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:

http://www.seafoodsource.com

http://www.junctionsolutions.com/


How FSMA changesWill 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


IntroductionIn 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 importsFSMA 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 dietarysupplements?

Are you a very smallimporter 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 acidcanned 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 OPTIONSThe 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.

Phot

o co

urte

sy o

f OO

CL





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:

For hazards controlledby foreign supplier that

could cause serious adverseconsequences 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?

For hazards controlled 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 differencesThe 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”:

•Toprovide“adequateassurances”productsareprocessedwith “at least the same level of public health protection” as FSMA preventive controls regulations

•Developedbytrainedindividual

¨ 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

•Onsiteauditingofforeignsupplier

•Periodicorlot-by-lotsamplingandtesting

•Periodicreviewofforeignsupplierfoodsafetyrecords

•Otherappropriaterisk-basedprocedures

FSVP

¨ Conduct verification activities

•Notproposed,butimplied

•Notproposed

SEAFOOD HACCP

¨ Develop and follow written Import Verification Procedures:

•Toensureproductprocessedinaccordance with requirements of 21 CFR 123

•Notrainingrequirement

¨ 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:

•Regularlyinspectingforeignsupplier

•Periodicallytestproductandwrittenguarantee

•ObtaincopiesofHACCPandsanitationmonitoringrecords

•Otherappropriateactivities

IMPORT VERIFICATION

¨ Conduct affirmative steps

•Continuingorlot-by-lotcertificatefromforeign government or third party

For a quick reference, below is a table with these key parallels.





Three steps to prepare for the futureBecause 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

OVERVIEWThis 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.

CONCERNSThis 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.

ConclusionThe 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.



how fsma changes_will_impact_ the_seafood_ business

Documents

fsma changes

key changes

proposed changes

seafood business introduction

seafood importers

distributors of seafood

percent of seafood

seafood businesses