Re: Docket No. FDA-2011-N-0146, Regulatory Information Number (RIN) 0910-AG66. Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
The Fresh Produce Association of the Americas (FPAA) appreciates the opportunity to submit comments on the Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party Auditor Rule). The FPAA represents U.S. companies involved in the growing, harvesting, and importation of fresh produce grown in Mexico and distributed throughout North America.
Because the proposed Accreditation of Third-Party Auditors/Certification Bodies rule will interact with all other proposed Food Safety Modernization Act (FSMA) rules, and because these regulations will impact the food industry for the foreseeable future, a single round of changes may not entirely reflect all necessary revisions for the proposed regulations. For these reasons, we support the request by the National Association of State Departments of Agriculture to issue a second draft of the rules implementing FSMA. We appreciate the FDA re-opening the comment period for certain provisions of the Produce Safety Rule and the Preventative Controls for Food Facilities Rule. However, in order to view all the proposed rules holistically, FPAA believes a second draft should be provided for all proposed rules, including the FSVP rule and the proposed rule for Accreditation of Third Party Auditors.
The FPAA joins many industry trade associations and the NASDA in working diligently through the proposed rules to provide meaningful comments. We are committed to making the regulations as effective as possible in advancing a strong national food safety program to implement FSMA. The FPAA has been a supporter of legislation to create a strong regulatory framework that would be science-based, commodity-specific and focus on the greatest public health priorities.
In working closely with many other industry groups and trade associations to analyze the proposed rules under FSMA, the FPAA has heard concerns regarding the complexity of the proposed rules, and whether some aspects of the regulations would truly enhance public health. In a case such as this –the most profound regulatory overhaul of food safety rules in some 70 years– it’s critical that FDA get this right. It is necessary for FDA to re-open the comment periods on all the previous proposed rules so as to be able to comment on the rules as a package. FDA made a commitment in numerous public hearings to allow stakeholders an opportunity to comment on the proposed rules as a package. We support this important commitment.
FPAA Supports the Appropriate Use of Accredited Third Party Auditors
The FPAA supports the use of third party auditors as a tool for ensuring and improving food safety practices. We emphasize that under FSMA the use of third party accredited auditors is for the purpose of VQIP certification and for mandatory (MIC) certification only. We support this approach and do not support mandatory accredited audit requirements for all foreign supplier verification under FSVP.
At the same time, we encourage FDA to continue to consider how to recognize the existing audit culture and practices used by foreign suppliers and importers of fresh produce from Mexico. For many years, our members have worked closely with growers in Mexico to meet U.S. requirements and the individual requirements of our customers across North America, Europe, and Asia. Audits are a common occurrence on farms in Mexico, and in addition to meeting customer requirements, growers work closely with third-party auditors to evaluate the efficacy of their internal food safety systems for their own business purposes. This partnership has led to continual improvement in food safety practices, and FDA should be mindful not to disrupt this positive food safety culture.
The FDA cannot logistically carry out audits for every company requesting or requiring one. The lack of staff, travel restrictions to certain countries and regions, and other issues necessitates reliance on f third-parties to perform audits. This also helps growers in developing nations, with limited government resources, to tap into a mechanism for improved food safety and increased trade to the United States.
We support measures to allow for regulatory audits by accredited third parties to be one option to comply with the Foreign Supplier Verification Program (FSVP). However, as we will discuss in our comments on FSVP, our position is that regulatory audits should not be a mandatory condition to meet requirements of FSVP.
FDA Should Not Collect Data without the Ability to Effectively Use the Data
An overarching concern regarding implementation of the third-party auditing and reporting to FDA is the agency’s ability to effectively and efficiently process the information it receives in a meaningful way and to tie that information into existing mechanisms, like the PREDICT system, to help FDA improve its risk-based targeting. Without a full integration of the FDA registration system, prior notice system, and PREDICT, FDA will continue to miss opportunities to better streamline data on individual companies exporting fresh produce to the United States.
