from the U.S.
For certification to China please use the Seafood Inspection Program Online Services Portal
(SISP): https://seafoodinspection.nmfs.noaa.gov/customer/customerlogin.html
For export certification to all other destinations please Send the export request form (see below
in Additional Resources) to nmfs.nsil.fm.export@noaa.gov.
There are three approaches used for certification
1. End item sampling and testing is required by certain export destinations. In this case, all
certification requests must be accompanied by satisfactory lab results performed by NSIL or an
approved third party laboratory.
2. NOAA SIP Fishery By-product Approved Establishment based on the system of control at the firm.
The system must be validated by a NOAA SIP audit and the collection of verification samples.
3. Annual Consultative Audit Inspection - NOAA SIP audits may be requested to meet country specific
export requirements. Under this type of service, a facility receives an audit report that can be
used by USDC or other government agencies to verify specific compliance for export certification.
Chapter 7 -Destination Specific Requirements

European Union (EU)
The EU requires facilities exporting fishmeal or oil under Regulations 1069/2009 and 142/2011 to be listed
on TRACES. Fishmeal and oil must be produced and shipped from facilities listed on TRACES in order to
be imported into the EU. Inclusion of US fishmeal and oil facilities on TRACES requires participation as an
Approved Establishment for Fishery By-products in the NOAA Fisheries Seafood Inspection Program, and
an approved process validation.
TRACES listing information is available on the EU’s website at:

https://webgate.ec.europa.eu/tracesnt/directory/publication/establishment/index#!/search?countryCo
de=US&sort=classificationSection.translation.
Exporters should have their importers confirm with the pertinent EU border inspection post (BIP)
authorities that all requirements for entry of the consignment have been met prior to shipment. This
includes verifying that all necessary information (in the interpretation of the BIP related to the specific
40
materials to be in the consignment) is posted on TRACES and that all required

documentation (e.g. export certificates) is available and satisfactory to the BIP.
Individual EU countries may have different or additional requirements than EU
requirements.
A certificate “for processed animal protein not intended for human

consumption,” according to the model listed in Regulation 1069/2009 and its
implementing Regulation 142/2011 (Chapter 1 certificate), must accompany U.S.
exports of fishmeal. For U.S. exporters, NSIL issues this certificate. Fishmeal
exports intended for the EU must be produced by EU - approved establishments.
The list of U.S. approved animal by-products establishments can be found
through the link: ttps://www.fisheries.noaa.gov/national/seafood-commerce-
certification/foreign-approved-lists
Shipments of fish oil not intended for human consumption are controlled by
different legislations and must be accompanied by a certificate according to the
regulation described in Regulation 142/2011 - Chapter 9 certificate - mentioned
above. For a complete overview of fish oil import requirements into the EU, see
link below:
https://ec.europa.eu/food/sites/food/files/animals/docs/bips_guidance_fish-
oil_en.pdf
EU Export Health Certificates for fisheries products not intended for human
consumption will only be issued if the product meets the following minimum requirements based upon
audit findings of the Seafood Inspection Program.
Minimum EU Export Requirements for Fish Meal:
To meet regulations for export of processed proteins to the EU, the processed animal protein or product
must contain exclusively processed animal protein not intended for human consumption that:
● has been prepared and stored in a plant approved, validated and supervised by the competent
authority in accordance with Regulation (EC) No 1069/2009;
● has been prepared exclusively with the animal by-products of aquatic animals, and parts of such
animals, except sea mammals, which did not show any signs of diseases communicable to humans
or animals;
● has an approved process validation method 7 in Chapter III of Annex IV to Regulation (EU) No
142/2011 ;
● each lot or consignment has been examined by the competent authority, where a random sample
is taken immediately prior to dispatch and found to comply with the following standards:
○ Salmonella: Absence in 25g: n=5, c=0, m=0, M=0
○ Enterobacteriaceae: n=5, c=2, m=10, M=300 in 1 g;
● the product has undergone all precautions to avoid recontamination with pathogenic agents after
treatment
● the end product has been packed in new or sterilized bags or transported in bulk in containers or
other means of transport that were thoroughly cleaned and disinfected with a disinfectant
approved by the competent authority before use which bear labels indicating “NOT FOR HUMAN
CONSUMPTION”; and
● The end product was stored in enclosed storage.
41
Minimum EU Export Requirements for Fish Oil:
To meet the regulations for export of fish oil to the EU, the fish oil must:
● consist of fish oil that satisfy the health requirements below;

