what new in fda seafood importation...

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Los Angeles District Office

What new in FDA Seafood Importation Procedures?

April 8, 2014

Dan Solis, Director Los Angeles District Import Operations

U.S. Food and Drug Administration

Presenter

Presentation Notes

Appreciation – Intro – FDA in the news in 2013 – 2014 to be equally a challenging year

Topics • Globalization • FDA Organizational Changes • Seafood Assignments and Focus for

FY 14 • Seafood Importation • Guidance and Resources • Seafood Inspections

Challenges Presented by Globalization

• World Wide Web has made purchasing products more global rather than purely domestic sources.

• More foreign facilities supplying global market • More outsourcing of manufacturing • Greater complexity in supply chains • Imports coming from countries with less

developed regulatory systems

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Presenter

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What caused this was the internet.

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Old Shenzhen

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China just 10 years ago

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New Shenzhen

Presenter

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Look at what developed in just 10 years. Technology boom and with it, product development and manufacturing in the global market.

Commissioner’s Response to Challenges: Organizational Changes

at a Higher Level • New Deputy Commissioners under

Commissioner Hamburg – Foods and Feeds : Michael Taylor – Global Operations: Howard Sklamberg – Operations: Walter Harris

• GO Directorate – OIP : Foreign Offices – ORA : Foreign, Port and Domestic Operations

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Office of the Chief Counsel Office of Chief Scientist

OFFICE OF GLOBAL REGULATORY

OPERATIONS & POLICY

OFFICE OF FOODS and VETERINARY

MEDICINE

OFFICE OF MEDICAL PRODUCTS &

TOBACCO

OFFICE OF OPERATIONS

OFFICE OF REGULATORY

AFFAIRS

Office of International

Programs

Center for Food Safety & Applied

Nutrition

Center for Veterinary Medicine

Center for Devices &

Radiological Health

Center for Drug

Evaluation & Research

Center for Biologics

Evaluation & Research Center for

Tobacco Products

Office of Special Medical Programs

National Center for

Toxicological Research FDA Organizational Chart

Office of Policy and Planning

Office of Information Management

(IT)

Office of External Affairs, Legilation, Secretariat, etc..

Presenter

Presentation Notes

In July of 2011 the Commissioner of FDA, Dr. Margaret Hamburg did a re-org of the FDA to help address the globalization of FDA Regulated Products. This created Directorates to run Food Regulatory Issues and Medical Products. One of the biggest impact was on the combining of ORA with OIP under the Office of Global Regulatory Operations and Policy.

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FDA’s New Legislations

• Food Safety Modernization Act (FSMA). Signed into law on January 4,

2011. The most sweeping reform of our food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. – Seven Proposed Rules right now:

• Produce Safety (Jan-2013) • Preventive Controls for Human Food (Jan-2013) • Foreign Supplier Verification Program (FSVP) – (Jul-2013) • Accreditation of third-party auditors for foreign facilities (Jul-2013) • Preventive Controls for animal foods (Oct-2013) • Mitigation for Intentional Adulteration of Food (Dec-2013) • Sanitary transportation of human and animal food (Feb - 2014)

– Draft Guidance: Prior Notice of Imported Food (Mar -2014) – Record Availability Requirements (Apr -2014) – Extensive outreach Domestic and Foreign

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Presenter

Presentation Notes

We talked about another way to meet challenges are new laws. New laws and authority helps but also adds new responsibilities to the Agency.

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FDA Regional Field Office – Pacific Region

Regional Field Office Oakland, Ca

Los Angeles District Office

Irvine, Ca

San Francisco District Office Alameda, Ca

Seattle District Office

Bothell, Wa

Pacific Regional Lab North-West Bothell, Wa

Pacific Regional Lab South-West Irvine, Ca

Presenter

Presentation Notes

Los Angeles District obviously belongs to the Pacific Region and the other cities in the Pacific Region are San Francisco and Seattle. There are also 2 Mega FDA Labs; one in Bothell, Wa and the Other one out here in Irvine, Ca.

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FDA Import Operation Mission Prevention and Investigation of

Adulterated, Unapproved and Misbranded FDA

Products from coming into the United States.