As an example of the concern about agency coordination of data, in section 1.652(b)(9) of the proposed rule, FDA states that for a regulatory audit the report must include “whether an entity has issued a food safety-related recall of an article of food from the facility during the 2 years preceding the audit and, if so, any such article(s) recalled and the reason(s) for the recall(s).” When a company is in the unfortunate position to execute a recall, it requires close coordination with FDA and potential placement on Detention Without Physical Examination (DWPE). Removal from DWPE requires close coordination with FDA to identify and take corrective actions for any detected deficiencies before a company can resume shipments to the United States. Therefore, the requirement to report recent recall activities is redundant given that FDA should have full awareness of recall actions of a specific firm and given that FDA worked directly with the firm on analyzing and improving their food safety procedures.
Referencing the registration number and identifying facility information on an audit report should give FDA access to that company’s history, including recent recalls and removals from DWPE. In the Purpose and Description, FDA states “it may be relevant in helping us to determine whether to accept a certification or other assurance by an accredited auditor/certification body for purposes of admitting a food into the United States under section 801(q) of the FD&C Act. Recent food safety related recalls might call into question the reliability of food certifications issued to the facility.” Again, working through the recall and removal from DWPE process, FDA has a significant understanding of the processes and procedures of a given firm, and the concern is that FDA is not integrating information gained under FDA enforcement activities. The agency should be able to collect and effectively analyze the data for use in targeting risk. The requirement that an audit report include information on recent recalls would be unnecessary and redundant for something that FDA already has access to. In addition, an auditor is at a facility to perform an audit on the on-site conditions at that time, and the auditor will not necessarily have access to past recall activity for a firm.
Audit Reporting Directly to FDA Should be Limited in Scope
Currently, audit reports are used by a facility’s management team and food safety staff. Audit reports represent an opportunity to assess progress, recommend changes and execute improvements. Thus they play an important role in continuous improvement in a food facility.
However, as audits, especially consultative audits, become viewable or even required by the FDA, with all the potential repercussions that carries with it, the basic role of audits will change. Facilities will become leery of conducting audits with accredited third parties, with the possible unintended consequence that the detail and frequency of reports would begin to decrease, as well as the preventive benefits of the process. Rather than conducting audits for improvements in food production, the new goal would be to pass FDA inspection.
If the scope of audit access by FDA changes, the audit reports will focus on a company’s not calling attention to itself versus maintaining oversight of a facility and its processes. This means that another set of audits and reports outside of the third-party scope would be developed for the company to truly look for problems and opportunities for improvement. Audits by accredited bodies will become a formality and a whole new set of documents and processes will exist for internal viewing. This unintended duplication of processes is costly, and will be a significant economic burden on small- and medium-sized companies. And, most importantly, will not improve food safety practices.
When FSMA was written, the goal was to provide FDA with the capacity to leverage third party audits to help it control risk for imported food. FDA does not have the resources to inspect many foreign facilities. As FDA moves forward with these programs, it is very important to ensure that third party audits, whether consultative or regulatory, continue to encourage improvement in the system and do not result in an inadvertent backward step.
The FPAA position on 1.656(c), Notification to FDA of a serious risk to public health, is that the standard should mirror existing requirements under the Reportable Food Registry and should meet the criteria of a Class I recall. The FPAA can envision instances in which companies are implementing new equipment designs or practices and are working with a food safety auditor to examine the efficacy of the system and to make adjustments where necessary. If the eligible entity could show that, just like with the Reportable Food Registry, conditions are met that show no potentially adulterated product left the control of the eligible party, then immediate notification should not be necessary.
The FPAA is particularly concerned about mandatory audit reporting for consultative audits (instances where auditors are required to report to FDA if they encounter a possible serious risk to public health) given that there is no clear mechanism to appeal an audit and given that there is not enough clarity in the proposed rule as to what constitutes a condition that could cause a public health hazard.