● contain exclusively fish oil not intended for human consumption;
● be prepared and stored in a dedicated fish plant approved, validated and supervised by the
competent authority in accordance with Regulation (EC) No 1069/2009;
● has been prepared exclusively with fish or other aquatic animals, except sea mammals, which
did not show any signs of diseases communicable to humans or animals or animal by-products
of aquatic animals originating from plants or establishments manufacturing products for human
consumption;
● the fish oil has been subjected to processing in order to kill pathogenic agents and has not been
in contact with other types of oils including rendered fats from other animal species;
● the fish oil must be traceable to laboratory analysis indicating compliance with the following
standards:
○ Salmonella: Absence in 25g: n=5, c=0, m=0, M=0
○ Enterobacteriaceae: n=5, c=2, m=10, M=300 in 1 gram.
● is packaged in new containers or in containers that have been cleaned and all precautions taken
to prevent their contamination or where bulk transport is intended, the pipe, pumps, and bulk
tanks and any other bulk container or bulk road tanker used in the transportation of the product
from the manufacturing plant either directly on the ship or into shore tanks or directed to plants
have been inspected and found to be clean before use; and
● bears labels indicating “NOT FOR HUMAN CONSUMPTION”
Canada
Canada requires facilities that intend to export animal products and by-products defined as rendered
products by CFIA to complete a CFIA facility questionnaire. The purpose of the Questionnaire is to identify
ruminants and/or SRM cross contamination risks. An annual on-site audit by the endorsing NOAA SIP is
required to verify that the information provided within the questionnaire is complete and accurate as
presented. The audit to facilitate issuance of the questionnaire must be done both within 6 months of the
questionnaire request and within the same calendar year. The facilities management controls and
responsibilities; feed safety programs; sanitation and prerequisite programs will be audited according to
the Policies, Procedures, and Requirements for the Approval of Facilities and Systems (available on the
SIP website). During the audit, a minimum of 5 verification samples collected randomly from multiple lots
of finished product will be collected aseptically by SIP auditors and sent to the National Seafood Inspection
Laboratory to test for Salmonella and Enterobacteriaceae.
Please read and follow the instructions found within the CFIA Facility Questionnaire for Animal Products
and Animal By-Products (APABP) document and submit the completed questionnaire to the appropriate
CFIA office, along with the import permit application required.
http://www.inspection.gc.ca/animals/terrestrial-animals/imports/policies/animal-products-and-by-
products/2002-10/facility-questionnaire/eng/1448237170015/1448237170920
Note: No questionnaire is required for fish oil. A completed questionnaire is required for all other
commodities listed as "rendered products" within the import policy: TAHD-DSAT-IE-2002-10-10
Animal Health Import Requirements for Raw Inedible Products and Rendered products.
42
Directions for completing the Questionnaire:

● The requestor should fill out the latest PDF version of the questionnaire, which can be found in
the link above. The requesting firm must provide the questionnaire to the auditor when they
arrive at the facility for the audit. Additional copies of the questionnaire can be completed for
the cost of $145.00 per copy.
● The facility audit and verification of the information on the questionnaire will be billed by the
SIP auditor. This is separate from the completion of the questionnaire which will be finalized and
billed by NSIL.
● The auditor will review and verify the information provided on the questionnaire. After verifying
the information the auditor will fill out Page 6: Date of annual inspection.
● The auditor does not sign the fields for the full-time, salaried veterinarian or apply a stamp to
the questionnaire.
● The auditor will get the following information from the requestor for NSIL to complete and bill
for the questionnaire.
● Bill information
● Address for completed questionnaire to be mailed to
● The auditor will send the questionnaire, billing information, and forwarding address to the
address below via FedEx or UPS. Also notify the NOAA veterinarian via email
(NMFS.NSIL.FM.EXPORT@NOAA.GOV) that a questionnaire will be sent.
National Seafood Inspection Laboratory
ATTN: NOAA Veterinarian
3209 Frederic Street
Pascagoula, MS 39567
● NSIL will review the questionnaire and submit the final bill before the Veterinarian signs, stamp
and send the completed questionnaire and any additional copies requested, and a copy of the
final NSIL bill to the requestor.
Testing for ruminant protein: For facilities that handle only fisheries products, PCR testing (by a laboratory
approved by APHIS or NSIL) for ruminant protein will be required annually. For facilities that handle other
animal proteins as well as fisheries products, PCR analysis for ruminant proteins will be required for each
shipment of fishmeal to Canada.
Certificate Requirements
All fishmeal, fish oil, and other aquatic animal proteins (used as feed and feed additives) to be exported
from the United States to Canada must meet the requirements listed above. A statement indicating “no
cross contamination with proteins other than fish” is required on each certificate issued. For facilities that
only handle or store fishmeal for export to Canada, certificates may be based upon an USDC annual audit
program.
Export certification to Canada for reprocessing and re-export to EU requires the firm must have a current
Questionnaire and be listed in traces.
43
Chile
The export requirement for Chile is a Certificate of Origin. The firm must be in good standing with the U.S.
FDA. In addition, if the raw materials are foreign sourced, then the firm must provide Legal Harvest
documentation.
Chile does not require an Export Health Certificate. Upon request, export health certification will be
provided to SIP Approved Establishments for Fishery By-products.
China
China requires facilities to implement HACCP and have a system to ensure the recall and traceability of
products. Products must meet the requirements of the United States and be allowed for free sale.
Effective July 1, 2012 all fish meal, fish oil, and other aquatic animal proteins (used as feed and feed
additives) to be exported from the United States to the People’s Republic of China (PRC) must meet the
requirements of General Administration of Customs People’s Republic of China (GACC) No. 118 Decree.
According to this decree all manufacturing facilities that produce feed and feed additives must be
registered with GACC. In order to be registered with GACC, a facility must SIP Approved Establishment
for Fishery By-products and be approved to export to PRC. Approval will only be given if all hygiene and
quarantine requirements of the PRC for imports of fish oil, fish meal and other aquatic animal proteins
are met. Upon approval, the SIP will add the facility to the list of approved facilities provided to GACC.
https://www.fisheries.noaa.gov/national/seafood-commerce-certification/foreign-approved-lists
SIP Requirements:
Facilities wishing to export fish meal, fish oil, and other aquatic animal proteins to the PRC must be a SIP
Approved Establishment for Fishery By-products not intended for human consumption and must provide
the required laboratory analysis for each shipment.
Certification Requirements
Export certificates for fishery by-product to the PRC will only be issued by SIP if the facility is approved for
export based upon compliance with PRC requirements as indicated by audit reports and laboratory testing
results including five randomly selected samples (200g of dry product or 8oz of liquid product each)
collected from each lot/consignment of product designated for export. The request for inspection and
results from third party laboratories must be submitted via email to NMFS.SI.Fishmeal@noaa.gov prior
to any export documentation being issued. All laboratory results and audit reports will be reviewed by
the SIP Regional Office responsible for issuing export certification to verify compliance with all PRC and
SIP requirements.
How to obtain certification to China
For certification to China please use the Seafood Inspection Program Online Services Portal (SISP):
https://seafoodinspection.nmfs.noaa.gov/customer/customerlogin.html
● Obtain the appropriate laboratory analysis for shipment. Verification that each shipment meets
the import country regulations will be done by SIP prior to issuance of the export documentation.
● Obtain and complete the Request for Certification / Fishmeal Exports (available online or from
the local SIP inspection office).
44
● Forward the completed form to: NMFS.SI.Fishmeal@noaa.gov within the same email forward all
3rd party laboratory reports or NOAA/NSIL reports that support the shipment requirements to
the destination country. All reports must identify “Lots sampled to the Lots being shipped.”
● When submitting the request, make sure to use the following instruction to label the subject line
in the email message: Company Name AND Facility FEI Number, country of destination, then use
A-Z to mark multiple shipments on a single day. Example: Roberts Fish House, #3014244321,
China, A Please make sure to use the correct FEI or CFN # listed officially on the Country of
Destination Approved Fishmeal Exporter List
● Allow up to 72 business hours for completion of documentation.
● All certificates will be delivered overnight via UPS unless otherwise noted.
Product Requirements
Raw materials used to produce fish oil, fishmeal or other aquatic animal proteins may be aquatic animals
caught in domestic waters or in the open sea; aquaculture animals; or by-products from plants
manufacturing aquatic products for human consumption.
Aquatic animals killed for disease eradication cannot be used as raw materials.
The product must not contain any ingredients of non-aquatic animals and must not be contaminated by
any products of animal origin from third countries. Products must be subjected to a heat treatment of at
least 85C for 15 minutes or other time/temperature combinations that have been validated to be
equivalent. Effective measures must be taken to prevent contamination both during and post processing.
Fish oil, fishmeal must not contain hazardous substances which pose a risk to public or animal health and
must be in compliance with the safety and hygiene standards listed below. All fish oil, fishmeal or other
aquatic animal proteins intended for export to the PRC must be tested and found to be negative for
ruminant proteins by PCR or other effective methods. Products for export must meet the following
microbiological requirements: Salmonella: Absent in 25 g: n=5, c=0, m=0, M=0, Enterobacteriaceae: n=5,
c=2, m=10, M=300 in 1 g.
The end product must be packaged in new, clean, sealed, impermeable, moisture resistant and not easily
broken materials and labeled in compliance with standards set by the PRC; or for bulk shipments, the
containers or other means of transport should be thoroughly cleaned and disinfected with a disinfectant
approved by the competent authority before use.
Each shipment must be accompanied with an original export health certificate.
Laboratory Testing Requirements:

Fishery By-product for export to the PRC must be in compliance with the PRC Hygiene standards listed
below and be tested at the frequency indicated. These tests may be performed by a third party laboratory
that has been recognized by the National Seafood Inspection Laboratory as a laboratory accredited against
ISO standards for the specific analyses being performed.
45
TESTING REQUIREMENTS FOR MEAL:

Test Criteria Frequency
Mercury ≤ 0.5 mg/kg Annually
Cadmium (Cd) ≤ 2.0 mg/kg Annually
Lead ≤ 10 mg/kg Annually
Chromium (Cr) ≤ 8 mg/kg Annually
Arsenic (As) ≤ 10 mg/kg Annually
Total count of mold ≤ 20000 cfu/g Annually
Salmonella Absence in 25 g: n = 5, c = 0, m = 0, M = 0 * During audits & Each

Lot/Consignment
Shigella Not detected Annually
Enterobacteriaceae n = 5, c = 2, m = 10, M = 300 in 1 g (Results may be During audits & Each

expressed as CFU/g or MPN/g depending upon Lot/Consignment
method of analysis) *
Total plate count ≤ 2,000,000 cfu/g Annually
Melamine ≤ 2.0 mg/kg Annually
Malachite green Not detected **
Dioxin ≤ 1.25 ng/kg Annually