Import Product Review • Entry Review (PREDICT) • Field Examinations • Product Sample Collection • Investigations

Inspections • Establishment Inspections • Facility Inspections • Importer Inspections

Investigations • Consumer Complaints • Emergency Response • Smuggling Investigations

Recall Seizure of Products at the Border

Presenter

Presentation Notes

What is the role of FDA’s Import Operations, basically it is the prevention and Investigation of adulterated, unapproved or misbranded FDA Products from getting into US Commerce. And the Operations do this through Sample Collection and analysis, through Import Product Review, Inspections, Investigations, recall and seizures.

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OGA Relationships FDA

FOREIGN GOVERNMENTS

CALIFORNIA FDB

LA COUNTY PUBLIC HEALTH

LAPD VICE DIVISION DEA (Drug Enforcement Administration)

FWS (Fish and Wildlife Service)

US POSTAL INSPECTORS

CBP (CUSTOMS AND BORDER PROTECTION)

HSI (Homeland Security Investigations)

CALIFORNIA DEPT. OF FOOD AGRICULTURE

SHARE THE SAME COMMON GOAL: PROTECT PUBLIC HEALTH

CALIFORNIA DEPT. OF PESTICIDES REGULATION

CA Board of Pharmacy

LA CITY ATTORNEY’S OFFICE

US Dept. of Agriculture (USDA – SITC, FSIS, Aphis, Agri)

CPSC (Consumer Product Safety Commission)

LA CITY FIRE DEPARTMENT

ORANGE COUNTY and Los Angeles DA’s OFFICE

LA DISTRICT ATTORNEY’S OFFICE

NOAA (National Oceanic and Atmospheric Administration )

FDA Foreign Offices

Headquarters Silver Spring, MD

Mexico City

San Jose

Santiago

Amman

London

Parma

Brussels

Pretoria

New Delhi

Mumbai

Beijing

Shanghai

Guangzhou

Presenter

Presentation Notes

13 foreign post 3 China – Investigates (10 mill in 16 more staff in China) 2 in India – 7 new Drug Investigators in India London and in Brussels 1 in Aman Jordon 1 in South Africa

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foods Product info, Firm info,

Country of Mfr. Info, Consignee

Entry filer Customs OASIS

IMPORT PROCESS

Review? No

FDA district entry reviewer

Yes

DIVISION OF FOOD

DEFENSE TARGETING

(DFDT)

OK? Yes No “May proceed”

message “FDA review”

message

PN screening – food

801(a) screening PREDICT

others foods

Presenter

Presentation Notes

Filers of Customs Brokers (Regulated by CBP or Customs and Border Protection) submits info into the CBP database. In the CBP system the product is flagged to different Federal Agencies. Any Food, Drug, Medical Device, Cosmetic, Vaccines, Vet Medicine and now Tobacco gets sent to FDA.

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FDA district entry reviewer

Entry filer

Initial action?

Field exam

Sample, analyze

Compliance Officer (Hearings

Officer)

“May proceed” message

Results?

Compliance action

Detain w/o physical exam

Detain/Refuse

Set Up Assignments or Investigations

Release

Good

Documents requested by FDA

Bad

IB release

???

Presenter

Presentation Notes

Hearings period is 14 days

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Newer IT Technologies • Upgrade IT Technology

• PREDICT

• ITACS – Import Trade Auxillary Communications System

• Paperless – Electronic Correspondence including (E-notices and E-Detain) – LOS-DO Imports has started a true paperless process from beginning to end.

• Upgrade Field Tools – Handhelds and portable devices

• Upgrade of FDA Databases

Presenter

Presentation Notes

Additional ways to address the challenges FDA faces is the use of Newer IT technologies

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PREDICT AT FDA (PREDICT) - Predictive Risk-based Evaluation for Dynamic Import

Compliance Targeting • Risk assessment tool – Improves screening and targeting • Assesses relative risk of FDA Regulated Products, comparability of

country, intelligence, data mining • Increases speed of FDA releases for low risk foods/compliant products;

reduce sampling and exams • Prioritizes higher risk FDA regulated shipments - increase sampling and

exams • MARCS Entry Review and PREDICT were first deployed in Los Angeles

District. Now all FDA Districts are using PREDICT. • What Districts and HQ found out through an evaluation of PREDICT, was

it was working. PREDICT is helping Entry Reviews look at higher risk shipments and May Proceeding Compliant Shipments.

Presenter

Presentation Notes

Dual purpose of rewarding comparable countries and also allows FDA to focus on higher risk entries.

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PREDICT method

• Use automated data mining and pattern discovery

• Utilize open-source intelligence

• Provide automated queries of Center databases where relevant (i.e., registration and listing, marketing approval status, low-acid canned food scheduled processes, etc.)

