How fsma changes_will_impact_ the_seafood_ business

How FSMA Changes
Will Impact the Seafood Business
CONTRIBUTOR
Lisa Weddig, National Fisheries Institute
Presented by:
Sponsored by:

How FSMA Changes Will Impact the Seafood Business
How FSMA changes
Will Impact the
Seafood Business
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
What is FSMA? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Seven major regulation changes . . . . . . . . . . . . . . . . . . . 3
Two key exemptions in fsma . . . . . . . . . . . . . . . . . . . . . 4
A focus on imports . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Proposed rule foreign supplier verification program . . . . . . . 4
Overview
Who is covered?
Fsvp requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Two options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Option one . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Option two . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Key differences . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Option one or two? . . . . . . . . . . . . . . . . . . . . . . . . . 9
Compliance dates . . . . . . . . . . . . . . . . . . . . . . . . . 9
What does all this mean for seafood importers? . . . . . . . . . 9
Parallels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Three steps to prepare for the future . . . . . . . . . . . . . . . 12
How will all this impact you? . . . . . . . . . . . . . . . . . . . . 12
Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Note: This whitepaper is the product of the transcript of a webinar of the same title produced by
SeafoodSource, and available online at www.seafoodsource.com. While the webinar speakers are cited here as
contributors, this whitepaper was not written by the contributors or speakers who appeared in the webinar, nor
is it endorsed by the contributors or speakers, or any company, organization or entity they represent. For more
information on how this whitepaper was produced, send inquiries via email to editor@seafoodsource.com.
© 2014 Diversified Business Communications

3 How FSMA Changes Will Impact the Seafood Business
Introduction
In 2011, when the U.S. Food Safety Modernization Act
(FSMA) was approved by President Obama, it was regarded
as the largest change in food safety laws in more than 70
years. The act represented a major overhaul of food safety
laws in the United States. In late 2013, the U.S. Food and
Drug Administration held two public hearings on proposed
changes to the law with regard to the oversight of imported
foods. While it is possible that the affects of the changes may
not be apparent in the short term, importers, processors and
distributors of seafood will want to pay particular attention to
these changes. That’s because more than 90 percent of seafood
consumed in the U.S. comes from overseas, so it goes without
saying that these changes will have an impact on how seafood
businesses operate.
So what are the key changes in the act? And, more
importantly, how will these changes affect your business
in the short and long-term?
What is FSMA?
The main themes of the Food Safety Modernization Act revolve
around the prevention of illnesses or food-borne outbreaks and
inspections, compliance and responses. The law also requires
the FDA to enhance partnerships with state food regulators,
other federal agencies in the United States and foreign food
agencies. Lastly, the act focuses on improving the safety of
imported foods.
Seven major regulation changes
In 2013, the Center for Food Safety and the Center for
Environmental Health sued the FDA for failing to meet
legislative deadlines that were given by the Congress in the
Food Safety Modernization Act. The FDA lost the lawsuit and
is under a court order to propose and finalize these rules. The
court mandated that the comment period for all seven rules
would need to be completed by March 31, 2014. The final
rules must be completed by June 30, 2015.
Ultimately, this act has caused the FDA to shift its focus from
taking responsive actions to taking preventative actions. The
law requires FDA to do many things including developing and
implementing seven new major regulations.
These seven new regulations include:
1. Preventive Controls for Human Food
This rule was proposed in January 2013 and the comment
period closed November 15, 2013.
2. Foreign Supplier Verification Program
This rule was proposed in July 2013 and the comment
period closed January 27, 2014.
3. Accreditation of Third Party Auditors program
This rule was proposed in July 2013 and the comment
period closed January 27, 2014.
4. Preventive Controls for Animal Food
This rule was proposed in October 2013 and comments are
due by late February 26, 2014.
5. Produce Safety Standards
This rule was proposed in January 2013 and the comment
period closed November 15, 2013.
6. Sanitary Transportation of Foods
This rule will be proposed by the end of January 2014.
7. Prevention of Intentional Adulteration
This rule was proposed December 24, 2013 and comments
are due March 31, 2014.