46
TESTING REQUIREMENTS FOR OIL:

Salmonella Not detected in 25g; Each Audit
n=5, c=0, m=0, M=0 *
Enterobacteriaceae n = 5, c = 2, m = 10, M = 300 in 1 g * Each Audit
Malachite green Not detected **
Dioxin ≤ 6.0 ng/kg Each audit
* n = number of samples to be tested; m = threshold value for the number of bacteria; the result is
considered satisfactory if the number of bacteria in all samples does not exceed m; M =maximum value
for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or
more samples is M or more; and c = number of samples the bacterial count of which may be between m
and M, the samples still being considered acceptable if the bacterial count of the other samples is m or
less.
** Not required for wild caught fish. Annually for aquaculture fish.
Note: As long as fish oil has been properly heat treated and processing CCPs are met, microbiological
testing is not required for facilities intending to ship to PRC.
Testing for ruminant protein: For facilities that handle only fisheries products, PCR testing (by a
laboratory approved by APHIS) for ruminant protein will be required annually. For facilities that handle
other animal proteins as well as fisheries products, PCR analysis for ruminant proteins will be required for
each shipment of fish meal to the PRC.
Verification Testing and Monitoring: In addition to third party laboratory testing, verification
sampling/testing and monitoring will be conducted in Federal Laboratories. The National Seafood
Inspection Laboratory (NSIL) will analyze verification samples collected by SIP auditors for microbiological
analysis including Salmonella, Enterobacteriaceae, Mold, and Total Plate Count. Test results from the
Food and Drug Administration’s Feed Contaminants Program, Feed Manufacturing compliance Program,
Illegal Drug Residue Program, and BSE/Ruminant Feed Ban Inspections will also be used as additional
verification of the safety and wholesomeness of the feed supply.
Japan
Japan export certification requires fishmeal to be produced in a processing plant dedicated only to
fishmeal production where no material of animal origin other than fish and shellfish protein of U.S. origin
is being processed and the fishmeal must be transported in a manner to avoid commingling with other
animal proteins. In addition, export health certification for fishery by-products not intended for human
consumption will only be provided to facilities that are NOAA SIP fishery By-product Approved
Establishments.
47
Peru
Peru export certification for fishery by-product requires that the facility produce aquatic animal products
only. Export health certification for fishery by-products not intended for human consumption will only be
provided to facilities that are NOAA SIP fishery By-product Approved Establishments.
In addition, the facility audit scope must determine compliance with the below statements. If the firm
ships without export health certification then the audit frequency is reduced to annual.
The fishery by-product
● material is derived only from animals that have never been in any region listed in9 CFR 94.18(A):
SEC. 94.18 restrictions on importation of meat and edible products from ruminants due to
bovine spongiform encephalopathy. See link https://www.ecfr.gov/cgi-bin/text-
idx?SID=f82aa5c70f867dbef6169c9299b93e23&mc=true&node=se9.1.94_118&rgn=div8
● were caught and handled on board vessels and were landed, handled and where appropriate
prepared, processed, frozen, thawed, packaged, marked, stored and transported hygienically
and in compliance with the relevant United States public health standards requirements of the
Code of Federal Regulation which have been recognized for this purpose as equivalent to the
European Community standards as prescribed in Council Decision 98/258/EC,
● have satisfactorily undergone health controls and organoleptic, parasitological, chemical, and
microbiological checks laid down for certain categories of fishery in compliance with the
relevant United States public health standards requirements of the Code of Federal Regulation
which have been recognized for this purpose as equivalent to the European Community
standards as prescribed in Council Decision 98/258/EC,
● do not come from toxic species or species containing biotoxins;
Chapter 8 - Sample Collection and Submission of Aquatic Animal By-

products (not intended for human consumption) to NSIL for Laboratory
Analysis
Note: For questions regarding by-products sample collection and/or submission, please contact:
Judy Stone (228) 762-8964 or
Johnathan Likens NSIL.Sample.Custodian@noaa.gov
Introduction
The USDC Aquatic Animal By-Products Inspection Program is a cooperative effort between the Seafood
Inspection Program (SIP) and the National Seafood Inspection Laboratory (NSIL). Surveillance samples of
fisheries by-products (not intended for human consumption) are collected from facilities participating in
the program and sent to NSIL as verification of the facilities sanitation and HACCP plans. Also, in order
to meet federal regulatory and foreign country import requirements, the collection of samples will be
conducted two times a year or within an operation season of product to be certified for export. This
document describes the procedure for submission of fisheries by-product samples to NSIL by SIP
inspectors. NSIL will email the results to the CSOs/CSIs collecting the samples and their immediate
supervisor and attach to the appropriate row in SmartSheets within 21 calendar days of receipt.
48
Samples are collected aseptically by SIP inspectors and submitted to NSIL via overnight carrier, U.S.
Postal Service, or delivered to the NSIL in person. Samples submitted to the NSIL for bacteriological
analyses provide a level of assurance regarding the absence or amount of certain possible hazards that
may be associated with the production of aquatic animal by-products. All samples are analyzed for
Salmonella and Enterobacteriaceae. Once a year, samples from each facility participating in the
program are also analyzed for Total Plate Count, Yeast & Mold and ruminant proteins. The objective for
the CSOs/CSIs is to obtain a representative sample of the product present at the time of the audit using
care and techniques to avoid sample contamination by microorganisms during the sampling procedures.
CSOs/CSIs should be familiar with aseptic sampling techniques through previous training, i.e. FDA
satellite downlink video entitled “Food Microbiological Control” and review these techniques prior to
collecting samples. The Technical Services Branch Training Section has made these videos available to
the field offices. Appropriate measures must be taken to prevent any sample contamination and
microbial growth or death during the handling, storage and transport of the samples to the laboratory.
Specific sampling technique questions should be directed to the NSIL.
CSOs/CSIs should observe all safety precautions implemented by the facility when collecting samples
and all other safety regulations of the Seafood Inspection Program. All samples shipped to NSIL should
be shipped following any relevant Department of Transportation regulations.
General Directions and Supplies