• Learning algorithm to adjust for future shipments

• Provides information from other ports.

PREDICT LINK

http://www.youtube.com/watch?v=sC1pt3gW2JI

http://www.youtube.com/watch?v=sC1pt3gW2JI

Seafood Assignments and Focus

• Misbranded Seafood • Histamine, Decomposed and Filth in

Seafood • Contaminated Seafood with Pathogenic

Bacteria and Viruses (C. Bot, Staph. Aureus, Salmonella, Listeria, Vibrio, Norovirus in shellfish

• Toxin producing seafood (mussels and scrombroid toxin producing

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Seafood Assignments and Focus

• Undeclared Allergen and Color Additives • Metal and Glass Inclusions • Methyl Mercury • Unapproved antibiotics – Chloramphenicol,

Nitrofurans • Radiation contaminated seafood • Denial of Inspections – foreign mfr • Lack of Seafood HACCP

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Misbranded Seafood Seafood substitution • "seafood substitution" in the marketplace -

where a low value species or a species with a potential food safety hazard is mislabeled and substituted in whole or in part for a more expensive species or for a species with no potential food safety hazard.

• Substituted and/or mislabeled seafood is considered to be misbranded by the FDA and is a violation of Federal law.

• FDA has used DNA based identification to prosecute Seafood Importers

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Import Seafood Priorities • High priority products, and foreign processors or

importers of high priority products, are assigned higher priority for surveillance activities. Lower priority products, processors, and importers are sampled or inspected less frequently with remaining resources.

• Whether produced domestically or by a foreign firm, examples of high priority products are the same and include: – ready-to-eat products such as hot- or cold-smoked fish – scombrotoxin-forming fish, such as tuna or mahi mahi – aquacultured seafood products – fish packed in reduced oxygen packages.

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Import Alerts

• Import Alerts = are public alerts on FDA products that the Agency has concerns about being Imported into the United States. Information on manufacturers, products and importers are provided as well as guidances.

http://www.fda.gov/ForIndustry/ImportProgra

m/ImportAlerts/default.htm

Presenter

Presentation Notes

Where can I go to get more information on Imported FDA Products?

Some other Seafood Import Alerts • Import Alert #16-120: Detention Without Physical Examination of Fish/Fishery

Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP – On December 18, 1997, 21 CFR Part 123 became effective. Under this

regulation, all fish and fishery products, whether foreign or domestic in origin, are required to be prepared, packed and held in facilities operating under mandatory HACCP requirements. Foreign processors who fail to meet these requirements may have entries subject to detention without physical examination until such time as such documentation demonstrating compliance is provided.

• Import Alert #99-32: DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION

– The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.

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What do I do if I want to Import FDA Regulated Products into the

United States? • Hire a certified Customs Broker. They know

many of the Government Requirements. • Do your homework of your commodity at

www.FDA.gov • Know Affirmation of Compliance Codes related

to your product. • Know what Port of Entry your products will be

shipped into. Different Ports may have different CBP Requirements.

http://www.fda.gov/

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Who Do I Contact for my Issue/Question

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How To Speed Through the FDA Import Process

Submit Good, accurate product Information when submitting to CBP

via ABI

Provide Information to FDA Investigators when Requested. Provide the entry number and/or

sample number as a reference.

Have Goods Ready for FDA

Investigators and provide locations

as early as possible.

DO NOT Distribute Goods until you get an FDA Release

For REFUSED entries: Schedule with the

REFUSAL Department when you want to

Destroy or Export the goods or merchandise

Find out who is in charge of your case and

communicate with that Officer only. Sending an email or calling multiple phone numbers will only

delay your entry

Presenter

Presentation Notes

Here’s a nice little bubble map to help you speed through the FDA Import Process

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RESOURCES AVAILABLE FOR YOU

• Website: 4th Edition FDA Seafood HACCP http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulator

yInformation/Seafood/ucm2018426.htm • Seafood Guidance Documents & Regulatory Information http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulator

yInformation/Seafood/default.htm

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm

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FORMS OF COMMUNICATION WITH FDA in LOS ANGELES IMPORTS

• Phone Numbers for LOS-DO Import Operations (Now in Long Beach, Ca)

– General status line (562) 256-7700 – Compliance status line (562) 256-7707 – Fax line (562) 256- 7701