Two key exemptions in FSMA
There are two key exemptions in FSMA that impact the
seafood industry. In FSMA Section 103, the Hazard Analysis
and Risk-Based Preventive Controls and Section 301, the
Foreign Supplier Verification Program, Congress gave an
exemption to facilities that are required to comply with and
that are in compliance with the Seafood Hazard Analysis and
Critical Control Points Program (HACCP) of the FDA. In the
two relevant proposed rules, the FDA extended the exemption
that was allowed by Congress.
Under the Preventive Controls for Human Food rule,
the FDA laid out a program for all foods, other than seafood
and juice. The FDA also updated the current Good
Manufacturing Practice regulations, which are current
under 21 CFR 110. Those proposed updates to Part 110
would apply to seafood processes.
A focus on imports
FSMA outlines that the FDA has to come up with a Foreign
Supplier Verification Program to require importers to ensure
the safety of the foods that they import. FSMA also gave the
FDA authority to develop a Voluntary Qualified Importer
Program (VQIP). If importers meet certain qualifications,
firms will be able to obtain quick entry of their food products.
The VQIP program is still in development.
The FDA also made some other enhancements geared toward
protecting the safety of imported foods. Improvements in
enforcement authorities are also in the works which will allow
the FDA to refuse entry of products if a foreign facility has
refused an FDA inspection of the facility.
When it comes to the certification for high-risk food imports,
the FDA has discretionary authority to require assurances of
compliance for high-risk foods. The FDA can also rely on
accredited third parties to certify that foreign food facilities
meet U.S. requirements. A proposed program allowing the
FDA to establish the accreditation of third-party auditors is
currently being considered.
Proposed Rule Foreign Supplier
Verification Program
OVERVIEW
Though several FSMA changes are relevant to those in the seafood
industry, arguably the most pertinent proposed rule is the Foreign
Supplier Verification Program (FSVP). That’s because importers of
seafood products and juice products that are in compliance with
HACCP regulations are exempted from these regulations.
FSMA has a series of requirements for importers. For example,
in accordance with this proposed rule, importers would be
responsible for ensuring that the food they bring into the U.S.
meets FDA safety standards. Importers would also be required to
develop, maintain, and follow an FSVP for each food imported,
unless an exemption applies. However, these requirements vary
based on the type of food product, category (or size) of importer,
the nature of the hazard identified in the food and who is in
control of the hazard.
But how these regulations affect the seafood industry and what
they will mean for your business is yet to be determined, especially
because these are only proposed requirements and may change.
WHO IS COVERED?
So, who exactly is an importer according to the FDA? The
FDA defines an importer as any person in the U.S. who has
purchased the food being offered for import. However, there
are several provisions associated with this definition. For
example, if there is no U.S. owner at the time of entry, the
importer is the U.S. consignee and if there is no U.S. owner

Do you import these foods?

¨ Juice, fish or fishery products subject to HACCP
¨ Food for personal consumption
¨ Alcocholic beverages
¨ Food that is transhipped
¨ Food for re-export
¨ Food for research or evaluation
(requires declaration at entry)
Would FSVP apply to me as a food importer?
Do you import dietary
supplements?
Are you a very small
importer or import from
a very small supplier
(< $500,000 in annual food sales)?
Modified requirements
would apply
(see Figure 2)
Do you import food from
a supplier in a country with
an officially recognized or
equivalent food safety system?
Modified requirements
might apply
(see Figure 2)
Do you import low acid
canned food (LACF)?
Modified requirements would apply
(see Figure 3)
You would be exempt from addressing
microbiological hazards in LACF
through FSVP (For all other hazards, see Figure 2)
You would
be EXEMPT
from FSVP
for those
foods
Your importation
of other food would be
SUBJECT to FSVP;
FSVP standard requirements
(see Figure 2)
would apply except as
specified below
*Image source: U.S. Department of Health and Human Services. U.S. Food and Drug Administration
Figure 1*

or consignee at time of entry, the importer is the U.S. agent
or representative of the foreign owner or consignee.
Figure 1 (see page 5) is a flow diagram created by the FDA
that shows whether or not the regulatory changes affect an
individual’s business—for example, those importing fish or
fishery products are exempted from the Foreign Supplier
Verification Program.
FSVP requirements
In accordance with the proposed FSVP requirements,
importers will need to conduct several activities for every
shipment of product they receive. This includes conducting
a compliance status review of foods and suppliers. Importers
will also need to conduct hazard analysis, supplier verification
activities and corrective actions (if necessary). That means
that if there are consumer complaints or any type of
food-borne illness outbreak, the importer will need
to take corrective action and amend their supplier
verification activities.
The FDA is even proposing that importers register and receive
Dun & Bradstreet Data Universal Numbering System numbers
(DUNS numbers). This unique set of numbers can be obtained
by any business and could be used as identification with entry.
This would allow FDA to link an entry to a specific importer.
The importer would also be required to maintain records
documenting the implementation of their Foreign Supplier
Verification Program.
Reassessment of the FSVP requirements will be conducted
every three years to evaluate the process and determine
if any change is needed.
TWO OPTIONS
The FDA has proposed two different options for this regulation
depending on the level of associated hazards involved with the
food that is being imported. These two options are based solely on
the risk of the hazard that had been identified during the hazard
analysis that the importer would conduct. The FDA broke up the
regulation in this way to allow the industry to comment on the two
different options; however, the final rule will only have one option.
PhotocourtesyofOOCL