The supervisory offices in each Region will purchase and store the items necessary to collect samples as
well as sterile bags/jars to ship samples to NSIL. For sampling of liquid products such as fish oil, the
company may need to supply sampling equipment to collect samples from large containers or tanks. The
CSO/CSI should make sure that all sampling equipment is sanitized appropriately before use.
Standard or typical items needed for aseptic sampling include:
Sterile Containers - Sterile single use whirl-pak bags, jars or other suitable vessel capable of holding at
least 200g of dry product or 8oz of liquid product each for shipping samples. (New, non-sterile jars for
fish oil collection may be used if no other are available).
Collecting Equipment - Sterile scoops, sterile gloves, sterile probes, or other suitable sample collection
tools, sterile knives or scalpels, disposable sterile scalpel blades.
Shipping Boxes
Plastic Bags – Plastic bags for packing each lot of samples and for collecting trash during sampling.
Labels and marker – Permanent markers and waterproof labels
Sterilizing agents – Alcohol wipes, other disinfectant wipes, solution for sanitizing hands or surfaces,
alcohol container with screw-type lid with isopropyl alcohol
49
Sample Numbers and Sample Sizes

Verification Samples: Verification samples are collected at each audit where finished product is
available. A minimum of 5 random samples (200g of dry product or 8oz of liquid product each) must be
collected. The samples should be representative of the product available at the facility.
Lot Samples: Five randomly selected samples (200g of dry product or 8oz of liquid product each) are
collected from each lot/consignment of product designated for export.
Sample Collection
Prior to sample collection, the responsible company representative should be notified of the intent to
collect samples and be told why it is a necessary verification aspect of the program. The CSO/CSI should
offer to take duplicate samples for the company.
After requesting to sample product, the CSO/CSI should make sure that all sample collection equipment
is available; should don clean protective clothing such as a lab coat, hat or hairnet; and wash and
sanitize hands.
Bulk Product: When sampling product stored in bulk, samples should be representative of the finished
product in the warehouse/storage container or specific lot to be tested. For dry, bulk product, using a
sterile scoop, scrape the surface (approximately 6 inches) of dry product away to allow access to
product a few inches into the pile. Collect product from the designated area and place in a sterile
sampling container. The sample collection location should be recorded on the warehouse map provided
by the company or designated by the CSO/CSI. A new sterile scoop and sample collection container
must be used for each sample collected. If possible, for liquid products stored in bulk, samples should
be collected using sampling devices provided by the company. If suitable sterile sampling devices are
not provided, the CSO/CSI should make arrangements to order appropriate disposable sterile sampling
equipment for the tank or vessel holding the liquid.
Packaged Product: If possible, samples should be collected of finished product prior to bagging or
packaging. If collecting samples in storage, collect from different pallets and pallet locations. When
collecting samples “on-line” , pre-label the sterile containers and have “on-line” personnel place the
sample from the line into the sterile container without touching the inside of the container. On
completion of filling, the sterile container should be closed and stored as appropriate. If product
material is not available before packaging, the CSO/CSI must collect the required number of samples
aseptically. Randomly collect the required number of larger packages from the storage area and move
them to a clean location, such as the QC lab. Place the package upon a previously cleaned and sanitized
counter top. The package surface to be opened should be wiped with an alcohol wipe to remove
surface contamination. Carefully open the cleaned area of the package with a sterile knife or scalpel.
Remove product using sterile gloves or scoops and place in sterile sample bags. Care should be taken to
avoid contact of the product with the outside of the container or non-sterile handling equipment. After
filling the collection container, promptly seal it to avoid contamination. Place all sample bags collected
50
from the facility or a specific lot of product into a separate large plastic bag prior to shipping. Gloves
and knives or scalpel blades and collection equipment should be changed between each sample being
collected. Prepare samples for shipment to the laboratory and return the opened packages to the
processing line or responsible company personnel.
NOTE: Due to the changing types of aquatic animal by-products requiring microbiological analysis, the
sample collection guidelines listed here may not be suitable for all types of samples and all storage
conditions. It is advisable to discuss the storage conditions of the product and determine the appropriate
sampling equipment needed prior to the audit. Contact NSIL if there are questions concerning how to
collect the samples.
Labeling Sample Containers