• General email address: [email protected] • LAX Office email address: [email protected] • Los Angeles District Consumer Complaint Hotline: (949) 608-3530 • FDA National Emergency Operations Number: 1-866-300-4374 • FDA General Inquiry: 1-888-INFO-FDA • For Adverse Event of illness call 1-800-FDA-1088 or online • For Drug Inquiries: [email protected] or (866)-405-5367 • For Medical Device Inquiries: [email protected] or (800) 638-

2041 Note: Fastest response is email.

mailto:[email protected]


http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm



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Leadership FDA Commissioner Margaret Hamburg

“As our world transforms and becomes increasingly globalized, it is vital that we come together as a global community – in new, unprecedented, and even unexpected ways – to build a public health safety net for consumers around the world.”

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Thank You For Your Attention!

www.fda.gov

Email address: [email protected]

Presenter

Presentation Notes

In Conclusion, here’s a website where you can learn more about what FDA is concerned about. I thank you for your attention and would be happy to answer any additional questions anyone may have.

FDA Seafood Imports The Importation and Regulatory Action Process Presented by CSO Elizabeth M. Dahl

Table of Contents • FDA Entry Review

• Import Alerts • FDA Examinations & Sample Collections • Compliance and Regulatory Actions • FDA Import Seafood HACCP Verification • FDA Seafood HACCP Inspections • Seafood Fraud • The Seafood List

Prior Notice and Entry Review FDA’s First Line of Defense

Prior Notice of Imported Food For Shipments Arriving:

Prior Notice Must Be Submitted:

By land via road No less than 2 hours before arriving at the port of arrival

By land via rail No less than 4 hours before arriving at the port of arrival

By air No less than 4 hours before arriving at the port of arrival

By water No less than 8 hours before arriving at the port of arrival

By international mail Before the food is sent

FDA Prior Notice Center answers questions about Prior Notice policies, procedures and interpretations Hours: 24 hours per day, 7 days per week Phone: 1-866-521-2297

Presenter

Presentation Notes

As part of the Bioterrorism Act of 2002 and regulation 21 CFR Part 1, Subpart 1, FDA requires advanced notice on shipments of imported food. Prior Notice is the electronic notification that food is arriving to the U.S. prior to its arrival. The time it must be submitted is dependent upon its mode of arrival. Prior Notice is either submitted by the broker through their ABI system or through PNSI which is the FDA website where you can also transmit the information. It asks for basic information about the shipment including products being shipped by who to who and in what quantity.

FDA Entry Review

Presenter

Presentation Notes

If an entry cannot be May Proceeded by the system it will be sent to an FDA reviewer. The FDA reviewer will try to make a determination about the product from the information transmitted by the filer. If more information is needed, the FDA reviewer will request documents such as the Customs Forms, Bills of Lading, Invoices, Packing List, Ingredients, etc. to be provided. Once the documents are reviewed, the FDA reviewer will either May Proceed the entry, set the entry up for exam, or send the entry to the Compliance Department for review. This last option happens when the product/importer/manufacturer has been added to Import Alert or when the product has had recent previous violations of the same kind or when it can be determined from the documents alone that the product may be violative. This process can be expedited by correctly and accurately submitting truthful and descriptive information to FDA. A lot of times in the field we will determine that the product labeling lists a different manufacturer or manufacturer address than what was transmitted to FDA. It is YOUR responsibility to verify that the documents you submit to FDA or to your broker reflect the actual manufacturer name and physical location the product was manufactured. Another no-no is submitting the exporter or shipper as the manufacturer. Accurate information significantly speeds up the processing of your entry.

Import Alerts

Detention Without Physical Examination 801(a) Appearance that article is adulterated or

misbranded

Presenter

Presentation Notes

Import Alerts require that the importer hold the shipment until it can be shown to FDA that the product is safe otherwise it is subject to exportation or destruction. The importer has the option to hire a private laboratory to take samples of the product for whatever reason it was added to Import Alert (filth, illegal colors, salmonella, listeria, etc). A manufacturer can be removed from import alert have 5 consecutive shipments have been found to be safe.

