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Food Importers and Manufacturers – New Regulations and Compliance Standards You Should Know About 4/8/2011

food importer regulationsIn January, the Food Safety Modernization Act was signed into law and the FDA is currently working its way through the implementation process. Perhaps the most groundbreaking part of this law is the requirement for food producers and manufacturers and processors to verify and certify their suppliers’ food safety processes.

Why start worrying about imported food and ingredients now? Over the last decade, more and more food has become available on America’s shelves and a good amount of it is imported; 15% of food to be exact. Certain foods have much higher percentages; such as 75% of seafood, 20% of vegetables and 50% of all fruits are imported. The FDA however, hasn’t had the bandwidth or the manpower to inspect more than 1 percent of all the imported food in most recent years.

What does this mean for food manufacturers and producers with international supply chains, from say, China? The new law places the responsibility on the business owners to verify and certify that their international suppliers are complying with the standards set by the FDA in the U.S. The goal of the FSMA is to ensure that imported food is just as safe as the food that is produced domestically and will require a great deal of cooperation and partnership from many different countries and agencies.

What is compliance and how do businesses become certified? At this point, the FDA is still creating the guidelines for how to become certified. However, food safety experts have suggested implementing a preventative, risk-based plan like HACCP. Although the FSMA rules will require actions beyond having a solid HACCP plan, it is said to be a great starting point for companies working towards future compliance.

Industry experts also suggest that as companies prepare for compliance, they should undergo a “gap analysis” to locate weaknesses and shortcomings in their food safety plans. With the results from the gap analysis, companies will then be able to address the issues before an FDA inspection, which when paired with a HACCP plan can help expedite the process for compliance.

The FDA must accomplish the following tasks by the indicated dates: (taken from the FDA’s website)

– Preventive Controls for Facilities – June 2012

– Produce Safety Standards – January 2013

Inspection, Compliance & Response

– Rules and Process for Administrative Detention – May 2011

– Recall Authority (May be mandated only by the Commissioner of the FDA or the Secretary for Health and Human Services) – Currently Active

– Suspension of Registration Regulations – May 2011

Imports

– Foreign Supplier Verification Program Guidance – January 2012

– Accredited Third-Party Certification Program – January 2013

– Mandatory Certification for High Risk Foods – Currently Active (but the definition of “high risk foods” is still in development)

The latest update in FSMA:

As the first big accomplishment of the Food Safety Modernization Act,  the FDA has released a user-friendly food recall database. The database is an easier way to allow consumers to access up-to-date information regarding current and past food safety scares. The database provides information sorted by type, such as food, drugs, animal health etc., but can also be searched by date, food type, or brand. If available, the product labels will be posted as well. This new database is one step in the long process of the food safety act’s implementation that will help create better communication between the governmental agencies and consumers.

You can also sign up for daily or weekly updates that deliver the most recent recalls directly to your inbox.

The database can be viewed and searched here: http://www.fda.gov/Safety/Recalls/default.htm

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Food Safety Modernization Act : The Breakdown (Part 3 – The Next Steps) 3/24/2011

Food Safety Modernization Act - FDAManufacturers and importers must move forward with this information and start making decisions.

What Next?:

-Any real certifications will most likely not happen for at least 12 months or more… “Implementing this law will require over a dozen separate rulemakings and at least 10 guidance documents. The implementation of the legislation will take more than three years.” Source

-Importers will be in the process of setting up their verification system, but the exact rules and requirements of certification are in progress.

-Businesses in the food industry are urged to start thinking about what this means for them and begin preparing for more strict inspections and regulations.

Q: Why do I need to act now if it will take the FDA a few years to write any new rules?

A: Reviewing your company’s food-safety, record-keeping and product-tracking procedures can lead to performance improvements and innovation. By being in the forefront of efforts to improve food safety and providing credible information to regulators and consumers, companies can not only get a leg up on the competition, but begin marketing their food safety practices to the public.

Within one and a half years, all registered facilities will be required to conduct a hazard analysis, implement preventive controls and develop a food safety plan to document the monitoring, correction, and verification of preventive controls. The food safety plan and all related documents must be made available to FDA during inspections. As part of its food safety plan, a facility may be required to document sanitation procedures, a recall plan, a food allergen control program, supplier verification activities, and environmental sampling testing. Plans such as these take time to create and implement; it is never too early to be safe.

In preparation for the FDA audits, our partner company FactoryAudits.com offers comprehensive Food Safety Assessments that analyze your facilities’ HACCP plan implementation, chemical control processes, pest control processes, sanitation risks and hazards and much more.