Labels should be filled out prior to sampling with the following information:
a. Company name
b. Product lot/code number
c. Sample number
d. Sample Date
e. Name of individual collecting samples
If sample containers are “write-on” sterile plastic bags, this information can be written directly on the
bags without using labels.
Information Form
The individual collecting the samples must completely fill out the National Seafood Inspection Lab
Sample Information Form for Aquatic Animal By-Products Not Intended for Human Consumption using
the following instructions:
Company Information
Company Full Name: Write the company’s full name (include vessel or plant name if applicable) as it
appears in the USDC Approved Establishments. If the company does not appear in the list, write the
company’s full name so that it will appear correctly in the NSIL database.
Company Contact’s Full Name: The company contact should be the company’s contact to address any
questions concerning the samples collected.
Company Location Address: Write the facility’s physical sampling location address as written in the
USDC Approved Establishments. If not on the list, write the address of the specific facility location from
which the samples were collected.
Company Contact’s Title, Phone Number and email address: Questions concerning the sample and
laboratory results will be submitted to the CSO/CSI collecting the samples, but we would also like to
have the contact information for someone at the company from which the samples were collected.
Full Name and Signature of Company’s Representative Acknowledging Samples were collected for
Analysis: Print the name and have the individual from the company that is present during the sampling
sign the form to acknowledge that samples were collected.
51
Product Information
Product State (√): Indicate the condition of the sample when it was shipped to NSIL.
Reason for Sample Submission (√): Indicate the reason for sample submission such as
audit/surveillance, lot/export certification, or other.
Product’s Full Description: Provide as much information about the product as possible including the
type (fish meal, fish oil, frozen fish scrap, etc.).
Product Packaging (√): Place a check mark next to the appropriate packaging.
Ingredient Statement (or attach label to back of information form): Include all ingredients listed.
Pack Date: Indicate the date the product was packaged.
Lot Size: Indicate units of mass (i.e. kg or MT)
Lot Number(s): It is important that the lot or code numbers provided allow trace back of the product in
case the submitted samples fail analysis.
Sample Information
Sample Date: Include the date the sample was collected.
Sample Size: Indicate the number of sub sample provided.
Sample Unit: Indicate the approximate number of grams of dry product or ounces of liquid product
collected of each sample (200g of dry product or 8oz of liquid product).
Name of CSO/CSI’s Immediate Supervisor: Write the name of your immediate supervisor. If a
submitted sample fails analyses, it is the laboratory’s responsibility to contact the supervisor in order
that he/she can take appropriate action.
Immediate Supervisor’s Telephone/email address: Write your immediate supervisor’s telephone and
email address. If a submitted sample fails analyses, it is the laboratory’s responsibility to contact he
supervisor via telephone and to forward analytical results via fax or email in order that he/she can take
appropriate action
Full Name of CSO/CSI Collecting Samples: Write your full name.
CSO/CSI’s Telephone/email address: Include your telephone and email address so that we can contact
you if there are questions about the samples.
Signature of CSO/CSI Collecting Samples: Sign the form to indicate that you collected the samples and
that the information on this form is accurate.
52
Packing Samples and Shipping Containers