OPTION ONE: With the first option
the type of verification activity being
proposed is based on the risk of hazard
and who will be controlling the hazard.
FDA is proposing for hazards that
can cause a serious adverse health
consequences or
death to humans
or animals
(SAHCODHA)
that annual on-site audits of the foreign
supplier be conducted. Figure 2 is another
FDA flow diagram that shows the various
requirements proposed with Option 1.
Perform food / supplier compliance status review
Conduct hazard analysis
( not required for microbiological hazards in produce )
Maintain written list of foreign suppliers
Proposed Standard FSVP Requirements
Are there hazards that are reasonably likey to occur?
For hazards controlled
by importer or
by its customer:
by foreign supplier that
could cause serious adverse
consequences or death:
For microbiological
hazards in produce:
For other hazards:
Reassess FSVP
Ensure importer identification at entry
Maintain records
Document
importer
or customer
in controlling
hazzard.
Conduct initial
onsite audit
and then
at least
annually.
Conduct initial
onsite audit
and then
at least
annually.
Conduct supplier
verfication from among:
¨ Onsite auditing
¨ Sampling and testing
¨ Review of foreign supplier
food safety records
¨ Other appropriate
procedure
Conduct investigative and corrective actions (as needed)
*Image source: U.S. Department of Health and Human Services. U.S. Food and Drug Administration
Figure 2*

Image source: U.S. Department of Health and Human Services. U.S. Food and Drug Administration
OPTION TWO: With
the second option a specific
verification activity is not being
proposed based on the severity
of the hazard. Figure 3 is
another FDA flow diagram that
shows the various requirements
proposed with Option 2.
Perform food / supplier compliance status review
Conduct hazard analysis
( not required for microbiological hazards in produce )
Maintain written list of foreign suppliers
Proposed Standard FSVP Requirements
Are there hazards that are reasonably likey to occur?
by importer or
by its customer:
For other hazards:
Reassess FSVP
Ensure importer identification at entry
Maintain records
Document
importer
or customer
in controlling
hazzard.
Conduct supplier
verfication from among:
¨ Onsite auditing
¨ Sampling and testing
¨ Review of foreign supplier
food safety records
¨ Other appropriate procedure
Conduct investigative and corrective actions (as needed)
Figure 3*

Key differences
The main difference between these two options is that the
first proposes different levels of foreign supplier verification
activities, depending on the hazard that has been assessed
during the hazard analysis. In option one, the flow chart shows
how the FDA breaks down what it expects importers to do
based on the risk associated with the food being imported.
The FDA also addresses what an importer should do if after
the hazard analysis the importer assesses that the hazards are
controlled by the foreign supplier, and that the hazard could
cause serious adverse health consequences or death to humans
or animals.
In this case, the FDA proposes that the importer conduct an
onsite audit for SAHCODHA hazards, with an additional
audit performed at the facility each year. For all other hazards
other than SAHCODHA, the importer will need to conduct
supplier verification activities. The FDA suggests various
activities, such as periodic onsite auditing, sampling and
testing, review of foreign supplier food safety records or other
appropriate procedures that an importer might develop.
Option two does not require the importer to assess the hazards
that have been identified as reasonably likely to occur as
SAHCODHA or other hazards. Instead in this option, the
importer is required to conduct verification activities, such as
onsite auditing, sampling and testing and a review of foreign
supplier food safety records. Therefore, in this case, all hazards
would fall under the same activities. There is also no specific
requirement for an annual onsite audit.
Option one or two?
When it comes to choosing between these two options,
opinions are mixed. On the one hand, consumer groups tend
to view option one as the better approach to ensuring the safety
of imported foods. But on the other hand, food processors
tend to feel that option two is more effective.
Compliance dates
It is important to note that these are only proposed regulations,
but the proposed compliance dates have been discussed. For the
Foreign Supplier Verification Program, compliance would be
18 months after publication of the final rule. The FDA is under
court order to have all the rules finalized by June of 2015 and is
proposing that the compliance be staggered; this is based on the
proposed compliance deadlines for the preventive controls rule
that has also been proposed.
The initiation of preventative control programs varies by firm
size. For example, small firms with less than 500 employees will
be given two years to become compliant with this program and
very small firms would be given 3 years. But everyone else will
only have one year to develop their program.
With this proposal, the Foreign Supplier Verification Program
regulation would kick in six months after the foreign supplier
is required to comply with the preventive controls regulations.
In other words, the earliest that an importer would need to
comply with a final Foreign Supplier Verification Program
would be near the end of 2016.
What does all this mean
for seafood importers?
As mentioned earlier, seafood is currently exempt from the
Foreign Supplier Verification Program. So what does all this
really mean for seafood importers and why do these changes
in FDA regulations matter to the industry?
In all likelihood, a trickle-down effect will be seen in the seafood
industry from Foreign Supplier Verification Program regulations.
In fact, in the preamble to these proposed regulations, the

