Issues: Food Safety

FDA Comments May 16 2008

PMA Comments to FDA on USDA on Third-party Certification Programs for Foods and Feeds

May 16, 2008

To: U.S. Food and Drug Administration/Center for Food Safety and Applied Nutrition, http://www.regulations.gov

Subject: Third-party Certification Programs for Foods and Feeds: Request for Comments

Docket Number – FDA-2008-N-0183

The Produce Marketing Association (PMA) is pleased to submit these comments to U.S. Food and Drug Administration (FDA) regarding the agency’s request for comments on third-party certification programs for foods and feeds.

PMA is the largest global not-for-profit trade association representing companies that market fresh fruits and vegetables. Our 2,200 members range from grower-shippers and supermarket retailers, to hotel and restaurant chains and overseas importers. Within the United States, PMA members handle more than 90% of fresh produce sold at the consumer level. PMA and its members are committed to improving food safety practices for produce, both domestic and imported, to further enhance the safety of our food supply.

We have been actively engaged in produce industry development and implementation of food safety practices and have worked closely with FDA, USDA, and other state and local agencies as a source of industry information, as a source of technical inputs, and as a supporter of the agencies in assuring public health. In developing our response on this issue, we incorporated comments and thoughts from our Chief Science Officer, Dr. Robert Whitaker.

Dr. Whitaker has been in the produce industry working in food safety for many years and has used third-party services domestically and internationally. He has extensive experience working for a produce company that exported produce to Europe and possesses keen familiarity with the practices of the certified third parties identified in the agency’s notice.

From a produce perspective, we would hope FDA would move to establish, or partner to create, a globally recognized food safety standard that incorporates the years of effort the produce industry has expended on the development of commodity-specific food safety programs, is based on best current science, and is grounded on the principals of risk assessment and risk management.

We support the certification of third parties to perform audits against this standard. The produce industry has a long history of using third parties to verify food safety practices in the U.S. and elsewhere, so the concept is not, of itself, problematic. If an FDA third-party certification program is done correctly, it could result in multiple certified third parties for suppliers to choose from creating competition that should stabilize auditing costs and incentivize auditors toward continuous performance improvement for the industry.

1. What domestic and foreign third-party certification programs for suppliers are currently in use by U.S. companies?

The produce industry long has used third-party auditors to verify individual producer food safety programs. For the most part, these third-party companies began operations in response to the explosion of packaged fruit and vegetable products in the early 1990s and industry realization that food safety was an important component of business operations. For the first time, the industry had to create food safety programs and needed consultation and auditing bodies to provide verification. This was augmented by the simultaneous development of Good Agricultural Practices (GAPs) in the mid-1990s and reinforced by FDA’s 1998 Guidance on GAPs. Industry needed to verify food safety practices were being followed and to report to producing companies and buyers tangible evidence of adherence and measured improvement.

Many third-party auditing companies sprang up or moved to a produce focus to meet this growing demand including: Primuslabs.com, Davis Fresh Technologies, Cook & Thurber, Scientific Certification Systems, AIB International, SGS, Silliker, etc. These companies perform GAP ranch, harvest, packinghouse and cooling/distribution audits as well as GMP/HACCP audits for processing/manufacturing operations. They are fee-for-service operations. Some also consult with a client to help train employees or develop food safety programs.

In the 1990s there was no real distinction within these third-party companies between third-party representatives who would consult with a supplier to help build a food safety program and then audit that company as the food safety program was implemented. In the last several years, most third-party operators have separated the consulting piece of their business from the auditing function to remove the apparent conflict of interest.

It is important to note however, that in the early days of building, developing, and evolving food safety programs in the produce industry, the consulting portion of the third-party interaction with growers, harvesters, and processors was critically important. The third parties represented a skill and knowledge base that was largely lacking in the produce industry, i.e. scientific and technical knowledge regarding food safety. This was a new area for the produce industry and many companies simply did not have the scientific sophistication and technical knowledge to build and implement these programs and therefore relied upon third parties to help them improve the safety of their products.