Keep checking back with us as we will continue to post about the progression of this Act.

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Food Safety Modernization Act : The Breakdown (Part 2 – The Impact) 3/24/2011

Did you miss Part One?… Food Safety Modernization Act: The Breakdown (Part 1 – The Facts)

Now that we have the background of the law covered, let’s dive into what this means to us and how it can impact our food sources and supply chains.

How will this law make imported food safer?

New authorities under the Act include:

  • Importer Accountability Importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety.
  • Third Party Certification – The FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with US food safety standards. In preparation for the FDA audits, our partner company FactoryAudits.com offers comprehensive Food Safety Assessments that analyze your facilities’ HACCP plan implementation, chemical control processes, pest control processes, sanitation risks and hazards and much more.
  • High Risk Foods – The FDA now has the authority to require that high-risk imported foods be accompanied by a credible third-party certification as a condition of admission into this country .
  • Additional resources – Foreign inspections will receive additional resources to complete necessary inspections.
  • Food Refusals The FDA now has the authority to refuse entry into the US of a food that has refused or failed U.S. inspection.

What is required to become a certified facility?

  • The FDA is in the process of developing a proposed rule that will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and will address soil amendments, worker health and hygiene, packaging, temperature controls, water, and other issues.
  • Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls, and specify the corrective actions the facility will take when necessary. Don’t get caught unprepared: these seafood processors were not following the food safety rules and now they are warned and red flagged to clean up their act.

The time line is dated from the date of the enactment (January 2011). The following items are to be completed by the FDA no later than the corresponding times. (According to the law at this point in time.)

FSMA Timeline

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Food Safety Modernization Act : The Breakdown (Part 1 – The Facts) 3/24/2011

food safety modernization actAs the Food Safety Modernization Act starts working its way through the implementation process, I thought it would be most helpful to post a breakdown of the act and what it means to importers and manufacturers of consumable products. As you will see, the Act is very new, but will definitely have a large impact on the regulations of the food industry and hence, the level of  security in our food safety system. Read on for more details.

Note: There are two more parts in this series to come!

S. 510 FDA – Food Safety Modernization Act (FSMA)

Background

  • U.S. consumers enjoy imported foods from more than 150 countries.
  • Previous food safety laws did not provide the FDA with necessary funding/staffing to properly regulate and inspect America’s food supply.
    -Less than two percent of all imported food was inspected in 2010. The latest food safety scare in China involves tainted pork, read the article here.
    -Approximately 600 foreign food facilities were inspected in 2010.
  • The U.S. Centers for Disease Control and Prevention estimate that there are approximately 76 million foodborne illnesses each year in the U.S.
    -Those illnesses cause more than 300,000 hospitalizations and 5,000 deaths annually.
    -Those illnesses also cost the country $152 billion annually.

The Approval of the New FSMA Law: December 2010

  • The 2010 Food Safety Modernization Act passed the Senate and the House last winter and was signed into law by President Obama on December 22, 2010.
  • The new law is considered the biggest change in food safety oversight in 70 years.
  • The two main outcomes of the law are as follows:
    1. The FDA will be allowed to force companies to issue recalls when they suspect food may be contaminated. (Activated Now)
    2. The law greatly increases the FDA’s ability to perform inspections on both foreign and domestic manufacturing facilities.

Food Safety Modernization Act Overview

What are the 5 major elements of the law?

  1. Preventive controls- For the first time, the FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.
  2. Inspection and Compliance- The law specifies how often FDA should inspect food producers.  FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
  3. Imported Food Safety- For the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
  4. Response- For the first time, the FDA will have mandatory recall authority for all food products.  FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors the requests for voluntary recalls.
  5. Enhanced Partnerships- The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals.

FSMA By the Numbers

Cost: $1.4 Billion – over next 4 years

Necessary Staffing: Over the next 4 years, the FDA will be hiring 2,000 new inspectors.

Inspection Schedule: The bill requires the inspection of 50,000 foreign and domestic food production facilities by 2015.

  • Inspections are to be completed by either the FDA or state, federal or local agencies acting on the FDA’s behalf.
  • Projected Foreign Facility Inspection Breakdown by Year:
    2011
    : 600 inspections
    2012
    : 1200 inspections
    2013
    : 2400 inspections
    2014
    : 4800 inspections
    2015
    : 9600 inspections

For your reference, you can read the full text of the act here.

Read part two of the series: Food Safety Modernization Act: The Breakdown (Part 2 – The Impact)

and part 3 of the series: Food Safety Modernization Act: The Breakdown (Part 3 – The Next Steps)

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