FDA Examinations & Sample Collections for Seafood

Reconciliation Exam Visual Inspection Organoleptic Inspection

Microbiology Chemical Decomposition Filth Aquaculture Drugs Low Acid Canned Foods/Acidified Foods

Presenter

Presentation Notes

FDA examinations consist of 3 parts: A reconciliation exam consists of determining if the product being seen matches the information submitted to FDA electronically and on paper such as the product itself, quantity, packaging, lot codes, value, storage conditions, manufacturer, shipper, importer. The visual examination will determine preliminarily whether the product appears to be in compliance by a variety of FDA techniques. And finally, some FDA investigators are trained to conduct organoleptic sensory exams to determine if the product needs additional decomposition analysis by a laboratory. Sample collections are based on inherent risk and likelihood of a hazard occurring. Sample collections include, but are not limited to, microbiology, heavy metals, decomposition, filth, antibiotics, pH and Aw to determine if a product is a low acid canned food or acidified food.

Compliance & Regulatory Actions FDA’s Regulation Experts

Compliance & Regulatory Actions

Detention or Release Testimony Period Private Laboratories Reconditioning or Refusal Destruction or Exportation

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Presentation Notes

Once a products are examined or sampled by FDA they are either Released for distribution or held in Detention pending more information. The importer is given a Testimony Period to present any evidence showing their products are safe and effective. This can include submitting private laboratory results. If the product can be brought into compliance, the importer may choose to recondition the product. If the product can not be brought into compliance, the product is Refused Admission to the U.S.. At this point, the importer has the option of exporting the product back to its country of origin or destroying the product under FDA supervision.

Seafood HACCP for Processors and Importers What to expect during an FDA inspection.

FDA Seafood HACCP Inspections Foreign Inspections Domestic Inspections Importer HACCP Verification

Presenter

Presentation Notes

FDA has increased the number of foreign inspections we conduct each year. Foreign Seafood HACCP inspections assist FDA in ensuring that the facility is capable of safely producing all products rather than looking at every single product a firm exports to the U.S. when it arrives. FDA assesses the foreign firms HACCP plan, good manufacturing practices, and sanitation practices. HACCP or Hazard Analysis Critical Control Points is a system of preventative controls to reduce the likelihood of a hazard occurring. Domestic U.S. inspections of firms that process seafood undergo a routine cGMP inspection (21 CFR Part 110) including Sanitation Control Procedures. These pre-requisite programs ensure a basic environmental and operating conditions for the production of safe, wholesome food.

Seafood HACCP Inspections Initial Interview FDA Hazard Analysis Evaluation of Processor Hazard Analysis Evaluation of Processor HACCP Plan Records Review Documentation of Objectionable

Conditions Plus 8 Key Areas of Sanitation

Presenter

Presentation Notes

In addition to the GMP inspection, an evaluation of the firm’s HACCP plan will be conducted. This evaluation determines if the firm can adequately prevent problems from occurring. An investigator will generally choose the highest-risk products to review. The inspector will do a walk through of the product process and develop a hazard analysis for the product. The investigator will then compare his/her analysis to the firm’s analysis to determine that the firm has adequately identified all critical hazards. The investigator will then review the firm’s written HACCP plan and evaluate all of the required elements for adequacy. Next, the investigator will observe the actual production process to determine if the firm is following their own HACCP plan. A records review will show whether the HACCP plan is properly and consistently implemented, including monitoring records, corrective actions, and verification records. 8 Key Areas of Sanitation: safety of water, safety and cleanliness of food contact surfaces, prevention of cross-contamination, hand-washing/hand-sanitizing/toilets, protection from adulterants, labeling/storage of toxic compounds, employee health, exclusion of pests Lastly, if there are any objectionable conditions, the investigator will document on an FDA-483 Reportable Observations form and discuss observations with management. The firm can discuss the observations and propose suggestions on how to improve. The investigator will document and include in their summary of the inspection.

Seafood HACCP Importer Verification

Sec. 123.12 Special requirements for imported products

This section sets forth specific requirements for imported fish and fishery products.

Importer verification. Every importer of fish or fishery products shall either: Written and Implemented Verification

Product Specifications Affirmative Steps (6 Options)

Competent Third Party to perform verification Records (21 CFR 123.9) Determination of compliance.