The third-party auditors mentioned here are largely U.S.-based, but many also have operations in Canada, Mexico, Central and South America. The GAP audits are largely based on the 1998 FDA guidance document with updates or revisions based on the evolution of GAPs, e.g. commodity-specific guidance (tomato, melons, and lettuce) and more recently leafy greens GAP metrics from California. For the most part, these GAP audits are uniform and consistent among auditing companies; 90% of the core questions are virtually identical and based on FDA guidance. It should be noted that pesticides and pesticide use is dealt with by local, state, and federal Environmental Protection Agency requirements.

The buying community has often contracted with selected third parties to develop proprietary GAP audits that are performed at the cost of the supplier by the third party for the buyer. These very often include add-on sections that the buyer feels are important to food safety and may include: biosecurity, product testing, ethical practices, environmental/sustainability issues, etc. The root cause of confusion and frustration by produce suppliers is these add-on areas and buyer requirements that suppliers use a specific auditing company or narrow selection of auditing companies. Often a single supplier may be asked to have GAP audits performed on ranches and harvest operations and cooling and packing operations by several customers resulting in three to five third parties having to essentially repeat the same audits over the course of the year causing redundancy and extra costs.

Some U.S.-based third-party auditors have strong certification programs. The market leaders have recognized the need to take their programs to accrediting bodies for review. ANSI and ISO have been employed. Some use outside parties to perform quality control on audits, and they track individual auditor performance for consistency. Until very recently, the marketplace has not demanded that suppliers use certified auditors and accredited standards in the U.S. There is a marked difference between U.S. and Europe and other regions in that in the U.S., the FDA, USDA, and EPA and the corollary state agencies have de facto set the standards through guidance and statutes. This type of leadership in food safety is not present in Europe or elsewhere, hence the emergence of an accreditation body like the Global Food Safety Initiative (GFSI) and certified auditors in Europe. With the move to a global marketplace and with retailers operating on a global stage, the focus has very recently moved to global certification.

Companies that export produce to Europe have also contracted to perform third-party audits originating in Europe. GlobalGAP (formerly EUREPGAP) is the most common of these. GlobalGAP is certified by GFSI. Until very recently, the audit was strongly tilted to pesticide use and chemical safety with very little emphasis on microbial food safety. Recently, ethical practices and social responsibility along with microbial elements have also been included. Exporting produce companies have been undergoing these audits since the late 1990s. At first it was difficult to find U.S. or North American third-party auditors that were certified to perform the audits. In more recent times, several of the U.S. third parties have become certified to perform these audits as the market demand increased. Other GFSI certified standards and audits have been largely absent from the U.S. BRC, SQF, and Dutch HACCP food safety audits are rarely used in the U.S. produce industry.

It is interesting to note that despite the European focus on accredited standards and certified audits, the major retailers there have begun to build proprietary food safety/ethical practices/environmental sustainability audits as evidenced by Tesco and Marks & Spenser’s branded audits. Some U.S. third parties have been certified to perform these audits.

2. Do the current third-party certification programs ensure compliance with FDA requirements?

For the most part U.S. third-party certification programs are built upon FDA guidance (GAP and processing HACCP), GMPs, EPA statutes on chemical use and other pertinent U.S. federal, state, and local regulations regarding labor, etc. The marketplace, via competition and the evolution of the understanding and implementation of food safety practices, has settled the core emphasis of these audits with the exception noted in question one above regarding proprietary audits developed by specific buyers. What is lacking in the U.S. is a formal statement or representation that the body of work developed by the produce industry and the FDA, EPA, USDA and others over the last several years is a de facto standard.

In the absence of this type of effort, the produce industry is left to a fragmented and conflicting approach of being required to follow or use FDA, EPA, or USDA guidance and laws while also bending to the multilayered demands of the buying sector, which includes globally recognized certification programs.

Given the reality that a great deal of produce is imported into the United States each year from around the world, it would make sense for FDA to become an accrediting body that could certify various food safety standards and third-party auditing entities on a global basis.

This might resemble the USDA’s National Organic Program (NOP) where the department essentially acts as the accreditor or standard holder that certifies third parties to audit and certify producers, etc. In this way, FDA could certify both U.S. and international third parties to perform audits to U.S. food safety standards and bring consistency to the level of food safety practices. This may alleviate FDA’s shortage of inspectors in countries around the world, at import locations, and domestically.