Not all unannounced audits occur during peak harvest or packing season, and indeed activity on a farm can vary greatly depending on the day, and even hour, of the day. Because of this lack of consistency in timing or frequency of such audits, this may limit the value of a consultative audit within a regulatory scheme.
Additionally, auditor calibration is an ongoing process, and it is not unlikely that two auditors could visit the same facility and find different results. Inadvertent mistakes in an auditor’s report or in understanding what constitutes a possible risk to public health could cause a company loss of business, damage to brand equity, economic damage and more, simply because of a mistake in the audit or confusion about what constitutes a situation requiring immediate notification to FDA. The FPAA requests that FDA clarify 1.620(b) regarding conditions that could cause a risk to public health.
Furthermore, there is a potential for fraud and abuse. A consultative auditor conceivably could be bribed or coerced into providing a false or misleading audit, in order to provide a competitive advantage to companies other than the one undergoing said audit.
Simply put, and for all of the reasons above, a company cannot request an official appeal of a consultative audit, therefore a consultative audit should not be considered within a regulatory regime.
FDA Should Not Require that FDA be the First Party Notified of a “Serious Risk to Public Health” During Audit
The FDA proposes to require mandatory reporting by the auditor to the certification company “immediately upon discovering, during a food safety audit, any condition that could cause or contribute to a serious risk to the public health” (1.650(a)(5)) The FDA further explains that the accredited body must immediately notify FDA of the finding. In the discussion of proposed 1.656(c), the FDA proposes to require “an accredited auditor/certification body to notify us [FDA] of a serious risk to public health prior to notifying its client, the eligible entity…We believe this will help ensure that eligible entities are aware of the notification requirement and will help emphasize to the accredited auditors/certification bodies their obligation to notify FDA of such condition.”
1.656(c) Notification to FDA of a serious risk to public health. An accredited auditor/certification body must immediately notify FDA electronically, in English, when any of its audit agents or the accredited auditor/certification body itself, discovers any condition, found during a regulatory or consultative audit of an eligible entity, which could cause or contribute to a serious risk to the public health, providing the following information:
(1) The name and address of the eligible entity subject to the audit;
(2) The name and address of the facility where the condition was discovered (if different from that of the eligible entity) and, where applicable, the FDA registration number assigned to the facility under subpart H of this part; and
(3) The condition for which notification is submitted.
While the language in proposed regulation in 1.656(c) does not specifically state that the accredited auditor/certification body must report first to FDA before the eligible entity, the FPAA would have serious concerns about requiring notification to FDA prior to the eligible entity, as discussed in the description of the proposed rule. Fruits and vegetables are highly perishable, and as such what is harvested today will be sorted, packed, and shipped today. If an auditor discovers a condition which could cause or contribute to a serious risk to public health, the eligible entity must be notified without delay. However, if FDA requires notification first, an auditor might delay in reporting the finding to the eligible entity– until they can contact their company or certification body to report the finding to FDA and until they hear from the company that FDA has been notified.
If an audit is taking place in a remote location with poor communication infrastructure or happens outside of the normal office hours of a centralized office of the accredited auditor or certification body, then notification to the eligible entity could be delayed by 24-48 hours. The delay would also impact the eligible entity’s ability to begin measures to identify where product is in the supply chain that may have already left the facility that day or in prior days and to begin immediate consultation with their importers about a potentially serious issue. The FPAA does not believe that notifying the eligible entity immediately upon discovering a potentially serious problem would lessen the awareness of the requirement to notify FDA as well.
Again, the FPAA thanks the FDA for the opportunity to comment on these proposed regulations. Accreditation of third-party auditors is an important component of the FDA and industry’s ability to work together to minimize risk and to focus limited resources appropriately.
Please do not hesitate to contact me if I can provide any additional information or clarification.
Sincerely,
Lance Jungmeyer
President
Fresh Produce Association of the Americas
Source: Fresh Produce Association of the Americas