Samples to be shipped to NSIL should be packed by the CSO/CSI collecting the samples. If samples are
shelf-stable, they can be shipped at ambient temperature in a sealed box or suitable container. If
samples require refrigerated or frozen storage, they should be held under these conditions and
packaged with gel packs or dry ice to maintain appropriate temperatures during transport.
When possible, samples should be shipped to the NSIL via overnight carrier or some other means to
assure a timely delivery to the NSIL.
Prior to shipping samples to NSIL, please notify the Sample Custodian via email
NSIL.Sample.Custodian@noaa.gov or call 228-762-8964 that you will be shipping samples.
All samples should be shipped to:

Sample Custodian
National Seafood Inspection Laboratory
3209 Frederic Street
Pascagoula, MS 39567
ADDITIONAL RESOURCES
A list of FDA Regional Laboratories may be found at
http://www.fda.gov/ICECI/Inspections/IOM/ucm124067.htm.
Verification testing for aquatic animal diseases and BSE will be done by USDA/APHIS approved
laboratories http://www.aphis.usda.gov/animal_health/lab_info_services/approved_labs.shtml and
http://www.aphis.usda.gov/animal_health/nahln/labs.shtml.
NOAA SIP website access to foreign approval lists https://www.fisheries.noaa.gov/national/seafood-

commerce-certification/foreign-approved-lists
ATTACHMENTS
National Seafood Inspection Lab Sample Information Form for Aquatic Animal Products Not Intended for
Human Consumption.
53
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Handbook Fishmeal For Use As Animal Feed

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Part 6 - NOAA Handbook: Fishmeal and Fishery By-products for use as animal

feed and industrial treatments, not intended for human consumption.

Chapter 1 - Introduction ............................................................................................................................. 2

Chapter 2 - Normative References

Chapter 3 - Terms and Definitions

Chapter 4 - Program Requirements

System Compliance Rating Criteria for By-product (not human consumption)

1.1.0 Management Responsibilities

1.1.1 Management commitment not properly implemented or communicated.

1.1.2 Feed safety policy not prepared or properly implemented.

1.1.3 Feed safety management system planning not properly performed.

1.1.4 Responsibility and authority not properly defined or communicated.

1.2.0 Feed Safety Team

1.2.1 Feed safety team leader not appointed.

1.2.3 Feed safety team is not interdisciplinary as applicable.

1.3.1 Effective external communication not established, implemented, or maintained.

1.3.2 Effective internal communication not established, implemented, or maintained.

location of equipment, surrounding environment, e) cleaning and sanitation programs, f) packaging,

1.4.0 Emergency Preparedness and Response

1.4.1 Emergency response procedures not established, implemented or maintained.

1.5.0 Management Review

1.5.1 Management review not properly performed or documented.

1.6.0 Resource Management

1.6.1 Necessary human resource competencies not identified.

1.7.0 Continual Improvement

1.7.1 Continuous improvement activities not performed.

b. 2.0 Feed Safety

2.1.0 Operational Prerequisite Programs

2.1.1 Operational prerequisite programs not present or not effective.

2.1.2 Operational prerequisite procedures not followed.

2.2.0 Hazard Analysis

2.2.1 Description of products, processes or control measures not properly performed.

All information described above shall be updated as necessary.

2.2.2 Hazard analysis not properly performed.

2.2.3 Hazard analysis not available.

2.3.0 HACCP Plan

2.3.1 No written HACCP plan when one is required.

2.3.2 Plan is not location and/or fish species specific.

A HACCP plan shall be specific to:

2.3.3 Hazard(s) is not listed in the plan.

2.3.4 Hazard(s) is not controlled.

1. No product enters commerce that is either injurious to health, is otherwise adulterated as a

1. Segregate and hold the affected product.

2. Ongoing verification activities. Ongoing verification activities including:

1. notification to relevant interested parties (e.g. statutory and regulatory authorities,

1. The name and location of the processor or importer;

3.2.1 Unsafe or unsanitary water supply.

Deficiency: Minor (Lack of hot water)/Major (Lack of sufficient water supply)

1. Wash their hands thoroughly to prevent contamination by undesirable microorganisms

3.9.1 Harborage and attractant areas present.

Systems Criteria Rating

Feed Audit Template

Finished product/primary packaging material not properly covered or protected.

Gap observed in the protective cover of the auger

Harborage and attractant areas present

Insufficient space between the wall

Summary and Conclusions

Corrective Action Request

Management Controls and Responsibilities