Alternatively, FDA could seek to align itself with an existing global accreditor, e.g. GFSI, and use that alliance to create a global standard that could be used as a basis to certify third-party auditors globally. In this instance it is critical that FDA take great care to choose carefully and engage industry experts in the process. The U.S. has a number of checks and balances already in place that do not exist elsewhere (EPA, USDA, FDA, state, local agencies) and individual produce companies via industry groups (California leafy greens, Florida Tomato, California Tomato Board, California Melon Board, etc.). In addition, private entities have been aggressively pursuing food safety and developing equity in programs (documentation, data handling, audits, etc.) that are well-established. It is equally important that any global approach be science- and risk-based with emphasis on commodity-specific approaches.

Regardless of approach, the U.S. produce industry is best served by having multiple third-party auditors that can be certified based on their ability to audit to an accredited standard. This promotes competition which can directly improve competency and control costs while providing produce suppliers with the ability to continue with historical third-party relationships and choices of service providers.

3. What are the obstacles to private sector participation in these third-party certification programs?

The produce industry has a long history of using third-parties to perform food safety audits. For the U.S. produce industry this would not be unique or new. The produce industry has historically been motivated to use third parties to audit food safety status by a desire to verify adherence to individual corporate programs using a trained, external expert or to meet buyer-specified requirements. Historically, and like any business sector, there have been outstanding third-party service providers with organized, science-based approaches and trained inspectors and those that are less competent. This has created a confidence crisis on occasion and a lack of confidence in the buying community. There is value in FDA having a mechanism to certify third parties:

It would provide a stamp of approval for that auditing company verifying that it is auditing to an approved standard and that it is using certified procedures, trained auditors, and evaluation practices that ensure consistency.
It would likely force the elimination of the conflict of interest issues and precipitate separation of third-party technical consulting activities from audit and inspection activities.
It would create a process whereby third parties could gain credibility in the eyes of suppliers and buyers and hopefully lead to buyers opening up auditor options to any FDA-certified auditing company or agency thereby giving suppliers and others in the supply chain choices of vendors.
It would create an environment where imported products and domestic products would need to meet the same food safety benchmarks with a net effect of improving public safety.

4. What incentives would increase participation in these third-party certification programs?

The FDA can certainly take steps to encourage participation in third-party certification programs:

As suggested by the agency, expedited treatment at ports of entry could be a strong incentive. Produce is highly perishable and quality at consumption points is critical. The use of third-party certification to improve clearance at import and thereby get the products into distribution faster and subsequently open up that saved time as shelf life for the product at distribution points is advantageous.
The publication of globally certified third-party providers may not necessarily encourage their use, but it would be a tremendous resource for suppliers and buyers as they source or produce in new areas, permitting immediate access to resources to perform audit services.
There is no doubt that as FDA moves to a risk-based inspection, the use of third parties could act as an incentive to ease import issues and create efficiencies.
Domestically, the use of FDA certified third-party auditors would gain acceptance by producers simply because producers would gain security in knowing that everyone is playing on a level playing field. It may serve to alleviate the frustration, real or perceived, over the feeling that not everyone is required to follow the same rules.

Ultimately, the greatest incentive to use the third-party program can be leveraged by the produce buying community. By simply requiring suppliers to use FDA-certified third parties for food safety audits domestically and internationally, buyers can set the process in place. For this reason, it is absolutely critical that as FDA moves forward with the third-party certification efforts, the agency engages the produce industry across the supply chain for input. If constructed correctly, the third-party certification program can meet the produce industry’s needs (potentially reduce current audit overload, provide multiple certified auditing entities, improve auditor competency, contain costs, and ensure standards are risk and science-based). At the same time it would address key FDA issues by providing for global audit presence through third parties, easing import logistical issues, permitting a risk-based inspection process, and establishing criteria to better focus domestic third-party inspection. Of course, the system will also address the industry’s and FDA’s over-arching objective of improving produce food safety.

Thank you for this opportunity to present our views. We look forward to working with the agency on this important issue and welcome any questions or opportunities for dialogue.

Dr. Robert J. Whitaker, Ph.D.

Chief Science Officer

Produce Marketing Association