Presenter

Presentation Notes

For imported products. All importers are required to have written and implemented verification that the products they are importing were processed in accordance with the requirements of Sec. 123.12 of Title 21 of the Code of Federal Regulations. This includes written Product Specifications such as the product name, product form, packaging, sizes, storage conditions, its intended use, etc. The product specifications might also list potential biological, chemical, and physical hazards and their controls. For example for the product “mahi-mahi” you might list histamine as a potential chemical hazard and list a limit whereby you would not accept the product. Written Verification also includes an Affirmative Step. Sec. 123.12 lists 6 options for meeting this requirement. Briefly these are 1. obtaining the foreign processors haccp and sanitation monitoring records for the lot imported, 2. a continuning lot-by-lot certificated from a qualified foreign government or competent 3rd party, 3. regularly inspecting the foreign processor, 4. maintaining an English copy of the foreign processors haccp plan and written guarantee that the imported product was processed according to their haccp plan, 5. privately analyzing the product and maintaining an English copy of a written guarantee from the foreign processor, or. 6. some other verification on an equivalent level

Seafood Fraud A growing and wide-spread problem

Seafood Fraud Mislabeled Substituted Species Economic Deception

Misbranding Adulteration

Dangerous Health Risks

Presenter

Presentation Notes

Seafood Fraud is present in many forms. With a large number of species, it is easy to deceive consumers. Some forms of seafood fraud include: Mislabeling Product: marketing Pacific Snapper as the more expensive species Red Snapper Substituted Species: using the cheaper Langostino instead of the more expensive Lobster at a restaurant or in a pre-packaged food Economic Deception: Misbranding: marketing food as wild-caught instead of farm-raised, labeling food as from a different Adulteration: over-glazing frozen fillets and charging more for the added weight, adding undeclared/illegal color additives Seafood Fraud not only hurts consumers wallets, but can also be a serious health hazard such as mislabeling products that contain shellfish, mislabeling species that have the ability to develop histamines, not declaring food additives such as nitrites or sulfites all of which can cause life-threatening allergic reactions.

Commonly Mislabeled Seafood

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Types of Seafood Mislabeling Wrong Acceptable Market Name: Red Snapper for Pacific Red Snapper Species Substitution: Sea Bream for Snapper; Langostino for Lobster Economic Deception: Farm-Raised vs. Wild; Country of Origin (Japan vs. Canada) Escolar – being called White Tuna Sea Bream – being called Snapper

Name that Fish

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Presentation Notes

Right is Cod, Left is Escolar Right is Grouper, Left is Nile Perch Left is Swordfish, Right is Mako Shark Left is Red Snapper, Right is Rockfish Right is Wild Atlantic Salmon, Left is Farmed Salmon. Farmed fish tend to have more fat.

The Seafood List Part 1: Vertebrates Section 1: Listed by Market Name Section 2: Listed by Scientific Name

Presenter

Presentation Notes

FDA has compiled The Seafood List which is comprised of 2 parts the vertebrate species and the invertebrate species. The list is further organized into 2 sections. The first section lists the species by Acceptable Market Names. The FDA has stated that they strongly encourage the use of the “Acceptable Market Name”. The “Common Name” may be used if the product is widely recognized by this name. FDA discourages the use of the “Vernacular Name”. The product may be considered “Misbranded” if it is not marketed with an acceptable name. This is determined on a case-by-case basis. Please refer to handout 2 for more information.

The Seafood List Part 2: Invertebrates Section 1: Listed by Market Name Section 2: Listed by Scientific Name

Presenter

Presentation Notes

The section lists the species by Scientific name.

DNA-based Seafood Identification

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Presentation Notes

FDA has created a database known as the Regulatory Fish Encyclopedia which shows high resolution images of fish in their whole and marketed forms (fillets, steaks) as well as other taxonomic, and geographic information about the species. In 2007, the FDA began adding DNA barcodes. An unknown species of fish can be sequenced and matched against the database for accurate identification. The Regulatory Fish Encyclopedia is available online through www.fda.gov

Guidance & References http://www.fda.gov/Food/GuidanceReg

ulation/HACCP/ucm2006764.htm http://seafood.oregonstate.edu/ 21 CFR Part 110 – Food Good

Manufacturing Practices 21 CFR Part 123 – Fish and Fishery Products Fish and Fishery Products Hazards and

Controls Guidance Manual HACCP Training Curriculum

Presenter

Presentation Notes

The first link is to the FDA website that gives a wide varierty of links to more HACCP information. The second link is a website listed on the FDA website that gives tons of information on Seafood HACCP, product safety, sanitation, generic HACCP forms and plans, regulations, consultants, and inspection information. The last 2 bullet points are the actual regulations on which we base our inspection criteria. The HACCP Training Curriculum gives specific examples and models of what would satisfy FDA requirements.

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006764.htm

http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006764.htm

http://seafood.oregonstate.edu/