FDA addresses this exemption. The FDA mentions that the
proposed Foreign Supplier Verification Program sets forth a
more comprehensive approach to verification than the existing
juice and seafood HACCP regulations. They also note that the
seafood importer regulations allow importers to obtain a copy of
the foreign processor’s HACCP plan and an attestation that the
foreign firm processes its seafood products in compliance with
the HACCP regulations without also requiring an onsite audit.
Ultimately, the FDA is considering whether it would be
appropriate in the future to initiate rulemaking to revise the
regulations applicable to importers of juice and seafood.
Parallels
There are many parallels between what the FDA is proposing
with the Foreign Supplier Verification Program and what seafood
importers are currently required to do under seafood HACCP.
Some of the requirements are quite similar. Under the Foreign
Supplier Verification Program, for example, importers are required
to develop and follow a Foreign Supplier Verification Program
that is designed to provide adequate assurances that the products
are processed with at least the same level of the public health
protection as FSMA preventive controls regulations.
Under current seafood HACCP regulations, seafood
importers are required to develop and follow written
importer verification procedures to ensure that the product
they’re importing is processed in accordance to the
requirements of 21 CFR 123. Under the Foreign Supplier
Verification proposal, the FDA is proposing that the verification
program be developed by a trained individual. With seafood
HACCP, there is no training requirement for developing
import verification procedure programs.
Two other elements of the proposed Foreign Supplier
Verification Program are not a part of the seafood HACCP
regulation. One is the review of compliance status of foreign
suppliers. There is no such requirement under seafood HACCP
at this time. Under the Foreign Supplier Verification proposal,
the importer is required to maintain a list of the foreign
suppliers for the foods that they are importing. Again, there
is no such requirement under seafood HACCP. In accordance
with this proposal, the importers must conduct a hazard
analysis for all foods that they are importing, identifying
hazards that are likely to occur. With seafood HACCP,
the importer is not required to do a hazard analysis,
but the importer is required to develop specifications for
all the seafood products that they are importing. Those
specifications need to be designed to ensure the product
is not adulterated, because it may be injurious to health
or processed in unsanitary conditions.
Verification activities are similar to what seafood importers
currently perform under seafood HACCP. But there are a few
exceptions. Some of the proposed verification activities under
Foreign Supplier Verification Program are onsite auditing of
the foreign supplier, doing periodic or lot-by-lot sampling and
testing as well as a periodic review of the supplier’s food safety
records. This is similar to the affirmative steps under seafood
HACCP which require regularly inspecting the foreign
supplier, periodically testing the product, and having a
written guarantee from the supplier that they’re following
the regulations or obtaining copies of the HACCP and
sanitation monitoring records.
There are two other affirmative steps that are allowed in the
seafood HACCP regulation that are not proposed in the
Foreign Supplier Verification Program. The first is the
continuing or lot-by-lot certificate from a foreign government
or a third party. While this is not proposed, it is implied
in the preamble and also in the preamble language of the
third-party audit program proposals. The one affirmative
step that is allowed in seafood HACCP that is not proposed
in the Foreign Supplier Verification Program is for the
importer to keep a copy of the HACCP plan from the
foreign supplier, along with a written guarantee that the
foreign supplier is following the seafood HACCP regulations.
The record requirement is very similar in both the seafood
HACCP regulation and the Foreign Supplier Verification
Program in that they both require the use of records of
procedures and product specifications. In the case of the
Foreign Supplier Verification Program, there is the need
for record of the hazard analyses. The Foreign Supplier
Verification Program requires corrective actions be taken
if there is a problem with the food being imported.
Reassessment also needs to be conducted every three years.

