FSMA: Better safe than sorry

by Lucy Sutton
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Undeniably, recent highly publicized outbreaks in several countries cast an all-too-bright spotlight onto food safety regulations. Authorities around the world realize that many challenges still must be overcome to ensure a safer food supply for everyone, and the US is no exception. Last year’s events changed the US regulatory landscape for good, and food processors will have to work diligently with authorities to comply and eventually lead the food production system to a better, safer place.

As an international food safety consultant, Rebeca López-García, PhD, has been bombarded with questions about the upcoming challenges in the regulatory environment. Principal of Logre International Food Science Consulting, Mexico City, Mexico, and a frequent contributor to Baking & Snack, Dr. López-García offered advice for dealing with some of those issues.

Baking & Snack: How has the regulatory landscape changed for the baking and snack industries?

Rebeca López-García: This past year, the regulatory landscape has changed dramatically in many areas. Of course, the most relevant change in the US is the Food Safety Modernization Act (FSMA). In reality, the core of the new law does not change basic good manufacturing practices (GMPs) and general preventive measures. The real change lies in the new enforcement and inspection authority conferred to the Food and Drug Administration (FDA).

According to FDA’s deputy commissioner for foods, Michael R. Taylor, “The new authorities give the food companies strong additional incentives for keeping their products safe, and that helps [FDA] achieve the new law’s goal, which is to protect consumers from unsafe food.” FSMA aims to bring food safety regulation in the US into the 21st century with a risk-prevention approach rather than a reactive model.

How has enactment of FSMA affected regulatory issues in North America so far?

It is unbelievable that a year has almost gone by since President Obama signed FSMA. This historic signature has changed the environment for the whole industry not only within the US but also at the international level.

According to a statement by FDA Commissioner Margaret A. Hamburg, the law directs the agency to oversee food safety in a way that applies “the best available science and good common sense to prevent the problems that can make people sick.” This does not sound new because the world should have been addressing food safety with science and common sense from the beginning. The real importance is that it provides FDA with new enforcement and inspection authorities. This is really quite crucial because in many countries, the regulatory framework is in place but it is the lack of enforcement capability that hampers success in protecting consumers.

What user fees might be imposed on domestic and/or international bakers and snack manufacturers, and how can they best avoid them?

FSMA does not require a registration fee. Also, there is no fee for an initial FDA inspection. There will, however, be a fee to cover reinspection-related costs when an initial inspection has identified certain food safety problems. Also, there will be fees associated with recalls.

The best way to avoid such fees is to comply with the requirements upon initial inspections and implement an adequate risk-based food safety control system that will enable your company to avoid a reinspection and, most importantly, a recall.

Fees will also be collected for administrative costs of the voluntary qualified importer program, for costs associated with issuing food export certifications and for costs of establishing and administering the third-party accreditation program. With the exception of food export certificates, the law requires FDA to publish a notice of any new fees in the Federal Register no later than 60 days before the start of each fiscal year.

On Aug. 1, FDA announced the fiscal year (FY) 2012 fee schedule for certain domestic and foreign facility reinspections, failure to comply with recall orders and certain importer reinspections. The fees apply only to those parties in the food and feed industry whose noncompliance results in FDA-conducted facility reinspections, recalls or follow-up inspections of a food offered for import after inspection found a problem materially related to food safety requirements. Reinspection must be conducted specifically to determine that compliance has been achieved.

According to information published by FDA, rates for FY 2012 are as follows: $224 an hour if no foreign travel is required and $325 an hour if foreign travel is required. These fees are effective Oct. 1, 2011, through Sept. 30, 2012. Payment must be made within 30 days of the invoice date, and any fee not paid within 30 days after it is due shall be treated as a claim of the US government. The fee schedule does not contain reduced fees for small businesses.

However, during FY 2012, FDA will consider waiving, in limited cases, some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation and other relevant factors. FDA intends to publish a guidance document covering this Economic Hardship Fee Reduction approach.

What documentation and/or monitoring will bakers and snack companies need to do in 2012 vs. what they presently do?

All facilities will have to go through the registration process with a biennial renewal. This requirement will contain an assurance that the Secretary of Health and Human Services will be permitted to inspect the facility.

In addition, FSMA establishes that the company must evaluate hazards that could affect food manufactured, processed, packed or held to identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and ensure the food is not adulterated.

For many companies that already implement a risk-based approach such as a hazard analysis critical control points (HACCP) system for managing food safety issues throughout their production system, the impact will not be great. However, US bakers were not required to apply HACCP, and; thus, this will present a new challenge.

The biggest challenge will be not only to comply with the paperwork but also to truly address the hazards with proper risk-management procedures. This requires experience and knowledge. Developing a plan may not be as complicated as actually implementing it properly while developing a new risk-management culture within the facility.

Facilities are required to maintain for not less than two years all records documenting the monitoring of the preventive controls, control of nonconformances, corrective actions and review of the efficacy of preventive controls and corrective actions as well as the written plan and documentation. Proper document control and record-keeping will be essential because the law expands FDA’s authority to gain access to records about potentially hazardous foods. In addition to examining records tied to a particular food that could pose a health hazard, the agency can now inspect records related to any other food it believes is likely to be affected in a similar manner.

