NOAA presentation about seafood inspection program and the Food Safety Modernization Act (FSMA). Presentation was given at the FDA in Los Angeles Sept 22, 2016 by Laurice Churchill

1. FDA
FSMA Compliance
Workshop
Office of
International
Affairs and
Seafood
Inspection
NOAA Fisheries
Seafood Inspection Program
“We know that NOAA is involved in
fisheries, but we really don’t know
what NOAA Seafood Inspection
does for the industry.”

2. US Department of Commerce/NOAA Fisheries
Seafood Inspection Program
NOAA Seafood Inspection
ensures that fish and fishery
processors and products meet:
• Regulatory requirements
and
• Quality specifications
So international and domestic
buyers and consumers can
have confidence in the seafood
products that they purchase.

3. NOAA Seafood Inspection Program
Federal Food Regulations in the United States
USDA is responsible for the safety, wholesomeness and labeling of meat,
poultry and processed egg products and FDA bears the same responsibility
for all other foods, including seafood.
EPA USDA H&HS USDC

4. NOAA Seafood Inspection Program
NOAA Fisheries (formerly NMFS)
Responsible for
stewardship of living
marine resources through
science-based conservation
and management and
promotion of the health of
their environment.
• March 15, 2015 – Presidential
Task Force Action Plan for
combatting IUU Fisheries and
seafood fraud.
To leverage capabilities and to
support a holistic “ocean to plate”
approach to seafood safety, quality,
sustainability and commercial
integrity, NOAA merged two of its
fisheries offices.

5. NOAA Seafood Inspection Program
FDA / NOAA Authority & FDA/NOAA Cooperative Agreement
FDA is the mandatory authority for
seafood inspection in the United
States
• FD&C Act, PHS Act, FP&L Act
• 21 CFR Part 110 (new 117) (GMPs)
• 21 CFR Part 123 (SHR)
• 21 CFR Part 101 (Labeling)
• Performs periodic audits of processors
of fish and fishery products to
determine compliance with:
• Food Safety
• Wholesomeness
• Proper Labeling
NOAA Seafood Inspection Program
Services were authorized by the:
• Agricultural Marketing Act of 1946
• Empowered USDC to create
regulatory requirements to carry out
fee-based programs for the food
industry per:
• 50 CFR Part 260
• Inspecting and grading of raw and
processed foods
Memoranda of Understanding
(MOU) with the FDA and USDA
 NOAA Seafood Inspection Program Approved
Establishments must meet all FDA requirements including:
 21 CFR parts 110, 123 and 101

6. FSMA requirements that affect Processors of fish and
fishery products subjected to 21 CFR Part 123
FSMA modifies 21 CFR
1.227 registration
requirements and now
requires that food
processors renew their
registration with the FDA
every 2 years.

7. FSMA authorized the promulgation of seven
regulations.
1. Preventive Controls for Human
Food Final Rule
2. Preventive Controls for Food for
Animals Final Rule
3. Standards for Produce Safety Final
Rule
4. Foreign Supplier Verification
Programs (FSVP) for Importers of
Food for Humans and Animals
Final Rule
5. Accredited Third-Party
Certification Final Rule
6. Sanitary Transportation of Human
and Animal Food Proposed Rule
7. Focused Mitigation Strategies to
Protect Food against Intentional
Adulteration Proposed Rule

8. Three of the 7 will affect seafood processors
subjected to 21 CFR Part 123.
1. Preventive Controls for Human
Food Final Rule
2. Preventive Controls for Food for
Animals Final Rule
3. Standards for Produce Safety Final
Rule
4. Foreign Supplier Verification
Programs (FSVP) for Importers of
Food for Humans and Animals
Final Rule
5. Accredited Third-Party
Certification Final Rule
6. Sanitary Transportation of Human
and Animal Food Proposed Rule
7. Focused Mitigation Strategies to
Protect Food against Intentional
Adulteration Proposed Rule

9. 21 CFR Part 117 goes into effect (staggered
implementation dates) beginning September 2016.
Today, we’ll talk about the
“Preventive Controls Rule for
Human Food.
• 21 CFR Part 117
Regulations on Sanitary
transportation and focused
mitigation strategies will be
implemented at later dates.