FSVP
¨ Develop and follow a Foreign Supplier
Verification Program – “FSVP”:
• To provide “adequate assurances” products are processed
with “at least the same level of public health protection”
as FSMA preventive controls regulations
• Developed by trained individual
¨ Review compliance status of foreign suppliers
¨ Maintain list of foreign suppliers for foods imported
¨ Conduct hazard analysis for all foods imported
and identify hazards RLTO and severity of hazards
¨ Conduct verification activities
• Onsite auditing of foreign supplier
• Periodic or lot-by-lot sampling and testing
• Periodic review of foreign supplier food safety records
• Other appropriate risk-based procedures
FSVP
¨ Conduct verification activities
• Not proposed, but implied
• Not proposed
SEAFOOD HACCP
¨ Develop and follow written Import Verification Procedures:
• To ensure product processed in accordance
with requirements of 21 CFR 123
• No training requirement
¨ No such requirement
¨ No specific requirement
¨ Develop product specifications for all imported products that
are designed to ensure product is not adulterated because it may
be injurious to health or processed in unsanitary conditions
¨ Conduct affirmative steps:
• Regularly inspecting foreign supplier
• Periodically test product and written guarantee
• Obtain copies of HACCP and sanitation monitoring records
• Other appropriate activities
IMPORT VERIFICATION
¨ Conduct affirmative steps
• Continuing or lot-by-lot certificate from foreign
government or third party
For a quick reference, below is a table with these key parallels.

Three steps to prepare
for the future
Because these changes are coming, it is important to prepare
for the future. For example, if you import ingredients or other
foods that are not seafood, don’t think you are exempt from
doing a Foreign Supplier Verification Program for those
non-seafood ingredients or foods. If you’re the direct importer,
you will be covered by the Foreign Supplier Verification
Program; what is exempted is the importation of fish and
fishery products.
There are three things that you can do to prepare for the future.
1. Make sure that you are meeting the current importer
verification requirements for all the seafood products
that you are importing.
2. Review your current affirmative steps to see if they
are sufficient to ensure supplier is following Seafood
HACCP regulation.
3. Ensure that foreign suppliers are familiar with the FDA’s
“Fish and Fishery Products Hazards and Controls Guide”
updated in April of 2011. This guide provides the basis of
the FDA’s assessment of compliance with 21 CFR 123.
Proposed Rule Accreditation
of Third-Party Auditors
OVERVIEW
This program is required in FSMA to allow FDA to use
third-party audits in a couple of key areas. It would give
the FDA assurance that certain foods that they might require
to be imported with a certificate are actually meeting U.S.
regulations. It also gives the FDA a way to work with
foreign governments.
HOW WILL ALL THIS IMPACT YOU?
This rule will only impact you if the FDA decides that there
are certain foods, when imported into the United States, that
pose a specific food safety risk to consumers. The FDA has
stated that they plan to use this authority minimally because
they have other authorities that they can use that essentially do
the same thing. They have import alert authority that allows
them to put countries, individual companies or individual
products on import alert for food safety issues. So, the FDA
only anticipates using this authority if they determine that the
foreign governments would not be able to handle a specific
food safety event in that country. A second reason that
FDA would require certification is if the importer wants to
participate in the Voluntary Qualified Importer Program.
In these two situations, the FDA would require certification
from an accredited third-party auditor. The proposed rule
the FDA has issued that outlines the third-party certification
program is directed at certification bodies, accreditation bodies
and audit companies. It also outlines the system that will be in
place to accredit the third-party auditors.
CONCERNS
This rule will only impact you if the FDA decides that there
are certain foods, when imported into the United States, that
pose a specific food safety risk to consumers. The FDA has
stated that they plan to use this authority minimally because
they have other authorities that they can use that essentially
do the same thing. They have import alert authority that allows
them to put countries, individual companies or individual
products on import alert for food safety issues. So, the FDA

only anticipates using this authority if they determine that
the foreign governments would not be able to handle a
specific food safety event in that country. A second reason that
FDA would require certification is if the importer wants to
participate in the Voluntary Qualified Importer Program.
In these two situations, the FDA would require certification
from an accredited third-party auditor. The proposed rule
the FDA has issued that outlines the third-party certification
program is directed at certification bodies, accreditation bodies
and audit companies. It also outlines the system that will be in
place to accredit the third-party auditors.
Conclusion
The proposed FSMA changes under consideration will impact
the seafood industry on many fronts, particularly when it
comes to importing products. Needless to say, the short and
long-term implications of these changes will present challenges
and struggles. And the complexity of these proposed changes
and their implications for the seafood industry serve to enhance
confusion and unease. While it is impossible to deny that these
changes will impact you and your business in some way, having
a better understanding of what these modifications mean will
allow you to better plan for the future and be in compliance if
and when they are initiated.
The FDA has numerous resources that will be helpful in
continuing these ongoing changes and challenges. For more
information about FSMA implications in the seafood industry,
visit: www.fda.gov/fsma.

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