The biggest challenge in managing food safety for many bakers will be to address contaminants that are not within their control. Cereal-based products will always be challenged by mycotoxin contamination because in most cases, once a product is contaminated, processing will not reduce contamination. Working closely with suppliers and making sure that the risk is managed throughout the production chain will remain a challenge for many bakers.

How likely is it that FDA will use its new mandatory recall power, and how can companies avoid it?

Although FDA now has more power and jurisdiction over mandating recalls, I believe in the past, the agency has done a good job of convincing companies to remove adulterated products from the market. At the international level, it is commonly believed that FDA has always had this authority. Thus, at the perception level, the new act has not changed reality. If FDA has more resources for inspection, it may be able to detect more issues than before, and the new recall power will help it stop products from entering the market.

Companies should always be prepared for a crisis. If they strive to comply with the new risk-management approach to preventing food safety incidents, they will be better prepared to avoid a crisis. But if a crisis strikes, companies should be prepared, follow their procedures, communicate and, most importantly, work hand-in-hand with the authorities to ensure consumer protection. This approach will also protect their products, their brand and their reputation. Ideally, a company should come back from a crisis stronger and better positioned to supply safe wholesome foods.

How has the science of food safety changed over the years? How much more effectively can agencies pinpoint the sources of a recall vs. several years ago and why?

The major change I see is that now there is a lot more awareness regarding the importance of taking a risk-based approach to the management of food safety. It is true that today’s better analytical techniques enable agencies to pinpoint the sources of contamination, but this is useless if there is no evolution in the way we manage food safety. The shift from reactive to preventive programs is definitely happening throughout the world, but it will take time to really create a better food safety culture.

What differences do US bakers have to navigate for domestic distribution vs. international?

Domestic distributors have to adapt to the new dispositions of FSMA. If they import products from international markets, they will have to comply with the requirement of ensuring that the sources are properly inspected and follow adequate risk-management practices.

International distributors now face new opportunities in the European market. In addition, bakers who export to Mexico had to adapt to that country’s new labeling requirements published in 2010 for which enforcement began in 2011.

In addition, the Global Food Safety Initiative (GFSI) and other certification standards such as British Retail Consortium (BRC) keep gaining momentum in the international market.

How does FSMA affect companies that import products to US markets from Canada, Mexico or elsewhere?

For many companies that now successfully import from Canada and Mexico, it will only be a matter of adapting their paperwork and complying with the inspection requirements since many of these companies have already established risk-based food safety management systems. The new requirements may be more difficult for smaller businesses that are trying to enter the market because they will have to upgrade their systems to comply and prepare themselves for inspection. David Elder, director of FDA’s Office of Regulatory Operations, said, “For imported foods, the primary difference under the new law is that, for the first time, importers will be specifically required to have a program to verify that the food products they are bringing into the country are safe.”

Another hurdle will be to identify qualified third-party auditors who participate in the FDA accreditation program and obtain the correct information verifying this. In many developing countries, it will be important to provide the most accurate information to exporting companies and avoid less-than-scrupulous companies that may try to take advantage of the lack of information and misguide companies into paying fees that are not required or obtaining certification that is not acknowledged by FDA.

My recommendation to companies in other countries is to try to get firsthand information from FDA. According to information from FDA, the international program has logged nearly 75,000 hits to its Web pages on the new food safety law as foreign companies that export food to the US scramble to learn how the law affects them. Many of the outreach materials have been translated into multiple languages to help communicate the new requirements. FDA has also defined the need for International Capacity Building to help exporters in different countries comply with the new provisions.

How does it affect companies that import ingredients? What sort of documentation or certificates of third-party certification do they need from their suppliers? What effects do the traceability measures specified by FSMA have on the international marketplace?

Importers may apply for the voluntary qualified importer program. An importer who intends to participate in the program will have to submit an application. The eligibility will be limited to importers offering food for importation from facilities that have been properly certified, and the Secretary of Health and Human Services will consider the risk of the food based on factors such as:

  • The known safety risks of the food to be imported
  • The compliance history of foreign suppliers used by the importer, as appropriate
  • The capability of the regulatory system of the country of export to ensure compliance with US food safety standards for a designated food
  • The compliance of the importer with the requirements of Section 805 of FSMA
  • The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls and sourcing practices of the importer
  • The potential risk for intentional adulteration of the food
  • Any other factor that the secretary determines appropriate.

Proper traceability and crisis management are still challenging for both domestic and international producers. This challenge must continue to be addressed to properly build capacity. Most successful exporting companies have implemented traceability based on the requirements of many high-value markets and, in many cases, contractual obligations with their major customers. Traceability should not be considered a burden; it is a tool to accurately determine the food linked to an outbreak and control the damage as effectively as possible. Proper crisis preparation and management are  good business practices that protect the brand and the company’s future, now they will also be a regulatory requirement.

According to the text of the law, nothing in the act (or an amendment made to the act) shall be construed in a manner inconsistent with the agreement established with the World Trade Organization or any other treaty or international agreement to which the US is a party.

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