10. How 21 CFR Part 117 will impact seafood processors
subjected to 21 CFR Part 123
There are 7 subparts to 21 CFR
Part 117.
• Subparts A, B and F do apply
to processors of fish and
fishery products covered by
21 CFR Part 123.
• Subparts C, D, E and G do not
apply to processors of fish
and fishery products covered
by 21 CFR Part 123.
Part 117
www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

11. How 21 CFR Part 117 will impact seafood processors
subjected to 21 CFR Part 123
Subpart A - Training
Requirement/Qualifications and
Subpart F – Record keeping
Requirements
Individuals involved in processing food
must be qualified to perform duties
Have necessary training, education, or
experience to perform job
Trained in principles of food hygiene and
food safety
Records of training in food hygiene and food
safety must be generated and maintained per
21 CFR Part 117 Subpart F.

12. How 21 CFR Part 117 will impact seafood processors
subjected to 21 CFR Part 123
Subpart B – Current Good
Manufacturing Practices
• GMP requirements are all
mandatory “must”
statements
• Explicitly incorporates
control of allergen cross-
contact.
• 21 CFR Part 117 B will
replace 21 CFR Part 110
per the FSMA
implementation schedule.
This course will teach the revised
current Good Manufacturing Practices
(GMPs) in Part 117 (b) instead of
teaching the soon to be obsolete Part
110 GMPs.

13. How 21 CFR Part 117 will impact seafood processors
subjected to 21 CFR Part 123
NOAA Approved
Establishments will be
required to meet
applicable provisions of 21
CFR Part 117.
NOAA SI will begin
performing these
expanded audits during
Q4 of CY 2016.

14. NOAA Seafood Inspection Program-Industry Services
Inspection
• Mission: to provide inspection
services for fish and fishery
products and processors to:
• Ensure safety and quality
• Enhance marketability
• Support sustainability
• Inspection and Grading
• Auditing
• Export Certification
• Consultative Services
• Training and Education

15. NOAA Seafood Inspection Program-Industry Services
Inspection
• NOAA SIP provides lot
inspection services for:
• Domestic & International
buyers and sellers of seafood
products.
• Lot inspections determine
whether products meet
approved buyer’s
specifications for:
• Net weight, counts other
labeling claims
• Quality attributes
• Results are documented and
certified.
•

16. NOAA Seafood Inspection Program-Industry Services
Grading
• NOAA SIP Grading Services
require that:
• Processors meet all food
processing regulations (50 CFR
Part 260, GMPs, Seafood HACCP
Regulation)
NOAA SIP Ensures and provides:
• The finished product quality
characteristics meet
published Grade Standard
requirements.
•

17. NOAA Seafood Inspection Program
Auditing
• NOAA SIP Auditing Services
• Verify whether processors meet
US Seafood Regulations.
• Processors who have met these
requirements may be listed on
the USDC’s Approved
Establishments list.
• NOAA’s Approved Establishments
(NOAA AE) include both U.S. and
international processors who
have meet FDA regulatory and
NOAA approved establishments
requirements by passing
quarterly audits.

18. NOAA Seafood Inspection Program
Export Certification
– $6.5 billion export trade for
seafood (2014)
– To meet destination
country’s import
requirements
• For safety and quality
• For sustainability
Certificate of Legal Origin
from the U.S.
• Currently 65 discrete
export certificates
– To meet aquatic health
requirements

19. NOAA Office of International Affairs and Seafood Inspection
In Conclusion
Mission: to provide inspection
services for fish and fishery
products and processors to:
• Ensure safety and quality
• Enhance marketability
• Support sustainability
Primary services:
• Inspection and Grading
• Auditing
• Export Certification
• Consultative Services
• Training and Education
• Seafood – ready for FSMA
• Approved Establishments
have been HACCP compliant
since 1992.
• USDC can help industry be
compliant!

20. NOAA Seafood Inspection Program
Conclusion
For More
information:
http://www.seafood.nmfs.noaa.gov/
Laurice.Churchill@noaa.gov
(562) 388-7346
Thank you!